Lawsuit Filed Against GlaxoSmithKline by..

Lawsuit Filed Against GlaxoSmithKline by Heart Bypass Patient

February 16, 2008.

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Philadelphia, PA: On February 12, 2008, a lawsuit was filed in the U.S. District Court for the Eastern District of Pennsylvania by Pat and Sandra Kelly of Grove, Oklahoma against GlaxoSmithKline, the maker of the poplar diabetes drug, Avandia. The lawsuit states that GSK was negligent, committed fraud, breached its warranty, failed to warn about the risks associated with the drug, and neglected pharmaco-vigilance. The plaintiffs state that these factors led to the serious injury of Mr. Kelly.

The lawsuit is alleging that Avandia caused Mr. Kelly, 59, to acquire myocardial ischemia, which is a heart condition that occurs when blood flow is reduced to the heart. This condition requires coronary revascularization and the condition itself is quite painful.

Kelly stated that he took the drug because of the claims that the drug reduces or eliminates the need for insulin.

After his first myocardial ischemic episode, stent placement surgery was required for Mr. Kelly on March 20, 2006, and then five months later he began suffering chest pains and had to undergo open-heart surgery in order to restore the flow of nutrients and oxygen to his heart through coronary artery bypass.

Kelly, a successful auctioneer for the past 40 years, frequently traveled throughout the country for his job, but says that the surgery has taken away his ability to do so and there are no jobs available for him.

The Kelly's attorneys allege that GSK knew that there was a high risk of heart failure associated with Avandia. Such conditions include heart attack and stroke.

Mr. Kelly's attorneys have stated that scientists with the FDA have estimated that the drug has caused approximately 83,000 heart attacks and they say that with such a number it is hard to believe that GSK had no knowledge of the heart failure risk associated with Avandia.

Also in the lawsuit, it alleges that GSK carelessly and negligently did not disclose to patients, regulatory authorities, and patients information and test results from its clinical trials that shows the connection between heart failure and Avandia. The lawsuit also alleges that GSK was careless in their promoting of Avandia by stating that the drug is safe and effective. According to the lawsuit, this indicates an failure to adequately warn the general public and the medical community of the risks associated with the drug and that it wasn't until the FDA took action that the medical community and the public was aware.

The complaint further alleges that GSK failed to continually monitor, analyze, and test the drug, which is also called pharmaco-vigilance.

As far as the warnings on Avandia, the label has seen many changes in the past seven years, but it wasn't until August 14, 2007 that GSK issued the first black-box warning. The warning warned patients that there may be an increased risk of heart failure. A second black-box warning was issued 2 months later regarding the increased risk of heart attacks and other events related to myocardial ischemic events.

Kelly's case is just one of many that have been filed across the United States and it is estimated that there are thousands of cases that have not yet been filed. The attorneys for the Kellys have stated that there is a national pharmaceutical litigation taking place that is within its early stages and that more and more people are coming forward to be a part of this litigation.

GSK has also encountered many lawsuits involving its popular drug Paxil. These cases range from wrongful death to personal injury. As for Avandia, the drug has dropped in sales since it was announced that the drug increases the risk of heart attacks.

By Ginger Gillenwater

Avandia Legal Help
If you or a family member have used Avandia and have suffered heart attack, liver damage, or osteoporosis after taking Avandia, please contact a lawyer involved in a possible [Avandia Lawsuit] to review your case at no cost or obligation.

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