Articles, News and Tweets

Articles and Tweets

1. UPDATE 1-Glaxo fires off 30-page rebuttal of Avandia claims (Reuters) ReutersAn excerpt from the article states that "Rejects allegations of concealing safety information * Says Senate report improperly casts Avandia as unsafe(Adds detail on Glaxo report, quotes) LONDON, Feb 24 (Reuters) - GlaxoSmithKline (GSK.L) stepped up the defence of its diabetes drug Avandia on Wednesday with a detailed 30-page response rejecting a critical report by U.S. lawmakers. The drugmaker said the Senate finance committee report did not present "an accurate, balanced, or complete view" of information about the drug and the company rejected allegations it had concealed safety data (link.reuters.com/bar62j). A spokeswoman for Glaxo, which issued a press release on Feb. 20 rejecting the committee's conclusion that Avandia was unsafe, said the lengthy "white paper" was the company's official response.” ....keywords: avandia, heart problems, heart attack, bone fracture-
   For more on Avandia, see Avandia at Legal Sleuth® or Avandia at Gooch Law Firm

2. A Face-Off on the Safety of a Drug for Diabetes (NY Times) NY TimesAn excerpt from the article states that "Three years ago, Dr. Steven E. Nissen, a cardiologist at the Cleveland Clinic, conducted a landmark study that suggested that the best-selling diabetes drug Avandia raised the risk of heart attacks. The study led to a Congressional inquiry, stringent safety warnings, a sharp drop in the drug’s sales and a plunge in the share price of GlaxoSmithKline, Avandia’s maker. The battle between Dr. Nissen and GlaxoSmithKline was waged from afar in news releases and published papers. But on May 10, 2007, 11 days before Dr. Nissen’s study was published in The New England Journal of Medicine, he and four company executives met face to face in a private meeting whose details have not been disclosed until now. Fearing he would face pressure and criticism from executives, Dr. Nissen secretly recorded the meeting — which is legal in Ohio as long as one party to the conversation is aware of the taping. On a recent day in his sunny office at the Cleveland Clinic, Dr. Nissen shared the contents of the recording with The Times. What was said at the 2007 meeting raises questions about science and ethics that have suddenly become keenly relevant. A Congressional investigation released Saturday concluded that GlaxoSmithKline had threatened scientists who tried to point out Avandia’s risks, and internal memorandums from the Food and Drug Administration show that some government health officials want Avandia withdrawn. The drug is still being taken by hundreds of thousands of patients, and sales last year were $1.19 billion. ” ....keywords: avandia, heart problems, heart attack, bone fracture-
   For more on Avandia, see Avandia at Legal Sleuth® or Avandia at Gooch Law Firm

3. Toyota Slapped with Subpoenas for Documents Related to Brake, Acceleration Problems (Fox) FoxAn excerpt from the article states that "Federal prosecutors have opened a criminal investigation into Toyota's safety problems, the company acknowledged Monday as it prepared to answer questions on Capitol Hill about its widespread vehicle recalls. The Japanese automaker said it received a subpoena from a federal grand jury in New York seeking documents related to unintended acceleration in its vehicles and the braking system of its Prius hybrid. Toyota also said it received a subpoena and a voluntary document request from the Los Angeles office of the U.S. Securities and Exchange Commission. The SEC is seeking documents related to unintended acceleration as well as to its disclosure policies and practices, Toyota said. The subpoenas are the latest demand for documentation from Toyota Motor Corp. Over the weekend, the company turned over documents to congressional investigators, with some boasting it saved money by obtaining a limited recall from regulators in 2007. The documents could create a big challenge for Toyota President Akio Toyoda, who is scheduled to testify at a House Oversight and Government Reform Committee on Wednesday. Two House committees are holding hearings this week on the Japanese automaker's recall of 8.5 million vehicles since the fall to deal with safety problems involving gas pedals, floor mats and brakes.” ....

4. Mom's antidepressants may delay baby's first steps (Reuters) ReutersAn excerpt from the article states that "When pregnant women take antidepressants, it sometimes causes their babies to hit developmental milestones late, Danish researchers reported on Monday. However, the delays--up to one month--still place the toddlers within the normal range of development. "These drugs have an effect on the fetus' brain," said Dr. Lars Henning Pedersen, who worked on the study. But, he said, the delays "may not matter for the child at all." Pedersen, from Aarhus University Hospital in Denmark, spoke to Reuters Health in a telephone interview. Today, as many as one in six pregnant women in the US are diagnosed with major depressive disorder, and most are treated with antidepressants such as Prozac, Zoloft or Paxil. The brain chemical targeted by these drugs--called serotonin--is involved in a host of biologic functions, from mood, to attention, to appetite and general brain development. While medicines that ratchet up serotonin levels help dampen depressive symptoms, it is not well understood how a human fetus reacts to such drugs, or how long their potential effects last. In the lab, for example, scientists have found that antidepressants given to a pregnant rat stifle the natural exploratory behavior of her offspring well into adulthood. For their study, published in the journal Pediatrics, Pedersen and his colleagues tapped into a nation-wide Danish database of more than 100,000 pregnancies. They identified some 400 women who took antidepressants during pregnancy as well as nearly 500 who were not on medication despite being depressed. Based on the women's own reports, the researchers then compared how many children in each group hit developmental milestones such as sitting without support, looking after sounds and venting irritation.” ....keywords: paxil, birth defects, birth injuries, septal defect, septal heart defect, pphn, Persistent Pulmonary Hypertension of Newborn (PPHN) -
   For more on paxil, see Paxil or PPHN at Legal Sleuth® or Paxil or PPHN at Gooch Law Firm

5. Senate report: Avandia maker knew of cardiac risks (AP) APAn excerpt from the article states that "A Senate report said Saturday that drug maker GlaxoSmithKline knew of possible heart attack risks tied to Avandia, its diabetes medication, years before such evidence became public. Sen. Max Baucus, chairman of the Senate Finance Committee, and Chuck Grassley, the committee's ranking Republican, released the report, which follows a two-year inquiry, on Saturday. They are also asking the U.S. Food and Drug Administration why it allowed a clinical trial of Avandia to continue even after the agency estimated that the drug caused 83,000 heart attacks between 1999 and 2007. The agency ordered a warning to be included on Avandia's label in 2007, saying that it might increase the risk of heart attacks, though the data on those risk was inconclusive. Soon afterwards Sen. Grassley, one of the FDA's toughest critics in Congress, disclosed that the agency's internal safety experts came within one vote of recommending a withdrawal of Avandia. The Senate report suggests sharp disagreements remain at the FDA over how to handle Avandia's risks.” .... keywords: avandia, heart problems, heart attack, bone fracture-
   For more on Avandia, see Avandia at Legal Sleuth® or Avandia at Gooch Law Firm

6. Glaxo to remove zinc from denture cream (Projo.com) ProjoAn excerpt from the article states that "The maker of Poligrip denture cream will stop making formulas containing zinc amid lawsuits claiming years of excessive use caused neurological damage and blood problems in consumers, allegedly crippling some. GlaxoSmithKline will stop making and marketing Super Poligrip Original, Ultra Fresh and Extra Care products in the U.S. The company plans to reformulate the creams without zinc. The company, based in London, reported more than $520 million in denture adhesive sales last year. It stressed that the products are safe when used as directed, but that some people use extra cream to correct ill-fitting dentures. Glaxo's voluntary action comes as hundreds of lawsuits are poised to go to trial, alleging Poligrip caused nerve damage, leading to a loss of balance, loss of sensation in the hands and feet, and leaving some patients paralyzed. "They made the right decision in the sense that it's going to prevent the crippling of more people," said attorney Andy Alonso of Parker Waichman Alonso LLP. "But it's too late for many of my clients." Alonso represents more than a hundred users of denture cream in Miami federal court, where several hundred lawsuits are being consolidated. The plaintiffs say the makers of zinc-based creams failed to warn consumers about potential risks. Alonso estimates about 30 million people in the U.S. wear dentures and use products like Poligrip..” ....

7. Controversial Diabetes Drug Harms Heart, U.S. Concludes (NY Times) NY TimesAn excerpt from the article states that "Hundreds of people taking Avandia, a controversial diabetes medicine, needlessly suffer heart attacks and heart failure each month, according to confidential government reports that recommend the drug be removed from the market. The reports, obtained by The New York Times, say that if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month because Avandia can hurt the heart. Avandia, intended to treat Type 2 diabetes, is known as rosiglitazone and was linked to 304 deaths during the third quarter of 2009. “Rosiglitazone should be removed from the market,” one report, by Dr. David Graham and Dr. Kate Gelperin of the Food and Drug Administration, concludes. Both authors recommended that Avandia be withdrawn. The internal F.D.A. reports are part of a fierce debate within the agency over what to do about Avandia, manufactured by GlaxoSmithKline. Some agency officials want the drug withdrawn because they believe there is a safer alternative; others insist that studies of the drug provide contradictory information and that Avandia should continue to be an option for doctors and patients. GlaxoSmithKline said that it had studied Avandia extensively and that “scientific evidence simply does not establish that Avandia increases” the risk of heart attacks. The battle has been brewing for years but has been brought to a head by disagreement over a new clinical trial and a Senate investigation that concluded that GlaxoSmithKline should have warned patients earlier of the drug’s potential risks. Avandia was once one of the biggest-selling drugs in the world. Driven in part by a multimillion-dollar advertising campaign, sales were $3.2 billion in 2006. But a 2007 study by a Cleveland Clinic cardiologist suggesting that the drug harmed the heart prompted the F.D.A. to issue a warning, and sales plunged. A committee of independent experts found in 2007 that Avandia might increase the risk of heart attack but recommended that it remain on the market, and an F.D.A. oversight board voted 8 to 7 to accept that advice..” ....keywords: avandia, heart attack, diabetes -
   For more on Avandia, see Avandia at Legal Sleuth® or Avandia at Gooch Law Firm

8. Information on Gadolinium-Containing Contrast Agents (FDA) FDAAn excerpt from the article states that "The U.S. Food and Drug Administration (FDA) has asked manufacturers to include a new boxed warning on the product labeling of all gadolinium-based contrast agents which are used to enhance the quality of magnetic resonance imaging (MRI).” ....keywords: gadolinium, mri, mra, nephrogenic systemic fibrosis, nsf, contrast agent, mri contrast agent, gadolinium contrast agent -
   For more on gadolinium, contrast agent or NSF, see Gadolinium or NSF at Legal Sleuth® or Gadolinium, Contrast agent or NSF at Gooch Law Firm

9. Questions and Answers on Gadolinium-Containing Contrast Agents 12/22/2006 (FDA) FDAAn excerpt from the article states that "1. What information is new since the Questions and Answers from June 2006? FDA’s previous information was limited to 25 cases in patients that received Omniscan for Magnetic Resonance Angiography (MRA) at doses higher than approved and recommended for Magnetic Resonance Imaging (MRI).
   FDA has received an additional 65 case reports of Nephrogenic Systemic Fibrosis/Nephrogenic Fibrosing Dermopathy (NSF/NFD) in patients who received Magnevist, Omniscan, and OptiMARK for MRI and MRA. NSF/NFD has now been reported in patients who received the recommended doses of the contrast agents. Researchers have found gadolinium deposits in the skin of patients who developed NSF/NFD. 2. What is gadolinium and what is its use in clinical medicine?
   Gadolinium is a paramagnetic metal ion. Paramagnetic ions, such as gadolinium, tend to move into magnetic fields. This trait makes paramagnetic ions such as gadolinium useful for MRI and MRA. Gadolinium-based contrast agents are manufactured by a chelating process, a procedure in which large organic molecules form a stable complex around the gadolinium. The chelate reduces the chances of toxicity that could result from exposure to free gadolinium. This stable complex is eliminated via the kidneys in patients with normal functioning kidneys. Gadolinium-based contrast agents are approved by FDA for use with MRI as a contrast agent to provide an improved image of body organs and tissues. Gadolinium-based contrast agents are also used for MRA, another imaging procedure used to evaluate blood vessels. 3. What is the difference between MRA and MRI? MRA is a special type of MRI used to study blood vessels. MRA is utilized to aid in the detection of heart disorders, stroke, and vascular diseases. 4. Can an MRI and MRA be performed without gadolinium-based contrast? Yes, MRI and MRA can be performed without contrast. MRI with gadolinium-based contrast agents provides additional diagnostic information as compared to MRI without contrast. The use of gadolinium-based contrast agents in MRA is not FDA approved. MRA with gadolinium-based contrast is thought by many radiologists to provide more detailed images of blood vessels than MRA without gadolinium-based contrast. 5. Are there any FDA approved MRA contrast agents? No. 6. Are there other approved MRI contrast agents that do not contain gadolinium? Yes. However, the two other approved MRI contrast agents, Feridex, I.V. (an iron-containing injectable solution) and Teslascan (a manganese-containing injectable solution) are FDA-approved only for the evaluation of lesions of the liver. Imaging contrast agents, such as iodinated contrast agents are used in Computed Tomography, plain X-ray and X-ray angiography. However, these iodinated contrast agents require X-ray imaging rather than MRI. 7. What is the concern regarding gadolinium-based contrast agents? Patients with moderate (glomerular filtration rate less than 60 mL/min/1.73m2) to end-stage (glomerular filtration rate less than 15 mL/min/1.73m2 or on dialysis) kidney disease who receive gadolinium-based contrast agents are at risk for developing a serious systemic fibrosing disease called Nephrogenic Systemic Fibrosis/Nephrogenic Fibrosing Dermopathy (NSF/NFD). As of December 21, 2006, FDA has received 90 reports of NSF/NFD in patients who received gadolinium-based contrast agents for MRI and MRA. In addition, researchers have found gadolinium deposits in the skin of patients with NSF/NFD. The association between NSF/NFD was first reported in a May 29, 2006, press release from the Danish Medicines Agency (DMA) and the April 2006 report by Grobner et al in Nephrology, Dialysis and Transplantation (2006) Vol 21 (4):1104-1108 and following erratum (2006) 21(6): 1745. 8. What is Nephrogenic Systemic Fibrosis/Nephrogenic Fibrosing Dermopathy (NSF/NFD)? NSF/NFD was first described in the medical literature in 2000. The first case of NSF/NFD was identified in 1997. The disease is observed in patients that have moderate to end-stage kidney disease. NSF/NFD causes fibrosis of the skin and connective tissues throughout the body. Patients develop skin thickening that may prevent bending and extending joints, resulting in decreased mobility of joints. NSF/NFD usually starts in the lower extremities. Fibrosis can also develop in the diaphragm, muscles in the thigh and lower abdomen, and lung vessels. The clinical course of NSF/NFD is progressive and may be fatal. 9. What is the treatment for NSF/NFD? There is no known treatment for NSF/NFD. Improved renal function (spontaneous or via renal transplantation) appears to slow or arrest NSF/NFD and may even result in a gradual reversal of NSF/NFD. Other treatments are being tested. 10. How many gadolinium-based contrast agents has FDA approved? Was NSF/NFD seen with all of the U.S.-approved gadolinium-based contrast agents? There are five FDA approved gadolinium-based contrast agents (Magnevist, MultiHance, Omniscan, OptiMARK, and ProHance). Of the 90 cases of NSF/NFD FDA has received, most have been associated with the administration of Omniscan. Other cases, however, have been associated with Magnevist and OptiMARK exposure. Although NSF/NFD has been reported for only 3 of the 5 gadolinium-based contrast agents, FDA believes that NSF/NFD may occur with the use of any of the approved gadolinium-based contrast agents.
   11. Do the gadolinium-based contrast agents cause NSF/NFD? Whether the gadolinium-based contrast agents are the only agents or conditions that may be associated with NSF/NFD in patients with renal disease is unknown. However, the 90 case reports FDA has received and the finding of gadolinium deposits in the skin of patients with NSF/NFD suggests that gadolinium-based contrast is a factor in the development of NSF/NFD in patients with moderate to end-stage kidney disease.
   12. What actions will FDA take regarding the new information about gadolinium-based contrast agent administration and the development of NSF/NFD in patients with moderate to severe kidney disease? FDA is continuing to evaluate the 90 case reports, is having ongoing discussions with NSF/NFD experts, is reviewing results of clinical trials with gadolinium-based contrast agents, and is working with the manufacturers to review all safety reports and adverse event reports. FDA will be initiating labeling changes for gadolinium-based contrast agents. 13. What information was known about serious side effects prior to the approval of gadolinium-based contrast agents? The five U.S. approved gadolinium-based contrast agents were approved between 1988 and 2004. In the combined pre-marketing studies for these approved gadolinium-based contrast agents, over 3000 patients were studied. The most common serious side effect from gadolinium-based contrast agents is an allergic reaction that is usually mild but is occasionally severe and even results in fatalities. Some patients develop skin conditions, such as rash, sweating, itching, hives, and facial swelling. Most of these conditions are allergic in nature. Gadolinium-based contrast agents can be very irritating to the veins into which they are injected, causing irritation of blood vessels and skin and the formation of blood clots. Very few patients with severely compromised kidney function or those on dialysis have been studied in clinical trials. The labels for gadolinium-based contrast agents caution that the risk of toxic reactions may be greater in patients with impaired kidney function because gadolinium is mostly excreted by the kidney. 14. What should patients do with this new information? If you have moderate to end-stage kidney disease and a physician has requested an MRI or MRA study with a contrast agent, ask if there are other contrast agents that could be used or other diagnostic tests that could be done. If gadolinium-containing contrast agents are necessary, physicians and patients should carefully select the contrast agent based on the individual patient’s medical care needs. If you have moderate to end-stage kidney disease and you received a gadolinium-based contrast MRA, you should tell your doctor. Call your doctor right away if any time after your gadolinium injection you get any of these conditions Skin and eyes Swelling, hardening and tightening of your skin Reddened or darkened patches on the skin Burning or itching of your skin Yellow raised spots on the whites of your eyes Bones and muscles Stiffness in your joints; problems moving or straightening arms, hands, legs, or feet Pain deep in your hip bones or ribs Muscle weakness 15. What should healthcare providers do in response to this new information? Physicians should consider the risks and benefits of using gadolinium-based contrast agents for MRI or MRA in patients with moderate to end-stage kidney disease. If such a patient receives gadolinium-based contrast agent, the physician should consider prompt dialysis. Physicians should also report all cases of NSF/NSD to the FDA’s MedWatch program either online, by regular mail or by fax, using the contact information at the bottom of this page.
   16. What additional actions are likely to follow? FDA will complete its ongoing analysis of these preliminary findings and then consider multiple options such as: modifying the product label or requiring additional studies. FDA may also consider other risk management options. 17. Where can I find more information about gadolinium-based agents and about NSF/NFD? The package inserts provide more information about all of the approved gadolinium-based agents. More information about NSF/NFD can be found at the following website: http://www.pathmax.com/dermweb/. ” ....keywords: gadolinium, mri, mra, nephrogenic systemic fibrosis, nsf, contrast agent, mri contrast agent, gadolinium contrast agent -
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10. Public Health Advisory - Gadolinium-containing Contrast Agents for Magnetic Resonance Imaging (MRI) (FDA) FDAAn excerpt from the article states that "The FDA is evaluating important safety information about gadolinium-containing contrast agents and a disease known as Nephrogenic Systemic Fibrosis or Nephrogenic Fibrosing Dermopathy (NSF/NFD) that occurs in patients with kidney failure. New reports have identified a possible link between NSF/NFD and exposure to gadolinium containing contrast agents used at high doses for a procedure called Magnetic Resonance Angiography (MRA). An MRA test uses magnetic resonance imaging to take pictures of blood vessels. During an MRA test, a drug known as a gadolinium-contrast agent is injected into a patient’s vein so blood vessels can be distinguished from other nearby tissues. The FDA has learned of 25 cases of NSF/NFD in patients with kidney failure who received Omniscan®, a gadolinium-containing contrast agent, and took the MRA test. The FDA is actively investigating whether exposure to a gadolinium-contrast agent for MRA is associated with the development of NSF/NFD. While FDA conducts its investigation, the following recommendations are being provided to health care providers and patients: Gadolinium-containing contrast agents, especially at high doses, should be used only if clearly necessary in patients with advanced kidney failure (those currently requiring dialysis or with a Glomerular Filtration Rate (GFR) = 15 cc/min or less). It may be prudent to institute prompt dialysis in patients with advanced kidney dysfunction who receive a gadolinium contrast MRA. Although there are no data to determine the utility of dialysis to prevent or treat NSF/NSD in patients with decreased kidney function, average excretory rates of gadolinium are 78%, 96%, and 99% in the first to third hemodialysis sessions, respectively (Okada, et al, Acta Radiologica, vol 42 p. 339, May 2001). Five gadolinium-containing contrast agents are FDA-approved for use during magnetic resonance imaging (MRI), a test that can look at internal body organs and tissues. The trade names of the U.S. approved gadolinium-containing contrast agents are: Omniscan, OptiMARK, Magnevist, ProHance, and MultiHance. None of these drugs are FDA approved for MRA. The dose of gadolinium-containing contrast agent given to patients undergoing an MRA test is often higher (up to three times) than the approved dose for MRI. NSF/NFD appears to occur in patients with kidney failure along with high levels of acid in body fluids a condition known as acidosis that is common in patients with kidney failure. Patients with NSF/NFD have tight and rigid skin making it difficult to bend joints. NSF/NFD may also result in fibrosis, or scarring, of body organs resulting in the inability of body organs to work properly and can lead to death. Diagnosis of NSF/NFD is done by looking at a sample of skin under a microscope. Scientists first identified NSF/NFD in 1997 and the cause of NSF/NFD is unknown. Worldwide, there are approximately 200 reports of NSF/NFD. The 25 cases of NSF/NFD were reported on May 29, 2006, by the Danish Medicines Agency. Among these, 20 cases occurred in Denmark and five cases occurred in Austria. The patients developed NSF/SFD within 3 months (range 2 weeks to 3 months) after receiving the gadolinium-containing contrast agent. The five patients from Austria are described in a publication: Grobner T. Gadolinium – a specific trigger for the development of nephrogenic fibrosing dermopathy and nephrogenic systemic fibrosis Nephrol dial Transplant. 21(4):1104-8. The FDA has not yet determined whether exposure by patients with kidney failure to gadolinium-containing contrast agents during an MRA test causes NSF/NFD. The FDA is gathering additional information about NSF/NFD and investigating whether other patients who received gadolinium-containing contrast agents developed NSF/NFD.” ....keywords: gadolinium, mri, mra, nephrogenic systemic fibrosis, nsf, contrast agent, mri contrast agent, gadolinium contrast agent -
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11. Public Health Advisory: Update on Magnetic Resonance Imaging (MRI) Contrast Agents Containing Gadolinium and Nephrogenic Fibrosing Dermopathy (FDA) FDAAn excerpt from the article states that "12/22/2006 Updated 5/23/2007 The FDA has received additional information about a new disease, known as Nephrogenic Systemic Fibrosis or Nephrogenic Fibrosing Dermopathy (NSF/NFD), which may occur in patients with moderate to end-stage kidney disease after they have had a Magnetic Resonance Imaging (MRI) or Magnetic Resonance Angiography (MRA) scan with a gadolinium-based contrast agent. An MRI scan provides clear and detailed pictures of internal organs. An MRA test uses a gadolinium-based contrast agent to take detailed pictures of blood vessels. During some MRI scans and all MRA scans, a gadolinium-based contrast agent is injected into a patient’s vein so blood vessels can be distinguished from other nearby tissues. As of December 21, 2006, FDA has received reports of 90 patients with moderate to end-stage kidney disease who developed NSF/NFD after they had an MRI or MRA with a gadolinium-based contrast agent. Their NSF/NFD began from 2 days to 18 months after exposure to the contrast agent. Many, but not all of these patients, received a high dose of the contrast agent; some received only one dose. In light of these reports, FDA is notifying health care providers and patients of the following: Patients with moderate to end-stage kidney disease who receive an MRI or MRA with a gadolinium-based contrast agent may get NSF/NFD which is debilitating and may cause death. Patients who believe they may have NSF/NFD should contact their doctor. Patients who develop NSF/NFD have areas of tight, rigid skin and may have scarring of their body organs. The signs of NSF/NFD also include: burning, itching, swelling, hardening and tightening of the skin; red or dark patches on the skin; yellow spots on the whites of the eyes; stiffness in joints with trouble moving or straightening the arms, hands, legs, or feet; pain deep in the hip bones or ribs; and muscle weakness. When a patient with moderate to end-stage kidney disease needs an imaging study, select imaging methods other than MRI or MRA with a gadolinium-based contrast agent for the study whenever possible. If these patients must receive a gadolinium-based contrast agent, prompt dialysis following the MRI or MRA should be considered. The FDA asks health care professionals and patients to report possible cases of NSF/NFD to the FDA through the MedWatch program either online, by regular mail or by fax, using the contact information at the bottom of this page. Worldwide, about 215 patients with NSF/NFD have been reported. Of these reports, the medical histories of 75 of these patients were reviewed in detail, and all of the patients had received a gadolinium-based contrast agent for an MRI or MRA. Researchers have identified gadolinium in skin biopsies of patients with NSF/NFD. Why NSF/NFD occurs in patients with moderate to end-stage kidney disease who receive gadolinium-based contrast agent is not yet known. The FDA is working with expert scientists to gather additional information about NSF/NFD. Currently there are five FDA approved gadolinium-based contrast agents, Magnevist, MultiHance, Omniscan, OptiMARK, and ProHance. These contrast agents are FDA approved for use during an MRI scan, but not for use during an MRA scan. Although NSF/NFD has been reported for only 3 of the 5 gadolinium-based contrast agents, FDA believes that there is a potential for NSF/NFD to occur with the use of any of the approved gadolinium-based contrast agents. You can find more details about NSF/NFD and gadolinium-based contrast agents in FDA’s Information for Healthcare Professionals Gadolinium-Based Contrast Agents for Magnetic Resonance Imaging (marketed as Magnevist, MultiHance, Omniscan, OptiMARK, ProHance). ” ....keywords: gadolinium, mri, mra, nephrogenic systemic fibrosis, nsf, contrast agent, mri contrast agent, gadolinium contrast agent -
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12. Gadolinium-containing Contrast Agents for Magnetic Resonance Imaging (MRI): Omniscan, OptiMARK, Magnevist, ProHance, and MultiHance (FDA) FDAAn excerpt from the article states that "Audience: Radiologists, Nephrologists, Dermatologists and other healthcare professionals
    [UPDATED 12/22/2006] FDA notified healthcare professionals that the Agency received a total of 69 case reports of patients with moderate to end-stage renal disease who underwent magnetic resonance imaging or magnetic resonance angiography and developed Nephrogenic Systemic Fibrosis/Nephrogenic Fibrosing Dermopathy (NSF/NFD). These reports provide more evidence for a causal relationship between gadolinium-based contrast agents and the development of NSF/NFD.
    [Posted 06/08/2006] FDA notified healthcare professionals and consumers that it is evaluating important safety information about gadolinium-containing contrast agents and a disease known as Nephrogenic Systemic Fibrosis or Nephrogenic Fibrosing Dermopathy (NSF/NFD) that occurs in patients with kidney failure. New reports have identified a possible link between NSF/NFD and exposure to gadolinium containing contrast agents used at high doses for a procedure called Magnetic Resonance Angiography (MRA). The FDA has learned of 25 cases of NSF/NFD in patients with kidney failure who received Omniscan, a gadolinium-containing contrast agent, and took the MRA test. The FDA is gathering additional information about NSF/NFD and is actively investigating whether exposure to a gadolinium-contrast agent for MRA is associated with the development of NSF/NFD and whether other patients who received gadolinium-containing contrast agents developed NSF/NFD. FDA has not yet determined whether exposure by patients with kidney failure to these products during an MRA test causes NSF/NFD. The FDA urges health care providers and patients to report adverse event information to the FDA online, by phone (1-800-FDA-1088) or by fax (1-800-FDA-0178).
    [December 22, 2006 - Drug Information Page - FDA] [June 08, 2006 - Public Health Advisory - FDA] [June 06, 2006 - Dear Healthcare Professional letter - GE Healthcare]” ....keywords: gadolinium, mri, mra, nephrogenic systemic fibrosis, nsf, contrast agent, mri contrast agent, gadolinium contrast agent -
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13. Weed killer atrazine may be linked to birth defect (Reuters) http://bit.ly/dzZMRnAn excerpt from the article states that "Living near farms that use the weed killer atrazine may up the risk of a rare birth defect, according to a study presented this past Friday at the annual meeting of the Society for Maternal-Fetal Medicine in Chicago. About 1 in 5000 babies born in the U.S. each year suffers from gastroschisis, in which part of the intestines bulges through a separation in the belly, according to the March of Dimes. The rate of gastroschisis has risen 2- to 4-fold over the last three decades, according to Dr. Sarah Waller, of the University of Washington, Seattle, and colleagues. Waller's team studied the potential link between the weed killer and the birth defect because, as they note in their conference abstract, "during the last 10 years, the highest percentage per population of gastroschisis was in Yakima County, in the eastern part of the state, where agriculture is the primary industry." Overall, Washington state has about double the national average of gastroschisis cases - an average of 43 cases per year, Waller told Reuters Health. The researchers looked at more than 4,400 birth certificates from 1987-2006 - including more than 800 cases of gastroschisis -- and U.S. Geological Survey databases of agricultural spraying between 2001 and 2006.” ....
    keywords: birth defect, birth injury - For more on birth defects or birth injuries, see Birth-Injury at Legal Sleuth® or Birth-Injury at GLF

14. Migraine drugs don't up birth defect risk: study (Reuters) http://bit.ly/9EuJP4An excerpt from the article states that "A study in nearly 70,000 pregnant women has found no link between migraine drugs called triptans and the risk of birth defects. However, the researchers did find a "slight increase" in the risk of excessive bleeding during labor, and the failure of the uterus to contract normally after delivery, for women who used the drugs while pregnant. Triptans are among the most powerful drugs used for migraine; others include aspirin, Excedrin, and ibuprofen. While as many as three in 10 women may develop migraines during their childbearing years, women often shy away from using such drugs during pregnancy because of safety concerns, according to study co-author Katerina Nezvalova-Henriksen of the University of Oslo in Norway and her colleagues. However, the authors of the study in Headache note, untreated migraine may itself carry risks for mother and child; some studies have linked it to pre-eclampsia, a potentially deadly pregnancy complication. "While it is important to exert caution when using any medications during pregnancy, this study indicates" that pregnant women can either start or continue taking triptans without "any major risk" of miscarriage, premature delivery, or other bad outcomes, the authors conclude. Nezvalova-Henriksen and her team studied nearly 70,000 women. Two percent, or 1,535, had used sumatriptan (Imitrex), rizatriptan (Maxalt), zolmitriptan (Zomig), or eletriptan (Relpax) in pregnancy.” ....
    keywords: birth defect, birth injury - For more on birth defects or birth injuries, see Birth-Injury at Legal Sleuth® or Birth-Injury at GLF

