Once again, a jury has sided with corporate defendants Bayer and Johnson & Johnson’s Janssen division in a lawsuit alleging injuries due to the use of their blood-thinning medication Xarelto. This most recent verdict comes in the wake of two trials in which the jury found for the defendants.
The most recent case, tried in a federal court in Mississippi, was one of forty Xarelto lawsuits selected to serve as “bellwether” trials, which are intended to assist both parties in the analysis of similar claims and planning legal strategies going forward. Janssen Pharmaceuticals has stated that it will continue to defend against all Xarelto claims, while a Bayer spokesperson said the company “stands behind the safety and efficacy of Xarelto and will continue to vigorously defend it.”
The first bellwether trial, held earlier this year before a federal judge in Louisiana, ended in a verdict for the defense because the jury determined that the plaintiff had failed to prove his case – specifically, his allegation that the manufacturers failed to educate prescribing doctors as to the importance of doing blood-clotting tests on patients prior to administering the drug. The second bellwether case was brought by a widower whose wife died from a stroke after taking Xarelto, who also alleged that package warnings were inadequate. In both cases, the jury disagreed, finding that the warnings were sufficient.
In the latest trial, 69-year-old plaintiff Dora Mingo alleged that she had suffered from acute gastrointestinal hemorrhaging as a result of taking Xarelto for four weeks following hip replacement surgery after she developed deep vein thrombosis. She asserted two causes of action under the Mississippi Product Liability Act, which require the plaintiff to prove that (A) the product was defective in design, and (B) the manufacturer failed to provide adequate warnings or instructions.
On the first point, Mingo’s counsel argued that Xarelto was defective in design because the product was brought on to the market without the existence of an antidote (currently in development by a San Francisco biotech firm, but not yet FDA-approved). On the second point, lawyers for the plaintiff alleged that Xarelto posed an “unreasonable danger” to patients because the manufacturers failed to direct physicians to perform a laboratory assessment of the patient’s blood in order to determine the risk of hemorrhaging prior to prescribing Xarelto.
Known as a “prothrombin time test,” this lab assay measures how long it requires a patient’s blood to clot, determining how well a medication is working. According to the plaintiffs, Bayer and Janssen did not adequately emphasize the importance of this routine lab test. After four hours of deliberation, the jury ruled that Ms. Mingo had failed to establish her claims of failure to warn.
While these three verdicts favoring Bayer and Johnson & Johnson may appear to be bad news for approximately 18,600 Xarelto plaintiffs awaiting their day in court, it should be kept in mind that there are 37 such bellwether cases remaining to be heard. The merit of Xarelto plaintiffs’ cases cannot be accurately determined until at least fifteen to twenty verdicts have been rendered. And there is still plenty of evidence to support those plaintiffs’ claims.