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Former FDA commissioner says Xarelto's manufacturers didn't warn patients of drug's risks

By Nicholas Malfitano | May 2, 2017

NEW ORLEANS – In the first week of the first federal bellwether trial connected to Xarelto, a former commissioner of the Food & Drug Administration (FDA) testified to his belief that the manufacturers of Xarelto misled patients on potential risks associated with the blood-thinning medication.

David Kessler, FDA Commissioner from November 1990 to February 1997, said in Louisiana federal court last week that “Janssen and Bayer withheld information about a simple lab test that could have been used to help doctors predict and prevent excessive bleeding.”

Kessler’s testimony criticized Janssen Pharmaceuticals, a Johnson & Johnson subsidiary, and Bayer, the manufacturers of Xarelto, and charged them with not providing patients with enough information about bleeding risks associated with the drug.

A large group of suits making that same allegation have been consolidated through the federal court system’s multi-district litigation (MDL) process, which utilizes bellwether trials to establish evidence and determine any settlement value for similar plaintiff claims.

The federal Xarelto MDL is listed as Case No. 2592, consolidating individual actions filed against Bayer, Janssen and its parent company, Johnson & Johnson. Judge Eldon E. Fallon of the U.S. District Court for the Eastern District of Louisiana is presiding.

Three other bellwether trials are scheduled for this year in federal courts in Louisiana (May), Mississippi (June) and Texas (July), respectively. Philadelphia’s Complex Litigation Center is also expected to see its first trial this year.

Plaintiffs 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, including the lack of a reversal agent in case of an emergency; aggressively marketing the drug as a more convenient alternative for Coumadin in patients needing blood thinners to reduce the risk of dangerous clots.

The plaintiff in the first bellwether trial is Joseph Boudreaux, 75, of Lockport, La. Boudreaux was prescribed Xarelto in 2014 for treatment of his heart condition, and claims he developed symptoms of gastrointestinal bleeding, which required “hospitalization, numerous blood transfusions and other interventions”, resulting in medical bills in excess of $100,000.

Boudreaux also took the stand during the first week of the trial, stating, “I got so weak I couldn’t go anymore," in reference to taking Xarelto for treatment of his atrial fibrillation.

Boudreaux claimed this reaction happened within a month of taking Xarelto.

“I feel very strongly that Xarelto was a major contributor to the major bleed that he had,” hematologist Cindy Leissinger testified, also in support of Boudreaux’s assertions.

A Janssen spokesperson recently stated the performance of the drug in patients matches that exhibited in its clinical trials, contrasting with 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.

Foster continued, “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.”

Andy Birchfield of the Beasley Allen law firm in Montgomery, Ala., and Brian Barr of the firm Levin Papantonio of Pensacola, Fla., are co-lead counsel in the case.

Liaison counsel for the plaintiffs in the 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.

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.

From the Pennsylvania Record: Reach Courts Reporter Nicholas Malfitano at

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