A woman has filed a lawsuit against the makers of a popular blood thinner medication after she suffered personal injury following its use.

Plaintiff Mary S. named Janssen Pharmaceuticals, its parent company Johnson & Johnson, and Bayer Healthcare Pharmaceuticals as the defendants in her Xarelto internal bleeding lawsuit. Her lawsuit joins nearly 17,600 others in the Xarelto internal bleeding multidistrict litigation currently underway in Louisiana federal court.

Because there were so many lawsuits against the makers of Xarelto that followed after individuals suffered personal injuries after using the drug, the Judicial Panel on Multidistrict Litigation consolidated all of these lawsuits under a single federal judge in a single court. This consolidation has served to conserve time and resources and allows for the consolidation of pretrial proceedings. It also helps avoid any conflicting rulings that may have resulted from litigating in differing courts.

Mary’s Xarelto internal bleeding lawsuit states that the makers of Xarelto “concealed their knowledge of Xarelto’s defects from the Plaintiff, the FDA and the general public by representing that Xarelto had been sufficiently tested and been found safe and/or effective for its intended use.”

The Xarelto internal bleeding lawsuit goes on to detail the concerns surrounding the clinical trials that were used base Xarelto’s FDA approval.

Xarelto (rivaroxaban) is an oral blood thinning medication that belongs to a class of drugs referred to as the new generation oral anticoagulants. Xarelto, along with Pradaxa and Eliquis, were developed as drugs intended to improve upon warfarin, the industry standard drug for the last 60 years.

While warfarin required frequent monitoring of blood levels, individual dosing and required that patients adhere to a diet by avoiding foods that would interact negatively with the medication, the new drugs did not have those limitations. They came with easier, more standardized dosing, the lack of need for continual monitoring and did not place any dietary restrictions on patients.

However, what warfarin did have that these drugs lacked when they were released onto the market was an effective antidote to reverse the anti-clotting mechanism of the drug. With warfarin, fresh frozen plasma or vitamin K could be administered to help stop any internal bleeding injuries by allowing the body to form a clot to stop the bleed.

None of the new generation oral anticoagulants had an antidote when they were released. Xarelto in Eliquis still do not have an antidote to assist patients when they are suffering from internal bleeding, and as a result, these patients can suffer from serious injuries or even death. Pradaxa has an antidote now, but for the first five years it was on the market, patients suffered severe Pradaxa internal bleeding injuries as well.

The Xarelto internal bleeding lawsuit states that the RECORD studies, the ROCKET AF studies and the EINSTEIN studies used as clinical trials to test the safety and efficacy of the drug were severely flawed. They stated that the results of these trials indicating that patients taking Xarelto had an increased risk of bleeding were not shared with physicians and the public in a clear and consistent manner.

As a result, Mary has brought forth a number of allegations against the defendants including negligence strict products liability, breach of express warranty, breach of implied warranties, fraudulent misrepresentation, fraudulent concealment and negligent misrepresentation. She is demanding a jury trial.

The plaintiff is seeking general damages, medical, incidental and hospital expenses, pre-and post-judgment interest, a refund on costs paid for Xarelto, consequential damages, punitive damages, attorneys’ fees and costs and any additional relief as deemed appropriate by the court.

The Xarelto Internal Bleeding Lawsuit is Case No. 2:17-cv-06962-EEF-MBN and is part of the Xarelto MDL In re: Xarelto (rivaroxaban) Products Liability Litigation, MDL No. 2592, in the U.S. District Court for the Eastern District of Louisiana.