There is an effective lab test to protect patients taking Xarelto, but that isn’t what jurors heard during last month’s trial against Johnson & Johnson’s Janssen Pharmaceuticals and Bayer – the makers of Xarelto. In fact, jurors heard the exact opposite information from witnesses testifying for the defendant companies. Attorneys who represented Dora Mingo in the third Xaretlo bellwether trial have asked the court for a retrial based on the discovery of the new evidence that contradicts the defendants’ testimony.
Near the end of the trial a new study was released that had been conducted and co-authored by Bayer’s own leading scientists and was published by the Journal of Thrombosis and Haemostasis. The study showed that prothrombin time or PT, which is a standard lab test, “may be used to assess anticoagulant activity” and is sensitive to rivaroxaban – the name of the drug marketed as Xarelto. Yet, defense witnesses testified at trial that PT is “dangerous, useless and meaningless” to use with Xarelto, Law360 reports.
“Had jurors known this, it would have changed the outcome of the trial,” said Andy Birchfield, Beasley Allen lawyer and co-lead attorney for Ms. Mingo. “These jurors were told no measuring or monitoring of any kind was required, or even possible. That is simply not true. The study by the Bayer scientists is just the latest example that they knew otherwise.”
Xarelto is an anticoagulant. The Food and Drug Administration (FDA) approved Xarelto to prevent strokes for patients with atrial fibrillation (A-fib), to prevent blood clots forming in post-orthopedic surgery patients, and to treat or prevent deep vein thrombosis and pulmonary embolism. The drugmakers marketed Xarelto as a more convenient alternative to the decades-old warfarin and one that did not require coagulation monitoring.
However, as Beasley Allen has previously explained, patients taking Xarelto have a higher bleeding risk than patients using other oral anticoagulants, and there is no reversal agent for Xarelto. Therefore, the monitoring is essential to determine if the patient will benefit from the drug or if the drug will exacerbate the already high risk of internal bleeding.
Dora’s claim is one of 18,561 claims in the Xarelto multidistrict litigation (MDL), according to the U.S. Judicial Panel on Multidistrict Litigation. The claims are consolidated in the United States District Court for the Eastern District for Louisiana with Judge Eldon E. Fallon presiding. Plaintiffs are suing over the drugmakers’ failure to warn consumers about the potential for Xarelto to increase a patient’s risk of internal bleeding.
Ms. Mingo experienced gastrointestinal bleeding after taking Xarelto for deep vein thrombosis, which she developed after hip replacement surgery in 2015. She had to be hospitalized and was placed in the Intensive Care Unit until doctors could stabilize her condition. If Janssen and Bayer had instructed the doctors caring for Ms. Mingo to monitor her while she was taking Xarelto, she may never have been put through the life-threatening experience, her lawsuit alleges.
* * *
Lawyers in Beasley Allen’s Mass Torts Section continue to investigate injuries suffered by patients who took Xarelto. Injuries include gastrointestinal, rectal and brain bleeds, and deaths caused by major bleeding events. If you would like more information, contact Joseph VanZandt, a lawyer in the Mass Torts Section. You can reach him at 800-898-2034 or by email at Joseph.Vanzandt@beasleyallen.com.
Journal of Thrombosis and Haemostasis
U.S. Judicial Panel on Multidistrict Litigation