It wasn’t long ago that Johnson & Johnson and Bayer came up victorious in the first bellwether trial over Xarelto’s bleeding risks. Now, they’re in court again defending the big-selling blood thinner against claims it caused a patient’s death.
Plaintiffs in the new case are the widower and children of Sharyn M. Orr, a grandmother who died in May 2015 at the age of 67 after suffering a brain hemorrhage. In opening statements, the family’s attorneys said J&J’s Janssen unit and Bayer put profits over patient health. Orr’s death was “completely avoidable,” according to the attorneys, who said the drugmakers concealed information vital for Xarelto's label.
Attorneys for the drugmakers, however, told jurors in New Orleans that bad things can happen to good people and that Xarelto did not cause Orr’s death. According to the defense, a different label would not have saved Orr’s life, and her cardiologist would still prescribe her Xarelto today.
“The health and safety of our patients is Bayer’s top priority,” a spokesperson told FiercePharma. “Real-world experience with 28 million patients in over 130 countries 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 vigorously defend it,” Bayer’s spokesperson said.
The case is one of about 18,400 claiming Xarelto's bleeding risks caused death and serious injury, according to Johnson & Johnson’s recent quarterly filing. It kicks off just weeks after the drugmaker prevailed in its first major trial over the anticoagulant’s risks. And while J&J fends off thousands of Xarelto cases, the number of trials claiming its talc products caused harm, including ovarian cancer, has grown to about 3,900, according to the filing.
As a second bellwether Xarelto case, the Orr family’s will be closely watched, because it will underline the legal strengths and weaknesses of both sides' cases. Bellwether trial results can lead to settlements as each side assesses its chances of future wins.
A third bellwether trial is scheduled for early August, according to the U.S. District Court for the Eastern District of Louisiana's website.
J&J and partner Bayer won their first major Xarelto case last month, when a jury in New Orleans decided the drugmakers didn’t fail to warn about Xarelto risks. A Janssen spokesperson said at the time that the decision “reflects the facts of this case and the appropriateness” of Xarelto’s prescribing information.
The drugmakers aren’t alone in fighting claims on their new-age anticoagulant, as rivals Bristol-Myers Squibb and Pfizer face more than 130 lawsuits over their blockbuster Eliquis’ bleeding risks. Last week, plaintiffs filed three new suits alleging the drugmakers “concealed their knowledge of Eliquis' defects” from prescribing physicians and the larger public.
Boehringer Ingelheim faced thousands of legal claims over Pradaxa, the first-to-market drug in the warfarin alternative class, and it settled 4,000 of them for $650 million in 2014.
Pfizer and BMS “believe that the claims in these cases lack merit,” the companies told FiercePharma. Last month, a judge in New York tossed a separate lawsuit against the companies on grounds that the med’s risks and lack of an antidote were public knowledge.
Xarelto was Bayer’s top-selling med last year at $3.24 billion and ranked third for J&J, with $2.5 billion in sales. BMS reported $3.34 billion in Eliquis sales last year.
Editor's note: Androvett Legal Media & Marketing provided details on the courtroom proceedings for this story.