“Part of my job here is to look into the crystal ball and see what cases are going to be supported by the science,” says Koon, a former JAG. “I’m looking at the FDA information and some of the studies that have been done on this class of drugs, and we see a product that is going to be somewhat similar to Praxada in terms of litigation.”
Xarelto was brought to market in 2011 by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. Like Praxada, it is prescribed to patients with atrial fibrillation (Afib), a condition that carries a high risk of stroke.
The new anticoagulants are considered an alternative to Warfarin, a long-standing blood thinner drug that has been in use since the 1950s.
Unlike Warfarin, Xarelto does not require monthly monitoring for possible increased bleeding risk. It is marketed as a new kind of anticoagulant that allows patients freedom from routine testing trips to the doctor.
“The fact that it needs no regular testing is really the crux of the problem,” says Koon.
A recent study done by a team from Brown University and published in JAMA-Neurology found that although the newer anticoagulants appear to lower the risk of intracranial bleeding events, they are also associated with a significant increase in gastrointestinal bleeds when compared to Warfarin.
Xarelto also requires that patients strictly follow the prescription directions and they should never abruptly stop using the anticoagulant.
Most important, should a bleed occur in Xarelto patients, there is no way to stop the hemorrhaging, and there is no easy coagulant available at this time.
“There is no antidote for bleeding in Xarelto patients,” says Koon. “That means it could be deadly.
“We know there were scientists who recommended Xarelto not be approved by the FDA,” says Koon. “I think when we peel away the layers, the science and information is going to show this is a dangerous drug.”
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“I enjoy this job because it is like constantly drinking from the fire hydrant,” says Koon. “There is just so much coming at you.
“I get to participate in trying to make a safer world out there, from my perspective,” adds Koon. “You cannot put corporations that act badly in jail, but you can make them pay money that makes them change their behavior,” says Koon.
David Koon is an attorney with Hughes & Coleman with offices in Louisville and Nashville. Koon specializes in mass torts and personal injury law. He is a former JAG. He holds a JD from Northern Kentucky University.