NEW ORLEANS – The manufacturers of Xarelto are not liable for the death of a Louisiana woman who was prescribed the blood-thinner drug and later died from complications resulting from a brain hemorrhage, a federal court jury has decided.

Per a jury verdict reached Monday from the U.S. District Court for the Eastern District of Louisiana, Bayer and Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, were not responsible for the 2015 death of 67 year-old Sharyn Orr, of Kenner, La.

In back-to-back federal bellwether trials, juries have cleared the manufacturers of Xarelto 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.

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.

However, 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.

Orr, an academic advisor at Tulane University, passed away in May 2015, just days after suffering a massive brain hemorrhage and subsequent to an attempt at life-saving surgery. She was prescribed Xarelto in February 2014 to treat her atrial fibrillation, and suffered the brain hemorrhage in April of the following year.

Attorneys for the plaintiffs, Orr’s widower Joseph Orr Jr. and surviving children, Joseph Orr III, Kelli Orr Walker and Kim Orr Deagano, claimed a 12-hour delay waiting for Xarelto to leave the decedent’s system, in order for doctors to safely perform emergency surgery without severe bleeding risk, led to her death.

Plaintiff counsel asserted a Prothrombin Time (PT) test, used to assess a patient for bleeding risks, would have informed doctors when it was safe to operate, but that Bayer and Janssen did not tell doctors the test worked for that purpose.

However, counsel for Xarelto’s manufacturers countered that the PT test isn’t scientifically reliable in their view and that Orr’s death was caused by other factors, such as the irreversible nature of her cranial bleeding.

Andy Birchfield of Beasley Allen in Montgomery, Ala. and Brian Barr of Levin Papantonio of Pensacola, Fla., served as co-lead counsel in the first federal bellwether case decided in May for Xarelto’s manufacturers, Boudreaux v. Janssen Pharmaceuticals, in addition to the instant action brought by the Orr family.

A mutual statement from the plaintiff lawyers in the wake of the second straight jury verdict for the defense indicated they remain undeterred, and will continue to pursue Xarelto litigation claims in future trials.

“On behalf of the Orr family, we want to thank the jury members for their service. We will continue to press forward with the legal claims of the thousands of innocent victims of this drug. The makers of Xarelto owe it to physicians and patients to be transparent about the risks posed by this drug. Physicians outside the U.S. knew as early as 2013 that patient monitoring and a simple blood test would be useful in predicting and identifying patients that are most likely to suffer serious bleeding. But, American doctors were told otherwise – an omission that could have saved our client’s life. The next trial – in August – has its own distinctive set of claims and circumstances, and we look forward to having a jury hear that evidence,” Birchfield and Barr said.

Janssen spokesperson Sarah Freeman also issued a response to the verdict.

“We offer our deepest sympathy to the Orr family for their loss. At Janssen, nothing is more important to us than the health and safety of the patients who use our medicines. The jury’s decision reflects the facts of this case and the appropriateness of Xarelto’s (rivaroxaban) FDA-approved labeling. Xarelto is an innovative medicine used to treat and reduce the risk of life-threatening blood clots. This is the second Xarelto trial and the second verdict in favor of the company. We will continue to defend against the allegations in this litigation,” Freeman said.

Bayer representative Christopher Loder provided further comment on the verdict.

“The defense verdicts in the first two trials affirm both the safety and efficacy of Xarelto, and that its FDA-approved label contains accurate, science-based information on the benefits and risks of this life-saving medicine. Significantly, the jury in the Orr case heard several different theories regarding the alleged inadequacy of the Xarelto label, and did not find there was sufficient evidence to support any of them,” Loder said.

“The health and safety of our patients is Bayer’s top priority. With more than five years on the U.S. market and 28 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.”

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 Eldon E. Fallon of the U.S. District Court for the Eastern District of Louisiana presided over the instant matter.

Two more bellwether trials are scheduled in federal courts in Mississippi (Aug. 7) and Texas (January 2018), respectively.

More than 1,430 lawsuits – most from out-of-state plaintiffs – will be handled eventually 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.

However, in 2016, the percentage for pharmaceutical lawsuits dropped to 74 percent.

From the Pennsylvania Record: Reach Courts Reporter Nicholas Malfitano at nickpennrecord@gmail.com

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