15. Hydroxycut linked to other cases of liver damage (Reuters) http://bit.ly/9TGbBQAn excerpt from the article states that "A new study strengthens evidence that the once widely advertised weight-loss supplement Hydroxycut caused serious liver damage in some users. Last May, 14 Hydroxycut products were recalled by the manufacturer, Canada-based Iovate Health Sciences, after the U.S. Food and Drug Administration (FDA) issued a warning to all consumers to stop using the supplements. The warning was based on 23 reports to the agency describing liver damage in Hydroxycut users -- ranging from inflammation to tissue death severe enough to require a liver transplant. The supplement was also linked to one death. Iovate said in May that it was recalling Hydroxycut because they "became aware that the U.S. Food and Drug Administration's assessment of 23 reports about consumers having experienced liver-related problems, as well as a small number of published case reports, was different from Iovate's analysis." They noted that "the number of adverse event reports described by the FDA is small relative to the many millions of people who have used Hydroxycut products over the 7 years." In the new study, reported in the American Journal of Gastroenterology, researchers analyzed 17 cases of liver damage among Hydroxycut users that had not yet appeared in the medical literature. Nine of the cases had been reported to the FDA, while eight were seen by the authors of the study. Looking at factors like patients' risk factors for liver disease and the timing of their Hydroxycut use, the researchers found that for eight of the liver-damage cases, there was a greater than 95 percent likelihood that the weight-loss aid was to blame. In five cases, the researchers concluded that Hydroxycut was "highly likely" the cause (a 75 to 95 percent chance), while it was probably to blame in two cases (a 50 to 74 percent chance). The last two cases were considered to be possibly linked to Hydroxycut use. This type of study cannot definitively prove cause-and-effect -- something that is often "challenging" to do in cases where a drug is suspected of causing a toxic effect, noted study co-author Dr. Tse-Ling Fong, an associate professor of medicine at the University of Southern California, Los Angeles. This is particularly true of dietary supplements, Fong told Reuters Health, because they do not have to be tested in clinical trials before going on the market, and little may be known about their potential for side effects.” ....
    keywords: hydroxycut, diet drug, liver damage, product liability - For more on hydroxycut, see Hydroxycut at Legal Sleuth® or Hydroxycut at GLF

16. Indian CEO: ‘U.S. Would Grant a Patent to a Piece of Toilet Paper’ (WSJ) http://bit.ly/dxLHHEAn excerpt from the article states that "India has become a hot market for multinational drug companies since it revised its patent laws to give more protection to brand-name medicine. But to hear the branded makers tell it, the patent welcome mat has some holes in it, a WSJ report recounts this morning. The drug makers point to three top-selling medicines that have failed in their efforts to win protection either through India’s patent office or the country’s court system. ” .... keywords: intellectual property, patent, patent infringement

17. Bursting Pipes Lead to a Legal Battle (NY Times) http://nyti.ms/9XpUmh An excerpt from the article states that "State and local governments across the country may have to replace their water systems because of defective pipes, according to a whistle-blower lawsuit unsealed this week.John Hendrix of Clifton, N.J., says faulty pipes made by his former employer, JM Eagle, have been installed in places like Nevada, where breaks have occurred.The whistle-blower, John Hendrix, accuses his former employer, one of the world’s largest pipe manufacturers, of falsifying test results about the quality of its products. Pipes that should last 50 years are in some cases rupturing in their very first year, according to Mr. Hendrix and some state documents. This can lead to explosions, leaks, fires and other dangers. Officials of the company, JM Eagle, dispute the allegations and say that the tests were done correctly. Mr. Hendrix said he uncovered the problem after he was asked to oversee the certification of a new manufacturing process that put the pipes through a prescribed battery of tests. He concluded that JM Eagle had been selling substandard plastic pipe since 1996, and that it had subsequently manipulated test results. When he told his superiors of his concerns, they said the problems were a normal “business risk,” according to the complaint. When he pressed harder, he was fired. Mr. Hendrix, 31, of Clifton, N.J., then began a whistle-blower lawsuit under federal and state statutes that allow private citizens to file on behalf of government agencies if they suspect a fraud. In his lawsuit, he asserts that less than half of JM Eagle’s pipe would have qualified for sale if it had been properly tested. “It became apparent to me that this was being done intentionally,” he said in an interview.” .... keywords: qui tam, whistleblower, federal false claims

18. Stents open clogged arteries(CNN) http://bit.ly/9UmVVTAn excerpt from the article states that "Stents, small metal scaffolding devices placed inside blood vessels around the heart, are used to treat conditions that result when arteries become narrow or blocked. Former President Clinton underwent a procedure to place two stents in one of his coronary arteries Thursday after experiencing chest "discomfort," his foundation said. A stent is very effective at reducing chest pain and treating a heart attack, said Dr. Clyde Yancy, president of the American Heart Association.In 2004, Clinton underwent a quadruple bypass operation to free four blocked arteries. For someone who has a history of heart problems, heart attack is the first concern, Yancy said.” .... keywords: stent, drug eluting stent, medicated stent, heart stent

19. Stents Are Increasingly Common but Not Without Risk (WSJ) http://bit.ly/9i64XSAn excerpt from the article states that "Stents, the tiny metal tubes used to relieve former President Bill Clinton's heart problem on Thursday, are one of medicine's most common devices and are implanted in about one million Americans annually. The devices are deployed during angioplasty procedures, which are used to clear obstructed arteries in the heart. A catheter inserted into an artery in the patient's groin is used to thread a balloon through the body to a blockage, in this case one of Mr. Clinton's coronary arteries. After the balloon is inflated to clear the obstruction, the stent—which resembles a tiny mesh scaffold—is then put in place to prop open the diseased artery.Video Animation: How Stents Work Since the first coronary stent was introduced by Johnson & Johnson in 1994, the technology has transformed treatment for coronary arteries, enabling millions of patients to avoid or delay undergoing bypass surgery. But their arrival has also sparked a controversy over whether cardiologists use them too soon or too often. "Stents really represent the most contemporary care for patients" with the symptoms Mr. Clinton is reported to have experienced on Thursday, said Clyde Yancy, president of the American Heart Association and a cardiologist at Baylor University Medical Center in Dallas. The most commonly used models are coated with a drug that is intended to prevent scar tissue from building up in and around the device.That complication typically has occurred within six months or so in about 30% or more of patients who got bare-metal stents. The drug-coated versions, marketed mainly by Abbott Laboratories, Boston Scientific Corp., and Medtronic Inc., as well as Johnson & Johnson, sharply reduce the likelihood of reclogging and the need for a repeat procedure.” .... keywords: stent, drug eluting stent, medicated stent, heart stent

20. Honda expands airbag recall as more Toyotas probed (Reuters) http://bit.ly/afm7wyAn excerpt from the article states that "Honda Motor Co said it would recall another 440,000 cars around the world for faulty airbags as rival Toyota Motor Corp faced further probes over its largest-ever safety crisis. Honda, Japan's No. 2 automaker, has now recalled close to 950,000 vehicles for airbag problems linked to one fatality and a total of 11 injuries in the United States. While auto recalls are not uncommon and Honda's is not huge, it comes at a sensitive time for an industry struggling to draw customers back to showrooms after a brutal downturn. Toyota President Akio Toyoda will come to the United States in early March to meet government officials and to visit the carmaker's local operations, delaying a trip initially scheduled for next week due to the heavy snowfall in Washington, the Nikkei newspaper reported. A Republican lawmaker, U.S. Rep. Darrell Issa, has invited Toyoda to meet with members of Congress the week of February 22. He is also urging the House Oversight Committee chairman to invite Toyoda to a February 24 hearing. A Toyota representative could not immediately be reached for comment. Toyoda's U.S. visit comes as the world's biggest automaker faces a storm of criticism over safety issues and perceptions that the carmaker has been too slow to respond. Toyota has up to 70,000 vehicles still stranded on U.S. dealer lots due to defective accelerator pedals that are the subject of a major safety recall, a top U.S. Toyota executive said on Wednesday. Bob Carter, Toyota's U.S. sales chief, said all Toyota U.S. dealers have parts to repair the accelerator pedals and that the dealers were focused on fixing customers' cars before tackling the vehicles in the inventory. Toyota U.S. dealers are repairing more than 52,000 gas pedals per day and have completed work on about 225,000 since they started late last week, Carter said. ” .... keywords: recall, defective product, product liability, personal injury

21. BP To Restart Hydrotreater At Texas Refinery - Filing (Fox) http://bit.ly/bNebKd keywords: chemical plant, petrochemical

22. Defibrillator Safety Questioned
    (WSJ)http://bit.ly/dhfjSG
    An excerpt from the article states that "Two defibrillator brands made by Boston Scientific Corp. have a design flaw that can result in the devices delivering potentially life-threatening shocks to the hearts of patients, authors of a medical journal article say. The defect can cause the Cognis and Teligen brand defibrillators to deliver the shocks when they aren't needed in the many patients who get the devices implanted just under the skin, according to an article in the journal HeartRhythm. The potential malfunction, while appearing to be extremely rare, could in theory affect any of the more than 90,000 devices implanted, said the authors. They advised physicians to look for the problem should the devices malfunction. Defibrillators deliver shocks or electronic pulses to hearts with abnormal rhythms so they beat normally. The devices have saved thousands of lives since patients in the U.S. who had suffered a cardiac arrest started getting them in the mid-1980s. Boston Scientific had warned in December that there was a problem with shocks with the defibrillators—the third of various types the company has disclosed with its Cognis and Teligen devices. But it said the problem was limited to the few patients who had the devices implanted deeper in their bodies, under their chest muscles. The Natick, Mass., medical device maker criticized HeartRhythm for publishing the article without a "detailed engineering analysis" of the highlighted device, and said the company's testing showed the problem didn't cause the defibrillator to deliver inappropriate shocks. Boston Scientific said the performance of the Cognis and Teligen lines "compares very favorably to the performance of similar devices and is well within accepted performance ranges." A spokeswoman for HeartRhythm said the journal had not seen the Boston Scientific statement and didn't have any immediate comment.” .... keywords: defibrillator

23. Merck Settles Some Vioxx Suits (WSJ) http://bit.ly/b2AFlG keywords: vioxx lawsuit

24. In a California Town, Birth Defects, Deaths and Questions (NY Times) http://nyti.ms/9Z7i1tAn excerpt from the article states that "KETTLEMAN CITY, Calif. — State and federal officials are scrambling to determine what caused the deaths of three children in this Central California farming town, which shares a ZIP code with the largest hazardous waste treatment site west of the Mississippi. The California Aqueduct borders the town. Over a 15-month period in 2007 and 2008, six children of mothers from Kettleman City were born with serious birth defects, including cleft palates, deformities and brain damage. Half of those infants subsequently died. And while health authorities have not placed any blame, the apparent cluster of defects has given new ammunition to environmentalists and local residents who have long been wary of the town’s proximity to the Kettleman Hills waste facility, a 1,600-acre landfill that lies in an unincorporated area less than four miles west of here. “We’ve always been saying, ‘The sky is falling, the sky is falling,’ ” said Maricela Mares-Alatorre, a Kettleman City resident and longtime critic of the facility. “Well, for those mothers, the sky fell.” Last week, officials from the Environmental Protection Agency toured the landfill and visited with families of the children with birth defects. That action came less than a week after Gov. Arnold Schwarzenegger ordered the State Department of Public Health and California’s Environmental Protection Agency to look into what he called “an abnormal percentage of birth defects” occurring here. On Tuesday, the first report from the state is expected to be delivered to the Kings County Board of Supervisors, which recently approved an expansion of the waste facility, owned by Waste Management, the largest recycler and waste-handling company in North America. The company operates hundreds of other landfills nationwide. The company says it welcomes the investigation and the visit from the E.P.A.’s regional administrator, Jared Blumenfeld. “We were proud to showcase our sophisticated, state-of-the-art facility,” said Bob Henry, the senior district manager of the Kettleman Hills facility in a statement, “and provide him an opportunity to see, firsthand, why we set the standard for safely managing hazardous waste.” .... keywords: birth defect, birth injury, personal injury

25. Hospitals Dispute Medtronic Data on Wires (WSJ) http://bit.ly/a8RDueAn excerpt from the article states that "Some leading hospitals are reporting failure rates for Medtronic Inc.'s fracture-prone defibrillator wires—including among young people—that are significantly higher than what the company has publicly disclosed. Medtronic, a medical-device maker, pulled the Sprint Fidelis defibrillator wires off the market in 2007 and substituted another type of wire with a lower failure rate. But an estimated 150,000 Sprint Fidelis wires, which are known as leads, remain implanted in U.S. patients. The company, and most doctors, generally advise patients not to have the leads surgically removed if they haven't fractured, because of the risk of complications. Medtronic says its own research shows the Sprint Fidelis leads survive for three years at least 95.4% of the time, for a failure rate of 4.6%. Reports from hospitals including the University of Rochester in New York state, the Minneapolis Heart Institute, the Mayo Clinic and the University of Ottawa, say the overall failure rate for Sprint Fidelis leads is as much as two times as great as the company's own data indicate. Some of the hospitals also report that the rate of fracture accelerates as the leads age. ".... keywords: sprint fidelis, sprint fidelis lead wire, lead wire fracture, medtronic sprint fidelis lead wire, lead failure, lead wire failure

26. Increasing hazard of Sprint Fidelis implantable cardioverter-defibrillator lead failure (Heart Rhythm) http://www.heartrhythmjournal.com/article/S1547-5271%2809%2900175-1/abstract (Heart Rhythm) keywords: sprint fidelis, sprint fidelis lead wire, lead wire fracture, medtronic sprint fidelis lead wire, lead failure, lead wire failure

27. FDA Drug Safety Communication: Risk of Progressive Multifocal Leukoencephalopathy (PML) with the use of Tysabri (natalizumab)(FDA) http://bit.ly/d4tSC3An excerpt from the article states that "[02-05-2010] The U.S. Food and Drug Administration (FDA) is alerting the public that the risk of developing progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection associated with the use of Tysabri (natalizumab), increases with the number of Tysabri infusions received. This new safety information, based on reports of 31 confirmed cases of PML received by the FDA as of January 21, 2010, will now be included in the Tysabri drug label and patient Medication Guide (see Data Summary for additional information). Tysabri was approved by the FDA in November 2004 for the treatment of relapsing forms of multiple sclerosis (MS). Tysabri is also approved by FDA for treating moderately to severely active Crohn's disease. Since 2006, Tysabri has only been available through a risk minimization plan called Tysabri Outreach Unified Commitment to Health (the TOUCH™ Prescribing Program). The program, developed by the FDA and the manufacturer of Tysabri, Biogen-Idec, is intended to make sure that healthcare professionals and patients understand the benefits and potential risks associated with the use of Tysabri, including the risk of PML.Under the TOUCH™ program, every patient who receives Tysabri is closely monitored for the occurrence of PML and other serious opportunistic infections. For additional information about the TOUCH™ program click here. Based on the available information, the FDA believes that the clinical benefits of Tysabri continue to outweigh the potential risks. Revisions to the drug label and patient Medication Guide, with the continued use of the TOUCH Prescribing Program, are intended to maximize the safe use of Tysabri and the identification of new PML cases. Additional Information for Patients * Tysabri is a medication that has been associated with PML and the risk of developing this disease increases with the number of Tysabri infusions received. * PML is a rare infection of the brain caused by the JC virus, which is a common virus often acquired during childhood. Most adults have been infected with JC virus, but do not develop PML. The virus appears to remain inactive until something (such as a weakened immune system) causes it to be reactivated. Once reactivated, the virus may infect the brain and cause PML. * People with a weakened immune system or people taking drugs that suppress their immune system (immunosuppressants) are most likely to get PML. Tysabri is an immunosuppressant medication. * The symptoms of PML may begin gradually, usually worsen rapidly, and vary depending on which part of the brain is infected. These symptoms may include difficulty with walking and other movements, decline in mental function, and problems with vision and speaking. Rarely, headaches and seizures occur. Symptoms of PML may be similar to multiple sclerosis (MS).
    * If PML is suspected, Tysabri treatment should be stopped and not resumed until further clinical evaluation is performed. * When patients have the clinical symptoms of PML, a PML diagnosis is made by an MRI of the brain and confirmation of the presence of JC virus in the cerebrospinal fluid.
    * Cases of Immune Reconstitution Inflammatory Syndrome (IRIS) have been reported after stopping Tysabri because of PML. IRIS is a condition that can occur after discontinuing immunosuppressant medications. During immune system recovery, patients can experience a severe inflammatory response to an infection and their symptoms can get worse, sometimes after a period of improvement. Additional Information for Healthcare Professionals
    * An update to the Warnings and Precautions section of the drug label has been added to inform healthcare professionals that the risk of PML increases with the number of Tysabri infusions received o There have been no reports of PML in patients treated for less than 12 months since Tysabri's remarketing.In patients treated with 24 to 36 infusions, the overall worldwide rate and the rate in the U.S. of developing PML is similar to the rate seen during clinical trials (1 case per 1,000 patients treated). Outside of the U.S., the rate is approximately 2 cases per 1,000 patients.The reasons for this difference are unknown. There is limited clinical experience beyond 36 Tysabri infusions either in clinical trials or in the postmarketing setting.
    o PML is diagnosed on the basis of clinical symptoms, MRI findings, and the detection of JC virus in the cerebrospinal fluid. o Tysabri should be withheld at the first sign or symptom suggestive of PML. o Continued clinical vigilance and close monitoring for the signs and symptoms of PML as dictated by the TOUCH™ Prescribing Program is necessary. * An update to the Warnings and Precautions section of the drug label has been added to inform healthcare professionals about the occurrence of Immune Reconstitution Inflammatory Syndrome (IRIS) in patients who developed PML and subsequently discontinued Tysabri. o IRIS is a rare condition characterized by a severe inflammatory response that can occur during or following immune system recovery, causing an unexpected decline in a patient's condition after return of immune function. o IRIS has been reported in patients who discontinue Tysabri as a result of developing PML, but not in patients who discontinue Tysabri for other reasons. o Many patients who stopped Tysabri due to PML and who received either plasma exchange or immunoadsorption (measures taken to decrease circulating Tysabri levels) developed IRIS days to several weeks after these treatments. o Healthcare professionals should monitor their patients for the development of IRIS and appropriate treatment of the associated inflammation after stopping Tysabri should be undertaken.The FDA continues to receive reports of PML in patients receiving Tysabri in the United States and overseas. Tysabri, an immunosuppressant medication, was first approved by the FDA in November 2004 for the treatment of relapsing forms of multiple sclerosis (MS). In February 2005, the marketing of Tysabri was suspended by the manufacturer after three patients in clinical trials (two patients in MS trials and one in a Crohn's disease [CD] trial) developed PML. In June 2006, the FDA approved an application for the re-marketing of Tysabri as monotherapy for the treatment of patients with relapsing forms of MS.Tysabri is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate MS therapy. In January 2008, Tysabri was also approved for inducing and maintaining a clinical response and remission in patients with moderately to severely active CD who have had an inadequate response to, or are unable to tolerate, conventional CD therapies.
    Since July 2006 (when marketing resumed) through January 21, 2010, there have been 31 confirmed cases of PML worldwide in patients using Tysabri. Of these 31 case reports, 10 were from patients in the U.S. As of January 21, 2010, eight patients have died. In all cases, patients were receiving Tysabri as monotherapy for the treatment of MS. There have been no postmarketing reports of PML in patients treated with Tysabri for CD. In the U.S., less than 2% of Tysabri use is in patients with CD. Tysabri is not approved for CD outside of the U.S. The risk of developing PML increases with the number of Tysabri infusions received. Tysabri is administered as a single intravenous infusion every four weeks. The overall worldwide cumulative rate of PML in patients who have received one or more Tysabri infusions is 0.5 cases of PML per 1,000 patients. Since Tysabri's re-marketing in the U.S., there have been no cases of PML in patients treated with Tysabri for less than 12 months. The overall worldwide cumulative rate of PML in patients who have received at least 24 infusions is 1.3 cases of PML per 1,000 patients. In the U.S., the cumulative rate of PML in patients who have received at least 24 infusions is 0.8 per 1,000 patients. Outside of the U.S., the cumulative rate of PML in patients who have received at least 24 infusions is 1.9 per 1,000 patients. Approximately 66,000 people, worldwide, have received at least one dose of Tysabri since marketing resumption (through December 31, 2009). Relatively few patients have received 36 infusions or more, either in clinical trials or since marketing resumption; therefore, the magnitude of the risk of PML and other adverse events in patients who have received 36 infusions or more is not able to be well characterized. The following table summarizes cumulative rates of PML according to geographic location and number of Tysabri infusions received since Tysabri re-marketing: Number of Tysabri infusions received Overall cumulative rate of PML per 1,000 patients Cumulative rate of PML per 1,000 patients outside of U.S. Cumulative rate of PML per 1,000 patients in U.S.
    > 1 0.5 0.7 0.3
    > 12 0.8 1.1 0.5
    > 24 1.3 1.9 0.8
    > 30 1.0 1.8 0.5
    The FDA and its international counterparts remain committed to tracking and monitoring for any change in the risk of PML associated with the use of Tysabri.This communication is intended to increase awareness about the risk of PML in patients treated with Tysabri.At this time, the FDA believes that the clinical benefits of Tysabri outweigh its risks. Tysabri will remain available to patients through the TOUCH™ Prescribing Program. Under this program, every patient who receives Tysabri is closely monitored for the occurrence of PML and other serious opportunistic infections. ".... keywords: progressive multifocal leukoencephalopathy (PML) [

28. Boston Scientific to Pay J&J $1.73B to Settle Stent Patent Disputes (WSJ) http://bit.ly/axWPkC keywords: patent, patent infringement, patent litigation, drug eluting stent, personal injury

29. Birth defect total in California town now at 6 (AP) http://bit.ly/cxDWec (AP) keywords: birth defect, birth injury, personal injury

30. [Levofloxacin-induced bilateral rupture of the Achilles tendon: clinical and sonographic findings] http://bit.ly/bI8Js2 (PubMed) An excerpt from the article states that "The fluoroquinolones are antibiotics widely used in the clinical practice. The concomitant use of corticosteroids and fluoroquinolones in elderly patients is recognised as a risk factor for developing clinically relevant tendon lesions. Fluoroquinolone-induced tendinopathy is underreported in the literature. A 67-year-old man, came to our observation complaining of 5 days history of bilateral heel pain. The patient had a medical history of sarcoidosis and was treated with a daily dose of 5 mg of prednisone. He was initially given oral levofloxacin (500 mg/die) for 10 days, because of an acute respiratory infection. Two days before the end of the antibiotic therapy, he developed bilateral heel pain. He denied any history of trauma. Physical examination revealed swelling and marked tenderness with mild palpation of the Achilles tendons at the calcaneal insertion. The ultrasound evaluation of the Achilles tendons revealed the following main abnormalities: diffuse thickening, loss of the "fibrillar" echotexture, blurred margins, and bilateral partial tendon tears. Bilateral Achilles tendon pain and rupture has been described as a rare adverse effect of fluoroquinolone treatment. Most of the fluoroquinolone-induced tendinopathies of the Achilles tendon are due to ciprofloxacin. To the best of our knowledge, this is the first description of bilateral Achilles tendon rupture due to levofloxacin. The risk/benefit ratio of the fluoroquinolones should be carefully considered and these drugs should be prescribed cautiously in elderly patients treated with corticosteroids. This case can be regarded as a representative example of the potential clinical efficacy of sonography in daily rheumatological practise."... keywords: levaquin, product liability, pharmaceutical liability, tendon rupture, Achilles tendon, tendinitis, personal injury

31. Lawsuit: Dentist's Drill Left in Woman's Head http://bit.ly/9nO7QO (Fox) keywords: personal injury

32. Studies Link Rare Ailment to Pain Pumps http://bit.ly/adFafM (NY Times) - An excerpt from the article states that "When the first cases popped up in orthopedic journals, they read like medical mysteries. Surgeons around the country reported that several active young patients had suddenly developed chondrolysis, a relatively rare ailment in which joint cartilage dies, leaving bone to grind on bone. Marcus Suhn's football career ended when the cartilage in his shoulder deteriorated. His shoulder joint was replaced. Whitney Moore developed chondrolysis after surgery for a shoulder injury. Chondrolysis has ended the athletic careers of dozens of high school and college students. In the most severe cases, it has required joint replacements. Many sufferers face lifetimes of pain and disability. “I’ve lost so many hours of sleep over this, I can’t tell you,” said Dr. David S. Bailie, an orthopedic surgeon in Scottsdale, Ariz., who said he had seen dozens of cases of chondrolysis since 2005. “There’s nothing worse than a surgeon doing something that causes a problem, not fixes a problem.” Although it is still unknown why chondrolysis develops, several medical studies have concluded that a likely culprit is a pain pump, a postsurgical medical device used to deliver local anesthetics to a specific area through a plastic tube. Whether the pumps caused the chondrolysis — and whether manufacturers should have done more to warn surgeons about the potential risks — is the subject of more than 150 lawsuits working their way through state and federal courts. Last Friday, an Oregon jury awarded nearly $5.5 million to a chondrolysis patient, and at least a dozen cases are expected to go to trial this year. Lawyers for the patients argue that the manufacturers disregarded safety in their quest to expand into the orthopedic market. But the manufacturers and some medical experts argue that more research is needed to determine whether pain pumps are to blame. Pain pumps became popular with orthopedic surgeons in the late 1990s because they were seen as an alternative to extended hospital stays and safer than prescribing narcotic painkillers. But the Food and Drug Administration never cleared the pumps for use in joints, and many in the medical profession now say that by exposing cartilage to local anesthetics for up to 72 hours, the devices turned otherwise harmless medications into toxins. In November, the F.D.A. issued a warning about using pain pumps in joints and ordered manufacturers of local anesthetics and pumps to change labels to discourage doctors from such uses.".... keywords: shoulder pain pump, chondrolysis, PAGCL, product liability

33. Opiate painkillers raise fracture risk http://bit.ly/dmHO5s (Reuters) - An excerpt from the article states that "Older adults who take powerful prescription painkillers known as opioids face an increased risk of bone fractures, especially at moderately high medication doses, a new study finds.Opioids are powerful narcotic pain medications that include morphine, oxycodone (Oxycontin and other brands) and hydrocodone (Vicodin and others). The drugs work well against severe pain in the short term, but their longer-term effectiveness for chronic pain is less clear. Moreover, with longer use comes the risk of addiction, in addition to side effects such as nausea, constipation, dizziness and sedation. That dizziness and sedation can also set opioid users up for falls, which, in older people especially, may result in serious fractures. The new study, published in the Journal of General Internal Medicine, confirms the risk of fracture associated with opioids, and also shows that moderately higher drug doses further the hazard. Researchers found that among more than 2,300 older adults with chronic pain, the risk of suffering a bone fracture was higher when patients were using an opioid for a prolonged period than when they were opioid- free.".... keywords: personal injury

34. America's Least Deadly Hospitals http://bit.ly/4R4scT (Forbes) - An excerpt from the article states that "When contemplating major surgery, many people go to whatever hospital their family doctor recommends. Others chose a hospital for its star surgeon or because they've seen billboard ads touting its specialties. Either way, it can be a fatal mistake. Every year 100,000 people die in hospitals because of preventable complications or hospital-acquired infections. Many more suffer serious harm as a result of well-intended treatments gone awry.".... keywords: medical malpractice, personal injury

35. FDA Announces Class I Recall of Certain Infusion Set Needles http://bit.ly/60ukSt (FDA) - An excerpt from the article states that "FDA NEWS RELEASE For Immediate Release: Jan. 26, 2010 Media Inquiries: Peper Long, 301-796-4671, mailto:mary.long@fda.hhs.gov Consumer Inquiries: 888-INFO-FDA FDA Announces Class I Recall of Certain Infusion Set Needles Huber needles used in implanted ports to withdraw blood, inject medications, and other solutions The U.S. Food and Drug Administration today announced a Class I recall of Exel/Exelint Huber needles, Exel/Exelint Huber Infusion Sets and Exel/Exelint “Securetouch+” Safety Huber Infusion Sets, manufactured by Nipro Medical Corporation for Exelint International Corporation. Huber needles are used to access ports implanted under the skin of chronically ill patients for repeated access to veins for the withdrawal of blood and infusion of medication, nutritional solutions, blood products, and imaging solutions. These needles should be designed to penetrate the port without cutting and dislodging any silicone cores (or slivers) from the ports into which they are inserted. Inspections conducted in October 2009 of Nipro facilities in Japan found that their needles “cored” in 60 to 72 percent of tests. The reason for this coring is related to design and manufacturing processes, which the FDA continues to investigate. There are more than 2 million units impacted by this recall in distribution nationwide. Recalled needles were manufactured from January 2007 to August 2009. Units subject to recall have a lot number that begins with “07,” “08,” “09,” and one of the following product codes or catalog numbers: ..... Hospitals, clinics and patients who have needles from these lists should immediately stop using these affected products and return any unused products to Exelint International Corporation. Direct all questions concerning this recall to:".... keywords: fda, recall, personal injury

36. New rule for truck, bus drivers: No texting http://bit.ly/bVw5w0 (CNN) - An excerpt from the article states that "Drivers of commercial trucks and buses are prohibited from texting under federal guidelines that U.S. Transportation Secretary Ray LaHood announced Tuesday. "We want the drivers of big rigs and buses and those who share the roads with them to be safe," LaHood said in a statement. "This is an important safety step, and we will be taking more to eliminate the threat of distracted driving." The prohibition is effective immediately. Truck and bus drivers who text while driving commercial vehicles may be subject to civil or criminal penalties of up to $2,750, the Department of Transportation said in a news release. The release did not offer specifics on how the prohibition will be enforced. One of the nation's largest groups representing professional truck drivers -- the Owner-Operator Independent Drivers Association -- expressed support for the goal but dismay at its implementation.
    "We support where they are going, but not how they got there," said Todd Spencer, the group's executive vice president. "Making their action effective immediately bypasses normal regulatory rulemaking processes. Those processes allow actions to be vetted for unintended consequences as well as potential implementation and enforcement problems. "We very much share in their goal, but their legal justification for taking immediate action raises many concerns." Cracking down on distracted drivers has been a focus of LaHood's since he took office last year. In September, he convened a two-day summit on the issue in Washington. The Transportation Department recently launched the Web site distraction.gov to raise awareness of the dangers of distracted driving. And this month, LaHood and National Safety Council President Janet Froetscher announced the creation of the advocacy group FocusDriven, a nonprofit that supports the families of distracted driving victims, modeled after Mothers Against Drunk Driving.]".... keywords: truck accident, 18 wheeler accident, semi-truck accident, personal injury

37. Meridia (sibutramine hydrochloride): Follow-Up to an Early Communication about an Ongoing Safety Review http://bit.ly/6wd0Ch (FDA) - An excerpt from the article states that "Cardiology and endocrinology healthcare professionals
    [Posted 01/21/2010] FDA notified healthcare professionals that the review of additional data indicates an increased risk of heart attack and stroke in patients with a history of cardiovascular disease using sibutramine. Based on the serious nature of the review findings, FDA requested and the manufacturer agreed to add a new contraindication to the sibutramine drug label stating that sibutramine is not to be used in patients with a history of cardiovascular disease, including:
    History of coronary artery disease (e.g., heart attack, angina) History of stroke or transient ischemic attack (TIA)
    History of heart arrhythmias, History of congestive heart failure, History of peripheral arterial disease, Uncontrolled hypertension (e.g., > 145/90 mmHg). Patients currently using sibutramine should talk with their healthcare professional to determine if continued use of sibutramine is appropriate and discuss any questions they may have about their treatment.
    [01/21/2010 - Follow-Up to the November 2009 Early Communication about an Ongoing Safety Review of Sibutramine, Marketed as Meridia - FDA] Previous MedWatch Alert: [11/20/2009 - Meridia (sibutramine hydrochloride): Early Communication about an Ongoing Safety Review]".... keywords: diet drug,Fen Phen, PPH, primary pulmonary hypertension, recall, product liability, personal injury

38. Fingertip Amputations Prompt Recall of Graco Strollers http://bit.ly/6MUNn0 (NY Times) - An excerpt from the article states that "About 1.5 million Graco strollers sold at Wal-Mart, Target and other major retailers are being recalled after some children’s fingertips were amputated by hinges on the products. The recall by Graco Children’s Products includes certain model numbers of its Passage, Alano and Spree Strollers and Travel Systems. The company, based in Exton, Pa., received seven reports of injury to children who had placed their fingers in a stroller’s canopy hinge as the canopy was being opened or closed. Five children suffered severed fingertips, and two children received cuts on their fingertips. The strollers were made in China by Graco and sold at AAFES, Burlington Coat Factory, Babies “R” Us, Toys “R” Us, Kmart, Fred Meyer, Meijer, Navy Exchange, Sears, Target, Wal-Mart and other retailers from October 2004 to December 2009. In announcing the recall Wednesday, the Consumer Product Safety Commission said the strollers posed an amputation and laceration hazard to children when the canopy was opened or closed. The government advised consumers to stop using the strollers and contact Graco to receive a free repair kit. The recall involves strollers made between October 2004 and February 2008. The model numbers and manufacture dates are on the lower inside portion of the rear frame, just above the rear wheels.".... keywords: recall, product liability, defective part, personal injury

