A woman has filed a product liability lawsuit against Janssen Pharmaceuticals, its parent company Johnson & Johnson and Bayer Healthcare Pharmaceuticals stating that their popular blood thinning medication, Xarelto, caused her to suffer personal injuries.

Plaintiff Wendy W. brought forth her Xarelto lawsuit within the multidistrict litigation currently underway in Louisiana federal court stating that she experienced Xarelto bleeding problems and that she had not been apprised of the risks prior to taking the medication.

Wendy states that she ingested Xarelto from approximately July 24, 2014, to Aug. 17, 2014. She experienced Xarelto bleeding problems and immediately discontinued use of the drug on Aug. 17, 2014.

“As a direct and proximate result of her use of Xarelto, plaintiff suffered serious and dangerous side effects including but not limited to adverse bleeding, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, diminished enjoyment of life, and financial expenses for medical treatment,” the Xarelto bleeding problems lawsuit states.

Xarelto, generically known as rivaroxaban, is an anticoagulant medication that was approved by the FDA in July 2011.

It is currently approved for a variety of uses including prevention and treatment of deep vein thrombosis and pulmonary embolism, blood clot prevention in patients undergoing hip replacement or knee replacement surgeries and prevention of heart attack and stroke in patients that have been diagnosed with atrial fibrillation, an abnormal heart rhythm.

The complaint goes on to state that the various clinical trials that were conducted in order to approve Xarelto for various uses were highly flawed. In one such set of studies, known as the RECORD studies, the lawsuit states that the manufacturers said that Xarelto was superior to another drug with similar rates of bleeding complications.

“However, the studies also showed a greater bleeding incidents with Xarelto leading to decreased hemoglobin levels and transfusion of blood,” the complaint states.

In fact, these studies were so flawed in design and conducted in a negligent manner that the FDA inspected the studies and found rampant violations including discarding of medical records, improprieties in randomization, on blinding, falsification and more, the lawsuit states.

“As a result, the FDA found that the RECORD 4 studies were so flawed that they were deemed unreliable,” the lawsuit claims.

The ROCKET AF study showed that Xarelto was non-inferior to warfarin, the industry standard for blood thinning oral medications for the past six decades.

The studies also showed a similar rate of bleeding for Xarelto and warfarin. “However, ‘bleeding from gastrointestinal sites, in the upper, lower, and rectal sites, occurred more frequently in the rivaroxaban group, as did bleeding that led to a drop in hemoglobin level or bleeding that required transfusion,’ ” the lawsuit states.

The Xarelto lawsuit goes on to detail that other studies conducted on Xarelto found that Xarelto bleeding problems were a concern. However, the makers of Xarelto failed to disclose all of the relevant information surrounding Xarelto bleeding problems to patients and physicians, leading to unnecessary complications that have been experienced by thousands of patients.

Wendy brings forth a number of allegations in her Xarelto bleeding problems lawsuit including strict liability, manufacturing defect, design defect, failure to warn, negligence, breach of express and implied warranties, negligent misrepresentation, fraud and violation of consumer protection laws/consumer fraud laws. She is seeking a jury trial.

Wendy is demanding judgment against the manufacturers of Xarelto including compensatory damages for pain, suffering, emotional distress, loss of enjoyment of life and more, academic damages for medical expenses and lost earnings, punitive and/or exemplary damages, pre-and post-judgment interest, attorneys’ fees and costs and any additional relief as the Court deems just and proper.

The Xarelto Bleeding Problems Lawsuit is Case No. 2:17-cv-05795-EEF-MBN, and is part of the Xarelto MDL, In re: Xarelto (rivaroxaban) Products Liability Litigation, MDL No. 2592 he U.S. District Court for the Eastern District of Louisiana.