Boehringer Ingelheim aims for clean slate with $650 million Pradaxa settlement, says analyst

After facing more than 2,000 law suits in the USA, claiming Pradaxa (dabigatran) caused severe or fatal bleeding, German family-owned pharma major Boehringer Ingelheim has reached a $650 million settlement of all state and federal cases in the  US litigation regarding Pradaxa.

According to Haylyn Wong, GlobalData senior analyst covering cardiovascular and metabolic disorders, Boehringer Ingelheim continues to stand by Pradaxa and the belief that the claims lacked any merit, and has stated that the settlement was conducted to allow the company to avoid the distraction and uncertainty of a lengthy litigation process.

Strategically, the announcement has been well timed, and comes hot on the heels of a positive safety evaluation made by the US Food and Drug Administration earlier in May, which concluded that Pradaxa has a favorable benefit-to-risk profile compared with warfarin, with a lower risk of clot-related strokes, bleeding in the brain, and death. Based on a post-marketing study of more than 134,000 patients, the FDA has decided that it will make no changes to the recommendations for Pradaxa’s use, an outcome that could counterbalance any negative repercussions the news of BI’s settlement may bring.