According to court records, Bayer AG and Janssen Pharmaceuticals are facing close to 6,000 lawsuits alleging that the companies failed to warn about the risks associated with Xarelto, an anti-coagulant drug. Plaintiffs in the litigation allege that the blood thinner caused irreversible bleeding, because Xarelto lacks an antidote. They accuse Bayer and Janssen of failing to disclose the lack of an antidote, alleging that the companies instead pushed Xarelto as a superior alternative to warfarin.
Warfarin is an anti-coagulant that requires blood monitoring and dietary restrictions. It has been on the market for decades. Plaintiffs in the litigation point out that bleeding in warfarin patients can be reversed.
Recently, clinical trial data has been called into question during the course of the Xarelto litigation. In September 2015, Bayer and Janssen told the U.S. Food and Drug Administration (FDA) that one of its blood testing devices used in an ongoing 3-year study was faulty. This raised concerns about erroneous data possibly being submitted to the New England Journal of Medicine (NEJM) and subsequent drug approval.
Duke University researchers responded to the situation. In a February 2016 letter to the NEJM, the researchers said a re-analysis showed that the flawed data did not affect the study’s overall findings. Even more questions were raised, however, when the New York Times cited a foreshadowing footnote in a legal brief. According to NYT, the footnote led some to question whether Bayer and Janssen were aware of the flawed data prior to FDA approval.
NYT reports that so far, the answers seem unclear. For instance, an independent laboratory had collected control data that may have shown the device was faulty. This data, however, was never submitted to the NEJM. Then, there was confusion about the existence of comparative data. When a peer reviewer asked researchers if comparative data existed, they said none did. Later, they clarified this response, stating that the question had been phrased in a manner that questioned if there was control data available throughout the entire study. They pointed out that control data was only collected twice during the six-month trial.