Pennsylvania Record

Saturday, August 17, 2019

Federal Xarelto trials ready to begin, could act as pre-cursor to Philly cases

By Nicholas Malfitano | Mar 28, 2017

PHILADELPHIA — Trials surrounding the blood-thinner Xarelto are set to begin next month in a Louisiana federal court, which may serve as a guide for how similar cases brought by those prescribed the medication will proceed in Philadelphia. 

Per Judge Eldon E. Fallon of the U.S. District Court for the Eastern District of Louisiana, bellwether trials in the Xarelto multi-district litigation (MDL) will begin in April. The federal Xarelto MDL is listed as Case No. 2592, consolidating individual actions filed against Xarelto’s manufacturers, Bayer and Janssen Pharmaceuticals.

Litigants charge Bayer and Janssen failed to properly warn patients that Xarelto use presented increased risks for cranial and gastrointestinal bleeding when taken once daily. Risks which the plaintiffs say, allegedly, would be greatly decreased if the drug was taken twice daily and monitored properly.

Before the main cases reach federal courtrooms, 40 bellwether cases are being selected as a result of a January 2016 order from Fallon. These bellwether actions will enable litigants and counsel to see how jury panels react to evidence presented.

At this point, the first four bellwether cases have been slated for hearings. The first trial will begin on April 24 in the U.S. District Court for the Eastern District of Louisiana; the second will begin on May 30 in that same court; the third will begin in June in the U.S. District Court for the Southern District of Mississippi; and the fourth will begin in July in the U.S. District Court for the Northern District of Texas.

Liaison counsel for the plaintiffs in this MDL are Gerald Edward Meunier of Gainsburgh Benjamin David Meunier & Warshauer, and Leonard A. Davis of Herman Herman & Katz, both based in New Orleans.

Defense liaison counsel in the MDL is James B. Irwin of Irwin Fritchie Urquhart & Moore, also of New Orleans, with lead counsel duties being handled by Steven J. Glickstein of Arnold & Porter Kaye Scholer in New York City, and Susan M. Sharko of Drinker Biddle & Reath, in Florham Park, N.J.

In addition to a grouping of Xarelto claims being processed in a Louisiana federal court, more than 1,300 lawsuits – most from out-of-state plaintiffs – will be handled eventually in Philadelphia’s Complex Litigation Center. The CLC has several mass tort programs, including cases over asbestos and Risperdal, and the percentage of claims belonging to out-of-state plaintiffs has traditionally been in the high 80s.

However, in 2016, the percentage for pharmaceutical lawsuits dropped to 74 percent.

CLC Director Stanley Thompson previously said resolutions reached during the MDL proceedings may prove helpful, but those case outcomes may not necessarily affect how things proceed for Xarelto litigation in Philadelphia.

Philadelphia attorney Max Kennerly of Kennerly & Loutey once termed clinical trial results for the drug “a total mess," citing an article for the Journal of the American College of Cardiology which listed “an unanticipated high rate of missing data, a lack of an expected dose response, a divergent impact between the cardiovascular risks of the low dose and the high dose, a lack of supportive external evidence for novel anticoagulants over standard dual antiplatelet therapy, and a lack of a statistically persuasive efficacy benefit.”

However, a Janssen spokesperson explained the performance of the drug in patients matches that shown in its clinical trials, in contrast to the view of plaintiffs’ counsel.

“Xarelto (rivaroxaban) is an important anticoagulant used to treat and reduce the risk of life-threatening blood clots. After more than five years on the U.S. market, and more than four million patients prescribed in the U.S. to date, the benefit-risk profile of Xarelto remains favorable and consistent with clinical trials,” Janssen’s William Foster said recently.

Foster added, “The process as outlined by the court is moving forward, and we will continue to defend against the claims raised in this litigation. All anticoagulants, or blood thinners, carry the risk of bleeding, and the prescribing information for Xarelto has always warned of these risks. Blood thinners are important and potentially life-saving medicines that should be taken by patients as prescribed and should not be discontinued without a discussion with a physician.”

As of this week, nearly 1,330 cases had been filed in the Xarelto program at the CLC, overseen by Judge Arnold New. The first cases there were filed in February 2014, and previously-reported indications point toward a bellwether case being heard in a Philadelphia courtroom, at the earliest, sometime later in 2017.

There have been 122 new Xarelto cases filed in Philadelphia this year, as of last week.

From the Pennsylvania Record: Reach Courts Reporter Nicholas Malfitano at

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