Zafarana v. Pfizer Inc.

724 F. Supp. 2d 545, 2010 U.S. Dist. LEXIS 72560, 2010 WL 2854170
CourtDistrict Court, E.D. Pennsylvania
DecidedJuly 20, 2010
DocketCivil Action 09-cv-4026
StatusPublished
Cited by26 cases

This text of 724 F. Supp. 2d 545 (Zafarana v. Pfizer Inc.) is published on Counsel Stack Legal Research, covering District Court, E.D. Pennsylvania primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Zafarana v. Pfizer Inc., 724 F. Supp. 2d 545, 2010 U.S. Dist. LEXIS 72560, 2010 WL 2854170 (E.D. Pa. 2010).

Opinion

MEMORANDUM AND ORDER

JOYNER, District Judge.

This case is now before the Court on Defendants’ Motion to Dismiss Plaintiffs’ Amended Civil Consumer Class Action Complaint (Doc. No. 17). For the reasons set forth below, Defendants’ Motion is GRANTED.

Factual Background 1

Plaintiffs bring this suit to recover for the actions taken by Defendants in marketing, promoting, and selling twelve of their prescription medications: Lyrica, Geodon, Relpax, DepoProvera, Zyvox, Lipitor, Zithromax, Zoloft, Zyrtec, Viagra, Aricept, and Norvasc. All of these drugs fall under the purview of the Federal Food, Drug, and Cosmetic Act (“FDCA”), which requires that all pharmaceutical drugs receive approval as being safe and effective for the treatment of specific conditions and in specific dosages. Further, the Act limits companies to promoting and marketing their drugs for these approved uses and dosages. Plaintiffs assert, however, that Defendants have a corporate culture that fosters ambivalence to the FDCA as well as a history of violating the Act in order to maximize profits on their approved drugs. For each of the drugs named in their Amended Complaint, Plaintiffs allege that Defendants engaged in a campaign of fraudulent and misleading marketing and advertised these drugs for off-label uses. This conduct culminated in the U.S. Department of Justice’s September 2, 2009, announcement that it had settled several qui tam actions brought against Defendants for their marketing of drugs in violation of the FDCA between January 1, 2001, and October 31, 2008, for which Defendants agreed to pay over $2 billion in fines.

Plaintiff Zafarana is a resident of New Jersey and was prescribed Lyrica to treat her idiopathic torticollis. The FDA approved Lyrica on December 30, 2004, as a treatment for diabetic peripheral neuropathy and postherpetic neuralgia. Later, on June 13, 2005, the FDA approved Lyrica for use as an adjunctive treatment of partial onset seizures in adults with epilepsy. Finally, Lyrica has been approved for the treatment of fibromyalgia. Plaintiffs, however, allege that the drug was also promoted for off-label use, including as a treatment for chronic pain, neuropathic pain, perioperative pain, and migraines. In addition, Defendants are alleged to have used unsubstantiated, false, and misleading comparative studies about the efficacy, safety, and cost-effectiveness of Lyrica. Plaintiff Zafarana took Lyrica from at least January of 2006 until January of 2007, and claims that it had no medical benefit for her condition. Further, Plaintiff alleges that she suffered from two side effects of Lyrica: weight gain and blurred vision. Finally, Plaintiff asserts that she paid a significant amount more for Lyrica than she would have paid for other, recog *550 nized, treatments for idiopathic torticollis, such as tylenol and stretching.

Plaintiff Dumville is currently a resident of Wisconsin, but in 2001 received treatment for his depression in Pennsylvania, and was prescribed Geodon and Zoloft for this condition. Geodon has received FDA approval for the treatment of schizophrenia and acute manic or mixed episodes associated with bipolar disorder. It can also be used to treat acute agitation associated with schizophrenia. Defendants are alleged, however, to have promoted Geo-don for the treatment of depression, bipolar maintenance, mood disorder anxiety, aggression, dementia, attention deficit hyperactivity disorder, obsessive compulsive disorder, autism, and posttraumatie stress disorder. In addition, Plaintiffs charge Defendants with marketing Geodon as being as safe, more effective, and less costly than other antipsychotics, but in doing so materially minimizing and concealing Geo-don’s serious side-effects, which include increased mortality in certain elderly patient populations and an increased risk of a potentially lethal heart arrhythmia. This marketing is alleged to have taken place from January 1, 2001, through December 31, 2007. Plaintiff Dumville was prescribed Geodon in 2001 to treat his depression. He alleges that he received no medical benefit from taking Geodon and “immediately” stopped taking it due to suffering from “a number of severe side effects,” although the exact nature of these side effects is undisclosed. Further, Plaintiff alleges that he could have been prescribed other, less expensive alternatives, including cognitive behavioral therapy, tricyclics, and MAO inhibitors.

Zoloft is an anti-depressant that inhibits the reuptake of serotonin by neurons, and was approved by the FDA in 1991 for the treatment of depression. In February of 2003, it was also approved for acute and long-term treatment of social anxiety disorder. Plaintiffs allege that, in promoting Zoloft, Defendants “paid illegal remuneration for speaker programs, mentorships, preceptorships, journal clubs and [gave] gifts including entertainment, cash, travel, and meals to health care professionals to induce them to prescribe Zoloft.” Although Plaintiff Dumville states that he was prescribed Zoloft to treat his depression, he does not state when he was prescribed the medication, for how long of a period he took the medication, whether it had any medical benefit on his condition, or whether he suffered from any side effects due to taking the medication. He does, however, state that generic versions of the drug were available at a substantially decreased price.

Plaintiffs’ Amended Complaint also contains detailed allegations about the marketing scheme for each of the drugs named in their Amended Complaint. In relation to Lyrica, Plaintiffs assert that Defendants took actions such as directing their sales representatives to discuss and use promotional materials that made representations as to the effectiveness of the drug in relation to other drugs when there were no peer-reviewed studies supporting these claims, directing sales representatives to contact doctors who did not treat any of the conditions that Lyrica was approved to treat, and using studies and speakers that supported off-label uses of Lyrica. Plaintiffs allege that these marketing strategies were developed at a series of “launch meetings” held from September of 2005 through November of 2005. Plaintiffs point to several specific times and events involved in this scheme, including the following: the September 12 through 15, 2005, formal launch of Lyrica at an Anaheim, California, meeting for the entire Western Region sales force; an October 12, 2005, e-mail to the sales force that authorized the promotion of “secondary *551

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Bluebook (online)
724 F. Supp. 2d 545, 2010 U.S. Dist. LEXIS 72560, 2010 WL 2854170, Counsel Stack Legal Research, https://law.counselstack.com/opinion/zafarana-v-pfizer-inc-paed-2010.