This is Part 3 of an ongoing series on the Cymbalta withdrawal lawsuits. It includes a timeline of the cases that have gone to court so far and their outcomes. I’ve included links to news stories on the cases wherever possible. Unfortunately, the mainstream media hasn’t paid much attention to the Cymbalta lawsuits, so many of the links come from Law360, a subscription-based legal news service. For readers who really want to delve into the details of these cases, I would suggest signing up for a free trial of Law360 and then brewing a big pot of tea or coffee because you’ll be reading for a few hours.
Part 2 of the series includes an interview with Baum, Hedlund, Aristei & Goldman, PC, one of the law firms representing thousands of patients who have been affected by Cymbalta’s withdrawal symptoms. Part 1 of the series addresses the basics of the Cymbalta lawsuits: What are the withdrawal symptoms, what does the research say about them, why were the lawsuits brought and helpful information for anyone planning to stop Cymbalta. As always, I’ll post any breaking news related to the lawsuits in my weekly news updates.
To make things easy, I’ve created a page dedicated to the Cymbalta lawsuits where you’ll find all of FedUpwithFatigue’s Cymbalta-related posts, links to news stories, support groups and other useful information.
Update 10/25/16: The Cymbalta lawsuits have been settled. Click here for details.
So, let’s get started with the timeline …
The U.S. Food and Drug Administration approves Cymbalta (generic name: duloxetine) for the treatment of fibromyalgia. “The approval of Cymbalta is important because it provides physicians and patients with a new treatment option shown to help reduce pain and improve functioning in this difficult-to-treat disorder,” said Madelaine Wohlreich, M.D., medical advisor and research physician with Eli Lilly& Co., Cymbalta’s maker.
(Curious about how well Cymbalta works? Then you may be interested in reading this post: Why your fibro meds aren’t working.)
Cymbalta’s profits rise 14 percent for the year, earning more than $3 billion worldwide.
The Institute for Safe Medication Practices issues a report on Cymbalta, concluding there are “major shortcomings in the official information for both patients and healthcare professionals. … Withdrawal symptoms were reported in 44-50 percent of patients abruptly discontinuing duloxetine at the end of clinical studies for depression, and more than half of this total did not resolve within a week or two. … [The] FDA-approved patient guide is materially deficient. It gives no hint of the persistence or severity of the symptoms known to occur. It does not address basic questions: What kinds of symptoms are most common? Should patients taper off the dose, and if so, how slowly? What should a patient do if depression or other symptoms recur?”
Attorneys file a lawsuit in the United States District Court for the Central District of California on behalf of all consumers who purchased Cymbalta since its launch in August 2004, alleging that drugmaker Eli Lilly & Co. “misrepresented the risks associated with taking Cymbalta and misled consumers about the frequency, severity and duration of ‘Cymbalta withdrawal.'” The plaintiffs say they’ve experienced headaches, dizziness, nausea, nightmares, anxiety, mania, suicidal ideation, brain zaps (which feel like a lightning bolt going off inside the head) and other symptoms after they stopped taking Cymbalta.
At the heart of the attorneys’ case is information contained in Cymbalta’s prescribing guide for physicians. Under the section entitled “discontinuation of treatment with Cymbalta,” the guide says, “Following abrupt or tapered discontinuation in adult placebo-controlled clinical trials, the following symptoms occurred at 1 percent or greater and at a significantly higher rate in Cymbalta-treated patients compared to those discontinuing from placebo: dizziness, headache, nausea, diarrhea, paresthesia, irritability, vomiting, insomnia, anxiety, hyperhidrosis and fatigue.”
While technically true, attorneys believe Eli Lilly purposely did not include Cymbalta’s high risk of withdrawal symptoms in its materials for physicians and patients. “Disclosing the true risks of Cymbalta withdrawal in its marketing and risk disclosure materials would have been harmful to Lilly’s sales,” the lawsuit reads.
Eli Lilly attorneys try unsuccessfully to have the Cymbalta lawsuits tossed out of court. Since Cymbalta is prescribed to patients by a physician, Lilly argues the plaintiffs “cannot establish the requisite link between Lilly’s alleged misrepresentation and their injuries. … [the lawsuit] assumes that Lilly owed Cymbalta consumers a duty to disclose safety information to them directly.” The judge doesn’t buy Lilly’s argument, and the lawsuits proceed.
Eli Lilly attorneys again try unsuccessfully to have the Cymbalta lawsuits thrown out of court, saying doctors were properly warned about the drug’s withdrawal symptoms. The lawsuits proceed.
