Healthy Skepticism Library item: 12838
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: media release
Lawsuit Against GSK Alleges Avandia To Blame For Injury Requiring Heart Bypass Surgery
Baum, Hedlund, Aristei & Goldman 2008 Feb 13
http://www.avandia-heart-lawyers.com/
Full text:
Pat Kelly and his wife Sandra Kelly of Grove, Oklahoma, filed a lawsuit on February 12, 2008, against Philadelphia-based GlaxoSmithKline (“GSK”), the maker of Avandia, in the U.S. District Court for the Eastern District of Pennsylvania – Case 2:08-cv-00667-RK, accusing GSK of causing serious injury to Mr. Kelly due to its negligence, fraud, breach of warranty, negligent pharmaco-vigilance and a failure to warn about the risks of its drug, Avandia.
The lawsuit alleges that Avandia (rosiglitazone maleate) caused Pat Kelly, 59, to suffer from myocardial ischemia, a painful heart condition caused by blockage or lack of blood flow to the heart, which required coronary revascularization.
After suffering his first myocardial ischemic event, Mr. Kelly underwent stent placement surgery on March 20, 2006. Then, on August 27, 2007, after suffering from chest pains, he was taken to the hospital again and required open heart surgery for coronary artery bypass grafting to restore the flow of oxygen and nutrients to his heart.
The attorneys for the Kelly family allege in the complaint that GSK knew, or should have known, that Avandia was associated with a significant increased risk of heart failure, myocardial ischemia and ischemic events such as cardiovascular mortality, myocardial infarction (heart attack), and stroke.
According to Mr. Kelly’s attorneys, “since FDA scientists estimate that Avandia has caused roughly 83,000 heart attacks it is difficult to believe GSK was either unaware of the risk or unable to discover the risk through appropriate investigation and analysis of its clinical trial data,” stated Mr. Kelly’s attorney, Roger Drake of Baum, Hedlund, Aristei & Goldman.
The lawsuit also alleges that GSK negligently and carelessly failed to fully disclose to physicians, patients, and regulatory authorities the results of testing and other information in its possession from its clinical trials that showed an association between Avandia and heart failure, heart attacks, myocardial ischemia and ischemic events such as cardiovascular mortality, myocardial infarction and stroke.
The complaint further alleges that GSK over-promoted Avandia, carelessly promoted it as safe and effective, and failed and refused to adequately warn the medical community and the consuming public of the risks associated with Avandia until the FDA finally took action.
The complaint includes a claim for negligent pharmaco-vigilance in that GSK has an ongoing duty to continually monitor, test, and analyze data regarding the safety and efficacy of its marketed drugs, including Avandia, but failed in that duty.
Baum Hedlund attorney Roger Drake states that, in the process of his firm’s previous litigation against GSK, the firm acquired a number of internal GSK documents regarding Avandia. He said that GSK may have used a similar method for concealing known side effects of Avandia, which Baum Hedlund discovered while litigating against GSK in thousands of cases involving Paxil. The firm is handling many Avandia wrongful death and personal injury cases, including cases in which patients have required stent placement surgery or coronary artery bypass grafting surgery.
Avandia Black-Box Warnings
The Avandia label has undergone several changes in the seven years leading up to the first black-box warning on August 14, 2007 which warned that patients taking Avandia may be at an increased risk of congestive heart failure. On November 19, 2007, a second black-box warning was added to the Avandia label regarding the potential increased risk of heart attacks and other myocardial ischemic events such as those suffered by Pat Kelly.
About Pat Kelly
Ever since he was a small child, Pat Kelly wanted to be an auctioneer. He did his first auction at the age of 13, attended auction college, and became a very successful professional auctioneer. He felt lucky to be doing something for a living that he loved and did well. Since taking Avandia, suffering myocardial ischemia, and having to undergo bypass surgery, his career has suffered. He has been unable to travel as often as he did before and his health problems have drained his energy and hindered his ability to auction with the same stamina and flair he had before.
Pat Kelly also loved wrestling. He wrestled as a young man, and two of his sons were wrestlers in school as well. His grandson is currently ranked number two in the state of Oklahoma. Pat used to coach wrestling, but since his Avandia experience, he had to stop and may never have the opportunity to pass on his knowledge and experience to his grandson.
