NEW ORLEANS – The initial bellwether trial to ascertain whether the manufacturers of Xarelto are liable for claims which allege the blood-thinning medication caused injury or death to more than 15,000 patients was slated to begin Monday in a Louisiana federal court.
The large group of suits 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 Xarelto’s manufacturers, Bayer, Janssen Pharmaceuticals 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.
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.
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.”
The plaintiff in the first bellwether trial is Joseph Boudreaux, 75, of Lockport, La. Mr. Boudreaux was prescribed Xarelto in 2014 for treatment of his heart condition, and claims he developed symptoms of gastrointestinal bleeding less than 30 days later, which required “hospitalization, numerous blood transfusions and other interventions.”
Andy Birchfield of the Beasley Allen law firm in Montgomery, Ala., and co-lead counsel of the plaintiffs’ steering committee for the Xarelto MDL said, “This trial is an important first step in raising broader awareness of one of the most high-risk drug treatments in medicine today and pursuing justice for the victims of this potentially deadly medication.”
Birchfield continued, “We look forward to the opportunity to present evidence that the defendants ignored their responsibilities to the U.S. medical community and to the thousands of patients and families affected by their negligence.”
Joining Birchfield as co-lead counsel is Brian Barr of the firm Levin Papantonio of Pensacola, Fla.
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.
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 nickpennrecord@gmail.com