The four Xarelto bellwether trials initially set to begin in February, but then rescheduled to begin in March, have been rescheduled again at both parties’ request. The first rescheduling occurred after the NBA All-Star Game was moved to New Orleans from Charlotte in response to North Carolina’s controversial public washroom law or “bathroom bill” — the state law restricting individuals to use only the facility that corresponds with their biological gender. Over 15,000 lawsuits have been consolidated in multidistrict litigation before Judge Eldon E. Fallon in in the Eastern District of Louisiana (Xarelto Products Liability Litigation, MDL No. 2592).
The revised bellwether trail schedule is as follows:
- First trial — April 24, 2017 in the Eastern District of Louisiana
- Second trial — May 30, 2017 in the Eastern District of Louisiana
- Third trial — To Be Set in June 2017 in the Southern District of Mississippi
- Fourth trial — To Be Set in July 2017 in the Northern District of Texas
The four lawsuits chosen for bellwether trials are:
- Boudreaux, Jr. et al v. Janssen Research & Development LLC et al (2:14-cv-02720)
- Orr et al v. Janssen Research & Development LLC et al (2:15-cv-03708)
- Mingo v. Janssen Research & Development LLC et al (2:15-cv-03469)
- Henry v. Jansen Research & Development LLC et al (2:15-cv-00224)
The first bellwether trial involves a Louisiana man with atrial fibrillation, who took Xarelto and suffered life-threatening gastrointestinal bleeding. Joseph Boudreaux Jr. took Xarelto for just under one month in 2014 before he was hospitalized for severe internal bleeding. He needed several blood transfusions and was hospitalized for five days as a result of his Xarelto bleeding episode. He then required follow-up medical treatment following his stay in the hospital. Boudreaux filed a Xarelto lawsuit against Janssen and Bayer in December 2014, accusing the two manufacturers of concealing their knowledge of Xarelto’s defects from physicians and patients like himself.
Blood Thinners & Bleeding
All blood thinners pose a risk for bleeding given the need to thin blood in an effort to avoid stroke-inducing blood clots which may form following some types of surgery or in relation to atrial fibrillation. Accordingly, strict monitoring of diet and other blood factors has been required to ensure that anti-coagulants are maintained at optimum levels to help mitigate stroke risk and the formation of blood clots. For patients on Coumadin (warfarin), the longstanding gold standard of blood thinners, careful management of diet and other blood properties has been essential.
Xarelto (rivaroxaban) is one of the three major direct oral anticoagulants (DOACs), together with Eliquis and Pradaxa, designed to minimize the kind of detailed management common with warfarin. The Food and Drug Administration (FDA) approved Xarelto for use in patients who had knee or total hip replacement surgery to reduce the risk of blood clots, and also to reduce the risk of stroke in people with atrial fibrillation. Following a fast-track regulatory review, the FDA approved the drug for general treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE). When first released, the manufacturers advertised Xarelto as being the “first and only once-a-day prescription blood thinner”. Xarelto has been shown to selectively block Factor Xa (“10a”), an enzyme required for blood clots to form, whereas warfarin interferes with vitamin K and other blood-clotting factors.
The Xarelto lawsuits allege that the drug’s manufacturers — Bayer Healthcare and Johnson & Johnson subsidiary Janssen Pharmaceuticals — failed to warn about Xarelto’s potential risks, most notably, uncontrollable bleeding. Further, plaintiffs have alleged that they were unaware that Xarelto was brought to market without an effective antidote, or reversing agent, which can help stem a Xarelto bleeding issue that could lead to death, whereas the blood thinning properties of warfarin can be reversed through the use of Vitamin K. Further, plaintiffs maintain it was irresponsible of the manufacturers to claim less monitoring of patients on Xarelto was needed when, in the absence of an antidote, more monitoring would be required.
Potential Reversal Agent
Portola Pharmaceuticals has developed a reversal agent for Xarelto and Eliquis, which has been submitted to the FDA for approval. Though the FDA designated Portola’s drug — AndexXa (andexanet alfa) — a Breakthrough Therapy, and granted it expedited review, approval was withheld pending additional information on its manufacture and whether it can be used as a reversal agent for two other blood thinners, Savaysa and Lovenox.