Philadelphia, PAA jury has found against units of Johnson & Johnson (J&J) and Bayer AG in the fourth bellwether Xarelto (Rivaroxaban) case being heard as part of a Xarelto mass tort. The award, nearly $28 million, is the first favoring a plaintiff, in this case Lynn Hartman, who alleged she suffered a serious gastrointestinal bleed while using the blood thinning medication. The jury found that the pharmaceutical companies failed to provide adequate warnings regarding the risks for bleeding associated with Xarelto.
Hartman’s case is one of more than 1,500 pending lawsuits, constituting a mass tort program in the Philadelphia County Court of Common Pleas to consolidate Xarelto-related product liability claims. Those claims essentially state that Janssen Pharmaceuticals Inc. and Bayer Healthcare Pharmaceuticals Inc, failed to provide information about the significantly higher rate of bleeding among US patients compared with those elsewhere in the world, reported in a clinical trial.
Evidence provided during the trial indicated that the annual rate of bleeding in US patients was 8.1 percent compared with 3.6 percent among study participants globally.
Further, Hartman claimed that the defendants did not provide adequate warning concerning the increased risk for bleeding in patients using aspirin as well as Xarelto, and that the companies failed to tell doctors that some patients end up with significantly higher levels of the medication in their blood than others.
Hartman’s attorneys also argued that the risk of adverse events associated with Xarelto was significantly higher than that of two other popular blood thinners Eliquis (apixaban) and Pradaxa (dabigatran).
Testimony from former Food & Drug Administration chief David Kessler, added gravitas to Hartmann’s allegations, when he told jurors that he believed the warning label for Xarelto lacked key information about the severity of the potential risk for bleeding associated with its use.
Xarelto (known generically as Rivaroxaban) is a new-generation anticoagulant, in a class of drugs known as direct thrombin inhibitors. It is a blood thinner used to reduce the risk of blood clots and strokes. Xarelto has also been marketed as being easier to use than warfarin (known by the brand name Coumadin), an older anticoagulant, because it does not require medical monitoring.
The case is Hartman v. Janssen Pharmaceuticals Inc. et al., case number 160503416, in the Court of Common Pleas of Philadelphia County, Pennsylvania.