Witness Testifies that Xarelto is “The Worst” of All Anticoagulants
An expert cardiologist who testified at the second Xarelto bellwether trial said that, of all the anticoagulants, Xarelto is “the worst.” The testimony was made against drug makers Janssen Pharmaceuticals and Bayer.
Frank W. Smart, MD, a board-certified doctor in cardiology at LSU School of Medicine, Testified that, “So Xarelto, of all the new oral anticoagulants, is the worst. And that’s well established in the medical literature and even by the FDA. The FDA said that Xarelto was equal to Coumadin. 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.”
The case is In Re: Xarelto (rivaroxaban) Products Liability Litigation, No. 2:15-CV-3708, before United States District Judge Eldon Fallon in the Eastern District of Louisiana.
Dr. Smart’s opinion was based on his own research, as well as internal company emails from drug manufacturers Janssen Pharmaceuticals and Bayer, and transcripts of U.S. Food and Drug Administration (FDA) reviewers’ opinions in which Xarelto was discussed.
Xarelto is a “Novel Oral Anticoagulant” or NOAC—a new oral anticoagulant. Instead of blocking clotting factor Vitamin K, Xarelto inhibits Factor Xa, which stops the prothrombin-to-thrombin conversion and thins a person’s blood.
“I read an article that was in one of the Canadian journals that was very impressive to me, and I started transitioning people off of Xarelto at that time and have completely abandoned the use of it,” the expert medical witness testified. “It was a twice-a-day drug crammed into a once-a-day prescription, and I thought that that was a poor idea. I still think it’s a poor idea.” He added that, “A practicing cardiologist sees people six, seven days a week and they don’t have time. They don’t physically have time to chase down information like this.” He also pointed out in his testimony that, “Coumadin has a black box warning that says: Bleeding is an issue. You really need to focus on this. Be careful. Monitor it, and then things like that. Xarelto, I believe, should have a black box warning as well because all the literature and the FDA said that there’s no difference.”
An FDA Black Box Warning is the strongest warning that the FDA puts on a medication.
After reading FDA transcripts, Dr. Smart said, “The conclusion seemed to be that if the FDA had had their druthers, the company would have tested a twice-a-day dose, but they went on to say that they didn’t have the capacity to force the company into doing that, and the only thing that they could do was to consider the information that had been presented to them at the once-a-day dose.
The ROCKET-AF trial of Xarelto on 7,000 patients with atrial fibrillation (Afib) found that “Xarelto was the worst in the class of these drugs. It was never shown to be superior to warfarin for either stroke or bleeding. But Eliquis, or apixaban, was shown to be superior for both,” Dr. Smart also testified.
The plaintiff attorney asked Dr. Smart: “So when we look at these drugs, if we look at Eliquis, Eliquis in the clinical trial, is shown to be superior in both safety and efficacy?” Dr. Smart responded “Yes, sir. To warfarin.”
The plaintiff attorney next asked “ So Eliquis is superior to them both. And then, when we look at Pradaxa compared to warfarin, was Pradaxa—was it superior to either —in either safety or efficacy?” Dr. Smart said “Yes, sir. It was superior in safety.”
Dr. Smart was asked “What about efficacy?” and answered “Equal.” When he was asked “And then, when we look at Xarelto, was Xarelto superior in safety?” he answered “No, sir.” When asked “Was it superior in efficacy?” he answered “No, sir.”
Dr. Smart specified that, “I think, again, playing Monday morning quarterback, I think had Eliquis been released at the time, there was no way that Xarelto would have been approved,” by the FDA, adding that, “It’s worst in class among the NOACs. 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.”
The personal injury attorneys at Parker Waichman LLP have decades of experience representing clients in lawsuits involving alleged drug injuries, including excessive Xarelto bleeds. The firm continues to offer free legal consultations to individuals with questions about filing a drug injury lawsuit.
As of first quarter 2017, more than 14,000 lawsuits brought against Xarelto were being held in a multidistrict litigation (MDL) in the United States District Court, Eastern District of Louisiana, MDL No. 2592 under Judge Eldon E. Fallon. Another 1,000 cases are on file in state court in Philadelphia, Pennsylvania and an additional 1,000 cases have been filed in Delaware.
When patients take warfarin, which is the generic name for the brand Coumadin, patients must undergo routine blood monitoring to ensure their risk of bleeding is minimized. There is an antidote to reverse the effects of warfarin should internal bleeding occur. Xarelto has been marketed to replace warfarin and is also prescribed to treat deep vein thrombosis (DVT—blood clots that form in a deep vein, typically the legs; pulmonary embolism (PE); and to minimize risks of blood clots following knee and hip replacement surgery. Xarelto is also approved to help prevent strokes in patients who have been diagnosed with atrial fibrillation, an irregular, often rapid, heart rate typically which typically leads to poor blood flow.
Xarelto was developed by Bayer Healthcare and Janssen Pharmaceuticals and was approved by the FDA in 2011 for the reduction of blood clot risks in patients who recently underwent knee or hip replacement surgery. In later 2011, approval was expanded to help prevent against stroke and dangerous blood clots in patients diagnosed with atrial fibrillation. Janssen Pharmaceuticals is a subsidiary of Johnson & Johnson.
Warfarin is an older generation blood thinner that has been prescribed for decades. Certain foods and drugs may interact with warfarin; therefore, patients who take warfarin must undergo regular blood testing to ensure warfarin blood levels are appropriate. Bleeding events in patients taking warfarin may be controlled with vitamin K. Meanwhile, Xarelto patients do not need to undergo regular testing; however, there is no antidote for uncontrolled bleeding resulting from the drug.
Plaintiffs allege that Xarelto drug makers knew that there is no antidote to reverse uncontrolled bleeding events, did not warn of this risk, and marketed the drug as a better option compared to warfarin. Johnson & Johnson’s failure to warn of the dangers associated with Xarelto and to release the drug with no antidote are the key issues in the 15,000 pending lawsuits.
Questions about Filing a Xarelto Injury Lawsuit
If you or someone you know is interested in filing a lawsuit involving Xarelto. Parker Waichman LLP offers free, no-obligation case evaluations. For more information call 1-800-YOURLAWYER (1-800-968-7529).