Federal Judge Clears Boehringer Over Pradaxa Death Lawsuit

Federal Judge Clears Boehringer Over Pradaxa Death Lawsuit

Introduction

Last week, Judge William Ray II of the U.S. District Court for the Northern District of Georgia issued an order concluding that Boehringer Ingelheim Pharmaceuticals Inc. has been awarded summary judgment over a Pradaxa wrongful death lawsuit that claimed the manufacturer failed to warn about the bleeding risks associated with the blood thinner.

The lawsuit, filed by Kimberly A. Lyons, on behalf of the estate of Cora Underwood, states that in 2016, Underwood, 75, was prescribed Pradaxa as per the recommended dosing instructions. Underwood was admitted to the hospital after suffering from Cardiac tamponade, which resulted in her death. Cardiac tamponade is a serious medical condition in which blood or fluids around the heart fills up, interfering with its functioning.

Lyons, in the suit, asserted that the cause of death was the high concentration of Pradaxa in the blood, which was the result of age and use of P-gb inhibitors. Boehringer was accused of failing to warn about the increased risk associated with age and other medications and for not recommending plasma monitoring to avoid such events. A paper published and sent to the Food and Drug Administration (FDA) in 2014 by Boehringer scientist Paul Reilly was also pointed to support the plaintiff's claims, but Judge Ray noted that the FDA was aware of the link between concentration levels and bleeding risks, which was mentioned in the paper.

Lyons also argued over the difference in European label for Pradaxa and pushed a design defect claim, both of which were rejected by the judge.

A spokesperson for Boehringer Ingelheim stated that plaintiffs' claims are preempted by six separate decisions from four different federal and state court judges based on the company's study on Pradaxa and data-sharing with the FDA, and the company considers that this decision should be applied on all other Pradaxa cases in its favor.