JACKSON, Miss. – For a third consecutive time, a federal court jury has declared the manufacturers of Xarelto are not liable for medical injuries allegedly resulting from a plaintiff being prescribed the blood-thinner drug.

A seven-person jury from the U.S. District Court for the Southern District of Mississippi decided Friday 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.

In now three 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.

Plaintiff counsel asserted a Prothrombin Time (PT) test, used to identify patients with bleeding risks, would have been to the plaintiff’s benefit in this case.

But, counsel for Xarelto’s manufacturers countered that the PT test isn’t scientifically reliable in their view.

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 to treat a blood clot in her leg.

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 two federal bellwether cases decided in May and June for Xarelto’s manufacturers, Boudreaux v. Janssen Pharmaceuticals Et.Al and Orr Et.Al v. Janssen Pharmaceuticals Et.Al, in addition to the instant action initiated by Mingo.

Birchfield issued a statement subsequent to the third straight jury verdict found for the defense, criticizing Xarelto’s manufacturers for allegedly placing profits over product and patient safety.

“On behalf of Ms. Dora Mingo, we want to thank jurors for their service. We will continue fighting for the thousands of innocent victims injured or killed by this drug. The makers of Xarelto need to be candid about the risks posed by this blood thinner,” Birchfield said.

“Johnson & Johnson, Janssen Pharmaceuticals and Bayer Healthcare engaged in aggressive direct-to-consumer, physician marketing and advertising campaigns, but gave little weight to the dangers of Xarelto because they were more focused on their business plan than patient safety. Health complications suffered by Ms. Mingo and thousands of others could have been avoided if physicians were told they could run a simple blood test to help identify patients at an increased risk of excessive bleeding.”

Janssen spokesperson Sarah Freeman also spoke to the latest verdict.

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

Bayer representative Sasha Damouni provided further comment on the matter.

“The defense verdicts in the first three 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. Plaintiffs’ attorneys in these cases have presented multiple theories to juries regarding the alleged inadequacy of the Xarelto label, and all three juries have rejected their claims and found in favor of the companies,” Damouni 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 initial two bellwether trials which took place in New Orleans, La., in addition to the instant matter in Jackson, Miss.

A fourth bellwether trial is scheduled for a Texas federal court in January.

About 1,490 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.

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

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