The husband of a Texas woman who died in 2013 has filed a wrongful death lawsuit against Janssen Pharmaceuticals and Bayer, alleging the drug company failed to adequately warn of the potentially fatal risks associated with the use of its blood thinner, Xarelto.

According to the Xarelto lawsuit, Lois M. began taking Xarelto around April 2011 upon direction of her physician and allegedly, as a direct result of ingesting Xarelto, suffered an irreversible internal bleed which led to her death on June 3, 2013.

The Xarelto wrongful death lawsuit claims that both Bayer and Janssen Pharmaceuticals knew of Xarelto side effects and failed to disclose the truth about the safety and efficacy of Xarelto to the medical community and the public.

The Xarelto lawsuit further accuses the drug companies of manufacturing a defective product, that Xarelto is dangerous, subjecting users to risks of blood clots and irreversible Xarelto bleeding, and that the drug makers failed to properly warn about the lack of a Xarelto bleeding antidote to reverse uncontrolled bleeding caused by the blood thinner.

Xarelto Bleeding Risks

Approved in 2011, Xarelto is one of three new generation blood thinners and is co-manufactured and marketed by Janssen Pharmaceutical and Bayer. Xarelto is commonly prescribed to prevent blood clots in patients suffering from atrial fibrillation, deep vein thrombosis (blood clots deep within the body), pulmonary bleeding, stroke, and for patients who have recently undergone a knee or hip replacement surgery.

It generally is prescribed as an alternative to warfarin, a blood thinner that was introduced in the 1950s. The most serious potential Xarelto side effect is severe internal bleeding that can result in death. Even more concerning is there is currently no available antidote to reverse the type of internal bleeding caused by Xarelto like there is with warfarin.

Other potential Xarelto injuries include thrombosis (blood clots); decreased hemoglobin (a substance that carries oxygen in red blood cells); cerebrovascular accidents (an event that leads to a cerebral hemorrhage); hematoma (a semisolid mass in the blood); peripheral edema (swelling of the lower limbs); and dyspnea (difficulty breathing).

Xarelto still does not have a “black box” warning informing patients or doctors that Xarelto can cause irreversible bleeds. In fact, a label change as recent as March 2014 still fails to contain this type of warning.

Xarelto Bleeding Lawsuits

The Xarelto bleeding lawsuit is seeking equitable relief, monetary restitution, and compensatory and punitive damages for Janssen Pharmaceutical’s and Bayer’s alleged deceptive marketing practices, putting profits before consumer safety, and directly causing the death of Lois M. by their willfully negligent actions.

The Xarelto Bleeding Lawsuit is Case No: 2:15-cv-01876-EEF-MBN and is incorporated into the larger Xarelto MDL Case No. 2592 in the U.S. District Court for Eastern District of Louisiana.