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Yaz Lawsuits Spell More Legal Trouble for Bayer

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More and more women are filing lawsuits against drug company giant Bayer Corporation because of side effects caused by their contraceptive Yaz and Yasmin (precursor to Yaz).

According to attorneys who have sued Bayer, the birth control pill has been associated with severe side effects such as heart attacks, blood clots and strokes.

Most lawsuits have centered on Bayer's negligent and fraudulent marketing. The lawsuits claim that Bayer has fraudulently represented that Yaz has been tested and was found to be safe. The lawsuits also detail how Bayer concealed the very dangerous side effects of the medication during its commercial.

Food Safety: Top 10 Riskiest Foods

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The Center for Science in the Public Interest released a new report today on the "Top Ten Riskiest Foods Regulated by the U.S. Food and Drug Administration". The report details ten common foods that account for 40 percent of all food-based illness outbreaks. So, what makes a food risky in the eyes of the CSPI?

More than 1,500 separate outbreaks were associated with the top ten riskiest foods, causing nearly 50,000 reported illnesses. Reported illnesses range from stomach aches to major issues such as kidney failure and death, and included fun stuff like Salmonella, E. coli, Listeriosis and Norovirus. The Top Ten Riskiest Foods:

SIGG Changes Its Story, Admits BPA In Water Bottles

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The manufacturer of a popular aluminum water bottle is under fire this week for not having disclosed that many of its bottles were manufactured with a lining made from the chemical bisphenol-A, or BPA.

Used to harden plastics and commonly found as a liner in cans and bottles, BPA has health risks both known and unknown, which have caused many consumers to step back from the use of plastic bottles to store food and beverages. Legislative bans on BPA-containing food containers have been gaining momentum.

Enter the lined aluminum bottle. Shiny, metallic, sleek, and (allegedly) totally plastic-free, the bottles have gained credibility as both environmentally friendly -- no more single-use disposable water bottles -- and health conscious -- no BPA worries. Swiss bottle manufacturer SIGG in particular gained significant market share, with its metal bottles retailing for upwards of $20 each at upscale stores like Whole Foods.

Will Alli Lawsuits Be Next?

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The magical, side-effect-free weight loss pill has for years been one of the elusive goals of pharmaceutical research. Now it appears that one more contender will have to undergo scrutiny of its safety record.

The FDA indicated Monday that it will investigate the possibility that the weight loss drug orlistat, sold as prescription Xenical and over the counter as alli (yes, lowercase "a," which we'll assume is some kind of savvy marketing tactic), is causing liver damage in some patients.

The FDA says it has received 32 complaints in the last ten years asserting that liver damage or failure resulted from patients taking alli or its prescription counterpart, and that it will look into whether the drug may be a cause. The complaints are summarized in a so-called "Early Communication," a "risk communication tool" that the FDA uses to let consumers know that it will be reviewing the safety of a drug.

One of the drugs' manufacturers, GlaxoSmithKline PLC, was quick to respond, emphasizing that no cause and effect relationship is yet known to exist, and that neither the government nor the manufacturers believe that consumers need to stop taking alli or Xenical just yet.

Are we on the verge of a wave of alli lawsuits?

Swine Flu Lawsuit On The Way

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The family of a New York City teacher who died of the H1N1 flu, or "swine flu," in May has begun a legal action against the city, but despite what's being reported by some sources, the action is not a lawsuit -- yet. It's a "notice of claim," and it's a reminder that getting compensated by the government for injuries often requires a very different process from a private suit.

Mitchell Wiener, a teacher at Intermediate School 238 in Hollis, Queens, contracted swine flu in May, becoming one of the very first cases seen in New York City, and died shortly thereafter in a hospital. His family asserts in their claim that the city was negligent in failing to properly warn Wiener of his potential exposure to the virus, and in acting too slowly to prevent the flu from spreading. So far, this describes a fairly standard wrongful-death suit based on a claim of negligence.

Merck, Schering-Plough Settle Vytorin/ Zetia Lawsuit

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Soon-to-be-merged pharmaceutical giants Merck and Schering-Plough agreed this week to settle a number of class-action lawsuits over their cholesterol-lowering drugs Vytorin and Zetia. The companies will spend a total of $41.5 million to settle the Vytorin and Zetia lawsuits, which accuse the drugs of being unsafe and ineffective.

