FDA launches investigation following questions about Xarelto clinical trial safety data from Bayer, Johnson & Johnson

by Michael Heygood

The Food and Drug Administration has launched an investigation into whether a faulty blood monitor may have compromised testing results that led to the agency’s approval of the bloodthinner Xarelto. Xarelto has been prescribed to millions of Americans since it was approved by the FDA and placed on the market in 2011.

Prior to receiving FDA approval, Johnson & Johnson and Bayer conducted a clinical trial for Xarelto known as Rocket AF, which lasted from 2006 to 2010 and involved about 14,000 patients. In Fall 2015, Johnson & Johnson informed the FDA that a device used in the clinical trial used to monitor patients taking warfarin known as INRatio had been recalled because it understated a patient’s risk of bleeding. The FDA is investigating whether the problems with INRatio may have caused doctors to give patients too much warfarin, which could have increased the number of bleeding events linked to the drug during the clinical trial and caused Xarelto to appear to carry a lower bleeding risk by comparison.

Researchers at Duke University who conducted the Xarelto clinical trial have also come under fire for failing to mention the existence of laboratory tests taken at two points during the trial that could have been used to determine whether readings generated by INRatio were accurate. Officials from the Yale University Open Data Access Project have asked Johnson & Johnson to make data from the Rocket AF clinical trial available as part of a standing agreement with the group so that experts can determine whether problems with the tests may have compromised the company’s results. Although Johnson & Johnson has agreed to make the data available, Bayer, the other drugmaker that marketed Xarelto, has refused.

Information about the FDA’s investigation into Johnson & Johnson and Bayer’s clinical trial for Xarelto were revealed in a legal brief filed recently by attorneys who are representing patients who have filed lawsuits against the two companies over severe bleeding episodes linked to the bloodthinning drug. Bayer and J&J are currently facing about 3,400 lawsuits in Pennsylvania and Louisiana filed on behalf of patients who suffered gastrointestinal bleeding, bleeding requiring a transfusion, or other severe bleeding episodes after being treated with Xarelto. The lawsuits allege that Bayer and J&J failed to properly warn patients about the risk of severe bleeding they could face from taking Xarelto.

Xarelto was marketed by Bayer and Johnson & Johnson to treat patients who were at risk of developing pulmonary embolism, deep vein thrombosis, or other blood clots, including patients who underwent hip or knee replacement surgery. Xarelto patients supposedly did not require the same level of monitoring as those who were prescribed warfarin. However, because there is no readily available antidote to counter Xarelto’s anticoagulant effects, it may be more difficult to stop severe bleeding episodes in patients who are taking the drug. This could increase their risk of severe and potentially deadly bleeding episodes.

Xarelto Lawsuits Filed Against Bayer, Johnson & Johnson

Lawsuits filed against Bayer, Johnson & Johnson, and their subsidiaries have accused the drugmakers of deliberately hiding information about the dangers of Xarelto from doctors and patients. These lawsuits have also alleged that the companies knew about the health risks of Xarelto years before this information was made public, yet failed to warn patients about the health risks they might face from the drug.

Patients who have suffered gastrointestinal bleeding or other major bleeding events caused by the use of Xarelto may be eligible to file a lawsuit and receive compensation for medical expenses and other losses caused by their injuries. The first step in taking legal action is to speak with an experienced pharmaceutical litigation attorney who can help guide you through the process of filing a claim.

The law firm of Heygood, Orr & Pearson has filed hundreds of lawsuits on behalf of patients who were injured by dangerous drugs. Heygood, Orr & Pearson has already filed several lawsuits on behalf of patients who were injured after taking Xarelto or another bloodthinner, Pradaxa. Our lawyers have handled more cases involving the fentanyl pain patch than all other law firms in the country combined, and have filed numerous lawsuits on behalf of patients who were injured after taking Yasmin, Actos, Avandia, Zofran, and other prescriptions medications.

The attorneys with the law firm of Heygood, Orr & Pearson have based their careers on the idea that the manufacturers of defective drugs and dangerous medical devices should be held responsible for their actions. Our law firm has tried hundreds of cases to verdict and has achieved settlements in hundreds more. In just the last few years, our lawyers have collected more than $200 million on behalf of our clients in cases relating to defective pharmaceutical products.

If you or a loved one has been injured by the use of drugs such as Xarelto or other dangerous medical products, contact the lawyers at Heygood, Orr & Pearson to find out more about whether you may qualify to file a lawsuit. For a free legal consultation and to find out more about filing a case, please call us toll-free at 1-877-446-9001, or by following this link to our free case evaluation form and answering a few simple questions to get started.

by Michael Heygood

Michael Heygood is a licensed attorney and partner at HO&P who focuses on insurance and corporate litigation, and other civil arenas. Michael has been named multiple times to the Super Lawyers List.