Boehringer Avoids Pradaxa Trial, Board Chair Deposition With $650 Mil. Settlement
This article was originally published in The Pink Sheet Daily
Executive Summary
Settlement expected to resolve approximately 4,000 Pradaxa personal injury claims.
Before the first Pradaxa (dabigatran) product liability case went to trail, Boehringer Ingelheim Pharmaceuticals Inc. reached a comprehensive $650 million settlement of federal and state product liability suits.
In a May 28 release, the company said it seeks to resolve approximately 4,000 claims with the settlement and that it expects most, if not all, of the plaintiffs to accept the settlement terms.
“BI stands resolutely behind Pradaxa and believed from the outset that the plaintiffs’ claims lacked merit,” Desiree Ralls-Morrision, senior VP and general counsel of Boehringer Ingelheim USA Corp., said in the release.
“Notwithstanding our strong belief that we would prevail in these lawsuits, this settlement allows BI to avoid the distraction and uncertainty of lengthy litigation and focus on our mission of improving patients’ lives.”
FDA approved Pradaxa in October 2010 to reduce the risk of ischemic stroke and systemic embolism in patients with nonvalvular atrial fibrillation. It was the first anticoagulant to enter the market since warfarin was approved in the 1950s.
The following year FDA began to investigate whether post-marketing reports of serious bleeding events in patients who took the drug were higher than anticipated based on clinical trial results. At that time the European Medicines Agency issued a safety update noting that worldwide there had been 256 spontaneous case reports of serious bleeding resulting in death associated with Pradaxa (Also see "Pradaxa Bleeding Deaths Spur FDA Concerns, European Label Changes" - Pink Sheet, 7 Dec, 2011.).
Personal injury suits were subsequently filed in the U.S. In August 2012, the Judicial Panel on Multidistrict Litigation transferred 21 actions to the Southern District of Illinois for consolidated pretrial proceedings. Plaintiffs alleged that they suffered severe bleeding or other injuries from taking Pradaxa and that Boehringer did not adequately warn prescribing physicians of the risks associated with the drug (Also see "Product Liability Hot Seat: Incretin Mimetics Follow Actos In Racking Up Claims" - Pink Sheet, 6 May, 2013.).
State cases were also consolidated in Connecticut, California, Delaware and Missouri.
The first MDL case had been scheduled for trial in September. In a May 20 case management order Judge David Herndon stayed all aspects of the litigation, including the deposition of Andreas Barner, chairman of Boehringer’s board of managing directors, until further notice. He directed counsel to appear in his chambers the following day to give a report on the status of settlement negotiations and why the case had not yet settled.
FDA Medicare Study Finds Lower Risk Of Strokes, Death With Pradaxa
Boehringer’s position may have been improved by the release of safety findings shortly before the settlement.
FDA issued a May 13 drug safety communication reporting the results of an FDA study in 134,000 Medicare patients 65 years or older comparing Pradaxa to warfarin (Also see "Pradaxa Increases GI Bleeding But Not Heart Attack Risk, Medicare Data Show" - Pink Sheet, 15 May, 2014.).
The study found that Pradaxa was associated with a lower risk of clot-related strokes, bleeding in the brain, and death, than warfarin. The study also found an increased risk of major gastrointestinal bleeding with use of Pradaxa compared to warfarin. And it found the risk of myocardial infarction was similar for the two drugs.
“Importantly, the new study is based on a much larger and older patient population than those used in FDA’s earlier review of post-market data, and employed a more sophisticated analytical method to capture and analyze the events of concern,” FDA stated.
“This study’s findings, except with regard to MI, are consistent with the clinical trial results that provided the basis for Pradaxa’s approval.”
The agency said that as a result of these findings it still considers Pradaxa to have a favorable benefit to risk profile and has made no changes to the current label or recommendations for use.
In November 2012 FDA said it had decided not to change its recommendations for use of Pradaxa, noting that a Mini-Sentinel assessment indicated that the bleeding rates associated with new users of Pradaxa were not higher than the rates associated with new users of warfarin (Also see "Mini Sentinel Alleviates FDA Concern Over Pradaxa Bleeding Issue" - Pink Sheet, 2 Nov, 2012.).
The agency’s investigation of Pradaxa safety is not over, however. FDA is using data from its Mini-Sentinel database to assess the occurrence of ischemic stroke, intracranial hemorrhage, and major extracranial hemorrhage in adults with atrial fibrillation who are new users of Pradaxa or warfarin. The agency posted a final draft protocol for the assessment in December (Also see "Pradaxa Bleeding Risk Gets Deeper FDA Scrutiny In Mini-Sentinel Project" - Pink Sheet, 7 Jan, 2014.).