The widely used blood thinner, Xarelto, has been the target of lawsuits that allege the drug has harmful, even fatal, side effects, and its maker failed to warn patients and their physicians. Plaintiffs claim Xarelto brings increased risks of irreversible and uncontrolled internal bleeding because the drug is manufactured without an agent that assists in clotting in the case of a bleeding emergency. For example, the traditional blood thinner, warfarin, is produced with the antidote vitamin K, which treats internal bleeding in case of an uncontrolled episode. The inconvenience with warfarin is that it requires regular blood monitoring. However, some of the lawsuits claim that if Xarelto’s makers had properly warned of the drug’s risks, patients would have opted for the safer warfarin, and doctors would have prescribed it over Xarelto.
Xarelto, generic name rivaroxaban, was approved for use in 2011. It is manufactured by Bayer and sold by the Johnson & Johnson subsidiary, Janssen Pharmaceutical. Xarelto was initially seen as a more expedient alternative to warfarin, which has been in use as a blood thinner for over fifty years. Xarelto is used to prevent blood clots in patients afflicted with atrial fibrillation, deep vein thrombosis, pulmonary embolism, patients who have recently undergone hip replacement or knee replacement surgery, and people prone to stroke.
Plaintiffs in the suits filed against Xarelto claim severe internal and external bleeding episodes required hospitalization as a direct result of taking the drug. The patients were uninformed of Xarelto’s potential dangers. Signs of uncontrolled internal bleeding include swelling, bruising, vision changes, weakness, confusion, severe headaches, and dizziness. Plaintiffs allege that Xarelto puts them at risk for serious and potential fatal injuries such as cerebral hemorrhaging and gastrointestinal bleeding.
In addition, lawsuits claim Xarelto was advertised as an optimal anticoagulant in relation to its competitors, in spite of evidence of higher rates of internal bleeding and higher rates of transfusions required for its users. Xarelto continued to be marketed as safe. Suits allege that not only patients were misled. Doctors were never informed of or made aware of ways to stabilize and heal a Xarelto user in case of an uncontrolled bleeding episode. Essentially, Xarelto users were not informed of the very serious risks to which the drug has been tied, including any and all external and internal bleeding complications and excessive blood loss. Users of the drug were never adequately warned of the perils of suffering a fatal bleeding episode.
Plaintiffs are seeking compensation from Xarelto’s manufacturers and marketers, whose product they allege is dangerous and defective. Reasons for compensation include emotional distress for patients and caregivers, financial loss as a result of ongoing care, emergency visits, lost wages, and funeral expenses. Xarelto users also are looking to seek punitive damages, which would be awarded in order to hold Bayer and Janssen Pharmaceutical accountable for knowingly producing and selling a flawed and potentially fatal product. Punitive damages also can act as a deterrent from other companies acting in a similar egregious manner.