JACKSON, Miss. – The third federal bellwether case revolving around blood-thinning drug Xarelto has begun; one which sees the claims of a Mississippi woman who was prescribed the blood-thinner drug for treatment of a blood clot, then allegedly suffered internal bleeding and anemia, go to trial.

A jury of five men and four women were selected in the U.S. District Court for the Southern District of Mississippi on Monday morning, for the case pitting 69 year-old Dora Mingo of Summit, Miss. against Bayer and Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson.

In previous 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.

Plaintiff counsel asserted a Prothrombin Time (PT) test, used to assess a patient for bleeding risks, was something Xarelto’s manufacturers didn’t inform and instruct doctors about. However, counsel for Xarelto’s manufacturers countered that the PT test isn’t scientifically reliable in their view.

Mingo, a grandmother and retired schoolteacher, was prescribed Xarelto in January 2015 for treatment of a blood clot in her leg. After taking Xarelto, Mingo alleges she suffered severe upper gastrointestinal bleeding and acute blood loss anemia.

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.

A prior mutual statement from the plaintiff lawyers indicated they will continue to pursue Xarelto litigation claims in future trials.

“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 previously issued a response to the continuing litigation.

“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. We will continue to defend against the allegations in this litigation,” Freeman said.

Bayer representative Christopher Loder previously added further comment.

“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, in addition to the instant matter in Jackson, Miss.

Another bellwether trial is scheduled to be heard in federal court in Texas this January.

About 1,480 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.

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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