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Xarelto Verdict Coverage
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J&J, Bayer Cleared of Responsibility in First Xarelto Trial
May 3, 2017 | Bloomberg
By Jef Feeley and Dana Hasselle
Johnson & Johnson and Bayer AG aren’t responsible for a Xarelto user’s internal bleeding, a jury found in the first trial over the blood-thinning drug. -
UPDATE 1-Bayer, J&J win first trial over Xarelto bleeding risks
May 3, 2017 | Reuters
By Nate Raymond
A federal jury has cleared Bayer AG and Johnson & Johnson of liability in the first trial to flow out of thousands of lawsuits blaming injuries on the blood thinner Xarelto, the drugmakers said on Wednesday. -
J&J Fends Off Xarelto Claims in First Bellwether Trial
May 3, 2017 | National Law Journal
By Amanda Bronstad
Johnson & Johnson scored a critical victory on Wednesday after a jury rendered a defense verdict in the first bellwether trial over the blood thinner Xarelto. -
J&J, Bayer prevail in bellwether Xarelto trial
May 3, 2017 | FiercePharma
By Eric Sagonowsky
The first trial over blockbuster Xarelto’s bleeding risks has swung in Bayer and Johnson & Johnson’s favor as a New Orleans jury on Wednesday decided the Big Pharma companies didn’t fail to warn a prescribing physician about bleeding risks. -
Bayer, Janssen Score Win In 1st Xarelto Trial
May 3, 2017 | Law360
By Emily Field
A Louisiana federal jury on Wednesday sided with Janssen and Bayer in the first bellwether multidistrict litigation over unstoppable bleeding allegedly caused by their blood thinner Xarelto, according to the companies.
Traditional Coverage
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J&J, Bayer Cleared of Responsibility in First Xarelto Trial
May 3, 2017 | Bloomberg
By Jef Feeley and Dana Hasselle
Johnson & Johnson and Bayer AG aren’t responsible for a Xarelto user’s internal bleeding, a jury found in the first trial over the blood-thinning drug.
J&J and Bayer didn’t defectively design Xarelto and didn’t mislead a Louisiana man and his doctors about the blood-thinning drug’s health risks, the federal jury in New Orleans found Wednesday.
The ruling was the first of more than 18,000 patient suits against J&J and Bayer, which jointly developed Xarelto, to come to trial. The companies face separate trials over three other Xarelto users’ claims in the next three months. Some users claim Bayer and J&J downplayed the medicine’s bleeding risks.
“We never expected the struggle to be an easy one,” Gerald Meunier, a lawyer for Joseph Boudreaux, a part-time security guard in his 70s, said after the verdict. “We realize Bayer and Janssen have a lot of resources and a lot of motivation to protect Xarelto.”
The drug is Bayer’s top-selling product, generating $3.24 billion in sales (3 billion euros) last year and $2.5 billion (2.3 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 as the New Brunswick, New Jersey, company seeks to replace revenue from its Remicade arthritis treatment, which lost patent protection a year ago.
“The jury’s decision reflects the facts of this case and the appropriateness of the Xarelto prescribing information,” William Foster, a spokesman for J&J’s Janssen unit, said in an emailed statement.
Bayer officials said the jury’s finding affirms the safety of the blood thinner, used to prevent blood clots that can lead to fatal heart attacks and strokes.‘Accurate’ Label
The verdict shows the drug’s “FDA-approved label contains accurate, science-based information on the benefits and risks of this life-saving medicine,” Chris Loder, a U.S.-based spokesman for the drugmaker, said in an emailed statement.
Xarelto belongs to a new class of drugs aimed at replacing Bristol-Myers Squibb Co.’s Coumadin, which has thinned patients’ blood since the 1960s. Some Xarelto users accuse J&J and Bayer of falsely marketing Xarelto as better than Coumadin because the companies said Xarelto patients didn’t need frequent blood tests.
Lawyers for Boudreaux and other former Xarelto patients stress the drug has no antidote, so it puts some users at high risk for bleeding out if they suffer an injury. Coumadin’s blood-thinning effects can be stemmed. J&J and Bayer officials should have warned consumers they could be tested to gauge their Xarelto bleed-out risk, patients’ attorneys claim.
