A Xarelto lawsuit filed on behalf of a Mississippi woman will head to trial next month, after the federal judge overseeing a massive litigation involving the blood thinner denied a defense bid for Summary Judgment on the plaintiffs’ failure-to-warn and design defect claims.
Xarelto is a novel anticoagulant that was first approved by the U.S. Food & Drug Administration (FDA) in October 2011. From its launch, the medication was touted as an improvement over warfarin, a decades-old blood thinner sold under the brand-name Coumadin. Among other things, Xarelto’s manufacturers promised that patients using their new drug would not be required to undergo regular blood tests to ensure proper dosage, a standard component of warfarin treatment.
More than 17,000 Xarelto bleeding claims have been consolidated in the U.S. District Court, Eastern District of Louisiana, before Judge Eldon Fallon. Plaintiffs involved in this litigation assert that promises of Xarelto’s superiority over warfarin were misleading, as internal bleeding associated with the older medication can be stopped via the administration of vitamin K. There is currently no approved antidote to reverse hemorrhaging that sometimes occurs with Xarelto. They also allege that Xarelto patients would actually benefit from a regular blood monitoring regimen.
According to her complaint, Dora Mingo began taking Xarelto in January 2015, after a deep vein thrombosis was discovered in her left leg. Mingo later developed a severe upper gastrointestinal bleed, which she alleges directly resulted from treatment with Xarelto. Mingo further claims that Xarelto was defectively designed, and accuses Bayer AG and Johnson & Johnson of failing to provide the public with adequate warnings of its risks.
In moving for Partial Summary Judgment, the defendants asserted that Mingo’s failure-to-warn and design defect claims were preempted by federal law. However, in an Order dated July 21st, Judge Fallon found that the question of preemption was not clear.
“The preemption of claims against name-brand drug manufacturers is not clear; neither Congress nor the Supreme Court has spoken directly on that issue. And until Congress or the Supreme Court does so, this Court is restrained to existing precedent,” Judge Fallon wrote. “The Levine Court held that a state failure-to-warn claim against a brand-name drug manufacturer was not pre-empted by federal law, finding that Congress had clearly intended for the judicial branch to work in concert with the FDA to protect against unnecessary risk.”
Next month’s trial will be convened in the in the U.S. District Court, Southern District of Mississippi. As a bellwether case, the outcome is expected to provide clues as to how juries might rule in similar Xarelto lawsuits.