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Xarelto MDL Judge Sets Limits on Joint Complaint Filings

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After May 19, 2016, plaintiffs will no longer be able to file joint complaints in the Xarelto MDL currently proceeding in the Eastern District of Louisiana. After that, only individual complaints will be allowed.

All federal Xarelto lawsuits were consolidated there in December 2014, and both sides have been working since then to prepare a small number of cases for early trials, which are scheduled to begin in February 2017. Until recently, U.S. District Judge Eldon Fallon, who was appointed to oversee the pre-trial proceedings, had allowed complaints containing multiple plaintiffs.

In a pretrial order issued March 22, 2016, however, the Judge noted that the litigation is entering a “new phase,” and that the court finds it “appropriate to terminate the Joint Complaint filing procedure.”

10 Plaintiffs Claim Xarelto Caused Internal Bleeding

One of these joint complaints was just filed in the MDL court on March 22, 2016, the same day as Judge Fallon entered the new order. That complaint involved 10 plaintiffs, all from different states. All of them alleged that after taking Xarelto (rivaroxaban), they suffered serious injuries.

An Oklahoma woman, for example, began taking Xarelto in January 2014, and suffered serious internal bleeding and had to be hospitalized. A Florida man started taking the drug in May 2014, and almost immediately suffered internal bleeding for which he was hospitalized.

The other stories are similar, with the plaintiffs claiming that manufacturers Janssen Pharmaceuticals, parent company Johnson & Johnson (J&J), and Bayer Pharma AG failed to provide adequate warnings as to the risks associated with the drugs, and overstated the benefits in their advertising materials. They also claim that the defendants failed to make clear that there was no readily available antidote to Xarelto bleeding.

Patients taking other anticoagulants, like warfarin, can be treated for excessive bleeding with vitamin K injections. There is no such treatment for Xarelto bleeding, which means that patients simply have to wait for the drug to clear from their systems—a dangerous and potentially deadly situation.

Plaintiffs Claim Xarelto Manufacturers Failed to Provide Adequate Warnings

The Xarelto MDL currently has more than 4,500 cases pending. All involve similar complaints, with plaintiffs stating that they weren’t aware of the seriousness of the risks linked to Xarelto. They also point out that the clinical trials used to gain FDA-approval for the drug were poorly managed.

The ROCKET AF study, for example, which was used to gain approval of Xarelto for reducing the risk of stroke and blood clots in patients with non-valvular atrial fibrillation, showed that Xarelto and warfarin were similarly effective, but that patients taking Xarelto were more likely to suffer gastrointestinal bleeding.

During the FDA’s review process, it noted that the warfarin group was not well managed, stating in an advisory committee meeting, “the data comparing [Xarelto] to warfarin are not adequate to determine whether [Xarelto] is as effective for its proposed indication in comparison to warfarin when the latter is used skillfully.”
Consumer watchdog group Public Citizen also noticed the issue and wrote a letter to the FDA opposing Xarelto’s approval. FDA clinical reviewers noted potential problems with Xarelto’s once-a-day dosing scheme as well, stating that a twice-a-day dosing might be safer and more effective, but the manufacturers kept the once-a-day dose and advertised Xarelto as being a more convenient option to warfarin.