In a recent New York Times article, it was reported that Johnson & Johnson and Bayer, the makers of the anticlotting drug Xarelto, were complicit in staying silent in what is claimed to be an effort to protect the drug from criticism over its safety. Xarelto is sold in the U.S. by Johnson & Johnson and overseas by Bayer. Sales in the U.S. in 2015 were nearly $2 billion. Xarelto is said to be the best seller in a new category of drugs used to break up blood clots.
The claim of deception comes from what was a letter published in The New England Journal of Medicine and written primarily by researchers at Duke University that omitted laboratory data about Xarelto. Xarelto is widely used as a replacement to Warfarin, which is an older blood thinner. Johnson & Johnson and Bayer hired the Duke Clinical Research Institute to run a 3-year clinical trial involving more than 14,000 patients that led to Xarelto’s approval by federal regulators.
Those research results have come under scrutiny since Sept. 20, 2015, when the companies notified regulators that a blood-testing device used in the study had malfunctioned.
The study compared patients who were using Warfarin with those who were using Xarelto in cases of strokes and bleeding events. The principal concern is that the faulty trial results may have convinced doctors to give patients the wrong dose of Warfarin, which could have favored Xarelto. There are more than 5,000 lawsuits pending against Johnson & Johnson and Bayer for patient injuries from using Xarelto. Lawyers in the federal court in New Orleans filed a motion to unseal documents. More than 500 individual patients have died using Xarelto.
Johnson & Johnson contends that the work done by the Duke research team was completed independently of the company. There was, however, a company employee serving on the trial’s executive committee. He recused himself “from the conduct of the reanalysis, the drafting of the research letter, and provided no feedback before it was submitted.” Bayer did not provide a comment on the subject.
Interestingly, a cardiologist, Dr. Steven Nissan of the Cleveland Clinic, served on the Food and Drug Administration (FDA) advisory panel that voted to approve Xarelto in 2011. He was one of two members who voted against the drug. He said any after-the-fact analysis would give doctors and patients answers. “Given the fact that the device was inaccurate, there is no way anybody could tell you what would have happened in the trial,” Nissan said. This revelation will serve only to increase the plaintiffs’ argument that Johnson & Johnson deceived the public about the safety of Xarelto and its dangerous side effects.
Kreisman Law Offices has been handling Xarelto injury lawsuits, pharmaceutical defect cases and toxic tort cases for individuals and families who have been injured or killed by the negligence of a manufacturer, distributor and marketer of pharmaceuticals, drugs and similar products for more than 40 years, in and around Chicago, in Addison, Bridgeport, Austin, Lakeview, Bronzeville, Tinley Park, Orland Park, Mundelein, Naperville, Schaumburg, in other areas around Cook County and around the country.
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