A California wrongful death lawsuit has been filed against the makers of Avandia, alleging that the Type 2 diabetes drug caused heart attacks, congestive heart failure, and other cardiovascular injuries which killed seven people.
The Avandia lawsuit was filed in the California Superior Court against GlaxoSmithKline (GSK), SmithKline Beecham and McKesson Corporation, alleging that the drug makers failed to disclose the increased risk of heart problems associated with Avandia.
According to the lawsuit, GSK performed an analysis in 2005 of multiple clinical trials which showed that Avandia users face an increased risk of adverse cardiovascular events. However, these results were not shared with the FDA until August 2006, and warnings were not provided to the public until 2007.
The public and most of the medical community first became aware of the heart problems associated with Avandia in May 2007, when a meta-analysis of those clinical studies was published in the New England Journal of Medicine. That report, which was written by independent researchers from the Cleveland Clinic, analyzed data from 42 different clinical trials involving nearly 28,000 people. The report found that Avandia side effects increase the risk of a heart attack by 43% and increase in the risk of cardiovascular death by 64% .
Avandia, which was approved by the FDA in 1999 for treatment of Type 2 diabetes, has been taken by approximately six million people in the United States. Prior to the New England Journal of Medicine article, Avandia was the second largest selling drug for GlaxoSmithKline, with annual sales of more than $2 billion in 2006.
Estimates have suggested that as many as 100,000 heart attacks could have been caused by Avandia since it was introduced, and a number of Avandia lawsuits have been filed in various state and federal courts throughout the U.S.
In October 2007, all of the federal Avandia litigation was consolidated by the Judicial Panel on Multidistrict Litigation before U.S. District Court Judge Cynthia M. Rufe in the Eastern District of Pennsylvania.
A Multidistrict Litigation, or MDL, is a procedure which allows the U.S Federal Court system to transfer all pending lawsuits with a common background to a single judge for pretrial proceedings. If these cases are not resolved during pretrial proceedings, these are remanded back to the court where they were originally filed for trial.