J&J and Bayer counter the U.S. Food and Drug Administration’s finding that Xarelto is “safe and effective” for patients seeking to avoid clots buttresses their claims the drug doesn’t pose undue risks. They also say millions of users have taken the drug without suffering bleeding side effects.
The companies also dispute the validity of the safety test designed to gauge Xarelto users’ bleeding risks, saying in court filings that the test didn’t provide useful information to doctors.
The cases are Boudreaux v. Janssen, 14-cv-2720 and In RE Xarelto Products Liability Litigation, 14-MD-2592, U.S. District Court, Eastern District of Louisiana (New Orleans).
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UPDATE 1-Bayer, J&J win first trial over Xarelto bleeding risks
May 3, 2017 | Reuters
By Nate Raymond
A federal jury has cleared Bayer AG and Johnson & Johnson of liability in the first trial to flow out of thousands of lawsuits blaming injuries on the blood thinner Xarelto, the drugmakers said on Wednesday.
The verdict by a federal jury in New Orleans came in a lawsuit filed by Joseph Boudreaux of Louisiana. It was the first in a series of test trials aimed at helping the plaintiffs and companies assess similar claims about bleeding risks.
"The jury's verdict affirms 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," Bayer said in a statement.
William Foster, a spokesman for J&J's Janssen Pharmaceuticals Inc unit, said the verdict reflected the case's facts and the appropriateness of Xarelto's prescribing information.
In a joint statement, Andy Birchfield and Brian Barr, lawyers for Boudreaux, said they were disappointed but would press on in similar cases.
"As always, we will learn from the experience of this trial, and continue to press forward with the legal claims of thousands of innocent victims whose lives have been shattered by Xarelto," they said.
The lawsuit is one of an estimated 18,000 lawsuits in federal and state courts related to Xarelto. The verdict came in the first of four test trials, or bellwethers, scheduled in the federal litigation. The next trial is May 30.
The U.S. Food and Drug Administration approved Xarelto in 2011. The drug is prescribed for people with a common heart rhythm disorder known as a trial fibrillation and to treat and reduce the risk of deep vein thrombosis and pulmonary embolisms.
But plaintiffs contend Xarelto was unreasonably dangerous and that J&J and Bayer, which jointly developed it, failed to warn patients about a serious risk of uncontrollable, irreversible bleeding in emergencies.
In Boudreaux's case, the 75-year-old said he was prescribed Xarelto in 2014 to treat a heart condition and suffered gastrointestinal bleeding, leading to his hospitalization and numerous blood transfusions.
Xarelto is among a new class of blood thinners aimed at replacing the Bristol-Myers Squibb Co's Coumadin, or warfarin, which has long been on the market.
Others include Boehringer Ingelheim's Pradaxa, which also became the subject of thousands of lawsuits claiming it caused bleeding in patients. Boehringer in 2014 reached a $650 million settlement to resolve those cases.
The case is In Re Xarelto Products Liability Litigation, U.S. District Court, Eastern District of Louisiana, No. 14-md-2592.
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J&J Fends Off Xarelto Claims in First Bellwether Trial
May 3, 2017 | National Law Journal
By Amanda Bronstad
Johnson & Johnson scored a critical victory on Wednesday after a jury rendered a defense verdict in the first bellwether trial over the blood thinner Xarelto.
The drug has become a poster child for tort reformers who object to rampant advertising by plaintiffs attorneys in cases involving pharmaceuticals and medical devices. Johnson & Johnson subsidiary Janssen Pharmaceuticals Inc. and Bayer brought in powerhouse litigator Beth Wilkinson of Washington, D.C.'s Wilkinson Walsh + Eskovitz to lead the defense team at trial, which took place in New Orleans.
It was the first of four bellwether trials slated for federal court—and the outcome isn't reassuring for plaintiffs. After less than two weeks of trial, the jury came back with its verdict about an hour after closing arguments wrapped up on Wednesday.
“The jury’s decision reflects the facts of this case and the appropriateness of the Xarelto prescribing information,” wrote Janssen spokesman William Foster in an emailed statement. “Xarelto is an innovative medicine used to treat and reduce the risk of life-threatening blood clots.”
Bayer spokesman Christopher Loder said the verdict “affirms both the safety and efficacy of Xarelto.”
