People who say they were injured by the antidepressant Cymbalta have filed lawsuits against its maker, Eli Lilly, and have been trying to gain class action certification from the courts. The U.S. Court of Appeals for the Ninth Circuit dismissed a class action in October 2017 that claimed Cymbalta caused severe withdrawal symptoms.
In October 2012, former users of the antidepressant Cymbalta filed a class action in the Central District of California asserting that they, and other persons similarly situated, were harmed because the drug’s maker, Eli Lilly, misrepresented the drug.
A class action is a type of legal action in which people join together to sue because they have similar claims against a common defendant or defendants. For the case against Eli Lilly to proceed as a class action, the court must certify the class. So, in August 2013, the plaintiffs moved for certification of classes of consumers in four states: California, Massachusetts, Missouri and New York.
However, the district court denied the plaintiffs’ motions for class certification on Dec. 18, 2014. Plaintiffs filed a petition with the U.S. Court of Appeals for the Ninth Circuit requesting permission to file an appeal of the denial of class certification. That too was denied.
Plaintiffs filed a second motion for certification under the consumer protection acts of New York and Massachusetts. The district court denied that motion for class certification on July 21, 2015.
Plaintiffs appealed to the Ninth Circuit U.S. Court of Appeals in June 2016. Their case was put on hold while the U.S. Supreme Court decided an unrelated case with similar legal issues involving Microsoft. When that decision came down in June 2017, Lilly pushed to have the class action against it dismissed.
The Ninth Circuit agreed with Lilly and dismissed the class action in October 2017.
Even before Cymbalta received approval from the U.S. Food and Drug Administration (FDA), Eli Lilly was looking at a potential lawsuit over its use. Key Cymbalta dates include:
Lawsuits against the pharmaceutical company, Eli Lilly, say Cymbalta users face “severe physiological and psychological symptoms when they attempt to stop” taking the drug, including dizziness, nausea, headache, fatigue, paresthesia, vomiting, irritability, nightmares, insomnia, diarrhea, anxiety, hyperhidrosis and vertigo. Most people may have taken the drug to treat depression or anxiety. But there are other FDA approved Cymbalta uses. These include treating diabetic peripheral neuropathy, fibromyalgia and certain kinds of chronic pain.
The lawsuits also say Eli Lilly deceived the public by including in the drug’s label that only 1 percent of users experienced withdrawal symptoms, when in reality studies show between 44 and 50 percent suffered from discontinuation problems.
Of those who suffered withdrawal effects, about half experienced “moderate” or “persistent” symptoms. And one in 10 experienced “severe” symptoms. The plaintiffs say “nowhere on Cymbalta’s label does it indicate the potential duration of withdrawal symptoms.”
Men and women who have filed Cymbalta withdrawal lawsuits say had they known the truth about the frequency, severity and duration of Cymbalta withdrawal they would not have started taking Cymbalta. Among the people who filed lawsuits against Eli Lilly are:
Jennifer Saavedra filed suit in California against Eli Lilly after she tried to stop using Cymbalta and experienced brain zaps, body shaking and tunnel vision. It took her a year to finally recover. In the meantime, her life was disrupted. Her complaint claimed withdrawal symptoms were more prevalent than Lilly claimed and that the company misled the public.
Melissa Stafford also filed her lawsuit in California. She was forced to continue using Cymbalta to avoid debilitating side effects. After she finally stopped taking the drug, she suffered for months. Her lawsuit accuses Lilly of deceiving the public about the risks of the drug.
Counsel for plaintiffs in 25 federal court proceedings against Eli Lilly tried unsuccessfully to have the then-filed cases and an unspecified number of future cases coordinated into a federal multidistrict litigation (MDL) in the U.S. District Court for the Central District of California. The purpose of an MDL is to avoid duplication and inconsistencies in the pretrial procedures and rulings and to conserve the resources of the parties, their counsel and the courts.
In a December 2014 order denying the MDL transfer, the U.S. Judicial Panel on Multidistrict Litigation took issue with the fact that the cases’ histories vary significantly and that only two firms represent the plaintiffs in all the actions. The panel did, however, recognize that the actions were “highly similar.”
The panel said in its order that it had been informed of 21 additional related federal actions. Plaintiffs’ counsel subsequently filed a second petition seeking MDL consolidation. The panel denied the petition in October 2015.
About 35 individual and multi-plaintiff cases have been filed in California state court. Many of the cases have been consolidated in a California Judicial Council Coordination Proceeding in Los Angeles. The first individual product liability cases went to trial in August 2015 and resulted in verdicts in favor of Eli Lilly. Two of the plaintiffs filed notices of appeal.
Claudia Herrera’s case against Eli Lilly became the first of four cases regarding Cymbalta withdrawal symptoms to go to trial in federal court in California in August 2015.
According to Herrera’s lawsuit, she began using Cymbalta in 2006 to treat her anxiety. In 2012, Herrera’s doctor instructed her to slowly stop taking the drug. Herrera says she suffered electric-like “zaps,” anxiety, spasms and suicidal thoughts, among other withdrawal symptoms, as a result.
Herrera accused Eli Lilly of downplaying its warnings to make Cymbalta more marketable. The jury cleared Eli Lilly of liability. Herrera filed a notice of appeal after losing her trial.
California is not the only state seeing legal actions against Cymbalta’s maker. In its 2015 annual report, Eli Lilly said it was “named in approximately 140 lawsuits involving approximately 1,300 plaintiffs filed in various federal and state courts alleging injuries arising from discontinuation of treatment with Cymbalta.” News reports from that same year say that the company faces more than 5,000 Cymbalta withdrawal cases. One publicized case is out of New York.
Jesse McDowell filed his lawsuit in New York, claiming Cymbalta’s label was inaccurate.
McDowell said he suffered “serious and life-threatening withdrawal symptoms” from Cymbalta. He argued that the drug’s label was misleading because it said the symptoms occurred in patients “at a rate of greater than or equal to 1 percent” when the actual rates were closer to 50 percent.
U.S. District Judge Robert W. Sweet tossed the suit, ruling the label adequately warned doctors about possible withdrawal symptoms. The federal judge said the label’s language followed FDA regulations.
Cymbalta was not on the market long before it became tied to the suicide of a 16-year-old boy. Peter Schilf began taking samples of the antidepressant given by his doctor in November 2004, just three months after the drug gained approval from the U.S. Food and Drug Administration (FDA) for treatment of depression. A month later, Schilf fatally shot himself on Christmas Eve. The FDA required its strongest warning, a black box warning, about suicide be added to the drug’s label in 2005.
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Cymbalta or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Cymbalta is not approved for use in pediatric patients. [see Warnings and Precautions (5.1), Use in Specific Populations (8.4), and Information for Patients (17.2).]
*Cymbalta black box warning label
In Eli Lilly’s 2016 annual report, the company reported it had reached a “settlement structure” in 140 Cymbalta lawsuits involving roughly 1,470 plaintiffs. The cases were pending in various state and federal courts and all involved patients who claimed injuries caused by discontinuing use of Cymbalta.
“We have reached a settlement framework which provides for a comprehensive resolution of nearly all of these personal injury claims, filed or unfiled, alleging injuries from discontinuing treatment with Cymbalta. There can be no assurances, however, that a final settlement will be reached.”
The cases included about 40 lawsuits combined in a California Judicial Counsel Coordination Proceeding in Los Angeles. The company reported that the first individual cases went to trial in 2015, and the company had won verdicts against four plaintiffs suing over Cymbalta.
Lilly reported that the company believed the lawsuits were without merit and was prepared to “defend against them vigorously” in reporting on the settlement plans.
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