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Opening arguments began this week in the Philadelphia Court of Common Pleas for a product liability lawsuit over the bleeding injury risk with Xarelto, serving as another “bellwether” trial for thousands of similar complaints filed by individuals nationwide.
Xarelto (rivaroxoaban) was introduced in 2011, as the second member of a new class of drugs known as novel oral anticoagulants. The drugs were were marketed as easier to use than warfarin, which had been the go-to anti-clotting treatment for decades. However, as an alarming number of adverse event reports involving severe Xarelto bleeding problems began to emerge, mounting litigation has been filed against the drugs manufacturers.
This is the first trial to take place in Pennsylvania state court, where about 1,500 claims have been filed. However, most cases have been filed at the federal level, where more than 18,000 cases over Xarelto are pending, each involving similar claims that individuals suffered severe and uncontrollable bleeds while using the anticoagulant. Plaintiffs allege that inadequate warnings and instructions were provided for consumers and the medical community.
The case involves a lawsuit filed by Lynn Hartman and her husband, which indicates that side effects of Xarelto caused severe internal bleeding. The opening arguments, originally scheduled for Monday morning, were delayed until Monday afternoon over concerns that a Janssen sales representative had contact with Hartman’s doctor.
Plaintiffs told Judge Michael Erdos, who is overseeing the trial, that Lynn Hartman’s doctor, Dr. James Aldridge, flipped his testimony after meeting the sales rep. Aldridge reportedly originally indicated that he would testify that Hartman’s gastrointestinal bleeding injuries were caused by Xarelto. However, after meeting with Janssen’s sales representative, he now claims he did not even know she had a gastrointestinal bleeding injury, according to her attorneys.
The sales representative met with Aldridge just a few weeks before the scheduled deposition of Aldridge, but plaintiff attorneys were originally unaware of the meeting. However, after discovering the meeting took place, they said that alarm bells went off due to a similar incident in a recent DePuy Pinnacle hip lawsuit in Texas. The same defense law firm is involved in both cases, and subsidiaries of Johnson & Johnson are involved in both claims.
Defense attorneys maintain that the sales representative only called Aldridge’s office, and neither met nor spoke with him. Judge Erdos has said he will review the testimony.
While this is the first state-level Xarelto lawsuit to go to trial, three prior cases went before federal juries, each resulting in defense verdicts in favor of the drug makers.
In May, the first Xarelto jury trial ended in a defense verdict, after a jury found that Joseph Bourdreaux, Jr. failed to meet the necessary burden of proof. In June, a second bellwether trial, involving claims filed by Sharon Orr, also ended in a defense verdict.
Similar allegations were raised in thousands of Pradaxa lawsuits filed several years ago, as that medication hit the market before Xarelto. However, the maker of that competing drug ultimately agreed to pay $650 million in Pradaxa settlements just before the first bellwether trials were set to begin, with an average of about $150,000 per claim.
While the outcomes of these early bellwether trials are not binding on other plaintiffs with claims bending, they are closely watched by the parties, and may influence Xarelto settlements, which would be necessary to avoid the need for thousands of individual trials nationwide.