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Court Confirms 40 Cases for Xarelto Bellwether Discovery Pool

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On December 12, 2014, the U.S. Judicial Panel on Multidistrict Litigation consolidated all federally filed Xarelto lawsuits into one court in the Eastern District of Louisiana. Since then, the parties have been involved in choosing potential cases to proceed to early bellwether trials.

In a March 7, 2016 order, Judge Eldon E. Fallon, who is overseeing the proceedings, confirmed the 40 Xarelto lawsuits that had been selected to be included in the discovery pool, and which have been scheduled for case-specific depositions over the coming months.

Parties Discussing Discovery Pool in Xarelto Litigation

A discovery pool of cases is created to help the parties gather evidence that may eventually be used in a small, select group of trials. Called “bellwether trials,” these cases help the parties gauge how juries may react to the evidence, which is likely to be repeated over and over again throughout the litigation. Depending on the outcome of those first few cases, the parties may be motivated to go back to the table for settlement negotiations.

In a joint report dated March 11, 2016, the parties indicated that they would be prepared to discuss the 40 cases, which were actually finalized in January. They added that they would also be ready to discuss matters including the plaintiff and defendant fact sheets, preservation orders, interactions with prescribing and treating physicians, and discovery.

All this is in preparation for the first bellwether trials, which are scheduled to begin between February and May 2017.

Xarelto Linked with Hundreds of Adverse Events

The FDA approved Xarelto (rivaroxaban) in July 2011 for the prevention of blood clots in patients going through hip and knee replacement operations. A “newer generation” anticoagulant, Xarelto was advertised as being superior to warfarin, the leading anticoagulant for decades, because it didn’t require dietary changes or blood monitoring.

The drug was later approved for the prevention of stroke in patients with non-valvular atrial fibrillation, and for the treatment and prevention of deep vein thrombosis. Since it was released on the market, however, the drug has been linked with hundreds of reports of adverse events, including blood clots and excessive gastrointestinal bleeding, sometimes leading to death.

Within just a year of its being on the market, Xarelto was named in the Institute of Safe Medicine Practices QuarterWatch publication as having a total of 356 cases of serious, disabling problems linked to, including severe blood clots in younger patients taking the drug after hip and knee replacement surgery.

Manufacturers were later warned by the FDA that their advertisement in the WebMD magazine was “false or misleading because it minimizes the risks associated with Xarelto and makes a misleading claim.” Indeed, many patients who eventually filed Xarelto lawsuits claim that the Janssen Pharmaceuticals and Bayer AG overstated the benefits of the drug, without adequately warning about the risks.

One of the most concerning issues is that there is no readily available antidote to the drug’s effects. Patients presenting with excessive bleeding have to just wait until the drug clears from their system, which can make these events particularly dangerous and potentially even deadly.