The dangers of the diabetes drug Avandia have been known for about five years, and resulted in a large number of Avandia injury lawsuits filed by individual patients. But as a pharmaceutical liability lawyer, I was pleased to also see news that state governments have settled a similar set of lawsuits alleging deceptive marketing by Avandia’s maker, GlaxoSmithKline. Led by the Oregon Department of Justice, 37 states and Washington, D.C. alleged that Glaxo withheld important safety information about Avandia when it failed to disclose a substantially increased risk of heart attacks among those using it. The risk was first disclosed in 2007 by an independent study; Glaxo initially argued that the study was flawed, but after drug regulators took action, it was required to publish a warning about the cardiovascular risks. The state settlements come after Glaxo pleaded guilty to federal criminal charges this summer and was fined $3 billion.
Avandia is an insulin sensitizer, which means diabetics take it to help their bodies become more sensitive to insulin. It was popular when it was first introduced, in part because it required no needles. It had $2.6 billion in annual sales in 2006. However, an independent study performed in 2007 found that Avandia users were substantially more likely to develop serious heart problems than diabetics who don’t use Avandia. In fact, the meta-analysis found that Avandia users had a 43 percent higher risk of having a heart attack. This was an especially serious problem because diabetes already increases a patient’s risk of heart problems. GlaxoSmithKline was later accused of knowing this for years before the study came out, but suppressing the information to protect its revenues. Federal regulators later severely restricted patients’ access to Avandia, and it has been taken off the market altogether in Europe.
A Congressional investigation later showed that the FDA’s own estimates suggested that Avandia might be responsible for as many as 83,000 extra heart attacks between 1999 and 2007. The state settlements announced this month allege that Glaxo’s marketing misled the public about Avandia’s cardiovascular risks. The settlement includes money to each state for attorney costs and state consumer protection programs. Glaxo also agreed to refrain from making unsupported safety claims, from presenting information that has been invalidated and from misrepresenting clinical trial results. In addition, the company must, for the next eight years, post summaries of its internal studies, trials and analyses. In a public statement, Glaxo emphasized that it was not admitting any wrongdoing and believes it acted responsibly in its marketing and studies of Avandia.
Glaxo may be the only entity that believes it behaved responsibly. Because our dangerous drug attorneys have followed this issue for several years, we have been able to observe this issue as it progressed from one study to a worldwide problem and the subject of thousands of drug injury lawsuits. When the 2007 study was released, showing the substantially increased risk of heart attack, Avandia’s manufacturer attacked its science, using its own studies—and conveniently omitting other internal studies that showed similar risks. When the coverup was later revealed, it formed the basis of numerous Avandia lawsuits across the United States. Our defective drug lawyers still welcome messages from people who believe they may have a claim and want to discuss it at a free consultation.
Carey, Danis & Lowe focuses its practice on defective and unreasonably dangerous drugs and medical devices. Based in St. Louis, we represent clients all over the United States. To learn more or tell us your story, call us today at 1-877-678-3400 or send us a message online.
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