June 26, 2014 — The wife of a man who bled to death after taking Xarelto (rivaroxaban) has filed a lawsuit against the drug-maker Janssen Pharmaceuticals, a unit of Johnson & Johnson, for failing to warn that Xarelto can cause uncontrollable bleeding.
After taking Xarelto for about six months, Mr. Packard developed bleeding in his brain (subdural hemorrhage) and was admitted to a hospital. Doctors were unable to stop the bleeding, even after drilling a right frontal burr hole in his skull. The bleeding ultimately caused or contributed to his death on June 28, 2012.
Unlike warfarin, a blood-thinner that can be de-activated with a dose of Vitamin K, Xarelto has no antidote. In an emergency situation, doctors might struggle to stop bleeding because a patient’s blood is unable to clot. Despite these life-threatening risks, Xarelto lacks a “Black Box” warning about irreversible bleeding.
According to the complaint:
“Defendants failed to adequately warn about the lack of an antidote to reverse uncontrolled bleeding caused by Xarelto®. Defendants merely indicated that there was a risk for bleeding and side-stepped the important issue of reversing the effects of Xarelto® should a bleed occur. Other safer alternatives to Xarelto® have an antidote that can reverse uncontrolled bleeding.”
Janssen and Johnson & Johnson are accused of failing to warn doctors and patients about the “extreme risks” posed by Xarelto. Similar allegations have been raised against Boehringer Inhelheim, which recently paid $650 million to settle thousands of lawsuits involving Pradaxa (dabigatran). Xarelto has been linked to hundreds of adverse events involving severe, uncontrollable bleeding.
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