“After weighing all the evidence, the jury rejected the plaintiff’s singular claim regarding a [blood] test that neither the FDA nor any other health regulator in 130 countries has said should be used by doctors to determine if patients should use or continue with Xarelto therapy,” he wrote.
More than 16,000 cases contend that Xarelto, an anticoagulant used to treat blood clots, caused plaintiffs to suffer from uncontrollable internal bleeding. Joseph Boudreaux Jr., the plaintiff, alleged he was hospitalized with severe internal bleeding one month after taking Xarelto. He and his wife, Loretta Boudreaux, sued in 2014.
The jury found that the defendants hadn’t failed to warn Boudreaux’s physician about the drug’s risks.
Andy Birchfield and Brian Barr, co-lead plaintiffs attorneys, said they were “disappointed with the outcome” and “continue to maintain that the manufacturers of Xarelto owe it to the medical community and patients to fully disclose the risks posed by this drug.”
“As always, we will learn from the experience of this trial, and continue to press forward with the legal claims of thousands of innocent victims whose lives have been shattered by Xarelto,” they wrote.
The next trial is set to begin May 30.
Xarelto, which ranks among the top in attorney advertising spending, has been a flash point for tort reformers like the U.S. Chamber of Commerce’s Institute for Legal Reform. They claim the advertising invites meritless cases and that dire warnings in attorney ads put patients at risk by convincing them to stop taking their medications.
House Judiciary Committee Chairman Bob Goodlatte, who co-authored a tort reform bill that the U.S. House of Representatives passed in March, referenced the Xarelto litigation in letters calling on the American Bar Association and various state bar groups to change their rules of professional conduct pertaining to attorney ads. The ABA has countered with a letter noting that the ads aren't "false and misleading."
Ahead of this month's trial, plaintiffs attorneys successfully brought motions in limine to keep references to attorney advertising out of the trial. The defendants fought the motions, insisting the evidence would show the lawsuit was driven by lawyers.
Many of the players on the plaintiffs' side were involved in the bellwether trials over painkiller Vioxx that led to a $4.85 billion settlement with Merck & Co. Inc. in 2007. The litigation is before the same judge, U.S. District Judge Eldon Fallon, a veteran MDL judge in the Eastern District of Louisiana. Birchfield, head of the mass torts section of Beasley, Allen, Crow, Methvin, Portis & Miles in Montgomery, Alabama, also was co-lead plaintiffs attorney in the Vioxx litigation.
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J&J, Bayer prevail in bellwether Xarelto trial
May 3, 2017 | FiercePharma
By Eric Sagonowsky
The first trial over blockbuster Xarelto’s bleeding risks has swung in Bayer and Johnson & Johnson’s favor as a New Orleans jury on Wednesday decided the Big Pharma companies didn’t fail to warn a prescribing physician about bleeding risks.
After a trial that just kicked off just last week, a federal jury answered “no” when asked whether the companies failed to provide a prescribing physician with adequate prescribing information for Xarelto.
Plaintiff Joseph Boudreaux brought the case against the drug companies, the first of more than 18,000 over Xarelto’s bleeding risks, claiming the next-gen anticoagulant caused internal bleeding, heart problems and a weeklong ICU visit.
In an emailed statement, Janssen spokesperson William Foster said the Wednesday decision “reflects the facts of this case and the appropriateness” of Xarelto’s prescribing information.
For their part, Boudreaux’s attorneys said in a statement that they are “disappointed” with the outcome. They added that they’ll “learn from the experience of this trial, and continue to press forward with the legal claims of thousands of innocent victims whose lives have been shattered by Xarelto.”
The case in New Orleans was the so-called bellwether trial over Xarelto risks as a backlog of other claims has mounted. Going forward, the jury’s decision could significantly alter the decision on whether the sides choose to settle.
Still, the plaintiff’s attorneys are steadfast in their claims “that the manufacturers of Xarelto owe it to the medical community and patients to fully disclose the risks posed by this drug and to encourage use of a simple test to predict and identify patients that are most likely to suffer serious bleeding.”
