Boehringer Ingelheim pays $650m to settle US Pradaxa litigation

The settlement enables Boehringer Ingelheim to focus solely on its mission of improving patients’ lives and allows the company to avoid the distraction and uncertainty of lengthy litigation.

The settlement was closed at 650 million US Dollar (appr. 470 million €). It comes after a reaffirmation from the US Food and Drug Administration (FDA) of the positive benefit-risk profile of Pradaxa, when it published the results of a Medicare study of more than 134,000 patients.

"Time and again the benefits and safety of Pradaxa have been confirmed in many clinical trials and in real world data analyses. This settlement does not change the facts about Pradaxa or its importance to patients," said Andreas Neumann, Head of the Legal Department and General Counsel, Boehringer Ingelheim worldwide.

"From the time Pradaxa launched, Boehringer Ingelheim properly advised healthcare professionals and patients about its benefits and safety, working closely with US, European and many other regulators to ensure healthcare professionals and patients had the information they needed."

Boehringer Ingelheim is proud of its employees who have worked for years to research, develop and offer to patients such an important medication as Pradaxa.

Pradaxa was the first oral anticoagulant approved in more than 50 years to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF).

"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," said Andreas Neumann.

"The US litigation system is described by some as a business where lawyers run advertising campaigns to find clients. 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," Andreas Neumann added.

There are approximately 4,000 claims that the company seeks to resolve with this settlement. Boehringer Ingelheim expects most, if not all, of the plaintiffs to accept the terms of the settlement and Boehringer Ingelheim will vigorously defend against those who do not.

FDA has publicly stated that Pradaxa 150 mg twice daily offers a positive benefit-risk profile and provides an important health benefit when used as directed to reduce the risk of stroke and systemic embolism in NVAF patients.

On May 13, 2014, FDA once again reaffirmed the positive benefit-risk profile of Pradaxa when used as directed when it issued a Drug Safety Communication that included results from a Medicare study comparing new users of Pradaxa and warfarin who had received a diagnosis of atrial fibrillation.

This included more than 134,000 Medicare patients, who were 65 years of age or older. The new study 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 compared to warfarin.

The study also found an increased risk of major gastrointestinal bleeding with use of Pradaxa as compared to warfarin, but unlike in RE-LY no increased risk of MI compared to warfarin.