As of April 27, all five bellwether trials over the anticoagulant medication Xarelto (rivaroxaban) have ended in outcomes for the defense. A spokesperson for Bayer lauded these decisions in her response to the latest outcome, saying “The defense verdict in this trial underscores again the safety and efficacy of this life-saving medicine, and the accuracy of Xarelto’s science-based, FDA-approved label.” A representative of co-defendant Janssen Pharmaceuticals added, “The jury’s decision reflects the appropriateness of the FDA-approved labeling for Xarelto.”
Plaintiffs disagree. Four days prior to the most recent verdict, plaintiffs' counsel filed a brief with the Fifth Circuit Court of Appeals, stating that Judge Eldon Fallon, who is presiding over current Xarelto multi-district litigation (MDL), improperly excluded evidence. The brief further states that Judge Fallon made an error when he refused to “charge all three juries about federal regulations mandating instructions about helpful laboratory tests.” Had the jurors been instructed to consider violations of said regulations, it might have strengthened the plaintiffs' cases, according to the brief.
This goes to one of the plaintiffs' main arguments: the drugmakers failed to inform physicians that a patient could be given ongoing blood tests to monitor and determine their risk of hemorrhaging while using Xarelto. Another lawyer for the plaintiffs noted that patients in other countries had “more complete information about Xarelto’s documented health risks” – but jurors were not allowed to consider this evidence.
Xarelto received FDA approval in 2011 for the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE), despite serious concerns about clinical trials. In 2015, the findings of an investigation published in the journal of the American Medical Association found that many FDA clinical trials did not follow protocols and were negligent when it came to patient safety. A number of studies failed to report adverse effects. This was the case with the ROCKET-AF trials, during which a blood meter used to measure clotting factor in a patient's blood was found to be inaccurate. Another Xarelto study, RECORD 4, was found unreliable because of discarded medical records and falsified records.
In the present cases, jurors were not permitted to hear evidence based on Xarelto packaging in Canada and other countries, which confirm the effectiveness of administering blood tests to patients. Another piece of evidence that was excluded in the third trial was a study from Bayer's own scientists, which validated the use of blood tests. Plaintiffs' attorney Frederick Longer, who serves on the MDL steering committee and filed the brief, told the National Law Journal that had this evidence been available to the jurors, it “probably would have changed the outcome of the trial.”
Currently, there are over 20,000 Xarelto lawsuits pending before the US District Court for the Eastern District of Louisiana. In his brief, Longer wrote that “Some issues raised in these appeals likely will be raised again in most, if not all, subsequent trials.” So far, Bayer and Janssen have prevailed – but a favorable decision by the appellate court could be a significant game changer in upcoming trials.