The respected medical journal JAMA Internal Medicine published a report Feb. 9 citing instances in which the U.S. Food and Drug Administration uncovered “misconduct” in the way clinical trials to test the efficacy of drugs are carried out. Sure enough, FDA inspections of clinical trials for the drug rivaroxaban, which goes by the brand name Xarelto, found irregularities.
The problems with Xarelto clinical trials are significant from legal and moral standpoints because nearly 100 federal Xarelto lawsuits already have been centralized before the U.S. District Court for the Eastern District of Louisiana for pretrial management. The cases center on the drug’s alleged unreasonable risk of uncontrollable bleeding.
The panel of federal judges that put those cases before one judge held, “These actions share common factual questions arising out of allegations that plaintiffs suffered severe bleeding or other injuries as a result of taking Xarelto (rivaroxaban) and that defendants did not adequately warn prescribing physicians or consumers of the Xarelto side effects, including the potential for severe or fatal bleeding and the unavailability of a reversal agent to counteract Xarelto’s anticoagulation effects. Issues concerning the development, manufacture, regulatory approval, labeling, and marketing of Xarelto thus are common to all actions.”
The FDA inspects clinical trial data and categorizes the data either as devoid of violations, as bearing violations not serious enough to warrant sanction or as “official action indicated,” abbreviated OAI, which means the clinical trial has a problem worthy of a regulatory crackdown.
The FDA classified a mere 2 percent of its 644 clinical trial site inspections as the very serious OAI during fiscal year 2013. Results from the inspection of blind clinical trial data for the generic Janssen Pharmaceuticals blood thinner were, to say the least, somewhat disconcerting.
As the JAMA Internal Medicine article points out, “Eight of 16 FDA inspections of sites involved in a clinical trial of rivaroxaban, a novel anticoagulant, had been rated OAI. These inspections had uncovered evidence of various transgressions, such as ‘systemic discarding of medical records,’ unauthorized unblinding, falsification, and ‘concerns regarding improprieties in randomization.’ Consequently, the entire study, RECORD 4 (Regulation of Coagulation in Orthopedic Surgery to Prevent Deep-Venous Thrombosis and Pulmonary Embolism 4) was deemed unreliable by the FDA. These problems are not mentioned in the article describing the study’s results or in other publications associated with the trial.”
The authors recommend, “The agency should make sure that any substantial evidence of misconduct is available to editors and readers of the scientific literature.”
The product liability attorneys at Reich & Binstock would prefer that pharmaceutical companies be forthright in the first place with all of the clinical trial data. First of all, it is the right thing to do. Moreover, alleged failure to warn consumers about supposed unreasonable risks is an issue in Xarelto lawsuits.
This report, with respect to Xarelto lawsuits, topples one more domino in the chain of alleged negligence.
The Xarelto Litigation Team at Reich & Binstock represents patients who claim that the use of Xarelto caused their serious injuries. Anyone else who believes they suffered bleeding injuries as a result of using Xarelto may be entitled to compensation, and they are welcome to contact one of the Xarelto attorneys at Reich & Binstock for a free consultation.
Contact Reich & Binstock either by calling the toll-free number below or by submitting an electronic message through its web page.
The U.S. Food and Drug Administration since 2011 approved Xarelto for the following purposes: to reduce the risk of deep vein thrombosis, or DVT, and pulmonary embolism, or PE, that might occur following knee replacement or hip replacement surgery; to actually treat DVT and PE and to reduce their recurrence following initial treatment; and to reduce the risk of stroke in people who have a type of abnormal heart rhythm called non-valvular atrial fibrillation.
