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The blood thinner (rivaroxaban) is not only inferior to the decades-old Coumadin (warfarin), is “the worst” of all the new generation oral anticoagulants on the market, an expert cardiologist testified during the second bellwether trial.
Dr. Frank Smart, the chief of cardiology and a professor of medicine at Louisiana State University School of Medicine, told jurors that he came to his conclusion based on a combination of his own research, internal company emails from blood thinner manufacturers Janssen Pharmaceuticals and Bayer, and transcripts of Food and Drug Administration (FDA) reviewers’ opinions, legal industry website MasssTortNexus.com reported.
More than 15,000 blood thinner lawsuits have flooded the U.S. court system, so many that a federal multi-district litigation—in the Eastern District of Louisiana—was created to more effectively manage the massive caseload.
Forty cases were chosen to be test cases in the product liability lawsuits, legally referred to as bellwether trials.
According to Smart’s testimony, medical literature supports his opinion that the blood thinner is the most inferior new generation anticoagulant on the market.
“The FDA said that was equal to Coumadin,” he testified. “The other drugs, which would be apixaban or Eliquis, dabigatran or Pradaxa and edoxaban or Savaysa, are in one shape or form superior either in anticoagulation effect or in bleeding or in both.”
“It’s worst in class among the (new oral anticoagulants),” according to Smart. “That’s pretty accepted. I mean, it’s a four-horse race, and they are the fourth horse. This adds concern that the approval was maybe less grounded in great science.”
He cited a clinical trial of 7,000 atrial fibrillation patients that found to be last in its class of drugs, noting that research indicates that Eliquis (apixaban), for example, is superior to Coumadin (warfarin) for either stroke or bleeding.
Coumadin (warfarin) has been on the market for more than 60 years, but requires patients to stick to dietary restrictions, mainly limiting foods that are rich in vitamin K as well as fish, liver, grapefruit, cranberries, green tea, cranberry juice and alcohol, all of which can reduce the drug’s effectiveness.
Patients taking Coumadin also must regularly have their blood monitored.
The blood thinner and its competitors are marketed as maintenance free. But thousands of plaintiffs allege that the drug makers failed to adequately warn about the risks of uncontrollable internal bleeding.
In the event of an internal bleeding episode, a dose of Vitamin K and plasma can reverse Coumadin’s anticoagulant effects, but with and the other newer anticoagulants, there is no approved antidote.
plaintiffs maintain that had they been aware of the lack of an antidote to stop internal bleeding, they would have opted not to take the drug.
Smart testified that he has stopped prescribing to his patients and opined that, like Coumadin, should have a black box warning—the FDA’s strictest warning—alerting consumers of the risk of irreversible bleeding.
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