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Xarelto Cooney Verdict Media Monitoring Report - August 30, 2018
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Philadelphia Jury Hands Bayer & Janssen Defense Win in Xarelto Litigation
Aug 30, 2018 | The Legal Intelligencer
By Max Mitchell
A Philadelphia jury has handed up a defense verdict in the latest trial over the adequacy of the warning labels for the blood thinner Xarelto. -
Bayer, Janssen Win Another Xarelto Injury Trial In Philly
Aug 30, 2018 | Law360
By Matt Fair
Bayer AG and Janssen Pharmaceuticals Inc. notched the latest in a string of victories in litigation over injuries allegedly linked to the anticoagulant medication Xarelto on Thursday as a Philadelphia jury rejected claims that the companies failed to provide adequate warnings about the drug’s risks. -
Bayer, J&J cleared of liability in latest Xarelto trial
Aug 30, 2018 | Reuters
By Tina Bellon
A Pennsylvania jury on Thursday found for Bayer AG and Johnson & Johnson in a case alleging their blood thinner Xarelto caused a man's excessive internal bleeding, handing defense attorneys another win in massive litigation over the blockbuster drug. -
Latest Xarelto trial brings sixth consecutive victory for its manufacturers, Johnson & Johnson and Bayer
Aug 31, 2018 | Pennsylvania Record
By Nicholas Malfitano
Manufacturers of blood-thinning medicine Xarelto have prevailed in a Philadelphia court for the third time and for the sixth time in total, defeating liability claims that the drug caused gastrointestinal bleeding in a plaintiff who was prescribed it.
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Philadelphia Jury Hands Bayer & Janssen Defense Win in Xarelto Litigation
Aug 30, 2018 | The Legal Intelligencer
By Max Mitchell
The verdict marked the second straight defense verdict out of Philadelphia for drugmakers Bayer and Janssen Pharmaceuticals, which saw similar wins in a string of cases tried last year in federal court. The decision Thursday was rendered after three weeks of trial, and less than a day of jury deliberation.
In statements emailed Thursday morning the defense companies said the verdicts underscore the safety of the drug and its warning label.
“Plaintiffs’ attorneys in these cases have presented multiple theories regarding the alleged inadequacy of the Xarelto label, and all of their claims have ultimately been rejected under applicable laws,” Bayer spokesman Dan Childs said.
“The jury’s decision affirms that the FDA-approved labeling for Xarelto adequately informs doctors of the potential risks and benefits of this important life-changing medicine,” Janssen spokeswoman Sarah Freeman said.
Wilkinson Walsh + Eskovitz attorneys Alexandra Walsh and Tamarra Matthews Johnson and Mike Zellers from Tucker Ellis represented the defendants during trial. Neil Overholtz of Aylstock, Witkin, Kreis & Overholtz, Ellen Relkin of Weitz & Luxenberg and Brad Honnold from Goza & Honnold tried the case for Cooney.
In a statement emailed Thursday, Overholtz said, “We are disappointed in the verdict but believe the evidence presented showed that Bayer and Janssen rejected requests of the FDA and outside experts to study the lower safer dose of Xarelto for a decade for economic reasons. Instead the evidence showed that dosing decisions were driven by investor relations and profit concerns instead of patient safety.”
In addition to the two defense verdicts out of Philadelphia state court, the defendants won three defense verdicts in federal court trials. The only plaintiffs win so far, which was a $28 million verdict awarded late last year, was later tossed out by the trial court.
According to court records, more than 1,900 Xarelto cases are pending in the mass tort program in the Philadelphia Court of Common Pleas. The parties are currently in the process of wading through 12 cases to determine which cases should go to trial next year.
Although some of the theories that have been presented at trial have differed slightly, all of the filed cases are based on claims that Bayer and Janssen failed to adequately warn about the dangers of the blood thinner.
Thursday’s verdict comes in a case involving Kevin Cooney, who suffered a severe bleed while taking the blood thinner, which had been prescribed after he suffered a pulmonary embolism.
During closing arguments Wednesday, Overholtz told jurors that, in a rush to bring Xarelto to the market, the drugmakers had failed to perform needed testing of lower doses of the drug. He argued that, after learning about the efficacy and risks of a 20 milligram dose of the blood thinner, the defendants should have worked to develop a 10 milligram dose—a dose that Overholtz told jurors likely would not have caused the severe bleed that his client, Cooney, suffered while taking Xarelto.
“‘Comfortable enough,’” Overholtz said, citing a Bayer email about whether its researchers should perform additional testing. “Is that what we want from our drug companies when they have a chance to find out more information?”
