Xarelto Litigation – Bellwether Update

Searcy Denney Scarola Barnhart & Shipley
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Searcy Denney Mass Tort Unit attorneys Brenda Fulmer and Cal Warriner have filed three more lawsuits on behalf of Florida and North Carolina residents who suffered bleeding in their brains and GI tracts following use of Xarelto. The dozens of individual personal injury and wrongful death lawsuits filed by Searcy Denney pharmaceutical lawyers over the past several years include a number of similar circumstances where patients suffered serious or lethal injuries following their ingestion of Xarelto, a popular blood thinner medication prescribed to patients with atrial fibrillation or for prevention of blood clots in their legs or lungs.

Xarelto Litigation – Filed Lawsuits

Lawsuits have been filed against the manufacturers of Xarelto (Janssen Pharmaceuticals, Johnson & Johnson, Bayer Corporation, Ortho-McNeil-Janssen and other domestic and global parent companies and subsidiaries). The lawsuits include claims that Xarelto is defective and unreasonably dangerous, that the drug was inadequately tested prior to FDA approval in 2011, that prescribing physicians and consumers have been given inadequate and inaccurate information about the adverse events associated with use of Xarelto as well as his effectiveness and risk profile when compared with Coumadin, a blood thinner that has been used for many decades for stroke prevention in patients with atrial fibrillation. The individual product liability lawsuits include counts for strict liability, negligence, misrepresentation, fraud, and breach of warranty.

These latest lawsuits will ultimately become part of the multidistrict litigation proceedings (also known as MDL No. 2592) for Xarelto defective drug claims, which are pending in federal court in New Orleans, Louisiana before Judge Eldon Fallon. Judge Fallon was appointed to oversee MDL No. 2592 for the Xarelto Products Liability Litigation in late 2014. Today, there are approximately 13,000 individual lawsuits filed and pending before Judge Fallon in the federal court coordinated proceedings. Judge Fallon’s role as an MDL judge has been to oversee the discovery phase of the case, which has been largely completed, as well as the conduct of the first jury trials for the national litigation. This process is known as a bellwether trial process, and is intended to allow the MDL judge to make rulings on various generic liability and evidentiary issues as well as providing feedback to the parties on the likely results for the litigation as a whole.

The First Bellwether Trial

The first Xarelto bellwether trial began on April 24, 2017, before Judge Fallon in federal court in Louisiana. This case involved the claims of a patient named Joseph Boudreaux from Louisiana. He developed a GI bleed after taking Xarelto.

Prior to the beginning of the trial, Judge Fallon ruled on a number of legal motions, including requests that the case be dismissed due to various legal defenses raised by the drug company defendants. The most critical motion was the one filed by the drug manufacturers seeking to dismiss claims that the warning label for Xarelto was legally inadequate on the basis of federal preemption, a federal law that essentially prevents individual patients from prosecuting lawsuits over the wording of the warning label where there is evidence that the FDA would have rejected a stronger warning being urged by the patient.

As you may recall with Xarelto, the FDA issued an unprecedented statement regarding the adequacy of the warning label and safety of the drug last year, which then became a critical document in the drug manufacturers’ efforts to dismiss Xarelto lawsuits. Judge Fallon denied most of these legal motions filed by the defendants, including the federal preemption motion, and ruled primarily in favor of the plaintiff with regard to the admissibility of critical evidence in the case from various medical and scientific experts.

During the course of the trial, the federal jury in New Orleans heard testimony and evidence regarding Mr. Boudreaux’s medical treatment and gastrointestinal bleeding injury, the warnings given to his prescribing physician by the drug companies, and details regarding how the drug manufacturer responded to alleged safety issues with Xarelto. On May 3, 2017, the jury returned its verdict in favor of the drug manufacturers and found that it was not liable for the injuries suffered by Mr. Boudreaux.

Three More Bellwether Trials Scheduled

Judge Fallon will begin the second Xarelto jury trial in federal court on May 30, 2017, in New Orleans. Once that jury trial is complete, the MDL judge will conduct two additional trials in June and July in federal courts in Mississippi and Texas. These cases involve bleeding injuries in the brain or gastrointestinal tract as well as both living and deceased patients. Additional trials are also expected to occur this year in state court in Philadelphia, where there are approximately 2,000 additional personal injury and wrongful death cases pending against the drug companies involved in the marketing of Xarelto.

While we are very disappointed with the jury’s decision in the first Xarelto trial, we are still hopeful of prevailing in all or most of the upcoming trials. The outcome of these initial trials does not determine what might happen in any of the other 15,000 pending cases, but is important in providing guidance to the parties regarding the merits of the litigation (with the results of the additional scheduled jury trials being very important as well). There have been no settlements of Xarelto cases thus far, nor do we expect any at this time as the drug manufacturer feels confident that it should not be held legally liable for bleeding injuries suffered by Xarelto patients. It is our hope that the plaintiffs in the upcoming trials will be successful in obtaining verdicts against the drug manufacturers. Once the bellwether trial process before Judge Fallon in the MDL proceedings is completed, it is likely that the judge will order that case-specific discovery, including depositions, be completed in the thousands of cases that remain so that those individual cases can be prepared for remand back to local federal courts for completion of discovery and preparation for individual jury trials.

 

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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