Plumlee v. Pfizer, Inc.
| Decision Date | 29 August 2014 |
| Docket Number | Case No.: 13-CV-00414-LHK |
| Court | U.S. District Court — Northern District of California |
| Parties | LAURA A. PLUMLEE, an individual, on behalf of herself and all other persons similarly situated, Plaintiff, v. PFIZER, INC., a New York Corporation, Defendant. |
Plaintiff Laura Plumlee ("Plaintiff") brings this putative class action against Pfizer, Inc. ("Defendant" or "Pfizer"), alleging that Defendant mislabeled its product Zoloft in violation of California law. Defendant moves to dismiss the First Amended Complaint, ECF No. 130, which Plaintiff opposed, ECF No. 137. Having considered the submissions of the parties and the relevant law, the Court hereby GRANTS Defendant's motion to dismiss the First Amended Complaint with prejudice.
Defendant Pfizer, Inc., a New York corporation headquartered in New York, New York, is a "pharmaceutical company involved in the research, development, testing, manufacture, production, distribution, marketing, and sale of numerous pharmaceutical products." First Am. Compl. ("FAC") ¶ 11, ECF No. 116. Pfizer manufactures and sells Zoloft, known generically as sertraline, which the Food and Drug Administration ("FDA") approved in 1991 for the treatment of major depressive disorder.1 Id. ¶ 22. Plaintiff Laura A. Plumlee is a resident of California. Id. ¶ 10. On or about March 18, 2005, Plaintiff was prescribed Zoloft to treat her ongoing depression, and she continued to purchase and ingest Zoloft until August 11, 2006, when she switched to a generic formulation of sertraline. Id. ¶¶ 98, 99.
Plaintiff alleges that Pfizer has made and continues to make a variety of unlawful, false, and misleading statements, and has concealed and continues to conceal material information, about the efficacy of Zoloft in treating depression. Id. ¶¶ 62-99. Plaintiff alleges that Pfizer made such misrepresentations and omissions both in marketing and advertising Zoloft and on its drug labeling, and that Plaintiff purchased Zoloft on the basis of these misrepresentations and omissions. Id. ¶¶ 98, 103.
Zoloft, known generically as sertraline, is a "selective serotonin reuptake inhibitor ("SSRI")." Id. ¶ 17. SSRIs like Zoloft are antidepressants that counteract what is theorized to be the "primary physiological cause of depression": deficient levels of serotonin in the brain. Id. SSRIs inhibit the brain's reuptake of serotonin, increasing otherwise deficient levels of serotonin in the brain, in effect treating depression by "balanc[ing] the brain's chemistry." Id. Plaintiff alleges that "scientists have never found evidence to prove the 'balancing brain chemistry' theory." Id.
The antidepressant industry is immense, generating revenue of approximately $11 billion peryear. Id. ¶ 15. Before its patent expired in 2007, Pfizer's annual sales of Zoloft were in excess of $3 billion. Id. ¶ 23. Over 20 million prescriptions of Zoloft or its generic sertraline are filled each year, and Plaintiff estimates Pfizer's total revenue from Zoloft since its launch at over $30 billion. Id.
Plaintiff alleges that despite Zoloft's commercial success, the majority of the studies demonstrated "there was no clinically or statistically significant difference between Zoloft and placebo in relieving depression." Id. ¶¶ 32-33. According to the FAC, Zoloft's efficacy as an antidepressant is due primarily to the placebo effect. Id. ¶ 22. That is, the reason Zoloft may be effective in treating depression is the patient's belief that the drug is effective, rather than the drug's pharmacological effects. Id. Plaintiff cites several studies that show antidepressants are particularly susceptible to the placebo effect. Id. ¶ 26. Because there is no "physiological test for determining the extent of a person's depression," researchers must rely on a patient's subjective evaluations to evaluate an antidepressant's effectiveness. Id.
According to Plaintiff, Pfizer knew before Zoloft was approved by the FDA in 1991 that it "had an efficacy problem." Id. ¶ 32. When Pfizer submitted its new drug application ("NDA") to the FDA in 1990, it included five placebo-controlled clinical trials that were designed to test Zoloft's efficacy in treating depression. Id. ¶¶ 36, 90. Of the five, two demonstrated a statistically significant effect over placebo, and three showed none. Id. ¶ 37.
The FDA Psychopharmacological Drugs Advisory Committee ("PDAC") found Zoloft met the statutory requirements for approval of an NDA: that the drug be safe, and that there be "substantial evidence" of the drug's efficacy. Id. ¶¶ 46, 58; see also 21 C.F.R. § 314.126. Plaintiff quotes several statements from the PDAC meeting discussing Pfizer's NDA for Zoloft, which suggest that the evidentiary support for Zoloft's efficacy "is not as consistent or robust as one might prefer it to be." FAC ¶ 60; see generally id. ¶¶ 53-57. Nevertheless, the PDAC recommended Zoloft for approval, and in 1991 the FDA approved it for the treatment of depression. Id. ¶¶ 58, 22.
