Judge in Xarelto Litigation Addresses Deficiencies in Plaintiff Fact Sheet Compliance

xarelto bleedingFor the fifth time since the federal Xarelto products liability MDL No. 2592 was created, US District Judge Eldon E. Fallon issued a pretrial order addressing the plaintiff’s fact sheets (PFS), which are used instead of interrogatories, because of alleged deficiencies by claimants in completing them properly.

The sprawling nationwide litigation has produced 14,935 lawsuits since the federal MDL was created in 2014 in New Orleans. Even more cases have been filed in state courts in Philadelphia and Los Angeles.

Non-compliant responses

In response to complaints by the defendants — Janssen Research, Johnson & Johnson and Bayer Healthcare — the judge set out a protocol in pretrial order No. 31 to deal with the late filing of PFSs, non-compliant responses and incomplete responses:

  • Where the PFS has not been filed on time, the defendants will send a letter to the plaintiff’s counsel requesting it be served within 20 days.
  • Where the PFS is timely but deficient because it doesn’t comply with the judge’s PFS orders, the defendant will send a letter to plaintiff’s counsel requesting the deficiencies be cured within 20 days.
  • By the first business day of the month, the companies will send the Plaintiff’s Liaison Counsel a list of cases with untimely responses, or a failure to provide medical records proving the use of Xarelto or other deficiencies.
  • After that, the Plaintiff’s Liaison Counsel has 30 days to provide comments or objections.
  • Five days after the comments are received, the defendants must file motions requesting orders to show cause why the cases should not be dismissed.

In January, California Superior Court Judge Kenneth R. Freeman in Los Angeles appointed the plaintiffs’ liaison counsel in the state’s Judicial Council Coordinated Proceedings (JCCP) for all Xarelto cases in the state courts. There are 31 cases pending involving 52 plaintiffs. A status conference was held on Dec. 12, when the parties agreed to submit plaintiff and defendant fact sheets.

In parallel litigation, some 1,100 claims have been filed in the Philadelphia Court of Common Pleas Xarelto Consolidated Litigation to date before Judge Arnold New. For more, read Two Reasons That More Attorneys File Xarelto Claims in Philadelphia Court. The first trial is scheduled for September 2017.

Did Xarelto kill Arnold Palmer?

Remember Arnold Palmer? He advertised blood-thinner Xarelto, which he took daily, in TV commercials until his death September 25, 2016 from gastrointestinal bleeding. Plaintiffs in thousands of lawsuits charge that the makers of the drug failed to warn and actually concealed that Xarelto causes uncontrollable internal bleeding. Meanwhile the defendants continue to promote the blockbuster drug aggressively as the cases mount in two courts. No settlement expected until the litigation affects stock price.

Xarelto is Rivaroxaban, approved by the FDA on July 1, 2011 to reduce stroke and blood clots — deep vein thrombosis (DVT) and pulmonary embolism (PE) — in patients with atrial fibrillation, a heart disorder. It has been prescribed to more than 4 million US patients, generating sales of $2 billion by fiscal year 2013.

The drug has no antidote to stop internal bleeding. The current label reads: Risk of bleeding: XARELTO can cause serious and fatal bleeding. For 2012 a  total of 2,081 “Serious Adverse Event” reports filed with the FDA it its first full year on the market, and 151 were deaths.


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