As 18,000 Xarelto lawsuits wait in the wings, first bellwether trial brings verdict in favor of Johnson & Johnson, Bayer.
By Laurence Banville
A federal jury in Louisiana has exonerated Johnson & Johnson and Bayer in the first trial held over the companies' blockbuster blood thinner medication Xarelto, according to Reuters. The trial began on April 24 and lasted just over one week.
Learned Intermediary Doctrine Stymies Xarelto PlaintiffIn a judgment issued on May 3, 2017, the New Orleans jury held that Xarelto's manufacturers had not failed to warn a Xarelto patient's medical team of the drug's link to severe internal bleeding. The case rested on the commonly-used "learned intermediary" doctrine. While some states require that individual patients receive sufficient warning, many suggest that a manufacturer's obligation to warn is exhausted after an "intermediary" medical professional has been adequately apprised of the dangers. Louisiana is one such state, in which the learned intermediary doctrine is routinely applied to limit the liability of pharmaceutical companies.
The plaintiff, Joseph Boudreaux, claims that a Xarelto prescription led to internal bleeding, cardiovascular ailments and a week-long stay in the Intensive Care Unit. While such risks are common to most anticoagulant drugs, Boudreaux argued that Xarelto's lack of an effective reversal agent rendered the med unreasonably dangerous. Now in his 70s, Boudreaux works as a part-time security guard, Bloomberg reports.
"Simple" Blood Test Could Prevent Bleeds, Attorneys SayIn a statement, the man's attorneys expressed "disappointment" with the verdict, but noted that the first Xarelto bellwether trial will serve as a learning experience. The legal team intends "to press forward with the [...] claims of thousands of innocent victims whose lives have been shattered by Xarelto." Lawyers maintain that Johnson & Johnson and Bayer failed to adequately warn the medical community and public of the prescription's risks.
Moreover, they say the companies should have been more aggressive in marketing a "simple test" that can be used to predict high-risk patients. "[Bayer and Johnson & Johnson] only accept science they like," plaintiffs' attorney Brian Barr said in his closing argument, "and decide to ignore science they don't like. They know if they require [a] blood test, they're terrified that doctors will just use another drug." Xarelto's main competitor, the decades-old blood thinner Coumadin (warfarin), comes with an effective antidote.
Three More Trials On Horizon According to Fierce Pharma, Joseph Boudreaux was the first patient to file a Xarelto lawsuit in the United States. His claim is now joined by around 18,000 other lawsuits, many of which have been consolidated in the US District Court for the Eastern District of Louisiana. The next bellwether trial, slated to be held in the Louisiana court, is expected to begin on May 30, 2017. A third trial, scheduled in the US District Court of Mississippi, will begin at some point in June, with a fourth kicking off in Texas the following month. Both Mississippi and Texas have adopted the "learned intermediary" doctrine as a valid defense argument.
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