Pradaxa Gastrointestinal Bleed Lawsuit Filed in Texas

A Texas man has filed a Pradaxa gastrointestinal bleed lawsuit against the manufacturer of the drug, Boehringer Ingelheim Pharmaceuticals, Inc. Arthur G. Hill claims the drug caused him to experience a severe gastrointestinal bleed in 2013, which he continues to suffer from to this day.

Pradaxa is a blood-thinning medication prescribed to decrease the risk of stroke and blood clots in patients with non-valvular atrial fibrillation. It is considered an anticoagulant, a substance that prevents blood clots. Pradaxa is the first new treatment alternative to warfarin (Coumadin), in almost 60 years.

Pradaxa gastrointestinal bleed lawsuit allegations

Hill was prescribed Pradaxa on April 1, 2013, for the ongoing treatment of his medically necessary blood thinning needs. Less than a month later, on April 29, 2013, he suffered a severe gastrointestinal bleeding incident that caused him to be hospitalized for nine days.

According to the claim, the “plaintiff experienced excessive and/or uncontrollable bleeding, which was caused and/or worsened by Plaintiff’s use of Pradaxa.”

The plaintiff is accusing the defendants of failing to provide adequate warnings on the bleeding risks associated with the drug.

“Prior to plaintiff’s use of Pradaxa, defendants knew or should have known of the defective nature of Pradaxa and persons who were prescribed and ingested Pradaxa for even a brief period of time, including the plaintiff, were at an increased risk for developing life-threatening bleeds,” states the claim. “Defendants, through their affirmative misrepresentations and omissions concealed from plaintiff and plaintiff’s physicians the true and significant risks associated with Pradaxa use.”

Causes of action in the complaint

The plaintiff is suing the defendant on ten counts, including:

• Count I: Strict Liability ─ Failure to Warn
• Count II: Strict Products Liability ─ Design Defect
• Count III: Negligence
• Count IV: Negligent Misrepresentation and/or Fraud
• Count V: Breach of Express Warranty
• Count VI: Breach of Implied Warranty ─ Merchantability
• Count VII: Breach of Implied Warranty ─ Fitness for a Particular Purpose
• Count VIII: Fraudulent Concealment
• Count IX: Deceptive Trade Practices
• Count X: Punitive Damages

FDA issues statement on Pradaxa

Pradaxa received FDA approval in October 2010. During the time period of October 2010 through the end of March 2011, approximately 272,119 prescriptions were written for the drug in the United States. During this time period, 932 “serious adverse event” Medwatch reports were filed with the FDA. This included at least 120 deaths and more than 500 reports of severe, life-threatening bleeding.

After evaluating new information on the risk of serious bleeding events associated with Pradaxa and warfarin, the FDA issued the following statement on November 2, 2012:

“The results of this assessment indicate that bleeding rates associated with new use of Pradaxa do not appear to be higher than bleeding rates associated with new use of warfarin, which is consistent with observations from the large clinical trial used to approve Pradaxa,” the statement read. “[The] FDA is continuing to evaluate multiple sources of data in the ongoing safety review of this issue.”

Pradaxa MDL established in Illinois

Approximately 2,000 Pradaxa injury lawsuits are currently pending against Boehringer Ingelheim under multidistrict litigation in the Southern District of Illinois. MDL 2385 was established in August 2012, under the direction of U.S. District Judge David R. Herndon.

All lawsuits involve similar allegations of the drug causing patients to suffer severe and sometimes even fatal bleeding incidents. Plaintiffs claim they did not receive sufficient warning of the potentially fatal bleeding events and doctors were not provided with an adequate reversal agent to stop the blood thinning effects of the drug.

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