One former Xarelto consumer is alleging negligence, fraud and other wrongdoing by the blood thinner’s manufacturers in one of the first Xarelto lawsuits filed by Jacobs & Crumplar, P.A. and The D’Onofrio Firm.
The complaint is being brought against the manufacturers and distributors of Xarelto, which include Janssen Research & Development, Janssen Pharmaceuticals, Johnson & Johnson and Bayer Corporation, among others.
In the suit, filed in March 2015 in The Court of Common Pleas of Philadelphia County, the Plaintiff is suing for damages in excess of $50,000 after suffering a gastrointestinal bleed as a direct result of taking a 20mg daily dose of Xarelto, which was prescribed by his physician to treat non-valvular atrial fibrillation.
Had the Plaintiff been adequately informed of the increased health risks that come with taking the drug, he would not have used it, according to the complaint.
Xarelto (rivaroxaban) is an oral anticoagulant that first came on the market in 2011 when it was approved by the Food and Drug Administration to help reduce the risk of blood clots, deep vein thrombosis and pulmonary embolisms following knee and/or hip replacement surgery, as well as to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
The developers of Xarelto have marketed the drug as a more convenient alternative to Coumadin (warfarin) since they claim that it requires “no regular blood monitoring” and has “no known dietary restrictions” like its predecessor does, according to the suit.
However, during the course of various studies that were conducted to test the effectiveness of Xarelto, it was discovered that while the blood thinner was a non-inferior treatment option, it also demonstrated an increased risk of adverse health effects such as serious bleeding, the suit states.
The complaint argues that Xarelto developers touted the positive results of the efficacy studies in their promotional and marketing materials but failed to similarly highlight the increased risk of suffering uncontrollable bleeding, therefore misleading the medical community and consumers about the potential effects of the drug.
As recent as March 2014, the Xarelto box label still does not have a “Black Box” to warn patients and prescribing doctors of the life-threatening risks that are associated with drug usage, according to the complaint. Additionally, a “Dear Doctor” letter that outlines the dangers of prescribing and administering the drug was not provided to doctors.
The suit also asserts that the drug’s manufacturers “failed to investigate, research, study and define, fully and adequately, the safety profile of Xarelto.” In the first quarter of 2012, the Institute for Safe Medication Practices “identified 356 reports of serious, disabling, or fatal injury in which rivaroxaban was the primary suspect drug.” After reviewing the same data, the manufacturers told the organization that it did not see any safety issues that needed to be addressed.
Beyond the fact that Xarelto manufacturers did not inform the Plaintiff and all others about the increased risk of uncontrollable bleeds while taking the drug, they also failed to warn or advise on how to intervene and stabilize a patient should a bleed occur, the suit alleges.
Furthermore, Xarelto advertisements did not provide an adequate disclosure to patients that “there is no drug, agent or means to reverse the anticoagulation effects of Xarelto and that such irreversibility could have life-threatening and fatal consequences.”
Heavily marketing Xarelto as a “one size fits all” drug that requires no blood monitoring or dietary restrictions caused patients and healthcare providers to be misinformed as to the necessity of routine monitoring of any person ingesting any blood thinning agent, according to the suit.
The complaint states that even if the Xarelto warnings were adequate, the drug “still lacks any benefit sufficient to tolerate the extreme risk posed by the ingestion of this drug.”
In the end, the Plaintiff is seeking compensatory damages to cover the cost of any past, present or future expenditures related to the gastrointestinal bleed that he suffered due to taking Xarelto and to pay for the lost wages, and pain and suffering as a result of his experience.
For further review, you can reference the entire 67 page redacted complaint (PDF) here.