PENNSYLVANIA RECORD

The daughters of a woman who died allegedly as a result of Pradaxa use

have filed a products liability complaint against the makers of the pharmaceutical.

Janine V. McHugh and Jennifer D. Merlino filed suit last week at the U.S. District Court in Philadelphia over the death of their mother, Dolores Reed, who is said to have developed a gastrointestinal hemorrhage in the spring of 2012, four months after her doctor prescribed Pradaxa for the treatment of non-valvular atrial fibrillation.

After suffering the hemorrhage, Reed, of Haverford, Pa., was taken to the Hospital of the University of Pennsylvania where she subsequently passed away.

“Plaintiff experienced excessive and/or uncontrollable bleeding, resulting in death, which was caused and/or worsened by Plaintiff’s use of Pradaxa,” reads the lawsuit, which was filed by attorney Michael M. Weinkowitz, of the Philadelphia law firm of Levin, Fishbein, Sedran & Berman.

The defendants named in the complaint, which are Boehringer Ingelheim Pharmaceuticals and various subsidiaries, are accused of over-promoting Pradaxa, which is a direct thrombin inhibitor that is designed to reduce the risk of stroke and embolism in patients with non-valvular atrial fibrillation, a type of heart rhythm disorder.

People with this type of ailment are known to have an increased risk of stroke, the suit states.

The complaint says that prior to Reed’s use of Pradaxa, the defendant drug companies knew or should have known that the original labeling of the drug did not adequately warn the plaintiff of the risks associated with using the medication.

The lawsuit argues that the defendants knew or should have known that patients, including Reed, were at an increased risk for developing life-threatening “bleeds” as a result of taking the medication.

Reed would never have taken the drug if she had been provided with adequate warnings that there is no agent to reverse the anticoagulation effects of Pradaxa, the complaint states.

Pradaxa was the first anticoagulation medication approved for use in the United States in more than 50 years for patients with non-valvular atrial fibrillation when the Food and Drug Administration approved the medication back in the fall of 2010, according to the complaint.

Prior to the FDA’s approval of Pradaxa, warfarin was the only such medication available in the country for reducing stroke and systemic embolism in patients with atrial fibrillation.

The defendants’ marketing campaign for Pradaxa included promoting it as being more effective than warfarin in preventing stroke and systemic embolism, providing an alternative to warfarin therapy because it does not require blood monitoring or dose adjustments, and requires no dietary restrictions, the suit says.

The lawsuit says that the drug companies spent significant money in promoting Pradaxa, including the $67 million spent in 2010; the drug, however, hadn’t been given FDA approval until Oct. 19 of that year.

“In the course of these direct to consumer advertisements, Defendants overstated the efficacy of Pradaxa with respect to preventing stroke and systemic embolism, failed to adequately disclose to patients that there is no drug, agent or means to reverse the anticoagulation effects of Pradaxa, and that such irreversibility could have permanently disabling, life-threatening and fatal consequences,” the complaint states.

As a direct result of using Pradaxa, Reed suffered physical pain, mental anguish, the need for lifelong medical treatment and eventual death.

The lawsuit contains counts of strict products liability, negligence, negligent misrepresentation and/or fraud, breach of implied and express warranties, negligence per se, and fraudulent concealment.

Reed’s daughters seek $75,000 in compensatory damages, unspecified punitive damages, interest, non-economic damages, attorney’s fees and costs.

 

The federal case number is 2:13-cv-06488-GP.