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Health See other Health Articles Title: Pfizer confronts surge of lawsuits over Lipitor Yahoo... (Reuters) - Pharmaceutical giant Pfizer is facing a mounting wave of lawsuits by women who allege that the company knew about possible serious side effects of its blockbuster anti-cholesterol drug Lipitor but never properly warned the public. In the past five months, a Reuters review of federal court filings shows, lawsuits by U.S. women who say that taking Lipitor gave them type-2 diabetes have shot up from 56 to almost 1,000. Lawsuits began to be filed not long after the Food and Drug Administration in 2012 warned that Lipitor and other statins had been linked to incidents of memory loss and a "small increased risk" of diabetes. According to plaintiffs' lawyers, women face a higher risk than men of developing diabetes from using Lipitor, and gain fewer benefits. The recent spike in lawsuits followed a decision by a federal judicial panel to consolidate all Lipitor diabetes lawsuits from around the country into a single Federal courtroom in Charleston, South Carolina. Pfizer opposed the consolidation, arguing it would prompt copycat filings. The first case is scheduled to be tried next July. Pfizer said in a statement that it denied liability and would fight the lawsuits. It is not uncommon for a drugmaker to get hit with thousands of lawsuits over its products after the FDA orders a label change alerting users to newly found risks. Takeda Pharmaceutical, for instance, is facing more than 3,500 federal lawsuits since 2011 when the FDA ordered it to update the label on its diabetes drug Actos to warn about bladder cancer. Takeda has denied liability. But several factors set the Lipitor diabetes cases apart from those against other drug companies. For one, Lipitor is the best-selling prescription drug of all time, racking up global sales of more than $130 billion since it went on the market in 1996. More than 29 million patients in the United States have been prescribed the drug, suggesting there is a vast pool of potential plaintiffs. On the other hand, potentially complicating matters for plaintiffs, the FDA emphasized the benefits of statins even as it warned of the risks. When the labeling change was released in 2012, a top FDA official underscored that the agency still stood behind the drugs: "Clearly, we think that the heart benefit of statins outweighs this small increased risk (for diabetes)," Amy Egan, a deputy director for safety at the agency's Division of Metabolism and Endocrinology, said in a statement at the time. Statins are a class of drugs that block the liver's production of cholesterol to reduce the risk of heart disease. Type 2 diabetes, once known as adult-onset or noninsulin-dependent diabetes, is a chronic condition that affects the way the body metabolizes glucose. RISKS AND BENEFITS The seemingly mixed message from the FDA suggests that litigation will focus on two questions: how big a diabetes risk do women using Lipitor face, and whether that risk is mitigated by the drug's cardiovascular benefits. H. Blair Hahn of Mount Pleasant, South Carolina, the lead lawyer appointed to represent Lipitor plaintiffs in federal court, said the plaintiffs contracted diabetes as a consequence of taking Lipitor, and that women with diabetes see the length and quality of their lives reduced. "We will ask a jury to decide what it's worth to take five years of someone's life," Hahn said. He said the nearly 1,000 cases filed so far represent 4,000 women, and that the number of cases could ultimately reach 10,000 or more. Pfizer said it believes Lipitor did not cause the plaintiffs' diabetes. Women who are prescribed Lipitor to control cholesterol may share other risk factors that make them vulnerable to the disease, such as high blood pressure or obesity, the company said. The Pfizer statement said there is an "overwhelming consensus" in the medical community about statins' benefits. BELLWETHER TRIALS The first Lipitor trial, scheduled for next July before U.S. District Judge Richard Gergel, will be one of several so-called "bellwethers" used to gauge the strength of other cases. If Pfizer prevails, it could persuade plaintiffs to accept smaller settlements or drop cases. Pfizer could also opt to settle before a single case is tried to avoid possible negative exposure or to prevent potentially damaging information from coming to light. If past settlements are any guide, Pfizer's potential exposure could be substantial. Bayer, the maker of one-time rival statin Baycol, paid $1 billion in 2005 to settle about 3,000 cases alleging the drug caused rhabdomyolysis, a disease that breaks down muscle tissue. Baycol was pulled from the market in 2001 after being linked to 31 deaths. In 2011 AstraZeneca said it would pay $647 million to resolve most of the 28,000 lawsuits it faced alleging its antipsychotic Seroquel caused diabetes and other injuries. Pfizer has not indicated that it has set aside any money specifically to cover potential future Lipitor judgments, according to its most recent quarterly filing with the U.S. Securities and Exchange Commission. Michael Green, an expert in mass torts at the Wake Forest University School of Law, said he did not expect Pfizer to settle at this stage, especially given the major obstacle plaintiffs still face. "(They) have to show they were actually harmed by this agent," he said. "That might be hard." (Reporting by Jessica Dye in New York; Editing by Ted Botha, Eric Effron and Amy Stevens and John Pickering) Poster Comment: sinecureseeker a nickle a day niacin tab lowers cholesterol just as well. dropped mine 40 pts in 3 mo. Surrealist Sell Lipitor, get diabetes, sell diabetes drugs, get arthritis and aching joints, sell arthritis drugs. It's a freakin' racket and Big Pharma knows how to make MONEY. 