Clark v. PFIZER INC.

990 A.2d 17, 2010 Pa. Super. 6, 2010 Pa. Super. LEXIS 7, 2010 WL 163583
CourtSuperior Court of Pennsylvania
DecidedJanuary 19, 2010
Docket754 EDA 2009
StatusPublished
Cited by21 cases

This text of 990 A.2d 17 (Clark v. PFIZER INC.) is published on Counsel Stack Legal Research, covering Superior Court of Pennsylvania primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Clark v. PFIZER INC., 990 A.2d 17, 2010 Pa. Super. 6, 2010 Pa. Super. LEXIS 7, 2010 WL 163583 (Pa. Ct. App. 2010).

Opinion

OPINION BY

ALLEN, J.:

¶ 1 Gregory Clark and Linda Meashey, individually and on behalf of others similarly situated (“Appellants”), appeal from the trial court’s February 9, 2009 order decertifying the class action and granting partial summary judgment in favor of Pfizer Inc. and Warner-Lambert Company, LLC (“Defendants”). We affirm the trial court’s order to the extent that it decerti-fied the class, concluding that Appellants *21 cannot satisfy the commonality and typicality requirements because individual issues of reliance and/or causation predominated the class’ claims. We vacate the trial court’s order insofar as it granted summary judgment against the class and/or their claims, concluding that the potential res judicata effect on the absent class members could forever bar their causes of action. Accordingly, we affirm in part and vacate in part.

¶ 2 On June 29, 2007, Appellants commenced this action on behalf of themselves and all other consumers who purchased the prescription drug Neurontin (or generic Gabapentin) for “off-label” uses that were not approved by the Food and Drug Administration (“FDA”). Defendants are the manufacturers and distributors of Neurontin. In 1993, the FDA approved Neurontin for treatment of partial seizures in adults, and in 2002, for management of post-herpetic neuralgia. These are the only two conditions/uses for which the FDA approved Neurontin. Physicians, however, are free to prescribe medication for any condition that they believe to be appropriate even if the medication was not approved by the FDA for that specific condition and/or use. This is known as “off label” prescribing and although permissible in the medical profession, federal law prohibits a drug manufacturer from promoting off-label uses of an FDA-approved medication.

¶ 3 Appellants alleged that beginning in 1995, Defendants deliberately and unlawfully promoted Neurontin to physicians for off-label uses for which the effectiveness had not been scientifically demonstrated. Appellants averred that Defendants engaged in a marketing scheme intended to convince the medical profession that Neurontin was effective for off-label uses, including the treatment of psychiatric disorders, pain syndromes, reflex sympathetic dystrophy, restless leg syndrome, fibromyalgia, anxiety disorder and migraine headaches. Appellants argued that Defendants accomplished this goal by soliciting anecdotal articles for insertion in medical journals, paying “opinion leader” physicians who prescribed Neurontin for off-label uses, and sponsoring medical education conferences which were actually paid promotional events. According to Appellants, Defendants had sales representatives ask doctors during details if they used other anti-epileptic drugs for painful neuropathies and also created internal objectives, strategies and tactics designed to increase sales of Neu-rontin for off-label uses. In addition, Appellants contended that Defendants promoted the prescription of Neurontin above the maximum doses approved by the FDA. In 2004, the United States Government charged Defendants with two counts of violating the Food, Drug and Cosmetics Act (the “FDCA”). Defendants pled guilty to two counts of unlawful marketing in violation of the FDCA and agreed to pay a $240 million fine. 1

¶ 4 In their complaint, Appellants asserted common law claims for misrepresentation, negligence, negligence per se, and breach of express warranty. 2 On June *22 29, 2007, the trial court granted Appellants’ motion for class certification. The trial court, inter alia, found that Appellants demonstrated the requirements necessary to sustain a class action: i.e., that the class was so numerous that joinder of all members would be impracticable; that questions of law or fact were common to the class; and that the class parties’ claims and defenses were typical of the entire class. Trial Court Opinion, 6/29/06, at Ills. Regarding the legal element of causation, the trial court found that the report of Dr. Meredith Rosenthal, an Assistant Professor of Health, Economics and Policy at the Harvard School of Public Health, sufficed to prove “a fraud upon the entire medical community of the country.” Id. at 17. In her report, Dr. Rosenthal concluded that Defendants’ unlawful conduct “would likely have resulted in impact” to the class members as “a large body of economic theory and empirical evidence suggests that pharmaceutical company marketing activities increase [prescriptions of Neurontin for off-label use.]” Id.

¶ 5 On October 23, 2007, the parties agreed to define the certified class as follows: “All individuals who were residents of Pennsylvania as of November 1, 2007 and who purchased Neurontin or its generic equivalent Gabapentin in the Commonwealth of Pennsylvania primarily for personal family or household purposes from 1995 to the present other than for treatment of partial seizures associated with epilepsy (as adjunctive therapy) or for management of post-herpetic neuralgia (pain associated with herpes zoster rash outbreaks).” Appellants then provided notice to the class members, informing them of the class action and their rights to opt out of the class.

¶ 6 Following further discovery, Defendants, on June 13, 2008, filed a motion to decertify the class. In that motion, Defendants argued that the class should be de-certified because recent evidence showed that Neurontin can be (and has been) effective in treating class members for many off-label conditions. Defendants also sought decertification on the ground that numerous doctors who prescribed Neuron-tin to class members for off-label uses did so for reasons wholly unrelated to any misrepresentation made by Defendants. In light of this evidence, Defendants argued that class certification was improper because Appellants could not establish, through common proof, that the individual class members suffered an injury, or that the prescribing doctors relied upon a false advertisement that caused an injury. In addition, Defendants filed a motion for summary judgment, contending that Appellants failed to adduce sufficient evidence in support of their class claims, and/or that the class claims failed as a matter of law.

¶ 7 By order dated February 9, 2009, the trial court granted partial summary judgment in favor of Defendants “on [Appellants’] class claims for breach of warranty.” Trial Court Opinion (T.C.O.), 4/17/09, at 5. The trial court found that there was “no evidence that [Appellants] saw, heard or in any way received any warranties that Neurontin could be used in circumstances not approved by the FDA.” Id. The trial court also granted summary judgment against the class as to all members “who actually benefited from off label use of Neurontin.” Id. at 5-6. The trial court found that the evidence revealed that some class members actually received a benefit from off-label use of Neurontin, and thus, *23 these class members suffered no cognizable legal injury. Id. In all other respects, the trial court denied Defendants’ motion for summary judgment, allowing the case to proceed on the class claims of misrepresentation, negligence and negligence per se.

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Cite This Page — Counsel Stack

Bluebook (online)
990 A.2d 17, 2010 Pa. Super. 6, 2010 Pa. Super. LEXIS 7, 2010 WL 163583, Counsel Stack Legal Research, https://law.counselstack.com/opinion/clark-v-pfizer-inc-pasuperct-2010.