Products Liability Law Reporter

Eugene Roberto, 65, suffered from atrial fibrillation, impaired renal function, and gastroesophageal reflux disease (GERD). After taking warfarin for six years, he grew tired of the required blood monitoring, so he switched to Pradaxa. Two years later, he suffered a gastrointestinal bleed while he was on vacation, necessitating 10 days in the hospital, including four days in the ICU. For the next six months, he remained tired, depressed, and nearly housebound while he recovered. Roberto, whose medical expenses totaled $42,000, now takes a different blood thinner but has a fear of suffering additional bleeding.

Roberto sued Boehringer Ingelheim Pharmaceuticals, Inc., the manufacturer of Pradaxa, alleging it failed to educate physicians on how to safely prescribe the drug, including proper dosing and testing requirements. The plaintiff asserted that his GERD and impaired kidney function placed him at higher risk of bleeding and, therefore, his blood levels should have been tested several times per year. Moreover, the plaintiff claimed, the defendant failed to include this known increased bleeding risk on Pradaxa’s label in the United States, despite providing such a warning in Europe.

The jury awarded more than $542,400, finding that the defendant had breached its duty to provide adequate warnings and instructions on the appropriate use of Pradaxa. The court also found that punitive damages were warranted.

Citation: Roberto v. Boehringer Ingelheim Pharm., Inc., No. CPL-HHD CV16-6068484S (Conn. Super. Ct. Hartford Jud. Dist. May 17, 2019).

Plaintiff counsel: AAJ member Neal Moskow, Fairfield, Conn.; and AAJ members C. Andrew Childers, Emily Acosta, and Yvette Ferrer, all of Atlanta.

Comment: In Knight v. Boehringer Ingelheim Pharm., Inc., 2019 WL 2144812 (S.D. W. Va. May 15, 2019), the family of a woman who became over-anticoagulated while taking Pradaxa sued Boehringer Ingelheim Pharmaceuticals and was awarded $1.25 million. See Knight v. Boehringer Ingelheim Pharms., Inc., PLLR News (Feb. 5, 2019). The defense moved for judgment as a matter of law on the plaintiff’s fraud and punitive damages claims, or for new trial. The court denied the motion, finding, in part, that the defendant had newly acquired information about Pradaxa and could have satisfied its state law duties without the federal government’s intervention by adding a warning via the federal “changes being effected” regulation, 21 C.F.R. §314.70(c)(6)(iii)(A). The court also concluded that there was sufficient evidence to support the jury’s finding that the defendant had acted with conscious, reckless, and outrageous indifference to the health, safety, and welfare of others by maintaining that all Pradaxa users do not require monitoring. Mr. Childers, Ms. Acosta, and Mr. Moskow represented the plaintiffs, along with AAJ members Hunter Linville and Russell Abney, both of Atlanta; AAJ member Harry Bell Jr., Charleston, W. Va.; and AAJ members Lisa Causey-Streete and Robert Salim, both of Natchitoches, La.