On May 28, 2014, the large German pharmaceutical company, Boehringer Ingelheim, announced that it had reached a settlement of all pending state and federal claims in the United States involving its blood-thinner drug, Pradaxa. The comprehensive settlement will involve the payment of $650 million to resolve approximately 4,000 claims involving Pradaxa.
On May 13, 2014, the FDA had issued a Drug Safety Communication that reported on its new study of more than 134,000 Medicare patients who were 65 years or older that found that among new users of blood-thinning drugs, Pradaxa was associated with a lower risk of clot-related strokes, bleeding in the brain, and death, than warfarin (Coumadin, Jantoven, and generics); that there was an increased risk of major gastrointestinal bleeding with the use of Pradaxa as compared to warfarin; and, that the risk of MI was similar for the two drugs.
As a result of the new study, the FDA stated, “we still consider Pradaxa to have a favorable benefit to risk profile and have made no changes to the current label or recommendations for use. Patients should not stop taking Pradaxa (or warfarin) without first talking with their health care professionals. Stopping the use of blood-thinning medications such as Pradaxa and warfarin can increase the risk of stroke and lead to permanent disability and death. Health care professionals who prescribe Pradaxa should continue to follow the dosing recommendations in the drug label.”
The FDA’s May 13, 2014 Drug Safety Communication was a follow-up to its November 2, 2012 Drug Safety Communication regarding Pradaxa in which it reported that its investigation into the actual rates of gastrointestinal bleeding and intracranial hemorrhage for new users of Pradaxa compared to new users of warfarin, using insurance claims and administrative data from the FDA’s Mini-Sentinel pilot of the Sentinel Initiative, found that the results of the Mini-Sentinel assessment indicated that bleeding rates associated with new use of Pradaxa did not appear to be higher than bleeding rates associated with new use of warfarin, which was consistent with observations from the large clinical trial used to approve Pradaxa. In light of such, the FDA did not change its recommendations regarding Pradaxa.
In announcing the $650 million settlement, the Head of the Legal Department and General Counsel of Boehringer Ingelheim worldwide stated, “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 … Furthermore we have to consider that juries composed of lay people have to decide about very difficult scientific matters. All this does not allow reliable predictions for the outcome of a huge number of individual trials and that is why we came to the tough decision to settle.”
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