New Orleans, LAThousands of Xarelto lawsuits have been filed against the makers of the blood thinner, alleging patients suffered serious injuries or even death as a result of taking the anticoagulant. Among the alleged Xarelto side effects are an increased risk of uncontrolled bleeding, which can turn into a fatal bleeding event. In addition to Xarelto, the makers of other blood thinners also face allegations of failure to adequately warn about the risks associated with their drugs.
According to court documents, one such lawsuit was filed in February by a woman who alleges she suffered serious side effects from using Xarelto. The plaintiff, Margaret Garvy, argues she only used Xarelto from May 8, 2014 to May 18, 2014 - 10 days. On May 18, she allegedly suffered hemorrhagic pericardial effusion, pericardial tamponade and plural effusion, requiring hospitalization and medical treatment and resulting in permanent injuries.
The lawsuit alleges patients were not adequately warned about the risks associated with Xarelto, but Garvy’s lawsuit further alleges the trials on which Xarelto was approved - the RECORD studies - were “flawed in design and conducted in a negligent manner.”
“In fact, FDA Official Action Indicated (‘OAI’) - rated inspections in 2009 disclosed rampant violations including, ‘systemic discarding of medical records,’ unauthorized unblinding, falsification, and ‘concerns regarding improprieties in randomization,’” the lawsuit claims. “As a result, the FDA found that the RECORD 4 studies were so flawed that they were deemed unreliable.”
Despite concerns about the RECORD trial, Xarelto was approved for use, partially based on a trial known as the ROCKET AF trial. That trial showed Xarelto was at least as good as warfarin in preventing stroke or systemic embolism in patients with non-valvular atrial fibrillation, according to the lawsuit. But Garvy alleges the study participants who received warfarin were not well managed, and as a result, Xarelto appeared to be non-inferior to warfarin, when the two groups could not have been adequately compared.
“The warfarin group in the ROCKET AF study was the worst managed warfarin study group in any previously reported clinical trial involving warfarin,” Garvy’s lawsuit alleges.
Of concern is that Xarelto was reportedly marketed as not requiring blood monitoring - which ensures patient’s blood plasma levels stay within certain guidelines - but critics and some patients say Xarelto is still safer if patients receive regular monitoring and dose adjustments.
As of April 15, 2015, there were 4,579 lawsuits consolidated for pretrial proceedings in MDL 2592 before US District Judge Eldon E. Fallon.
The Garvy lawsuit is Garvy v. Janssen Research & Development, et al., Case number 2:16-cv-01359, US District Court, Eastern District of Louisiana.
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