FDA Launches Investigation into Xarelto Clinical Trials After Reports that Blood-Detecting Device Malfunctioned During Tests

The U.S. Food and Drug Administration (FDA) has launched an investigation into whether the agency was correct in approving the prescription blood thinner Xarelto. Since hitting the market in 2011, Xarelto has been prescribed to millions of patients. Major household product and drug manufacturer Johnson & Johnson created Xarelto and submitted the product for clinical testing prior to seeking approval from the FDA.

The drug was developed as a replacement for warfarin, an older prescription intended to prevent strokes from occurring in patients that suffer from atrial fibrillations, which is a heart-rhythm disorder. Administering warfarin requires close supervision to prevent complications from arising. Too little warfarin can lead to strokes, while too much can lead to other dangerous complications.

The FDA, which is tasked with overseeing the regulation, safety, and approval of pharmaceutical drugs in the U.S., has asked Johnson & Johnson a number of questions regarding whether the company knew that a blood-testing device used in the clinical trials was malfunctioning during the tests. The issue has also come up in pending lawsuits brought by individuals against Johnson & Johnson, claiming they suffered severe injuries as a result of taking Xarelto. Documents filed in the litigation indicate that physicians had questioned the accuracy of the device while the trials were underway and that Johnson & Johnson eventually launched a special investigation into the device’s efficacy, but it failed to provide this information to the FDA when seeking approval for Xarelto.

To recover compensation from a drug manufacturer, a plaintiff must show that the drug was unreasonably dangerous or that the company failed to include proper safety warnings and instructions with the device. This type of claim is known as a product liability claim and usually uses a strict liability standard. Unlike in a negligence claim, the plaintiff does not need to prove that the defendant failed to exercise due care. There are a number of other claims that an injury victim can bring against a drug manufacturer, including breach of warranty claims, negligence, and consumer fraud.

The clinical trial in question was conducted by Dr. Robert M. Califf, who is also the President’s current nominee to become the FDA’s head administrator. The trial encompassed some 14,000 patients around the world and ran from 2006 to 2010. Concern over its efficacy first arose in the fall of 2015 when Johnson & Johnson and Bayer, which distributes Xarelto internationally, informed regulatory officials that the blood-testing device had been recalled during 2014 after it was found that the device was misreporting the risk of bleeding in each trial patient.

Alere manufacturers the blood-testing device, which is called INRatio, and it was used in the trial to help doctors determine whether patients were receiving the correct amount of warfarin. The clinicians then compared the incidences of strokes and bleeding experienced by patients taking warfarin to those taking Xarelto.

According to Johnson & Johnson, it chose the Alere brand device because it had FDA approval, and it was simple to use. Regarding the allegations that the device was defective, the company has said that it acted in the best interests of the patients and doctors by taking urgent and diligent action upon finding out about the potential issue.

If you or someone you love has suffered injuries as the result of a dangerous pharmaceutical, you may be entitled to compensation. At Moll Law Group, our experienced team of dangerous drug lawyers have provided compassionate, diligent, and personalized legal counsel to victims throughout the United States, including in New York, Illinois, Texas, and Florida. Call us at 313-462-1700 or contact us online to set up a free consultation.

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