Lawsuit Alleges Diabetes Drug Caused Man's Heart Condition
By Richard Seward
Published on February 20, 2008
Pat Kelly, of Grove, Oklahoma, filed the lawsuit on Feb. 12. In it, he names Philadelphia-based GlaxoSmithKline as the defendant, claiming the drug manufacturer is liable for negligence, fraud, breach of warranty, and failure to warn of the risks associated with its drug.
Kelly, an auctioneer, claims that while he was taking Avandia to treat diabetes in March 2006, he suffered a myocardial ischemic event, requiring him to undergo stent placement surgery. After suffering chest pains in August 2007, Kelly returned to the hospital, this time requiring open-heart surgery.
Attorneys for the Kelly family say GlaxoSmithKline was aware of the risk of heart failure associated with Avandia, citing scientific estimates that the drug has caused approximately 83,000 heart attacks. The lawyers argue that GlaxoSmithKline should have been able to determine its product’s risk by conducting investigations and analyzing data obtained in its clinical trials of Avandia.
In the last year, the FDA has twice asked GlaxoSmithKline to change the labeling on Avandia packages to mention a potential increased risk of heart problems associated with the drug. On Aug. 14, 2007, in response to one such request, GlaxoSmithKline added a "black-box" warning to Avandia packages warning that individuals using the drug may be at an increased risk of congestive heart failure. Three months later, a second black-box label warning of the increased risk of heart attack and other myocardial ischemic events was added.
Since taking Avandia and undergoing bypass surgery, Kelly has had to limit his travel, and his health problems have had a negative impact on his ability to continue as an auctioneer, his lawyers say.
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