Zetia lowers cholesterol by blocking the digestive system from absorbing the cholesterol in food. Vytorin combines Zetia with the statin Zocor, which lowers cholesterol levels by blocking the production of an enzyme that the body uses in making its own cholesterol. The theory behind Vytorin was that attacking cholesterol on two fronts, so to speak, would be more effective in lowering cholesterol levels and preventing heart disease.

But the 2008 publication of a study by Merck and Schering-Plough cast doubt on the drugs' efficacy. The "ENHANCE" study showed that the combination drug Vytorin was actually slightly worse than Zocor alone at preventing heart disease. The companies' two-year delay in releasing these results fueled the criticism, and the lawsuits.

Lawsuits Allege Yaz and Yasmin Side Effects

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Pharmaceutical manufacturer Bayer HealthCare faces a series of federal lawsuits alleging that its oral contraceptives Yaz and Yasmin (brand names for the drugs drospirenone and ethinyl estradiol) have serious side effects that Bayer did not adequately disclose to consumers.

The birth control related lawsuits were filed last week in Ohio and Wisconsin, according to a press release by the law firm representing the plaintiffs. The four women who filed suit allege that they suffered side effects including deep vein thrombosis, pulmonary embolism, and stroke while taking Yaz or Yasmin pills. The suits allege that Bayer failed to warn of these potential complications.

Failure-to-warn claims are one of several legal theories under which pharmaceutical-drug-liability suits typically proceed. Pharmaceutical manufacturers are required to disclose known side effects to consumers, either directly or by making relevant information available to physicians, and to take reasonable steps to continue to ascertain and disclose side effects as long as the drug is on the market. Besides having a significant profit motive, a drug's manufacturer is assumed to be the leading expert on the drug's chemistry, with a responsibility to share this expertise in the name of consumer safety.

Drugs that contain the pain-killing ingredient propoxyphene -- including the popular prescription medications Darvon and Darvocet -- will need to carry stronger warnings and detailed instructions on safe use by patients, under orders issued today by the U.S. Food and Drug Administration (FDA).

The action is aimed at reducing the growing number of fatal overdoses linked to drugs containing propoxyphene, and it's part of the FDA's larger effort to appropriately assess and regulate the safety of painkiller medications flooding the U.S. drug market.

"Prescribers and patients should be aware of propoxyphene's potential risks when used at doses higher than those recommended," Janet Woodcock, M.D, director of the FDA's Center for Drug Evaluation and Research said in an FDA News Release on the Darvon and Darvocet Order. "Therefore, the FDA is requiring manufacturers to provide more information to help physicians and patients decide whether propoxyphene is the appropriate pain therapy," Woodcock added.

Stop-Smoking Drugs Will Carry Suicide Warning

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The popular stop-smoking drugs Chantix and Zyban will carry strong "black box" warnings on risky mental health side effects, as suicides among users of the drugs continue to rise, the FDA announced today.

The new warnings will be required on the prescribing information for Chantix (made by Pfizer) and Zyban (manufactured by GlaxoSmithKline), and "will highlight the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts when taking these drugs," the FDA says.

The "black box" warnings -- so named because the cautionary information must be prominently displayed inside a black box, set off against other text in the drug's packaging -- were ordered based on reports of mental health problems and suicidal behavior submitted to FDA safety officials.

Vicodin, Percocet Bans Could Be On the Way

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The widely-prescribed painkillers Vicodin and Percocet could be banned in the U.S., if the FDA follows the recommendations of a panel of medical experts that met earlier this week.

The advisory panel assembled on Monday and Tuesday to evaluate the health risks of over-the-counter and prescription medications containing acetaminophen, and to recommend a course of action that might reduce health problems associated with these products -- specifically, the incidence of liver damage caused by high doses of acetaminophen. (For more background, see FDA Looking at Acetaminophen and Liver Damage.)

The panel looked at OTC acetaminophen medications like Tylenol and Excedrin; OTC "combination drugs" like NyQuil and Theraflu, which include acetaminophen and cold medications; and prescription drugs like Vicodin and Percocet that combine potent levels of acetaminophen with a narcotic.