Xarelto manufacturers win jury verdict in first federal bellwether trial on drug's potential risk liability

By Nicholas Malfitano | May 5, 2017

NEW ORLEANS – The manufacturers of blood-thinner drug Xarelto have prevailed in the first federal bellwether trial to determine whether they were responsible for failing to provide a patient's prescribing physician with adequate instructions for the drug's safe use.

According to a Louisiana federal court jury, Bayer and Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, did not fail to provide Dr. Kenneth Wong, cardiologist for plaintiff Joseph “Johnny” Boudreaux, adequate warnings when it did not include information on a test that the plaintiff claimed should be used to assess a patient for bleeding risks when taking Xarelto, the Prothrombin Time (PT) test.

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 that can lead to heart attacks, strokes and pulmonary embolisms.

However, 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.

A 75 year-old resident of Lockport, La., Boudreaux was prescribed Xarelto in 2014 for treatment of his heart condition, and claimed he developed symptoms of gastrointestinal bleeding less than 30 days later, which required “hospitalization, numerous blood transfusions and other interventions.”

Andy Birchfield of Beasley Allen in Montgomery, Ala. and Brian Barr of Levin Papantonio of Pensacola, Fla., acted as co-lead counsel in the first bellwether case. In a mutual statement, the attorneys expressed both dissatisfaction in the jury’s finding and anticipation for future litigation.

“While we are disappointed with the outcome, on behalf of our team and Mr. and Mrs. Boudreaux, we want to express our appreciation to the jury for their service and consideration during this long and complex trial. We continue to maintain that the manufacturers of Xarelto owe it to the medical community and patients to fully disclose the risks posed by this drug and to encourage use of a simple test to predict and identify patients that are most likely to suffer serious bleeding,” Birchfield and Barr said.

“As always, we will learn from the experience of this trial, and continue to press forward with the legal claims of thousands of innocent victims whose lives have been shattered by Xarelto. We look forward to the upcoming trial in late May, which has its own distinctive set of claims and circumstances.”

Janssen spokesperson William Foster issued a response to the verdict, on behalf of the pharmaceutical firm.

“At Janssen, nothing is more important to us than the health and safety of the patients who use our medicines. The jury’s decision reflects the facts of this case and the appropriateness of the Xarelto (rivaroxaban) prescribing information. Xarelto is an innovative medicine used to treat and reduce the risk of life threatening blood clots,” Foster said.

Christopher Loder, a representative for Bayer, also offered comment on the verdict.

“The jury’s verdict affirms both the safety and efficacy of Xarelto, and that its FDA-approved label contains accurate, science-based information on the benefits and risks of this life-saving medicine. After weighing all the evidence, the jury rejected the plaintiff’s singular claim regarding a PT test that neither the FDA nor any other health regulator in 130 countries has said should be used by doctors to determine if patients should use or continue with Xarelto therapy,” Loder said.

“With more than five years on the U.S. market and 28 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. Bayer stands behind the safety and efficacy of Xarelto and will continue to vigorously defend it.”

The group of more than 18,000 Xarelto lawsuits 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 Johnson & Johnson. Judge Eldon E. Fallon of the U.S. District Court for the Eastern District of Louisiana presided over the instant matter.

Three other bellwether trials are scheduled in federal courts in Louisiana (May 30), Mississippi (Aug. 7) and Texas (January 2018), respectively.

Nearly 1,400 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

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