Cymbalta® Withdrawal Lawsuit

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Cymbalta Withdrawal Lawsuit History

A Cymbalta Withdrawal Class Action Lawsuit was Filed in California in 2012

The first federal district court case filed against Eli Lilly and Company alleging that Cymbalta causes a high percentage of patients who attempt to stop taking it, to experience withdrawal reactions (contrary to the label), was Saavedra v. Eli Lilly and Company, Case No.: 2:12-cv-09366, (C.D.CA, 2012). The case, filed on October 31, 2012 and amended on January 1, 2013, is a class action lawsuit brought on behalf of Cymbalta consumers in California, New York, Massachusetts and Missouri.

Saavedra v. Eli Lilly and Company Case No.: 2:12-cv-09366, (C.D.CA)

The case alleges that, because Lilly omitted important information about the drug’s withdrawal risks in the company’s labeling and marketing materials, consumers were unable to make an informed choice and should be compensated accordingly.

The Cymbalta withdrawal lawsuit also includes a damages claim for individual injuries Saavedra suffered as a result of withdrawals. The case is pending before the Honorable Judge Steven V. Wilson in the United States District Court for the Central District of California in Los Angeles.

In addition to the class action case, individual Cymbalta withdrawal personal injury lawsuits have been filed in various courts across the United States.

  • In 2013, seven Cymbalta withdrawal lawsuits were filed across the country (in Arizona, California, New York and Pennsylvania).
  • On August 8 and August 11, 2014, several more Cymbalta withdrawal lawsuits were filed in California, Florida, Georgia, Louisiana, Maryland, Minnesota, Ohio, Oregon, North Carolina, Pennsylvania, and Wisconsin.

Thousands of people have come forward seeking legal help after suffering from Cymbalta withdrawal.

Allegations in Consumer Class Action and Personal Injury Lawsuits

Consumers and healthcare professionals nationwide have not been fully and accurately informed of the frequency, severity, and/or duration of Cymbalta withdrawal since Cymbalta first entered the market in 2004. Lilly, through its nationwide marketing strategy, led consumers and healthcare professionals to believe that Cymbalta withdrawal is rare or uncommon. In truth, a significant percentage of Cymbalta users experience withdrawal.

The Cymbalta Label Misleadingly Suggests 1% Withdrawal Risk

The Cymbalta label has generally stated: “Discontinuation symptoms have been systematically evaluated in patients taking duloxetine [Cymbalta]. Following abrupt or tapered discontinuation in placebo-controlled clinical trials, the following symptoms occurred at a rate greater than or equal to 1% and at a significantly higher rate in duloxetine-treated patients compared to those discontinuing from placebo: dizziness, nausea, headache, fatigue, paresthesia [electric shock-like sensations], vomiting, irritability, nightmares, insomnia, diarrhea, anxiety, hyperhidrosis [excessive sweating] and vertigo….”

Cymbalta’s label and prescription information, which is uniform nationwide, mischaracterizes the frequency, severity, and/or duration of Cymbalta withdrawal, i.e., “symptoms occurred at a rate greater than or equal to 1% …”

Cymbalta’s warning label … is unfair and unlawful. It suggests that withdrawal symptoms occur in approximately one (1) percent of users. A reasonable consumer or prescribing healthcare professional reading this warning would gain very little meaningful information about the actual frequency, severity, and/or duration of Cymbalta withdrawal and would reasonably conclude that the likelihood of withdrawal symptoms was generally rare or approximately one (1) percent.

Cymbalta Study Shows at Least 44% to 51% Withdrawal Risk, 9.6% to 17.2% are Severe

In truth, Cymbalta withdrawal is frequent and severe. In six (6) double blind trials of Cymbalta funded, designed, and conducted by Lilly, approximately forty four (44) percent of users experienced some withdrawal symptoms. David G. Perahia, et al., Symptoms Following Abrupt Discontinuation of Duloxetine Treatment in Patients with Major Depressive Disorder, 89 Journal of Affective Disorders 207, 208 (2005).

Of those withdrawal symptoms, 50.6% were moderate and 9.6% were severe.

Moreover, during a much larger open-label trial (where users were aware they were taking Cymbalta) involving 1,279 subjects, approximately fifty-one (51) percent of users experienced some withdrawal symptoms. Of those withdrawal symptoms, approximately 46.3% were moderate and 17.2% were severe. The results of studies funded, designed, and conducted by Lilly indicate that approximately half of Cymbalta users experience withdrawal symptoms when they stop taking the drug.

Nowhere on the Cymbalta label does it indicate that a significant percentage of users who take Cymbalta, i.e., up to fifty-one (51) percent, experience withdrawal symptoms or that the majority of those withdrawal symptoms will be moderate or severe.

