NEW YORK (Reuters) - Eli Lilly & Co on Tuesday will confront the first U.S. trial over allegations it failed to warn users of its popular antidepressant Cymbalta that they could suffer severe withdrawal symptoms, including suicidal thoughts and electric shock-like sensations.
Plaintiff Claudia Herrera is one of about 250 people who have sued Lilly over Cymbalta, and the company faces three more trials later this month involving similar claims, according to a lawyer for Herrera, R. Brent Wisner.
These early trials will be a critical test for litigation over the drug, which had $3.9 billion in sales in 2013 before losing patent protection at the end of that year and brought in $561 million in the first half of 2015.
Cymbalta, part of a class of antidepressants known as serotonin and norepinephrine reuptake inhibitors, was approved by the U.S. Food and Drug Administration in 2004 to treat major depressive disorder. Later, approval was expanded to include generalized anxiety disorder and fibromyalgia.
Its label warns that 1 percent or more of users who discontinue Cymbalta may experience symptoms like nausea, irritability and insomnia, and that other symptoms such as sensory disturbances and seizures had been reported.
But plaintiffs suing Lilly allege that withdrawal symptoms are far more common, pointing to a 2005 analysis from the Journal of Affective Disorders that found more than 44 percent of patients reported at least one discontinuation symptom.
A Lilly spokeswoman declined to comment specifically on Herrera’s allegations and said that the company would vigorously defend that case and others.
According to Herrera’s lawsuit in California federal court, she started taking Cymbalta in 2006 for anxiety. When her doctor instructed her in 2012 to ease off gradually, she said that she suffered electric-like “zaps,” anxiety, spasms and suicidal ideation, among other symptoms.
Herrera accused Lilly of downplaying its warnings to make the drug more marketable. Lilly said in court filings that it gave sufficient warnings, and that her doctor was aware of the potential risks.
A similar case is set for trial in California starting Aug. 11.
Other Cymbalta lawsuits have been less successful. A New York judge last year granted Lilly a win in a case similar to Herrera’s and twice, a federal judge in California has denied plaintiffs’ motions for class certification on consumer-protection claims related to Cymbalta marketing.
The California trials, and two more scheduled to start in Virginia in late August, will be the first opportunities for juries to evaluate the underlying claims.
“The success or failure of these cases will give us a good sense of how they are playing to these juries,” Wisner said. “Even if we lose, we have every intention of moving forward with the litigation.”
Reporting by Jessica Dye; Editing by Caroline Humer and Lisa Shumaker