An In Depth Look At The Xarelto Case
Johnson & Johnson and Bayer, who were recently sued as part of several mass tort litigations on both state and federal levels, have agreed to pay $775 million to settle approximately 25,000 lawsuits involving the blood thinner Xarelto, which is jointly sold by both companies. They decided to split the settlement evenly between them.
Warafin, Xarelto, And Andexxa
Intended as a replacement for Warafin, which had been on the market for about 60 years, Xarelto thins the blood in order to prevent arterial fibrillation, a rhythmic heart disorder, and to prevent the types of blood clots that cause pulmonary embolisms, strokes, and heart attacks. It was approved by the U.S. Food and Drug Administration (FDA) in 2011.
The lawsuits allege that the medication triggered substantial bleeding that led to death and grave injury. The episodes were resistant to standard treatments, and patients had to endure years without an antidote. Last year, however, the FDA approved Andexxa, which successfully stops bleeding induced by Xarelto. The medication is sold by Pfizer and Bristol-Myers Squibb.
Interestingly, patients taking Warafin, the original drug, had to be closely monitored, including undergoing frequent blood tests, to confirm that the drug was working at all. Too little of the drug could result in a stroke, too much could result in the kind of stomach bleeding exhibited in the Xarelto cases.
Statements And AccusationsBoth state and federal cases blame the companies for failing to warn about potentially fatal bleeding that can occur when the drug is ingested. Interestingly, neither company admitted liability, with each noting in separate statements that they had won in six previous lawsuits that actually went to trial.
Hartman Etal vs. Janssen Pharmaceuticals, Inc Etal
Plymouth, Indiana resident Lynn Hartman, 75, was prescribed Xarelto by her doctor and took the drug from March 2013 to June 2014. Throughout that time Hartman claims she experienced gastrointestinal bleeding, at which point she stopped taking the drug. Hartman drew from the Xarelto amended master complaint to bring the following claims: design defect, manufacturing defect, negligent misrepresentation, breach of express warranty, failure to warn, breach of implied warranty, and both fraud and violation of consumer protection laws in Indiana and Pennsylvania.
A Flawed Clinical Trial?
Lawyers for the plaintiffs in previous lawsuits questioned whether the initial clinical trial that resulted in the drug’s approval was inherently flawed due to a defective blood-testing monitor that was used throughout the study. Essentially, the lawyers claimed the machine skewed the results. However, the FDA eventually stepped in and concluded that the defects had no bearing on the trial’s outcome.
The device in question is the INRatio, which is sold by Alere. The INRatio was originally used to test whether patients were administered correct doses of Warafin. During the trial, the plaintiff’s attorneys compared the overall number of bleeding occurrences experienced by patients taking Xarelto to those who used to take Warafin. One of the key questions regulators are examining is whether the defective INRatio may have given doctors inaccurate information, which caused them to prescribe too much Warafin.
The Defendants Settle Despite Winning Streak In State And Federal Courts
Johnson & Johnson and Bayer’s decision to settle seems all the more perplexing in light of a specific 2018 case that saw the plaintiff, Lynn Hartman, awarded $28 million, only to have the ruling subsequently reversed by Judge Michael Erdos. This decision was quickly followed by another victory for the defendants.
Lawyers for the plaintiffs in the second case accused Johnson & Johnson and Bayer of spreading “inaccurate or misleading statements regarding the present status of the Xarelto litigation in an attempt to undermine the soundness of plaintiffs’ failure-to-warn claims”.
The defendants responded to this accusation by detailing the specific accusations against them they deemed to be false. First, they were accused of improper testing prior to release, as well as lacking a black box warning about potential bleeding risks. Second, they said they were accused of failing to inform doctors about certain testing. The latter theory was eventually rejected in three multi district litigation (MDL) trials.
Michael M. Weinkowitz, a member of the plaintiff’s legal counsel, claimed the reversal had more to do with the doctor who wrote Hartman’s prescription: “The dismissal was based on a very narrow issue related to Mrs. Hartman’s prescribing physician. However, the court also ruled that the jury’s punitive damages verdict was appropriate and that sufficient evidence existed for the jury to find that the defendants acted with reckless disregard for human life.”
Weinkowitz went a step further in suggesting that the jury’s $26 million in punitive damages “has far broader implications for the Xarelto litigation as a whole”, thus implying that this ruling could be the turning of the tide.
The Defendant’s Decision Bears Similarities To An Older Case
In 2014, German pharmaceutical manufacturer Boehringer Ingelheim paid $650 million to settle approximately 4,000 lawsuits over their drug Pradaxa, which was facing similar accusations of injuries and bleeding deaths. Their response was strikingly similar to Johnson & Johnson and Bayer’s: “Time and again, the benefits and safety of Pradaxa have been confirmed.”“