Bristol-Myers Squibb and Sanofi-Aventis have filed a motion for summary judgment in the long-running Plavix litigation, calling for the U.S. District Judge presiding over the cases to dismiss all remaining lawsuits, maintaining that plaintiffs’ failure to warn claims are pre-empted by federal law.
The first Plavix lawsuits were filed more than 10 years ago, and the federal litigation has been centralized before U.S. District Judge Freda L. Wolfson in the District of New Jersey since February 2013, where the cases are consolidated as part of an MDL, or multidistrict litigation. Each of the claims raise similar allegations that the drug makers failed to provide adequate warnings that side effects of Plavix may increase the risk of various injuries, including gastrointestinal bleeding, severe ulcers, a rare blood disorder known as thrombotic thrombocytopenic pupura (TTP) and other complications.
There are currently about 220 cases pending before Judge Wolfson for coordinated pretrial proceedings, with several cases already dismissed by the Court.
Last month, defendants filed a motion for summary judgment (PDF), which seeks to have all of the remaining Plavix cases dismissed. The drug makers argue that plaintiffs’ labeling expert, Dr. Randall Tackett, has acknowledged that the FDA knew about the extent of Plavix bleeding risks, but did not force the company to make the drug carry a strong enough warning label.
According to the defendants, Tackett’s assertions that the FDA “got it wrong” are preempted by federal law, which they interpret as indicating the FDA’s labeling decisions cannot be second-guessed in a liability claim.
Plaintiffs filed a response in opposition (PDF) to the summary judgment motion last week, arguing that previous Supreme Court rulings have indicated that to get a summary judgment in such a case, defendants must prove they made an effort to change the label warning to something more appropriate, following either new information or additional analysis of old information, and that they must show that the FDA did, or clearly would have, rejected their efforts to strengthen the warning label. Those rules are governed by the FDA’s Changes Being Effected (CBE) regulations.
“Plaintiffs claim that Plavix’s label was inadequate, because the placement of risk information about bleeding outside the ‘Warnings’ section minimized the severity of those risks,” the response states. “The record shows that the Defendants had multiple opportunities, and were presented with numerous studies, to make use of the CBE regulation to correct this inadequacy after Plavix’s initial approval – both due to data recovered from postapproval studies, and to the accumulation of post-marketing data. As a result, Defendants’ claim of preemption must fail absent clear evidence that FDA would have rejected changes made under the CBE regulation, evidence that Defendants cannot provide.”
Defendants have asked the court to address the summary judgment motion at a joint hearing scheduled for November 15-16, which is set to address expert testimony admissibility and to resolve case-wide dispositive motions.
Last week, Judge Wolfson did grant summary judgment in one case filed over Plavix gastrointestinal bleeding injuries. However, that case was dismissed because the judge found that there was no evidence that either the plaintiff, or her doctor, would have chosen a different drug even if there had been stronger Plavix warning labels.