Individual Avandia lawsuits filed across the U.S. have been consolidated into Multi-District Litigation in the U.S. federal trial court for the Eastern District of Pennsylvania in Philadelphia, PA. There currently is no national Avandia class action lawsuit pending in the United States.
MDL 1871, “In Re: Avandia Marketing, Sales Practices and Products Liability Litigation,” was created on October 16, 2007, by the United States Judicial Panel on Multidistrict Litigation. The MDL Panel noted that Avandia lawsuits filed against GlaxoSmithKline arise out of common claims “that certain diabetes drugs manufactured by GSK — Avandia and/or two sister drugs containing Avandia (Avandamet and Avandaryl) — cause an increased risk of heart attack and other physical injury” and that GSK failed to warn patients of Avandia’s cardiovascular risks. In addition, the MDL Panel found that formation of an Avandia MDL would, “eliminate duplicative discovery, avoid inconsistent rulings, and conserve the resources of the parties, their counsel and the judiciary.”
The Avandia lawsuits were filed after research published in the May 2007 issue of The New England Journal of Medicine linked Avandia use to a significant increase in heart attack risk and the risk of death from cardiovascular causes. The study’s author, cardiologist Dr. Steven Nissen of the Cleveland Clinic, became an outspoken critic of the Type 2 diabetes drug and called for the FDA to order Avandia recall.
The same month, the FDA issued a black box warning that Avandia may increase the risk of congestive heart failure (CHF). The FDA ordered revisions to the Avandia black box warning in August 2007 and and November 2007. The August 2007 revision of the black box warning added the risk of the diabetes drug causing heart failure to worsen. The November 2007 revision finally added Avandia heart attack risk to the black box warning.
On September 23, 2010, the FDA announced tight new restrictions on Avandia use in the United States. Many view the new FDA Avandia restrictions to be, in effect, a FDA Avandia recall. Shortly after the action was announced, Dr. Nissen told the Wall Street Journal that he expected the new FDA restrictions on Avandia to limit the use of the diabetes drug in the U.S. by 99%.