Xarelto MDL Continues to Grow

The Xarelto multidistrict litigation in Louisiana continues to grow, as another lawsuit was added to the ongoing proceedings on February 11. Estella Roethler filed a lawsuit individually and as the representative of the estate of Augustina Asocar Rodriguez.

Rodriguez was prescribed and ingested the blood thinning medication from approximately January 2014 to February 2014, when she suffered life-threatening bleeding incidents the lawsuit claims was a direct result of the medication. On June 21, 2015, Rodriguez died as a result of those injuries.

The Xarelto lawsuit accuses Janssen and its affiliates of failing to provide adequate warning of the risks associated with the drug, including that there is no reversal agent for Xarelto.

Plaintiff sues on 12 counts

Roethler’s lawsuit contains 12 actions against the defendants, including:

• Negligent Misrepresentation
• Breach of Express Warranty
• Failure to Warn
• Fraud
• Strict Liability
• Violation of Consumer Protection Laws/Consumer Fraud Laws
• Negligence
• Wrongful Death
• Breach of Implied Warranty
• Design Defect
• Survival Action
• Manufacturing Defect

Xarelto MDL 2592

The Xarelto MDL was established on Dec. 12, 2014, under the direction of U.S. District Judge Eldon E. Fallon. At the time, the litigation consisted of 21 lawsuits pending in 10 districts, but that number has since grown to over 2,800 lawsuits, as of Feb. 2016.

The defendants initially opposed the creation of the MDL for a number of reasons, arguing that personal facts concerning each plaintiff’s case would overshadow common factual issues and asserting their belief that it would cause an inundation of copycat lawsuits without merit. They also argued that overlapping discovery information on common issues could be handled through informal coordination and claimed the circumstances of attorney advertising suggested that the cases lacked merit.

Ultimately, the JPML determined the cases presented enough common issues — the sufficiency of the Xarelto warning label regarding the risk of severe bleeding events and other injuries, the results of select clinical trials and the alleged need for blood monitoring — to merit the creating of an MDL.

Bellwether preparations underway

Judge Fallon has indicated that Xarelto bellwether trials will begin in early 2017. In November 2015, he issued Case Management Order No. 3, stating that 40 individual cases would be selected for the discovery pool. Plaintiffs selected 10 cases, defendants collectively chose 10 cases and the remaining 20 cases were selected at random — with venue restrictions put in place to ensure a well-rounded discovery pool. Each side was permitted to strike one randomly selected case without cause.

Case Management Order No. 3 also noted that the parties were previously given the opportunity to determine their own parameters for the discovery pool, but were unable to resolve their differences.

In December 2014, Judge Fallon issued Case Management Order No. 4, indicating that plaintiffs must satisfy all of the criteria in one of the following categories to be eligible for the discovery pool:

• Plaintiff took Xarelto to lower the risk of stroke and systemic embolism as a result of nonvalvular atrial fibrillation and claims to have suffered a gastrointestinal bleed or death from a gastrointestinal bleed and was between the ages of 50 and 90 at the time of the alleged incident.
• Plaintiff between the age of 40 and 80 — at the time of the alleged incident — took Xarelto to treat deep vein thrombosis, pulmonary embolism and/or to lower the risk of recurrence of either of these two conditions and claims to have suffered a gastrointestinal bleed or died from a gastrointestinal bleed.
• Plaintiff ingested Xarelto to reduce the risk of stroke and systemic embolism from nonvalvular atrial fibrillation and claims to have suffered from rectal bleeding or death from rectal bleeding and was between 50 to 90 years of age at the time of the alleged incident.
• Plaintiff took Xarelto to treat DVT, PE and/or to reduce the risk of occurrence, but allegedly suffered from rectal bleeding or death from rectal bleeding and was between the ages of 40 to 80 when the alleged event occurred.
• Plaintiff ingested Xarelto to lower the risk of stroke and systemic embolism from nonvalvular atrial fibrillation and claims to have suffered a brain bleed/hemorrhagic stroke or death and was in the 50-to-90-year age group at the time of the alleged incident.
• Plaintiff took Xarelto to treat DVT, PE and/or to reduce the risk of recurrence and claims to have suffered a brain bleed/hemorrhagic stroke or death from the brain bleed/hemorrhagic stroke and was 40 to 80 years of age at the time of the alleged incident.

Resources Resources