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Boehringer Ingelheim Reaches $650 Million Settlement in Pradaxa Litigation

May 29, 2014

Boehringer Ingelheim has reached a $650 million settlement for lawsuits filed over the anticoagulant Pradaxa (dabigatran). In a news release, the company said that it reached the settlement without admitting any liability or wrongdoing. However, thousands of lawsuits allege otherwise. Boehringer Ingelheim said that the settlement is expected to resolve 4,000 claims.

Pradaxa is a blood thinner prescribed to patients who suffer from atrial fibrillation. The drug has been marketed as a superior version of warfarin, an older drug anticoagulant that requires frequent blood testing and dietary restrictions. Although Pradaxa does not have these restrictions, there have been significant safety concerns over its irreversible bleedings risks. If a patient taking warfarin suffers from internal bleeding, then healthcare professionals are able to use vitamin K and other antidotes to stop the hemorrhaging. There is no antidote to stop the bleeding in Pradaxa patients.

The Safety Information for Pradaxa states that the drug “increases the risk of bleeding and can cause significant and, sometimes, fatal bleeding.” The information also admits that there is no reversal agent for Pradaxa, noting that hemodialysis can remove the drug from the body but this method is limited.

The U.S. Food and Drug Administration (FDA) issued a Drug Safety Communication on May 13th stating that Pradaxa was linked to a lower risk of clot-related strokes, bleeding in the brain and death, but had a higher risk of major gastrointestinal bleeding. The notification was issued following the results of an FDA Medicare study.

Lawsuits filed over Pradaxa allege that the drug caused serious, and in some cases fatal, bleeding. People who file the lawsuits also accuse Boehringer Ingelheim of failing to warn about the risks. According to one lawsuit filed in the U.S. District Court of Philadelphia, the FDA received 500 reports of Pradaxa-related deaths as of December 31, 2011. In addition, Pradaxa has been linked to 900 reports of gastrointestinal bleeding, 300 reports of rectal bleeding and over 200 reports of cerebrovascular accidents.

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