39. Living With a Formerly Fatal Blood Cancer http://bit.ly/6lBzzY (NY Times) - An excerpt from the article states that "In December 2005, a series of mysterious symptoms — night sweats, easy bruising, swollen ankles and breathlessness upon exertion — prompted Barry to see his doctor. Only six months earlier, a physical exam had found nothing abnormal. But now Barry’s white blood cell count was through the roof. A bone marrow test the next day revealed a genetic abnormality called the Philadelphia chromosome that is the signature of chronic myelogenous leukemia, or C.M.L., a blood cell cancer that in the last decade has been transformed from ultimately fatal to nearly always treatable, usually until something else claims the patient’s life. Despite his illness, Barry, a lawyer who for privacy reasons asked that his last name not be used, is living a normal life. “I go to the gym, go to work, travel, play with my grandson — that’s the best,” he said in an interview. “In some of my support groups, people have been living with the disease now for 10 or 12 years.” Before 2000, fewer than half of C.M.L. patients survived seven years; now nearly 90 percent are alive seven years after diagnosis and, like Barry, lead relatively normal lives. (The basketball star Kareem Abdul-Jabbar announced in November that he had been living with the disease for nearly a year.) “C.M.L. has become a chronic disease leading to a normal life span in the majority of patients,” Dr. Elias Jabbour of the University of Texas M.D. Anderson Cancer Center said last month in a teleconference workshop sponsored by CancerCare. “As for quality of life, among more than 3,000 patients who have been followed now for almost 10 years, there’s been no significant increase in the incidence of infection, other cancers or other causes of death when compared to the normal population.” What led to this turnaround was identification of the genetic marker of the disease and development of a drug called Gleevec (imatinib), which attacks the leukemia-promoting protein, tyrosine kinase, found in 95 percent of C.M.L. patients. Since the approval in 2001 of Gleevec, a drug that inhibits activity of this protein, two other even more powerful tyrosine kinase inhibitors have been approved by the Food and Drug Administration to treat the disease. Barry, for example, is now on the third generation of anti-C.M.L. drugs, Tasigna (nilotinib), after his cancer became resistant to control by Gleevec and he developed an uncontrollable side effect to its successor, Sprycel (dasatinib). A Model of Complexity But while the success to date with C.M.L. has been nothing short of inspirational, the experience over the past decade with this genetically relatively simple cancer has demonstrated why it is so challenging to find cures for other cancers, most of which are much more complex. As sometimes happens with C.M.L., all it takes for a cancer to escape the stranglehold of modern therapies is for one cancer cell to develop a treatment-resistant mutation and take over. “C.M.L. is a disease we always considered to be a model of genetic abnormality,” Dr. Jorge E. Cortes, a leukemia specialist at M. D. Anderson, said in an interview. “All one needed to do is design a drug directed at that abnormality and get a great response. Then we started to uncover just how heterogeneous this ‘homogeneous’ disease really is. “The expression of certain genes is very different in different patients. While the majority of patients respond well to Gleevec, some don’t, some respond initially and then lose the response, and some develop mutations that may or may not be sensitive to the drugs.” Among patients who develop resistance to the treatments, Dr. Cortes said, “only about half have a mutation that we can detect.” “And in those with a mutation,” he continued, “the presence of mutated cells seems to affect the nonmutated cells and make them more resistant to treatment. Even in a disease that is genetically simple, these leukemic cells don’t just roll over and die, even if attacked by very effective weapons. They find ways to survive.” In the M.D. Anderson publication OncoLog last June, Dr. Cortes said: “We’ve clearly changed the natural history of this disease with imatinib, but it doesn’t work for everybody. We still need to improve therapy, in both newly diagnosed and resistant disease.” Another problem is an inability to know for certain if and when the disease has been cured. For as long as a drug is working, patients must now continue to take it every day to keep the disease suppressed. And the cost is astronomical — $98,000 a year, Barry said. He is now on Medicare, and in just one month he reached the “doughnut hole” in the program’s drug benefit, during which he must pay the full cost of treatment before the insurance resumes. Still, Barry remains very encouraged. As he learned from the latest conference of the American Society of Hematology, “they’re working on vaccines and drug combinations, as well as additional drugs for C.M.L., to address a mutation that current drugs don’t handle.”".... keywords: CML, benzene, toxic exposures, toxic tort, benzene exposure

40. 635,000 cribs recalled for risk to infants http://bit.ly/4xuVGU (CNN) - An excerpt from the article states that "About 635,000 cribs sold at major discounters nationwide have been recalled by Dorel Asia SRL for strangulation and suffocation hazards that killed one child and injured 10 others, the government said Thursday. The U.S. Consumer Product Safety Commission said that the hardware holding up the side of the crib can fail, causing the drop side of the crib to detach, which could trap and suffocate a child. About 635,000 Dorel Asia stationary and drop-side cribs are affected by the recall. The drop side is "the side of the crib that caregivers can move up and down to get a child in or out of the crib," said Kim Dulic, a spokeswoman for the CPSC. "When the drop side detaches it creates a space in which an infant or toddler can become entrapped and suffocate or strangle," the organization said in the statement. Infants are also at risk of entrapment and possible strangulation if a slat on the crib is damaged, which can occur when the crib is in use, in storage, during shipping and handling and while putting the crib together or taking it apart. ".... keywords: recall, product liability, defective part

41. Chrysler vehicles recalled for possible brake failure http://bit.ly/682nNz (CNN) - An excerpt from the article states that " Chrysler Group is recalling about 24,000 late-model Chrysler, Dodge and Jeep vehicles to fix a defective part that could cause sudden, unexpected brake failure. The recall applies to some 2010 model year Chrysler Sebring and Dodge Avenger sedans, Dodge Nitro and Jeep Liberty SUVs, Jeep Commander and Grand Cherokee SUVs and 2009 and 2010 model year Ram trucks. Some of these vehicles could have an improperly formed brake booster rod retaining clip, and some Ram trucks may have been built without the piece. The part is necessary for consistent and proper functioning of the brakes. Chrysler is not aware of any crashes or injuries related to the problem, according a document Chrysler filed with the National Highway Traffic Safety Administration. A Chrysler representative was not immediately available to provide additional comment on the recall.”.... keywords: recall, product liability, defective part, brake failure, auto accident

42. Britain apologizes 50 years after Thalidomide scandal http://bit.ly/7RlFL7 (Reuters) - An excerpt from the article states that "The British government apologized on Thursday to sufferers from the thalidomide scandal, half a century after thousands of babies were born with birth defects after their mothers took the morning sickness pill. "The government wishes to express its sincere regret and deep sympathy for the injury and suffering endured by all those affected when expectant mothers took the drug thalidomide between 1958 and 1961," health minister Mike O'Brien told a hushed parliament. "We acknowledge both the physical hardship and the emotional difficulties that have faced both the children affected and their families as a result of this drug, and the challenges that many continue to endure, often on a daily basis," he said. "I know that a lot of Thalidomiders have waited a long time for this," O'Brien said, using the terms survivors of the drug use to refer to themselves. The thalidomide scandal triggered a worldwide overhaul of drug-testing regimes and boosted the reputation of the U.S. Food and Drug Administration, which proved a lone voice in refusing to approve the drug. Thalidomide was marketed internationally to pregnant women in the late 1950s and early 1960s as a treatment for morning sickness. About 10,000 babies were born around the world with defects caused by the drug, ranging from malformed limbs to no arms or legs..”.... keywords: birth defects, paxil, pphn, persistent pulmonary hypertension of the newborn (PPHN), heart defects, birth injury

43. Kodak sues Apple, RIM over digital camera patents http://bit.ly/8fjA9M (AP) - An excerpt from the article states that "Eastman Kodak Co. said Thursday it is suing Apple Inc. and BlackBerry maker Research in Motion Ltd. over technology related to digital cameras in their iPhone and BlackBerry smart phones. Kodak, a maker of digital cameras and other photography products, filed a complaint with the U.S. International Trade Commission, alleging the iPhone, Apple's hottest gadget, and Research in Motion's camera-enabled BlackBerry devices infringe on a Kodak patent covering technology for previewing photos. Kodak is asking the federal agency that oversees trade disputes to bar Apple and RIM from shipping the phones. The agency has the power to order Customs to stop imports of products and parts made with contested technology. Kodak also filed separate lawsuits against Apple in U.S. District Court in Rochester, claiming an infringement of patents related to digital cameras and certain computer processes. It is asking for unspecified monetary damages and a court order to end the disputed practices. Sales of iPhones and BlackBerrys aren't immediately threatened. Patent cases can take months or years to resolve, and agreements over licensing and royalty payments often emerge. But the trade commission is viewed as a fast-track mediator that typically resolves such intellectual-property disputes in 12 to 15 months. RIM and Apple officials declined to comment.”.... keywords: patent, infringement, patent litigation, patent lawsuit, intellectual property lawsuit, patent infringement

44. Health care: A 'goldmine' for fraudsters http://bit.ly/5OxJea (CNN) - An excerpt from the article states that "There's a group of people who really love the U.S. health care system -- the fraudsters, scammers and organized criminal gangs who are bilking the system of as much as $100 billion a year. Health care identity theft dominated all other crimes in the sector last year, according to Louis Saccoccio, executive director of the National Health Care Anti-Fraud Association (NHCAA), an advocacy group whose members include insurers, law enforcement and regulatory agencies. The most common method of health care identity fraud occurs when someone with legitimate access, such as a hospital administrator or a doctor's assistant, sells patients' information to organized criminal groups. Increasingly, criminal groups are hacking into digital medical records so that they can steal money from the $450 billion, 44-million-beneficiary Medicare system -- making the government, by far, the "single biggest victim" of health care fraud, according to Rob Montemorra, chief of the FBI's Health Care Fraud Unit. All the stolen information includes medical insurance data and Social Security numbers, explained James Van Dyke, president of Javelin Strategy & Research, a research firm specializing in trends in security and fraud initiatives.”.... keywords: qui tam, federal false claims, fraud, whistleblower

45. Woman 'Regrows' Face After Allergic Reaction Causes Skin to Fall Off http://bit.ly/5lWD7z (Fox) - An excerpt from the article states that "Four years ago, Eva Uhlin had a fever so she took acetaminophen. The next day, the then 15-year-old found her body covered in blisters. She was admitted to the burn unit of University Hospital in Linkoping in Sweden, and doctors diagnosed her with toxic epidermal necrolysis. She was given morphine to relieve the pain. But Uhlin's skin started to fall off as doctor's examined her. Uhlin lost much of her face's surface over the next few years, as well as skin from various parts of her body and her fingernails.”.... keywords: stevens-johnson syndrome, toxic epidermal necrolysis (ten)

46. Nexus Name Irks Author's Estate http://bit.ly/7Ar0dG (WSJ) - An excerpt from the article states that "As Google Inc. launches its Nexus One phone, one call that the company hasn't made is to the family members of science-fiction author Philip K. Dick, who complain the device's name infringes on one of Mr. Dick's most famous novels. "We feel this is a clear infringement of our intellectual-property rights," said Isa Dick Hackett, a daughter of Mr. Dick and the chief executive of Electric Shepherd Productions, an arm of the Dick estate devoted to adapting the late author's works. "Our legal team is dealing head-on with this," she said Tuesday. An attorney for the estate declined to elaborate on what legal steps it has taken. Philip K. Dick's novel, 'Do Androids Dream of Electric Sheep?,' was the basis for the 1982 film 'Blade Runner.' Mr. Dick's 1968 novel, "Do Androids Dream of Electric Sheep?," which served as the basis for the 1982 cult film "Blade Runner," follows a bounty hunter chasing androids known as Nexus-6 models. Ms. Hackett believes Google referenced that work in coming up with the name for its new phone, but the company never called her family or attorneys for permission to license the name. A Google spokesman declined to comment. Ms. Hackett argues the association between the phone and the book are cemented by the fact that the Nexus One runs Google's Android operating system. Google has its "Android system, and now they are naming a phone 'Nexus One,'" she said. "It's not lost on the people who are somewhat familiar with this novel." Attorneys who specialize in trademark disputes don't see a clear-cut case. One key issue is whether consumers are likely to be confused and think Mr. Dick's estate was associated with Google's phone. ”....

47. F.D.A. to Seek New Standards on Human Test Data http://bit.ly/8Ghq6r (NY Times) - An excerpt from the article states that "The Food and Drug Administration is developing guidelines that will set tougher scientific standards for data from tests on humans that makers of medical devices submit when seeking approval of their products, a top agency official said.Dr. Jeffrey Shuren, a top federal health official, criticized the device approval process. Dr. Jeffrey Shuren, the acting director of the Center for Devices and Radiological Health, said in a telephone interview on Monday that the F.D.A. most likely will soon urge device makers to take steps like using more sharply defined targets to measure the success of clinical trials. The agency may also urge producers to more closely follow patients enrolled in such trials to determine whether the targets are met, he added. His comments were made before the release on Tuesday of two studies that found shortcomings in some clinical trials accepted by the F.D.A. over the last decade in connection with the approval of high-risk cardiovascular devices. Such products include pacemakers, implanted defibrillators and the tiny tubes known as coronary stents, which are used to prop open clogged blood vessels. One review was performed by the F.D.A. and researchers from the Beth Israel Deaconess Medical Center in Boston. The other review, which was published in The Journal of the America Medical Association, was conducted by researchers at the University of California, San Francisco. Both studies looked at the scientific quality of the clinical trials submitted to F.D.A. from 2000 to 2007. In recent years, the agency has come under criticism from lawmakers, researchers and patient advocates for the standards it uses in approving medical devices. The issue of F.D.A. oversight has also taken on particular significance because of a recent United States Supreme Court decision that has shielded makers of high-risk devices from patient lawsuits if their product was approved by the agency. The F.D.A.-sponsored study found that more than 40 percent of the studies used to approve cardiovascular devices had lacked high-quality data about either the treatment or safety goals of the study. In addition, that study also found that about 25 percent of trials had failed to adequately follow the outcomes of a sufficient number of patients, a level the review defined as 90 percent or more of patients initially enrolled in a trial. The study’s findings demonstrate that submitted studies frequently lack important details, including information about subjects and study end point definitions,” researchers reported in the review, which was posted Tuesday on the site of The American Journal of Therapeutics. Dr. William H. Maisel, a cardiologist at the Beth Israel Deaconess Medical Center who was involved in the study, said the review did not find a correlation between lower-quality data and problems related to the devices. However, he said he thought the potential for such links existed. “It is important that the F.D.A. and manufacturers do things differently,” said Dr. Maisel, who has served as an adviser to the agency on heart devices and who has been a frequent critic of agency actions. In an unusual move, Dr. Shuren and other F.D.A. officials said they were releasing their study earlier to rebut what they said were inaccuracies in the report in The Journal of the America Medical Association. That review was far more critical of the device approval process than the agency-sponsored report and concluded that the F.D.A. had approved cardiovascular devices based on data that “lacked adequate strength.”....

48. FDA, Health Organizations to Study Safety of Medications Taken During Pregnancy http://bit.ly/6UAozP (FDA) - An excerpt from the article states that "A new research program called the Medication Exposure in Pregnancy Risk Evaluation Program (MEPREP) will fund research to study the effects of prescription medications used during pregnancy. The program is a collaboration among the U.S. Food and Drug Administration and researchers at the HMO Research Network Center for Education and Research in Therapeutics (CERT), Kaiser Permanente’s multiple research centers and Vanderbilt University. About two-thirds of women who deliver a baby have taken at least one prescription medication during pregnancy according to a journal article published in the American Journal of Obstetrics and Gynecology. There are very few clinical trials that test the safety of medications in pregnancy due to concerns about the health of the mother and child. “This program is a great example of FDA and the private sector working together to improve the health of pregnant women and their children,” said Margaret Hamburg, MD, Commissioner of Food and Drugs. "These data will guide regulatory policy and influence medical practice." To overcome the challenges presented by the lack of clinical trial data about the use of medications during pregnancy, the research program will link health care information for mothers and their babies in each of the participating research sites. Collectively, the 11 participating sites have health care information for about 1 million births over the past seven years (2001-2007). Many of the mothers associated with these births likely used medication during their pregnancies and now, with the program in place, the FDA and participating researchers have a systematic and timely way of retrieving information from this network. “This collaborative effort creates a unique resource to study the effects of medication in pregnant women and their children,” said Gerald Dal Pan, M.D., director of the Office of Surveillance and Epidemiology at the FDA’s Center for Drug Evaluation and Research. “Results of these studies will provide valuable information for patients and physicians when making decisions about medication during pregnancy.” The program blends clinical and research expertise and population-based databases from 11 health plan-affiliated research sites including Kaiser Permanente (Northern California, Southern California, Georgia,, Pacific Northwest, and Colorado regions); Harvard Pilgrim Health Care Institute, Group Health Research Institute, HealthPartners, Lovelace Clinic Foundation, the Meyers Primary Care Institute, and Tennessee State Medicaid, and the FDA. The HMO Research Network CERT Data Center at the Department of Population Medicine of Harvard Medical School and Harvard Pilgrim Health Care Institute, led by Richard Platt, M.D., M.S., is the coordinating center for the program. Lead researchers include Susan Andrade, Sc.D. HMO Research Network William Cooper, M.D., M.P.H. (Vanderbilt); Robert Davis, M.D., M.P.H. (Kaiser Permanente Georgia); Craig Cheetham, Pharm.D.; (Kaiser Permanente Southern California); and De-Kun Li, M.D., Ph.D. (Kaiser Permanente Northern California). The investigators have collaborated on numerous studies related to medication use during pregnancy and birth outcomes, as well as studies on the effects of anti-depressant medications, antibiotics, and cardiovascular medications on birth defects and perinatal outcomes. A Steering Committee composed of representatives from each participating site and the FDA will oversee MEPREP activities and provide overall scientific leadership. FDA epidemiologist, Pamela E. Scott, Ph.D., is the FDA project lead and chair of the Steering Committee.

49. Outback Steakhouse Settles Sexual-Discrimination Suit for $19 Million http://bit.ly/8tBpip (WSJ)

50. Studies Spotlight Problems in FDA Device Approvals http://bit.ly/517M3h (WSJ) - An excerpt from the article states that "Two leading medical journals have found flaws in how the Food and Drug Administration approves cardiovascular medical devices, saying some products reached the market based on tests that were inadequate and open to bias. The studies come as the FDA is facing intense pressure to overhaul the medical-device approval process following several incidents in which the agency acknowledged missteps, including the case of a knee device that was approved a year ago under political pressure. Jeffrey Shuren, acting director of the FDA's device division, acknowledged weaknesses in clinical trials used to approve some cardiovascular devices. One of the studies was co-authored by an FDA scientist. Dr. Shuren said the FDA has begun toughening standards for device approvals and intends to do more. Dr. Shuren said he wanted companies to work closely with the FDA in setting specific goals for their studies, which hasn't always been the case. "We want to be clear to manufacturers about what is expected of them," he said. He said the FDA is also reviewing clinical studies used to approve hip and spinal implants. The agency is asking companies to include more women in their studies and looking at approvals of pediatric devices, he said. Jeffrey Gibbs, a lawyer with the Washington firm of Hyman Phelps & McNamara, said spinal implants are a fast-growing segment of the medical device industry. "There has been concern within industry as well as the FDA that there wasn't enough robustness of the data, and some studies weren't well-validated," Mr. Gibbs said. The FDA device division has stepped up warning letters, recalls and other enforcement actions, he said........."

51. As Bones Age, Who’s at Risk for Fracture? http://bit.ly/8ZFsw0 (NY Times) - An excerpt from the article states that "For the millions of Americans with bones that are thinning as they age, this question arises: Who should be treated with bone-enhancing drugs? Until recently, many doctors and drug companies that make these medications were saying almost everyone — especially older white women, who are at highest risk of one day suffering an osteoporotic fracture. These low-trauma fractures are debilitating and costly, adding more than $17 billion a year to the national health care bill. Among elderly people who fracture a hip, 10 percent to 20 percent die within six months; many more spend the rest of their lives in nursing homes or needing full-time home care. The National Osteoporosis Foundation reports that “about one out of every two Caucasian women will experience an osteoporosis-related fracture at some point in her lifetime, as will approximately one in five men.” “Although osteoporosis is less frequent in African-Americans,” the foundation continues, “those with osteoporosis have the same elevated fracture risk as Caucasians.” But the drugs currently available to enhance bone density are far from perfect. They are expensive, they can have side effects, and they are only about 50 percent effective at preventing fractures. Before any treatment, possible risks should be weighed against known benefits. If you have osteoporosis, defined as a T score — the standard measure of bone density — of minus 2.5 or lower, or you have already had an osteoporotic fracture of the forearm, hip, shoulder or spine, the answer is clear: treat. For you, experts say, the benefits of treatment are expected to far outweigh the risks. But what about the much greater number of women and men whose bones are not as strong as they were at age 30 but who have not yet become osteoporotic — with T scores in the hip or spine of minus 1 to minus 2.5? They are said to have osteopenia, which may or may not eventually lead to osteoporosis. Who among them would most likely benefit from treatment?”........"

52. An Underground Campaign http://bit.ly/5yAdp5 (NY Times) - An excerpt from the article states that "LAWMAKERS debating health care reform in recent weeks haven’t been reticent about blaming trial lawyers for driving up the nation’s medical costs by pursuing large malpractice awards. Trying to fend off any limits to patient lawsuits, the lawyers decided to press their arguments in a new location — the subway system here. Lawmakers and their aides arriving on Capitol Hill by Metro, as the subway is known, pass through a blizzard of brightly colored ads on the platform and the walls and hanging from the ceiling. They bear the lawyers’ message that nearly 100,000 people die each year from medical errors, and that tort reform won’t fix the health care system. “We wanted a prominent space to educate key people about the number of people who are killed annually by medical errors,” said Anthony Tarricone, president of the American Association for Justice, formerly known as the Association of Trial Lawyers of America. The lawyers, who introduced their subway campaign this month, anticipated that they would be a target for senators looking to control health care costs, said Mr. Tarricone, a Boston plaintiffs’ lawyer. During the debate, several senators introduced amendments, including one called “loser pays” — meaning the person who loses the lawsuit must pay all the legal costs — to clamp down on medical liability lawsuits. None was adopted.The trial lawyers argue in the ads that patients need legal recourse because preventable medical errors are the sixth-leading cause of death in America, killing at least 98,000 people a year. (The ads’ tag line is: “Tell Congress to Put Patients First. There Are 98,000 Reasons Why You Should.”) The campaign Web site, 98000reasons.org, calls that number equivalent to two 737s crashing every day for a year — and the ads include two small images of planes. The figure comes from a 1999 report called “To Err Is Human,” from the federal Institute of Medicine, part of the National Academy of Sciences. This is the most recent nationwide figure, said Mr. Tarricone, who added that the number of deaths and injuries could be higher because the “problem has only gotten worse.”........"

53. J&J expands recall of Tylenol arthritis caplets http://bit.ly/7ItTuA (Reuters) - An excerpt from the article states that "A voluntary recall of Tylenol Arthritis Pain Caplets is being expanded because of consumer reports of an unusual moldy odor with the 100-count bottles, the U.S. Food and Drug Administration said late on Monday. The FDA said it and Johnson & Johnson were expanding the recall to all available product lots of the pain caplets with the distinctive red EZ-open cap. The initial recall involved five lots of the product in November after reports of an unusual musty or mildew-like odor that was associated with nausea, stomach pain, vomiting and diarrhea, the FDA said. The agency said the odor was believed to have been caused by the breakdown of a chemical used to treat wooden pallets that transport and store packaging materials........"

54. Senior-citizen volunteers fight Medicare fraud http://bit.ly/8XBOl4 (PE.com) - An excerpt from the article states that "The first box that arrived at Shirley Shupp's door was filled with braces to help with her arthritis. Then came a motorized scooter, just like the one the 69-year-old already owned. She hadn't asked for any of it - but Medicare was apparently footing the bill. "There was just something that wasn't right about it," the Houston woman said. So Shupp contacted her local Senior Medicare Patrol, which did its own research and then referred the matter to investigators. The equipment, worth thousands of dollars, was returned, the case was handed over to prosecutors and the perpetrators were charged with Medicare fraud. The Senior Medicare Patrol is one of the least-known forces in the government's effort to eliminate such fraud, which drains billions of dollars a year. But it is seen as a valuable part of the Obama administration's bid to overhaul health care and bring down costs. The 4,700 senior citizen volunteers who serve as the government's eyes and ears have been credited with saving taxpayers more than $100 million since 1997. The program relies on elderly people to apply a lifetime's worth of common sense and skepticism. "They can tell when something just doesn't feel right to them," said Anne Gray, who works on the SMP program in Santa Ana, Calif. The patrol, which evolved from another program founded in 1995, now has at least one unit in every state. SMP sends its volunteers to senior centers, retirement communities and elsewhere to encourage Medicare beneficiaries to guard their personal information, beware of too-good-to-be-true offers on medical equipment and carefully review their benefit statements. The patrol also collects tips on potential scams and fields calls from senior citizens who believe their Medicare accounts have been fraudulently billed. When all they have is a whiff of something fishy, SMP participants often keep probing until they have enough information to send on to the FBI and investigators with the Centers for Medicare and Medicaid Services. "It really is detective work," said Barbara McGinity, director of the SMP in Houston........"

55. Have acute pancreatitis? Go to a big hospital http://bit.ly/7ncxzY (Reuters) - An excerpt from the article states that "New research suggests that patients who go to hospitals that admit 118 or more people with pancreatitis each year experience shorter stays and lower death rates, and have lower hospital bills than patients who go to hospitals that admit fewer than 118 people with pancreatitis each year. In general, the hospitals dealing with more pancreatitis cases tended to be larger, urban, research centers and serve a greater black or Hispanic population. The findings, which appear in the journal Gastroenterology, are based on a review of more than 416,000 cases of acute pancreatitis treated in US hospitals from 1998-2006. Dr. Shimul A. Shah of the University of Massachusetts Medical School in Worcester and colleagues say reasons for the difference in outcomes from low- and high-volume hospitals may have to do with the availability of intensive care, specialists, and the latest technology at the various hospitals. "Given the rising incidence of acute pancreatitis and the reported costs exceeding $2 billion annually in the United States, our study suggests that referral of complicated cases of acute pancreatitis to high-volume centers should be discussed at a policy level," Shah and colleagues conclude........"

56. FDA Says 'Unlikely' That Vytorin, Zetia Increase Cancer Risk http://bit.ly/4KW9Bm (WSJ) - An excerpt from the article states that "The U.S. Food and Drug Administration on Tuesday said it's "unlikely" Merck & Co.'s cholesterol drugs Vytorin and Zetia increase the risk of cancer or cancer-related death. Still, the FDA said it can't "definitively" rule out that the drugs may be associated with increased cancer risk. "Based on the currently available information, FDA believes it is unlikely that Vytorin or Zetia increase the risk of cancer or cancer-related death, but at this time an association cannot be definitively ruled out," the agency said in a posting on its Web site Tuesday. The FDA's views come after it finished a review of a clinical trial that shocked investors and the medical community when it showed an increased risk of cancer and deaths from cancer in patients taking Vytorin compared with those given a placebo. Vytorin is a single-tablet combination of the drugs simvastatin and Zetia, which work by different mechanisms to lower bad cholesterol. Simvastatin is sold by Merck under the brand Zocor, but has been available from several generic manufacturers after losing U.S. patent protection in 2006. ......."

57. Court Affirms Injunction Against Microsoft http://bit.ly/68cQQV (WSJ) - An excerpt from the article states that "A federal appeals court on Tuesday affirmed a $290 million patent infringement judgment against Microsoft Corp. and reinstated an injunction that bars the company from selling current versions of its flagship Word software........"

58. No link Seen Between Acetaminophen, birth defects http://bit.ly/5tkQUf (WSJ) - An excerpt from the article states that "Acetaminophen is the active ingredient in Tylenol and certain other painkillers, and is often found in over-the-counter cold and flu remedies. Taken as directed, acetaminophen is considered safe during pregnancy, making it the medication of choice for pregnant women's body aches and fevers. However, there are still some questions about whether the drug can contribute to birth defects. Studies looking at birth defects as a broad group have either found no link to acetaminophen use or have yielded inconclusive findings. Some research, meanwhile, has suggested that the drug may be linked to a higher risk of a birth defect called gastroschisis -- but other studies have found no such connection. Gastroschisis refers to a defect in the abdominal wall that allows the intestines to protrude; it has been linked to aspirin use during pregnancy. In the new study, researchers analyzed data from a large U.S. study that included more than 11,600 children born with congenital defects such as spina bifida, cleft lip and various defects affecting the brain, heart, lungs, limbs and gastrointestinal system. They were compared with 4,500 children born with no major anomaly.Overall, the study found, there was no evidence linking mothers' acetaminophen use in the first trimester to a heightened risk of any birth defect. In fact, women who took the medication to treat a first-trimester fever had a lower risk of certain birth defects -- including gastroschisis -- than women who did not treat their fevers with acetaminophen......."

59. GE Sues a Doctor for Libel http://bit.ly/7CpwZE (WSJ) - An excerpt from the article states that "For a while now, the FDA and other regulators have been looking at safety risks associated with a few drugs patients sometimes take before getting MRI scans. While it’s common for new risks to crop up with established drugs, the Times of London this weekend highlighted an interesting twist in this case: GE has filed a libel suit in Britain against a Danish radiologist who gave a talk about the risks associated with Omniscan, a GE drug that’s one of the medicines regulators have been looking at. The doctor, Henrik Thomsen, gave a presentation to about 30 people two years ago in Oxford, the article says. He described a cluster of cases at his hospital in Copenhagen where kidney patients who received Omniscan developed a rare disorder called nephrogenic systemic fibrosis. One of the patients died......"

60. Rare disease attacks, burns woman's skin http://bit.ly/6gtt9L (NY Times) - An excerpt from the article states that "Ten years ago, a national panel of health care experts released a landmark report on medical errors in the American health care system. Published by the Institute of Medicine, “To Err is Human: Building a Safer Health System” estimated that as many as 98,000 people died in hospitals each year as a result of preventable mistakes. Being hospitalized, it turned out, was far riskier than riding a jumbo jet. While the report offered comprehensive strategies to improve safety, its main conclusion was that medical errors were primarily a result of “faulty systems, processes and conditions that lead people to make mistakes or fail to prevent them.” Spurred on by this finding, health care leaders across the country began addressing errors believed to be a result of systemic flaws. They instituted more rigorous hospital accreditation standards and procedures, increased public reporting and transparency and established systemwide safety changes like the mandatory use of checklists, the placement of hand sanitizing gel dispensers throughout hospital wards and the regulation of physician duty hours. For nearly a decade, this paradigm of systems failure defined the national movement to improve patient safety. But more recently, some health care safety experts have begun questioning the assumption underlying the report’s conclusions: that only health care systems, and not individual clinicians, could be held accountable for medical mistakes. Dr. Robert M. Wachter, a professor of medicine at the University of California, San Francisco, and a national leader in patient safety, recently published two critiques of the safety movement, one in Health Affairs and one in The New England Journal of Medicine. Both urge physicians to begin acknowledging their individual roles in medical errors. “A blame-free culture carries its own safety risks,” he writes. “As we enter the second decade of the safety movement, while the science regarding improving systems must continue to mature, the urgency of the task also demands that we stop averting our eyes from the need to balance ‘no blame’ and accountability.”......"

