Xarelto

The label for the blood thinner Xarelto was front and center during opening statements Monday in the first trial over the stroke-prevention medication.

Attorneys for the plaintiffs contended drugmakers Janssen Pharmaceutical and Bayer downplayed key warnings to boost sales and manipulated the approval process to make the drug seem more effective and safer than other medications.

“In a word, this is the bible for the drug,” Douglas & London attorney Gary Douglas told the 14 jurors as he held the lengthy, single sheet of the label covered in fine print. He added that, although the label was approved by the U.S. Food and Drug Administration, “We will show you that FDA approval of Xarelto is not what it’s cracked up to be. Like many government agencies, they’re not perfect. What a shock.”

Beth Wilkinson of Wilkinson Walsh & Eskovitz also showed the jurors the label, but she said everything the defendants are accused of leaving out is included.

“Anything about stacking the deck, that’s just false,” Wilkinson said. “None of that was secret.”

Opening statements in Hartman v. Janssen began Monday afternoon in Philadelphia Court of Common Pleas Judge Michael Erdos’ courtroom.  The start of trial was delayed after plaintiffs counsel Monday morning raised concerns about an allegedly previously undisclosed contact between a Janssen sales rep and a treating doctor for the plaintiff, Lynn Hartman.

Hartman is the first bellwether trial to begin in states court. Over the summer, defendants won all three cases that went to trial from the consolidated litigation being handled in federal court. More than 18,000 cases are pending in the federal multidistrict litigation over Xarelto, which makes it the second largest litigation nationwide, second only to the consolidated pelvic mesh litigation. More than 1,500 Xarelto cases are pending in Philadelphia.

During the roughly 75-minute opening on behalf of the plaintiffs, Douglas focused on what he called the “grossly inadequate” label, and said it failed to take into account the magnitude of the risks involved.

Levin Papantonio Thomas Mitchell Rafferty Proctor attorney Ned McWilliams accompanied Douglas in making the opening statement, and went over the study the defendants conducted comparing Xarelto to Warfarin, which was an earlier class of blood-thinner. According to McWilliams, the defendants “stacked the deck” with doctors who were not well equipped to handle Warfarin, which helped make Xarelto seem more effective.

“This was an intentional act, and they knew what they were doing,” McWilliams said. ”Don’t stack the deck when peoples’ lives are literally in the balance.”

Wilkinson, however, said details about those studies, including how well the patients taking Warfarin were managed, were included on the label. Both Hartman and her treating physician knew of the risks, and the treating doctor further testified that even with the additional information about the magnitude of the risk, she still would have prescribed the drug to Hartman, Wilkinson told the jury.

Wilkinson also showed jurors a detailed animation of how atrial fibrillation, a heart condition that Hartman suffered from, can lead to blood clots and stroke, which can cause severe brain damage.

“She understands those risks and she thinks the benefits outweigh those risks,” Wilkinson said.