Multidistrict litigation mediation has led to the settlement of about 25,000 Avandia lawsuits. Avandia was GlaskoSmithKline’s once-blockbuster type 2 diabetes drug.
This November, U.S. District Judge Cynthia Rufe appointed a mediator to preside over settlement negotiation for the cases, setting a 75-day deadline for the majority—85%–of the cases. Although Judge Rufe called the effort a “major success,” it was unclear if the threshold was met, wrote Bloomberg Businessweek.
Judge Rufe did announce that “Mediation will no longer be the focus of this court’s effort. We will resolve the remaining cases through litigation,” Businessweek said, noting that the settlements go back more than 10 years. Over 2,500 Avandia lawsuits are consolidated before Judge Rufe while other cases remain pending nationwide. To date, 50,000 other cases were resolved in both state and federal court, according to Businessweek. “From what I’m hearing today, there aren’t a lot of cases left to be tried, and not all those cases will make it to trial,” Rufe said.
Judge Rufe ordered attorneys for plaintiffs in Avandia lawsuits to meet with those representing Glaxo and an appointed independent mediator in hopes of reaching accord on the thousands of lawsuits. The first of what could be an endless stream of Avandia cases was about to go to trial in mid-January before Judge Rufe ordered the mediation session, which is when the 75-day deadline to reach settlement was imposed.
As we’ve mentioned, the lawsuits are among thousands more which claim Glaxo hid data showing Avandia increased the risk of heart attacks, stroke, and death over other drugs. Avandia generated $3 billion annually for the British company at the height of sales. In the past year, those figures significantly dropped, most specifically after the U.S. Food & Drug Administration (FDA) severely restricted access to Avandia and advised physicians to use the drug to control a diabetic’s blood sugar levels only as a last resort. The agency cited numerous studies and a growing number of adverse reaction reports in deciding to, essentially, remove Avandia, then the top Type 2 diabetes drug, from the market.
Meanwhile, Glaxo said in November that it was paying $3 billion to settle U.S. criminal and civil investigations into whether it marketed the diabetes drug and other medications illegally, noted Businessweek.
Glaxo agreed to cease marketing Avandia as a treatment for Type 2 diabetes, respecting the demands of the FDA and other regulatory agencies worldwide, which all believe the drug carries a risk of causing heart attacks and stroke more than other available treatments. Glaxo never noted those risks in any clinical data; however, those filing lawsuits believe the company had been presented ample evidence of those risks.
GlaxoSmithKline has been the focus of a federal investigation since 2004 over alleged illegal marketing and suppression of negative evidence on the side effects of Avandia and several other of its top-selling drugs. Bloomberg previously cited a 2007 incident in which a University of North Carolina professor told U.S. officials he was pressured by Glaxo to mute his criticisms of Avandia, specifically related to its link to heart attacks and stroke, ever since the drug was first introduced in America in 1999.