A federal jury in the Southern District of Mississippi returned a Defense verdict in the case of Dora Mingo, a Mississippi resident and the third Xarelto bellwether Plaintiff to proceed to trial this year. U.S. District Judge Eldon E. Fallon presided over the trial which commenced on Aug. 7 in Jackson, Mississippi. Prior to trial, Judge Fallon denied multiple summary judgment motions filed by Defendants Bayer and Johnson & Johnson’s pharmaceutical unit, Janssen Pharmaceuticals. Janssen has exclusive rights to market Xarelto in the United States, while Bayer markets and sells Xarelto outside the United States.
In 2015, Plaintiff Dora Mingo developed a deep vein thrombosis (DVT) following hip replacement surgery. She was prescribed Xarelto to treat the DVT. After taking Xarelto for just 21 days, she suffered severe gastrointestinal bleeding, which required hospitalization in the ICU, multiple blood transfusions, and a life-saving surgical procedure to stop the bleeding. Although the jury found that Xarelto caused Ms. Mingo’s gastrointestinal bleed, it did not hold the Defendants liable for failing to instruct Ms. Mingo’s doctors about available laboratory tests to measure Xarelto’s effects on patients.
Xarelto is a new-generation anticoagulant approved by the U.S. Food and Drug Administration (FDA) in 2011 to prevent clots and strokes for patients who suffer atrial fibrillation, and to treat or prevent deep vein thrombosis and pulmonary embolism. Xarelto has high inter-patient variability, which means that Xarelto’s blood-thinning effect varies greatly from one patient to the next. For years, Defendants have known that standard laboratory tests, including a test called Neoplastin PT, can be used to determine the effect Xarelto has on each patient and to identify patients at a significantly increased risk of bleeding on Xarelto.
Jurors considering this issue in the first three bellwether trials have had to navigate complicated medical testimony and scientific literature. Additionally, jurors have had to decipher conflicting statements and positions by Defendants, who continue to say one thing in court in this country and something entirely different in foreign countries and peer-reviewed medical literature.
Janssen has informed doctors in the United States through Xarelto’s product label and sales representatives that it is not necessary or even possible to monitor Xarelto’s effect on a patient’s blood. Meanwhile, Bayer has told doctors in Canada and Europe that Xarelto can be monitored with standard laboratory tests and has provided instructions on how to conduct such tests.
What’s more, medical literature published by Bayer scientists and released the same day as closing arguments in the Mingo trial supports Plaintiffs’ position that a standard laboratory test, Neoplastin PT, can be used to measure Xarelto’s effect on patients. This, along with other newly released and developing medical literature, provides further support for the use of Neoplastin PT to monitor Xarelto’s effects and to identify patients at significantly increased risk of bleeding on Xarelto. However, despite what their own scientists say, Bayer and Janssen’s lawyers and paid experts have been telling jurors that PT testing is meaningless and even dangerous for patients on Xarelto.
The lawyers in our firm’s Mass Torts Section who are working on this litigation will continue to work to expose the Defendants’ inconsistencies on this critical issue affecting the health and safety of thousands of patients who have been prescribed Xarelto. The Xarelto MDL (MDL Number 2592) in the United States District Court for the Eastern District of Louisiana includes more than 19,000 cases. A fourth Xarelto bellwether trial has been selected, but a trial date has not been set. The next Xarelto trial is set for November 2017 in the Philadelphia Court of Common Pleas, where approximately 2,000 Xarelto cases are pending. A total of six Philadelphia cases have been set for trial in the coming months. If you need more information, contact Andy Birchfield, head of our Mass Torts Section, at 800-898-2034 or by email at Andy.Birchfield@beasleyallen.com.