A new lawsuit was filed on July 5, 2018 in U.S. District Court for the Eastern District of Louisiana concerning the anticoagulant Xarelto. The anticoagulant Xarelto is a blood thinner that is part of the class of drugs known as New Oral Anticoagulants (NOACs) created to compete with warfarin, a blood thinner that has been used successfully for several decades.

The complainant, Donald K., says he ingested the anticoagulant Xarelto for a ten-day period from June 25 to July 5, 2016. Donald experienced bleeding in his gastrointestinal tract which he postulates is a direct consequence of taking this NOAC.

He joins other complainants with his individual action under multidistrict litigation (MDL) No. 2592. The defendants are Janssen Research & Development, Johnson & Johnson Inc., Bayer Healthcare Pharmaceuticals and related subsidiaries.

The History of the Anticoagulant Xarelto in the U.S.

The anticoagulant Xarelto was approved for the commercial marketplace by the U.S. Food and Drug Administration (FDA) on July 1, 2011. The approved uses of this blood thinner was prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) for total knee arthroscopy (TKA) or total hip arthroscopy (THA).

The FDA approval of Xarelto was based upon several pre-market clinical trials which are now collectively referred to as the RECORD studies. Purportedly, these clinical trials produced data supporting the presupposed conclusion of Xarelto’s manufacturers that their anticoagulant was superior to warfarin after knee or hip replacement.

Allegedly, the rates of bleeding between the two blood thinning drugs were comparable, but transfusions were often needed with Xarelto because of the frequency of bleeding incidents and lowered hemoglobin levels.

The Xarelto lawsuit further alleges that the RECORD studies were found by the FDA in 2009 to be scientifically and statistically flawed in how they were set up and managed.

An official FDA report indicated that some medical records were simply thrown away, others contained false notations, and certain aspects of the drug trial were revealed to the researchers. This “unblinding” activity allegedly violates normal protocol when conducting drug performance research.

Despite these questions of clinical trial reliability, the anticoagulant Xarelto had its approval expanded to include prevention of stroke in atrial fibrillation in early November 2011.

This approval was ostensibly based upon a different clinical trial series known as ROCKET AF. According to the lawsuit narrative, the ROCKET AF study set out to compare Xarelto and warfarin, but the warfarin group was ill-managed.

This poor management of the warfarin-ingesting group whose drug is dose-dependent allegedly made the resultant data easy to skew in favor of the NOAC. The ROCKET AF showed that Xarelto was non-inferior to warfarin thus providing the FDA with supporting documentation that it could be a viable choice.

Donald brings ten counts against the defendants in this lawsuit including but not limited to breach of implied and express warranty, negligence, failure to warn and design defect.

He asks for a trial by jury with a favorable award that includes compensation for his pain and suffering, reimbursement of all court costs and attorney fees, economic losses from lost earnings and medical care. Donald also requests that punitive damages being assessed against the defendants.

The Anticoagulant Xarelto Lawsuit is Case No. 2:18-cv-06520-EEF-MBN in the U.S. District Court for the Eastern District of Louisiana.