Consumer Protection Laws and Prescription Meds: A Poor Fit

Purchasers of prescription medications often file class actions in large, multidistrict litigation alleging that they were defrauded by manufacturers. In these actions, patients, many of whom disclaim any physical injury, become plaintiffs in the hope of obtaining a refund and, in some instances, treble or punitive damages. Yet, the consumer protection statutes relied on by these plaintiffs are a poor fit for claims based on prescription medications. This article discusses several of the unique defenses available to defendant manufacturers, which arise from the discord between these statutes and prescription medications.

Liability Requires Proof of a Causal Connection or Reliance by the Consumer — Consumers Rely on Their Physician, Not the Manufacturer

Most consumer protection statutes require that a plaintiff establish some link or connection between an alleged misrepresentation made by the defendant manufacturer and the consumer's purchase of the product at issue. In other words, plaintiffs must usually show that the alleged misstatement about the product either resulted in or in some way affected their decision to purchase the product. In some instances, a showing of justifiable reliance is also required, either as a result of an express provision within the statute or as part of the court's analysis of causation.

But in the context of pharmaceutical litigation, the plaintiffs are different for a simple reason: a patient cannot obtain a prescription medication without a physician's intervening decision to prescribe it. This makes it difficult for the patient to show that any misrepresentation communicated to him or her resulted in the purchase of the prescription medication. Under the learned intermediary doctrine, the manufacturer's obligations to warn about the safety of its products run to the physician, not the patient. Consumer protection statutes, therefore, should not provide a cause of action to the purchaser of a prescription medication because a direct link to the patient is absent.

In a recent decision involving the prescription diabetes medication Avandia, Federal District Judge Cynthia Rufe dismissed a consumer class action brought under the Pennsylvania consumer protection statute for these reasons. The court held that the learned intermediary doctrine barred plaintiff's claims because the plaintiff could obtain Avandia only with a physician's prescription, and the claims concerning his physicians' exposure to and reliance on alleged misleading information were insufficient. Morgan v. SmithKline Beecham Corp. (Avandia Mktg., Sales Practices & Prods. Liab. Litig.), No. 10-2401, 2013 U.S. Dist. LEXIS 96869, at *8 (E.D. Pa. July 10, 2013).

Other federal judges have reached the same conclusions.

For example, in another decision interpreting the Pennsylvania consumer protection law, District Judge Curtis Joyner dismissed a consumer class action...

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