A Florida couple is adding their Xarelto lawsuit to a large-scale litigation over blood thinner side effects.

Plaintiffs Nereida and Genaro V. say that Genaro began taking Xarelto in February 2015 as part of his treatment regimen for atrial fibrillation. Then on the first day of March, he allegedly suffered a hemorrhagic pericardial effusion with tamponade.

Genaro says he had to be hospitalized, undergo blood transfusions, and seek medical treatment from various physicians in his home town of West Palm Beach. He claims his health has never recovered to the state it was in prior to the injury.

Nereida and Genaro now allege Genaro’s injuries were Xarelto side effects that they could have been avoided had the drug’s manufacturers provided a proper warning.

Their lawsuit names several defendants including Bayer Corp., Janssen Pharmaceuticals, and Janssen’s parent company Johnson & Johnson, all of whom have allegedly been involved in the development, manufacture or sale of Xarelto.

Xarelto Lawsuit Accuses Manufacturers of Hiding Danger

In their Xarelto lawsuit, Genaro and Nereida allege that Xarelto is “defective, dangerous to human health, unfit and unsuitable to be marketed and sold in commerce.” The couple alleges Janssen failed to provide proper warnings about possible Xarelto side effects.

They allege that the defendant manufacturers knew about the dangerous blood thinner side effects associated with Xarelto, yet concealed what they knew from the medical community and the general public.

For example, the couple claims, some of the clinical trials revealed an association between Xarelto and higher rates of bleeding injuries. In a set of studies known as the RECORD studies, researchers found a higher incidence of bleeding events severe enough to require blood transfusion.

In a later study known as the ROCKET AF study, the study subjects taking Xarelto showed more frequent gastrointestinal bleeding, the couple says.

Genaro and Nereida also argue that the defendants pushed too hard to have Xarelto approved for once-daily dosing. They say that manufacturers wanted to market the drug as having an easier dosing schedule, but compromised patient safety in doing so.

They quote FDA reviewers who noted that twice-daily dosing would produce more stable blood levels of the drug, possibly providing better efficacy and a better safety profile.

One reviewer in particular expressed concern that the once-daily dosing schedule was “a mistake” and that it was being pushed “more for a marketing advantage rather than for the scientific data that was available.”

The couple’s Xarelto lawsuit raises claims based on theories of strict liability, manufacturing defect, design defect, failure to warn, negligence, breach of warranty, negligent misrepresentation, fraud, and violation of state consumer protection laws.

Nereida, as Genaro’s spouse, is bringing a claim for loss of consortium to compensate for the effect of Genaro’s injuries on their marital relationship.

The couple seeks an award of compensatory damages to cover economic harm like medical expenses and lost earnings, and also non-economic harm like pain, suffering and emotional distress.

They would also like an award of punitive damages to help deter the defendants from engaging in any similar allegedly “wanton, willful, fraudulent” or “reckless” acts in the future.

The Xarelto Lawsuit is Case No: 9:16-cv-80684, in the U.S. District Court Southern District of Florida, West Palm Beach Division.