Hartman v. Janssen
It was hailed as a superior alternative to warfarin, a cumbersome medication requiring careful monitoring at the risk of either a stroke (too small a dose) or catastrophic bleeding (too large a dose). Xarelto, also known as rivaroxaban, has been associated with episodes of uncontrolled internal bleeding. Because there is no antidote for rivaroxaban-caused bleeding, the condition can be life-threatening. Premature discontinuation of Xarelto can increase the potential risk.
At The James Esparza Law Group, our Xarelto injury attorneys in Salt Lake City know it is the alleged failure of manufacturers Janssen Pharmaceuticals, Inc. (a subsidiary of Johnson & Johnson) and Bayer AG to warn of this serious complication that has spurred 18,500 patient lawsuits in recent years.
These early bellwether cases have been closely watched by product liability attorneys in Utah and around the country, with the first win occurring in 2017, when a Pennsylvania state court jury awarded plaintiff $1.8 million in compensatory damages and $26 million in punitive damages. The basis for the verdict was the company’s failure to warn of the bleeding risk. Plaintiff’s attorney explained that serious complications suffered by thousands of patients were avoidable, if only Xarelto manufacturers had properly informed doctors about the potential risks. That particular case, Hartman v. Janssen Pharmaceuticals, Inc. et al, involved a plaintiff who suffered severe gastrointestinal bleeding.
Xarelto’s Trouble History
Xarelto was first approved by the U.S. Food & Drug Administration (FDA) in 2011, despite medical reviewers recommending against approval, indicating concerns that patients given warfarin during the trial were poorly managed, meaning Xarelto would have been handed an advantage in comparisons.
Still, it’s become a blockbuster money-maker for the manufacturers, prescribed to millions of patients in the U.S., accounting for 7 percent of Johnson & Johnson’s overall pharmaceutical revenues and generating $2 billion in sales in the U.S. alone.
However, just two years after Xarelto hit the market, the FDA issued a warning letter to manufacturers about potential bleeding risks.
The following year, the FDA mandated two “black box” warnings, one about the heightened risk of bleeding when someone suddenly stops taking the drug and another for the risk of spinal or epidural hematoma. Black box warnings appear on a prescription drug’s label, and are designed to call attention to serious or life-threatening risks of taking that drug.
In 2016, the FDA launched an investigation to determine whether a defective blood testing device may have compromised the results of a clinical trial of Xarelto. The agency sought answers to detailed questions, such as whether the manufactures had any indication the device was malfunctioning during the clinical trial. Rocket AF, the name of the clinical trial, involved 14,000 patients globally between 2006 and 2010 and sought determination of compare the risks of bleeding and strokes for users of Xarelto versus users of warfarin. Questions about the blood testing device first surfaced in 2014, when manufacturers informed regulators the device had been recalled. The Duke Clinical Research Institute that oversaw the trial insists the faulty device had not affected the clinical trial’s outcome. Still, regulators remain concerned the defect could have resulted in patients receiving the wrong dose of warfarin, which would lead to more uncontrolled bleeding episodes and give Xarelto an unfair advantage.
Despite Duke’s insistence the faulty device didn’t affect research outcomes, one of the renowned cardiologists on the FDA advisory panel who voted not to approve Xarelto back in 2011 told The New York Times there was no way anybody could know what would have happened in the trial, given that the device was inaccurate.
Further, the researchers’ response to the query raised more questions because it did not include central laboratory tests that could have been used to make sure accurate readings were being given. And the European drug agency that conducted a similar study did include evidence of such tests, but they were conducted by the drug companies, not independent researchers.
That same year, Xarelto injury attorneys alleged in federal court that Bayer and Johnson & Johnson misled editors of one of the world’s most prestigious medical journals, The New England Journal of Medicine. They alleged a letter written by Duke University researchers omitted critical lab data, and that the manufacturers stayed quiet about it, raising serious ethical and safety concerns.
Now, there are tens of thousands of Xarelto lawsuits pending, with 5,000 in a multi-district litigation in the U.S. District Court’s Eastern District of Louisiana. Of those, approximately 500 involve patient deaths.
While only a few Xarelto lawsuits have gone to trial, what most have in common is they allege manufacturers Johnson & Johnson and Bayer falsely marketed the drug as being more effective in halting strokes than warfarin and being easier to use, given that Xarelto use didn’t need constant blood plasma level monitoring.
Failure to warn is considered a marketing defect in a product liability lawsuit. It can be alleged even when no design flaw or manufacturing defect exists. Although many helpful drugs have serious side effects, patients and physicians may willingly accept the trade-off, but they deserve to be fully informed. Inadequate instructions or improper warnings put consumers at risk, which means any hidden or non-obvious dangers need to be clearly stated.
One of Xarelto’s defenses has been that patients can’t definitively prove that physicians would not have prescribed the drug even if they had the blood-clotting warning.
The first several bellwether cases resulted in jurors siding with manufacturers. It wasn’t until the $28 million verdict in the Philadelphia case that plaintiffs had a major win. That victory is likely to impact the odds manufacturers will settle pending and future Xarelto cases, which Forbes estimates would cost approximately $3.25 billion for all of them. By comparison, German pharmaceutical manufacturer Boehringer Ingelheim paid $650 million to settle some 4,000 lawsuits pertaining to use of Pradaxa, another blood-thinner.
Our Utah Xarelto injury attorneys in Salt Lake City recognize that this litigation is incredibly complex, and those affected have a big decision to make when it comes to choosing a lawyer.
Contact the Salt Lake City Xarelto injury attorneys at the James Esparza Law Group by calling toll-free 800-745-4050.
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Our dedicated attorneys in Salt Lake City can help you file your Xarelto lawsuit and navigate through what is a confusing process.