J&J, Bayer Win Second Trial Over Blood-Thinning Drug RisksBy and
Patients claim Xarelto can cause unstoppable bleeding
Companies say the drug is safe and risks fully outlined
Johnson & Johnson and Bayer AG aren’t responsible for the death of a 67-year-old woman whose family blamed the blood-thinning drug Xarelto, a New Orleans jury found.
The verdict is the second straight win for the companies, which jointly developed the drug. There are still more than 18,000 patient lawsuits over Xarelto, which has been linked to at least 370 deaths, according to U.S. Food and Drug Administration reports.
The patients claim Xarelto can cause unstoppable bleeding and that Bayer and J&J failed to provide an antidote or inform doctors or consumers of a blood test that could measure a patient’s bleed-out risk.
Bayer and J&J say Xarelto is safe and bleeding risks are fully outlined in the drug’s warning label. The companies dispute the validity of the blood test, arguing that it doesn’t provide useful information to doctors.
“All medications have risks and benefits, and this one has a huge benefit and it has risks,’’ Beth Wilkinson, the companies’ lawyer, told jurors Monday. “When put in context of all patients who have to take it, the risks are still small.’’
Xarelto is Bayer’s top-selling product, generating $3.24 billion (2.9 billion euros) in sales last year and $2.5 billion (2.2 billion euros) in 2015 for the Leverkusen, Germany-based pharmaceutical company. Xarelto is J&J’s third-largest seller, bringing in $2.29 billion in 2016 for the New Brunswick, New Jersey, company.
U.S. regulators approved Xarelto in 2011 to prevent blood clots in users undergoing knee and hip surgeries. The drug’s use was later extended to patients who suffer from irregular heartbeats and are at high risk of stroke.
Sharyn Orr, a Tulane University academic adviser, began taking Xarelto in February 2014 for treatment of atrial fibrillation. Orr died in May 2015, 10 days after suffering a massive brain hemorrhage.
“We are certainly disappointed for the Orr family,” Andy Birchfield, Orr’s lawyer, said after the trial. “We thought the evidence was compelling that they definitely had important safety information shared outside the U.S. that was not shared with doctors in the U.S. We are disappointed in the results but we appreciate the process.”
Xarelto caused the brain bleed and doctors waited until the drug left her system before performing emergency surgery, her family’s lawyers said. That 12-hour delay cost Orr a chance of being saved, they said.
A blood test was taken that would have let doctors know that it was safe to operate but the companies hadn’t informed physicians that the test worked for such a use, they said.
Orr underwent emergency surgery to relieve swelling on the brain, but the doctors were unsuccessful, Birchfield said in closing arguments Monday. “The only thing that deprived them of that opportunity early Saturday morning was that she was on Xarelto and the instructions had not told doctors what they needed to know.’’
The companies contend that the Prothrombin Time, or PT, test isn’t scientific. But, Brian Barr, another Orr family attorney, told jurors Monday that Bayer’s label outside the U.S. tells doctors the test “may be useful,’’ to detect bleeding risks in situations such as overdoses, acute bleeding or urgent surgery.
Xarelto didn’t cause the brain bleed, which was set off by her high blood pressure, the companies argued at trial. Orr was taking the medication to prevent stroke, but had other serious disorders beyond hypertension, including poorly managed diabetes and chronic kidney disease, Bayer and J&J said in court papers.
“She was declining internally every year while she was facing those conditions,’’ Wilkinson told the jury Monday. “She was on five different medications for hypertension.’’
A different warning or a quicker surgery wouldn’t have saved her, Bayer and J&J said.
The bleeding was “deep in her brain where they couldn’t remove it,’’ Wilkinson said. When Orr went into the hospital, the doctor saw micro aneurysms in her eyes and knew that the bleeding in the brain was fatal, she said.
The PT test “would not have helped Mrs. Orr.’’ Wilkinson pointed to a recent article in a science publication that said, in part, that “clinicians can no longer rely on normal PT to determine that an anti-coagulated patient is safe to undergo an invasive procedure.’’
“The defense verdicts in the first two trials affirm both the safety and efficacy of Xarelto, and that its FDA-approved label contains accurate, science-based information on the benefits and risks of this life-saving medicine,” Christopher Loder, a Bayer spokesman, said following the verdict. “Bayer stands behind the safety and efficacy of Xarelto and will continue to vigorously defend it.”
J&J will also continue to fight the lawsuits, company spokeswoman Sarah Freeman said.
“The jury’s decision reflects the facts of this case and the appropriateness’’ of Xarelto’s FDA-approved labeling, she said in an email. “Xarelto is an innovative medicine used to treat and reduce the risk of life-threatening blood clots.’’
The next trial begins Aug. 7 in federal court in Jackson, Mississippi.
The case is Orr v. Janssen Research & Development, 15-cv-03708, U.S. District Court, Eastern District of Louisiana (New Orleans).
— With assistance by Jef Feeley