A Connecticut woman alleges her father’s death could have been avoided had he been given a proper warning about Xarelto life-threatening bleeding.

Plaintiff Laura B. is bringing this claim on behalf of herself and that of the estate of her late father, Wilfred B.

She is bringing a wrongful death claim seeking compensation for her own losses related to Wilfred’s death.

Laura says Wilfred took was prescribed the blood thinning medication Xarelto in February 2014 and took it until December of that year.

That month, Wilfred allegedly suffered a lower gastrointestinal bleed that eventually led to his death, she says.

Laura now asserts her father’s gastrointestinal bleed and subsequent death was caused by the Xarelto he took. She argues the drug’s manufacturers failed to publish proper warnings and safety information about the risk of Xarelto life-threatening bleeding.

In her Xarelto lawsuit, Laura names as defendants Janssen Pharmaceuticals Inc., its parent company Johnson & Johnson, Bayer Healthcare Pharmaceuticals, and other related business entities. All these companies have been involved in the design, manufacture, marketing or distribution of Xarelto, she claims.

Studies Evaluated Risk of Xarelto Life-Threatening Bleeding

Xarelto is an anticoagulant medication approved by the FDA relatively recently in 2011. It was initially approved to help prevent deep venous thrombosis and pulmonary embolism in patients who had recently undergone hip or knee replacement surgery.

Today, it’s often prescribed to patients with non-valvular atrial fibrillation, who are at an increased risk of having a stroke. The anticoagulant effect of Xarelto prevents blood clots from forming that can travel to the brain and cause a stroke.

But as with all anticoagulants, Xarelto creates a risk of excessive bleeding. Laura cites clinical studies that found Xarelto users suffered gastrointestinal bleeding more frequently than those who used the older anticoagulant medication warfarin.

In the ROCKET AF study, she says, researchers found that Xarelto users suffered more frequent bleeding from gastrointestinal sites, bleeding that led to a drop in hemoglobin, and bleeding that required transfusion.

Laura says that the risk of Xarelto life-threatening bleeding is made more of a problem by the drug’s lack of an antidote.

Unlike warfarin, which can be counteracted using vitamin K, Xarelto has no other drug that can reduce its anticoagulant effect. (A proposed antidote was rejected by the FDA earlier this year. The agency said it would ask the antidote’s manufacturer to provide more information.)

She points out that when Xarelto was originally approved, its U.S. label did not bear a warning about the lack of an antidote but instead only mentioned it in the section on overdosage.

Laura’s Xarelto lawsuit is one of over 7,200 similar actions that have been combined into a single multidistrict litigation, or MDL, in a federal court in Louisiana. These claims have been combined in the interest of conducting pretrial procedures more efficiently.

The Xarelto Lawsuit is Case No. 2:16-cv-16076, in the in the U.S. District Court for the Eastern District of Louisiana. It’s part of the Xarelto Multidistrict Litigation, In re: Xarelto (Rivaroxaban) Products Liability Litigation, MDL No. 2592, also in the U.S. District Court for the Eastern District of Louisiana.