61. Rare disease attacks, burns woman's skin http://bit.ly/4NBBlW (Fox) - An excerpt from the article states that "Two weeks ago, Yasmin Hernandez was a vibrant, loving woman, devoted wife and mother of five young children. Now, she lies in a hospital bed, heavily sedated, because her skin is burning from the inside out. And her family is asking for prayers. Hernandez has developed toxic epidermal necrolysis, a condition so rare that the chances of getting it are about one in a million. Toxic epidermal necrolysis, or TEN, is the more severe form of Stevens-Johnson Syndrome, both of which are skin diseases that are caused by a reaction to medication. FOX 13 medical reporter Dr. Joette Giovinco says the medical field is still unclear about pinpointing the exact mechanism that causes TEN and SJS. "Medications can precipitate it. Antibiotics, non-steroidal, anti inflammatory drugs, anti-seizure drugs, anti-psychotic drugs," Giovinco said. Yasmin's husband Benjamin says his wife took a drug on December 3 to treat bipolar disorder before she got sick. "She had a fever of 109. I thought my thermometer was broken. I rushed her to the hospital," Benjamin said. Now, the blistering from TEN is literally burning Yasmin's skin off her body, and she is bandaged from head to toe. She is on a ventilator at an Orlando hospital, and her husband says she stands a 30 percent chance of survival......"

62. 26 Arrested in Three States in Medicare Fraud Schemes http://bit.ly/7sNSQP (NY Times) - An excerpt from the article states that "Federal agents arrested 26 suspects in three states on Tuesday, including a doctor and nurses, in a crackdown on Medicare fraud totaling $61 million. Yudel Cayro was among those arrested in Miami on Tuesday. Arrests in three separate cases in Brooklyn, Detroit and Miami included a Florida doctor accused of running a $40 million home health care scheme that falsely listed patients as blind diabetics so he could bill for twice-daily nurse visits. The Department of Justice and the Department of Health and Human Services said 32 indicted suspects lined up bogus patients and otherwise billed Medicare for unnecessary medical equipment, physical therapy and infusions for H.I.V. The doctor in Miami, Dr. Fred E. Dweck, along with 14 people with whom he worked, was accused in an indictment of running a scam to tap a Medicare program that pays high rates to care for the sickest patients. Dr. Dweck referred about 1,250 Medicare beneficiaries for expensive and unnecessary home health and therapy services, the indictment said, and bribed the owners of two clinics in Miami to join the scam. He also faked medical certifications, according to the indictment......."

63. Aviation Injuries, Aloft and on the Ground http://bit.ly/5aOSmc (TCEQ) - An excerpt from the article states that "More than 1,000 people a year are hospitalized for aviation-related injuries, with only one-tenth of them passengers in commercial aircraft. Researchers have analyzed data from 2000 through 2005, gathering information on crashes, parachuting accidents, airport maintenance worker injuries and passenger injuries sustained on the ground, among others. The report, which appears in the December issue of Aviation, Space, and Environmental Medicine, uses a group of health care databases maintained by the federal government’s Healthcare Cost and Utilization Project. Only 10.6 percent of those hospitalized were traveling in commercial aircraft. More than 32 percent were injured in private planes, and almost 11 percent in gliders or hang gliders. Unsurprisingly, jumping out of an airplane is quite dangerous: 28.9 percent of those injured were parachutists. More than 28 percent of all injuries were to the lower limbs. And while burns were seen in just 2.5 percent of the patients, they accounted for 17 percent of deaths after hospitalization....."

64. Cleanup in Midland County: West County Road 112, Midland, TX Information on the chromium contamination in the groundwater near West County Road 112, Midland, TX. http://bit.ly/5ZvyJr (TCEQ) - An excerpt from the article states that "On April 8, 2009, the TCEQ collected a groundwater sample from a water well on West CR 112 that indicated hexavalent chromium at 5250 parts per billion. The maximum contaminant level (MCL) for chromium is 100 parts per billion. Additional private-water-well sampling has been performed on West CR 112. Several of these sampled wells indicated levels of hexavalent chromium above the MCL. The source of the contamination is still undetermined.Current Activities The TCEQ has extended its current sampling area and will continue to expand the sampling area until the extent of the contamination is defined. To date, approximately 234 water wells have been sampled and the TCEQ has installed approximately 41 anion-exchange water filtration systems at homes where total chromium has been detected above the MCL. Due to fluctuations in total chromium levels in groundwater, some of the wells with filtration systems currently show total chromium levels below the MCL. This finding is not unusual due to the dynamics of groundwater flow in the Trinity aquifer. With respect to chromium, the anion-exchange filtration systems provide water that is safe for all household uses. These filtration systems are currently being installed and maintained at no cost to the homeowner. The TCEQ has screened area wells for Volatile Organic Compounds (VOCs), Semi-Volatile Organic Compounds (SVOCs), and Total Petroleum Hydrocarbons (TPH). No other contaminant plumes have been identified. No other contaminants have been identified that would interfere with the filtration systems. TCEQ continues to sample wells with filters to monitor the filtration systems and will resample wells outside the currently established groundwater plume to monitor plume movement. The TCEQ held a community meeting on May 28, 2009 at 7:00p.m. at the Midland County Horseshoe, 2002 Cotton Flat Road, Midland, TX. A powerpoint slideshow was presented. On June 3, 2009 the Texas Department of State Health Services, in cooperation with the U.S. Department of Health and Human Services Agency for Toxic Substances and Disease Registry, completed a letter health consultation which evaluates the potential health effects of chromium in private water wells in the area around West County Road 112 in Midland, Texas. A community meeting was held on Tuesday, June 30, 2009 at 6:00 p.m. at the Midland County Horseshoe, 2002 Cotton Flat Road, Midland, TX. A powerpoint presentation was shown. An Open House Availbility Session was held on Thursday, September 24, 2009, from 6:00p.m. to 8:00p.m., at the Midland County Horseshoe, 2002 Cotton Flat Road, Midland, TX. The Open House Availability Session was of an informal come-and-go format that allowed for one-on-one questions and answers between residents and staff from the TCEQ and Midland County....."

65. FDA Approves First Generic Aricept to Treat Dementia Related to Alzheimer’s Disease http://bit.ly/71sWG2 (FDA) - An excerpt from the article states that "The U.S. Food and Drug Administration approved the first generic versions of Aricept (donepezil hydrochloride) orally disintegrating tablet s on Dec. 11. Donepezil hydrochloride is indicated for the treatment of dementia related to Alzheimer’s disease. Although other generic versions of donepezil hydrochloride are already available, the orally disintegrating tablets dissolve on the tongue, without having to be swallowed whole. This may make it easier to take the medication for older or disabled patients who have difficulty swallowing. “Generics offer greater access to health care for all Americans,” said Gary Buehler, director of the FDA’s Office of Generic Drugs. “Health care professionals and consumers can be assured that FDA-approved generic drugs have met the same rigorous standards as the brand-name drug and are the same as the branded in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.” Alzheimer’s disease is an irreversible, progressive brain disease that slowly destroys memory and thinking skills and, eventually, the ability to carry out the simplest tasks of daily living. In most people with Alzheimer’s disease, symptoms first appear after age 60. Alzheimer’s disease is the most common cause of dementia among older people, but it is not a normal part of aging. ...."

66. How Much Does a CT Scan Raise the Risk of Cancer? http://bit.ly/5V5jxt (WSJ) - An excerpt from the article states that "We’ve been writing for a while now about the risk of cancer associated with CT scans, an issue doctors have begun to pay more attention to as the use of CT scans has soared. A few papers published this afternoon in the Archives of Internal Medicine add a bit to the discussion; one estimated that the roughly 72 million CT scans performed in the U.S. in 2007 will ultimately cause some 29,000 cases of cancer. A separate study that’s less likely to lead to eye-popping headlines but includes some interesting findings caught our eye: CT scans expose patients to more radiation than is commonly believed, and the amount of radiation a patient is exposed to varies wildly, even for a given type of scan. Doctors commonly say a CT scan of the abdomen and pelvis, a frequently performed scan, exposes patients to 8 to 10 mSv of radiation, but the study found that the median exposure was actually 66% higher. (Here’s an explanation of mSv, which is a unit of radiation.) What’s more, the researchers found that the radiation for a given type of scan varied by a factor of more than 10 — meaning that some patients received far, far more radiation than others who had the same type of scan. The study looked at scans from more than 1,000 patients who were treated at four different hospitals, and each hospital showed significant variation from patient to patient for the same type of scan. So the variations weren’t solely the result of differences between hospitals. While there are reasons that some patients need to be given higher doses of radiation than others, the variation observed in the study is “dramatic and much greater than widely considered acceptable,” according to the authors, who include docs from UC San Francisco and a few other institutions...."

67. Apple countersues Nokia for patent infringement http://bit.ly/8oPOOl (Reuters) - An excerpt from the article states that "Apple, maker of the popular iPhone, was responding on Friday to a lawsuit that arch-rival Nokia filed in October. That suit accused Apple of infringing 10 Nokia patents for technologies such as wireless data, speech coding and security. The countersuit heats up the fight between the two companies. While relative newcomer Apple trails Nokia in cellphone shipments, its iPhone has been gaining a lot of ground against the market leader in the smartphone segment. In court documents, Apple denied infringing the Nokia patents and said that the patents asserted by Nokia were not essential for technology standards used in cellphones. It said the countersuit was filed in the same Delaware court where Nokia brought its case. Apple also said that Nokia had engaged in anti-competitive behavior and did not live up to commitments to license its own technology at fair and reasonable terms. The 13 patents that Apple cited in its countersuit involve various computing technologies including graphical interfaces, teleconferencing, power conservation and touch screen technologies -- features popularized by its iPhone. In response, Nokia said that the countersuit does not change anything fundamental in the original case, but noted that it would take time to study the suit. "They have infringed our patents since the iPhone launch in 2007," a Nokia spokesman said. While the battle may go on for some time, analysts see the companies eventually coming to a licensing agreement.." ...."

68. FDA to weigh safety of AstraZeneca's Crestor http://bit.ly/4Rekn1 (Reuters) - An excerpt from the article states that "AstraZeneca wants permission to promote the drug, Crestor, for preventing heart disease in people with normal cholesterol levels, but with other risk factors based on findings of a large study known as Jupiter. A Food and Drug Administration reviewer, commenting on a higher number of diabetes cases reported with Crestor patients, said that, at the current time, the benefits seen in the Jupiter trial "outweigh the risk, but further clinical trials are needed to further define this benefit/risk ratio." The Jupiter trial "was relatively short in duration" and "therefore the long-term complications are unknown," the reviewer said. The reviewer also said the agency felt it was a "chance finding" that gastrointestinal-related deaths were higher in Crestor patients compared with a placebo. The comments were included in documents the FDA released ahead of a meeting on Tuesday of a panel of outside advisers. The advisory panel will be asked to comment on the diabetes and gastrointestinal findings before deciding whether to recommend approval for expanded use, according to a November 12 memo. The FDA also will seek input on a higher number of patients who reported a "confusional state" in the Crestor group, the memo said. The Jupiter study showed Crestor cut deaths, heart attacks and strokes in middle-aged people with healthy cholesterol, but elevated levels of C-reactive protein, which is associated with heart disease. The FDA said it would ask the advisory panel to "keep in mind that an estimated 6 million middle-aged and older men and women in the United States" meet the criteria of people in the study....."

69. Why You May Soon Hear a Lot More About CRP Testing http://bit.ly/5pmA4r (WSJ) - An excerpt from the article states that "AstraZeneca wants to sell its cholesterol drug Crestor to certain people with normal cholesterol levels. A panel of FDA advisers is meeting next week to consider the proposition, and the agency just put out a hefty pre-meeting memo that summarizes the risks and benefits. (If you don’t want to read the whole memo, Dow Jones Newswires story hits the high points.) AstraZeneca’s request is based on a big study called Jupiter, which found the drug reduced the risk of serious heart problems in patients with normal cholesterol but high levels of something called C-reactive protein, or CRP. The company wants FDA approval to use the drug to treat patients like those in the study....."

70. Poor Care in Hospital Forces Docs to Amputate Severely Burned Girl's Legs http://bit.ly/5GR1KJ (Reuters) - An excerpt from the article states that " Doctors said they were forced to amputate the legs of a toddler who was being treated for severe burns to her hands, health24.com reported. Thembisa Nikelo, 2, was brought to the Far East Rand Hospital in Springs, South Africa in September after she suffered burns on her face and hands. When her legs became gangrenous, the girl was transferred to Charlotte Maxeke Johannesburg Academic Hospital, and it was there that doctors amputated her legs. Doctors said the gangrene did not set in because of the IV drips they used to treat Thembisa, but they were concerned that the child received sub-standard care at the hospital....."

71. Eli Lilly Isn’t Planning to Buy Its Way Around the Patent Cliff http://bit.ly/7q4WJK (Reuters) - An excerpt from the article states that "Eli Lilly knows a thing or two about the patent cliff: Between now and 2013, patent protection will expire on drugs that account for more than half of its current revenue, this morning’s WSJ notes. Plenty of big pharma players face this kind of problem, and many companies have looked to buy their way out of trouble — witness this year’s big Pfizer-Wyeth and Merck-Schering Plough deals. But Lilly emphasized at its annual analyst day yesterday that it didn’t plan to go down that road. Instead, the company is relying largely on its own pipeline of experimental drugs. Analysts are wary of the strategy, in part because some of Lilly’s promising new drugs still have to be studied for a few years before the company can apply to bring them to market. Here are a few tidbits from the latest analyst notes:....."

72. Adequate sleep tied to healthier diets in truckers http://bit.ly/7yE0HL (Reuters) - An excerpt from the article states that "Getting plenty of sleep not only helps keep truck drivers safe and alert on the road, it also seems to fuel healthy eating habits, new research hints.HEALTH In surveys of truckers working at U.S. trucking terminals, those who felt they regularly got adequate sleep tended to consume more fruits and vegetables and fewer sugary drinks and snacks, Dr. Orfeu M. Buxton, at Harvard Medical School in Boston, Massachusetts, and colleagues found. These real-world findings are consistent with laboratory studies showing that insufficient sleep increases hunger and "induces greater eating, especially unnecessary snacking," Buxton noted in an email to Reuters Health. Buxton and associates assessed self-reported diet, sleep, and job-related factors of 542 male Teamster union members who were 49 years old on average. Sixty-six percent worked as pick-up and delivery truck drivers, 20 percent as over-the-road truckers, and 15 percent served dual roles as dockworkers and truck drivers, they note in the American Journal of Public Health." ...."

73. Bone Drugs Appear to Cut Breast Cancer Risk http://bit.ly/4XWpDD (WSJ) - An excerpt from the article states that "A popular class of bone-building drugs known as bisphosphonatesappear to significantly reduce women's risk of breast cancer, according to research being presented Thursday at the San Antonio Breast Cancer Symposium. In one study, researchers analyzed data from the huge National Institutes of Health-sponsored Women's Health Initiative and found that users of bisphosphonateshad nearly a third fewer cases of breast cancer compared with nonusers. A second study involving more than 4,500 post-menopausal women in Israel with and without diagnoses of breast cancer found that those who reported using bisphosphonatesfor at least five years were around 30% less likely to receive a cancer diagnosis, even after controlling for other risk factors such as family history and use of other medications. Low bone density had been linked with lower risk of breast cancer in previous studies, so women being treated with bisphosphonatesfor osteoporosis bone loss were examined in the two latest studies. But neither study was a clinical trial in which women were randomly assigned to take bisphosphonatesor not and the results of the groups compared. As a result, it still isn't known whether the drugs used to treat weak bones were actually responsible for the reduced risk of cancer. In addition, bisphosphonates have side effects, including bone and muscle pain as well as rare but serious cases of jaw bone death that have resulted in hundreds of lawsuits by plaintiffs alleging improper warning about the drugs." ...."

74. New Blood Thinner Could Replace Warfarin to Fight Venous Clots http://bit.ly/7cZwpw (Forbes) - An excerpt from the article states that "A new blood thinner called dabigatran etexilate may be just as effective in preventing dangerous venous clots as an old standby, warfarin, but much easier for doctors and patients to manage, a new study finds. Dabigatran is marketed as Pradax in Canada and Pradaxa in Europe; it is not yet approved for use in the United States. The new study, published early online Dec. 6 by the New England Journal of Medicine, follows on the heels of two other promising reports presented at the American Heart Association meeting in Orlando, Fla., last month. Those studies found that dabigatran appeared safe and effective in preventing blood clots when patients were treated for acute coronary syndrome, a cluster of symptoms that might indicate a heart attack; it was also found superior to warfarin in preventing strokes in patients with the irregular heartbeat known as atrial fibrillation. In the new trial, warfarin and dabigatran seemed to perform equally well in helping patients with potentially dangerous clots in their veins avoid a subsequent clot or death over the next six months. But it is in its ease of use that the newer drug appears to outshine warfarin, the authors of this latest study say. Doctors have for years been looking for a safe alternative to warfarin, which is notoriously difficult to manage. "For patients and health-care providers, dabigatran is a far more convenient drug than warfarin because it has no known interactions with foods and minimal interactions with other drugs and therefore does not require routine blood-coagulation testing," wrote the international team of researchers led by Dr. Sam Schulman of McMaster University and the Henderson Research Center in Hamilton, Ontario, Canada. In the prospective trial, which was funded by dabigatran's maker, Boehringer Ingelheim, nearly 1,300 patients who had experienced a venous thromboembolism (VTE) received 150 milligrams of dabigatran in pill form twice a day. Another group of almost 1,300 patients was given warfarin, adjusted in dose to suit their particular needs. Six months after the therapies began, 30 patients on dabigatran experienced another VTE compared to 27 patients on warfarin, for a 0.4 percent difference in risk, the authors report. Side effects such as major or minor bleeding were similar between the two groups, with slightly more bleeding events occurring in those on warfarin. Based on the results, the authors conclude that, "a fixed dose of dabigatran is as effective as warfarin, has a safety profile that is similar to that of warfarin, and does not require laboratory monitoring." ...."

75. Hundreds File Abuse Claims Against Jesuits http://bit.ly/87vPA5 (NYT) - An excerpt from the article states that "More than 500 people have filed claims accusing Jesuits of sexually abusing children across the Northwest. Related Times Topics: Roman Catholic Church Sex Abuse Cases The claims vary in severity and span decades and geography. People were required to file their accusations by Nov. 30, a deadline imposed by the federal judge overseeing the Chapter 11 bankruptcy of the Oregon Province of the Society of Jesus. That organization includes Jesuits in Alaska, Idaho, Montana, Oregon and Washington. The Jesuits already have settled 200 sex-abuse claims. The Jesuits claim to have so far spent about $25 million. In bankruptcy documents the Jesuits claim to have $4.8 million in assets and liabilities of $61.8 million. ...."

76. Consumer group claims Zhu Zhu hamsters unsafe http://bit.ly/7Lindj (CNN) - An excerpt from the article states that "The maker of Zhu Zhu hamsters, one of the hottest-selling toys of the holiday season, defended its product after a consumer Web site said one of the toy hamsters carries high amounts of a potentially hazardous substance. The light-brown version of the Zhu Zhu hamsters, "Mister Squiggles," has unsafe levels of antimony, according to Dara O'Rourke, co-founder of the California-based GoodGuide. "We found levels of about 93 to 106 parts per million," O'Rourke told CNN. "The new federal standard is about 60 parts per million." Antimony is used in textiles and plastics to prevent them from catching fire, according to the U.S. Department of Health and Human Services' Agency for Toxic Substance and Disease Registry. Prolonged exposure can cause lung and heart problems, ulcers and diarrhea, according to the U.S. Centers for Disease Control. The toy manufacturer, St. Louis, Missouri-based Cepia LLC, disputed GoodGuide's findings and said its products are safe. "All our products are subjected to several levels of rigorous safety testing conducted by our own internal teams, as well as the world's leading independent quality assurance testing organization, and also by independent labs engaged by our retail partners," Russ Hornsby, CEO of Cepia, said in a written statement. "The results of every test prove that our products are in compliance with all government and industry safety standards."...."

77. Information for Healthcare Professionals: Risk of Neural Tube Birth Defects following prenatal exposure to Valproate http://bit.ly/8JRHOr (FDA) - An excerpt from the article states that "The FDA is reminding health care professionals about the increased risk of neural tube defects and other major birth defects, such as craniofacial defects and cardiovascular malformations, in babies exposed to valproate sodiumand related products (valproic acid and divalproex sodium) during pregnancy. The FDA will be working with the manufacturers of these products to address labeling changes. Healthcare practitioners should inform women of childbearing potential about these risks, and consider alternative therapies, especially if using valproate to treat migraines or other conditions not usually considered life-threatening. Women of childbearing potential should only use valproate if it is essential to manage their medical condition. Those who are not actively planning a pregnancy should use effective contraception, as birth defect risks are particularly high during the first trimester, before many women know they are pregnant. FDA has required a patient Medication Guide for each antiepileptic drug (AED), including valproate. The valproate Medication Guide will explain the benefits and risks of valproate and encourage patients to discuss options with their healthcare professional. Valproate sodium is marketed as Depacon. Dilvalproex sodium is marketed as Depakote, Depakote CP, Depakote ER. Valproic acid is marketed as Depakene and as Stavzor. Pregnant women using valproate or other AEDs should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry (1-888-233-2334; www.aedpregnancyregistry.org). This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available. To report any unexpected adverse or serious events associated with the use of this drug, please contact the FDA MedWatch program using the information at the bottom of the page. Background FDA first approved Depakene (valproic acid) in 1978 for the treatment of epilepsy. More recently, FDA approved valproate for the treatment of bipolar disorder and migraine headaches. As valproate's indications for use expand, it is critical that all health care professionals caring for women of childbearing potential and taking valproate for any indication be informed that valproate causes an increased risk of major birth defects. Awareness of the therapeutic benefits and risks of valproate and alternative therapies, as well as the risks of untreated disease, is critical for informed prescribing and counseling of all women taking valproate.
    Valproate and Birth Defect Risk Valproate use during pregnancy increases the risk of major malformations, including neural tube defects. In the United States, about 1 in 1500 babies is born with a neural tube defect. The risk of neural tube defects is much higher in babies born to mothers treated with valproate during the first 12 weeks of pregnancy, with the risk increasing to 1 in 20 babies.
    Data from the NAAED Pregnancy Registry show that the rate of major malformations in babies born to women with epilepsy taking valproate (monotherapy) is almost 4 times higher than the rate of major malformations in babies born to women with epilepsy taking a different antiepileptic drug. The NAAED Registry reported a major malformation rate of 10.7% (95% C.I. 6.3% – 16.9%) in the offspring of women exposed to an average of 1,000 mg/day of valproic acid monotherapy during pregnancy (dose range 500 – 2000 mg/day). The major malformation rate among the internal comparison group of 1,048 women with epilepsy who received any other antiepileptic drug monotherapy during pregnancy was 2.9% (95% CI 2.0% to 4.1%). Sixteen major malformations occurred in the offspring of 149 women who used valproate during pregnancy, and these malformations included neural tube defects, craniofacial defects, cardiovascular malformations and malformations involving other body systems. Folic Acid and Neural Tube Defects
    Studies in the general population show that folic acid supplementation prior to conception and during early pregnancy reduces the risk of neural tube defects. To ensure adequate folic acid intake, women of childbearing potential should use FDA approved folic acid prescription drugs and not rely on dietary intake or supplements alone. Considerations for Health Care Professionals
    Valproate use during early pregnancy increases the risk of major malformations in the baby. The rates for neural tube defects in babies exposed to valproate during the first trimester are 30 to 80 times higher than the rate for neural tube defects in the general U.S. population. In pregnant women with epilepsy, valproate monotherapy is associated with a four-fold higher rate of major malformations than other antiepileptic drug monotherapies. Women of childbearing potential who are considering valproate therapy or who are taking valproate should be advised of both the risks of their medical condition and the medicines used to manage their condition.
    Healthcare professionals should counsel women of childbearing potential taking valproate about the increased risk of major malformations, including neural tube defects, when valproate is used during pregnancy.Healthcare practitioners should recommend use of effective contraception for women who are not planning a pregnancy and discuss the relative risk and benefits of appropriate alternative therapies. Untreated or inadequately treated epilepsy or bipolar disorder during pregnancy increases the risk of complications in both the pregnant mother and her developing baby. Healthcare professionals should inform patients that taking folic acid before and during the first trimester of pregnancy can decrease the risk for congenital neural tube defects. Available prenatal diagnostic testing to detect neural tube defects and other malformations should be offered to all women who become pregnant while taking valproate. Women who become pregnant while taking valproate or other antiepileptic drug (AEDs) are encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling the toll-free number 1-888-233-2334. Information on the registry can also be found at the website www.aedpregnancyregistry.org. This registry gathers information about the effects of antiepileptic drugs during pregnancy. Information for Patients: Using valproate during pregnancy increases the chance of having a baby with a birth defect. Neural tube defects, such as spina bifida, are the birth defects most often seen with valproate use in early pregnancy.These defects of the brain and spinal cord occur when the developing spinal canal does not close normally.
    For this reason, a woman of childbearing potential should generally not take valproate unless it is considered essential for her treatment. Women of childbearing potential are women who have passed puberty and have not passed through menopause and have not had their uterus or ovaries removed. Women of childbearing potential who do take valproate should use effective birth control (contraception) while taking valproate. Women who are planning a pregnancy or who become pregnant while taking valproate should contact their healthcare professionals immediately.They should talk to their healthcare professionals about the best way to treat their health conditions before and during pregnancy. Healthcare professionals may discuss other treatment options. Valproate should not be stopped without talking to a healthcare professional, even in pregnant women. Stopping valproate suddenly can cause serious problems. Not treating epilepsy or bipolar disorder can be harmful to women and their developing babies. Women who become pregnant while taking valproate or other antiepileptic drugs (AEDs) should consider enrolling in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. Women can do this by calling the toll-free number 1-888-233-2334. This pregnancy registry gathers information about the safety of antiepileptic drugs during pregnancy. It is important to know that birth defects also occur in babies born to women who are not taking any medicines and who do not have other risk factors, but they occur less often (in about 3 out of every 100 babies). Taking folic acid supplements before getting pregnant and during early pregnancy has been shown to lower the chance of having a baby with a neural tube defect. Women should tell their healthcare professionals about all the medicines they take, including prescription and non-prescription medicines, vitamins, and herbal supplements, and should not start a new medicine without first talking with a healthcare professional....."

78. New Fight Erupts Over Pursuit of Asbestos Claims http://bit.ly/7OCIoM (WSJ) - An excerpt from the article states that " Giant trust funds were designed to alleviate some of the problems of protracted asbestos-related litigation. But these billion-dollar trusts have come under fire from insurance companies and legal scholars contending that they lack transparency, pay questionable claims and unfairly enrich plaintiffs' lawyers. Trusts aren't required to disclose personal information about claims. That lack of transparency, some experts say, creates the potential for abuse. Some fear trust money won't go to people who most need it...."

79. U.S. group asks FDA to ban Abbott diet drug http://bit.ly/4W7G2i (WSJ) - An excerpt from the article states that " Abbott Laboratories Inc's weight-loss drug Meridia should be banned immediately because of heart-related risks, a consumer group said on Thursday in a petition to U.S. regulators. Public Citizen said early results from a large international study called Scout added to the group's previous concerns that Meridia could cause heart problems.
    "The fact that (Meridia) actually increased the number and percentage of cardiovascular events (in the study) ... should mandate its immediate removal from the market," Public Citizen, a consumer advocacy group, said in a petition filed with the Food and Drug Administration. Abbott spokesman Kurt Ebenhoch said the drug remained safe when used as directed. Meridia, or sibutramine, "is not recommended or approved for use in more than 90 percent of the patients who participated in the Scout study," he said....."

80. Baby Boys May Be at Risk From Mom's Bug Spray Use http://bit.ly/7nm8dG (Forbes) - An excerpt from the article states that "Male babies of women who use insect repellents during the first three months of pregnancy appear to be at increased risk for a birth defect called hypospadias, researchers report. This birth defect, which affects about two of every 500 male infants, involves premature shortening of the urethra, the tube that carries urine from the bladder to the opening of the penis. In the new study, a research team from Barcelona and London compared 471 babies born in England with hypospadias and 490 babies without the birth defect. The infants' mothers were asked about their lifestyles and environmental factors, including the use of insect repellents and biocides, such as pesticides or weed killers, during pregnancy. The use of individual biocides didn't appear to be associated with an increased risk of hypospadias, but the use of several biocides was associated with a 73 percent increased risk, according to the report published online Dec. 1 in the journal Occupational and Environmental Medicine. The researchers also found that the use of insect repellents during the first three months of pregnancy was associated with an 81 percent increased risk..."

81. Apple, Psystar reach partial settlement http://bit.ly/6K0El9 (TUAW) - An excerpt from the article states that "Details are still sketchy, but apparently Apple and Psystar have reached partial settlement in the ongoing saga between the two companies. It appears that in return for paying Apple unspecified damages on its copyright claims (most of which were ruled in Apple's favor in a summary judgment motion last month), Apple will drop its remaining claims against Psystar, including those for trademark violation. Apple also agreed not to execute on those damages until all appeals have been exhausted. A more detailed document is due to be filed later, but the idea is that the matters before the court will be reduced to only the issue of permanent injunction, a motion Apple filed last week. If the court accepts the terms of the settlement, there will be no need for a trial. Psystar appears to completely concede (though it's not like it had any further leg to stand on) copyright violation, by arguing that whatever the court decides to do with the permanent injunction barring sale of its computers with OS X pre-installed, that it not extend such an injunction to Psystar's Rebel EFI software product."......" For more information on intellectual property - copyright infringement, see our Copyright Infringement page.

82. Merck To Supremes: Investors Should Have Sued Us Sooner http://bit.ly/4BbsUb (WSJ) - An excerpt from the article states that "Here’s what a lawyer for Merck told the Supreme Court yesterday: … there was abundant information in the public domain as of 2001 at least suggesting the possibility that [Merck] had engaged in securities fraud. The company is taking that somewhat surprising position to bolster its case in investor lawsuits that allege the company downplayed the safety risks of Vioxx. Specifically, Merck has argued that investors waited too long to file the suits. (Investors have two years to sue from the time they should have suspected fraud.) So the lawyers on both sides are arguing over when investors had enough information to file a lawsuit. ."......" For more information on securities and fraud, see our Securities and stockbroker fraud page.

83. Childhood Lead Exposure Causes Permanent Damage: Study http://bit.ly/74jYTp (Forbes) - An excerpt from the article states that "Childhood exposure to lead can cause permanent brain damage, a new study has found. "What we have found is that no region of the brain is spared from lead exposure. Distinct areas of the brain are affected differently," study author Kim Cecil, an imaging scientist at Cincinnati Children's Hospital Medical Center and a professor of radiology, pediatrics and neuroscience at the University of Cincinnati College of Medicine, said in a news release. The study included 33 adults, mean age 21, who were enrolled as infants in the long-term Cincinnati Lead Study, which looked at prenatal and early childhood exposure in 376 infants from high-risk areas of Cincinnati between 1979 and 1987. The study participants had blood lead levels ranging from 5 micrograms to 37 micrograms per deciliter, with a mean of 14. They had IQ deficiencies and histories of juvenile delinquency and criminal arrests. Functional MRI was used to monitor the participants' brains while they did two tasks that assess attention, decision making and impulse control. The scans showed that in order to complete a task that required inhibition, participants with elevated blood lead levels required activation from additional regions within the brain's frontal and parietal lobes."......"For more information on toxic exposure and torts, see our Toxic Tort page.