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Bayer, Janssen Score Win In 1st Xarelto Trial
May 3, 2017 | Law360
By Emily Field
The jury found in favor of Johnson & Johnson unit Janssen Pharmaceuticals Inc. and Bayer HealthCare Pharmaceuticals Inc. in the first of four bellwether trials in the MDL. Plaintiff Joseph Boudreaux’s trial started April 24; he, along with other patients or their representatives in the MDL, accused the drug companies of knowing about the unstoppable bleeding, but not warning doctors.
The jury found that the drugmakers did not fail to provide Boudreaux’s cardiologist, Dr. Kenneth Wong, adequate instructions for the safe use of Xarelto.
"The jury’s decision reflects the facts of this case and the appropriateness of the Xarelto prescribing information,” William Foster, a spokesman for Janssen, said in a statement. “Xarelto is an innovative medicine used to treat and reduce the risk of life-threatening blood clots."
The jury rejected Boudreaux’s singular claim regarding a blood clotting test that neither the U.S. Food and Drug Administration nor any other health regulator in 130 countries has said should be used by doctors to determine if patients should use or continue with Xarelto therapy, a Bayer spokesman said in a statement.
“With more than five years on the U.S. market and 28 million patients prescribed worldwide in over 130 countries, real-world experience 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 spokesman Chris Loder said. “Bayer stands behind the safety and efficacy of Xarelto and will continue to vigorously defend it.”
Boudreaux had claimed he started taking Xarelto to control his atrial fibrillation in January 2014 and less than a month later was hospitalized for dangerous gastrointestinal bleeding requiring blood transfusions. He says Janssen and Bayer misrepresented the safety of the drug to both the public and the FDA and that there are issues surrounding certain clinical trial results.
Xarelto, also known as rivaroxaban, is used to reduce the risk of stroke and life-threatening blood clots in patients with nonvalvular atrial fibrillation — a common heart rhythm disorder — and to treat blood clots lodged in an artery in the lungs, among other cardiovascular ailments.
Boudreaux claimed he began taking the drug to control his atrial fibrillation in January 2014 and was hospitalized less than a month later for dangerous gastrointestinal bleeding, which required multiple blood transfusions.
Days before his trial started, U.S. District Judge Eldon Fallon denied two motions for partial summary judgment, citing federal preemption as a defense to claims over the alleged Xarelto misdosing and a label with allegedly inadequate warnings.
Judge Fallon said the companies hadn't made a convincing showing that FDA regulations prevented them from updating labels or creating more tailored dose-analysis guidelines.
Patients in the MDL claim that the companies told the medical community, the FDA and the public that Xarelto had been tested and was safe for its approved use, even though it wasn’t.
Specifically, the plaintiffs say there’s no antidote to the drug, so if a hemorrhage does occur, there’s nothing available to stop the bleeding.
The Xarelto cases were first consolidated in December 2014 and some suits have been filed in state court. Sales totaled $582 million for the drug during its first full year on the market, rising a few years later to $2 billion for the 2013 fiscal year.
But at the end of the 2012 fiscal year, more than 2,000 reports were filed with the FDA linking seriously harmful events to Xarelto, 151 of which resulted in death, the suits allege.
“While we are disappointed with the outcome, on behalf of our team and Mr. and Mrs. Boudreaux, we want to express our appreciation to the jury for their service and consideration during this long and complex trial,” Andy Birchfield of Beasley Allen Crow Methvin Portis & Miles PC said in a statement. “As always, we will learn from the experience of this trial, and continue to press forward with the legal claims of thousands of innocent victims whose lives have been shattered by Xarelto.”
The plaintiffs' steering committee is represented by Leonard Davis of Herman & Katz LLC, Gerald Meunier of Gainsburgh Benjamin David Meunier & Warshauer LLC and Andy Birchfield of Beasley Allen Crow Methvin Portis & Miles PC.
Janssen is represented by Susan Sharko of Drinker Biddle & Reath LLP and Richard Sarver and Celeste Coco-Ewing of Barrasso Usdin Kupperman Freeman & Sarver. Bayer is represented by Beth Wilkinson of Wilkinson Walsh Eskovitz, David Dukes of Nelson Mullins Riley & Scarborough and William Hoffman of Arnold & Porter Kaye Scholer LLP, among others.
The case is In re: Xarelto (Rivaroxaban) Products Liability Litigation, case number 2:14-md-02592, in the U.S. District Court for the Eastern District of Louisiana.
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