Pennsylvania Xarelto Trial Begins Amidst Witness Tampering Concerns
The first bleeding-related Xarelto case to be heard in state court began in Pennsylvania earlier this month, but not before prosecutors questioned if a pharmaceutical sales rep had attempted to sway a physician’s testimony.
This bellwether case is being watched ahead of more than 1,500 Xarelto claims that have been combined in a mass tort program in Philadelphia, and another 21,000 in other states nationwide. While the Philadelphia case of Hartman v. Janssen represents the first state trial for Xarelto, three similar trials in federal court earlier this year all turned out in the defendant’s favor, signaling that patients in future trials may have an uphill climb in the courtroom.
Xarelto is a blood thinning medication approved by the U.S. Food and Drug Administration in 2011. It is used for the prevention of strokes in people with atrial fibrillation, as well the treatment of people suffering from deep vein thrombosis and pulmonary embolism and the prevention of deep vein thrombosis for hip or knee implant surgery patients.
Xarelto has been marketed jointly by Bayer AG and Johnson & Johnson’s Janssen Pharmaceuticals as a better alternative to Warfarin, an earlier class of blood thinner; however, while internal bleeding caused by Warfarin may be stopped with an intake of vitamin K, there is no known reversal agent for Xarelto-caused bleeding. In the Xarelto cases piling up across the country, plaintiffs are claiming that they experienced such internal bleeding due to their use of medication.
Rigged Clinical Trials and Downplayed Warnings?
Indiana resident Lynn Hartman used Xarelto for just over a year to treat paroxysmal atrial fibrillation. She was ordered to cease taking the medication in June of 2014, after spending four days in the hospital due to gastrointestinal bleeding.
Hartman quit using Xarelto and has not experienced any further issues since. She blames the episode on the medication, and is claiming that the drug’s label should have included additional warnings.
Thus far, attorneys for Hartman have focused on both the drug’s labeling, which they argue downplayed key warnings, as well as a clinical trial for the medication, which they said was “rigged.”
Gary Douglas, an attorney with Douglas & London PC, described Xarelto’s labeling as “grossly inadequate.” And attorney Ned McWilliams, of the Levin Papantonio firm, said that a clinical trial intended to compare Xarelto’s safety and efficacy to that of Warfarin’s had been packed with patients from Eastern Europe, where Warfarin dosing is more likely to be mishandled.
“They intentionally rigged a clinical trial,” McWilliams said, contending that the drug manufacturer “did it on purpose” and pointing out that North American data was not isolated on the label until September 2015.
Attorneys for Johnson & Johnson and Bayer, however, argued that Xarelto’s labeling had always been clear, including detailing the high number of Eastern European participants used in the trial, as well as warnings that the medication can cause bleeding.
Attorney Beth Wilkinson, of Wilkinson Walsh & Eskovitz, also said that both Hartman, as well as her physician, were aware of the risks associated with Xarelto and proceeded to use it anyway. In fact, the attorney said, the plaintiff’s physician further testified that after having learned more about the risks of the drug she would still have prescribed Xarelto to Hartman.
“She understands those risks and she thinks the benefits outweigh those risks,” Wilkinson said.
As the trial rolled into its second week, Hartman’s team turns to a former official of the U.S. Food and Drug Administration. David Kessler, who headed up the agency under President George H.W. Bush, as well as President Bill Clinton, opened week two hammering one of the plaintiff’s central arguments, describing to jurors how Xarelto’s risks were understated on the labeling and failed to sufficiently warn about the risk of internal bleeding.
Xarelto Trial Sidestory: Plaintiffs Cry Foul
Prior to the start of the Pennsylvania Xarelto trial, Hartman’s legal team raised questions about the possibility that a pharmaceutical sales representative may have attempted to sway the plaintiff’s physician’s testimony.
Hours before the trial began on Nov. 6, the plaintiff’s attorneys filed a motion requesting that the defense be barred from playing the deposition of Dr. James Aldridge, who treated the plaintiff for internal bleeding. There were concerns about a recently revealed pre-testimony visit to Aldridge’s office by the drug rep; in the subsequent testimony, Aldridge contradicted his own medical records, saying he did not believe Xarelto had contributed to the plaintiff’s injuries.
The defense was required to detail any contacts sales representatives had with physicians involved in any pending Xarelto cases. Janssen filed a report detailing the contacts in June, but the contact to Aldridge’s office was not disclosed until a supplemental filing in October.
The drug maker’s legal team produced an affidavit from the sales representative, in which she denied having any personal contact with Aldridge when visiting his office. The plaintiff’s team, however, said they needed to question the representative about the visit.
Judge Michael Erdos, of the Philadelphia County Court of Common Pleas, apparently agreed with Hartman’s team. On Nov. 8 he agreed to require the sales rep to undergo a mid-trial deposition.