Cymbalta Class Action Certification
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.
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 9th Circuit U.S. Court of Appeals, but Eli Lilly has asked the court to reject the appeal based on a June 2017 U.S. Supreme Court decision. That ruling, in an unrelated case involving Microsoft, found federal appeals courts had no jurisdiction to decide the appeal.
A Timeline of Cymbalta Lawsuits and Settlements
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:
College student Traci Johnson commits suicide while taking part in Cymbalta clinical trial. FDA later concludes suicide was not related to Cymbalta
FDA approves Cymbalta
Shortly after being prescribed Cymbalta, 16-year-old Peter Schilf commits suicide on Christmas Eve. His parents file a lawsuit against Eli Lilly
Eli Lilly agrees to an undisclosed settlement in Traci Johnson’s death before a lawsuit is filed
Former Cymbalta users file class-action lawsuit in California federal court
Lilly settles lawsuit with Peter Schilf’s parents for undisclosed amount
South Carolina federal court rules in favor of Eli Lilly in lawsuit claiming the company failed to warn of withdrawal symptoms
Cymbalta users seek class-ction certification in California, Massachusetts, Missouri and New York
Plaintiffs in 28 federal lawsuits over Cymbalta seek to combine their cases into a multidistrict litigation (MDL)
U.S. Judicial Panel on Multidistrict Litigation denies plaintiffs request for an MDL
U.S. District Court denies class-action certification, plaintiffs appeal to 9th Circuit Court of Appeals
Plaintiffs again request an MDL, this time including more than 40 lawsuits
Lilly records first of four verdicts in its favor in individual lawsuits over Cymbalta
Judicial Panel on Multidistrict Litigation (JPML) denies second request for a Cymbalta MDL
9th Circuit denies appeal for Cymbalta class action lawsuit
Lilly reports it has “reached a settlement framework” in 140 pending Cymbalta lawsuits
9th Circuit considers second appeal in Cymbalta class-action lawsuit
Lawsuits against 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.
Of their many claims in court documents, plaintiffs say Eli Lilly:
- “Overstated the efficacy of Cymbalta” and “downplayed and/or failed to state the true withdrawal side effects associated with Cymbalta”
- Failed to properly warn patients about the risks and of the “frequency, severity, and/or duration of Cymbalta withdrawal”
- Benefitted from patients who started taking Cymbalta again (becoming physically dependent on the drug) to avoid terrible side effects
- Advertised the benefits of the drug, even those that were not proven
- Produced a defective drug
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.”
People Who Filed Lawsuits
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.
Withdrawal complications that lead patients and their families to file Cymbalta lawsuits include:
- Brain Zaps
- Suicidal thoughts
- Weight changes
Multidistrict Litigation Denied
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.”
Plaintiffs in all actions allege:
- They suffered a variety of withdrawal symptoms after discontinuing use of Cymbalta
- The label for the drug fails to adequately warn of the risks of such symptoms
- Eli Lilly’s promotional campaigns for the drug have overstated its efficacy while understating, downplaying or failing altogether to state its withdrawal side effects
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.
California Cymbalta Trials
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.
Herrera v. Eli Lilly & Co.
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.
Cymbalta New York 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 the company faces more than 5,000 Cymbalta withdrawal cases. One publicized case is out of New York.
McDowell v. Eli Lilly & Co.
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 NORPRAMIN 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. NORPRAMIN is not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use.)
A lawsuit filed against Eli Lilly, the manufacturer of Cymbalta, said neither Schilf nor his mother was told that some Cymbalta users were inclined toward suicide. It also claimed doctors were not informed that a participant during a trial of the drug hanged himself.
In April 2013, Eli Lilly agreed to settle the suit before it went to trial. The amount of the settlement was kept confidential.
Eli Lilly Reports ‘Settlement Structure’ for Cymbalta Lawsuits
In its 2016 annual report, Eli Lilly reported the company 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.”
- According to an Eli Lilly report
The cases included about 40 lawsuits combined in a California Judicial Counsel Coordination Proceeding in Los Angeles. The company reported the first the individual cases went to trial in 2015, and the company had won verdicts against four plaintiffs suing over Cymbalta.
Lilly reported the company believed the lawsuits were without merit and was prepared to “defend against them vigorously” in reporting on the settlement plans.
Emily Miller is an award-winning journalist who has held writing and editorial positions with numerous print and online publications around the U.S. She draws on her background as both a patient and a journalist to help readers understand complex health topics. Her most recent experience is in writing about litigation involving medicines that cause life-altering side effects.
- Palmer, E. (2013, April 10). Lilly settles long-running lawsuit tying Cymbalta to teen's suicide. Retrieved from http://www.fiercepharma.com/sales-and-marketing/lilly-settles-long-running-lawsuit-tying-cymbalta-to-teen-s-suicide
- Reuters. (2015, August 7). U.S. jury clears Eli Lilly in first Cymbalta withdrawal trial. Retrieved from http://www.reuters.com/article/us-eli-lilly-cymbalta-trial-idUSKCN0QD01K20150808
- Lexis Legal News. (2017, February 23). 9th Circuit Stays Cymbalta Class Withdrawal Appeal Pending Supreme Court Case. Retrieved from http://www.lexislegalnews.com/articles/15069/9th-circuit-stays-cymbalta-class-withdrawal-appeal-pending-supreme-court-case
- Feeley, J. (2015, Jun 24). Lilly Facing First Trials Over Cymbalta Withdrawal Symptoms. Retrieved from https://www.bloomberg.com/news/articles/2015-06-24/lilly-facing-first-trials-over-cymbalta-withdrawal-warnings
- U.S. Department of Justice. (2009, January 15). Eli Lilly and Company Agrees to Pay $1.415 Billion to Resolve Allegations of Off-label Promotion of Zyprexa. Retrieved from https://www.justice.gov/archive/opa/pr/2009/January/09-civ-038.html
- Law360.com. (2014, November 7). Lilly Defeats Cymbalta Label Suit As Possible MDL Looms. Retrieved from https://www.law360.com/articles/594712/lilly-defeats-cymbalta-label-suit-as-possible-mdl-looms
- U.S. Judicial Panel on Multidistrict Litigation. (n.d.). Overview of Panel. Retrieved from http://www.jpml.uscourts.gov/overview-panel-0
- Eli Lilly. (2016). Make It Better and Better Eli Lilly and Company 2015 Annual Report and Proxy Statement. Retrieved from http://files.shareholder.com/downloads/LLY/4075049298x0x882148/56D78424-8D60-470D-BE5D-975D890947A4/English.PDF