In what is probably one of the boldest allegations to come to light in the last few years, plaintiffs accuse Johnson (J&J) and Bayer Corp. (Bayer ) of false advertisement claims regarding Xarelto’s safety, in particular as the pharmaceutical companies deliberately avoided to adequately warn patients about the dangerous consequences of the absence of a reversing agent. All the advertisement on Xarelto (rivaroxaban) found in medical journals, relied on safety claims that where backed by unreliable and poorly managed data studies that Johnson & Johnson (J&J) and Bayer Corp performed during the drug’s initial tests. All the data used by the US Food and Drug Administration (FDA) to approve Xarelto, was provided by the same companies: Johnson (J&J) and Bayer Corp. (Bayer ). The data was thus considered to be adequate to define Xarelto as a drug possessing an appropriate risk/benefit profile for the patients’ target it was intended to.
Xarelto was designed to be an easy-to-use, once a day oral anticoagulant, and as an alternative to the other staple blood-thinner treatment: Warfarin (Coumadin). Unlinke Warfarin though, one of the main selling points of Xarelto is that it does not require constant blood monitoring. This last characteristic has been used as an advertisement slogan throughout the entire marketing campaign. Due to its inherent life-threatening dangerousness though, this same information turned out to be potentially lethal for many patients, and in turn represented the starting point of the Xarelto Lawsuit.
Xarelto is the most widely publicized drug in the medical journals that doctors and physicians read to keep track of the latest medical and pharmaceutical advancements. One of the most blatant lies that both patients and the medical community were lead to believe, was telling them that a reversing agent such as vitamin K was available and ready in case of an emergency.
Xarelto is used in the treatment of atrial fibrillation, deep vein thrombosis or pulmonary embolism. More recently a few more medical studies with allegedly fabricated data were published, and Xarelto has been approved for patients who underwent of knee and hip replacement surgery. What makes this medication incredibly dangerous though is the fact that even the smallest accidents such as a deep cut or lesion can cause a bleeding event that there’s no way to stop, potentially threatening the patient’s life and preventing the hip and knee from properly healing.
The Xarelto lawsuit asserts that several cases of improper dosing were reported, as well as a significant number of lost medical records, falsifications, and unreliable and/or badly handled data influenced and also encumbered the outcomings of many of the studies referenced in the advertising materials proposed to physicians.
Ads in medical journals focused on Xarelto’s ability to stop systemic embolism and stroke, inducing physicians to prescribe this much more expensive medication over safer and cheaper options such as warfarin. Plaintiffs maintain and assert that doctors weren’t informed of hazards inherent to Xarelto, as the producers did not supply sufficient gains causing the lawsuit on xarelto to begin.