Overholtz told jurors during his closing arguments that internal emails from Bayer, which initially developed the drug, showed that some researchers believed there should have been more studies aimed at lower doses of the drug. He said the company didn’t want to delay the drug’s launch, fearing it could lose out on as much as $4 billion. The company, he said, only decided to study the lower doses when it became clear that Eliquis, a competing blood thinner, was set to hit the market after Xarelto’s initial release.
Johnson, who gave part of the closing arguments for the defendants, told jurors that Cooney had been in danger of suffering a fatal blood clot when he was prescribed the medication, and that his treating doctor properly weighed the risks of a serious bleed with the risk of another stroke. She also contended that the label adequately warned about the risks, and that the bleed Cooney suffered could have happened with any blood thinner.
Walsh also told the jury that researchers had definitely considered additional testing of lower doses, and none of the emails were meant to be secretive. She said that any company would want to consider what additional testing may be needed, but, given the severity of the blood clots that Xarelto is meant to treat, the company did not feel that testing the efficacy of lower doses was needed at that time.
“When you push for a lower dose in patients with risk for [pulmonary embolism] and [deep vein thrombosis], people have more PE and DVT,” Walsh said.
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Bayer, Janssen Win Another Xarelto Injury Trial In Philly
Aug 30, 2018 | Law360
By Matt Fair
Bayer AG and Janssen Pharmaceuticals Inc. notched the latest in a string of victories in litigation over injuries allegedly linked to the anticoagulant medication Xarelto on Thursday as a Philadelphia jury rejected claims that the companies failed to provide adequate warnings about the drug’s risks.
The verdict represents the third win that Bayer and Janssen have secured in as many Xarelto-related trials in Philadelphia County, and it follows a separate trio of victories the companies earned in cases tried as part of a federal multidistrict litigation program out of Louisiana.
“Bayer and Janssen have had successful outcomes in all six cases that have gone to trial, and the defense verdict in this trial again underscores the safety and efficacy of this life-saving medicine and the accuracy of Xarelto’s science-based, FDA-approved label,” Bayer spokesman Dan Childs said in a statement.
The latest case centered around claims from a New Jersey resident, Kevin Cooney, that he suffered a gastrointestinal bleed after taking Xarelto as a precaution against his developing venous thromboembolism.
According to court records, Cooney claims that Bayer and Janssen should have recommended a lower dose of the drug for patients like him, and that the dose he received — 20 milligrams — created an unreasonable risk of internal bleeding.
Cooney argued that Bayer and Janssen failed to test a lower dose to see if it had a more favorable risk-benefit profile for prevention of venous thromboembolism.
He said in court papers that the higher dose put him “at an unreasonably high risk of bleeding simply because defendants did not want to risk loss of market share by timely conducting proper dosing studies to assess the safest effective dose.”
Bayer and Janssen, however, have argued that bleeding was a well-known risk with Xarelto and that it was mentioned as a possible side effect some 70 times in the medication’s labeling.
Ultimately, jurors sided with the two companies.
Ellen Relkin, an attorney with Weitz & Luxenberg PC representing Cooney, said she stood by Cooney's claims despite the verdict.
"We are disappointed in the verdict but believe the evidence presented showed that Bayer and Janssen rejected requests of the FDA and outside experts to study the lower safer dose of Xarelto for a decade for economic reasons," she said in a statement. "Instead the evidence showed that dosing decisions were driven by investor relations and profit concerns instead of patient safety."
Cooney’s position regarding the safest effective dose of the medication is the latest theory that plaintiffs have pursued in Xarelto cases that have been tried in Philadelphia.
An initial trial last year centered around whether Bayer and Janssen negligently failed to include information in Xareto’s warning label about a clinical study that showed a higher rate of bleeding among patients in the U.S. than patients elsewhere in the world.
That case resulted in a $28 million verdict in December, but a judge later threw out the verdict based on testimony that additional warnings would not have changed a prescribing doctor’s decision to offer the drug.
A second case, in which a jury returned a defense verdict in April, involved claims that Bayer and Janssen had designed a clinical study about the risks of taking Xarelto, Plavix and aspirin in tandem — a treatment plan referred to as triple therapy — to involve patients on a lower dose of Xarelto than was typically prescribed.
“Plaintiffs’ attorneys in these cases have presented multiple theories regarding the alleged inadequacy of the Xarelto label, and all of their claims have ultimately been rejected under applicable laws,” Childs said in his statement on behalf of Bayer.
Janssen similarly praised Thursday’s verdict.
“Today’s jury’s decision affirms that the FDA-approved labeling for Xarelto adequately informs doctors of the potential risks and benefits of this important, life-changing medicine,” spokeswoman Sarah Freeman said. “At Janssen, nothing is more important to us than the health and safety of the patients who use our medicines. We stand behind the safety and efficacy of Xarelto and will continue to defend against the allegations made in this litigation.”
