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Connecticut Widow Files Pradaxa Wrongful Death Lawsuit

Carrie Thompson, a resident of Granby, Connecticut, is suing McKesson Corporation and Boehringer Ingelheim Pharmaceuticals for the wrongful death of her husband. She claims that the defendants failed to adequately warn consumers and the prescribing health care community about the risks of Pradaxa internal bleeding, despite substantial knowledge of the drug’s dangers. The plaintiff filed suit on July 2, 2013 in California Superior Court (San Francisco).

Thompson’s spouse, the decendent, was prescribed the blood thinning medication for his non-valvular atrial fibrillation and shortly thereafter suffered an intracranial hemorrhage, which despite several life saving measures, led to his untimely death. According to allegations in her Pradaxa lawsuit, the decedent experienced uncontrollable bleeding that was caused and/or exacerbated by the anticoagulant.

Court documents state that as a direct and proximate result of using Pradaxa, John Thompson sustained “grievous bodily injuries, including severe physical and mental pain and suffering, medical expenses and loss of life,” all resulting from his use of the medication.

Irreversible Pradaxa internal bleeding linked to 500 deaths

Warfarin (Coumadin) was the blood thinning medication of choice for physicians up until 2010, when Boehringer Ingelheim launched its blockbuster Pradaxa (dabigatran). Unlike its predecessor, Pradaxa didn’t require a strict dietary regimen or regular blood tests, making it much more convenient for thousands of patients. After the drug entered the stream of commerce in October 2010, Pradaxa sales skyrocketed, thanks to an aggressive marketing campaign that purportedly overstated the safety and efficacy of the drug while omitting the fact that Pradaxa had no known antidote to stop major bleeding events.

In its first year on U.S. markets, nearly 300,000 prescriptions were written for Pradaxa and robust sales netted Boehringer more than $1 billion in 2011 alone.

However, by December 31, 2011, the U.S. Food and Drug Administration had been inundated with hundreds of reports detailing Pradaxa internal bleeding events, 500 of which had proven fatal. In the span of just 14 months on the market, the blood thinner had been linked to 900 incidents of gastrointestinal hemorrhages and 200 cerebrovascular events, with many health care providers fearing an increase in Pradaxa–related deaths.

Though black box warnings on bleeding risks were placed on Pradaxa labels in some foreign countries, this hasn’t taken place in the States. On its part, the FDA says that regulators will continue evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa.

Echoing claims made by more than 700 other plaintiffs, Carrie Thompson says that the defendants produced a defective and unreasonably dangerous drug in that the labeling was insufficient to warn doctors and the public of serious and potentially fatal bleeding events. She further alleges that unlike Warfarin-induced bleeding, which can be staunched with Vitamin K, Pradaxa internal bleeding has no effective antidote, putting patients at unnecessary risk.

Boehringer Ingelheim charged with intentional misrepresentation

The plaintiff’s suit levels several causes of action against the defendants, including:

  • Strict Products Liability – Failure to Warn
  • Negligence
  • Breach of Express Warranty
  • Fraud and Intentional Misrepresentation
  • Negligent Misrepresentation

Thompson is also demanding punitive damages for the acts and omissions of the defendants which she claims were malicious and done with a conscious disregard for the health and safety of the public, including her now deceased husband.  Her Pradaxa lawsuit is one of the latest faced by Boehringer Ingelheim, which is also named as defendant in the ongoing Pradaxa products liability multidistrict litigation (MDL) in U.S. District Court for the Southern District of Illinois.