Boehringer Ingelheim seeks FDA approval for Pradaxa to treat DVT and PE

Apr 21 2015

Legal-Bay LLC, The Lawsuit Settlement Funding Company, announced today that Pradaxa's maker, Boehringer Ingelheim Pharmaceuticals, is seeking FDA approval for its blood thinner to treat DVT and PE. According to PBR, Boehringer submitted a supplemental new drug application (sNDA) to the FDA in hopes that Pradaxa will be approved for the prophylaxis of deep venous thrombosis (DVT) and pulmonary embolism (PE) for patients who have undergone a primary elective total hip replacement surgery (Legal-Bay also assists patients with DePuy, Stryker, Biomet hip lawsuit funding and assistance with finding a hip recall law firm). If the FDA approves the Pradaxa request, this will be the fourth indication for Pradaxa.

Boehringer Ingelheim reached a $650 million settlement in May of 2014 over their blood thinner, Pradaxa, on approximately 4,000 cases filed in state and federal courts (In re: Pradaxa (Dabigatran Etexilate) Products Liability Litigation, case number 3:12-md-02385, in the U.S. District Court for the Southern District of Illinois). The lawsuits alleged that Pradaxa may cause bleeding events to occur which cannot be controlled and may even be fatal. The Federal Pradaxa lawsuits were consolidated into multidistrict litigation in the U.S. District Court for the Southern District of Illinois under Judge David R. Herndon in August of 2012 and the settlement was reached in May of 2014. Despite agreeing to the settlement, Boehringer Ingelheim denied any misconduct or unlawful activity, stating that they believed the settlement allows their company "to avoid the distraction and uncertainty of protracted litigation over years and years."

Since the Pradaxa litigation settlement, now a new blood thinner, Xarelto, is also the target of lawsuit claims being filed in both state and federal courts for similar injuries (In Re: Xarelto Products Liability Litigation, No. 2592). The Pradaxa settlement value was approximately $160K average per case; plaintiff attorneys close to the litigation believe that Xarelto cases could see similar settlement amounts if the plaintiffs can prove their cases in a court of law. Xarelto's maker, Bayer and Johnson & Johnson's Janssen Pharmaceutical Division, continue to fight the suits.

Chris Janish, CEO of Legal-Bay, commented on the recent news on the blood thinner drugs, "We are seeing that the blood thinner drug market continues to expand with requests for additional FDA approvals, even while settlements have been announced for large amounts in the Pradaxa litigation, and new cases are being filed every day in the Xarelto litigation. We understand the need for some of these drugs in the market, however, we continue to support and assist patients who are in need of lawsuit funding services or help with finding a qualified blood thinner attorney."

SOURCE Legal-Bay LLC