It’s been nearly a year since Boehringer Ingelheim, the German manufacturer of Pradaxa, announced it would pay $650 million to settle nearly 4,000 U.S. lawsuits claiming the anticoagulant causes excessive and uncontrollable bleeding, yet lawsuits continue to be filed.

The latest Pradaxa lawsuit to join multidistrict litigation against Boehringer Ingelheim was filed March 3 by plaintiff Doris H. of Tennessee, who claims she was hospitalized for nearly a month to treat severe bleeding in her leg, hip and knee.

Doris joins thousands of other Pradaxa users who claim they never would have taken the anticoagulant if Boehringer had warned them they were at an increased risk for developing life-threatening bleeds. Pradaxa has been linked to at least 237 deaths and over 1,000 reports of near-fatal bleeding events in the U.S. alone.

Background: Pradaxa Safety Questioned

Pradaxa was approved in 2010 as an anticoagulant meant to prevent blood clots after surgery. It was the first of a new generation of anticoagulants designed to be an alternative to Warfarin (coumadin), the go-to anticoagulant for decades. Warfarin required additional monitoring and a limited diet. Pradaxa did not.

However, if a patient experienced internal bleeding from Warfarin, an antidote was available that could minimize complications. Pradaxa has no such antidote, so when patients suffer from a Pradaxa bleeding event, it is significantly harder to treat.

Boehringer has been accused of failing to properly inform users and the medical community about potential Pradaxa internal bleeding and the lack of a bleeding antidote. Instead, they allowed the drug to be extremely profitable while they, “overstated the efficacy of Pradaxa with respect to preventing stoke and systemic embolism,” according to the Pradaxa bleeding lawsuit filed by Doris.

From Oct. 1, 2010 until the end of March 2011, approximately 272,1191 Pradaxa prescriptions were written in the United States. During that same period, there were 932 Pradaxa-associated “Serious Adverse Events” Medwatch reports filed with the FDA, including at least 120 deaths and over 500 reports of severe life-threatening bleeding, according to the Pradaxa lawsuit.

“From April 1, until the end of June 2011, there was an additional 856 Pradaxa‐associated “SAE” Medwatch reports filed with the U.S. Food and Drug Administration including at least 117 deaths and over 510 reports of severe life‐threatening bleeding,” the Pradaxa lawsuit continues.

Pradaxa Bleeding Lawsuits

Boehringer’s failure to warn against Pradaxa internal bleeding complications has caused numerous individuals to file Pradaxa bleeding lawsuits against the company, including Doris.

Doris used Pradaxa from May 19, 2011 until December 21, 2011. “As a result of Plaintiff’s ingestion of Pradaxa, Plaintiff suffered a severe bleed in her leg, hip, and knee for which she was hospitalized from June 1, 2014 through June 22, 2014,” according to her Pradaxa bleeding lawsuit.

The plaintiff claims she was unaware of the dangerous Pradaxa complication that could arise due to the lack of a bleeding antidote for Pradaxa.

Doris claims her life has been permanently affected by the Pradaxa internal bleeding experienced. “Plaintiff has suffered severe personal injuries, physical pain, mental anguish, diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring, and/or medications, and a fear of developing any of the above named health consequences,”  Pradaxa lawsuit contends.

Doris, like many other Pradaxa lawsuit plaintiffs, is seeking damages from Boehringer for failure to warn, design defect, negligence, negligent misrepresentation, breach of warranty, and fraudulent concealment.

In May 2014, Boehringer agreed to a $650 million Pradaxa settlement to resolve about 4,000 lawsuits. Plaintiffs received an average payout of over $160,000 each.

Doris’ case joins the Pradaxa MDL known as: In Re; Pradaxa (Dabigatran Etexilate) Products Liability Litigation MDL No. 2385 filed in the U.S. District Court of the Southern District of Illinois.

MDLs are often used to simply the legal proceedings. They can prevent conflict verdicts and repeated evidence.

The Pradaxa Bleeding Lawsuit is Case No. 3:15-px-00230.