Janssen Pharmaceuticals is facing an astonishing number of lawsuits over its controversial blood thinner, Xarelto. Among the nearly 7,000 dangerous drug lawsuits are 10 recently filed wrongful death cases.
The plaintiffs in the 10 wrongful death cases live in different parts of the country, but they have one thing in common – they would like to see Janssen held responsible for its negligence. Each set of plaintiffs in the 10 death cases has had relatives die from complications relating to Xarelto. Because there is no consistent way to reverse the effects of Xarelto, excessive bleeding cannot be stopped and patients are at risk of severe complications including death.
The plaintiffs in the wrongful death lawsuits point to a letter sent to the company in 2013 from the U.S. Food and Drug Administration (FDA). The letter addressed an advertisement in WebMD magazine that included the phrase, “Xarelto is the first and only once-a-day prescription blood thinner for patients with AFib not caused by a heart valve problem, that is proven to reduce the risk of stroke – without routine blood monitoring.”
The FDA found that this statement was “false or misleading because it minimizes the risks associated with Xarelto and makes a misleading claim.” But Janssen neither responded to the FDA’s letter nor did it change the statements made in its advertisements. Janssen Pharmaceuticals went on to use the very same misleading statement in other print advertisements and TV commercials.
Plaintiffs allege the warning letter and Janssen’s inaction constitute blatant negligence due to the company’s failure to warn patients and doctors of the risks associated with Xarelto. Although the company denies all wrongdoing, with the vast number of lawsuits, Janssen certainly has some explaining to do.
Just last month, the FDA rejected a blood thinner antidote produced by Portola Pharmaceuticals that was designed to help stop uncontrollable bleeding events caused by Xarelto and other newer generation anticoagulant medications. While Portola is not giving up on AndexXa, it will certainly be some time before an antidote is available to patients.