Jim Boyle Jun. 12, 2014, 3:35pm


A federal judge at the U.S. District Court for the Eastern District Court of Pennsylvania has

ordered 53 claims severed from a mass tort against Glaxo SmithKline over injuries caused by the diabetes drug Avandia.

Judge Cynthia Rufe ordered eight complaints remanded on May 15, and the severed cases have been re-filed individually by attorneys seeking damages for alleged injuries and deaths linked to the use of the prescription medication.

Since 2007, more than 50,000 Avandia lawsuits have been filed against GSK, with the company settling most of them out of court for an aggregate cost of more than $750 million, according to Reuters. GSK also paid the U.S. Department of Justice a $3 billion settlement in 2012 over charges that it had withheld data on the health risks of Avandia and used deceptive marketing practices to sell antidepressants Paxil and Wellbutrin.

Avandia was first approved in 1999 for use as medication against type 2 diabetes, but the plaintiffs claim that GSK knew even back then that there were serious health concerns, such as increasing the possibility of a heart attack. Plaintiffs claim that in 1999, the pharmaceutical giant attempted to quash a paper written by Dr. John B. Buse, a diabetes expert, who had concerns about the effects of Avandia on the heart.

A year later, Dr. Buse wrote to the Food and Drug Administration about the possible side effects at approximately the same time that advocacy group Public Citizen petitioned the FDA to revise Avandia's labeling, plaintiffs say.

Following three separate studies that reviewed data from hundreds of clinical trials, the FDA added a black box warning to Avandia in 2007.  The warning states that Avandia and other diabetes medications may cause heart failure in certain patients. Between September 2010 and February 2011, the government pulled Avandia from the shelves, and it could only be received through special orders, but those restrictions have been removed.

Federal Avandia lawsuits have been consolidated to a multidistrict litigation group in the U.S. District Court for the Eastern District of Pennsylvania. GSK has set aside more than $6 billion to pay settlement costs in future lawsuits.

The resubmitted lawsuits read basically the same, asking the court for relief from damages caused by GSK's alleged negligence, breach of implied warranty, fraudulent misrepresentation and in cases such as James Franklin, wrongful death.

Franklin's widow, Cindy, has also sued for loss of consortium and says that her husband suffered a fatal case of angina caused by Avandia's defects. All of the suits, filed by Media, Pa., attorney Raymond Peppelman, say that the company disregarded the warnings by the FDA and used deceptive practices in its labeling to increase the bottom line.

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