Boehringer Ingelheim Pharmaceuticals is facing a new product liability claim, alleging serious adverse side effects of Pradaxa. The suit comes from a Mississippi man who claims he received inadequate warnings about potential adverse side effects of Pradaxa.

The man alleges the pharmaceutical company either knew or should have known about the possible adverse side effects of Pradaxa, and is having his claim join a growing multidistrict litigation (MDL). Plaintiff Dale Z. is filing this Pradaxa bleeding lawsuit alleging serious internal bleeding complications were directly caused by the anticoagulant.

Dale was prescribed Pradaxa on April 11, 2016, to prevent the onset of blood clot attacks. He started the medication on May 6, 2016.

Dale says he followed all prescription instructions and did not deviate from medical instructions. Even with this diligence and doing nothing to increase the likelihood of complications, Dale still allegedly experienced adverse side effects of Pradaxa.

Not even a month later, on June 3, 2016, Dale reportedly suffered serious gastrointestinal bleeding and had to be hospitalized for seven days. Dale survived his ordeal, but he filed legal action soon after discovering that other patients had suffered adverse side effects of Pradaxa.

At all times relevant, Dale and his physicians had agreed Pradaxa was a good choice for him based on the company’s marketing materials. Boehringer Ingelheim allegedly failed to disclose all the potential adverse side effects of Pradaxa that patients could experience.

Overview of Pradaxa Bleeding Complications

Pradaxa is a popular anticoagulant that was released into the market in 2010. It was the first blood thinner medication to be released since warfarin in the 1950s. Since the release of Pradaxa, two other new generation anticoagulants have entered the market: Xarelto and Eliquis in 2011 and 2012, respectively.

Each of these medications work by inhibiting the body’s clotting mechanism to reduce the risk of dangeroud blood clots. However, this treatment mechanism also prevents the body from recovering from internal bleeding injuries, causing the need for emergency intervention.

With the release of Praxbind in 2015, Pradaxa became one of the only other available anticoagulants besides warfarin with a reversal agent. For years, warfarin was the only anticoagulant with a mechanism (Vitamin K) that could be implemented to stop internal bleeding.

However, even with this bleeding antidote, patients may still be at risk for adverse side effects of Pradaxa. The FDA started an investigation on Dec. 7, 2011, after receiving reports of gastrointestinal bleeding; injury reports are still being submitted.

The agency stated it was trying to determine if Pradaxa had an increased risk of internal bleeding, and were questioning the results of the RE-LY trial. Boehringer Ingelheim allegedly knew the adverse side effects of Pradaxa for years, but failed to notify they public of these problems.

Dale has opted to file his Pradaxa bleeding lawsuit filed in MDL No. 2385, where it will stand alongside other Pradaxa claims alleging similar injuries. Dale states that he never would have agreed to take Pradaxa, if he had known about the potential internal bleeding complications.

This Pradaxa Bleeding Lawsuit is Case No. 3:17-cv-00846-DRH-SCW, in the U.S. District Court for the Southern District of Illinois.