84. Justice Department Recovers $2.4 Billion in False Claims Cases in Fiscal Year 2009; More Than $24 Billion Since 1986 http://bit.ly/Dcu8k (DOJ) - An excerpt from the article states that "The United States secured $2.4 billion in settlements and judgments in cases involving fraud against the government in the fiscal year ending Sept. 30, 2009, the Justice Department announced today. This represents the second largest annual recovery of civil fraud claims in history, and brings total recoveries since 1986, when Congress substantially strengthened the civil False Claims Act, to more than $24 billion. "Rooting out fraud and safeguarding taxpayers from illegal conduct are among the Justice Department’s highest priorities," said Tony West, the Assistant Attorney General for the Civil Division. "I applaud the dedication of the public servants who investigate and prosecute fraud, and the courage of the many private citizens who risk their careers by reporting fraud." Assistant Attorney General West continued, "The cases that the department pursued this year illustrate the government’s commitment to maintaining the integrity of the health care system, ensuring that members of our military and law enforcement community are safe, and protecting consumers from fraudulent schemes. The extraordinary success of this public-private partnership goes far beyond the $2.4 billion recovered to additional billions saved through deterrence and vigilance." Assistant Attorney General West also commended the substantial efforts of the federal and state agencies that investigate and support these matters. "We are grateful for the dedication of other federal agencies and the state attorneys general and Medicaid Fraud Control Units. This cooperation allows us to bring all of our resources to bear in combating fraud against both the federal and state governments." The government’s partnership with private citizens in the fight against fraud was cemented in 1986, when Congress amended the False Claims Act, the United States’ primary tool against government fraud. The amendments strengthened the act by, among other things, revising the statute’s qui tam provisions, which were intended to encourage whistleblowers to come forward with allegations of fraud. The 1986 amendments reduced the barriers to citizens suing on behalf of the government and increased the incentives to filing such suits. Assistant Attorney General West paid tribute to the amendments’ sponsors, Senator Charles Grassley and Representative Howard L. Berman. "Without Congress’ support in enacting this important legislation," the Assistant Attorney General explained, "recovering the billions of taxpayer dollars lost through fraud since 1986 would not have been possible." Assistant Attorney General West further expressed his gratitude to Senators Grassley and Patrick J. Leahy and Representative Berman for their support of the Fraud Enforcement and Recovery Act of 2009, which made additional improvements to the False Claims Act and other fraud statutes. Noting that several courts had narrowed the scope of the False Claims Act, the Assistant Attorney General stated, "The 2009 amendments clarify the act and give the Justice Department a powerful tool in its efforts to pursue those who cause losses to the United States and harm to taxpayers." Of the $2.4 billion in settlements and judgments obtained in fiscal year 2009, nearly $2 billion was recovered in lawsuits filed under the False Claims Act’s qui tam provisions. These provisions authorize private persons, known as "relators," to file suit on behalf of the United States against those who have falsely or fraudulently claimed federal funds. Such cases run the gamut of federally funded programs, from Medicare and Medicaid to defense and other government procurement contracts, federally insured mortgage and other federal housing programs, disaster assistance loans, agricultural subsidies and more. Persons who knowingly make false claims for federal funds are liable for three times the government’s loss plus a civil penalty of $5,500 to $11,000 for each claim. Relators recover 15 to 25 percent of the proceeds of a successful suit if the United States intervenes in the qui tam action, and up to 30 percent if the United States declines and the relator pursues the action alone. ."......"For more information on Qui Tam, whistleblower statutes and the Federal False Claims Act see our Qui Tam page.

85. Ninth Circuit Allows Settling Whistle-Blower Defendant to Sue Third Party http://bit.ly/8tEIsw (AL) - An excerpt from the article states that "The Justice Department announced Thursday that it had secured nearly $2 billion from lawsuits filed under the False Claims Act's qui tam provisions in the year ending Sep. 30. And it promised to do more. Tony West, assistant attorney general for the civil division, said in a statement, "Rooting out fraud and safeguarding taxpayers from illegal conduct are among the Justice Department’s highest priorities." Given the importance being placed on False Claims Act cases, a decision out of the Ninth Circuit on Wednesday should take on greater significance, especially for parties that end up settling but don't admit to any wrongdoing. (To us, that seems to be pretty much everybody.) The Ninth Circuit ruled that the False Claims Act does not preclude a settling defendant from seeking recovery and bringing claims against a third party for its alleged violations. The case before the appeals court involved a company called Cell Therapeutics Inc. (CTI), which developed a drug to treat leukemia that the Food and Drug Administration approved in 2000. But the company also marketed the drug for other uses, and a whistle-blower at CTI sued the company on behalf of the government, claiming that CTI was ripping off Medicare. CTI eventually settled the case with the government and the whistle-blower for $10.5 million, but it did not admit any wrongdoing."......"For more information on Qui Tam, whistleblower statutes and the Federal False Claims Act see our Qui Tam page.

86. Vicks nasal spray recalled over bacteria http://bit.ly/8XBoBq (CNN) - An excerpt from the article states that "Procter & Gamble is recalling Vicks Sinex nasal spray in the United States, Britain and Germany after finding it contained bacteria, the company said. Procter & Gamble said it announced the voluntary recall after finding the bacteria in a small amount of product made at a plant in Germany. There have been no reports of illness from the bacteria, but it could cause serious infections for people with weakened immune systems or those with chronic lung conditions such as cystic fibrosis, Procter & Gamble said late Thursday. The bacteria poses little risk to healthy people, the company said. Cincinnati, Ohio-based Procter & Gamble said it detected the problem during routine quality control at the plant. Analysis so far shows the problem is limited to a single batch of raw material mixture involving three lots of product, which were sold only in the three countries affected by the recall, the company said. In the United States, the recalled product is Vicks Sinex Vapospray 12-hour Decongestant Ultra Fine Mist with lot number 9239028831."......"For more information on Pharmaceutical liability, see our Pharmaceutical liability page.

87. Soldiers Sue KBR-Halliburton For Toxic Exposure From "Burn-Pits" http://bit.ly/1kRdAz (TPM) - An excerpt from the article states that " A trickle of lawsuits by US soldiers against KBR-Halliburton for toxic exposure from enormous open "burn-pits' at US bases in Iraq and Afghanistan is turning into a deluge as the number of suits more than doubled in the last few weeks. Dozens of US military personnel have filed 34 lawsuits against US defense contractor KBR for allegedly incinerating toxic waste and releasing it into the atmosphere in Iraq and Afghanistan." [...] "Every type of waste imaginable was and is burned on these pits, including trucks, tires, lithium battery, Styrofoam, paper, rubber, petroleum-oil-lubricant products, metals, hydraulic fluids, munitions boxes, medical waste, biohazard materials (including human corpses), medical supplies (including those used during smallpox inoculations), paints, solvents, asbestos insulation, items containing pesticides, polyvinyl chloride pipes, animal carcasses, dangerous chemicals and hundreds of thousands of plastic water bottles," the lawsuit claims. This slow-breaking story includes wrongful-death suits from massive exposure to "thick, noxious smoke - coming off of flames sometimes colored blue or green by burning chemicals - to hang over U.S. bases and camps across Iraq and Afghanistan since 2004."......"For more information on Toxic exposure or Mesothelioma, see out Toxic Exposure and Mesothelioma pages.

88. Former Smoker Sues Philip Morris, Wins $300 Million http://bit.ly/47fGJk (WSJ) - An excerpt from the article states that "Florida’s never-ending tobacco litigation continued not to end this week. A woman in South Florida who smoked Benson & Hedges for 25 years sued Philip Morris and was awarded $300 million. Most of the award — $244 million — was punitive damages. The balance was compensatory damages for the woman, who has emphysema, the Associated Press reports. She’s 61; she started smoking in 1968 and stopped in 1993."......"For more information on Tobacco litigation, see Gooch Law Firm.

89. RockHard Laboratories Issues a Voluntary Nationwide Recall of Specific Lots of RockHard Weekend Marketed as Dietary Supplement http://bit.ly/8qzie (FDA) - An excerpt from the article states that "RockHard Laboratories announced today that it is conducting a voluntary nationwide recall of the company’s dietary supplement sold under the name RockHard Weekend (RHW) specific to the following Lot Numbers: Blister Pack: T12 705 08 (exp: 10/11) / T12 705 09 (exp: 3/12, 8/12) 3ct Bottle: R417 0509 (exp: 09/12) 8ct Bottle: T237-0509 (exp: 06/12) RockHard Laboratories is conducting a voluntary recall after being informed by the Food and Drug Administration (FDA) that voluntary lab analysis found that RHW, specific to the above lot numbers, contains sulfoaildenfil, an analogue of Sildenfil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED) making RockHard Weekend an unapproved drug. The active drug ingredient is not listed on the product label. The undeclared ingredient may pose a threat to consumers because the analogue may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance. RockHard Laboratories takes the upmost pride in its quality control by outsourcing production to a certified, independent lab. It is through this outside lab that RockHard Laboratories maintains the highest quality standards possible and can quickly take action. RockHard Laboratories has identified that one of the lab’s raw ingredients, sourced from China, was being unknowingly tainted with sulfoaildenfil. RockHard Laboratories takes this recall very seriously and recommits to the diligent work required in ensuring its products remain free of any potentially unapproved chemicals. RHW is sold nationwide in single blisters, 3-count and 8-count bottles. RockHard Laboratories advises any customers in possession of RHW to return any unused product for a full refund to the company directly. Customers can call 1.800.562.0543 for instructions on the return and refund process......."

90. Cardiovascular Systems ViperSheath Sheath Introducer - Recall http://bit.ly/11p1lw (FDA) - An excerpt from the article states that "Cardiovascular Systems, Inc. and FDA notified healthcare professionals of a nationwide recall of all lots of the ViperSheath Sheath Introducer on behalf of Thomas Medical due to reports about stretching or fracture of the sheath during use.
    In the event of a device fracture, separated segments of the device may require unplanned open surgery to remove the retained segments or control bleeding. Since this device is coil reinforced, any separation of the cannula (a flexible tube inserted into the body) has the potential to expose portions of the coil, creating the potential for vessel dissection or perforation. The recall encompasses products distributed from March 25, 2009 to October 21, 2009, and includes the following lot ranges and catalog numbers: Lot range: S28117 through S29174 Catalog numbers: VPR-ISH 5 X 85, VPR-ISH 6 X 85, VPR-ISH 7 X 85, VPR-ISH 5 X 45, VPR-ISH 6 X 45, VPR-ISH 7 X 45......"

91. Panel Urges Mammograms at 50, Not 40 http://bit.ly/1RRHS (NY Times) - An excerpt from the article states that "Most women should start regular breast cancer screening at age 50, not 40, according to new guidelines released Monday by an influential group that provides guidance to doctors, insurance companies and policy makers.Cindy Davis, a nurse in the breast cancer division of the MD Anderson Cancer Center in Houston, went over the files of Starla Trayal, a patient. The new recommendations, which do not apply to a small group of women with unusual risk factors for breast cancer, reverse longstanding guidelines and are aimed at reducing harm from overtreatment, the group says. It also says women age 50 to 74 should have mammograms less frequently — every two years, rather than every year. And it said doctors should stop teaching women to examine their breasts on a regular basis. Just seven years ago, the same group, the United States Preventive Services Task Force, with different members, recommended that women have mammograms every one to two years starting at age 40. It found too little evidence to take a stand on breast self-examinations. The task force is an independent panel of experts in prevention and primary care appointed by the federal Department of Health and Human Services. Its new guidelines, which are different from those of some professional and advocacy organizations, are published online in The Annals of Internal Medicine They are likely to touch off yet another round of controversy over the benefits of screening for breast cancer. Dr. Diana Petitti, vice chairwoman of the task force and a professor of biomedical informatics at Arizona State University, said the guidelines were based on new data and analyses and were aimed at reducing the potential harm from overscreening. While many women do not think a screening test can be harmful, medical experts say the risks are real. A test can trigger unnecessary further tests, like biopsies, that can create extreme anxiety. And mammograms can find cancers that grow so slowly that they never would be noticed in a woman’s lifetime, resulting in unnecessary treatment. Over all, the report says, the modest benefit of mammograms — reducing the breast cancer death rate by 15 percent — must be weighed against the harms. And those harms loom larger for women in their 40s, who are 60 percent more likely to experience them than women 50 and older but are less likely to have breast cancer, skewing the risk-benefit equation. The task force concluded that one cancer death is prevented for every 1,904 women age 40 to 49 who are screened for 10 years, compared with one death for every 1,339 women age 50 to 74, and one death for every 377 women age 60 to 69. The guidelines are not meant for women at increased risk for breast cancer because they have a gene mutation that makes the cancer more likely or because they had extensive chest radiation. The task force said there was not enough information to know whether those women would be helped by more frequent mammograms or by having the test in their 40s. Other experts said women with close relatives with breast cancer were also at high risk. Dr. Petitti said she knew the new guidelines would be a shock for many women, but, she said, “we have to say what we see based on the science and the data.” The National Cancer Institute said Monday that it was re-evaluating its guidelines in light of the task force’s report. But the American Cancer Society and the American College of Radiology both said they were staying with their guidelines advising annual mammograms starting at age 40......"

92. FDA sees varying risk from MRI agents (Contrast agents - Gadolinium, MRI Contrast Agent and Nephrogenic systemic fibrosis - NSF (skin disorder)) http://bit.ly/1xvqUo (Reuters) - An excerpt from the article states that "Imaging agents used with MRI scans appear linked to varying risks for a potentially fatal skin disease, U.S. Food and Drug Administration staff said in documents released on Tuesday. The FDA said a staff review found the highest risk of the skin disease, nephrogenic systemic fibrosis, was associated with GE Healthcare's Omniscan, Bayer AG's Magnevist and Covidien's Optimark. The lowest risk was associated with Prohance and Multihance, made by Bracco Diagnostics, the agency said......"

93. Clopidogrel (marketed as Plavix) and Omeprazole (marketed as Prilosec) - Drug Interaction http://bit.ly/4Bsw2s (FDA) - An excerpt from the article states that "FDA notified healthcare professionals of new safety information concerning an interaction between clopidogrel (Plavix), an anti-clotting medication, and omeprazole (Prilosec/Prilosec OTC), a proton pump inhibitor (PPI) used to reduce stomach acid. New data show that when clopidogrel and omeprazole are taken together, the effectiveness of clopidogrel is reduced. Patients at risk for heart attacks or strokes who use clopidogrel to prevent blood clots will not get the full effect of this medicine if they are also taking omeprazole. Separating the dose of clopidogrel and omeprazole in time will not reduce this drug interaction. Other drugs that are expected to have a similar effect and should be avoided in combination with clopidogrel include: cimetidine, fluconazole, ketoconazole, voriconazole, etravirine, felbamate, fluoxetine, fluvoxamine, and ticlopidine....."

94. Abbott’s Niaspan Reduces Plaque Buildup in Arteries http://bit.ly/40YSHU (Bloomberg) - An excerpt from the article states that "Combining Abbott Laboratories’ cholesterol pill Niaspan with another drug called a statin reduced plaque buildup in the neck’s main arteries more than the statin alone, a study found. Patients taking Niaspan and a statin had a 1.1 millimeter reduction in the thickness of their carotid arteries, the vessels that carry blood to the brain, over 12 months, researchers said in a study released today by the Journal of the American College of Cardiology. Those taking just a statin had an increase in arterial thickness. “This is the first demonstration of an incremental effect of Niaspan, added to statin treatment, when compared with placebo,” the researchers wrote. Abbott, based in Abbott Park, Illinois, rose 34 cents, or less than 1 percent, to $50.91 at 4 p.m. in New York Stock Exchange composite trading. Whitehouse Station, New Jersey-based Merck rose 33 cents, or 1.1 percent, to $31.26. ...."

95. Merck Cholesterol Pill Sales May Drop 20% After Study http://bit.ly/1dKLYQ " target="_blank"> http://bit.ly/1dKLYQ (Bloomberg) - An excerpt from the article states that " Nov. 10 (Bloomberg) -- Merck & Co. may face a third negative study result within two years for its cholesterol pills Vytorin and Zetia, which have lost 14 percent of sales since January and could sink further. The latest trial, scheduled to be presented Nov. 16, pits Merck’s drugs against Abbott Laboratories’ Niaspan, a modified form of vitamin B3 used to maintain healthy cholesterol levels. A win by Niaspan may discourage more doctors from prescribing Merck’s Vytorin and its component Zetia, said Steven Nissen, chief of cardiology at the Cleveland Clinic in Ohio. The results are likely to show that Niaspan unclogged arteries better than Vytorin, said Seamus Fernandez, a Leerink Swann & Co. analyst in Boston, and Larry Biegelsen, an analyst with Wells Fargo Advisors LLC in New York. Such a finding may trim revenue for Vytorin and Zetia by $800 million yearly, or 20 percent, Fernandez said. Since January, sales have declined by $480 million to about $3 billion. “The longer Zetia goes with a series of trials that are not favorable, the more questions get raised about whether it is a good choice” for doctors and patients, Nissen said in a Nov. 5 telephone interview. This study “is another major test for Vytorin and Zetia, which have come under a lot of criticism regarding whether they are, in fact, effective.” ...."

96. Merck Cholesterol Woes May Rise on Loss to Abbott http://bit.ly/2zDVyi (Bloomberg) - An excerpt from the article states that "A finding that Merck & Co.’s cholesterol pills Vytorin and Zetia didn’t reopen clogged arteries as well as Abbott Laboratories’ Niaspan has set off a medical debate on heart treatment strategies. In a clinical trial reported yesterday, researchers found a decrease in the thickness of artery walls in patients given Niaspan, while those on Zetia had no change. Artery thickness is believed to be a predictor of risk in heart attack and stroke because it restricts blood flow, the researchers said. The results released at the annual American Heart Association meeting in Orlando, Florida, may raise doctor awareness of the role of good cholesterol, or HDL, in heart health. It could also pump up sales for Abbott’s drug, a form of niacin, or Vitamin B, that increases HDL, and mean less revenue for Merck’s Zetia and Vytorin, which combines Zetia with the statin simvastatin to lower bad cholesterol, or LDL. “There will be an up-tick in the use of niacin because of this,” said Steven Nissen, chief of cardiology at the Cleveland Clinic in Ohio, in an interview yesterday. “It was quite a compelling result. Yes, it is a small study; yes, it isn’t a substitute for a large definitive outcomes trial. But I do think it will get attention, and I do think it will inform us about the choices we have about what therapies we should administer.” ...."

97. Crash of Medical Helicopter Near Reno Kills Crew of Three http://bit.ly/21VQO1 (NY Times) - An excerpt from the article states that "A medical helicopter crashed early Saturday north of Reno near the Nevada-California state line, killing the three crew members aboard, officials said. The helicopter, an Aerospatiale AS350, crashed about 29 miles northwest of Reno in Lassen County, Calif., around 2 a.m. Saturday, said a Federal Aviation Administration spokesman, Ian Gregor. All three people aboard were killed. The helicopter had dropped off a patient at Renown Medical Center and was returning to its base in Susanville, Calif., Mr. Gregor said. The aircraft was destroyed in the crash and fire. The cause of the crash was not known. Mr. Gregor said the pilot had not been communicating with air traffic controllers at the time of the accident. Investigators from the F.A.A. and the National Transportation Safety Board headed for the scene on Saturday........" For more information on aviation related cases, see GLF or Legal Sleuth - Aviation page

98. Feds ignored Medicare scam warnings for years http://bit.ly/2R0f6P (AP - Florida Today) - An excerpt from the article states that "For three years, the federal agency in charge of preventing Medicare fraud repeatedly ignored internal watchdog warnings about swindlers stealing millions of dollars by scamming several programs, documents show.
    The Centers for Medicare and Medicaid Services received roughly 30 warnings from inspectors over three years - mostly under the Bush administration - but didn't respond to half of them, even after repeated letters, according to records provided to The Associated Press by U.S. Sen. Charles Grassley's office. A July 2008 warning said organized crime had infiltrated the system and was costing more than $1 million dollars for each phony Medicare provider license the crooks obtained. The letter got no response, Grassley said. He and other critics said lack of oversight in the federally administered program is part of an estimated $60 billion a year in Medicare fraud. "There's no good answer for why the bureaucracy turned a blind eye, and it's a breach of the public trust," said Grassley, an Iowa Republican and ranking member of the Senate Finance Committee. Fighting the fraud is key for the Obama administration, which hopes to pay for a large chunk of its proposed national health care overhaul by cracking down on those who cheat Medicare. Despite the lapses, Obama's Health and Human Services Secretary Kathleen Sebelius said the Centers for Medicare and Medicaid Services typically responds to fraud warnings promptly, and has investigated more than 300 since 2006. She was not satisfied that all fraud alerts were receiving sufficient responses and her office is implementing a new process for tracking the red flags........." For more information on Qui Tam & False Claims Act cases, see GLF or Legal Sleuth - Qui Tam & False Claims Act & whistleblower page

99. Google’s Pitch to FDA for Online Drug Ads http://bit.ly/3YM2RM (WSJ) - An excerpt from the article states that "Sure, dozens of groups are speaking at this week’s FDA meeting on online advertising for drugs and medical devices.
    But we’re particularly interested in what Google had to say, given the company’s 800-pound-gorilla status in online advertising — as well as the flurry of FDA warning letters earlier this year regarding drug ads that ran with Google searches. Those letters, which said the brief text ads didn’t include required risk information, created a lot of uncertainty about what’s OK and what isn’t for online ads. Google wants the FDA to create a standard template for the ads, which would include a link to the drug’s main page, a warning about safety risks and a second link to more risk information. NPR’s Shots blog has posted the slides Google used in its presentation; see page 12 of the slide deck for an example of what Google has in mind. (The drug industry came up with a somewhat similar set of recommendations, which is outlined here.) In its presentation, Google said drug makers have responded to the FDA warning letters by changing the text in their ads; in one example, the phrase “learn about seasonal allergy treatment” was changed to “find more important product information.” Perhaps not surprisingly, given this example, click-through rates have fallen since the changes were put in place (see pages 9 and 10 of the slide deck).........."

100. How to avoid falling victim to a hospital mistake http://bit.ly/3nAaFV (CNN) - An excerpt from the article states that "When Kerry Higuera started bleeding three months into her pregnancy, she feared she was miscarrying. Heading to the emergency room seemed like the prudent thing to do. Higuera says she'll regret that decision for the rest of her life. When Higuera arrived at Banner Thunderbird Medical Center in Glendale, Arizona, that February morning in 2008, she was put in a room and told to wait for a nurse to come get her. Soon, a nurse poked her head into her room. "She said, 'Kerry?' and I said, 'Yes,' and she said, 'I'm going to take you for a little walk' and I followed her down the hallway," says Higuera, a mother of four who lives in Peoria, Arizona. "She brought me to the CT scan room, and I said, 'Is this really what I need to have done?' And the nurse said, 'Yes, this is what the doctor wants. He wants a CT scan of your abdomen,' and I said, 'OK,'" Higuera remembers. After the scan, the nurse led Higuera back to a room to wait for the doctor. "I was so scared. I told my husband, I'm sure I've had a miscarriage. I'm sure the doctor is going to come and tell us we lost the baby," she says. Video: Steps to avoid medical errors But that wasn't what happened at all. After about half an hour, Higuera says the emergency room physician, two radiologists and a representative from the hospital's human resources department came into her room. "I started to cry and asked if I'd miscarried, and they said no, I was still pregnant. My husband and I said, 'Oh, that's great!'" she remembers. But then they told the Higueras there was something else they needed to know. "They said, 'We made a mistake; we did something we shouldn't have done,' and I was like, 'What do you mean?'" Higuera remembers. "They said 'There's another patient here named Kerry, and you two are the same age. We mixed you up. She was supposed to have the CT scan, not you.' " While no large studies have been done on the effects on the fetus of performing a CT scan to a pregnant woman's abdomen, experts say a fetus exposed to radiation can, in some cases, develop physical and mental growth problems In statement e-mailed to CNN, Bill Byron, senior director for public relations and online services at Banner Health, wrote, "Ms. Higuera is represented by legal counsel in this matter and it appears to be moving towards litigation; therefore, Banner Health is unable to provide any comment at this time." Higuera's lawyer, David Patton of Scottsdale, Arizona, provided CNN with Higuera's records from her visit to Banner Thunderbird. "The patient was unintentionally scanned as she was confused with another patient," reads one report. "There was a misidentification of the patient and inadvertently this patient [Kerry Higuera] had a CAT scan of the abdomen and pelvis performed," reads another report. "[The scan] had been ordered for another patient with a similar first name.".........."For more information on medical malpractice cases, see GLF or Legal Sleuth - Medical malpractice page

101. FDA Finds Bits of Steel and Rubber in Genzyme Drugs http://bit.ly/2ATJbr (Fox) - An excerpt from the article states that "Federal health regulators have found tiny particles of trash in drugs made by Genzyme, the second time this year the biotechnology company has been cited for contamination issues. The Food and Drug Administration said Friday that bits of steel, rubber and fiber found in vials of drugs used to treat rare enzyme disorders could cause serious adverse health effects for patients. Despite those problems, the FDA said the products would remain on the market, because there are few alternative treatments. FDA regulators say doctors should closely inspect vials for particles before injecting them into patients. Doctors should return the product to Genzyme if they suspect contamination, the agency said. Physicians should also watch for potential allergic reactions, blood clots and other problems in patients. Shares of Genzyme Corp. dropped $3.89, or 7.3 percent, to close at $49.28 Friday. The FDA announcement is the second case of contamination this year for the company based in Cambridge, Mass. In June, Genzyme was forced to shut down a key production facility due to viral contamination. Genzyme said in a statement it "remains committed to reducing the frequency of foreign particles in all of our products." The company sent a letter to physicians saying the particles represent a "theoretical safety risk," though no medical complications have been reported. The drugs affected by the latest announcement include: Cerezyme, Fabrazyme, Myozyme, Aldurazyme and Thyrogen. All are manufactured at a biotech plant in Allston Landing, Mass., where FDA regulators are conducting an inspection.".........."For more information on medical malpractice cases, see GLF or Legal Sleuth - Medical malpractice page

102. Investors Win More Broker Cases http://bit.ly/fMv8q (WSJ) - An excerpt from the article states that "Investors pummeled by last year's market meltdown are increasingly taking their brokers to task. In the first eight months of this year, investors' securities arbitration complaints against stockbrokers surged 65% from the same period in 2008. The 4,991 claims filed exceeded the tally for all of 2008, according to the Financial Industry Regulatory Authority (Finra), Wall Street's self-regulation arm. Linda Fienberg, Finra's president of dispute resolution, expects to end the year with nearly 7,500 cases filed, the highest level since 2004, when investors were still reeling from the technology-stock wreck. "Lots of people are very upset with their brokers, and not just because of a bad market," says Brian Smiley, of law firm Smiley Bishop & Porter in Atlanta, and president of the Public Investors Arbitration Bar Association. "A huge number of people were put into investments that they thought were relatively risk-free but were actually very speculative." Brokerage arbitration, a system run by Finra and previously by the National Association of Securities Dealers, is virtually the only way for investors to seek redress. While the system has long been criticized as being stacked against investors, the picture is starting to change. Investors won some 45% of the cases decided this year through August, up from 37% in 2007, according to Finra. For claims under $1 million -- the bulk of the total -- winning investors are typically getting about half the amount they seek, says Richard Ryder, editor of the Securities Arbitration Commentator. "Suitability" claims, which revolve around the broker's responsibility to the customers to learn their objectives and recommend suitable investments, have predominated in this year's filings, Mr. Ryder says......." For more information on securities and stockbroker fraud, see GLF or Legal Sleuth - Securities and Stockbroker Fraud page

103. Antipsychotic Drugs, Elderly Patients and Omnicare’s Settlement http://bit.ly/1fRLzU (Forbes) - An excerpt from the article states that "So Omnicare, a big pharmacy that specializes in providing drugs to nursing-home patients, will pay $98 million to settle allegations that the company “solicited or paid a variety of kickbacks,” according to this statement from the feds. The WSJ story gets into all the details, but one wrinkle in particular caught our eye: Omnicare was accused of soliciting and receiving kickbacks from J&J in exchange for recommending the company’s antipsychotic drug Risperdal. This touches on the broader issue of the widespread use of antipsychotic drugs among nursing home patients. Risperdal, like other drugs in its class, comes with this warning: “Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.” Risperdal isn’t approved for treating mental problems that stem from dementia. Nevertheless, as the Chicago Tribune reported last week and the WSJ reported in 2007, Risperdal and other antipsychotics have been widely used for nursing-home patients with dementia (though there have been efforts to curb use of the drugs)......" For more information on Federal False Claims, Qui Tam and whistleblower laws, see GLF or Legal Sleuth - Qui Tam page

104. How Safe Are Popular Reflux Drugs? http://bit.ly/4oQHs (Forbes) - An excerpt from the article states that " Millions of Americans take drugs like Nexium, Prevacid and Prilosec to ease the erosive effects of acid reflux, but do these medicines put patients at risk for other health problems? Experts remain divided on the potential dangers these common prescription medications might pose. The drugs belong to a class of pharmaceuticals called "proton pump inhibitors," or PPIs, which are generally considered safe and effective. But lately these acid-reducing medications have been the subject of studies linking their use to a number of health risks, from an increased rate of hip fracture to a greater likelihood of diarrhea and community-acquired pneumonia. Dr. Kenneth W. Altman, an associate professor of otolaryngology at Mount Sinai School of Medicine in New York City, draws attention to some of the potential consequences of PPI use in a commentary published in the November issue of Otolaryngology -- Head and Neck Surgery.I really want to emphasize this is an important class of medication and it's helping a lot of people," Altman said. Still, the scientific literature raises questions that require further study, he said, such as how the body's metabolism of PPIs affects blood levels of other drugs processed in the liver.”........" For more information on Reglan and Tardive Dyskinesia, see GLF / Legal Sleuth - Reglan page

105. Focused Radiation May Help Some With Lung Cancer http://bit.ly/1PfRfq (Forbes)- An excerpt from the article states that "Three-year survival was 100 percent for people with early-stage lung cancer and good lung function who were treated with radical stereotactic radiosurgery using CyberKnife, according to a new study funded by the product's maker. Standard care for people with small lung tumors calls for surgical removal of the affected lobe, but some people cannot have surgery because of other medical conditions, such as heart disease or emphysema. "Our goal has been to find a reasonable option for patients who don't want or can't tolerate surgery," the study's lead author, Dr. Brian T. Collins, a radiation oncologist at the Lombardi Comprehensive Cancer Center at Georgetown University Hospital, said in a news release from the university. "What we discovered is a very promising option that may be relevant for other stage 1 patients as well. More follow-up with these patients is planned to see how they progress five years after treatment."...."For more information on mesothelioma lung cancer, see GLF / Legal Sleuth - Mesothelioma page

106. Bayer Says Swissmedic Sees No Higher Risk for Drosperinone Pills http://bit.ly/hdR8Z (Reuters) - An excerpt from the article states that "* Blood loss reduced by 458 millilitres over 90-day period * Results to underpin EU filing next year * Bayer sees up to 500 mln eur in annual sales from pill Bayer's (BAYGn.DE) new birth control pill Qlaira was shown to reduce excessive menstrual bleeding in a late-stage drug trial, the company said, underpinning its plan to widen the use of the pill in Europe. The Phase III study showed that Qlaira helped reduced blood loss by 458 millilitres on average over a 90-day period, while the blood loss in a control group of women on placebo was lowered by only 93 millilitres, the German drugmaker said on Monday. Participants on Qlaira -- from which Bayer expects up to 500 million euros ($730 million) in annual sales -- also had better haemoglobin and blood iron parameters. In May, Bayer brought Qlaira to European markets, initially pureley as a contraceptive. It plans to file for EU approval to extend the pill's use to alleviate heavy or prolonged menstrual bleeding next year, a company spokeswoman said. Bayer filed for regulatory approval of the pill in the United States both as a contraceptive and to treat excessive bleeding in July. Bayer is trying to build on the market success of its existing birth control pills, which it obtained as part of its acquisition of rival Schering. The group of pills comprising the Yasmin, YAZ and Yasminelle brands are Bayer's best-selling pharmaceutical product, generating 1.2 billion euros in revenues last year....." For more information on Yaz and Yasmin, see GLF or Legal Sleuth - Yaz and Yasmin page

107. The “Tootsie Roll” Recipe: Biotech Managers Charged With Fraud http://bit.ly/33xCy3 (Forbes) - An excerpt from the article states that "What is it with bone-growth products? Over the past year, we’ve seen the federal probe into Medtronic’s Infuse implant, and allegations of faked research on the product by an Army doc. Then, yesterday, the feds said that Stryker’s biotech unit, along with the unit’s former president and current sales managers, had been indicted on charges of fraud for off-label marketing of OP-1, Stryker’s own bone-growth product. OP-1 was approved by the FDA for a very narrow use. But the feds say the company encouraged unapproved use by giving surgeons “recipies” for combining OP-1 with another product, and molding the combination into “cigars,” “tootsie rolls” or “vienna sausages.” The feds also say that “serious medical problems arose in a number of patients from this untested mix of products.”........" For more information on False Claims Act, Qui Tam and whistleblowers, see GLF / Legal Sleuth - Qui Tam page

108. Jury Awards $1.25 Million in Infant's Misdiagnosis Death http://bit.ly/4l1S1V (Fox)- An excerpt from the article states that "The St. Louis County jury deliberated about 3 1/2 hours Monday night to decide Dr. Kevin Krause was negligent in his treatment of Andrew Morrow, who died Jan. 31, 2008. The Morrow family attorney Terry Wade said Andrew was misdiagnosed twice over four days. He was incorrectly diagnosed with influenza and later with gastroenteritis. The boy died of gangrenous appendicitis with a blood stream infection and shock. His appendix leaked bacteria into his abdomen. Evidence presented at trial showed Krause had too many patients too close together and too little time...."For more information on Medical mistakes, see GLF / Legal Sleuth - Medical Malpractice page

109. World Trade Center Workers Have More Cases of Acid Reflux http://bit.ly/2Z8MYG (Forbes) - An excerpt from the article states that "World Trade Center rescue workers can add another illness to the list of health problems that may have resulted from exposure to Ground Zero toxins and the ensuing mental anguish of the tragedy -- gastroesophageal reflux disease (GERD). A new study shows that 41 percent of World Trade Center responders have GERD, twice that of the general population. GERD is a condition in which the lower esophageal sphincter doesn't function properly, allowing the stomach's contents to rise up into the esophagus, causing a burning sensation in the chest or throat.The likelihood of having GERD was linked to mental health disorders, including post-traumatic stress disorder and depression. The more extensive the mental health issues, the more likely patients were to have GERD........" For more information on Tardive Dyskinesia, Reglan (gastric reflux), see GLF / Legal Sleuth - Reglan page

110. Should Doctors Get Public Report Cards? http://bit.ly/4gmN8g (Forbes)- An excerpt from the article states that "Health policy wonks love to talk about “paying for quality,” and giving patients more information. Front-line docs are often skeptical about how, exactly, that “quality” gets measured, and what information would be useful for patients. In the context of that debate, it’s worth taking a look at this WSJ story about public report cards for Minnesota doctors........."