3-2 Paul This "mitigation" principle should be considered invalid and have no bearing on this case: The so-called benefits of Lipitor are not in question, here. What is in question is whether the manufacturer thoroughly researched and studied the final product before release and was completely honest to the public about its side-effects. Furthermore, to assume that chemically blocking the liver's production of cholesterol is a reasonable approach to cardio-vascular health is sheer folly: For one thing, cholesterol is the pre-cursor to cortisol, one of the most prevalent and important energy-producing and altering hormones in the human body. If you inhibit or shut off the production of cholesterol by a drug seen as a foreign agent or teratogen by the liver, it incites the inflammatory response throughout the body, and that means an entire laundry list of possible symptoms and conditions.6-1 HarryT Lowering Cholesterol has never been clinically proven to prevent heart disease or increase longevity. Most of our hormones the keep us healthy depend on Cholesterol. Cholesterol is needed to make Pregnenolone - The Master Hormone that HUNDREDS of your hormones depend on. Insulin included. We are told to stay away from saturated fat. Your lung surfactant is 100% saturated fat. Your hormones depend on saturated fat. Our vegetables and fruit and meats are loaded with Endocrine Disruptors - they block our Endocrine Hormones. These are the pesticide and herbicide residues in our food. We are bombarded with plastic esters and rubber chemicals that do the same. After following the Food Pyramid and lining up for pills to block our Cholesterol (That makes our health giving hormones), we have to ASK for Prescriptions to BREATHE. Prescriptions to have SEX. Prescriptions to METABOLIZE BLOOD SUGAR FROM EATING FOOD. These hormones have been taken away from you by the crooked AMA who get kickbacks from the Pharmaceutical Companies every time the Doctors create another Lifelong DEPENDENCY ON A STINKING DRUG that does what your own body USED TO DO FOR ITSELF.12-4 bha These women are completely clueless. One of the symptoms of metabolic syndrome X, which occurs in prediabetes, is elevated cholesterol and lipid levels. Most of these women were probably taking atorvastatin because they already had pre- type 2 diabetes. Let's make it clear. This pre-Type 2 diabetes is the same disease as type 2 diabetes except it doesn't get labeled type 2 diabetes until the fasting glucose reaches 126 mg/dL or more. In other words, full blown type 2 diabetes is just a more extreme case of metabolic syndrome X. Most of these women have pre-type 2 diabetes because of lifestyle choices--eating too many calories, binging on carbohydrates, and obesity. Instead of these women getting themselves in shape and losing weight, they think they can be cured by little pills. Now they want to blame a pharmaceutical company for their lifestyle choices. Take the fork out of your mouth. Have a proper diet and exercise! 8-6 Ron This, and other cholesterol reducing drugs, has been implicated in the rise of dementia and Alzheimer's due to the drugs' reducing good cholesterol that help form memories. Nelson Statins do more harm than good. The damage to kidneys and muscle tissue is serious. Rhabdomyolysis is a major side effect of these drugs. Cholesterol actually helps increase production of an important component of the nervous system that facilitates proper nerve cell communication, and prevents the onset of brain diseases such as Parkinson's and Alzheimer's disease. So why the band wagon to reduce levels...? One makes you bigger and the other makes you small as the song goes. Drug companies are killing us.... get off the drugs ! 1-4 Post Comment Private Reply Ignore Thread Top • Page Up • Full Thread • Page Down • Bottom/Latest Begin Trace Mode for Comment # 1.
#1. To: Tatarewicz (#0)
It's not only detrimental to women. My silly brother got on Statins and now his stomach is a mess. He can't eat all sorts of things that were perfectly fine for 50 years. Now he is on the gluten free bandwagon. He claims his doctor treated him like a guinea pig, which is true to some extent. However, he never did any research into the statin he opted to take. I think he was, like so many others, looking for a little pill to remedy what diet, exercise, and will power were meant to cure. The damage from Statin use is coming into view and we will see more of these lawsuits. Cholesterol is in every single sell in the body and essential to deliver hormones, screwing with every cell in the body with a chemical substance foreign to the body is insanity. Bro learned the hard way and many others will too.
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