The anticoagulant Xarelto has drawn yet another Xarelto lawsuit, this time from two plaintiffs who are suing together.

Plaintiff Bernard R. of Texas filed the Xarelto bleeding lawsuit on behalf of his late wife Grace. Grace took Xarelto for the first six months in 2013, until she suffered a gastrointestinal bleed that June. Plaintiff Willard W. of Arkansas Xarelto from March to June 2013 and also suffered a gastrointestinal bleed.

Bernard and Willard are suing Janssen Pharamceuticals, Johnson & Johnson, Bayer Corporation, and their related companies, all of whom the plaintiffs allege are involved in the production and sale of Xarelto.

Xarelto is a blood thinner that got its first FDA approval in July 2011. Since then, it has been approved for treatment and prevention of pulmonary embolism and deep vein thrombosis and for reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

The plaintiffs’ Xarelto lawsuit recounts much of the criticism of the clinical trials conducted in the course of FDA approval, casting doubt on whether Xarelto is truly a safe product.

Despite the flaws in the clinical trials, the plaintiffs allege that the drug makers used the results from them to promote Xarelto as a safe and effective product. Xarelto sales reached about $2 billion in 2013, which plaintiffs attribute in part to the defendant’s spending $11 million during the same year on Xarelto marketing.

The FDA has already warned the defendants at least once about exaggerating the features of Xarelto in their advertising. In June 2013, the federal agency gave the manufacturers notice that some of their promotional material was “false or misleading” because it minimized the risks associated with Xarelto, and because it made a “misleading claim” about dosage adjustments.

Contrary to the defendants’ representations about Xarelto, the drug’s track record, as Bernard and Willard recount, is not as positive. According to the plaintiffs, within one year after Xarelto’s introduction to the market, the FDA received 2,081 Serious Adverse Event reports related to Xarelto, 151 of which resulted in death.

Plaintiffs also say that in the first eight months of 2013, German regulatory authorities received 968 adverse event reports related to Xarelto, 78 of which resulted in death.

Bernard and Willard’s Xarelto lawsuit raises claims for strict liability, defective design and manufacturing, failure to warn, negligence, breach of warranty, negligent misrepresentation, fraud, violation of consumer protection laws, and loss of consortium (a claim based on the effect of Xarelto side effects on the plaintiffs’ marital relationships).

They seek compensation for pain, suffering and emotional distress and for medical and other expenses. They also seek reimbursement of their attorneys’ fees and costs of litigation and an award of punitive damages.

This claim is part of the Xarelto multidistrict litigation, or MDL. An MDL is a consolidation of large numbers of individual claims that share many common issues.

The Xarelto Lawsuit MDL is Case No. 2:15-CV-01858 in the U.S. District Court for the Eastern District of Louisiana under MDL No. 2592.