Boehringer Ingelheim Pays $650M to Settle Lawsuits Set for Trial

Boehringer Ingelheim, the manufacturer of Pradaxa, has agreed to pay $650 million to settle thousands of lawsuits brought in state and federal courts by patients and their families who claimed that the drug manufacturer failed to properly warn  of serious and potentially fatal bleeding from use of the drug. Considered a warfarin replacement, Pradaxa, approved in 2010 as the first in a new class of blood thinners to prevent blood clots, was touted as a convenient drug because it did not require any tests or dietary restrictions. From its initial approval in October 2010 through December 2013, there were approximately 6.2 million prescriptions dispensed and 934,000 patients who received a prescription for Pradaxa from U.S. outpatient retail pharmacies.

FDA study. Earlier this month, the FDA issued a Drug Safety Communication noting that an FDA study of 134,000 Medicare patients aged 65 years or older found risks lower for clot-related strokes, bleeding in the brain, and death, but higher for gastrointestinal bleeding with Pradaxa use compared to warfarin. More importantly, the FDA noted that its study was based on a much larger and older patient population than those used in the agency’s previous review of post-market data, and employed a more sophisticated analytical method to capture and analyze the events of concern. Additionally, the FDA noted that the study’s findings, except with regard to myocardial infarction, are consistent with the clinical trial results that provided the basis for Pradaxa’s original approval.

The FDA concluded that it considered Pradaxa to have a favorable benefit to risk profile and made no changes to the current label or recommendations for use. Patients were recommended that they should not stop taking Pradaxa (or warfarin) without first talking with their health care professionals. In addition, health care professionals who prescribe Pradaxa should continue to follow the dosing recommendations in the drug label.

Settlement value. In a press release, Boehringer senior vice president and general counsel Desiree Ralls-Morrison noted that the manufacturer “stands resolutely behind Pradaxa and believed from the outset that the plaintiffs’ claims lacked merit.” However she stated that although Boehringer believed it would prevail in the litigation, that the settlement allowed the manufacturer to “avoid the distraction and uncertainty of lengthy litigation and focus on our mission of improving patients’ lives.” Boehringer expected that most, if not all, of the litigants involved in the over 4,000 pending lawsuits would accept the terms of the settlement, but noted it would continue to defend itself in court against those that did not. Boehringer pointed out that the 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 non-valvular atrial fibrillation (NVAF)patients.

Patients and their families had alleged that the company misled patients and their doctors about Pradaxa’s risks and about its advantages over warfarin. Safety concerns arose because patients using Pradaxa were presenting at emergency rooms with life-threatening bleeding. Currently, there is no effective means to stop bleeding once it begins for patients on Pradaxa.

The first case was set to go to trial in September.