Rosenbaum & Rosenbaum, P.C. | May 17, 2016 | Defective Drugs
Thousands of lawsuits are now being filed against the manufacturers of the blood thinner, Xarelto. These claims include that patients of Xarelto, have suffered serious injuries and even death as a product of taking the anti-coagulant drug. Specifically, they allege that the side effects of Xarelto include excessive and most importantly, uncontrollable bleeding which they were not sufficiently warned of by the makers of Xarelto. In fact, alarming questions are now being raised about the reliability in critical data of the type of testing that was used that ultimately led to Xarelto being approved for market use.
ROCKET AF was a study used to compare the effects of Xarelto versus another blood thinner, Warfarin, in atrial fibrillation patients. This trial demonstrates the similar risks and effects of stroke and major bleeding events for each blood thinner and the basis of the FDA’s approval of Xarelto. However it is alleged in the thousands of lawsuits against the manufacturers of Xarelto that not only were patients not adequately warned of the risks, but that these trials on which Xarelto was approved were severely flawed. Specifically, it is alleged that the Warfarin group was not properly managed during the ROCKET AF study and therefore, the two groups could not have been sufficiently compared. For example, the portable device used to monitor and regulate Warfarin was severely defective. This effected the portrayal of Xarelto as being an equal, one-dose alternative to other blood thinners on the market.
This device, the Alere INRatio and INRatio2 Pt/INR Monitor System, determines each patient or subjects INR or International Normalized Ratio levels and was the subject of a Class I FDA recall in 2015. According to the FDA, Class I recalls are the most serious type of recall. The device was meant to determine the INR levels for each subject taking either Warfarin or Xarelto and the data used to compare the relationship between the coagulation time of each subject and the normal coagulation time. It is claimed that this defective device caused inaccurate INR levels to be collected painting an erroneous picture of the effectiveness of Xarelto and masking its now undeniable risks. This study has been accused of inadequately concluding that Xarelto, compared with Warfarin provides important safety benefits for AF patients, based on a defective method and device.
Patients taking Xarelto should consult with their doctor immediately. As the number of lawsuits grow daily for defective drugs, more and more inadequacies of the testing and warnings of Xarelto are beginning to come to light. The negligence and greed of the anti-coagulants manufactures have led to serious injury, prolonged hospital stays and death.