New Data Could Add $1.5 Billion To Sales Of Johnson & Johnson Blood Thinner
Plaintiff attorneys from the recently decided trio of bellwether cases in the federal multi-district litigation surrounding blood thinner drug Xarelto have filed motions seeking retrials, believing newly released medical evidence contradicted the cases’ courtroom testimony and would have swayed the jury to find for their clients.
In August, a seven-person jury from the U.S. District Court for the Southern District of Mississippi decided that Bayer and Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, were not responsible for the internal bleeding and anemia suffered by Dora Mingo, 69, of Summit, Miss.
During the trial, jurors were told that “no practical and effective lab test exists to protect patients taking Xarelto from excessive bleeding and sometimes death.” Defense witnesses testified that a lab test called prothrombin time or PT, is “meaningless” and even “dangerous to use with Xarelto.”
However, unbeknownst to Mingo’s attorneys at the time, a new study and medical article conducted and co-authored by leading Bayer scientists was released as the trial neared its end. The report, published by the Journal of Thrombosis and Haemostasis, advocates the PT test as one which “may be used to assess anticoagulant activity and has been shown to be sensitive to Rivaroxaban.”
Rivaroxaban is the technical name of the drug better known as Xarelto.
Mingo’s co-lead counsel, Andy Birchfield of the Beasley Allen law firm in Montgomery, Ala., maintains knowledge of this new study would have led to a different result in court.
“Had jurors known this, it would have changed the outcome of the trial. These jurors were told no measuring or monitoring of any kind was required [when using Xarelto], or even possible. That is simply not true. The study by the Bayer scientists is just the latest example that they knew otherwise,” Birchfield said.
Mingo, a grandmother and retired schoolteacher, says she suffered both severe upper gastrointestinal bleeding and acute blood loss anemia – allegedly, after being prescribed Xarelto in January 2015 following hip replacement surgery.
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 which can lead to heart attacks, strokes and pulmonary embolisms.
Plaintiffs and their counsel 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.
Plaintiff counsel asserted the PT test, which has been used to identify patients with bleeding risks for years, would have been to Mingo’s benefit in this case.
In contrast, counsel for Xarelto’s manufacturers countered that the PT test isn’t scientifically reliable.
During the recent trial, Mingo’s attorneys also presented to jurors what they believed was another inconsistency concerning Xarelto, this one involving the labels on the drug that doctors read in the Canada and the United States.
In Canada, the Xarelto label informs Canadian doctors that in some circumstances, they can use the PT test with Xarelto patients. However, Mingo’s attorneys say no such advisory language appears on the U.S. label for Xarelto.
“The inconsistencies are inexcusable. Yet the defendants continue to try to put the blame on the U.S. Food and Drug Administration. Manufacturers, not the FDA, are the rulers of their label. Changes can be made without FDA approval,” Birchfield said.
Janssen spokesperson Sarah Freeman provided an official response to the plaintiff attorneys’ motion for a retrial and accusations over the alleged differences in the language of the drug’s labels between Canada and the U.S.
“We have full confidence in the verdict returned by the jury in the Mingo trial, which was amply supported by the evidence. We believe there is no new evidence that justifies a retrial,” Freeman stated.
“We will continue to defend against the allegations in this ongoing litigation as they contradict years of scientific data and the FDA’s repeated confirmation of Xarelto’s safety and efficacy. We believe Xarelto’s FDA-approved labeling has always warned of bleeding events – a known risk associated with anticoagulation – and appropriately informs physicians of the information that they need to make treatment decisions with their patients. Patients should take Xarelto as prescribed and not discontinue use without first discussing with a physician.”
Bayer representative Chris Loder said the plaintiffs were given “wide latitude” by the Mingo court to prove their case but failed to do so.
“The Court has denied two similar new trial motions for the Boudreaux and Orr cases, and the arguments raised in the Mingo motion are equally meritless. The article referenced in the Mingo motion is similar to articles that plaintiffs used during the Mingo trial,” Loder said.
“With more than 31 million patients prescribed Xarelto worldwide, real world research continues to confirm that the benefit-risk profile remains favorable and consistent with clinical trials 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 vigorously defend it.”
Loder added on Sept. 19, similar plaintiff motions for new trials in the first two bellwether trials, Boudreaux and Orr, were denied by Judge Eldon E. Fallon of the U.S. District Court for the Eastern District of Louisiana.
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 Fallon presided over the initial two bellwether trials which took place in New Orleans, La., in addition to the instant matter in Jackson, Miss.
In three federal bellwether trials, juries have cleared Xarelto’s manufacturers of liability relating to claims that the drug caused internal bleeding, which plaintiff attorneys allege led to severe injuries or deaths in patients who used it.
A fourth bellwether trial is scheduled for a Texas federal court in January.
About 1,520 lawsuits – most from out-of-state plaintiffs – will be handled 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.
In 2016, the percentage for pharmaceutical lawsuits dropped to 74 percent.
However, in 2017, the most recent CLC stats show that figure has jumped to an unprecedented 94 percent.