Johnson & Johnson Pharmaceutical Division Hid Data on Xarelto
Posted on behalf of Phillips Law Group on Oct 12, 2016 in Defective Drug
Janssen Pharmaceuticals, the pharmaceutical division of Johnson & Johnson (J&J), has been accused of knowingly using a defective device during the testing trials of Xarelto, an anticoagulant, which has been shown to cause permanent damage or death from internal bleeding.
A recent report from the British Medical Journal claims that the drug company knew that the INRation medical monitoring system that was used in the original Xarelto drug trial had been recalled for tracking and reporting errors.
Investigators state that the INRation device used to monitor blood clotting in test subjects produced inaccurate results. They claim that Janssen hid the use of the INRation device from the Federal Food and Drug Administration (FDA), which put trial subjects at risk.
The INRation device was recalled by the FDA in 2014 after discovering that it yielded lower results than methods normally conducted in a controlled lab setting. Investigators believe that Janssen also hid the results from Bayer, the company that distributes J&J’s pharmaceutical products outside of the U.S. However, both Bayer and Johnson & Johnson knew that the device was used in more recent tests.
Concerns about the reliability of the INRation device date back to 2008. During that time, Janssen set up a safety recheck program to check the accuracy of the trial’s findings. The company, however, neglected to reveal the entirety of its findings to the FDA.
Instead, the compromised data from the original trial was used to approve Xarelto to prevent blood clots and strokes in patients after surgery. The drug has proven to be a successful product for the company, earning almost $2 billion dollars in 2015 and becoming one of the most popular anticoagulants available.
However, patients who were prescribed Xarelto quickly began reporting internal bleeding that resulted in hospitalization and, in some cases, death. Now almost 11,000 people have filed Xarelto lawsuits against the drug manufacturer for its dangerous side effects.
If you or a loved one have suffered due to the effects of Xarelto, you may be entitled to compensation. Contact the defective drug attorneys at Phillips Law Group for a free review of your case to see how we can help.
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