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Xarelto: Is It Dangerous?

XareltoYou’ve probably seen the commercials. The most vivid to me was the one with Arnold Palmer, Kevin Nealon, and Brian Vickers. They are playing a round of golf and speaking to each other in shockingly sophisticated ways about the many benefits and occasional side effects of the drug Xarelto. These guys sound like pharmacists or physicians, not athletes and comedians. It is a perfect example of direct-to-consumer pharmaceutical marketing.

Xarelto quickly became a blockbuster drug when it hit the market in 2011. Xarelto (or rivaroxaban) was approved for sale by the FDA in July 2011. It was supposed to represent the next major advancement in blood thinning (anti-coagulant) medication. Xarelto was developed to prevent serious conditions that sometimes arise after surgeries (such as artificial hip and knee surgeries). As an anti-coagulant, it was intended to prevent pulmonary embolism (PE) and deep vein thrombosis (DVT) and strokes. The patients Xarelto was intended to help were those with atrial fibrillation (or irregular heartbeat), who were a group of people more vulnerable to PE, DVT, and stroke after surgery. Eventually, the FDA expanded approval of Xarelto to treat all patients with PE and DVT and atrial fibrillation.

Aggressive Marketing

Janssen Pharmaceuticals and Bayer Corportion, the makers of Xarelto, marketed the drug as superior to warfarin. Warfarin (Coumadin) had been on the market for more than fifty years, but it had certain side effects; patients on warfarin required restrictions on their diets and needed routine blood tests. Janssen and Bayer quickly marketed Xarelto to the medical community and directly to patients, stating that the drug was easier and did not require monitoring or dietary restrictions. In fact the manufacturers stated that Xarelto was superior to warfarin in many ways, the biggest advantage of which was its convenience, as it could be taken once a day by mouth to prevent clots, PE, and DVT.

The Problem Was  . . .

Xarelto patientIn studies, Xarelto appeared to cause a higher rate of internal bleeding. While other anti-coagulants may also cause internal bleeding, it appears there is no available “antidote” for stopping internal bleeding in patients taking Xarelto. With warfarin, vitamin K has been shown to stop bleeding. But there is no vitamin K “parallel” for people taking Xarelto. For Xarelto, it can take 24 hours for a dose to get out of the body. That means that if internal bleeding starts, the patient may simply have it wait it out and hope it stops on its own.

In the first year after Xarelto was approved for sale, data shows that 65 patients died. Based on statistics from lawsuits, since then hundreds of people have died while taking Xarelto. The lawsuits are mounting. Plaintiffs allege that Janssen and Bayer failed to adequately warn consumers of the risk of uncontrollable internal bleeding from taking Xarelto. Plaintiffs also are alleging negligence, breach of express and implied warranties, fraud, and violation of consumer protection laws.

Currently more than 7,000 lawsuits have been filed by people injured after taking Xarelto.

Nevertheless, Janssen and Bayer have made billions on the sale of Xarelto. It is truly a blockbuster drug, and hugely profitable for the manufacturers. It remains on the market, and it remains a drug the manufacturers continue to advertise directly to consumers.

On December 12, 2014, the Judicial Panel on Multidistrict Litigation (JPMDL) created an MDL specifically for Xarelto lawsuits. The MDL is in the U.S. District Court for the Eastern District of Louisiana (New Orleans) with Judge Eldon E. Fallon presiding.

Xarelto MDL Court Extends Time, Schedules Bellwether Trials

On August 18, 2016, the federal judge overseeing the Xarelto MDL issued an Order stating that plaintiffs who have already filed their Complaints in the federal court of Louisiana handling the Xarelto MDL shall have ninety (90) days to serve the Complaint with the Summons. This Order seems mainly directed at the delays that have occurred getting summonses from the court to Plaintiffs after they have filed their lawsuits in the MDL. In any event, it is always wise to keep a close watch on all orders coming out of the MDL in which you are a plaintiff.

In addition, the MDL Court recently identified three dates to begin Xarelto “bellwether trials.” Those cases will be tried March 13, 2017, April 24, 2017, and May 30, 2017. A bellwether case is a representative case chosen for its broad characteristics which have much in common with many of the remaining cases. After the jury verdicts are reached in bellwether cases, the committees for the plaintiffs and defendants often use these bellwether trial results to get a sense of case values and to negotiate a larger settlement.

In Re: Xarelto (Rivaroxaban) Products Liability Litigation, MDL 2592