Boehringer Ingelheim Pays $650 Million to Resolve Pradaxa Bleeding Lawsuits in Federal MDL

Pradaxa, known generically as dabigatran, reached the U.S. market in 2010 as a new generation of blood thinner designed to prevent strokes in patients with atrial fibrillation. Boehringer Ingelheim marketed the drug as a convenient alternative to warfarin, one that required no routine blood monitoring. What the company did not adequately disclose, plaintiffs alleged, was that dabigatran lacked a reversal agent: if a patient on the drug began to bleed internally, physicians had no approved antidote to stop it.

More than 540 people who took Pradaxa died in 2011 alone. Thousands of others experienced serious complications, including gastrointestinal hemorrhages, brain bleeds, and rectal bleeding. Because dabigatran worked by a different mechanism than warfarin, the standard reversal drugs had no effect. Patients and their families filed suit across the country, arguing that Boehringer Ingelheim had known about the severity of the bleeding risk and had chosen to bury it behind marketing copy emphasizing convenience.

A federal judicial panel consolidated the bulk of the claims into MDL No. 2385 in the Southern District of Illinois, assigned to Judge David Herndon. Judge Herndon appointed a 27-lawyer plaintiffs' leadership group, structured as an executive committee, liaison counsel, and a steering committee, to coordinate discovery and pre-trial strategy across the thousands of pending cases. In Case Management Order No. 4, entered September 27, 2012, the court named Tor Hoerman of TorHoerman Law, based in Edwardsville, Illinois, as one of five plaintiffs' co-lead counsel on the executive committee, placing the firm at the center of document review, expert development, and settlement negotiations.

By May 2014, Boehringer Ingelheim had agreed to pay $650 million to resolve roughly 4,000 U.S. cases. The company denied any wrongdoing, stating publicly that it settled 'to avoid the distraction and uncertainty of protracted litigation over years and years.' It maintained that Pradaxa carried a favorable benefit-to-risk profile. Nonetheless, the manufacturer agreed to the payment before any of the four federal trials Judge Herndon had scheduled between August 2014 and February 2015 ever occurred.

Boehringer Ingelheim did not submit its FDA application for a reversal agent, Praxbind, until early 2015, nearly a year after the settlement closed. The agency approved it in October 2015. No reduction of the $650 million settlement was reported.