On Tuesday, a jury entered a verdict of $27.8 million against Johnson & Johnson’s Janssen Pharmaceuticals, Inc. and Bayer AG’s Bayer Pharmaceuticals Inc. in the first state court trial out of the Philadelphia County Court of Common Pleas’ mass tort program consolidating Xarelto-related injury lawsuits. Plaintiff, Indiana resident Lynn Hartman, sought damages after she was hospitalized in 2014 with a gastrointestinal bleed. She stated she required four blood transfusions to counter the injury. Ms. Hartman testified she took Xarelto for more than a year – to treat her atrial fibrillation – before her hospitalization. She blamed her Xarelto use for the hospitalization, noting that she subsequently used another blood thinner without incident. The jury agreed with her and awarded $1.8 million in compensatory damages and $26 million in punitive damages.

The plaintiff’s claims were based, in part, on allegation that Janssen and Bayer manipulated the clinical trials for Xarelto and failed to adequately warn patients of the bleeding risks involved with Xarelto use. Former FDA Chief David Kessler testified at trial that, in his opinion, the drug’s warning label did not sufficiently inform doctors or patients of the severity of the potential bleeding risks.

Janssen and Bayer responded to these allegations by arguing the warning label statement that Xarelto “can cause serious and fatal bleeding” was more than sufficient warning of the drug’s bleeding risks. Additionally, the defendants relied upon testimony of Ms. Hartman’s treating physician that she would still have prescribed Xarelto to the plaintiff even with the heightened warning, even though she felt additional information should have been included on the label.

Witness Tampering Allegations

This trial was not without its share of drama. At the beginning of trial, the plaintiff’s attorneys alleged witness-tampering by a Janssen sales representative. The representative had visited one of Ms. Hartman’s treating physicians, Dr. Aldridge, prior to the physician’s deposition. During the deposition, Dr. Aldridge testified that he did not believe the plaintiff’s gastrointestinal bleed had been cause by Xarelto; his testimony seemed to contradict his notes made during Ms. Hartman’s 2014 hospitalization.

Judge Michael Erdos, who presided over the trial, granted the plaintiff’s request to take Dr. Aldridge’s deposition during the trial. Granting a mid-trial deposition is an unusual event, to be sure. However, following the deposition, Judge Erdos denied Ms. Hartman’s request to use the doctor’s testimony during trial. The judge’s denial was grounded in what he determined to be a lack of evidence showing an attempt to influence Dr. Aldridge’s testimony.

Where Does Xarelto Litigation Go from Here

Lynn Hartman’s case was one of approximately 1,500 cases pending in the Philadelphia County Court of Common Pleas. The federal multidistrict litigation currently has around 20,000 cases. Three bellwether trials have concluded from the MDL. All three trials resulted in verdicts in favor of Janssen Pharmaceuticals and Bayer Pharmaceuticals. The next Philadelphia trial is scheduled to begin in January.

Johnson & Johnson and Bayer officials have stated they will appeal the December 5, 2017 Philadelphia verdict.