THL – TorHoerman Law

Pradaxa Blood-Thinning MedicineAdverse Side Effects Reported

Pradaxa Lawyers

Pradaxa is a prescription, blood-thinning medicine used to reduce the risk of stroke and blood clots in people with atrial fibrillation. Pradaxa bleeding events are alleged to have resulted in thousands of injuries, some resulting in fatal bleeding deaths. More than 4,000 lawsuits were filed as a result of the adverse side effects.

Litigation Updates

4,000 Cases Settled by TorHoerman Law

May 29, 2014 - THL announced the settlement of nearly 4,000 cases filed by individuals who claimed they were injured by Pradaxa usage.  The manufacturer, Boehringer Ingelheim, admits no wrongdoing.  Tor Hoerman was a co-lead attorney in the litigation that leads to this settlement of $650 million.

Cases Consolidated Into MDL

August 2012 – Nearly 4,000 Pradaxa cases are consolidated into a multidistrict litigation.

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What is Pradaxa?

Pradaxa (dabigatran) is a prescription medication used to prevent strokes in atrial fibrillation patients. The medication was designed to prevent strokes by thinning the blood enough to prevent a blood clot from forming in the heart and traveling to the brain. Manufactured by German company Boehringer Ingelheim, the drug was approved for use by the U.S. Food & Drug Administration (FDA) in October 2010. Although Pradaxa has only been on the market since 2010, its hype began long before.

Prior to approval, Boehringer Ingelheim ran “informational” commercials about atrial fibrillation. Following the media hype, Pradaxa gained momentum as the result of the RE-LY clinical trial sponsored by Boehringer Ingelheim Pharmaceuticals. The RE-LY trial concluded that vitamin K antagonists such as warfarin (or Coumadin – on the market for more than 50 years) are cumbersome to use because of their multiple interactions with food and drugs and because they require frequent laboratory monitoring.

Not surprisingly, the clinical trial sponsored by Boehringer Ingelheim suggested that there was a need for a new anticoagulant agent that could be a therapeutic simplification. That is where Pradaxa came in and was subsequently predicted to become one of the leading therapies in the atrial fibrillation drug market.

Unfortunately, as of November 14, 2014, 35,549 reports of a serious adverse event identified Pradaxa as the primary suspect drug causing the event.

According to voluntary reports to the FDA from health professionals and consumers, in 2011, Pradaxa surpassed all other monitored drugs in several categories, including the overall number of reports (3,781), deaths (542), hemorrhage (2,367), acute renal failure (291) and stroke (644).

In October 2015, the FDA approved an antibody, Praxbind (idarucizumab), which has been shown to reduce the anticoagulation effects of Pradaxa.

 

Pradaxa Side Effects

Did you suffer from the following side effects while taking Pradaxa?

  • Experienced a bleeding event that required blood transfusions;
  • Experienced a bleeding event that required hospitalization, serious injury, and/or death.

Please contact your doctor to consider whether Pradaxa may currently, or will, cause an issue.

 

Pradaxa Lawyers

If you have any questions regarding a Pradaxa lawsuit, please contact the Pradaxa lawyers at TorHoerman Law.

+ - References

Thomas, Katie. "Study of Drug for Blood Clots Caused a Stir, Records Show." The New York Times, The New York Times, 5 Feb. 2014, www.nytimes.com/2014/02/06/business/study-of-blood-clot-drug-pradaxa-unnerved-its-maker-documents-suggest.html.