Pradaxa Settlement Announced as Boehringer Ingelheim Agrees to Pay $650M

Thousands of lawsuits against Boehringer Ingelheim (BI) will soon be resolved after the company agreed to settle the majority of cases filed in state and federal courts over its blockbuster drug Pradaxa. The proposed settlement – a reported $650 million – will resolve around 4,000 claims stemming from allegations that the company issued insufficient warnings about the risks associated with the anticoagulant. These risks, which prompted a safety announcement from the FDA in December 2011, specifically referred to “serious bleeding events” occurring in users of the drug. The suits further alleged that BI failed to advise medical professionals about the proper use of Pradaxa, failed to provide an antidote for its drug, and even withheld knowledge about the bleeding risk from the FDA.

The problem seems not to be that Pradaxa poses a bleeding risk, but more that this risk was not accurately reflected on the drug’s label and in relevant BI literature.

The settlement is no indication that BI is admitting fault, though:

Sour grapes? BI’s presenting the settlement as a calculated move to avoid the lengthy litigation process – and the costs involved – and to shift the company’s focus once more onto “improving patients’ lives.” Pradaxa has generated sales of more than $1 billion since its 2010 launch, and though patients continue to allege that there is no antidote for the drug, the FDA has recognized the drug as effective, and gave Pradaxa a positive benefit-risk analysis.

The problem seems not to be that Pradaxa poses a bleeding risk, but more that this risk was not accurately reflected on the drug’s label and in relevant BI literature.

The settlement remains subject to final approval, after which patients and their families will be able to make their claims.