The surviving spouse of a Texas man is suing pharmaceutical company Boehringer Ingelheim, claiming its drug Pradaxa caused her late husband severe injury and ultimately death.

Plaintiff Jean F.’s husband Roy was one of thousands of patients who have been prescribed Pradaxa. Unfortunately, after taking Pradaxa, Roy developed complications and died. Jean is now bringing this lawsuit as the representative of Roy’s estate. She claims that Pradaxa’s increased risk of excessive, irreversible bleeding make it a defective product. She alleges Boehringer Ingelheim intentionally withheld information about Pradaxa’s dangerous side effects, failing to adequately warn physicians and patients about potential complications. Jean claims Roy’s increased illness and death resulted directly from Pradaxa’s defects and Boehringer Ingelheim’s failure to warn.

The pleadings do not specify what Roy’s illness was, why he was prescribed Pradaxa, or what his complications were. Generally, Pradaxa is prescribed to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. Many similar lawsuits have been filed based on Pradaxa’s increased risk of life-threatening bleeding and other dangerous side effects.

Jean’s claims include failure to warn, design defect, negligence, misrepresentation, breach of warranty, violation of federal branding requirements, and fraudulent concealment. She seeks payment for medical expenses and other economic harm, pain and suffering, punitive damages, and costs of litigation.

The Pradaxa Bleeding MDL is titled In re: Pradaxa (Dabigatran Etexilate) Products Liability Litigation, MDL No. 2385, in the U.S. District Court for the Southern District of Illinois.

Pradaxa’s history

Pradaxa (also marketed under its generic name dabigatran and outside the United States as Pradax and Prazaza) was a breakthrough drug when it hit the market following FDA approval in October 2010. It was the first drug in over 50 years approved for anticoagulation in patients with non-valvular atrial fibrillation, a market dominated for years by warfarin (also known by its trade name Coumadin). Unlike with warfarin, patients taking Pradaxa need not submit to dietary restrictions, periodic blood testing, and dose adjustments. These improvements over warfarin initially made Pradaxa extremely successful: in its first year on the market, Pradaxa sales worldwide exceeded $1 billion.

Unfortunately, Pradaxa shares a common side effect with other anticoagulants in that it increases the risk of excessive bleeding. And unlike with warfarin, there is no reversal agent that can neutralize the anticoagulation effects of Pradaxa. Once a patient on Pradaxa starts bleeding, he or she may not be able to stop.

Soon after Pradaxa entered the market, the FDA began receiving thousands of reports of deaths and severe, life-threatening bleeding potentially associated with Pradaxa. Reported conditions include gastrointestinal hemorrhages, rectal hemorrhages, and cerebrovascular accidents. The FDA and regulatory authorities in other countries have responded with new warnings regarding Pradaxa and additional labeling requirements. This new awareness of Pradaxa’s dangerous side effects has led to the current wave of Pradaxa lawsuits against Boehringer Ingelheim.