Xarelto manufacturers, Bayer and Johnson & Johnson face new allegations claiming that they provided misleading information about laboratory tests. Allegations are that Johnson & Johnson and Bayer are responsible for the publication of research data that ignored faults in testing methods and painted Xarelto as a safer replacement to warfarin. Ultimately this omission is at the heart of consumer complaints of unknowingly take severe risks when using the blood-thinning medication.
What is Xarelto?
Xarelto, also known as rivaroxaban, is an anticoagulant (blood-thinning) medication used to treat:
- Atrial Fibrillation (an irregular heartbeat condition),
- deep vein thrombosis (DVT; blood clots forming in extremities such as the legs),
- pulmonary embolisms (a blockage of the pulmonary arteries in your lungs, usually caused by DVT), and
- blood clotting risks following knee or hip replacement surgery.
J&J and Bayer advertise that Xarelto reduces the unnecessary needs of blood monitoring, dietary restrictions, or frequent dosage adjustments. Lawsuits against the blood thinner and its manufacturers claim that it was not properly tested or documented prior to receiving its market approval by the U.S. Food and Drug Administration (FDA) in 2011. The alleged side effects of the drug include:
- rectal and intestinal bleeding
- brain hemorrhaging
These side effects are supposedly untreatable because there is no antidote to Xarelto. (See the warnings and precautions for Xarelto concerning the risk of bleeding.)
What are the new allegations?
Duke University’s Clinical Research Institute was hired by both pharmaceutical companies to conduct a three-year clinical trial with Xarelto and warfarin to compare the number of bleeding and stroke incidents experienced by over 14,000 patients. The results of Duke’s trials led to Xarelto’s FDA approval, but an investigation revealed that:
- The device used to test the two drugs may have been faulty and was providing Xarelto with an unfair advantage;
- Duke published its researchers’ analysis of the trial in the New England Journal of Medicine (NEJM) claiming that the faulty device didn’t change the results; and
- Duke failed to relate the results of other testing methods that analyzed the device’s findings, a fact that wasn’t made known to the journal’s publisher until it was noted by The New York Times.
J&J and Duke both claim that they work independently of each other. However, J&J’s refusal to provide the additional lab results and Xarelto’s compromised safety adds ammunition to the victims’ allegations of the companies’ fraudulent behavior.
How do the new allegations affect lawsuits?
The allegations that J&J and Bayer misinformed the NEJM by omitting information from Duke’s lab test results could directly correlate with both doctors and patients becoming misled concerning the safety of Xarelto. This allegedly willful misinformation may add additional evidence supporting the lawsuits’ claims of fraud and patient endangerment, which could potentially benefit the victims’ cases. Duke claims that the defective testing device did not influence the results.
Get the legal help you need
Over 5,000 lawsuits have been filed against J&J and Bayer over the Xarelto scandal. Five hundred of these lawsuits involve the loss of loved ones due to complications with Xarelto. This possible discovery of fraudulent behavior will most likely add a considerable advantage to the patients’ cases against the companies. If you or someone you know has suffered from complications with using Xarelto, contact a local personal injury attorney to find out what you can do to protect your rights and seek compensation for your hardship. You don’t need to suffer in silence—get the help you deserve.