Avandia Maker Faces More Lawsuits

Marshall, TXGlaxoSmithKline, maker of Avandia, faces more lawsuits alleging that patients suffered from serious Avandia side effects. Among the more severe side effects is the reported link between Avandia and heart attacks. Some critics say the risk of a heart problem is too high, while patients file lawsuits alleging they were harmed by the use of Avandia.

One such lawsuit was filed in Texas, alleging the plaintiff, Frank Casteel, took Avandia for 5 years and then underwent heart bypass surgery. According to the Southeast Texas Record, the suit was filed against Smithkline Beecham Corp., doing business as GlaxoSmithKline. The plaintiff claims that GlaxoSmithKline knew its drug was unreasonably dangerous, knew that patients were not informed about the risks associated with Avandia and still marketed and distributed the drug. Furthermore, the suit alleges that the pharmaceutical maker disclosed positive information about Avandia, but concealed or withheld any negative information about the drug's safety.

According to the lawsuit, Avandia was unreasonably dangerous and defective due to inadequate warnings and inadequate testing. The lawsuit seeks punitive damages based on what it alleges was "intentional disregard for the safety and rights of plaintiff, as well as the general public and/or consumers."

Meanwhile, 12 people filed lawsuits in April against GlaxoSmithKline, alleging that the pharmaceutical giant was negligent in its research of Avandia, resulting in either them or their loved ones having heart attacks. According to those lawsuits, the company misled doctors and patients about the health risks of Avandia and 2 other medications, Avandaryl and Avandamet. The plaintiffs claim GlaxoSmithKline was aware of the "defective nature" of the medications but marketed them regardless. The plaintiffs seek financial compensation for medical expenses, lost wages and impaired earning capabilities, punitive and exemplary damages and court costs.

As reported in the Salt Lake City Desert News, on April 30, 2009, a spokesperson for GlaxoSmithKline said that the company is prepared to defend Avandia and that once the facts are known, the drug will be vindicated.

Avandia was approved by the US Food and Drug Administration in 1999 for treatment of type 2 diabetes. A May 2007 study, done by Dr. Steven Nissen, found that patients who took Avandia had an increased risk of heart attack. The same month, the FDA issued a safety alert regarding Avandia, which stated, "Safety data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia."

The FDA has not recalled Avandia, saying that data on the medication provides "contradictory evidence about the risks in patients treated with Avandia."

Critics, such as advocacy group Public Citizen, say that patients should not take Avandia, that it should be removed from the market because of the increased risks. The organization argues that there are older drugs that are safer for patients to take, making Avandia an unnecessary risk.

"Our answer to the question, 'Does the overall risk-benefit profile of Avandia support its continued marketing in the US?' is clearly no," said Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen in his 2007 testimony before the FDA's Advisory Committee meeting regarding Avandia.

"There is no evidence of any uniquely beneficial clinical outcome for Avandia and growing evidence in multiple organ systems (cardiac, liver, bone, bone marrow) of unique risks. If this drug were up for approval today, based on what is now known, it would be summarily rejected. There should not be a double standard for removing it from the market."