Law360 (August 30, 2018, 7:01 PM EDT) — 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 and Janssen on Thursday were successful in a suit alleging the companies did not provide adequate warnings about the risks of the anticoagulant Xarelto, the latest in a string of victories in litigation over the drug. (Getty)
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.
–Editing by Aaron Pelc.
Update: This story has been updated to include a statement from an attorney for the plaintiff.