One of the most vital aspects of the xarelto class action is the application of the “learned intermediary doctrine”. A common misperception by the public is that a pharmaceutical manufacturer like Bayer or Janssen Pharmaceuticals (the current defendants in the multidistrict litigations in Pennsylvania and Louisiana) has a duty to warn xarelto users regarding the risks hemorrhages, strokes, and bleedouts. This is a misconception.
In reality, if pharmaceutical manufacturers can show that they adequately informed the doctor of the risks of their drugs, then the manufacturers can shield themselves from product liability suits, even if ultimately patients do not receive any warnings. In reviewing manufacturer warnings, it is tempting to analyze the FDA Black Box Warnings and the Medication guide, both of which the FDA approves. A Black box warning appears on a prescription drug label and highlights life threatening or serious adverse effects for the consumer. Medication Guides are paper copies that accompany prescription medicines which deal with both general and specific information on harmful or threatening drug effects. However, a Xarelto lawsuit lawyer is more interested in the FDA approved prescribing information ie. Determining what manufacturers provided to the prescribing doctors.
Xarelto / Rivaroxaban belongs to a class of drugs known as NOACs – Non Vitamin K Dependent Anticoagulants. Other drugs in this class include Pradaxa and Eliquis. These specific NOACs were all evaluated against warfarin, a traditional anticoagulant, and underwent clinical trials and obtained FDA approval. Moreover, Xarelto defendants like Bayer AG and Janssen Pharmaceuticals touted NOACs and being more effective and safer than Warfarin, employing direct to consumer advertising (DTC). Interestingly, only the USA and New Zealand permit DTC advertising of prescription drugs.
To successfully succeed on a pharmaceutical liability suit, it is critical that a xarelto attorney prove the prescribing physician did not have enough information as to the risks and benefits of xarelto upon drafting the prescription. As Xarelto litigation develops, the key component for a xarelto law firm is to prove the doctor would never have prescribed rivaroxaban (the official medical term for xarelto) had they had a complete picture of the risks of xarelto bleeding problems. A xarelto lawsuit based on inadequate or misinformation communicated to physicians focuses on three (3) major areas. The first area is whether the manufacturer sufficient communicated risks of xarelto as a blood thinner or whether doctors commonly knew the risks of rivararoxaban. The second area is whether rivaroxaban manufacturers accurately communicated the benefits of the blood thinner without exaggeration. The final area is whether the manufacturer in any way misled the prescribing doctor about the risks or benefits of xarelto.
Xarelto in particular was tested against Warfarin to obtain FDA approval, and marketed as being more effective and safer than Warfarin. Despite no antidote for uncontrolled bleeding caused by Xarelto (as opposed to warfarin which uncontrolled bleeding could be controlled by Vitamin K), Janssen and Bayer heavily marketed Xarelto. It should be noted that the pharmaceutical manufacturers did include a warning in the FDA approved prescribing information that a specific antidote for rivaroxaban was not available. An argument can be made that such warnings were inadequate.
However, the most damning aspects of the prescribing information were inadequate representations of the benefits and safety of Xarelto over warfarin. Specifically, scientific research now reflects xarelto is not as effective as warfarin. The manufacturers exaggerated the benefits to push greater prescriptions. Nor is xarelto safer than warfarin given the major risk of unsafe bleeding events. It should also be noted that the xarelto dosage of 1x per day leaves Xarelto users with diminished protection against coagulant protection for extended periods of time. If you are considering a lawsuit from xarelto side effects, please contact Baseluos Law Firm immediately.