111. Cell Phone May Reduce Bone Density in Hips http://bit.ly/326lcm (Forbes) - An excerpt from the article states that "Wearing a cell phone on your hip may reduce bone density in an area of the pelvis commonly used for bone grafts, a new study suggests. Turkish researchers used dual X-ray absorptiometry to measure bone density at the upper rims of the pelvis (iliac wings) in 150 men who carried their cell phones on their belts. The men carried their phones for an average of 15 hours a day, and had used cell phones for an average of six years. Bone density was slightly reduced on the side of the pelvis where the men carried their cell phones, the study found. The difference wasn't statistically significant and didn't approach bone level density reductions seen in people with osteoporosis. However, the men were relatively young (average age 32), and further bone weakening may occur, said Dr. Tolga Atay and colleagues at Suleyman Demirel University in Isparta........"

112. Metal: Panacea or Placebo? http://bit.ly/13mO6s (WSJ) - An excerpt from the article states that "From ancient Egypt to the Internet age, the medicinal properties of metals have been touted for millennia. Yankee pitcher Joba Chamberlain and Olympic marathoner Kara Goucher (below) are among the many professional athletes who believe their titanium-coated necklaces enhance performance. Wearing copper is said to reduce arthritis pain and inflammation. Magnets supposedly increase circulation, relieving stiffness and pain. Gold and silver theoretically enhance cognitive function and the body's ability to repair itself. Titanium, though unknown in ancient times, is said to help stabilize the body's flow of energy—so much so that many Major League Baseball players have been draping themselves with titanium-coated necklaces in official team colors...."

113. Radiation From Medical Scans Soaring http://bit.ly/12Q74T (Forbes) - An excerpt from the article states that " Americans' exposure to radiation from medical procedures has exploded over the past few decades, to six times the level of 1980, a new report shows. In 2006, almost 380 million diagnostic and interventional radiological procedures were performed in the United States, on top of 18 million nuclear medicine examinations.
     "Back in about 1980, 15 percent of radiation that the U.S. population got was from medicine and the rest was predominantly from natural background radiation," noted Dr. Fred Mettler Jr., U.S. Representative to the United Nations Scientific Committee on the Effects of Atomic Radiation and a professor of radiology at the University of New Mexico in Albuquerque. "In the last 20 years, medical exposure has gone up between 600 and 700 percent from what it was, and it is now the biggest source of radiation to the U.S. population."..."

114. Note to Middle-Aged Women: Your Heart-Attack Risk is Rising http://bit.ly/SUubB (WSJ) - An excerpt from the article states that " There’s a growing recognition that heart-attack risk rises for women after menopause — and that cardiovascular disease is the leading killer of U.S. women. Now it may be time to pay more attention to heart attack risk for younger women. In recent decades, heart-attack risk rose for women aged 35 to 54, even as it fell for men in the same age group, according to an analysis published today in the Archives of Internal Medicine. The shift was significant, though the absolute prevalence is still way higher for men in that age group...."

115. U.S. healthcare system wastes up to $800 billion a year http://bit.ly/1iLkCI (Reuters) - An excerpt from the article states that "The U.S. healthcare system is just as wasteful as President Barack Obama says it is, and proposed reforms could be paid for by fixing some of the most obvious inefficiencies, preventing mistakes and fighting fraud, according to a Thomson Reuters report released on Monday. The U.S. healthcare system wastes between $505 billion and $850 billion every year, the report from Robert Kelley, vice president of healthcare analytics at Thomson Reuters, found. "America's healthcare system is indeed hemorrhaging billions of dollars, and the opportunities to slow the fiscal bleeding are substantial," the report reads. "The bad news is that an estimated $700 billion is wasted annually. That's one-third of the nation's healthcare bill," Kelley said in a statement. "The good news is that by attacking waste we can reduce healthcare costs without adversely affecting the quality of care or access to care." One example -- a paper-based system that discourages sharing of medical records accounts for 6 percent of annual overspending. "It is waste when caregivers duplicate tests because results recorded in a patient's record with one provider are not available to another or when medical staff provides inappropriate treatment because relevant history of previous treatment cannot be accessed," the report reads. Some other findings in the report from Thomson Reuters, the parent company of Reuters: * Unnecessary care such as the overuse of antibiotics and lab tests to protect against malpractice exposure makes up 37 percent of healthcare waste or $200 to $300 a year. * Fraud makes up 22 percent of healthcare waste, or up to $200 billion a year in fraudulent Medicare claims, kickbacks for referrals for unnecessary services and other scams. * Administrative inefficiency and redundant paperwork account for 18 percent of healthcare waste. * Medical mistakes account for $50 billion to $100 billion in unnecessary spending each year, or 11 percent of the total. * Preventable conditions such as uncontrolled diabetes cost $30 billion to $50 billion a year......." For more information on Federal False Claims Act, Qui Tam and whistleblowers, see GLF / Legal Sleuth - Qui Tam page

116. Bayer Says Swissmedic Sees No Higher Risk for Drosperinone Pills http://bit.ly/4gNo6y (Reuters) - An excerpt from the article states that "Bayer AG said Switzerland’s drug regulator Swissmedic sees no increased risk of deadly blood clots from its contraceptive pills containing the synthetic hormone drospirenone compared with similar products on the market......" For more information on Yaz and Yasmin, see GLF / Legal Sleuth - Yaz and Yasmin page

117. Bayer Sued, Accused of Hiding Yaz Risk to Boost Sales http://bit.ly/QWySX (Reuters) - An excerpt from the article states that " Bayer AG, Germany’s largest drugmaker, was sued by two Pennsylvania pension funds and accused of misrepresenting the safety and effectiveness of the Yaz contraceptive to boost sales. Bayer unlawfully promoted the drug from March 2006 to March 2009 by concealing side effects including blood clots, heart attacks and pulmonary embolisms, two health and welfare funds for firefighters and city employees said in a federal court complaint made public today in Philadelphia. The Yasmin family of birth control pills, known as Yaz, Yasmin and Yasminelle, were Bayer’s top-selling drugs last year, bringing in about $1.8 billion, a 17 percent increase over 2007. About 300 cases have been filed against the company over Yaz. Roughly 200 have been filed in federal litigation consolidated in East St. Louis, Illinois. Another 50 have been consolidated in state court in Philadelphia. Women who took the drug to prevent pregnancy or treat premenstrual disorder or acne may have suffered side effects including strokes, heart attacks, gallbladder disease and sudden death, according to the complaints......" For more information on Yaz and Yasmin, see GLF / Legal Sleuth - Yaz and Yasmin page

118. Women Should Take Safest Birth-Control Pill, Researchers Say http://bit.ly/Fw2Se (Reuters) - An excerpt from the article states that "Doctors should prescribe the birth- control pills that are the least likely to cause blood clots, according to a study of more than 3,000 women published today in the British Medical Journal. Oral contraceptives containing levonorgestrel and a low dose of estrogen, such as Bayer AG’s Microgynon 30, were associated with the lowest risk of blood clots in the leg or lungs, researchers at Leiden University Medical Center in the Netherlands found. Birth-control pills containing desogestrel, cyproterone acetate or drospirenone carried about 1.5 to 2 times the risk of clots, they found. All the pills in the study were equally effective in preventing pregnancy, the researchers said. Doctors sometimes prescribed certain contraceptives for acne, seborrhea or hair growth or to minimize weight gain while on the pill, even though “there is no clear evidence” to support the acne or weight- gain claims, they wrote. The choice should be based on reducing serious side effects such as clots, the researchers said. “Our results clearly show that the safest option with regards to the risk of venous thrombosis is an oral contraceptive containing levonorgestrel combined with a low dose of estrogen,” the researchers wrote. The study enrolled 1,524 patients who suffered from thrombosis, or clots, and 1,760 controls and looked at eight types of contraceptive pills on the market. About 57 percent of the control patients and 44 percent of the thrombosis patients took levonorgestrel, while 26 percent of the thrombosis patients were on desogestrel......" For more information on Yaz and Yasmin, see GLF / Legal Sleuth - Yaz and Yasmin page

119. Bayer Says Court Invalidates Patent on Contraceptive http://bit.ly/3Bc2am (Reuters) - An excerpt from the article states that "Bayer AG's patent on the birth control pill Yasmin was invalidated by a federal judge in New Jersey in a victory for generic-drug maker Barr Pharmaceuticals Inc. Barr rose as much as 14 percent in extended trading. Bayer said it may appeal today's decision and is evaluating the effect of the court's ruling on the Yaz birth control pill, a related drug that was approved for sale in the U.S. in 2006 and is protected by the same patent. Bayer said it has marketing exclusivity on Yaz until March 2009. Yasmin sales in the U.S. were $488.1 million last year. The family of contraceptives that includes Yasmin and Yaz generated $1.58 billion in 2007 sales for Leverkusen, Germany-based Bayer. The line of contraceptives is the company's best-selling pharmaceutical product, Bayer said Feb. 28. ``Bayer disagrees with the court's decision and will consider its legal options in this regard,'' Bayer said in a statement. ``The company will continue to vigorously defend its intellectual property.'' Woodcliff Lake, New Jersey-based Barr, the second-biggest U.S. maker of birth-control pills behind Watson Pharmaceuticals Inc., is seeking to sell a generic version of Yasmin. ``Clearly, this is a positive development for the company, and we are evaluating what the potential impact could be on our earnings guidance for 2008,'' Barr Chairman Bruce Downey said in a statement......" For more information on Yaz and Yasmin, see GLF / Legal Sleuth - Yaz and Yasmin page

120. 'Better' test for asbestos cancer http://bit.ly/1scK9r (BBC News) - An excerpt from the article states that "The cancer develops long after exposure to asbestos but patients usually have a limited life expectancy. The test developed by a team at Oxford University looks at levels of a protein closely linked to the cancer in fluid around the lungs. A UK lung expert welcomed the American Journal of Respiratory and Critical Care Medicine study. A simple test which can exclude the diagnosis without resort to more invasive methods would be welcomed Dr Paul Beckett, British Thoracic Society Mesothelioma is an invariably fatal tumour found in the surface of the lung. While relatively rare, it is very difficult to treat because of its location and because it does not seem to respond well to chemotherapy.The disease has been found in people with no history of exposure to asbestos, but inhaling the dust released by the mineral when it is broken up is known to be a key risk factor....." For more information on Yaz and Yasmin, see GLF / Legal Sleuth - Yaz and Yasmin page

121. New Technique Can Help Diagnose Mesothelioma http://bit.ly/21REqd (Redorbit) - An excerpt from the article states that "A new technique may help clinicians hone in on a diagnosis in patients presenting with a pleural effusion of unknown cause.The study, led by principal investigator Y.C. Gary Lee, Ph.D., appears in the September 1 issue of the American Thoracic Society's American Journal of Respiratory and Critical Care Medicine. "Pleural effusion, or the accumulation of fluid in the pleural cavity, can be maddeningly difficult to diagnose as a wide variety of malignant and benign causes exist," said Helen Davies, M.R.C.P., specialist registrar and research fellow at the Oxford Centre for Respiratory Medicine and Oxford University, lead author of the study. "One of the causes, malignant pleural mesothelioma, is a relatively rare cancer, but its incidence is rapidly increasing on a global scale". Currently, the first-line test for mesothelioma in patients with a pleural effusion is pleural fluid cytology, but this test is not very sensitive. Dr. Davies and her colleagues undertook the study to determine whether there would be additional clinical benefit to looking at pleural fluid mesothelin, a protein released in high quantities into the pleural fluid of most patients with mesothelioma. They obtained pleural fluid samples from 209 patients referred to a specialized respiratory clinic. Levels of soluble mesothelin were measured in all samples.Their results demonstrated median pleural fluid mesothelin levels were over six times greater in patients with mesothelioma than in patients with metastatic carcinomas, and ten times greater than in patients with benign effusions......" For more information on Mesothelioma and asbestos exposure, see [See GLF / Legal Sleuth - Asbestos and Mesothelioma

122. Mesothelioma victims seek expanded rights to sue http://bit.ly/1V2U4Y (Chicago Tribune) - An excerpt from the article states that "Dorothy Kuykendall choked back tears Thursday as she told a legislative committee about her bout with mesothelioma, a deadly disease she believes was caused by asbestos she was exposed to as factory worker decades ago. “My husband is 13 years older than I am, and I was sure I would be able to take care of him until he died, but that’s not going to happen,” Kuykendall, 76, of Terre Haute, told the Commission on the Courts. “He’s caring for me, and with all my medical bills, I’m afraid he won’t have enough income to live in our home.” Kuykendall and several others are on a quest to have an Indiana law amended to allow more time for workers to file lawsuits against those who exposed them to asbestos. Mesothelioma is a form of lung cancer strongly tied to asbestos exposure.They say an Indiana Supreme Court interpretation of state law gives people exposed to asbestos only 10 years after that exposure to start legal action. But lung cancer, asbestosis and mesothelioma can take decades to develop after the initial exposure.They want an exception to be made that would give them up to two years after they are diagnosed to file lawsuits against those who knowingly exposed them to the deadly toxin. Supporters of the law change say Indiana is the only state that does not provide exceptions to its laws for the often latent diseases.“They only ask that they have the right to go to court to see if someone is responsible,” said Russell Sipes, an attorney and advocate for people exposed to hazardous substances. “There are people out there who are getting off because enough time has gone by.”Sipes, citing the U.S. Centers for Disease Control, said 55 to 70 people in Indiana die from mesothelioma each year. " For more information on Mesothelioma and asbestos exposure, see [See GLF / Legal Sleuth - Asbestos and Mesothelioma

123. Four Pharmaceutical Companies Pay $124 Million for Submission of False Claims to Medicaid : http://bit.ly/U2kNr (US DOJ) - An excerpt from the article states that "Mylan Pharmaceuticals, UDL Laboratories, AstraZeneca Pharmaceuticals and Ortho McNeil Pharmaceutical have entered into settlement agreements for a total of $124 million to resolve claims that they violated the False Claims Act by failing to pay appropriate rebates to state Medicaid programs for drugs paid for by those programs, the Justice Department announced today. The Medicaid Prescription Drug Rebate Program was enacted by Congress in 1990 out of concern for the costs the Medicaid was paying for outpatient drugs. By agreeing to participate in the Medicaid Rebate Program and signing these rebate agreements, the four companies agreed to pay quarterly rebates to Medicaid that were based upon the amount of money that health care program paid for each company’s drugs. The precise amount of a rebate is determined in part by whether a drug is considered an "innovator" drug or a "non-innovator" drug. The rebate that must be paid for innovator drugs is higher than the rebate for non-innovator drugs. Each of the companies agreed to pay a settlement to resolve allegations that it had sold innovator drugs that were manufactured by other companies and had classified those drugs as non-innovator drugs for Medicaid rebate purposes.... As a result of the improper classification of these drugs, the companies underpaid their rebate obligations under the Medicaid Rebate Program. This case was brought under the False Claims Act, which allows for private persons to file suits on behalf of the government. The whistleblower, Ven-A-Care, a corporation located in Key West, Fla. will receive a total of $10,787,392 as its share of today’s recovery...." For more information on Qui, Federal False Claims and Whistleblower statutes, see [See GLF / Legal Sleuth - Qui Tam, Federal False Claims Act/Whistleblower

124. Jury orders Glaxo to pay $2.5M in Paxil case (Paxil birth defect) : http://bit.ly/1UNgpk (AP News) - An excerpt from the article states that "A Philadelphia jury has ordered GlaxoSmithKline to pay $2.5 million over birth defects allegedly caused by its antidepressant drug Paxil. .... The jury found the company guilty of negligence but not outrageous conduct, and rejected punitive damages. Plaintiff Michelle David of suburban Philadelphia has a son born four years ago with several heart defects. ... The Food and Drug Administration issued warnings in 2005 that Paxil may be associated with birth defects......" For more information on Paxil, see [See GLF / Legal Sleuth - Paxil - birth defect (heart/lung)

125. Warning: Ads may cause anxiety, other symptoms (Yaz and Yasmin) : http://bit.ly/8govG (Dallas MN) - An excerpt from the article states that "Confession: I've come to a point in my life when I can no longer understand TV commercials. There's one in particular, for the uniquely named medication Yaz, that messes with my head. A woman with a hypnotic stare and voice – who's attending some party on a rooftop – tells us that we may have seen some other Yaz commercials "that were not clear." She attempts to rectify this. She fails. "Yaz contains DRSP, a different kind of hormone," the woman says in her rapid-fire way, "that for some reason may increase potassium too much – so you shouldn't take Yaz if you have kidney, liver or adrenal disease because this could cause serious heart and health problems." OK, a lot to take in. But the sentence in most need of a diagram is this one: "Serious risks include blood clots, stroke and heart attack, so women – especially over 35? – shouldn't smoke, because it increases those risks." Wait. Slow down, lady! I suspect that adding smoking into the equation is designed to throw off us simpletons. And it succeeds. I rewound this commercial three times just to figure out all the words she was throwing at me....."

     [See GLF / Legal Sleuth - Yaz / Yasmin]

126. Top-selling birth-control pills battle new image problems : http://bit.ly/wHxyE (Seattle Times) - An excerpt from the article states that "The oral contraceptives Yaz and Yasmin are the top-selling pharmaceutical line for Bayer HealthCare, largely as a result of marketing that presents them as much more than mere pregnancy prevention. Yaz, in particular, the top-selling birth-control pill in the United States, owes much of its popularity to multimillion-dollar ad campaigns that have promoted the drug as a treatment to combat acne and severe premenstrual depression. Yaz, a newer sister drug to Yasmin, contains less estrogen. The franchise had worldwide sales of about $1.8 billion last year, based on Bayer's successful positioning of Yasmin and Yaz as the go-to drug brands for women younger than 35. But recently, the Yaz line's image has been clouded by concerns from some researchers, health advocates and plaintiffs' lawyers. They say the drugs put women at higher risk for blood clots, strokes and other health problems than do some other birth-control pills. Those critics, though, are up against a large European study, sponsored by Bayer, the German pharmaceutical company, that reported the opposite conclusion. The Bayer-financed study said cardiovascular risks in women taking Bayer products were comparable to those taking an older formula of birth-control pills. But regulators are finding other faults with the Yaz franchise. The Food and Drug Administration (FDA) cited Bayer this year for running misleading television commercials and last month for not following proper quality-control procedures at a plant that makes hormone ingredients.
     ...."

     [See GLF / Legal Sleuth - Yaz / Yasmin]

127. Health Concerns Over Popular Contraceptives (Yaz/Yasmin) : http://bit.ly/2c106w (NY Times)- An excerpt from the article states that "The oral contraceptives Yaz and Yasmin are the top-selling pharmaceutical line for Bayer HealthCare, largely as a result of marketing that presents them as much more than mere pregnancy prevention. Yaz, in particular, the top-selling birth control pill in the United States, owes much of its popularity to multimillion-dollar ad campaigns that have promoted the drug as a quality-of-life treatment to combat acne and severe premenstrual depression. Yaz, a newer sister drug to Yasmin, contains less estrogen. The franchise had worldwide sales of about $1.8 billion last year, based on Bayer’s successful positioning of Yasmin and Yaz as the go-to drug brands for women under 35. But recently, the Yaz line’s image has been clouded by concerns from some researchers, health advocates and plaintiffs’ lawyers. They say that the drugs put women at higher risk for blood clots, strokes and other health problems than some other birth control pills do. Those critics, though, are up against a large European health study, sponsored by Bayer, the German pharmaceutical giant, that reported the opposite conclusion. The Bayer-financed study said that cardiovascular risks in women taking Bayer products were comparable to those taking an older formula of birth control pills. But regulators are finding other faults with the Yaz franchise. The Food and Drug Administration early this year asked Bayer to correct misleading television commercials. Last month, the agency cited the company for not following proper quality control procedures at a plant that makes hormone ingredients.In e-mail responses to a reporter’s queries, the American unit of the company said that its birth-control drugs had been and continued to be extensively studied and that the company stood behind their safety. The company also said it had responded to the F.D.A.’s questions about manufacturing practices, which it said it took very seriously. ....."

     [See Gooch Law Firm/Legal Sleuth - Yaz/ Yasmin]

128. U.S. Loosens Control Over ICANN : http://bit.ly/V6i1r (WSJ) [See Gooch Law Firm or Legal Sleuth - Intellectual Property - Domain Name Dispute] - An excerpt from the article states that "The U.S. Commerce Department and a California-based group charged with managing Web site domain names announced Wednesday that they have severed an 11-year partnership, putting the U.S. government's stamp of approval on a private-sector model for directing the Internet. The move comes after European regulators and other critics have said the U.S. government could wield too much influence over a system used by hundreds of millions of people worldwide. Those critics have complained, among other things, about the slow rollout of Internet addresses entirely in languages other than English. The U.S. government stopped short of cutting its ties with the organization. The Commerce Department still will play an active role in deliberations of the Internet Corporation for Assigned Names and Numbers, or ICANN. ICANN performs a critical function for companies like Verisign Inc. or NeuStar Inc. that manage Web domains. Versign is keeper of the most popular Web suffix, ".com." NeuStar manages ".biz." E-commerce firms also are dependent on ICANN to ensure that Web traffic is directed to them, as well as companies like Go Daddy Group Inc. that sell Web site names. The Commerce Department and ICANN have now entered into an "affirmation of commitments" in which the parties pledge to "a multi-stakeholder, private-sector-led, bottom-up policy development model" for the Internet, according to the new agreement. Commerce will be actively involved in ICANN's activities as a member of the group's Governmental Advisory Committee...."

129. Floor Mats Prompt Largest Toyota Recall : http://bit.ly/23dvL5 (WSJ) [See Gooch Law Firm or Legal Sleuth - Auto Accident] - An excerpt from the article states that " Toyota Motor Corp. said Tuesday it would carry out its largest safety recall ever after reports that accelerator pedals had become trapped under floor mats, causing vehicles to speed up even after drivers lifted their foot off the pedal. WSJ Detroit bureau chief Neal Boudette and Dow Jones Newswires' Jeff Bennett discuss the outlook for U.S. auto sales numbers. While "Cash for Clunkers" gave auto makers a boost in July, the outlook remains grim for some. Toyota issued a safety advisory for owners of eight models sold under the company's Toyota and Lexus brands, urging them to remove the floor mats. The advisory, issued in conjunction with a similar warning by the National Highway Traffic Safety Administration, covers about 3.8 million vehicles. "This is the largest action that Toyota has taken in the U.S.," a company spokesman said during a conference call with reporters. Toyota said it needed to further examine the problems of individual models before issuing an official recall and that it would launch a broader safety campaign as early as next week.The advisory follows a fatal crash in San Diego this month that prompted Toyota to order dealers to inspect cars for mismatched floor mats. Toyota officials said that accident was still under investigation...."

130. FDA eyes possible risk with iron drug : http://bit.ly/17YZrh (Reuters) [See Gooch Law Firm or Legal Sleuth - Benzene Exposure - Toxic Tort or Exposure] 9/28/2009 16:46:10 from web - An excerpt from the article states that "U.S. health officials are looking into whether patients with a certain bone marrow disorder are more at risk for death and serious complications with the drug Exjade, made by Novartis AG. Those with myelodysplastic syndrome (MDS) may have a higher risk of kidney failure, potentially fatal bleeding and death with use of the drug, which helps regulate iron levels in patients who receive regular blood transfusions, the U.S. Food and Drug Administration said on Friday. In a notice on its website, the agency said it was investigating reported complications in patients using the drug but that several factors make it difficult to draw any conclusions without a closer look...."

131. Poll Finds Support for Ban on Texting at the Wheel : http://bit.ly/32p9Or (NY Times) [See GLF/Legal Sleuth Truck or 18 wheeler Accident] - An excerpt from the article states that "The public overwhelmingly supports the prohibition of text messaging while driving, the latest New York Times/CBS News Poll finds. Ninety percent of adults say sending a text message while driving should be illegal, and only 8 percent disagree. Articles in this series examine the dangers of drivers using cellphones and other electronic devices, and efforts to deal with the problem There is no difference in support based on region of the country, party identification, marital status or whether the respondent owns a cellphone, the poll found. More than 80 percent of every demographic group say sending text messages while driving should be illegal, but some are more adamant about such a prohibition than others. Parents, whether or not their children are adults, are more inclined to support a ban than people without children. Women are more in favor of outlawing the practice than men. Liberals are more likely to say texting should be legal than moderates or conservatives. Sixteen percent of respondents under 30 say texting while behind the wheel should be legal; only 1 percent of respondents 65 and older agree. Suburbanites are less inclined to favor a ban than city dwellers or people in rural areas. ..."

