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Xarelto Russell Verdict Report Day 2 - 4-30-18
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Bayer, J&J win latest trial over Xarelto bleeding risks
Apr 27, 2018 | Reuters Westlaw
By Nate Raymond
A Pennsylvania state court jury on Friday found Bayer AG and Johnson & Johnson not liable in a lawsuit by a New Jersey man who said the drugmakers failed to warn about internal bleeding risks associated with their blood thinner Xarelto. -
Strong Xarelto Label Warnings Lead To Another Jury Win For Bayer And Janssen
Apr 28, 2018 | The Pink Sheet
By Brenda Sandburg
Bayer Corp. and Janssen Pharmaceuticals Inc. seem to have the best defense against product liability suits claiming they did not provide adequate warning that Xarelto (rivaroxaban) increases the risk of bleeding: labeling that repeatedly specifies the risk. -
Bayer and Janssen win in Philadelphia Xarelto trial
Apr 30, 2018 | The Pharma Letter
By Staff
After two week of trial and two days of deliberation, a Philadelphia jury has up a defense verdict in favor of Germany’s Bayer (BAYN: DE) and Johnson & Johnson (NYSE: JNJ) subsidiary Janssen Pharmaceuticals, finding that the label on the blood thinner Xarelto (rivaroxaban) adequately warned patients about the danger of severe bleeds, reported the publication Legal Intelligence. -
Defense Verdict Returned In 2nd Pennsylvania Xarelto Injury Trial
Apr 30, 2018 | Lexis Legal News
By Staff
A Pennsylvania state court jury on April 27 returned a defense verdict for Janssen Pharmaceuticals Inc. and Bayer Healthcare Pharmaceuticals Inc. in the state’s second complex litigation Xarelto trial (Daniel I. Russell, et al. v. Janssen Pharmaceuticals, Inc., et al., No. 150500362, Pa. Comm. Pls., Philadelphia Co.).
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Bayer, J&J win latest trial over Xarelto bleeding risks
Apr 27, 2018 | Reuters Westlaw
By Nate Raymond
A Pennsylvania state court jury on Friday found Bayer AG and Johnson & Johnson not liable in a lawsuit by a New Jersey man who said the drugmakers failed to warn about internal bleeding risks associated with their blood thinner Xarelto.
The verdict by a jury in the Philadelphia County Court of Common Pleas marked the latest win for the companies as they face thousands of lawsuits by people who say they suffered injuries after being prescribed the anticoagulant.
"Plaintiffs' attorneys in these cases have presented multiple theories regarding the alleged inadequacy of the Xarelto label, and all of their claims ultimately have been rejected under applicable laws," Bayer said in a statement.
The verdict came in a lawsuit filed by Daniel Russell, who said that he suffered gastrointestinal bleeding and severe anemia requiring several blood transfusions after taking Xarelto in May 2013 to reduce his risk of stroke.
J&J's Janssen Pharmaceuticals Inc unit in a statement said that it stands behind the safety and efficacy of Xarelto and will continue to defend itself in litigation.
Michael Weinkowitz, a lawyer for Russell at Levin Sedran & Berman, did not respond to a request for comment.
The Food and Drug Administration approved Xarelto in 2011. It is prescribed for people with atrial fibrillation, a common heart rhythm disorder, and to treat and reduce the risk of deep vein thrombosis and pulmonary embolisms.
The drug is Germany-based Bayer's top seller, bringing in 3.3 billion euros ($4 billion) last year. The blockbuster drug generated $2.5 billion in sales for J&J in 2017.
But plaintiffs contend Xarelto was unreasonably dangerous and that J&J and Bayer failed to warn patients about a serious risk of uncontrollable, irreversible bleeding in emergencies.
Bayer and J&J contend Xarelto's label adequately warns of bleeding risks.
Friday's verdict came in one of around 22,900 cases that J&J says are pending in federal and state courts blaming injuries on Xarelto. The companies have faced four other trials nationally over the drug, losing only one prior case in Philadelphia.
