Pharmaceutical giant GlaxoSmithKline has agreed to settle about 20,000 heart attack lawsuits brought by former users of its Type 2 diabetes medication Avandia.
The lawsuits are among thousands more which claim GlaxoSmithKline (GSK) hid data showing the leading diabetes drug on the world market for several years increased the risk of heart attacks, stroke and death over other drugs.
Terms of this latest settlement were not disclosed in a report from Bloomberg. GSK has previously settled another 15,000 Avandia lawsuits for $700 million. The company has also agreed to pay $3 billion settling federal charges it violated Food and Drug Administration laws by illegally marketing its top-selling drug and one of the best selling drugs worldwide. Avandia generated $3 billion annually for the British company at the height of sales.
Those figures have dropped considerably in the last year, specifically after the U.S. Food & Drug Administration (FDA) severely restricted access to the drug and advised physicians to use Avandia to control a diabetic’s blood sugar levels only as a last resort. The agency cited numerous studies and a growing number of adverse reaction reports in deciding to essentially remove Avandia, then the top Type 2 diabetes drug, from the market.
A U.S. District Judge ordered attorneys for plaintiffs in Avandia lawsuits to meet with those representing GSK and an appointed independent mediator in hopes of reaching accord on the thousands of lawsuits. The first of what could be an endless stream of Avandia cases was about to go to trial in mid-January before Judge Cynthia Rufe ordered the mediation session, setting a 75-day deadline to reach settlement. She is presiding over more than 2,500 Avandia lawsuits filed in federal courts. Thousands more have been filed in state courts across the country and the first scheduled to go to trial was in a California court. That case has been resolved by the settlement. Rufe expected the mediation process to resolve more than 85 percent of the pending Avandia lawsuits.
GSK has agreed to cease marketing Avandia as a treatment for Type 2 diabetes, respecting the demands of the FDA and other regulatory agencies around the world which all believe the drug carries a risk of causing heart attacks and stroke more than other available treatments. These risks were never noted by GSK in any clinical data though those filing lawsuits believe the company had been presented ample evidence indicating the drug
The drug company has been the focus of a federal investigation since 2004 over alleged illegal marketing and suppression of negative evidence on the side effects of Avandia and several other of its top-selling drugs. Bloomberg cites a 2007 incident in which a University of North Carolina professor told U.S. officials he was pressured by GSK to mute his criticisms of Avandia, specifically related to its link to heart attacks and stroke, ever since the drug was first introduced in America in 1999.