132. Gauging Your Distraction : http://bit.ly/cvZrE (NY Times) [See Gooch Law Firm or Legal Sleuth - Truck or 18 wheeler Accident] 9/28/2009 16:42:44 from web
133. Understanding Why Truckers Crash - http://bit.ly/khGlR (NY Times) [See GLF or Legal Sleuth Truck or 18 wheeler Accident] 9/28/2009 16:41:11 from web
134. Truckers Insist on Keeping Computers in the Cab : http://bit.ly/MSuhn (Reuters) [See GLF or Legal Sleuth Truck or 18 wheeler Accident] 9/28/2009 16:40:15 - An excerpt from the article states that "Crisscrossing the country, hundreds of thousands of long-haul truckers use computers in their cabs to get directions and stay in close contact with dispatchers, saving precious minutes that might otherwise be spent at the side of the road. The trucking industry says these devices can be used safely, posing less of a distraction than BlackBerrys, iPhones and similar gadgets, and therefore should be exempted from legislation that would ban texting while driving. “We think that’s overkill,” Clayton Boyce, spokesman for the American Trucking Associations, said of a federal bill that would force states to ban texting while driving if they want to keep receiving federal highway money. The legislation will be discussed at a conference on distracted driving in Washington, starting Wednesday, organized by the Transportation Department. The issues raised by truckers show the challenges facing advocates for tougher distracted-driving laws, given that so many Americans have grown accustomed to talking and texting behind the wheel.Mr. Boyce, who said the industry does not condone texting while driving, said computers used by truckers require less concentration than phones. The trucks “have a screen that has maybe two or four or six lines” of text, he said. “And they’re not reading the screen every second.” Banning the use of such devices, he added, “won’t improve safety.”But some safety advocates and researchers say the devices — which can include a small screen near the steering wheel and a keyboard on the dash or in the driver’s lap — present precisely the same risk as other devices. And the risk may be even greater, they note, given the size of 18-wheel tractor trailers and the longer time required for them to stop...."
135. Rise in ATV injuries...Children’s Memorial Hermann Hospital...: http://bit.ly/261Fm (MHH) - The articel states that "As severe ATV injuries rise sharply among Houston children, trauma specialists at Children’s Memorial Hermann Hospital--home to the Gulf Coast region’s only Level I pediatric trauma center--today called on families to use helmets at all times and to refrain from allowing youngsters to drive adult ATVs. “Allowing children to operate adult ATVs is like handing them a loaded gun to play with,” said Stephen Fletcher, M.D., pediatric neurosurgeon at Children’s Memorial Hermann Hospital and associate professor of clinical surgery at the University of Texas Medical School at Houston. “These are powerful motor vehicles, and many well-intentioned adults do not understand how easily they can lose control of an ATV until it happens to them. Children should not be driving adult ATVs at all.” At Children’s Memorial Hermann, trauma specialists treated 29 children with ATV related injuries in 2007, and in 2008, they treated 46, an increase of 58 percent. In 2009 to date, specialists already have treated 37 children, including one fatality.“The numbers just keep climbing, and many of the children we see have severe injuries that require extensive rehabilitation,” Dr. Fletcher said...." [See GLF or Legal Sleuth Yamaha Rhino Rollover] 9/25/2009 from web 10:15:23
136. FDA: Institute of Medicine to Study Premarket Clearance Process for Medical Devices : http://bit.ly/149Z1s (FDA) [See GLF or Legal Sleuth] 9/23/2009 from web 16:50:30

137. Colonic involvement in Stevens-Johnson syndrome : http://bit.ly/lF4I4 (BMJ)An excerpt from the article state that "Severe gastrointestinal tract involvement is a rare manifestation of Stevens-Johnson syndrome (SJS). The case is described of a 17 year old man who developed SJS secondary to phenytoin. In addition to the cutaneous, ocular, and oral mucosal lesions typical of SJS, he also developed persistent, bloody diarrhoea associated with life threatening malnutrition...." [See GLF or Legal Sleuth-Stevens-Johnson Syndrome] 9/21/2009 from web 18:47:26

138. On the Lookout for Stimulus Fraud : http://bit.ly/2FNNwl (NY Times) - An excerpt from the article state that "It would not ordinarily go down in the annals of crime. But when Robert Fitzsimmons was arrested this summer and accused of cashing a check made out to his long-dead father at a Pay-O-Matic check cashing store in Manhattan, he became one of the first people in the country accused of stealing some of the $787 billion in federal stimulus mone. And officials fear there could be many more to come. At issue was one of the millions of $250 stimulus checks that were sent to all Social Security recipients in May; Mr. Fitzsimmons was accused of cashing one that was made out to his late father, according to a complaint filed in Federal District Court in Manhattan, which goes on to accuse him of stealing Social Security money for at least four years. His lawyer, Julia Gatto, said he intended to plead not guilty...." [See GLF or Legal Sleuth-Qui Tam/Fraud/Whistleblower) 9/20/2009 from web 17:43:37

139. Health Ills Abound as Farm Runoff Fouls Wells : http://bit.ly/12G544 (Ny Times) - An excerpt from the article states that "All it took was an early thaw for the drinking water here to become unsafe. There are 41,000 dairy cows in Brown County, which includes Morrison, and they produce more than 260 million gallons of manure each year, much of which is spread on nearby grain fields. Other farmers receive fees to cover their land with slaughterhouse waste and treated sewage. In measured amounts, that waste acts as fertilizer. But if the amounts are excessive, bacteria and chemicals can flow into the ground and contaminate residents’ tap water. In Morrison, more than 100 wells were polluted by agricultural runoff within a few months, according to local officials. As parasites and bacteria seeped into drinking water, residents suffered from chronic diarrhea, stomach illnesses and severe ear infections. “Sometimes it smells like a barn coming out of the faucet,” said Lisa Barnard, who lives a few towns over, and just 15 miles from the city of Green Bay..." [See GLF or Legal Sleuth® - Toxic Exposure] 9/20/2009 from web 17:40:01

140. Calif. lawmaker plans hearings on soda-obesity link : http://bit.ly/1DKkbP (Reuters)- An excerpt from the article states that "The California lawmaker who spearheaded a high-profile anti-obesity effort across the country's most populous state is now training his sights on sugar-sweetened drinks. Sen. Alex Padilla, who led a campaign requiring big restaurant chains to disclose calories in meals, said on Thursday he planned to hold hearings in November on the link between soda consumption and obesity. The announcement from Padilla -- who chairs the California Senate's Select Committee on Obesity and Diabetes -- coincides with the release of a study that shows nearly two-thirds of children aged 12 to 17 gulp down at least one sugar-sweetened beverage daily. According to the UCLA Center for Health Policy Research and the California Center for Public Health Advocacy, 62 percent of children aged 12 to 17, and 41 percent of children aged 2 to 11, drink at least one sugar-sweetened beverage a day. "I don't think that most parents truly appreciate the role soda pop has in causing weight gain," Padilla said. "It is unfortunate that soda is actually cheaper than milk and even bottled water in many instances."..." 9/17/2009 from web 14:38:39
141. Threat of lead has not gone away for children : http://bit.ly/1bi5It (Reuters) - An excerpt from the article states that "Lead pollution in the environment remains a health hazard for children. Research released today reveals that blood lead concentrations well below the accepted "safe" level harm youngster's intellectual and emotional development. Researchers from University of Bristol in the UK measured blood lead levels in 488 youngsters at age 2 and a half and linked these levels to scores on standardized assessment tests at age 7 to 8. There was a clear link between blood lead levels in early childhood and academic performance by the ages of 7 and 8, the researchers report in the Archives of Disease in Childhood. Children with blood lead levels between 2 and 5 micrograms per deciliter performed significantly better on standardized tests than those with blood lead levels above 5 micrograms per deciliter, they found. Blood lead levels between 5 and 10 micrograms per deciliter were associated with significantly poorer scores for reading (49 percent lower) and writing (51 percent lower). A doubling of the blood lead level from 5 to 10 micrograms was associated with a 0.3 point fall in standardized test scores. Currently, the internationally accepted "safe" threshold of blood lead is 10 micrograms per deciliter, but Dr. Alan Emond, who led the current study, is now calling for this figure to be halved to just 5 micrograms per deciliter based on his team's findings...." [See GLF/Legal Sleuth® - Lead Exposure and Toxic Exposure] 9/17/2009 from web 14:32:26
142. Shockwave Treatment May Not Be Best for Shoulder Pain: http://bit.ly/4i9g3j (Forbes) - An excerpt from the article states that "Supervised exercise is better than shockwave treatment for relieving chronic shoulder pain, according to a new study. Shockwave treatment is widely used to treat shoulder pain, even though a number of studies have suggested that it's not effective. To investigate, Norwegian researchers studied 104 men and women, aged 18 to 70, who'd had shoulder pain for at least three months. The study patients were randomly selected to receive either radial extracorporeal shockwave treatment (low to medium energy pulses delivered into the tissue) once a week for four to six weeks, or supervised exercise consisting of two 45-minute sessions a week for up to 12 weeks. All of the patients were told not to use any additional treatments except analgesics, including anti-inflammatory drugs. The participants were assessed at six, 12 and 18 weeks, and their pain and disability were measured using a recognized scoring index...." [See GLF/Legal Sleuth® - Shoulder Pain Pump & PAGCL] 9/16/2009 from web 17:10:12
143. Timing, Type of HRT May Determine Breast Cancer Risk : http://bit.ly/BJCXU (Forbes) - An excerpt from the article states that "The timing and type of hormone replacement therapy women take to relieve menopausal symptoms seem to determine the degree of breast cancer risk they face, a new French study suggests. Overall, starting estrogen-progestagen therapy soon after menopause appears to boost the risk of breast cancer, even when only used for short periods of time, according to the study, which was published in the Sept. 14 online issue of the Journal of Clinical Oncology. Women who began the therapy in the three years after menopause and took it for two years or less had a 54 percent higher risk of breast cancer compared to those who never used the therapy, said study co-author Francoise Clavel-Chapelon, a researcher at the Institut Gustave Roussy in Villejuif, France. 9/16/2009 17:06:58 from web
144. Chemical pollutants linked to fewer female births : http://bit.ly/SDqmG (Reuters) - An excerpt from the article states that "High exposure to certain now-banned industrial chemicals may lead to fewer female births, a new study suggests. The findings, reported in the journal Environmental Health, add to evidence that the two groups of related chemicals -- polybrominated biphenyls (PBBs) and polychlorinated biphenyls (PCBs) -- may affect human reproduction. PBBs were once widely used as flame retardants in plastics, electronic and textiles, while PCBs were used in everything from appliances and fluorescent lighting to insulation and insecticides. While the chemicals were banned in the 1970s as potential health hazards, they remain a public-health concern because they linger in the environment and accumulate in the fat of fish, mammals and birds. For the current study, researchers used data from a group of Michigan residents who, in the early 1970s, had been inadvertently exposed to high levels of PBBs; the chemicals had been accidentally mixed into animal feed, leading to human exposure through contaminated meat, eggs and milk. The researchers observed that, from 1975 to 1988, women in the study group had a higher-than-average rate of male births, relative to the national average. There was also a suggestion of increased odds of a male birth when both parents' combined PBB exposure was particularly high -- above the midpoint for the study group -- compared with couples whose PBB exposure was lower...." 9/16/2009 from web 17:03:23
145. Chairman’s Mark Baucus - America’s Healthy Future Act of 2009 : http://bit.ly/35EZp - 9/16/2009 from web
146. Putting a Price on Sunshine: It’s $10 in the Baucus Bill : http://bit.ly/k1epe (WSJ) - An excerpt from the article states that "In addition to everything else, the Baucus bill wants to make drug and other medical companies to report payments to doctors and hospitals when they pass certain levels. How much triggers a report, you ask? Any individual payment over $10 or total payments to a recipient of more than $100 a year. Under the bill unveiled by Sen. Max Baucus today, drug, device and medical-supply makers would be required to provide a slew of details to Health and Human Services going beyond the names and addresses of those receiving money. The reports would have to include whether the payment was for marketing, education or research purposes, the specific name of the drug, device or medical supplies and “any other category of information that the Secretary determines appropriate,” according to the bill. See p. 176 of the bill. Also, if a doctor requests that the money be transferred to another person or entity, that information should be disclosed as well. And should this provision in the Baucus bill become law, it would trump all state disclosure laws, unless the state law requires reporting beyond the federal statute...." 9/16/2009 from web 16:09:43
147. Ten Symptoms Too Dangerous To Ignore : http://bit.ly/k1epe (Forbes) - An excerpt from the article states that "Common sense tells us that symptoms like acute chest pain and abdominal pain or persistent fevers and headaches are important reasons to seek medical attention. Yet some patients, because they lack access to a physician or are simply too distracted or stubborn to make the phone call, disregard such symptoms until it's too late. Dr. Joseph W. Stubbs, president of the American College of Physicians and an internist in Albany, Ga., has treated both types...." 9/16/2009 from web 16:01:42
148. Two More Brain Infection Cases Emerge in Tysabri Patients (WSJ) - An excerpt from the article states that "Two more cases of a rare brain infection have emerged in users of the multiple-sclerosis drug Tysabri, sold by Biogen Idec Inc. and Elan PLC, the first such incidences since Biogen stopped updating investors of the situation in July. At that time, Biogen had confirmed 11 cases of progressive multifocal leukoencephalopathy, or PML, since the drug's relaunch in July 2006; Tysabri was pulled from the U.S. market in 2005 because of PML concerns. A Biogen spokeswoman said the Cambridge, Mass., biotech company is neither commenting on nor confirming the existence of additional cases as long as the PML rate is consistent with the rate of one-in-1,000 patients implied by the label. The new cases appear to be in line with the label's rate....": http://bit.ly/GJO5w (WSJ) - 9/14/2009 from web 18:28:04 [See GLF or Legal Sleuth® for more information on the drug Raptiva & PML]
149. Defibrillators may not save women, study finds : http://bit.ly/3x2Wr4 (Reuters) - An excerpt from the article states that "Despite their widespread use, implantable defibrillators to protectagainst deadly heart rhythms do not prevent deaths in women with advanced heart failure, U.S. researchers said on Monday. They said implantable defibrillators -- which detect abnormal heartrhythms and offer a life-saving shock to restore a regular heartbeat -- do not appear to protect men and women equally. "There seems to be much less significant benefit" in women, said Dr.Christian Machado of Providence Hospital Hear Institute and Medical Center in Michigan, whose study appears in the Archives of Internal Medicine...." 9/14/2009 from web 18:28:40
     
150. Merck Case Over Fosamax Ends in Mistrial in New York : http://bit.ly/o7xvE (Bloomberg) - An excerpt from the article states that "A federal judge declared a mistrial in the first case to go to a jury over claims that Merck & Co.’s osteoporosis drug Fosamax causes so-called jaw death after a lone juror refused to exonerate the company. Jurors in federal court in New York said today a one-day “cooling-off period” brought no agreement, and U.S. District Judge John Keenan ended the trial. On Sept. 9, the holdout juror said she was physically threatened during deliberations. “I’m declaring a mistrial,” Keenan said. “The jury is excused....” [See GLF or Legal Sleuth® for more information on the drugFosamax/Bisphosphonate] 9/14/2009 from web 12:17:25
     
151. Commentary: New face of addiction in America : http://bit.ly/13WAoJ (CNN) - An excerpt from the article states that "Addiction in America has a new face: prescription drugs. Last year, prescription drugs replaced heroin and cocaine as the leading cause of deadly overdoses.And celebrities are showing us that mixing prescription pills -- the pills you may have in your home right now -- could be just as deadly as shooting up heroin or snorting cocaine. Adam Goldstein, aka DJ AM, seems to be the latest well-known victim of a deadly dose of drugs. The celebrity DJ was found dead in his New York apartment on August 28. A law enforcement source tells People magazine that Goldstein was found with eight undigested OxyContin pills in his stomach plus a ninth in his mouth. (The medical examiner's office told HLN it would not release any information on the case until further testing is completed....") 9/14/2009 from web 12:06:40
     
152. Clean Water Laws Are Neglected, at a Cost in Suffering : http://bit.ly/35zGwa (NY Times) - An excerpt from the article states that "Jennifer Hall-Massey knows not to drink the tap water in her home near Charleston, W.Va.In fact, her entire family tries to avoid any contact with the water. Her youngest son has scabs on his arms, legs and chest where the bathwater — polluted with lead, nickel and other heavy metals — caused painful rashes. Many of his brother’s teeth were capped to replace enamel that was eaten away. Neighbors apply special lotions after showering because their skin burns. Tests show that their tap water contains arsenic, barium, lead, manganese and other chemicals at concentrations federal regulators say could contribute to cancer and damage the kidneys and nervous system...." [See GLF/Legal Sleuth® - Toxic Exposures/Torts] 9/13/2009 from web 13:32:35
153. FDA Opens New Warning Letter Website : http://www.fda.gov/ICECI/En... 9/11/2009 from web 11:43:35
154. Health Tip: Recognizing Gallstones : http://bit.ly/4LsdF (Forbes) - The article states that "Gallstones are stones of varied sizes that form in the gallbladder, and are usually composed of cholesterol or excess bilirubin in the bile. Some gallstones cause no symptoms, while others can cause significant pain...." [See GLF/Legal Sleuth® - Yaz or Yasmin - gallbladder injury or problems] 9/11/2009 from web 11:23:44
155. Health Tip: Are You Pregnant and Depressed? : http://bit.ly/3Erzin (Forbes) - The article states that "Many women become depressed while they are pregnant, or shortly after the baby is born. The U.S. National Women's Health Information Center says these factors increase the likelihood of developing depression during or after pregnancy:..." [See GLF or Legal Sleuth® - Paxil] 9/11/2009 from web 11:23:37
     
156. Report Cards for Hospitals May Be Misleading: http://bit.ly/2fXFX4 (Forbes) - The article states that "A new study questions the value of hospital report cards and national rankings when it comes to neurology and neurosurgery. Researchers with Loyola University Health System in Chicago say the mortality index, a statistic to gauge the number of deaths a facility has in a given area of medical care, may be inflated -- indicating a higher-than-normal death rate -- at hospitals that specialize in severe traumas, have busy emergency departments or have high numbers of patients on government-subsidized Medicaid...." [See GLF or Legal Sleuth® - Medical Malpractice] 9/11/2009 from web 11:23:34
157. U.S. government nervous about stimulus fraud, scams: http://bit.ly/etv7Z (Reuters) - The article states that "As billions of dollars from the economic stimulus plan pour through the U.S. economy, members of Congress, the administration and regulatory agencies are increasingly worried about the risks of fraud.Earl Devaney told Congress on Thursday the Recovery Accountability and Transparency Board he chairs is investigating those who may have misappropriated stimulus money.His board has "forwarded more than 100 matters to various IGs (inspector generals to ensure heightened scrutiny of specific procurements that board staff has identified as potentially problematic...." [See GLF or Legal Sleuth - Qui Tam/Fraud/Whistleblower) 9/11/2009 from web 11:23:29
158. HHS and USDA Unveil New Food Safety Consumer Website
     
159. Merck loses effort to dismiss 24 Fosamax cases: - The article states that "A Manhattan federal judge has rejected Merck & Co's effort to dismiss 24 cases alleging that its Fosamax drug treatment for osteoporosis causes jaw damage. In an opinion released Wednesday, U.S. District Judge John Keenan ruled that the plaintiffs could introduce testimony by two doctors to show that the drug can cause jaw damage after less than three years of continuous use. Keenan said the evidence is sufficiently reliable to allow a rational jury to establish such a connection. He said individual plaintiffs will then be allowed to present expert testimony that Fosamax caused them to suffer such damage, and that such testimony could by itself "make causation a genuine issue of fact for trial." Merck was not immediately available for comment..." [See Gooch Law Firm or Legal Sleuth® websites for more information on Fosamax and Bisphosphonates]
160. High levels of lead in bone hard on the heart: (Reuters) - The article states that "Lots of lead in the bones may make for an unhealthy heart, new research suggests. Older men with the highest levels of the metal in their bones were more than twice as likely to die over the study's 9-year follow-up than their peers with the lowest bone lead levels, while their risk of dying from heart-related causes was nearly six times greater, Dr. Marc G. Weisskopf of the Harvard School of Public Health in Boston and his colleagues found. "This is yet another prod to try and raise the issue of bone lead being at least as important to monitor as blood lead," Weisskopf told Reuters Health. He pointed out that US occupational standards for lead exposure are currently based on measuring blood levels, which can return to normal a few months after exposure ends. Bone lead, on the other hand, can show exposure that happened years or even decades ago...." [See Gooch Law Firm or Legal Sleuth® websites for more information on Toxic Torts or Lead Exposure] 3:32 PM Sep 8th from web
161. Merck Faces First Trial of Claim That Fosamax Attacks Jawbone: (Bloomberg) - The article states that "Merck & Co., the drugmaker facing 900 lawsuits over claims that its osteoporosis drug Fosamax causes the death of jawbone tissue, goes to trial tomorrow in a case that may affect all the others. The trial in New York of the first case of the group, filed by Shirley Boles, 71, will be one of three so-called bellwether cases that may point the way to out-of-court settlements. “In mass litigation, all eyes are on the first trial, not only because it shows the strategy of each side, but also because it’s the first information about how jurors respond to the evidence,” said Howard Erichson, a law professor at Fordham University in New York and an expert on civil procedure...." [See Gooch Law Firm or Legal Sleuth® websites for more information on Fosamax and Bisphosphonates] 5:53 AM Sep 3rd from web
     
162. Statement on FOSAMAX® (alendronate sodium) Product Liability Trial: (Merck.com) - The site states that "Merck & Co., Inc. will vigorously defend itself in a jury trial set to begin today, in the United States District Court for the Southern District of New York. The company believes the evidence will show that FOSAMAX did not cause Shirley Boles to develop dental and jaw-related problems as she claims and that Merck provided appropriate and timely information about FOSAMAX to the medical, scientific and regulatory communities. In Shirley Boles v. Merck & Co., Inc., the plaintiff alleges she used FOSAMAX from 1997 to 2006. Plaintiff further alleges that she suffered various jaw problems and complications following two tooth extractions in June 2002, including a several day hospitalization in 2004 to treat her condition. “Unfortunately, Ms. Boles had medical problems that cause people to develop jaw problems, regardless of whether they were taking FOSAMAX,” said Paul Strain of Venable LLP, outside counsel for Merck. “She had significant periodontal disease and a history of smoking up to a pack of cigarettes a day, which can result in poor wound healing. The evidence will show that Ms. Boles would have experienced dental and jaw-related problems whether she took FOSAMAX or not.” Judge John F. Keenan of the U.S. District Court for the Southern District of New York will preside over the trial...." [See Gooch Law Firm or Legal Sleuth® websites for more information on Fosamax and Bisphosphonates] 5:46 AM Sep 3rd from web
     
163. Drug giant Pfizer to pay record $2.3B fine: (CNN) - The article states that "Pharmaceutical giant Pfizer has agreed to pay a record $2.3 billion settlement to resolve criminal and civil liability for illegally promoting certain pharmaceuticals, the Justice Department announced Wednesday. Pfizer pays record fine to avoid prosecution for illegally promoting certain drugs. Officials from the Justice Department and the Department of Health and Human Services said the world's largest drug company promoted four drugs for use on certain ailments or at dosages that were not approved by the Food and Drug Administration. One of those drugs was the anti-inflammatory medication Bextra, which Pfizer pulled off the market in 2005 after it was linked to increasing the risk of heart attacks and strokes...." [See Gooch Law Firm or Legal Sleuth® websites for more infomation on Qui Tam-Whistleblower-Federal False Claims] 5:30 AM Sep 3rd from we
     
164. ATV accident survivor shares harrowing tale: (Hou. Chron.) - The article states that "...A hospital spokeswoman said doctors — Children's Memorial Hermann Hospital has the region's only Level 1 pediatric trauma center — treated 29 ATV crash cases in 2007, 46 in 2008 and 37 so far this year. Nationally, 40,000 children younger than 16 suffered ATV-related injuries in 2007; 107 of them died. Fletcher noted that those numbers reflect only injuries serious enough to need treatment at a major hospital. As doctors and others who intervened in her son's case stood at her side, Angela West tearfully spoke of how her son nearly died. Zach, whose initial injuries — a fractured skull and punctured carotid artery — were followed by a stroke, spent seven weeks at the Texas Medical Center hospital and an additional six at HealthBridge Children's Hospital....” [See Gooch Law Firm or Legal Sleuth® websites for more information on ATV or Yamaha Rhino Rollover/rollovers accident] 3:28 PM Sep 2nd from web
165. Effects of oral contraception with ethinyl estradiol and drospirenone ...: (PubMed) - The article states that "...CONCLUSIONS: The recently introduced combination of ethinylestradiol and drospirenone induced the heightening of lipid peroxidation correlated with high levels of copper, a situation that could be associated with increased cardiovascular risk....” [See Gooch Law Firm or Legal Sleuth® websites for more information on Yaz or Yasmin birth control] 3:24 PM Sep 2nd from web
     
166. The venous thrombotic risk of oral contraceptives...: (BMJ) [See Gooch Law Firm or Legal Sleuth® websites for more information on Yaz or Yasmin]10:24 AM Aug 31st from web
     
167. JAMA: Study on Clinical Efficacy of Clopidogrel Therapy: (JAMA) [See Gooch Law Firm or Legal Sleuth® websites for more information on Drug Eluting Heart Stent] 2:49 PM Aug 25th from web
168. Gene variation strongly predicts Plavix response: (Reuters) - The articles states that "“A common gene variation explains why many people are not helped by the widely prescribed blood thinner Plavix, U.S. researchers said on Tuesday in a study confirming earlier research and paving the way for tests to screen patients before they get the drug. They said one version of the gene CYP2C19, carried by nearly a third of the general population, plays a major role in their response to Plavix or clopidogrel, an $8 billion a year drug made by Sanofi-Aventis and Bristol-Myers Squibb Co to prevent heart attacks and strokes....” [See Gooch Law Firm or Legal Sleuth® websites for more information on Drug Eluting Heart Stent]2:47 PM Aug 25th from web 
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169. Hip fracture rates have dropped, Canada study finds: http://bit.ly/tWsA8 (Reuters) - The article states that "“Hip fracture rates have declined among the elderly for a variety of reasons, but the disabling injury is still a major health threat as populations age, Canadian researchers said on Tuesday. A steady year-over-year decline in fracture rates since 1985 predates widespread use of drugs used to treat osteoporosis and preserve bone density, the researchers said, even though drugs that first entered the market in the mid-1990s likely played a role. "I don't honestly think there's just one factor that accounts for all of this," said Dr. William Leslie of the University of Manitoba in Winnipeg, who led the study published in the Journal of the American Medical Association. Between 1985 and 2005, more than 570,000 Canadians were treated for hip fractures. Over those two decades, the rate of hip fractures declined 32 percent in women and 25 percent in men, with the largest decrease among adults aged 55 to 64....” (WSJ) [See Gooch Law Firm or Legal Sleuth® websites for more information on Bisphosphonates]2:05 PM Aug 25th from web
     
170. Tobacco seen killing 6 million people next year: http://bit.ly/131Z5H (Reuters) - The article states that "“Tobacco use will kill 6 million people next year from cancer, heart disease, emphysema and a range of other ills, global cancer experts said in a report issued on Tuesday. The new Tobacco Atlas from the World Lung Foundation and the American Cancer Society estimates that tobacco use costs the global economy $500 billion a year in direct medical expenses, lost productivity and environmental harm. "Tobacco's total economic costs reduce national wealth in terms of gross domestic product (GDP) by as much as 3.6 percent," the report reads. "Tobacco accounts for one out of every 10 deaths worldwide and will claim 5.5 million lives this year alone," the report said. If current trends hold, by 2020, the number will grow to an estimated 7 million and top 8 million by 2030....” 1:59 PM Aug 25th from web
171. FDA Moves Forward on Implementation of Tobacco Law: http://bit.ly/6eFEM (FDA) 1:57 PM Aug 25th from web
     
172. Stabilet Infant Warmer - FDA Class 1 Recall: http://bit.ly/O1qiw (FDA)
173. Antidepressant Alternative for Pregnant Women: Shock Therapy: http://bit.ly/s3wyA (WSJ) - The article states that "Pregnant women should consider psychotherapy as an alternative to antidepressants, but those with more severe or recurrent bouts of depression should remain on their meds during pregnancy, according to a new report from two big physicians’ groups. But there’s an alternative treatment for the sickest depressed women, the guidelines say: electroconvulsive therapy, often called shock therapy. ECT, which involves an electric current that induces a seizure in the brain, has been “long regarded as a safe and effective treatment for severe depression in pregnancy,” the guidelines say. It may be particularly help for for women who aren’t helped by medication, or when a disorder is life-threatening. It doesn’t appear to be harmful to either the mother-to-be or the unborn children when they are carefully monitored, according to the guidelines...." [See GLF or Legal Sleuth® for more information on Paxil & PPHN]
174. Even modest fitness may extend lifespan: http://bit.ly/ztCYF (Reuters) - The article states that "People who stay even moderately fit as they age may live longer than those who are out-of-shape, a new study suggests. The study, of nearly 4,400 healthy U.S. adults, found that the roughly 20 percent with the lowest physical fitness levels were twice as likely to die over the next nine years as the 20 percent with the next-lowest fitness levels. That was with factors like obesity, high blood pressure and diabetes taken into account -- underscoring the importance of physical fitness itself, researchers report in the journal Medicine and Science in Sports and Exercise...."
     
175. Surgeon Tied to Bone Product Inquiry Resigns: http://bit.ly/10aEId (NY Times) - The article states that "A former Army surgeon accused of falsifying a study on a bone growth product used on severely injured Iraq war veterans has resigned his teaching position at Washington University in St. Louis, a spokeswoman said Tuesday night. The surgeon, Dr. Timothy R. Kuklo, 48, was placed on leave earlier this year while the university investigated charges against him. Medtronic, a maker of the bone growth product Infuse, also suspended his consulting contract. The company paid him nearly $800,000 the last few years. “Dr. Kuklo has agreed to voluntarily resign from the university, effective September 30, 2009,” Joni Westerhouse, a spokeswoman for the medical school, said in an e-mail message Tuesday. “Dr. Kuklo will have no clinical, research, or educational duties for the University between now and that date.” Dr. Kuklo tendered his resignation on July 30, according to Don Clayton, associate vice chancellor and director for medical public affairs. University officials declined to comment further....” [See GLF or Legal Sleuth® for more information on the Medtronic Infuse Bone Graft]
     