In that case, a jury awarded an Indiana woman and her husband $27.8 million in December over claims she was hospitalized in 2014 with gastrointestinal bleeding after taking Xarelto. But a judge in January later overturned the verdict.
The case is Russell v. Janssen Pharmaceuticals Inc et al, Philadelphia Court of Common Pleas, Pennsylvania, No. 150500362.
For Russell: Michael Weinkowitz of Levin Sedran & Berman
For Bayer: Albert Bixler and Leslie Hayes of Eckert Seamans Cherin & Mellott and Brian Stekloff, Lori Alvino McGill and Jeremy Barber of Wilkinson Walsh + EskovitzFor J&J: Susan Sharko, Chanda Miller, David Abernethy and Rodney Hudson of Drinker Biddle & Reath
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Strong Xarelto Label Warnings Lead To Another Jury Win For Bayer And Janssen
Apr 28, 2018 | The Pink Sheet
By Brenda Sandburg
Bayer Corp. and Janssen Pharmaceuticals Inc. seem to have the best defense against product liability suits claiming they did not provide adequate warning that Xarelto (rivaroxaban) increases the risk of bleeding: labeling that repeatedly specifies the risk.
In the fifth case to go to trial, Russell v. Janssen, jurors in a state court case in Philadelphia issued a verdict for the drug makers on April 27. The jury verdict form asked them: Do you find that the Xarelto warnings were inadequate? They answered "no," making the questions as to whether inadequate warnings were the proximate cause of harm to the plaintiff and the amount of compensatory damages moot.
With the verdict, Bayer and Janssen now have a 5-0 score in Xarelto product liability litigation. They won the first three bellwether trials held to date in federal multidistrict litigation (MDL) in the Eastern District of Louisiana. They lost the first case in the Philadelphia Court of Common Pleas, Hartman v. Janssen, when a jury issued a $28m verdict against them in December. However, Judge Michael Erdos reversed the verdict, finding that the plaintiff's prescribing doctor had been adequately warned of the bleeding risk. Erdos presided over the Russell trial as well.
"Bayer and Janssen have had successful outcomes for all five cases that have gone to trial, and the defense verdict in this trial underscores again the safety and efficacy of this life-saving medicine, and the accuracy of Xarelto's science-based, FDA-approved label," Bayer said in a statement. "Plaintiffs' attorneys in these cases have presented multiple theories regarding the alleged inadequacy of the Xarelto label, and all of their claims ultimately have been rejected under applicable laws."
Janssen also issued a statement saying the jury's decision reflects the appropriateness of the FDA-approved labeling for Xarelto and that it will continue to defend against the allegations made in the litigation.
Brian Barr, of Levin Papantonio, and Laura Feldman, of Feldman & Pinto, attorneys for the plaintiff, could not be reached for comment.
Theories Of Liability
In the MDL bellwether trials, plaintiffs' attorneys alleged that the companies failed to instruct physicians about the need to evaluate Xarelto's anticoagulant effect on individual patients with the use of a laboratory test to measure "prothrombin time" (PT). In the first Philadelphia trial, they claimed inadequate label warnings. And in the second trial they alleged that the label did not adequately warn of bleeding risks with the triple therapy of Xarelto, Plavix (clopidogrel), and aspirin.
During April 6 opening statements in that trial, Levin Papantonio's Barr said over and over that Bayer and Janssen had been "silent" about the bleeding risk with the anti-coagulant. He said the labeling did not specify that the bleeding risk was too high for patients like the plaintiff, Daniel Russell, who took Xarelto for prevention of stroke while also taking Plavix and aspirin for prevention of a heart attack. Russell experienced severe gastrointestinal bleeding as a result of taking Xarelto in May 2013. (Also see "Xarelto Liability Suit: Is Label 'Silent' About Increased Bleeding Risk?" - Pink Sheet, 8 Apr, 2018.)
