Pennsylvania Record

Tuesday, April 7, 2020

Federal judge rules 1,200 Xarelto lawsuits will be removed from MDL for disposition in separate trials

By Nicholas Malfitano | Mar 13, 2018


NEW ORLEANS – A federal judge has ruled that 1,200 product liability lawsuits filed against the manufacturers of anti-coagulant drug Xarelto will soon be removed from their multi-district litigation (MDL) status, for resolution in separate jury trials.

In a significant decision sure to have ramifications on the hearing of future Xarelto cases, Judge Eldon E. Fallon of the U.S. District Court for the Eastern District of Louisiana ordered March 8 that of the 18,000 total suits contained in the Xarelto MDL, 1,200 of them will be remanded to their original trial courts, in two separate groups of 600. 

Among each selected group of 600 lawsuits, 200 will be chosen by the plaintiffs’ steering committee, another 200 will be selected by the defendants and 200 more will be chosen by the federal court at random.

According to the terms of Fallon’s order, the first group of 600 lawsuits will be chosen by April 30 and the second group will be chosen by Aug. 30. After all 1,200 lawsuits are selected, each one will be subject to a case-specific discovery process.

Andy Birchfield, co-lead plaintiff counsel of the plaintiffs’ steering committee and member of the Beasley Allen firm in Montgomery, Ala. said, “These cases are important, and the facts need to be heard by juries in open court. We are prepared to take these lawsuits to court one-by-one anywhere in the country until Xarelto’s makers take the basic steps necessary to correct the known health and safety risks associated with this drug.”

The Food & Drug Administration (FDA) approved Xarelto in 2011 for prescription to patients suffering from a rhythmic heart disorder called atrial fibrillation and to prevent blood clots which can lead to heart attacks, strokes and pulmonary embolisms.

Plaintiffs and their counsel charge Xarelto’s manufacturers with failing to properly warn patients that Xarelto use presented increased risks for cranial and gastrointestinal bleeding when taken once daily and not properly monitored.

Plaintiff counsel believe the PT test, which has been used to identify patients with bleeding risks for years, would have been beneficial to plaintiffs negatively affected by the drug. In contrast, counsel for Xarelto’s manufacturers countered that the PT test isn’t scientifically reliable.

Reactions to Fallon's order from Xarelto’s manufacturers indicate they are prepared to meet the 1,200 separate trials head-on with a strong defense.

“We will continue to defend against the claims raised in this litigation as they contradict years of scientific data and the FDA’s repeated confirmation of Xarelto’s safety and efficacy,” Sarah Freeman, spokesperson for Janssen Pharmaceuticals, said.

“Xarelto’s FDA-approved labeling has always appropriately informed physicians of the information that they need to make treatment decisions with their patients. The prescribing information for Xarelto clearly, prominently, and repeatedly warns of the risk of bleeding, which is a known risk associated with all anti-coagulants. Patients should take Xarelto as prescribed and not discontinue use without first discussing with a physician.”

Bayer representative Christopher Loder communicated similar sentiments.

“This case management ruling was expected and is simply the next step in the administration of this litigation. The company will continue to pursue dispositive motion practice as appropriate. Juries in three MDL cases all found in favor of Bayer and Janssen, who also prevailed in the first case to be tried in the Philadelphia County Court of Common Pleas. We are confident that we will continue to prevail in any jurisdiction in this litigation, stand behind the safety and efficacy of Xarelto, and will continue to vigorously defend it,” Loder said.

“The health and safety of our patients is Bayer’s top priority, and we are dedicated to protecting patients’ right to have access to innovative and life-saving medicine. With more than five years on the U.S. market and 33 million patients prescribed worldwide in over 130 countries, real-world experience continues to confirm the favorable benefit-risk profile of Xarelto for patients who have a high risk of life-threatening blood clots that may cause strokes and other serious medical complications.”

The federal Xarelto MDL is listed as Case No. 2592, consolidating individual actions filed against Bayer, Janssen and Johnson & Johnson. Fallon presided over the initial three federal bellwether trials, two of which took place in New Orleans, La., plus another in Jackson, Miss.

In all three federal bellwether trials, juries cleared Xarelto’s manufacturers of liability relating to claims that the drug caused internal bleeding, which plaintiff attorneys allege led to severe injuries or deaths in patients who used it. A fourth bellwether case was dismissed with prejudice.

A separate case originating in the Philadelphia County Court of Common Pleas had initially resulted in a landmark $27.8 million verdict for the plaintiffs involved, but was later reversed on an issue connected to the subject litigant’s prescribing physician.

Nearly 1,700 other cases – most from out-of-state plaintiffs – will be handled 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.

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

However, in 2017, the most recent CLC stats show that figure jumped to an unprecedented 94 percent.

U.S. District Court for the Eastern District of Louisiana case 2:14-md-02592

From the Pennsylvania Record: Reach Courts Reporter Nicholas Malfitano at

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Philadelphia County Court of Common PleasU.S. District Court for the Eastern District of Louisiana