Recently, three cases in the Xarelto multi-district litigation (MDL) ended in defense verdicts in favor of Xarelto’s manufacturers, Bayer, Janssen, and Johnson & Johnson. These lawsuits, specifically the Orr trial, the Boudreaux trial, and the Mingo trial, stem from the manufacturers’ failure to provide instructions regarding routine prothrombin time (PT) testing for patients with a high risk of bleeding while on Xarelto. In addition, the plaintiffs argued that defendants misled doctors about whether tests were available to assess effects and risks of the medicine.
Since the cases ended in verdicts for the drug manufacturer, the Plaintiffs are now appealing for new trials. The plaintiffs argue that the defense verdicts are a result of the district court wrongfully admitting evidence, denying admission of other evidence, and giving improper instructions to the jury.
In the legal brief, these arguments for new trials are broken down into four main points:
- In the Orr and Boudreaux trials, the Plaintiffs were not allowed to introduce Xarelto labels and instructions from other countries, a peer-reviewed publication about PT testing, or a draft letter from Bayer about the benefits of PT testing. If the Plaintiffs could have admitted these three exhibits into evidence, the jury could have seen that other countries require Bayer and Johnson & Johnson to warn about side effects, tests, and risks that they failed to warn about in the United States. Also, this evidence tends to prove that the makers of Xarelto were and are aware of its risks as well as the ways that doctors can protect and monitor their patients by performing PT tests.
- In the Mingo case, there was evidence discovered two weeks after the start of the trial. When evidence is discovered after trial begins, the court may grant a new trial. The new evidence was a scientific study and scholarly article that showed the benefits of PT testing, specifically in relation to Xarelto. Further, the study and article were performed and co-authored by six of Bayer’s scientists and two Bayer consultants. This evidence directly conflicts with what Bayer and Johnson & Johnson said at trial and therefore could have likely changed the outcome of the trial.
- In the Boudreaux case, Dr. Peters, a doctor of Bayer and Johnson & Johnson, was allowed to talk about his wife’s use of Xarelto and his opinion of the drug’s safety and effectiveness. This evidence was wrongfully admitted since Dr. Peters was testifying in a professional manner, not a personal one, and since he was not the doctor who prescribed his wife the medicine. Nevertheless, the jury heard this evidence and used it in determining that Xarelto is safe.
- In all three cases, plaintiffs allege that the court gave the jury instructions that were inadequate. Rather than providing the clear instructions proposed by the Plaintiffs, the court failed to instruct and explain about federal regulation requirements that arise when a laboratory test aids in identifying effects and reactions to a drug, and the liability of a drug maker when he fails to advise doctors of these tests and effectively fails to warn. In turn, the juries were left confused and without a clear idea of how liability may be established.
For these reasons, the Plaintiffs argue that the three defense verdicts should be reversed and new trials should be ordered. While only three trials are directly at issue now, there are over 20,000 pending cases in the MDL that may be affected.
You can follow along with the massive Xarelto multi-district litigation and these three appeals here. You can also contact me if you have any questions or concerns.