A widely-reported side effect of the prescription drug Xarelto is internal bleeding, leading to serious and various permanent internal bodily injuries.

Cases of Xarelto bleeding have reportedly left patients suffering complications more dangerous than what they were led to expect, leading many of them to raise legal claims against the drug’s manufacturer.

In one such claim, plaintiff Marlene C. has filed a Xarelto lawsuit claiming she experienced Xarelto side effects beyond what she was led to expect.

Marlene alleges she took Xarelto for approximately three weeks in November 2013. According to her Xarelto lawsuit, she suffered severe manifestations of Xarelto bleeding. These injuries are coagulopathy, gastrointestinal bleeding, atrial fibrillation, acute anemia and acute rectal bleeding. Marlene says she had to be hospitalized and treated for her injuries.

Defendants named in the Xarelto lawsuit are Janssen Research & Development LLC, Janssen Ortho LLC, Janssen Pharmaceuticals, Inc., Johnson & Johnson, Bayer Healthcare Pharmaceuticals, Inc., Bayer Pharma AG, Bayer Corporation, Bayer Healthcare LLC, Bayer Healthcare AG, and Bayer AG.

Marlene alleges the defendants named are responsible for having “designed, researched, manufactured, tested, advertised, promoted, marketed, sold, distributed, and/or have recently acquired the Defendants who have designed, researched, manufactured, tested, advertised, promoted, marketed, sold and distributed Xarelto.”

Xarelto is in the drug class known as New Oral Anticoagulants (NOACs). It is a blood-thinning drug designed to prevent stroke and blood clots.

The FDA has approved Xarelto to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, and as a preventive for blood clot injuries in patients undergoing hip and knee replacement surgeries. Additionally, the drug was approved to treat Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).

Several uses of Xarelto were approved based on a series of clinical trials. According to Marlene, the defendant pharmaceutical companies promoted the positive results of the RECORD, the ROCKET AF, and the EINSTEIN studies in order to boost sales of Xarelto.

Reports of Xarelto Bleeding

However, Marlene claims, defendants failed to state Xarelto patients showed “increased risk of gastrointestinal bleeding and bleeding that required transfusion, among other serious bleeding concerns.”

The FDA approved the use of Xarelto in July 2011, for patients undergoing hip or knee replacement surgeries based in part on the RECORD studies. According to Marlene, the RECORD studies (Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Venous Thrombosis and Pulmonary Embolism studies) allegedly failed to report a higher rate of internal bleeding leading to lower blood levels and transfusion of blood.

Marlene alleges that in 2009, the FDA numerous problems with the way this study was conducted, including “systemic discarding of medical records,” unauthorized unblinding, falsification, and “concerns regarding improprieties in randomization.” Marlene claims the RECORD studies had too many flaws and was considered unreliable by the FDA.

In November 2011, the FDA approved Xarelto for “reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation in the U.S” based on the ROCKET studies.  Again, Marlene claims, these studies were also flawed.

The Xarelto lawsuit also says that “at the close of the 2012 fiscal year, a total of 2,081 new Xarelto-associated SAE [Severe Adverse Effects] reports were filed with the FDA, [in Xarelto’s] first full year on the market, ranking tenth among other pharmaceuticals in direct reports to the FDA. Of those reported events, 151 resulted in death, as compared to only 56 deaths associated with warfarin.”

Despite the information listed in the SAE reports, Marlene says the defendants failed to communicate to patients and those in the health care industry about the risks of Xarelto bleeding.

Marlene claims the defendants’ failures resulted in her life-threatening Xarelto bleeding, permanent injuries, physical and mental pain, and economic loss. She asks the court for compensatory, economic, punitive and or exemplary damages; prejudgment and post-judgment interest; attorney fees and court costs; and any other relief the court deems proper.

The Xarelto Lawsuit is Case No. 8:17-cv-00438, in the U.S. District Court for the District of Nebraska.