2014 saw nearly two dozen lawsuits filed against Janssen Pharmaceuticals and Bayer Corp. over the blood thinner Xarelto. These cases were recently consolidated before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana, as it was found that the cases have enough common complaints to warrant centralization. The Honorable Judge Fallon presided over the 2007 Merck & Co. Vioxx lawsuits, which resulted in a $4.85 billion settlement for the plaintiffs.
Xarelto (rivaroxaban) is an anticoagulant, which is a type of pharmaceutical that works as a blood thinner. The drug is taken orally and was developed by Bayer and Johnson & Johnson’s New Jersey-based unit, Janssen Pharmaceuticals. Blood thinners are used to prevent dangerous blood clots that can obstruct blood flow to vital organs. Unlike older anticoagulants that require doctors to prescribe specific doses for each individual, Xarelto belongs to a new type of oral anticoagulant that is prescribed in one uniform dose. The Food and Drug Administration (FDA) approved Xarelto for use in patients who have had knee or hip replacement surgery to reduce the risk of blood clots, reducing the risk of stroke in people with Atrial Fibrillation. Following a fast-track regulatory review, the FDA approved the drug for the general treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).
Xarelto carries a black box warning for an increased risk of blood clots. Black box warnings are the most serious type of warning issued by the Food and Drug Administration (FDA) and are reserved for drugs that carry a significant risk of serious or life-threatening adverse effects. One of the most severe side effects of Xarelto is uncontrolled bleeding. Because Xarelto prevents clotting, the hemorrhaging will continue until the drug is flushed out of the system. Doctors recommend that patients with liver or kidney problems, as well as those who are pregnant, breastfeeding or planning to breastfeed, should not take Xarelto. In addition, people who are on Xarelto and have spinal injections, epidurals or surgery have an increased risk of forming a blood clot in the spine that can cause paralysis. The risk of spinal clotting is increased for people who take NSAIDS like aspirin and ibuprofen (Advil) or people who have a history of spinal problems and surgery. Xarelto also has an extensive list of drug interactions that can cause serious problems, including increased bleeding risk. Xarelto has been linked to serious side effects including gastrointestinal bleeding, brain bleeding, other internal bleeds, and death.
Many authorities claim that New Oral AntiCoagulants (“NOACs”), such as Xarelto, require additional measures to be safe for the patients because these drugs are blood thinners. The plaintiffs in the Xarelto lawsuits allege that patients given NOACs should be monitored in order to avoid bleeding episodes. The manufacturers do not believe this is necessary for Xarelto users. Unlike many other anticoagulants on the market, Xarelto’s bleeding episodes are not reversible and can be fatal.
If you’ve been affected by Xarelto or other anti-coagulants, contact the experienced class action attorneys at Smiley Injury Law today.