$650 Million Pradaxa Settlement Ends Legal Ordeal for 4000 Victims

One day after a committee of eight plaintiffs’ attorneys was named by US District Judge David Herndon to negotiate a master Pradaxa settlement with the manufacturer Boehringer Ingelheim, the German drug giant announced it has agreed to pay $650 million to settle 4,000 Pradaxa lawsuits, or approximately $165,000 per complaint.

If the claimants agree to the settlement as expected, the announcement should bring to a close more than 2,350 product liability lawsuits which have been consolidated as part of an MDL, or Multidistrict Litigation, centralized before U.S. District Judge David R. Herndon in the Southern District of Illinois. The Pradaxa settlement may also now eliminate the need for what would have been hundreds of individual suits taking place across the country.

The majority of the suits follow a common theme: allegations that Boehringer Ingelheim failed to provide adequate warning to consumers and the medical community about the risk of severe and potentially life-threatening gastrointestinal (GI) bleeding problems associated with the controversial anticoagulant.

The suits also note Pradaxa’s lack of a reversal agent in the event of a gastrointestinal bleed, a major cause of concern in the medical community.

Most, if not all, plaintiffs expected to accept Pradaxa settlement

The Pradaxa settlement concluded a busy week in Judge Herndon’s courtroom. On May 20, the judge issued a case management order that stayed all aspects of the Pradaxa litigation, including a scheduled deposition of Boehringer Ingelheim’s CEO. The order required the court appointed mediator and a group of plaintiffs’ attorneys to appear in Judge Herndon’s chambers to provide a “full and detailed report of the status of settlement negotiations and why the case has not yet settled.”

On May 27, Judge Herndon issued another case management order, appointing a group of eight attorneys to serve on a Pradaxa Claimants’ Negotiating Committee (PCNC), whose job would be to negotiate the terms of a settlement agreement with Boehringer Ingelheim. On May 28, Boehringer Ingelheim made its announcement of the $650 million Pradaxa settlement in a press release stating that it expected most, if not all, complainants to accept the settlement.

Pradaxa settlement is not an admission of guilt, says manufacturer

Boehringer Ingelheim officials said that the Pradaxa settlement is not an admission of guilt or that Pradaxa is unsafe.

“We continue to stand resolutely behind Pradaxa and believed from the outset that the plaintiffs’ claims lacked any merit,” Andreas Neumann, head of the company’s legal department, said in the press release. “Notwithstanding our strong belief that we would prevail in these lawsuits, this settlement allows our company to avoid the distraction and uncertainty of protracted litigation over years and years.”

Pradaxa (dabigatran) was first approved by the FDA in October 2010 for prevention of strokes among patients with atrial fibrillation. It was promoted as a more convenient and effective alternative to the market leading anticoagulant at the time, warfarin, also known as Coumadin, because it did not require the burdensome monitoring of drug levels in the blood that warfarin mandated.

However, shortly after its introduction, the FDA received a record number of adverse event reports after patients experienced uncontrolled bleeding events. There have been thousands of reports of injuries and hundreds of deaths associated with Pradaxa use since it was introduced by Boehringer Ingelheim.

Many doctors have expressed concerns about the aforementioned lack of an effective reversal agent for Pradaxa. While doctors are able to reverse the blood thinning effects of warfarin with a dose of vitamin K, there is no such antidote available for Pradaxa users.

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