The lack of a Xarelto antidote leaves patients without a ready way to control dangerous bleeding injuries, according to a new Xarelto lawsuit.

Plaintiff John M. says he started taking Xarelto sometime around November 2013. Later that month, he suffered a contusion with edema in his left shoulder.

John now says that contusion was a direct result of his ingestion of Xarelto, an anticoagulant medication made and promoted by defendants Janssen Pharmaceuticals, Johnson & Johnson, Bayer Healthcare Pharmaceuticals, and their related companies.

He alleges these companies have not done enough to warn patients about the risk of excessive bleeding associated with Xarelto. Had he been properly advised of that risk himself, he claims, he would not have taken Xarelto.

Plaintiff: Patients at Greater Risk Without Xarelto Antidote

In his Xarelto lawsuit, John points out that there is no Xarelto antidote that can reverse the drug’s anticoagulant effect.

Xarelto differs in that regard from the older anticoagulant warfarin. Patients taking warfarin can use vitamin K to reduce the drug’s anticoagulant effect. The availability of an antidote means that unexpected bleeding injuries or emergency surgery are less of a problem for warfarin patients.

But patients like John do not have the benefit of a Xarelto antidote they can rely on. Unlike warfarin, Xarelto was released onto the market with no available reversal agent that can stem its anticoagulant effect.

Without a Xarelto antidote, patients who suffer unexpected bleeding or emergency surgery may simply have to wait for their bodies to finish metabolizing the Xarelto already in their bloodstream.

The lack of an antidote and the risk of bleeding itself are two points that John alleges the defendants failed to properly impress upon Xarelto patients and their doctors. John cites clinical studies that show patients taking Xarelto suffered gastrointestinal bleeding more frequently than those who took warfarin.

Other studies showed an increased risk of adverse events associated with Xarelto, such as complications requiring prolonged hospitalization or discontinuation of Xarelto.

John also takes issue with the once-daily dosing schedule, alleging that schedule puts patients at risk for excessive peaks and dips of medication levels. Clinical trials of Xarelto showed patients would be at less of a risk with twice-daily dosing, he says.

He also quotes an FDA reviewer who expressed concern that the companies devised a once-daily schedule more to gain a marketing advantage than to promote any therapeutic benefit.

In his Xarelto lawsuit, John raises claims based on theories of strict liability, manufacturing defect, design defect, failure to warn, negligence, breach of warranty, misrepresentation, fraud, and violation of state consumer protection laws.

John is also asserting a loss of consortium claim on behalf of his wife Marge. A harmed person’s spouse can claim loss of consortium to seek compensation for the effects of the injury on the couple’s marital relationship.

This Xarelto Lawsuit is Case No. 2:17-cv-00164 in the U.S. District Court for the Eastern District of Louisiana. The Xarelto Multidistrict Litigation is In re: Xarelto (Rivaroxaban) Products Liability Litigation, MDL No. 2592, also in the U.S. District Court for the Eastern District of Louisiana.