In the opening statement for Bayer and Janssen, Brian Stekloff, of Wilkinson Walsh & Eskovitz, pointed to the depositions of the two physicians who prescribed Xarelto to Russell, in which they said they stood by their prescribing. He also showed a short clip of Russell's deposition, in which he said he knew of the increased risk of bleeding from taking Xarelto with Plavix and with aspirin. Stekloff also placed the labeling on an overhead projector and used a highlighter to underline the warnings of the combined use.
In addition to the labeling, the defense emphasized that the plaintiff had atrial fibrillation and had undergone a cardiac stent procedure to treat a blocked artery, and thus needed anticoagulation therapy.
Bayer and Janssen's victory shows the importance of having strong label warnings of a product's risks and the value of going to trial to fight product liability claims.
Boehringer Ingelheim Corp. faced similar suits alleging its blood thinner Pradaxa (dabigatran) caused severe bleeding and other injuries. It entered a $650m settlement agreement in May 2014 covering 4,590 claimants before the first bellwether trial was held. (Also see "Boehringer Avoids Pradaxa Trial, Board Chair Deposition With $650 Mil. Settlement" - Pink Sheet, 28 May, 2014.)
After BI announced the agreement, Xarelto cases were consolidated in multidistrict litigation for pre-trial proceedings. The Xarelto litigation is now the biggest involving a pharmaceutical product, with approximately 20,000 plaintiffs in the federal MDL and state courts. Bellwether trials, a small group of lawsuits chosen to be tried first, give an indication of what will happen with future litigation.
The next trial is scheduled to begin in Philadelphia on June 7. The case is Rush v. Janssen.
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Bayer and Janssen win in Philadelphia Xarelto trial
Apr 30, 2018 | The Pharma Letter
By Staff
After two week of trial and two days of deliberation, a Philadelphia jury has up a defense verdict in favor of Germany’s Bayer (BAYN: DE) and Johnson & Johnson (NYSE: JNJ) subsidiary Janssen Pharmaceuticals, finding that the label on the blood thinner Xarelto (rivaroxaban) adequately warned patients about the danger of severe bleeds, reported the publication Legal Intelligence.
The jury, deliberating in the second Xarelto trial to come before a Philadelphia Court of Common Pleas jury, rendered its verdict Friday morning.
The jury handed up the fourth defense verdict in Xarelto litigation in state and federal courts. A $28 million plaintiff’s verdict from a Philadelphia state court jury earlier this year was set aside by the trial judge.
“Bayer and Janssen have had successful outcomes for all five cases that have gone to trial, and the defense verdict in this trial underscores again the safety and efficacy of this life-saving medicine, and the accuracy of Xarelto’s science-based, FDA-approved label,” said Bayer spokeswoman Carolyn Nagles in a statement issued on Friday, adding: “Plaintiffs’ attorneys in these cases have presented multiple theories regarding the alleged inadequacy of the Xarelto label, and all of their claims ultimately have been rejected under applicable laws.”
The next Xarelto trial to be held in Philadelphia is set to start June 11.
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Defense Verdict Returned In 2nd Pennsylvania Xarelto Injury Trial
Apr 30, 2018 | Lexis Legal News
By Staff
A Pennsylvania state court jury on April 27 returned a defense verdict for Janssen Pharmaceuticals Inc. and Bayer Healthcare Pharmaceuticals Inc. in the state’s second complex litigation Xarelto trial (Daniel I. Russell, et al. v. Janssen Pharmaceuticals, Inc., et al., No. 150500362, Pa. Comm. Pls., Philadelphia Co.).
The verdict was returned in the Philadelphia County Common Pleas Court.
Janssen spokesperson Sarah Freeman said in a statement that the verdict “reflects the appropriateness” of Xarelto’s approved labeling.
Daniel I. Russell, now 76, of Lavalette, N.J.,...The remainder of this article is under paywall at: https://www.lexislegalnews.com/articles/26330
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