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

In the Xarelto internal 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 defendants Janssen Pharmaceuticals and Johnson & Johnson of knowing the drug could cause severe side effects that they did not disclose to patients or doctors.

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 systematic 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 was introduced in the U.S. 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 older anticoagulants such as warfin.

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 after 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.

According to David’s complaint, the FDA claimed that the trials involved “’systematic discarding of medical records,’ unauthorized unbinding, falsification, and ‘concerns regarding improprieties in randomization.'” The FDA and ultimately deemed the trials unreliable as a whole, David says. 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 a 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 its predecessor.

David suggests that as a result of this information, Xarelto’s approval was based on unreliable information about the drug’s efficacy and safety, So despite its FDA approval, David says, it was likely to cause problems.

The Xarelto internal bleeding lawsuit goes on to state that a large part of Xarelto’s appeal in the drug market was based on the fact that it was marketed as a drug that consumers could take once a day, as opposed to twice a day like the drug’s predecessors, and the drug would perform as well despite the new dosing strategy. The drug was marketed as an appealingly easy alternative to preceding treatments because of the once-daily dosage.

The lawsuit argues that part of the problems with the drug (causing bleeding, blood clots, and stroke) were related to its dosage, citing FDA reviewer 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 the U.S. District Court for the Eastern District of Louisiana.