Thousands of Pradaxa Lawsuits Settled for $650 Million

May 28, 2014 — Boehringer Ingelheim announced they will pay $650 million to settle up to 4,000 lawsuits involving Pradaxa (dabigatran), a blood-thinning medication that was introduced in 2010.

Lawsuits claim that Boehringer failed to adequately warn about the bleeding risks of Pradaxa, including its lack of an effective reversal-agent. Over 2,200 lawsuits are currently centralized in federal Multi-District Litigation (MDL No. 2385) in the Southern District of Illinois.

The first “bellwether” trials were scheduled to begin later this year. Boehringer chose to avoid the uncertain outcome, time, and expense of jury trials by agreeing to a settlement. According to Andreas Neumann, Head of the Legal Department and General Counsel:

“We continue to stand resolutely behind Pradaxa® and believed from the outset that the plaintiffs’ claims lacked any merit. 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.”

Since it was approved in 2010, the U.S. Food and Drug Administration (FDA) has received thousands of adverse event reports involving serious or fatal bleeding. Although bleeding is a common side effect of blood-thinning medications, experts are concerned that Pradaxa may have unique risks because it lacks an effective reversal agent — unlike warfarin, which can be reversed with a dose of Vitamin K.

Earlier this month, the FDA completed a study of 134,000 Medicare patients over age 65 and found that Pradaxa had a higher risk of gastrointestinal bleeding than warfarin, but a lower risk of stroke and death. The FDA stated that it continues to believe Pradaxa has “a favorable benefit to risk profile.”

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