Plaintiff alleges that, in connection with marketing and labeling Zoloft, Pfizer made various misrepresentations and omissions which Plaintiff contends violate several California consumer protection laws. Id. ¶¶ 127, 136-151, 123.
First, Plaintiff alleges that "Zoloft's drug label has never properly disclosed the clinical trial data required to properly understand Zoloft's efficacy" or given consumers or prescribing healthcare professionals "significant clinical trial information . . . to determine . . . if purchasing or prescribing Zoloft is worth the risks." Id. ¶ 63. Plaintiff challenges Zoloft's drug label as misleading because it: (1) "suggests that all clinical trials performed on Zoloft supported efficacy when, in fact, there were at least three negative or failed efficacy trials that indicated Zoloft could not outperform placebo," (2) suggests that "numerous clinical trials" support efficacy, and (3) "fails to disclose that the two clinical trials that supposedly demonstrated Zoloft's efficacy were clinically insignificant." Id. ¶¶ 64-66, 70. Plaintiff contends that "[b]ecause the drug label contains material omissions of fact, Pfizer prevented consumers and prescribing healthcare professionals from having enough information to make an informed decision about whether to purchase or prescribe Zoloft." Id. ¶ 5.
Second, the FAC alleges that "Pfizer has engaged in selective and biased publication of Zoloft's clinical trials with the aim of promoting favorable studies and suppressing negative ones." Id. ¶ 74. Plaintiff alleges Pfizer was able to prevent disclosure of unfavorable clinical results by having outwardly unbiased researchers sign non-disclosure agreements, mandating that researchers obtain Pfizer's permission before publishing any clinical data, limiting researchers' access to the raw clinical data, and placing researchers whose trials demonstrated a lack of efficacy on a "do-not-use-in-the-future" list. Id. ¶ 75. These practices, according to the FAC, are "just one component of a larger marketing scheme designed to mislead consumers and healthcare professionals about Zoloft's likelihood of efficacy." Id. ¶ 74.
Third, Plaintiff alleges that Pfizer engaged in an extensive ghostwriting campaign to improve perceptions of Zoloft's efficacy in the scientific and medical communities. Id. ¶ 79. Thisprogram involved paying "key opinion leaders" to put their names on articles authored by Pfizer or its agents, articles which would then be published in targeted medical journals. Id. According to Plaintiff, the purpose of this program was to "promote efficacy, highlight [the] drug's superiority to a competitor(s), leverage good will with academic investigators, increase media and public perception of the drug and Pfizer, and provide tools for sales force to drive prescriptions based on data." Id. ¶ 83 (internal quotation marks omitted).
Fourth, Plaintiff alleges that Pfizer directly paid "key opinion leaders" and distinguished scientists to support Zoloft, while concealing these financial relationships from the larger scientific community. Id. ¶ 85.
Finally, the FAC alleges that after Pfizer obtained FDA approval of Zoloft, it embarked on a "massive [marketing] campaign to promote Zoloft as an effective and reliable treatment for depression." Id. ¶ 87. Plaintiff alleges that Pfizer encouraged healthcare professionals to prescribe Zoloft by providing them tickets to various theater and sporting events, and paying for ski trips, stays at luxury hotels, and meals at "fancy" restaurants. Id. ¶ 88. Plaintiff also alleges that Pfizer sent sales representatives—"typically young attractive people"—to visit healthcare professionals and "brief" them on Zoloft's efficacy, again with the purpose of giving healthcare professionals the impression that Zoloft was a reliable and effective medication for depression. Id. ¶ 89. In addition to these "direct-to-prescriber" efforts, Plaintiff alleges that Pfizer created numerous print and video advertisements to promote Zoloft, all of which "gave the false and misleading impression that Zoloft was a tremendously effective drug for the treatment of depression." Id. ¶ 90.
Plaintiff alleges that on or about March 18, 2005, she was prescribed a 50 mg daily dose of Zoloft by her psychiatrist to treat her ongoing depression. Id. ¶ 98. As her treatment progressed over the next four years, Plaintiff's dosage was increased to 100, 200, and 400 mg per day. Id. Plaintiff continued to purchase and ingest Zoloft until August 11, 2006. Id. Between March 18, 2005 and August 11, 2006, Plaintiff spent a total of approximately $171 to purchase Zoloft. Id. ¶ 100. Including both payments from Plaintiff and her insurance company, Pfizer received a totalof approximately $3,727 over the same period. Id. After August 11, 2006 ...
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