J&J Hid Faulty Device from FDA in Xarelto Clinical Trial
Posted by PKSD Law Firm on Oct 12, 2016 in Dangerous Drugs
When investigators examined a key trial involving Bayer’s Xarelto, they used a specific monitoring device to track the occurrence of blood clots in trial participants called INRatio. The device was later recalled due to tracking errors.
According to new evidence and a related report from the British Medical Journal, Johnson &Johnson knew about the faulty device and incorrect data and may have hidden the information from the Food and Drug Administration.
Investigators became concerned about the data provided by INRatio monitoring equipment in 2008 and started a recheck of the reliability of the data. Bayer noted that it did not know about the recheck until early in 2016. It alleges that Janssen, the company that managed the trial, deliberately did not tell Bayer about the recheck.
Bayer and Janssen note that only a small percentage of the information is likely considered inaccurate, and these small inaccuracies would not compromise the overall results of the study. The European Medicines Agency reports that patients should still continue to use Xarelto as directed by their doctors.
Effect on Xarelto Lawsuits
This new information could spark additional lawsuits regarding Xarelto. Evidence like this could support claims that both Johnson & Johnson and Bayer misled patients about the safety and effectiveness of the blood thinner.
Some Xarelto users have experienced uncontrolled internal bleeding, which has led to significant long-term problems. A 2016 study by David J. Graham published in JAMA Internal Medicine fuels concerns regarding increased bleeding and mortality compared to similar drugs in patients that have atrial fibrillation (AF).
Bayer, Johnson & Johnson, and Boehringer Ingelheim, the drug’s manufacturer, are all facing thousands of lawsuits across the country regarding the drug. In 2014, Boehringer Ingelheim settled 4,000 lawsuits by paying $650 million to victims. Another 11,000 patients have filed claims against Johnson & Johnson, Janssen, and Bayer, arguing that Xarelto is unsafe and ineffective.
If you or a loved one has been negatively affected by Xarelto, you may have legal options. Contact the drug injury lawyers at Pitman, Kalkhoff, Sicula, & Dentice for more information.