By Georgia D. Koutouzos, J.D.
A federal jury in West Virginia concluded that the Germany-based pharmaceutical company Boehringer Ingelheim’s fraudulent conduct with respect to its prescription blood-thinner Pradaxa® led to the death of a U.S. consumer, awarding the decedent’s representatives $250,000 in compensatory damages and $1 million in punitive damages (In re Pradaxa (Dabigatran Etexilate) Products Liability Litigation—Knight v. Boehringer Ingelheim Pharmaceuticals, Inc.), October 18, 2018.).
Claims. A West Virginia woman suffered gastrointestinal bleeding and acute post-hemorrhagic anemia, and ultimately died from those conditions, after having taken the prescription anticoagulant dabigatran etexilate, manufactured by Boehringer Ingelheim Pharmaceuticals (BI) and marketed under the brand name Pradaxa®. As the first new treatment alternative to warfarin in more than 50 years for patients with nonvalvular atrial fibrillation, Pradaxa was launched by the drug maker in North America in 2010.
The company’s testing and marketing materials asserted that Pradaxa had fewer drug interactions than warfarin and that the frequent laboratory tests needed to manage warfarin blood levels were not recommended for patients taking the new medication. Unlike warfarin—which must be adjusted for individual patient blood levels on an ongoing basis—Pradaxa was approved by the U.S. Food and Drug Administration in a "one size fits all" dose of 150 mg twice a day.
After the patient’s death, her representatives filed suit against BI, contending that the company had widely disseminated direct-to-consumer advertising campaigns designed to influence patients (including the decedent) to make inquiries to their prescribing physicians about Pradaxa and/or to request prescriptions for the medication. In the direct to consumer advertisements, BI allegedly overstated the efficacy of Pradaxa with respect to preventing stroke/systemic embolism and failed to adequately disclose to patients that there is no drug, agent, or means to reverse Pradaxa’s anticoagulation effects and that such irreversibility could have permanently disabling, life-threatening, and/or fatal consequences. Furthermore, the representatives contended that the drug maker concealed its knowledge that Pradaxa can cause life threatening, irreversible bleeds from the decedent, other consumers, the general public, and the medical community, and failed to warn of the medication’s irreversible nature in the "Warnings and Precautions" section of the product’s initial warning label.
The complaint in the lawsuit included causes of action for strict liability, negligence, negligent misrepresentation/fraud, fraudulent concealment, negligence per se, breach of express and implied warranties, and wrongful death/survivorship. Demanding a jury trial, the representatives sought compensatory and punitive damages, plus wrongful-death damages, pre- and post-judgment interest, attorney fees, and costs.
Jury verdicts. The case was tried to a jury and, in its first-phase verdict, the jury found BI liable for fraud, but not strict liability failure to warn, negligent failure to warn, or breach of warranties. In addition, the jury determined that the decedent’s representatives proved that she would not have taken Pradaxa absent the drug maker’s fraudulent conduct. The jury also concluded that Pradaxa proximately caused the decedent’s injuries but failed to conclude that the medication caused her death, awarding her representatives $50,000 in economic damages and $200,000 in non-economic damages.
Finally, the jury concluded that the decedent’s representatives proved by clear and convincing evidence that BI acted with actual malice toward the decedent or that the company had acted with conscious, reckless, and outrageous indifference toward the health, safety, and welfare of others. Consequently, in the second-phase verdict, the jury awarded the $1 million in punitive damages to the plaintiffs.
The case is No. 3:15-cv-06424.
Attorneys: C. Andrew Childers (Childers Schlueter & Smith, LLC) for Claude R. Knight. Ben J. Scott (Butler Snow LLP) and Gretchen M. Callas (Jackson Kelly) for Boehringer Ingelheim Pharmaceuticals, Inc.
Companies: Boehringer Ingelheim Pharmaceuticals, Inc.
MainStory: TopStory JuryVerdictsNewsStory DamagesNews WarningsNews CausationNews DrugsNews WestVirginiaNews
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