Case details

Anti-depressant’s label misled on dangers, user contended

SUMMARY

$0

Amount

Verdict-Defendant

Result type

Not present

Ruling
KEYWORDS
reduced intake, severe withdrawal symptoms, spasms, suicidal thoughts
FACTS
In 2012, plaintiff Claudia Herrera, on her doctor’s instructions, began to taper off her dosage of Cymbalta, an anti-anxiety medication she had been taking since 2006. She claimed that as she reduced her intake, she suffered severe withdrawal symptoms, including spasms and suicidal thoughts. Herrera sued the drug’s maker, Eli Lilly Co., alleging failure to warn and intentional misrepresentation. Herrera was one of approximately 250 plaintiffs who have sued Eli Lilly, claiming that the company failed to adequately warn about withdrawal symptoms caused by Cymbalta. (Herrera’s husband, Peter Lowry, who had joined suit, was no longer a plaintiff at trial, though he did testify as a fact witness.) Cymbalta is part of a class of antidepressants known as serotonin and norepinephrine reuptake inhibitors. It was approved by the U.S. Food and Drug Administration in 2004 to treat major depressive disorder. Subsequent approval was expanded to include generalized anxiety and fibromyalgia, a chronic musculoskeletal disorder. Herrera claimed that Eli Lilly failed to disclose on the warning label for the medication that 44.4 percent of users in its own studies suffered discontinuation side-effects. She asserted that instead, Cymbalta’s label initially disclosed that only 2 percent or more experienced certain side-effects. The Indianapolis-based drugmaker misrepresented the warning in order to increase sales and prevent consumers from choosing other medications, according to Herrera. Eli Lilly contended that its warnings about discontinuation risk were appropriate, and included a warning prominently placed about symptoms most likely to be linked to the medicine. The company stated that the 44.4 percent figure cited by Herrera was irrelevant, because 22 percent of users of a placebo in the study also reported side effects. Eli Lilly pointed out that the label nevertheless discloses that withdrawal side-effects were significantly more frequent in users of Cymbalta than in those who took a sugar pill, or placebo., Herrera stated that she suffered sensations of electric-like “zaps,” anxiety, spasms, and suicidal thoughts, among other symptoms when she began to ease off dosage of Cymbalta.
COURT
United States District Court, Central District, Los Angeles, CA

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