PHILADELPHIA – The second Xarelto state court trial in Philadelphia connected to product liability claims for blood thinner Xarelto was recently resolved with another jury verdict for the drug’s manufacturers – their fifth total victory in such litigations between state and federal courts.
The verdict was reached April 27 in a case brought by plaintiff Daniel I. Russell of Lavallette, N.J. against Xarelto’s manufacturers, Janssen Pharmaceuticals and Bayer in the Philadelphia County Court of Common Pleas, and presided over by Judge Michael Erdos.
Janssen Pharmaceuticals spokesperson Sarah Freeman indicated the verdict supports Xarelto’s safety and efficiency with its patients.
“The jury’s decision reflects the appropriateness of the FDA-approved labeling for Xarelto. This is the fifth decision rendered in favor of the defendants in these cases. At Janssen, nothing is more important to us than the health and safety of the patients who use our medicines. We stand behind the safety and efficacy of Xarelto and will continue to defend against the allegations made in this litigation,” Freeman said.
Co-manufacturer Bayer expressed similar sentiments at the news of the defense verdict.
“Bayer and Janssen have had successful outcomes for all five cases that have gone to trial, and 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. Plaintiffs’ attorneys in these cases have presented multiple theories regarding the alleged inadequacy of the Xarelto label, and all of their claims ultimately have been rejected under applicable laws,” Bayer representative Carolyn Nagle stated.
“The health and safety of our patients is Bayer’s top priority. With more than five years on the U.S. market and 39 million patients prescribed worldwide in over 130 countries, real-world experience continues to confirm the favorable benefit-risk profile of Xarelto 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 continue to vigorously defend it.”
Michael M. Weinkowitz of Levin Fishbein Sedran & Berman in Philadelphia, plaintiff counsel for Russell, explained in a brief email that he intended to appeal the decision.
After three consecutive verdicts for the defense in the federal court Xarelto bellwether trials, a Philadelphia court jury initially awarded a landmark $27.8 million amount to Xarelto plaintiffs Lynn and Allen Hartman of Plymouth, Ind. – however, that result was later overturned due to an issue with plaintiff Lynn Hartman’s prescribing doctor, notching four consecutive defense verdicts.
Now, the Russell verdict makes five.
Currently, more than 1,730 cases – 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 jumped to an unprecedented 94 percent.
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 believe the PT test, which has been used to identify patients with bleeding risks for years, would have been beneficial to plaintiffs negatively affected by the drug. In contrast, counsel for Xarelto’s manufacturers countered that the PT test isn’t scientifically reliable.
A separate 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. U.S. District Court Judge Eldon E. Fallon presided over the initial three federal bellwether trials, two of which took place in New Orleans, La., plus another in Jackson, Miss.
In all three federal bellwether trials, juries 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.
Philadelphia County Court of Common Pleas case 150500362
From the Pennsylvania Record: Reach Courts Reporter Nicholas Malfitano at nickpennrecord@gmail.com