A lawsuit alleges that the blood thinner Xarelto causes severe, undisclosed side effects including internal bleeding, blood clots, and stroke.

In the Xarelto bleeding lawsuit, plaintiff David S. claims that he suffered an internal bleed in February 2016 as a direct result of taking the blood thinner Xarelto. The Xarelto internal bleeding lawsuit accuses the companies that developed and marketed the drug, Janssen Research & Development and parent company Johnson & Johnson, knew the drug could cause severe side effects that they did not disclose to consumers.

Xarelto was marketed and distributed as an anticoagulant, or blood thinner. According to the Xarelto lawsuit, the primary purpose of the drug was to “reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, to treat [and reduce the risk of] Deep Vein Thrombosis and Pulmonary Embolism, and for prophylaxis of DVT for patients undergoing hip and knee surgery.”

However, the lawsuit alleges that the drug actually can cause stroke and blood clots, as well as internal bleeding.

Xarelto History

Xarelto was introduced in the United States on July 1, 2011. It was categorized as part of a class of drugs labeled “New Oral Anticoagulants,” along with drugs such as Pradaxa and Eliquis, and was supposed to replace longstanding preceding anticoagulants such as warfarin.

Preceding its release in the U.S., Xarelto was subjected to extensive testing for safety in a series of clinical trials. The goal of the trials was to determine if Xarelto was safe and effective in regulating blood coagulation in orthopedic surgery, with the objective of preventing deep vein thrombosis and pulmonary embolism.

In 2009, the FDA questioned the integrity of the studies, saying that the testing was full of violations regarding accuracy and reliability of findings. The FDA claimed that the trials involved “systematic discarding of medical records,” and falsification, and voiced “concerns regarding improprieties in randomization.” The FDA ultimately deemed the trials unreliable as a whole; however, despite these concerns, the FDA approved the drug in 2011.

The Xarelto internal bleeding lawsuit alleges that Xarelto’s approval by the FDA hinged on a study that showed that the drug was as effective as its predecessor in preventing blood clots in orthopedic surgery patients. The lawsuit then goes on to argue that the study was faulty and the study’s data used incorrectly in such a way that made it easy for Xarelto to appear as if it performed as well as Coumadin.

David’s lawsuit suggests that as a result of this information, Xarelto’s approval was based on unreliable information about the drug’s efficacy and safety, therefore was likely to cause problems.

A large part of Xarelto’s appeal in the drug market was based on the fact that it was advertised as a drug that consumers could take once a day, as opposed to twice a day like the previous anticoagulant, and would perform as well or better. The drug was marketed as an appealingly easy alternative to preceding treatments because of the once-daily dosage.

The lawsuit argues, however, that part of the problems with the drug (causing bleeding, blood clots, and stroke) were related to its dosage, citing Dr. Steven E. Nissen who says “my concern was that the dose was selected more for a marketing advantage rather than for the scientific data that was available, and was a mistake…”

The lawsuit implies that the new dosing was approved after further shoddy research into the drug.

The Xarelto Internal Bleeding Lawsuit is Case No. 2:18-cv-01154-EEF-MBN, in U.S. District Court, Eastern District of Louisiana.