A South Carolina federal judge rules in Eli Lilly’s favor in the case of an Iraq War veteran who says he experienced brain zaps and other symptoms after discontinuing Cymbalta.
A New York federal judge rules in Eli Lilly’s favor in the case of Jesse McDowell who says he experienced withdrawal symptoms after discontinuing Cymbalta. The judge believes doctors were adequately warned about the drug’s possible withdrawal symptoms.
The U.S. Judicial Panel on Multidistrict Litigation refuses to consolidate more than two dozen Cymbalta lawsuits, citing the cases are in various stages of development and consolidation wouldn’t be efficient for the court.
A New York federal judge refuses a request to review the case of Jesse McDowell, saying there’s no new information.
A Texas-based case involving plantiff Marilyn Pickaree (who represented herself during the court proceeding) is thrown out of court because she exceeded the two-year statute of limitations to file her claim.
Pickaree says she took Cymbalta for four or five days in 2008, and then stopped – at her doctor’s direction – because it caused severe chest pains, which required a hospital visit. After discontinuing the drug, she claims she suffered severe withdrawal effects for several weeks, including insomnia, headaches, stomach pain and loss of appetite.
A judge strikes down Eli Lilly’s argument to dismiss the first two California-based Cymbalta lawsuits. Jury trials are set for August. By this time, the law firms of Baum, Hedlund, Aristei & Goldman, PC, Pogust, Braslow & Millrood LLC, Keller Rohrbach, LLP and Deskin Law Firm are representing more than 2,000 plaintiffs who claim they were injured (or in some cases, died) as a result of stopping Cymbalta.
The first plaintiff, Claudia Herrera, heads to court. Herrera took Cymbalta for six years and said she felt “desperate” for months after stopping the drug. During testimony, she described Cymbalta as a “poison” and said she wouldn’t have taken it had she known about the drug’s high rate of withdrawal symptoms. Her symptoms included anxiety, dizziness, insomnia and brain zaps.
Herrera’s attorneys argue Cymbalta’s high rate of withdrawal symptoms should be included on a warning label since Eli Lilly’s own research indicates that 44-50 percent of Cymbalta users experience withdrawal symptoms upon discontinuing the drug suddenly. Eli Lilly’s attorneys “countered … that the 44 percent figure wasn’t relevant to prescribers because in the same studies, 22 percent of subjects discontinuing a placebo also reported side effects.”
Lilly attorneys argue that it’s well-known that antidepressants can cause withdrawal symptoms if users stop taking them “cold turkey,” and that it’s standard practice for physicians to have patients gradually wean off of such drugs over time.
The jury rules in favor of Eli Lilly.
Later on in August 2015
A California federal judge cuts short the trial of Erin Hexum, ruling in Eli Lilly’s favor. During testimony, Hexum’s physician indicates he cannot remember if he read Cymbalta’s prescribing guide. The judge reasons that if the physician can’t remember reading the guide, then how can attorneys argue that the misleading information contained in the guide is responsible for the plaintiff’s symptoms.
Hexum had taken Cymbalta for fibromyalgia for about a year. When she stopped, she said she developed severe cramping, which required an emergency room visit. She was later diagnosed with a seizure disorder and lost her driver’s license.
Late August 2015 and early September 2015
A Virginia federal judge tossed Gilda Hagan-Brown and Janine Ali’s fraud claims, saying the women didn’t present enough evidence to prove Eli Lilly had committed fraud by publishing misleading information regarding Cymbalta’s withdrawal effects. On Sept. 1, a federal jury rules in Eli Lilly’s favor on a separate negligence claim.
Both women took Cymbalta for fibromyalgia and said they experienced depression, migraines, pain, fatigue and brain zaps after stopping the drug in 2012.
California plaintiffs Erin Hexum and Claudia Herrera file appeals in their cases.
Later September 2015
Three Cymbalta lawsuits involving 69 plaintiffs are transferred from California to Indiana where Eli Lilly is headquartered.
The U.S. Judicial Panel on Multidistrict Litigation rejects a bid to consolidate (for the second time) more than 40 Cymbalta lawsuits, saying the cases are in different stages of development.
The Cymbalta lawsuits have been settled. Click here for the details.
Interested in learning more? Click over to my Cymbalta lawsuits page, which includes links to my previous Cymbalta-related posts, news stories, attorney information and much more! Stay up-to-date by subscribing below.