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Defense Relies on Learned Intermediary Doctrine to Win First Xarelto Trial

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In April 2017, the first bellwether trial in Xarelto Multidistrict Litigation (MDL) was tried. The Xarelto MDL is located in the Eastern District of Louisiana, which is where the first trial took place.

The lawsuit was filed by a man who claimed to have started taking Xarelto in 2014 to help prevent his risk of stroke due to atrial fibrillation. Less than a month later, he was hospitalized with dangerous gastrointestinal bleeding.

The plaintiff’s doctors were able to save him, but he required multiple blood transfusions that resulted in medical bills totaling over $100,000. He blamed manufacturers Janssen Pharmaceuticals, parent company Johnson & Johnson, and Bayer AG for failing to provide adequate warnings about the risks associated with their drug, and sought to recover damages for his injuries.

The case came to a close in May 2017. The Louisiana jury returned a defense verdict, finding the drug makers were not liable for failure to warn. The next trial is scheduled to begin in Louisiana at the end of May.

Former FDA Commissioner Testifies on Plaintiff’s Behalf

According to Pennsylvania Record, plaintiffs called former FDA commissioner Dr. David Kessler to testify on regulatory matters. Dr. Kessler testified that the Xarelto manufacturers withheld important information about the drug and its effectiveness—information that could have helped prevent excessive bleeding injuries.

Dr. Kessler criticized the manufacturers for failing to provide patients and their doctors with adequate warnings about the risks associated with the drug.  The manufacturers, he testified, could have easily recommended that patients get regular blood monitoring while taking the drug to ensure that the patient wouldn’t suffer an excessive bleeding injury.

The companies, instead, overstated the convenience of Xarelto, assuring patients they didn’t have to have blood monitoring.  This information would have been particularly helpful to certain populations who already have an increased risk for excessive bleeding.

The plaintiff’s counsel emphasized that unlike warfarin, Xarelto has no readily available antidote for excessive bleeding, making it more dangerous to the patient. A hematologist also testified that Xarelto was a substantial factor in causing plaintiff’s gastrointestinal bleed.

Defendants Lean on Learned Intermediary Doctrine

The Xarelto manufacturers, meanwhile, argued that all blood-thinners like Xarelto carry risks of bleeding, and they warned of these risks in their prescribing information. The plaintiff’s doctors also testified that they believed they were right to prescribe Xarelto, and they were aware of the bleeding risks.

In Louisiana, manufacturers are required to warn only the medical professional of the potential side effects of a drug. The defense relied on the “learned intermediary” doctrine in their defense, which provides that, as long as the doctor is aware of the risks, the manufacturer cannot be held liable for those risks. Since the plaintiff’s doctors stated they were aware of the risks, the jury ultimately agreed with the defendants that they had provided adequate warnings and instructions regarding the drug’s risks.

Nearly 18,000 other Xarelto lawsuits are pending in this MDL and in other courts around the country. It is unclear how this first decision will affect future outcomes. The next case will be tried in Louisiana, the third in Mississippi, and the fourth in Texas.