Cymbalta Withdrawal Lawsuits to Proceed Without MDL Consolidation

The U.S. Judicial Panel on Multidistrict Litigation (JPML) has denied a motion that sought to consolidate and centralize all Cymbalta lawsuits filed throughout the federal court system, which all involved similar allegations that side effects of the drug may cause severe withdrawal problems. 

Eli Lilly currently faces at least 25 product liability lawsuits filed on behalf of former users of the antidepressant claiming that the drug maker failed to adequately warn about the risk of withdrawal and other psychological side effects of Cymbalta.

Following oral arguments heard last week, the U.S. JPML issued an order (PDF) on Wednesday, denying a request to establish a federal multidistrict litigation (MDL) for the cases, finding that there are too few complaints and that the claims are at varied, and often advanced, steps in the discovery process, minimizing any benefit that would be provided by centralized management of the cases by one judge.

A group of plaintiffs filed a motion to establish a Cymbalta MDL for the withdrawal lawsuits in August, asking that cases filed in U.S. District Courts throughout the country be transferred to the Central District of California to avoid duplicative discovery, prevent conflicting pretrial rulings and to serve the convenience of the parties, witnesses and the courts. Eli Lilly opposed that motion.

“Unquestionably, these actions share factual issues concerning Cymbalta’s development, marketing, labeling, and sale,” the U.S. JPML wrote in the order denying the request. “Nevertheless, we are not convinced that centralization…is warranted in these circumstances.”

The denial was based on three factors. First, the judges said that the procedural postures of the actions are significantly varied, meaning the Cymbalta withdrawal lawsuits are at very different stages. The judges pointed out that the discovery cutoff for two of the first lawsuits filed is this weekend. However, more recently filed lawsuits “are still in their infancy.”

The fact that discovery was nearly completed in some cases was the panel’s second mark against consolidation. The third was the fact that all of the claims have been, to date, filed by two law firms.

Cymbalta Withdrawal Side Effects

According to a 2012 report by the Institute for Safe Medication Practices (ISMP), early clinical studies have shown that about half of patients who abruptly discontinued use of Cymbalta suffered withdrawal symptoms. About 10% of those cases involved severe problems and more than half of the cases involved side effects that lasted longer than a week or two.

Cymbalta (duloxetine) was approved by the FDA in 2004, for the treatment of depression. It is part of a family of drugs known as selective serotonin reuptake inhibitors (SSRIs), which have been linked to symptoms of withdrawal since at least 2001.

Instead of providing clear information about the risk of serious and potentially severe withdrawal symptoms with Cymbalta, plaintiffs in the lawsuit allege that the medication guide and label provided with the drug provided only a very vague warning, indicating:

“Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.”

Both the ISMP and plaintiffs in these recent lawsuits indicate that the warning is far from adequate in conveying the specific risks of Cymbalta withdrawal.

ISMP called the warning “materially deficient,” pointing out that it does not tell patients what to be concerned about, how many patients could be affected, how severe the symptoms could be, and does not tell them the best way of quitting Cymbalta.

Eli Lilly told the ISMP that they referred patients to their doctors and pharmacists, but the independent group noted that the information given to doctors did not include withdrawal problems as something to discuss with their patients.