Plaintiff Samuel S. of Ohio has added his Xarelto lawsuit to a multidistrict litigation now going on in federal court in New Orleans.

This MDL is a consolidation of several individual Xarelto lawsuits into a single action in a single court. Generally, the plaintiffs in these Xarelto lawsuits blame Xarelto for dangerous episodes of gastrointestinal bleeding and other types of excessive blood loss. They allege the risks involved in Xarelto bleeding are too high for the drug to be considered safe. They also accuse the manufacturers of Xarelto of failing to properly address those risks in their labeling and marketing.

Defendants in the Xarelto MDL are Janssen, its parent company Johnson & Johnson, Bayer Healthcare Pharmaceuticals Inc. and their related companies.

Xarelto Bleeding

Xarelto, or rivaroxaban, is an anticoagulant medication that is indicated to reduce the risk of stroke in patients with non-valvular atrial fibrillation; to treat deep vein thrombosis and pulmonary embolism, and to prevent their recurrence; and to prevent deep vein thrombosis in patients following hip or knee replacement surgery.

Xarelto is one of a new class of anticoagulants that recently entered the market. Prior to then, warfarin (also sold under the brand name Coumadin) had been the go-to anticoagulant medication for most patients since the 1950s.

Warfarin does come with the disadvantages of requiring dietary restrictions and ongoing monitoring of blood levels. Janssen’s marketing for Xarelto says it does not impose the same requirements on patients, plaintiffs allege.

However, as with the other new anticoagulants, there is no other medication that can control Xarelto bleeding once it starts. Excessive bleeding caused by warfarin can be resolved by administering vitamin K. Plaintiffs argue that Janssen’s labeling for Xarelto should have disclosed this fact in the “Warnings” section.

The joint complaint for the Xarelto MDL cites criticism by the FDA of the clinical studies used during Xarelto’s FDA approval process. Inspection during an earlier set of studies known as the RECORD studies allegedly revealed “’systemic discarding of medical records,’ unauthorized unblinding, falsification, and ‘concerns regarding improprieties in randomization.’” Plaintiffs report that based on these findings, the FDA deemed the RECORD 4 studies unreliable.

Similar FDA findings cast suspicion on a later set of studies known as the ROCKET-AF studies. These studies were conducted to compare Xarelto to warfarin as a preventive for stroke and systemic embolism in patients with non-valvular atrial fibrillation. The FDA found, however, that the researchers’ control of the warfarin group was poor enough to make the resulting data inadequate to determine Xarelto’s effectiveness as compared to warfarin.

The FDA also questioned the ROCKET-AF researchers’ study of only once-daily Xarelto dosing. The agency noted that certain clinical information suggested that twice-daily dosing would result in lower peak blood levels and might therefore result in greater efficacy and possibly more safety. An FDA doctor expressed concern that the once-daily dosage was selected more for marketing advantage than for scientific reasons.

The Xarelto Lawsuit is Case No. 2:15-CV-2210, in the U.S. District Court for the Eastern District of Louisiana.