Cooney is represented by Ellen Relkin of Weitz & Luxenberg PC, Neil Overholtz of Aylstock Witkin Kreis & Overholtz PLLC, and Brad Honnold of Goza & Honnold LLC.
Neil Overholtz (Aylstock,Witkin, Kreis & Overholtz) and Brad Honnold (Goza & Honnold)
The defendants are represented by David Abernathy, Chanda Miller, Susan Sharko and Rodney Hudson of Drinker Biddle & Reath LLP, Michael Zellers of Tucker Ellis LLP, Albert Bixler and Leslie Hayes of Eckert Seamans Cherin & Mellott LLC, Robert Heim and Judy Leone of Dechert LLP, and Alexandra Walsh, Tamarra Matthews Johnson and Rakesh Kilaru of Wilkinson Walsh & Eskovitz.
The case is Kevin Cooney v. Janssen Pharmaceuticals Inc. et al., case number 160602012, before the Court of Common Pleas of Philadelphia County, Pennsylvania. -
Bayer, J&J cleared of liability in latest Xarelto trial
Aug 30, 2018 | Reuters
By Tina Bellon
A Pennsylvania jury on Thursday found for Bayer AG and Johnson & Johnson in a case alleging their blood thinner Xarelto caused a man's excessive internal bleeding, handing defense attorneys another win in massive litigation over the blockbuster drug.
The jury at Philadelphia's Court of Common Pleas reached the verdict after a nearly four-week trial in the case of 63-year-old New Jersey resident Kevin Cooney, who claimed Xarelto was defectively designed and that Bayer and J&J should have manufactured the medication in lower doses to minimize bleeding risks.
Bayer and Janssen Pharmaceuticals, a unit of J&J, in statements said the jury decision affirmed the adequacy of Xarelto's warning label and underscored the drug's safety and efficacy.
Thursday's verdict marked the sixth ruling for the defense in trials over Xarelto, a so-called modern anticoagulent with the active ingredient rivaroxaban. Federal juries cleared the companies of liability in three 2017 bellwether trials that were part of a consolidated multidistrict litigation.
The companies also won an April trial in Philadelphia and a Philadelphia trial court judge in January overturned the only plaintiff-friendly jury verdict in another case.
"Plaintiffs' attorneys in these cases have presented multiple theories regarding the alleged inadequacy of the Xarelto label, and all of their claims have ultimately been rejected under applicable laws," Bayer said in a statement.
Neil Overholtz of Aylstock Witkin Kreis Overholtz, Brad Honnold of Goza & Honnold and Ellen Relkin of Weitz & Luxenberg, lawyers for Cooney in the latest Philadelphia trial, said they were disappointed with the verdict.
"(We) believe the evidence presented showed that Bayer and Janssen rejected requests of the FDA and outside experts to study the lower safer dose of Xarelto for a decade for economic reasons," the attorneys said in a statement.
Cooney was prescribed Xarelto in 2014 after he suffered a pulmonary embolism and took the medication until the end of 2015, when he had to be hospitalized with gastrointestinal bleeding, according to his 2016 complaint. He received three units of blood transfusions after losing nearly a third of his blood, the lawsuit said.
Plaintiffs have made various allegations about Xarelto, Bayer's best-selling drug.
They claim a plasma heparin test, which can determine a patient's risk of bleeding, would have prevented many injuries and should have been included on the drug's warning label. Plaintiffs also allege manufacturers held back data showing Xarelto's bleeding risk is significantly greater among patients who take the drug in combination with other blood-thinning medications, such as Aspirin.
The companies, which jointly developed Xarelto, have denied those allegations and said the drug's FDA-approved label provides "complete, accurate and science-based information on the medicine's benefits and risks."
Bayer and J&J face more than 24,800 cases over Xarelto in state and federal courts across the United States. The majority of those cases, some 22,000, are consolidated in MDL proceedings before U.S. District Judge Eldon Fallon in New Orleans, Louisiana. Around 1,900 state court cases have been consolidated in Philadelphia's Court of Common Pleas.
The case is Kevin Cooney v. Janssen Research & Development at the Philadelphia Court of Common Pleas, case no. 160602012
For plaintiff: Neil Overholtz of Aylstock Witkin Kreis Overholtz
For defendants: Tamarra Matthews Johnson and Alexandra Walsh of Wilkinson Walsh + Eskovitz; Mike Zellers of Tucker Ellis
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Aug 31, 2018 | Pennsylvania Record
By Nicholas Malfitano
Manufacturers of blood-thinning medicine Xarelto have prevailed in a Philadelphia court for the third time and for the sixth time in total, defeating liability claims that the drug caused gastrointestinal bleeding in a plaintiff who was prescribed it.
