A Colorado couple are the latest plaintiffs to join multidistrict litigation against three major drug companies over Xarelto gastrointestinal bleeding. The named defendants are Janssen Pharmaceuticals, Johnson & Johnson, and Bayer AG.

Background of the Case

Xarelto is part of a class of medications known as “Novel Oral Anti-Coagulants” (NOACs). These prescription drugs have been associated with uncontrollable hemorrhaging. Until recently, there was no antidote or treatment other than emergency dialysis.

Upon the advice of his physician, plaintiff Frank M. says he began taking Xarelto in early February 2013 for the prevention of clotting and resultant embolism. On or around May 24, 2017, he says he experienced an episode of uncontrollable Xarelto gastrointestinal bleeding, resulting in injury, pain and psychological distress.

Xarelto Gastrointestinal Bleeding: How and Why

Xarelto (rivaroxaban) was first granted FDA approval in 2011. Originally developed by Bayer AG, it is currently marketed by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson.

Specifically, Xarelto is a “Factor Xa inhibitor.” Factor Xa (pronounced “Ten-A”) is a biochemical substance produced by the liver. When present in the bloodstream, Factor Xa binds to another biochemical, known as “Factor V,” which requires Vitamin K. The binding of these two factors, combined with Vitamin K, forms thrombin – which in turn, results in the formation of blood clots.

Prior to the development of NOACs, warfarin – a type of rodenticide – was the primary treatment for patients at risk of blood clotting and embolism. Warfarin, sold under the brand name Coumadin, prevents Vitamin K from doing its job. Unlike Xarelto gastrointestinal bleeding, hemorrhaging from warfarin can be stopped by giving the patient large doses of Vitamin K. This is why warfarin patients must avoid foods such as leafy greens, legumes, and cruciferous vegetables.

In contrast, Xarelto prevents the formation of thrombin in the first place by inhibiting Factor Xa – so Vitamin K is irrelevant. Unfortunately, this also meant that, prior to the recent introduction of an antidote, there was virtually no way to stop an episode of Xarelto gastrointestinal bleeding once it got started.

One of the major questions in ongoing litigation against the drug makers is: did they know about these dangers before they submitted their New Drug Application to the FDA?

The Rising Number of Lawsuits

Frank’s Xarelto gastrointestinal bleeding lawsuit is only one of the hundreds that have been filed against the drug’s manufacturers. These lawsuits have been consolidated into what is known as multidistrict litigation. In an MDL, unlike a class action, plaintiffs all bring their individual cases before a single judge. This helps to streamline the process, allowing the sharing of judicial resources and enabling pre-trial discovery (presentation of evidence) to be carried out in a single venue.

Once the cases are ready for trial, a number of “bellwether” cases are selected in order to determine how other cases may be decided. If juries consistently find the defendants liable for Xarelto gastrointestinal bleeding during the bellwether stage, the drug makers may decide to offer a settlement rather than fight ongoing legal battles.

Plaintiffs Frank M. and his wife Ruth Ann are seeking economic damages for medical expenses and lost earnings, compensatory damages for pain and suffering, and punitive damages in the amount of $25 million.

Their Xarelto Gastrointestinal Bleeding Lawsuit is Case 2:18-cv-11028-EEF-MBN.