The Controversial Approval of Xarelto by the FDA

The controversy over Xarelto approval by the FDA and alleged irregularities in the conduct of the ROCKET-AF clinical trial continue to hang over the heads of Bayer and Janssen (a division of Johnson & Johnson), the manufacturers and marketers of Xarelto, in the national MDL litigation. Since the inception of the Xarelto MDL proceedings before Judge Fallon in New Orleans, the plaintiffs have contended that there were irregularities in the ROCKET-AF clinical study, which served as the basis for approval of the drug in the United States several years ago. The plaintiffs contend that irregularities in the conduct of that study underestimate the risks of serious Xarelto bleeding events (GI bleed, cardiac tamponade, intracranial hemorrhage, etc.) associated with Xarelto while overstating the benefits of the drug in preventing strokes when compared with warfarin (also known as Coumadin).

Over the past few months, there have been a number of motions filed in the MDL federal court proceedings seeking to unseal a number of documents that may help to shed light on this issue. In February of 2016, the New York Times wrote an investigative report on irregularities that may have occurred during the clinical study.

On March 16, 2016, the Editor in Chief of the British Medical Journal sent a letter to Judge Fallon requesting that confidential information that has been uncovered during the course of the litigation be released to the public “so that appropriate review and scrutiny may take place. The documents at issue here are not a trivial matter:  they relate directly to ongoing regulatory investigations and question the safety of a medicine that is being taken by millions of patients around the world.” The BMJ Editor’s request specifically noted the need for release of sealed documents that relate to, among other things, “that the sponsor, Janssen, was aware of a malfunctioning device during the ROCKET-AF trial” and “evidence of possible misconduct during the peer review process of Duke Clinical Research Institute’s reanalysis of ROCKET-AF data, which was published in the New England Journal of Medicine.” On February 3, 2016, the British Medical Journal published an article entitled “Rivaroxaban:  can we trust the evidence?” which shed light into the possible use of a faulty device during the ROCKET-AF trial.

On March 15, 2016, the Project on Government Oversight (“POGO”), a nonprofit watchdog organization, also wrote to Judge Fallon seeking release of the sealed Xarelto documents that are included in the MDL discovery production. This group is particularly interested in the details regarding the ROCKET-AF clinical trial, oversight of Xarelto by the FDA and the European Medicines Agency, and the involvement of Dr. Robert Califf (who is now the Commissioner of the FDA) in the clinical trial that led to the FDA’s approval of Xarelto.

In its letter, POGO noted to Judge Fallon: “In the litigation before you, plaintiffs and defendants have given sharply divergent accounts of evidence that remains under seal, leaving all others to wonder which account if either is accurate. The press and the public should be permitted to see the evidence in this case and assess it for themselves.” The letter to the judge closed by saying: “All too often, class action lawsuits and the like raise important questions involving the public interest and are then resolved on terms that forever bury the answers. Please do not allow that to happen in this case. Please unseal the evidence as complete and expeditiously as possible.”

The judge’s order does not directly address these requests other than to make the letters part of the MDL record. Judge Fallon did, however, enter orders relating to the Plaintiffs’ Motion to Challenge Confidentiality Designations and directed that certain exhibits be delivered to the Food & Drug Administration. Also, it appears that there are a number of investigations ongoing by these watchdog organizations, regulatory agencies, and medical journals with regard to these troubling issues.

(Originally printed at
http://www.jdsupra.com/legalnews/xarelto-s-approval-by-the-fda-83977/