Boehringer Ingelheim announced it will pay $650 million to resolve about 4,000 state and federal lawsuits alleging the company’s blood thinner Pradaxa caused patients to suffer serious bleeding events.
Boehringer Ingelheim denied any wrongdoing and said the settlement is being offered to avoid lengthy litigation. The drug company said it expects most, if not all, the plaintiffs to accept the terms of the settlement, and it will vigorously defend itself against those who do not.
Pradaxa (dabigatran) was the first drug to be approved from a new class of blood thinners. The drug has been plagued with reports of excessive bleeding complications since it was approved by the Food and Drug Administration (FDA) in 2010 to prevent strokes in patients with atrial fibrillation.
The blood thinner was reportedly linked to as many as 900 gastrointestinal bleeds and 500 bleeding deaths. The FDA conducted a lengthy investigation into the claims, ultimately issuing a safety communication earlier this month warning that patients using Pradaxa were at greater risk for dangerous gastrointestinal bleeding events.
Boehringer Ingelheim continues to stand by Pradaxa, stating that the company properly advised doctors and patients about the drug’s benefits and safety, and working with drug regulators from countries where the drug is approved for use.
Pradaxa became the first blood thinner in more than 50 years to replace warfarin for blood clot treatment and prevention. One drawback with warfarin is that it requires patients to be regularly monitored because of bleeding risks.