Zoloft Class Action Claims Drug Company Misled Consumers about Zoloft’s Ability to Treat Depression

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Baum Hedlund, Aristei & Goldman, and Pendley Baudin & Coffin have filed a consumer fraud class action lawsuit alleging that drug manufacturer Pfizer, Inc. deliberately and falsely misled consumers regarding the effectiveness of the company’s antidepressant, Zoloft (generic name sertraline).

Zoloft has generated over $30 billion in sales since its release in 1991, but research suggests that the drug is, at best, little more effective than a sugar pill.

The class action lawsuit, case no. 13-CV-00414-PSG, filed on January 29, 2013, alleges that Pfizer orchestrated a massive marketing campaign designed to convince, in the face of the vast majority of clinical trial data to the contrary, that Zoloft was a very effective (e.g., “Zoloft has helped millions with depression”) and safe treatment for depression.

The lawsuit alleges that Pfizer engaged in a consistent and deliberate pattern of withholding from consumers and physicians critical information regarding Zoloft’s true effectiveness (or lack thereof), including the following:

• The majority of clinical trials designed to substantiate Zoloft’s effectiveness demonstrated that it was not superior to placebo.
• The minimal difference between Zoloft and placebo in the only two studies that showed Zoloft had more of an effect than placebo was obtained through data manipulation and was of little or no consequence to resolving people’s depression.
• Pfizer has pursued a policy to ensure that consumers and healthcare professionals remain unaware of the results of negative studies.
• By means of “ghostwritten” medical journal articles (written by Pfizer or companies hired by Pfizer) and hidden payments to prominent physicians (known as key opinion leaders), Pfizer has concealed its significant influence over Zoloft’s manufactured image of apparent effectiveness.
• Pfizer’s actions demonstrate a deliberate pattern of deception that has made it impossible for prescribing physicians to weigh the risks versus benefits of the drug and for consumers to make informed decisions about whether to take Zoloft. The lawsuit seeks to require Pfizer to stop its alleged unlawful conduct, including changing the drug label (package insert) for Zoloft to disclose the negative studies which show Zoloft’s true efficacy (or lack thereof).

The lawsuit also seeks to recover monetary damages “for the millions of consumers who were tricked into purchasing Zoloft.”

The class action lawsuit was filed in the United States District Court for the Northern District of California, San Jose Division, on behalf of Laura A. Plumlee, of Watsonville, California, and on behalf of consumers nationwide and in California who purchased and/or paid for Zoloft for the treatment of depression from its launch in 1991 to the present.

The lawsuit follows a 60 Minutes segment that aired on February 19, 2012 called “Treating Depression: Is there a placebo effect?”

Irving Kirsch, an associate director of the Placebo Studies Program at Harvard Medical School analyzed all of the available clinical trial data for a number of antidepressants, including Zoloft, and found that the “difference between drug and placebo is very, very small,” and “in half of the studies, non-existent.” In his recently published book, “The Emperor’s New Drugs,” Kirsch explained that the “drug companies knew how small the effect of their medications were compared to placebos, and so did the FDA and other regulatory agencies. The companies found various ways to make the data seem more favorable to their products … My colleagues and I hadn’t really discovered anything new. We had merely revealed their ‘dirty little secret’.”

Corroborating Dr. Kirsch, recently retired director of the FDA’s division of psychiatry products, Dr. Thomas Laughren, admitted to 60 Minutes that the difference between the antidepressants and placebo is “modest.” In fact, as far back as 1991, prior to Zoloft’s approval in the United States, FDA officials expressed fears that the agency’s approval of Zoloft would be challenged because the FDA is not “as demanding as it ought to be in regard to its standards for establishing the efficacy of antidepressant drug products.”

Internal FDA and Pfizer documents support the allegations in the complaint, illustrating that Zoloft’s efficacy is far from what Pfizer has represented to doctors and the consuming public.

Zoloft and the Placebo Effect

Drug makers are required to test drugs for efficacy and safety and submit the results to the FDA before the drug is approved. During these clinical trials, up to hundreds of patients are given either the drug being tested or a placebo (a sugar pill that has no medicinal benefit). Neither the patients nor the researchers testing the drug are supposed to be aware of which patients are receiving the actual medication.

In trials of antidepressants, patients are interviewed about their symptoms (usually using the 17-question Hamilton Rating Scale for Depression, or “HAM-D”) before, during, and at the end of the trial period, which usually lasts six to eight weeks, to determine how much their symptoms have diminished. Their answers are assigned a numerical value and summed to give an overall HAM-D depression score. The higher the score, the worse the depression.

However, many people experience significant symptom relief simply as a result of a belief that they are taking an active medication, even when the pill they are taking is a placebo. This is known as the placebo effect and it can be very powerful – so powerful in fact that, in many trials, those taking the sugar pill achieve as much symptom relief, according to HAM-D scores, as those taking the drug. Unless a drug company can provide to the FDA at least two clinical trials in which the patients receiving the drug achieve significantly more symptom improvement as measured by the HAM-D than those taking a placebo, the agency will not approve the drug.