In Cooney v. Janssen Research & Development, LLC Et.Al, plaintiff Kevin F. Cooney, 63, of Morristown, N.J, said he was prescribed Xarelto in 20 milligram-doses by Dr. Michael Scola of Regional Cancer Care Associates, also in Morristown, in November 2014.
Cooney took the drug for approximately 13 months until December 2015, and claimed that year-plus-long use was the cause of his injuries.
In his June 2016 complaint, Cooney alleged he suffered “gastrointestinal bleeding requiring four days of hospitalization and transfusions of at least three units of packed red blood cells and an esophagogastroduodenoscopy” on Christmas Day 2015, an injury diagnosed by Dr. Kelly Ayre at Morristown Medical Center, in Morristown, N.J.
Cooney initially pursued claims of strict liability, manufacturing defect, design defect, failure to warn, negligence, breach of express warranty, breach of implied warranty, negligent misrepresentation, fraud and violations of Pennsylvania’s Unfair Trade Practices and Consumer Protection Law. Through previous proceedings in the matter, only the “failure to warn” claim remained – predicated on what the defendants either knew or should have known at the time Cooney was prescribed Xarelto.
Representatives of Xarelto’s manufacturers, Janssen Pharmaceuticals and Bayer Pharmaceuticals, offered comment on the latest Xarelto verdict.
“Today’s jury’s decision affirms that the FDA-approved labeling for Xarelto adequately informs doctors of the potential risks and benefits of this important life changing medicine. This is the sixth consecutive decision rendered in favor of the defendants in these cases,” Janssen spokesperson Sarah Freeman said.
“At Janssen, nothing is more important to us than the health and safety of the patients who use our medicines. We stand behind the safety and efficacy of Xarelto and will continue to defend against the allegations made in this litigation.”
Bayer representative Dan Childs echoed those sentiments.
“Bayer and Janssen have had successful outcomes in all six cases that have gone to trial, and the defense verdict in this trial again underscores the safety and efficacy of this life-saving medicine and the accuracy of Xarelto’s science-based, FDA-approved label. Plaintiffs’ attorneys in these cases have presented multiple theories regarding the alleged inadequacy of the Xarelto label, and all of their claims have ultimately been rejected under applicable laws,” Childs stated.
“The health and safety of our patients is Bayer’s top priority. With more than five years on the U.S. market and 42 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 stands behind the safety and efficacy of Xarelto and will continue to vigorously defend it.”
The Food & Drug Administration (FDA) approved Xarelto in 2011 for prescription to patients suffering from a rhythmic heart disorder called atrial fibrillation and to prevent blood clots which can lead to heart attacks, strokes and pulmonary embolisms.
Plaintiffs and their counsel charge Xarelto’s manufacturers with failing to properly warn patients that Xarelto use presented increased risks for cranial and gastrointestinal bleeding when taken once daily and not properly monitored.
Plaintiff counsel believe the PT test, which has been used to identify patients with bleeding risks for years, would have been beneficial to plaintiffs negatively affected by the drug. In contrast, counsel for Xarelto’s manufacturers countered that the PT test isn’t reliable for assessing the anti-coagulant activity of Xarelto, for purposes of clinical decision-making.
Currently, more than 1,910 cases – most from out-of-state plaintiffs – will be handled in Philadelphia’s Complex Litigation Center. The CLC has several mass tort programs, including cases over asbestos and Risperdal, and the percentage of claims belonging to out-of-state plaintiffs has traditionally been in the high 80s.
In 2016, the percentage for pharmaceutical lawsuits dropped to 74 percent. In 2017, CLC stats show that figure jumped to an unprecedented 94 percent. Statistics recently released from the CLC for the first half of 2018 show the rate of out-of-state plaintiffs only dropped slightly, to 84 percent.
A separate group of more than 18,000 Xarelto lawsuits have been consolidated through the federal court system’s multi-district litigation (MDL) process, which utilizes bellwether trials to establish evidence and determine any settlement value for similar plaintiff claims.
The federal Xarelto MDL is listed as Case No. 2592, consolidating individual actions filed against Bayer, Janssen and Johnson & Johnson. U.S. District Court Judge Eldon E. Fallon presided over the initial three federal bellwether trials, two of which took place in New Orleans, La., plus another in Jackson, Miss.
After three consecutive verdicts for the defense in the federal court Xarelto bellwether trials and a fourth case being voluntarily dismissed with prejudice, a Philadelphia court jury initially awarded a landmark $27.8 million amount to Xarelto plaintiffs Lynn and Allen Hartman of Plymouth, Ind. – however, that result was later overturned due to an issue with plaintiff Lynn Hartman’s prescribing doctor, notching four consecutive defense verdicts.
Another previous defense verdict in the case brought by New Jersey’s Daniel I. Russell made five, and the result of the instant case involving Cooney brings the total number of defense verdicts to six.
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