Xarelto’s Original Study Comparing the Drug to Warfarin Appears to Have Been Skewed
In 2010, The New England Journal of Medicine released a study Rivaroxaban versus Warfarin in Nonvalvular Atrial Fibrillation. The study was called the Rocket-AF study and was a comparative study of safety and effectiveness between Xarelto and Warfarin. The drug was approved for public consumption in 2011, in part due to the finding that the makers of Xarelto, Bayer and Johnson & Johnson, purported after the conclusion of the study. Soon after the drug went to market, reports of serious and fatal side effects began to surface. In light of these reports, many claims and allegations have been part of a rapidly rising number of court cases against the makers of Xarelto. Included in these allegations is the claim that a device used in the study was defective and led to skewed findings. In fact, internal company documents have been brought to light as part of these claims showing that Johnson & Johnson knew about the defective device yet continued with the study and released the results.
In large part, Xarelto’s success has been propagated by an ad campaign based largely on claims that the drug was more effective, safer and less obtrusive than its leading competitor, Warfarin. Patients who use Warfarin are required to undergo regular blood monitoring, dietary restrictions, and dosage adjustments. Warfarin can also have dangerous side effects but the risks are known and there are ways to counteract many of these side effects. Xarelto aggressively promoted the drug as being exempt from the need of blood monitoring, dosage adjustments and as a safer alternative to Warfarin. These claims by the makers of Xarelto were substantiated by the findings of the ROCKET-AF study. Xarelto’s popularity exploded and the drug quickly became one of the fastest growing pharmaceuticals on the market, in large part due to their claims of being as effective and safer than Warfarin. Soon, however, it became apparent that Xarelto was not as safe as advertised. Thousands of patients and their families have experienced life-threatening and fatal side effects from using Xarelto.
In the aftermath of thousands of injured or deceased patients and a rising tide of litigation against Bayer and Johnson & Johnson, the statistical methods, and validity of the study have come under severe scrutiny. A device called INRatio was used in the study to gauge a patient’s international normalized ratio (INR), which is an international parameter used to adjust dosages has now been found to have been defective. The malfunction of this device skewed the study’s results which showed Xarelto to be as effective as and safer than Warfarin. The defective device would have caused doctors to gather incorrect data and likely they were administering the incorrect dosages of Warfarin to the patients in the study. Controversy over the study has ensued with investigations yielding different opinions concerning the validity of the ROCKET-AF study. However, groups such as the European Medicine Agency (EMA) and the Duke Clinical Research Institute who have attempted to defend the study both have vested interests in positive results. The Duke team was the group that actually performed the trial to begin with and members of the EMA were actually members of the company that makes the device. This conflict of interest cannot be ignored, especially in light of all the problems that have ensued since the drug hit the market. In addition, Johnson & Johnson has funded subsequent studies in an attempt to validate the findings of the ROCKET-AF study themselves. Yet again, these studies can’t be trusted as there is such a tremendous conflict of interest.
Once the FDA got involved in investigating the INRatio device, they sent warning letters to the makers of the devices reporting that their devices were producing clear inaccuracies in gauging patient’s dosage parameters. The matter was ignored until finally in 2014 the company recalled the devices from the market. The fact the device was recalled casts a dark shadow over the ROCKET-AF study and its findings. The FDA continues to investigate the validity of the ROCKET-AF study and how the defective INRatio device likely skewed the results. This has not been lost on plaintiffs or their legal counsel as these cases are getting underway. It is clear that Bayer and Johnson & Johnson knew about the defective device used in their ROCKET-AF study and it is clear that they have been negligent in the testing and promotion of Xarelto. The first of the Xarelto Lawsuits, which is a bellwether trial, scheduled for March 2017, is now underway in Louisiana. Subsequent trials around the country are scheduled to get underway throughout 2017 and certainly, more will follow.