A woman from North Carolina added her Xarelto lawsuit to multidistrict litigation currently underway in a Louisiana federal court.

Plaintiff Tandy B. says she was prescribed Xarelto in October 2014 and suffered bleeding in gastrointestinal tract soon thereafter in November 2014.

She now argues her injuries could have been avoided had manufacturer Janssen Pharmaceuticals given a proper warning about the risk of Xarelto bleeding.

According to this blood thinner lawsuit, Xarelto is one of a group of drugs called New Oral Anticoagulants, or NOACs. These drugs entered the market a few years ago as alternatives to warfarin (also known by the brand name Coumadin), which had a decades-long reputation as an established anticoagulant drug.

All of these anticoagulants have found FDA-approved application as preventatives of stroke and systolic embolism in patients with non-valvular atrial fibrillation.

Tandy says that defendants Janssen, Bayer Pharmaceuticals, and Johnson & Johnson over-promoted Xarelto. She says the defendants marketed the drug as being suitable for single daily dosing and as not requiring regular blood testing and dosage adjustment that warfarin requires. These purported advantages were referred to as the “Xarelto Difference,” she says.

But Tandy’s Xarelto lawsuit alleges data from clinical trials calls the safety of the Xarelto Difference into question. She notes that during the FDA approval process, reviewers questioned the safety of once-daily dosing for Xarelto. The reviewers referred to clinical data showing peaks and dips in Xarelto blood levels that they said could have been avoided by using twice-daily dosing.

FDA reviewers also recommended dosage monitoring for Xarelto patients, but the defendants chose not to use that information, Tandy says.

Tandy also cited clinical data that showed an increased risk of bleeding in gastrointestinal tract in patients who took Xarelto. She points to the results of the ROCKET AF study, which found that compared to patients taking warfarin, those who took Xarelto had more frequent instances of gastrointestinal bleeding, bleeding that caused a drop in hemoglobin, and bleeding that required transfusion.

The Xarelto MDL

This blood thinner lawsuit is filed as part of a multidistrict litigation, or MDL, that puts thousands of similar claims under the supervision of a single court. Many plaintiffs like Tandy are claiming Xarelto caused dangerous bleeding in gastrointestinal tract. Some plaintiffs in the MDL are the relatives of persons who died from their bleeding following Xarelto treatment.

The court is in the process of selecting the first few of these thousands of blood thinner lawsuits to go to trial. Judge Eldon E. Fallon has asked each side to choose 10 representative cases each, which the court will then combine with 20 cases of its own selection to make a pool of 40 so-called “bellwether” cases.

While the outcomes of these cases are not binding on the other cases, it should promote settlement of those remaining cases by giving the parties an idea of how a jury will receive the evidence and arguments. Trial in these first Xarelto lawsuits is expected to start in 2017.

The Xarelto Lawsuit is Case No. 2:15-cv-04273 and is filed as part of the Xarelto MDL No. 2592 in the U.S. District Court for the Eastern District of Louisiana.