176. MRI: Is gadolinium safe for people with kidney problems?: http://bit.ly/2cbouQ (Mayo Clinic) - The article states that " [See GLF/Legal Sleuth® - Gadolinium Contrast)]
177. Crohn's disease: http://bit.ly/zVjAK (Mayo Clinic) - The article states that "Crohn's disease is an inflammatory bowel disease (IBD). It causes inflammation of the lining of your digestive tract, which can lead to abdominal pain, severe diarrhea and even malnutrition. The inflammation caused by Crohn's disease often spreads deep into the layers of affected bowel tissue. Like ulcerative colitis, another common IBD, Crohn's disease can be both painful and debilitating and sometimes may lead to life-threatening complications. While there's no known medical cure for Crohn's disease, therapies can greatly reduce the signs and symptoms of Crohn's disease and even bring about long-term remission. With these therapies, many people with Crohn's disease are able to function well...." [See GLF or Legal Sleuth® - Accutane (inflammatory bowel disease- IBD)]
178. Ulcerative colitis: http://bit.ly/WQzyP (Mayo Clinic) - The article states that "Ulcerative colitis, an inflammatory bowel disease (IBD) that causes chronic inflammation of the digestive tract, is characterized by abdominal pain and diarrhea. Like Crohn's disease, another common IBD, ulcerative colitis can be debilitating and sometimes can lead to life-threatening complications. Ulcerative colitis usually affects only the innermost lining of your large intestine (colon) and rectum. It occurs only through continuous stretches of your colon, unlike Crohn's disease, which occurs in patches anywhere in the digestive tract and often spreads deep into the layers of affected tissues. There's no known cure for ulcerative colitis, but therapies are available that may dramatically reduce the signs and symptoms of ulcerative colitis and even bring about a long-term remission...." [See GLF or Legal Sleuth® - Accutane (inflammatory bowel disease)] 2:21 PM Aug 17th from web
179. Elders lack knowledge of stroke signs, risk factors: http://bit.ly/2Ottpwc (Reuters) - The article states that " 2:06 PM Aug 17th from web
180. Blood pressure drug reverses MS symptoms in mice: http://bit.ly/149WE (Reuters) - The article states that "A widely used blood pressure drug may hold promise as a treatment for multiple sclerosis, U.S. researchers said on Monday. Lab tests found the generic drug lisinopril, developed by Merck and sold as Prinivil or Tensopril, prevented paralysis in mice with a form of MS. "Lisinopril was quite powerful, and could even reverse paralytic disease (in mice)," said Dr Lawrence Steinman of Stanford University School of Medicine in California, whose study appears in the Proceedings of the National Academy of Sciences. Lisinopril, also sold by AstraZeneca as Zestril, is an angiotensin-converting enzyme, or ACE inhibitor. It acts by blocking angiotensin, a hormone that makes blood vessels contract, increasing blood pressure...." 2:05 PM Aug 17th from web
181. America's Most Medicated States: http://bit.ly/27CvBJ (Forbes) - The article states that "Much of the American South is ailing, with West Virginia the worst off--at least, if the rate of prescription drug use is any indication. The state filled 17.7 prescriptions per capita compared to a national average of 11.5, according to Verispan, a health care information company. Alabama, South Carolina, Tennessee, Arkansas, Louisiana, Kentucky and Missouri also have prescription drug-use rates well above the national average...." [See GLF or Legal Sleuth® - Prescription Drug Liability] 1:58 PM Aug 17th from web
182. Amgen osteoporosis drug denosumab wins a vote of confidence from FDA panel: http://bit.ly/2OSug (LA Times) - The article states that " - The article states that "Biotech leader Amgen Inc. cleared a major hurdle in its push to win approval for its experimental osteoporosis drug from the Food and Drug Administration. An FDA advisory committee on Thursday recommended the drug, denosumab, for women being treated for osteoporosis as well as for men experiencing bone loss because of prostate cancer treatment, saying it helps prevent bone fractures. But in a 12-3 vote, the panel of medical experts did not recommend the drug for use by women as a preventive medicine for the bone-thinning disease or to fight bone loss in women undergoing breast cancer treatment. Before it would be willing to recommend the drug for those uses, the committee said, it would like to see more data on long-term use of the drug...." 12:19 PM Aug 14th from web
183. Osteoporosis drugs effective in killing flu viruses: http://bit.ly/NT43n (Reuters) - The article states that "Two existing drugs used to treat osteoporosis may be effective in killing influenza viruses, including the new H1N1 swine flu and the H5N1 bird flu viruses, researchers in Hong Kong have found. The two drugs are pamidronate and zoledronate, which are marketed by Novartis AG under the brand names Aredia and Reclast, respectively. In their experiment, the researchers exposed human cells that had been infected with the influenza viruses to the two drugs. They observed that the drugs triggered extra production of a type of white blood cell called yd-T cells, which went on to kill human cells that were infected with the flu viruses...." 12:13 PM Aug 14th from web
184. FDA Approves Saphris to Treat Schizophrenia and Bipolar Disorder: http://bit.ly/18QjV0 (FDA) 12:08 PM Aug 14th from web
185. Barr Laboratories, Inc. issues a voluntary nationwide recall of Dextroamphetamine/Amphetamine: http://bit.ly/TJpK9 (FDA)12:07 PM Aug 14th from web
186. Screening Could Lead to More Potent Cancer Drugs: http://bit.ly/mjR3n (NY Times) 12:06 PM Aug 14th from web
187. Osteoporosis-linked fracture rates up dramatically: http://bit.ly/10XpkJ (Reuters) - The article states that "The number of Americans hospitalized for osteoporosis-related fractures and other injuries has climbed 55 percent since 1995, a U.S. government report finds. In 2006, Americans had more than 254,000 hospital stays for injuries related to the bone-thinning disease -- with fractures of the hip, spine and ribs among the most common, according to the study by the Agency for Healthcare Research and Quality (AHRQ). The figure represents a considerable increase in the rate of such hospitalizations over just one decade. In 1995, the rate of hospital stays for osteoporosis-related injuries was 55 per 100,000 people; in 2006, it was 85 per 100,000...." 12:04 PM Aug 14th from web
188. THE WAY WE LIVE NOW (Fat Tax): http://bit.ly/t0ndE (NY Times - The article states that "Two years ago, the Cleveland Clinic stopped hiring smokers. It was one part of a “wellness initiative” that has won the renowned hospital — which President Obama recently visited — some very nice publicity. The clinic has a farmers’ market on its main campus and has offered smoking-cessation classes for the surrounding community. Refusing to hire smokers may be more hard-nosed than the other parts of the program. But given the social marginalization of smoking, the policy is hardly shocking. All in all, the wellness initiative seems to be a feel-good story...." 12:03 PM Aug 14th from web
189. FDA Issues Public Health Notification on Glucose Monitoring Technology: http://bit.ly/2iMMdk (FDA)12:02 PM Aug 14th from web
190. Not enough shut-eye may raise diabetes risk: http://bit.ly/ZP0SL (Reuters) 2:18 PM Aug 13th from web
191. Scientists Reverse Multiple Sclerosis in Mice: http://bit.ly/IdQ2n (Forbes) - The article states that "An experimental treatment that suppresses the immune system to put multiple sclerosis into remission completely reversed the disease in mice, Canadian scientists say.In MS, the immune system attacks the central nervous system. The new treatment, called GIFT15, is composed of two proteins, GSM-CSF and interleukin-15, that are fused in the lab. Normally, the individual proteins act to stimulate the immune system, but when they're stuck together, the proteins suppress immune response, the researchers explained. They do this by converting B-cells -- a type of white blood cell normally involved in immune response -- into immune suppressive cells...." 2:14 PM Aug 13th from web
192. Dementia Studies Find Diet, Exercise Matter: http://bit.ly/4wlDiE (WSJ) - The article states that "Two studies published in this week's Journal of the American Medical Association add to evidence that long-term lifestyle habits may reduce the risk of mental decline in old age. The first study, a long-term look at 1,880 elderly people in New York City, found that a Mediterranean-type diet and physical activity each were linked to less risk for Alzheimer's disease. The Taub Institute for Research on Alzheimer's Disease and the Aging Brain at Columbia University Medical Center released the data as part of a larger research project on aging. The second study, a shorter-term observation of 1,410 patients in France, found some correlation between a Mediterranean-type diet and slower cognitive damage. Nikolaos Scarmeas, the author of the first study, grew up eating fish and vegetables in Athens, Greece. Now the neurologist suggests more people take up his mother's cooking. Marked by high consumption of foods such as vegetables, legumes and cereals, served with olive oil, in addition to moderate fish and alcohol intake, the traditional diet has long conferred better cardiovascular health...." 2:12 PM Aug 13th from web
193. New, but Not Improved? Incorporating Comparative-Effectiveness Information into FDA Labeling: http://bit.ly/Y4Dmt (NEJM) - The article states that "New technologies, including prescription drugs and medical devices, are a major driver of increases in U.S. health care expenditures, which have grown by an estimated 71% since 2000.1 The U.S. market for drugs and devices is regulated by the Food and Drug Administration (FDA), which scrutinizes clinical trial data for evidence of safety and efficacy. Although the FDA has been criticized for missteps and inefficiencies in its approval process, these are not the causes of increasing health care expenditures. More relevant is FDA oversight of the labeling and promotion of medical products...." 2:11 PM Aug 13th from web
194. LA sports arena hosts health clinic of last resort: http://bit.ly/AVhQ9 (Reuters) 10:29 AM Aug 13th from web
195. Abbott expanding study of its popular Xience stent: http://bit.ly/Jc8Wi (AP) 10:18 AM Aug 13th from web
196. 9/11 Responders May Be At Raised Myeloma Risk: http://bit.ly/3qt7bq (Forbes) - The article states that "Preliminary findings suggest that responders to the attacks on the Twin Towers on 9/11 may be at higher risk for multiple myeloma, a cancer of the blood. Notably, half of the cases identified among law enforcement officers were under the age of 45. Multiple myeloma is usually a disease of the elderly. "This is very preliminary," cautioned Dr. Mitchell Smith, director of the Lymphoma Service at Fox Chase Cancer Center in Philadelphia. "It could turn out to be a statistical fluke and means nothing or it could be the tip of the iceberg and we'll see an increase in the next 10 years," he said. "The concerning thing," he added, "is it makes biological sense. There is certain data that multiple myeloma is associated with an increased exposure to certain chemicals. It has never been shown with inhaled chemicals but this amount of exposure probably did get into the blood." Smith was not involved in the study...." 2:23 PM Aug 10th from web
197. A Primer on the Details of Health Care Reform: http://bit.ly/FY7Cl (NY Times) - The article states that "At any rate, the federal government already holds sway over the health care system through Medicare, Medicaid and various insurance programs for children, veterans, military personnel and other federal employees. The federal government will account for 35 percent of the expected $2.5 trillion in health spending this year, and that does not include subsidies built into the tax code...." 2:12 PM Aug 10th from web
198. 28 Illnesses Are Linked to Recalled Ground Beef: http://bit.ly/12BBRz (NY Times) - The article states that "Health officials in three Western states said Friday that at least 28 people had reported illnesses tied to recalled ground beef that might be tainted with salmonella. On Thursday, Beef Packers Inc. of Fresno recalled nearly 826,000 pounds of ground beef produced from June 5 to 23. The Food Safety and Inspection Service of the Agriculture Department said the beef was sent to retail distribution centers in Arizona, California, Colorado and Utah, with some sold at Safeway Inc. and Sam’s Club. On Friday, the department confirmed that California, Colorado and Wyoming had reported illness linked to the recalled beef...." 2:11 PM Aug 10th from web
199. Health care's big money wasters: http://bit.ly/fWjnk (CNN) - The article states that "That's half of the $2.2 trillion the United States spends on health care each year, according to the most recent data from accounting firm PricewaterhouseCoopers' Health Research Institute. What counts as waste? The report identified 16 different areas in which health care dollars are squandered. But in talking to doctors, nurses, hospital groups and patient advocacy groups, six areas totaling nearly $500 billion stood out as issues to be dealt with in the health care reform debate...." 5:56 AM Aug 10th from web
200. Lawsuits Question After-Hours Demands of Email and Cellphones: http://bit.ly/4vCkjS (WSJ) - The article states that "Two recent lawsuits raise a question that many employees and employers have deliberated: Should hourly workers be paid for time spent responding to work calls or emails while off the clock? The federal suits highlight the legal issues sparked by the proliferation of personal technology as well as the blurring of work and free time. Last month, three current and former employees sued T-Mobile USA Inc., claiming they were required to use company-issued smart phones to respond to work messages after hours without pay. In a March suit, a former CB Richard Ellis Group Inc. maintenance worker seeks pay for time spent after hours receiving and responding to messages on a work-issued cellphone. "This is about 'What is work?'" said Dan McCoy, an employment lawyer and partner at Fenwick & West LLP who isn't involved in either case...." [See GLF/Legal Sleuth® - Fair Labor Standards]5:55 AM Aug 10th from web
201. American poet Carl Sandburg supposedly said, "Time is the coin of your life. You spend it. Do not allow others to spend it for you."4:32 AM Aug 7th from web
202. Salmonella illnesses prompt beef recall: USDA: http://bit.ly/14gTu0 (Reuters) - The article states that "An outbreak of salmonellosis in Colorado prompted the recall of 825,769 lbs of ground beef by a California beef company, the U.S. Agriculture Department said on Thursday. Beef Packers Inc of Fresno, California, is recalling the beef, which was produced from June 5 to 23 and has the establishment number "EST. 31913." The beef may be linked to the Colorado illnesses, USDA said...." 4:25 AM Aug 7th from web
203. Slippery bathrooms cause many injuries in kids: http://bit.ly/jy261 (Reuters) - The article states that "Every year in the US, more than 40,000 children and teens get treated in emergency rooms for preventable injuries suffered in bathtubs or showers. Most of these injuries are from slips and falls that could be avoided simply by making bathtub and shower surfaces -- and bathroom floors, too -- less slippery, says Dr. Gary Smith, Director of the Center for Injury Research and Policy at Columbus, Ohio's Nationwide Children's Hospital. "We know how to prevent these injuries," Smith told Reuters Health. "I wish all problems were this easy to fix." "We should be engineering this problem out of existence," he added...." 4:09 AM Aug 7th from web
204. Studies Question Using Cement for Spine Injuries: http://bit.ly/1kK3Q2 (New York Times) - The article states that "Two new studies cast serious doubt on a widely used and expensive treatment for painful fractures in the spine. The treatment, vertebroplasty, injects an acrylic cement into bones in the spinal column to ease the pain from cracks caused by osteoporosis, the bone-thinning disorder common in older people. Doctors began performing it in this country in the 1990s, patients swore by it — some reporting immediate relief from terrible pain — and it soon caught on, without any rigorous trials to determine whether it really worked. The new studies are exactly the kind of research that health policy experts and President Obama have been calling for, to find out if the nation is spending its health care dollars wisely, on treatments that work. A bill passed by Congress this year provides $1.1 billion for such so-called comparative effectiveness research...." 4:08 AM Aug 7th from web
205. Anglers Divided Over New Florida License Program : http://bit.ly/1aqaTt (New York Times) - The article states that "One of the few things Eddy Corea enjoys since being laid off 18 months ago is fishing from the shore. He considers it a human right, free and natural, like breathing. “It should be in the Constitution,” he said, before dropping his line into Biscayne Bay on a recent sultry afternoon. So, no, he was not aware of a new state law requiring that those who fish from the shore buy a license for $9. And no, Mr. Corea does not plan to pay. Like many other rod-and-reelers in Florida this week, he said he would not be part of an effort to muddy the once-free waters with government regulation. The people at the Florida Fish and Wildlife Conservation Commission say they have heard it all before. The 1989 law that established licenses for saltwater and freshwater fishing did not include onshore anglers because state lawmakers wanted to keep some of the fun free...." 4:07 AM Aug 7th from web
206. Sotomayor Faces Heavy Workload of Complex Cases : http://bit.ly/ZTAKZ (New York Times - The article states that " )4:07 AM Aug 7th from web
207. Yamaha's Rhino: For Some A Deadly Ride : http://bit.ly/16lQEH (CBS) - The article states that "In the swath of Kentucky called the Land Between The Lakes, the Turkey Bay Off-Highway Vehicle Area is a rugged expanse of hills and woodlands crisscrossed by 100 miles of trails. Test drivers came here in July, 2002, to try out the Yamaha Rhino, a new breed of off-road vehicle then in development, and had a mishap that would resonate years later.
     Keisuke "Casey" Yoshida, president of a U.S. subsidiary of Yamaha Motor Co. Ltd., was behind the wheel of a Rhino prototype. Ike Miyachi, a company vice president in charge of Rhino development, rode beside him in the passenger seat. After descending a long hill to flat ground, the Rhino tipped over, giving Miyachi a foot injury. At a meeting weeks later, Yoshida raised a question that now seems prophetic. "Casey wants update on instability of vehicle for future liability cases," according to minutes obtained by CBS News. The Rhino was a hit, with more than 150,000 sold after its introduction 15 months later in fall, 2003. But the vehicle, which looks like a cross between a golf cart with attitude, and an all-terrain vehicle, or ATV, is at the center of a legal firestorm. At least 59 riders have been killed in Rhino accidents, according to the Consumer Product Safety Commission. More than 440 wrongful death and personal injury lawsuits are pending, and Yamaha has settled others. Many stem from rollovers in which drivers or passengers fell or were flung through the open door space to the ground, then smashed by the 1,100 pound vehicle. Adults and children as young as 3 years old have suffered gruesome injuries, including amputated limbs and crushed legs, arms or heads. Plaintiffs say the Rhino is dangerously unstable due to its unusually narrow stance, high ground clearance and lack of a rear differential to help in turning. They also claim the Rhino's seat belts tend to unspool during rollovers, resulting in belted occupants being partially ejected. The Rhino has "significant problems," said Inez Tenenbaum, who in June became chairman of the U.S. Consumer Product Safety Commission. "The public needs to be aware that, already, 59 people have been killed in these vehicles."..." [See GLF or Legal Sleuth® - ATV Yamaha Rhino Rollover Litigation] 4:04 AM Aug 7th from web
208. PTSD raises heart disease risk in Iraq war vets: http://bit.ly/NfRY9 (Reuters) - The article states that "Veterans who come home from Iraq and Afghanistan with posttraumatic stress disorder (PTSD) and other mental health diagnoses are hit with a double whammy: They also have greater risk factors for heart disease, according to a report in the Journal of the American Medical Association. PTSD related to military service has been linked to heart disease in the past, but, to the authors' knowledge, the present study is the first to examine the association for veterans of the current Iraq and Afghanistan conflicts. Given the time frame of the recent wars, the authors of the study did not look at heart attacks or other events, but examined risk factors for heart disease instead. PTSD and other mental disorders, such anxiety disorder, more than doubled the risk of tobacco use, for example, which is a well-known risk factor...." 4:44 PM Aug 5th from web
209. Another Cholesterol Drug to Join the U.S. Market: http://bit.ly/3IfJzT (WSJ) - The article states that "Who knew there would be another statin added to the crowded U.S. cholesterol-drug market? The FDA approved a new one yesterday. The medicine, known generically as pitavastatin, will be sold under the brand name Livalo by a company called Kowa Pharmaceuticals America. Novartis gave up on pitavastatin in 2005 (and took a $266 million charge when it did so). “The discontinuation of NKS104 was widely anticipated due to the emergence of liver enzyme elevations and the lack of a major clinical differentiation over AstraZeneca’s superstatin Crestor,” Bob Pooler, analyst in Zurich at private bank Lombard Odier Darier Hentsch, told Dow Jones Newswires at the time. A Novartis spokeswoman tells the Health Blog that the market was a factor in the company’s decision, but it was also a “strategic decision” in which the company decided to focus on other conditions like hypertension and metabolic disorders instead...." 4:44 PM Aug 5th from web
210. Medical Papers by Ghostwriters Pushed Therapy (Hormone Replacement Therapy): http://bit.ly/1gdntp (New York Times) - The article states that "Newly unveiled court documents show that ghostwriters paid by a pharmaceutical company played a major role in producing 26 scientific papers backing the use of hormone replacement therapy in women, suggesting that the level of hidden industry influence on medical literature is broader than previously known...." 4:41 PM Aug 5th from web
211. Sex Hormone Protein May Predict Type 2 Diabetes: http://bit.ly/151ruy (Forbes) - The article states that "A protein that carries and activates sex hormones throughout the body may also predict those at high risk of developing type 2 diabetes, a new study finds. The protein, called sex hormone-binding globulin (SHBG), regulates the levels of testosterone and estrogen in the blood. Researchers suspect it also plays a role in the development of type 2 diabetes. "Basically, we have identified plasma SHBG as a strong and significant marker for type 2 diabetes development in initially healthy men and women," said lead researcher Dr. Simin Liu, professor and director of the Center for Metabolic Disease Prevention in the School of Public Health at the University of California Los Angeles, David Geffen School of Medicine. Low levels of SHBG were a significant predictor for the risk of development of type 2 diabetes, the researchers found. "To our knowledge, there are few biomarkers for type 2 diabetes prediction that have presented both genetic and plasma phenotypic evidence like ours," Liu said...." 4:33 PM Aug 5th from web
212. Merck, Schering-Plough paying $41.5 million to settle class-action lawsuit over Vytorin: http://bit.ly/16PMP9 (San Francisco Examiner) - The article states that "Merck & Co. and Schering-Plough Corp. said Wednesday they will pay $41.5 million to settle lawsuits claiming the drugmakers, partners on two blockbuster cholesterol drugs, delayed unfavorable study results because they would hurt sales. In January 2008, the companies released long-awaited study data showing Vytorin and Zetia were no more effective than an older, less-expensive cholesterol treatment at reducing plaque buildup in arteries of people whose genes gave them stratospheric cholesterol. Instead, the study showed $100-a-month Vytorin, which combines Zocor and Zetia, was perhaps a bit worse than Zocor alone, which is sold as a generic for a third as much. The study also cast doubt on whether Zetia, which works by a different mechanism, has much effect on cholesterol levels, and subsequent data have raised questions about their safety. The companies finished the study, called ENHANCE, in 2006. Merck and Schering-Plough were criticized for not releasing the data earlier, and didn't do so until Congress began investigating the delay. The lawsuits, brought by consumers, insurers and others who paid for the two drugs, questioned both their effectiveness and their safety...." 4:32 PM Aug 5th from web
213. FDA Approves New Cholesterol-Lowering Drug: http://www.fda.gov/NewsEven... (FDA) 4:25 PM Aug 5th from web
214. In Patent Slip-Up, Merck Names Previously Undisclosed Compound: http://bit.ly/qoZjM (WSJ) - The article states that "Editors always worry that a candid remark on a reporter’s story (”This doesn’t make sense!”) will accidentally find its way into print. It happens to us and, as it turns out, it happens to patent lawyers, too. This Merck patent application inadvertently included some stray notes from an anonymous commenter. “I plan to DELETE the entries in Table 3…” the commenter writes, going on to name a previously undisclosed compound in Merck’s pipeline, MK-8712. The patent application involves new kinds of antibiotics designed to overcome bacterial resistance. At the end of dozens of pages of mind-numbing formulae come the stray notes. One of them identifies a particular compound of the many named in the application as “a likely backup candidate” — drug-company lingo for the compound that would be tried in clinical trials if the first one doesn’t work. We learned about the application from Derek Lowe’s blog In the Pipeline. Lowe, a chemist who works in the drug business, notes that companies usually try not to give away too much about which compounds they like best. But, he adds, “all is for naught if your legal team’s strategy comments are included in the Special Bonus Director’s Cut version of the application.” A Merck spokesman, Ronald Rogers, said the accidentally included information “doesn’t really have any competitive value.” He confirmed the error and said it’s actually “not that uncommon a mistake” in the industry. It will be “corrected in due course,” he said..." [See GLF/Legal Sleuth® - IP/Patent Litigation] 4:23 PM Aug 5th from web
215. More Research Links Cardiovascular Health to Alzheimer’s: http://bit.ly/g2Agi (WSJ) - The article states that "More data this week suggesting that common risk factors for heart disease may also raise the risk of developing Alzheimer’s: A study of nearly 10,000 people found that having high cholesterol during midlife increased the risk of developing Alzheimer’s disease in old age. The finding was based on cholesterol measurements taken in the 1960s and early 70s, when the patients were in their early 40s, and on Alzheimer’s Disease diagnoses that came decades later. Among those whose cholesterol was “desirable” during middle age (below 200 mg/dl), 4% developed Alzheimer’s in old age; among those with high cholesterol (240 mg/dl or above), 5.6% developed Alzheimer’s. After adjusting for other variables, the researchers found that people with high cholesterol were 57% more likely than those with desirable levels to develop Alzheimer’s.
     ..." 4:22 PM Aug 5th from web
216. Weight-loss surgery safe, but sleep apnea increases risk: http://bit.ly/18ZnMb (CNN) - The article states that "Weight-loss surgery isn't risk-free, but a new study suggests that in the hands of a skilled surgeon, it may be safer than previously thought. However, some people -- including those with sleep apnea or a history of blood clots -- are more likely to have problems with surgery than others, according to a study published this week in the New England Journal of Medicine. Weight-loss surgery is safer, but could cause complications for people with sleep apnea or a history of blood clots. "The overall conclusion that we reached is that bariatric-surgery safety is actually quite good," said Dr. Bruce Wolfe, a professor of surgery at the Oregon Health and Science University. In the past, bariatric procedures have been associated with death rates of 2 to 3 percent and complication rates of up to 24 percent. However, the obesity epidemic is fueling a rise in such surgeries, prompting concerns about their safety. In 2005, 171,000 people underwent bariatric surgery, more than 10 times the number that had the procedure in 1994. To assess the safety of such operations, Wolfe and his colleagues looked at 4,776 patients in the first month after having a bariatric procedure. They found that 4.3 percent of patients had a serious problem, such as a blood clot or needing another operation, and 0.3 percent, or 15 patients, died within a month after surgery -- a complication rate similar to other types of surgery.
     ..." 4:34 PM Jul 29th from web
217. FDA warning about Steam Dietary Supplement: http://bit.ly/M5rfs (FDA) 4:32 PM Jul 29th from web
218. Spine Surgeon Didn't Disclose Medtronic Pay in Testimony: http://bit.ly/c36Jx (WSJ) - The article states that "In May 2006, University of Minnesota spine surgeon David Polly urged a Senate committee to fund research into the severe arm, leg and spine injuries suffered by soldiers in Iraq and elsewhere. Dr. Polly told the committee he was testifying on behalf of the American Academy of Orthopaedic Surgeons and referenced his prior work caring for soldiers as a surgeon at the Walter Reed Army Medical Center. What Dr. Polly didn't disclose during his testimony was that his trip to Washington was paid for by Medtronic Inc., the big medical-device maker whose bone growth product, called Infuse, has been used to treat soldiers, according to company records. Dr. Polly and colleagues in Minnesota subsequently received a $466,644 Department of Defense grant for a two-year study beginning in February 2007 to evaluate Infuse in cases where an injury is also infected, according to the university. Read a letter from Sen. Grassley to the University of Minnesota, with details on Dr. Polly's billing records. (7.8 MB) Dr. Polly was paid $1.14 million by Medtronic for consulting services from 2004 to 2007. Details of Dr. Polly's consultant billing were provided by Medtronic to Sen. Charles Grassley, an Iowa Republican who has been scrutinizing the relationship between academics and industry...." [See GLF/Legal Sleuth® - Medtronic Infuse Bone Graft] 4:23 PM Jul 29th from web
219. Rice Krispies Complete With Snap, Crackle and Immunity: http://bit.ly/16pGYx (WSJ) - The article states that "After the FDA fired a warning shot across the bow of General Mills for touting Cheerios as lowering cholesterol, the Health Blog has been taking a closer look at what other claims are being made these days in the cereal aisle. There we saw Kellogg’s Rice Krispies with a banner proclaiming “Now Helps Support Your Child’s Immunity” splashed across the box. Kellogg rolled out a revamped Rice Krispies product line this month that boosts the amount of vitamins A, B, C and E in the cereal to 25% of the recommended daily value from 10% of daily value, according to Susanne Norwitz, Kellogg’s director of brand public relations. Studies show that these vitamins “play an important role” in the body’s immune system and “nutritionists and dieticians generally recommend that at least 25% of nutrient intake occur at breakfast,” she wrote in an email. General Mills had raised the FDA’s ire for a box claim that Cheerios Toasted Whole Grain Oat Cereal was “clinically proven to lower cholesterol.” Such a claim needs FDA approval of the product as a drug, the agency wrote to General Mills in May. (The FDA says the company has responded to the letter and is fully cooperating. The agency is currently “in discussions” with the company, according to an FDA spokeswoman.)..." 4:20 PM Jul 29th from web
220. Dozens Arrested in Medicare Bust: http://bit.ly/qLtkx (WSJ) - The article states that " [See GLF or Legal Sleuth® - Qui Tam/Fraud] 4:17 PM Jul 29th from web
221. Study: Texting while driving more dangerous for truckers: http://bit.ly/jlRyN (CNN) [See GLF or Legal Sleuth® - Truck Accident] 1:46 PM Jul 28th from web
222. CFTC poised to move aggressively on position limits: http://bit.ly/Qj3nK (Reuters)1:43 PM Jul 28th from web
223. FDA issues warning on Body Building Products (Marketed as Containing Steroids or Steroid-like Substances): http://bit.ly/qX3UM (FDA) 1:20 PM Jul 28th from web
224. Injecting Value Into Medical Decisions: http://bit.ly/3yY7t6 (WSJ) 1:08 PM Jul 28th from web
225. Older Diabetics Should Avoid Dementia Meds: http://bit.ly/3fsHPy (Forbes) 1:07 PM Jul 28th from web
226. House Dem leaders: No health care vote as recess nears: http://bit.ly/3uWQuu (CNN) 1:06 PM Jul 28th from web
227. U.S. stops Viagra trial against sickle cell: http://bit.ly/KtTQs (Reuters) 1:06 PM Jul 28th from web
228. Breakfast: Why is it so important to weight control?: http://bit.ly/10lS2t (Mayo Clinic) 10:10 AM Jul 27th from web
229. Report Sees Agent Orange Link to More Illnesses: http://bit.ly/24BO9w (NY Times) 10:09 AM Jul 27th from web
230. Colorado: Hepatitis Case Widens: http://bit.ly/2gvmW (NY Times) 10:08 AM Jul 27th from web
231. For Some Kidney Patients, Home Dialysis Is Better: http://bit.ly/3j8q88 (Forbes) 10:07 AM Jul 27th from web
232. Allergy drugs may fight diabetes, obesity: http://bit.ly/NL3xc (Reuters) 10:06 AM Jul 27th from web
233. A Bid to Tax Health Plans of Executives: http://bit.ly/Zq92v (NY Times) 10:05 AM Jul 27th from web
234. Medtronic to pay Abbott $400M to settle stent suits: http://bit.ly/43Ovt (Chicago Tribune) [See GLF or Legal Sleuth® - DES/Stent] 9:59 AM Jul 27th from web
235. Los Angeles Jury Convicts Equipment Suppliers of Medicare Fraud: http://bit.ly/3truff (US HHS) [See GLF or Legal Sleuth® - Qui Tam/Fraud] 8:49 AM Jul 22nd from web
236. Small Molecule (miR-21) Might Play Big Part in Lung Cancer: http://bit.ly/QReqp (Forbes)[But also see GLF or Legal Sleuth®-Tarceva & SJS] 4:29 PM Jul 18th from web
237. Fetal Alcohol Disorders Often Misdiagnosed as ADHD: http://bit.ly/tpGIk (Forbes) 4:21 PM Jul 18th from web
238. Another hepatitis case linked to Colorado hospital: http://bit.ly/3s9dp (See article on links to Texas & New York) 4:16 PM Jul 18th from web
239. FDA Urges Consumers Not to Purchase or Use Certain Gel-Filled Teethers: http://bit.ly/eFCt7 (FDA - Luv N’ Care Nuby/Cottontail... teethers) 3:59 PM Jul 18th from web
240. Alzheimer's gene may impair middle-aged memory: http://bit.ly/18s1yJ (CNN News) 3:53 PM Jul 18th from web
241. Young You Corporation Issues a Voluntary Nationwide Recall of Weight Loss Pills: http://www.fda.gov/Safety/R...10:23 AM Jul 17th from web
242. Drug-eluting stents: Do they increase heart attack risk?: http://bit.ly/eYwH (Mayo)-[See Gooch Law Firm/Legal Sleuth®-Drug Eluting Stent] 9:09 PM Jul 16th from web
243. FDA reviewing possible heart risks with asthma drug-Xolair: http://www.reuters.com/arti...12:40 PM Jul 16th from web
244. F.D.A. Approves Eli Lilly Blood Thinner, With a Warning: http://bit.ly/xwoku (NYT)- [See Gooch Law Firm/Legal Sleuth®-Drug Eluting Stent] 5:05 PM Jul 12th from web
245. Matrixx slides after disclosing Zicam lawsuits: http://bit.ly/b53hx (The Seattle Times) - [See Gooch Law Firm or Legal Sleuth® - Zicam] 4:46 PM Jul 12th from web
246. Osteoporosis treatments and adverse events: http://bit.ly/vUOhZ [See GLF or Legal Sleuth® - Bisphosphonates - Fosamax et al.] 9:41 PM Jul 11th from web
247. Roche discontinues sales of acne drug Accutane amid tough generic competition: http://bit.ly/A9tt9 [See GLF or Legal Sleuth® - Accutane/IBD] 9:04 PM Jul 11th from web
248. Kolcraft Recalls 1 Million Play Yards Due to Fall Hazard: http://www.cpsc.gov/cpscpub... (US CPSC) 9:46 AM Jul 9th from web
249. More Scrutiny Urged for Bottled Water: http://bit.ly/TnzWd (WSJ) 9:38 AM Jul 9th from web
250. FDA Approves Alimta As Lung-Cancer Maintenance Therapy: http://bit.ly/XbAY0 (CNN) [See GLF or Legal Sleuth® - Asbestos/Mesothelioma cancer] 9:25 AM Jul 9th from web
251. Oral bisphosphonate use and the prevalence of osteonecrosis of the jaw: http://bit.ly/o9VC8 (JADA) [See GLF or Legal Sleuth® - Fosamax and bisphosphonates] 9:37 PM Jul 8th from web
252. Endometriosis ups risk of preterm birth study: http://bit.ly/q6PJx (Reuters) 3:37 PM Jul 8th from web
253. Play-Yard Recall Revives Child-Safety Issues: http://bit.ly/1jXMjx (WSJ) 3:32 PM Jul 8th from web
254. Stronger Warnings Ordered for Painkillers: http://bit.ly/1RU2f (WSJ) 3:31 PM Jul 8th from web
255. Bone Proteins Costly In Surgery, Study Says: http://bit.ly/bFB1O (WSJ) [See also GLF or Legal Sleuth® - Medtronic Infuse Bone Graft] 1:17 PM Jul 3rd from web
256. Birth weight appears associated with leukemia: http://bit.ly/fuSM0 (Reuters) [See also Legal Sleuth® - Breaking-News.html] 1:13 PM Jul 3rd from web
257. FDA may put restrictions on Tylenol - http://www.thestar.com/arti... (Toronto Star) [See also Legal Sleuth® - Breaking-News.html] 12:40 PM Jun 30th from web
258. Miami Physician Sentenced...$10 Million Medicare Fraud: http://bit.ly/4PhDg (US Dept. HHS) [See Qui Tam/Fraud on GLF or Legal Sleuth®) 9:17 AM Jun 30th from web
259. Colorado beef company expands recall due to possible E. coli: http://bit.ly/Sixxf6:33 AM Jun 30th from web
260. GM To Take On Future Product Liability Claims: http://bit.ly/dR19y6:04 AM Jun 28th from web
261. NTSB to probe problems on other Airbus flights: CNN - http://tinyurl.com/m39sh7 (See Aviation on GLF or Legal Sleuth®) 12:54 PM Jun 26th from web
262. Matrixx Receives SEC Inquiry Following Warning About Zicam: Wall Street Journal - http://tinyurl.com/n3v4ub - (Product Liability-Zicam) 12:49 PM Jun 25th from web
263. U.S. Charges 61 in Medicare Crackdown: http://online.wsj.com/artic... - (Qui Tam/Fraud/Federal False Claims Act) 9:37 AM Jun 25th from web
264. EPA Announces Libby Montana Public Health Emergency re: Asbestos: http://www.epa.gov/region8/...4:39 PM Jun 24th from web
265. Zicam Nasal Product Recall Starts: http://bit.ly/13GIrW 9:14 AM Jun 24th from web
266. Gooch Law Firm is proud to announce the launch of Mesothelioma.tel. Mesothelioma.tel is a mesothelioma/asbestos resource presented by Gooch Law Firm. - (Mesothelioma.tel) 3:15 PM Jun 23rd from web
267. Gooch Law Firm is proud to announce the launch of Legal Sleuth® legal website and newsletter For All Things Legal™. - (www.legalsleuth.com) 2:52 PM Jun 23rd from web
268. Major Medical Journal Supports the Medical Device Safety Act of 2009: http://content.nejm.org/cgi...2:25 PM Jun 23rd from web
269. US CPSC and Yamaha Motor Corp. announce a free repair program to address safety issues w/Rhino 450, 660, and 700.: http://tinyurl.com/mw6cl92:19 PM Jun 23rd from web [See Gooch Law Firm or Legal Sleuth for more information on Yamaha Rhio Rollover Accident and ATV)
270. U.S. Supreme Court Rules Against Wyeth re: Preemption (State Law not Preempted): http://tinyurl.com/nrvsoy2:16 PM Jun 23rd from web
271. FDA Warns About Risk of Wearing Medicated Patches During MRIs: http://tinyurl.com/lv962y2:11 PM Jun 23rd from web
272. Asbestos-related cancer deaths still rising in U.S.: http://tinyurl.com/lptg8n9:33 AM Jun 23rd from web (See Gooch Law Firm or Legal Sleuth websites for more information on mesothelioma cancer and asbestos)

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