Discovery continues in the multi-district litigation (MDL) of cases related to Xarelto, a prescription blood thinner used to reduce the risk of blood clots.
“What is being alleged by the plaintiffs who are bringing lawsuits is that the warnings for the medication are inadequate,” Michael Monheit, founder of Monheit Law told the Louisiana Record recently.
Plaintiffs have alleged that Xarelto poses an increased risk of uncontrolled bleeding, strokes, blood clots and brain hemorrhages.
“Obviously every drug has some side effects,” Monheit said. “So the question isn’t whether or not a drug should be ever used, but the situation under which it should be used.”
The allegations include a claim that the medication lacks an antidote to its anti-clotting mechanism. This could lead to uncontrolled bleeding. The lawsuits allege that if patients and doctors had known the risks of the medication, they would not have used it. Monheit said that increased awareness of these risks will be one of the major effects of the litigation.
“The implication is that awareness will be greater about what these possible side effects are, and as a result, doctors will probably take those side effects into consideration when deciding what’s the best medication to put a patient on,” Monheit said.
Janssen Pharmaceuticals Inc, the company that makes Xarelto, stands behind its product, which was released and approved for sale in 2011.
“Xarelto is an important anticoagulant used to treat and reduce the risk of life-threatening blood clots," Kristina Chang, director of Product Communication for Janssen said in a statement. "After more than three years on the U.S. market, and more than 3 million patients prescribed in the U.S. to date, the benefit-risk profile of Xarelto remains favorable and consistent with clinical trials. We will continue to defend against the claims raised in this litigation.
A transfer order consolidated cases to the Eastern District of Louisiana in December 2014. The original transfer order included six actions in the district of southern Illinois and recognized 21 constituent actions as well as more than 30 potential tag-along actions across 22 districts. Since then, the number of cases has grown to more than 2,800.
In January, a new pretrial order provided an updated exemplar joint complaint.
“This again gets back down to the efficiency,” Monheit said.
The joint complaint provides a format for new complaints going forward. Each plaintiff that joins the MDL agrees that they are filing the same basic complaints.
The Xarelto MDL is still in the early stages. Monheit predicts another year of discovery before the first bellwether case goes before U.S. District Judge Eldon E. Fallon.
“After those individual cases go to trial, then it’s possible that there can be discussions for settlement because both the plaintiff and the defendant have a good idea of what’s going to happen,” Monheit said.
Legal experts have compared the Xarelto cases to the Pradaxa MDL. Thousands of cases involving the prescription blood-thinner Pradaxa were settled in favor of the plaintiffs for thousands of dollars. Plaintiffs in the Pradaxa cases also alleged that Boehringer Ingelheim, the makers of Pradaxa, had failed to adequately notify patients that the drug did not include an antidote to bleeding events.