The study also noted that the withdrawal symptom data compiled during Lilly’s clinical trials was gathered from “spontaneous reports” of symptoms (patients volunteering symptoms), and not using the more accurate “symptom checklist.” The authors state that use of a symptom checklist would likely produce even higher incidence rates of withdrawal symptoms.

antidepressant-solutionThe Actual Risk is More Likely in the Range Between 66% and 78%, According to Expert

NOTE: According to Dr. Joseph Glenmullen, a clinical instructor in psychiatry at Harvard and author of the book, The Antidepressant Solution – A Step-by-Step Guide to Overcoming Antidepressant Withdrawal, Dependence, and “Addiction,” the true risk is more likely in the range between 66% and 78% due to Cymbalta’s “half-life.” Read Declaration of Joseph Glenmullen, M.D. re Cymbalta withdrawal reactions and Worst Offenders – The half-lives, elimination times, and typical onset of withdrawal symptoms after stopping antidepressants, taken from Dr. Glenmullen’s book.

Lilly Exaggerates Efficacy of Cymbalta

Lilly has also overplayed the efficacy (effectiveness) of Cymbalta. Seeking to capture a greater segment of the antidepressant market, in 2005, Lilly initiated the direct-to-consumer marketing campaign: “Depression hurts. Cymbalta can help.” Cymbalta advertisements bearing this slogan appeared ubiquitously on television, in print and on the internet. Lilly’s advertising campaign made it appear that Cymbalta not only treated depression but that it also treated physical pain associated with depression.

Scientists reviewing the Cymbalta data have concluded that Lilly’s claims are misleading. For example, in a 2008 article published in Psychotherapy and Psychosomatics, the author concluded that “the marketing of duloxetine as an antidepressant with analgesic properties for people with depression does not appear to be adequately supported.”

The Manipulation of Medical Literature

Lilly has also augmented its misleading advertising campaigns by engaging in selective and biased publication of its clinical trials of Cymbalta. By way of example, Lilly has generally published only favorable studies of its Cymbalta clinical trials and refused to publish any of the negative and unfavorable studies. Such selective publication of clinical trial data gives the impression that the drug is safer and more effective than it actually is.

In a recent study published in the New England Journal of Medicine, researchers obtained clinical trials for antidepressants (including Cymbalta) that had been submitted to the FDA and compared them with studies that had been published. The authors found that there was a “bias towards the publication of positive results” and that, “according to the published literature, it appeared that 94% of the trials conducted were positive. By contrast, the FDA analysis shows that 51% were positive.” The authors found that, as a result of such selective publication, the published literature conveyed a misleading impression of Cymbalta’s efficacy resulting in an apparent effect size that was 33% larger than the effect size derived from the full clinical trial data. See Erick H. Turner et al., Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy, 358 New Eng. J. Med. 252 (2008).

Lilly’s Cymbalta Profits

Lilly’s misleading direct-to-consumer promotional campaigns, its misleading presentation of Cymbalta’s efficacy and its failure to adequately warn regarding Cymbalta’s withdrawal and dependency side effects, have paid off financially for Lilly. Cymbalta has become a “blockbuster” drug with over $3 billion dollars in annual sales.

In the past few years, Cymbalta has been the second most profitable drug in Lilly’s product line.

Institute for Safe Medication Practices Finds “Serious Breakdown” in Warning Doctors and Consumers about Cymbalta Withdrawal

In October 2012, the Institute for Safe Medication Practices (ISMP), a non-profit healthcare consumer safety watchdog, issued findings from its independent investigation of Cymbalta adverse events found in the FDA Adverse Event Reporting System (FAERS). See QuarterWatch, Monitoring FDA MedWatch Reports, Why Reports of Serious Adverse Drug Events Continue to Grow, Oct. 3, 2012, ISMP.

The ISMP’s investigation uncovered “a signal for serious drug withdrawal symptoms associated with duloxetine (Cymbalta),” and detailed for the public what Lilly already knew: “[W]ithdrawal symptoms were reported in 44-50% 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 ISMP report continued: “[W]e identified a serious breakdown at both the FDA and the manufacturer, Eli Lilly and Company, in providing adequate warnings and instructions about how to manage this common adverse effect.

The ISMP also explained:

Good patient information is essential because abrupt withdrawal effects are likely to affect about 50% of duloxetine patients; they will be severe in at least 10% of that total, and persistent in half. Instead of clear warnings and useful instructions, the duloxetine patient Medication Guide says only:

  • “Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.”

This 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 kind 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?

Is there a way to tell whether these are withdrawal symptoms or the previous illness returning?

We could not identify any FDA-approved or company information for patients about how to discontinue duloxetine. We specifically asked Lilly how the company responded if a patient asked for assistance in stopping duloxetine. “If a consumer requests additional information we inform them to consult their physician because they know the patient’s complete medical history,” the company said. Consumers could also obtain the prescribing information intended for physicians.

In conclusion, the report minced no words in its indictment of Lilly’s product information: “A major lapse has occurred in the FDA-approved information for patients about the risks of stopping duloxetine.”

Before stopping any medication you must first consult with your healtcare provider.