Direct-to-consumer Advertising of Prescription Drugs: After a Decade of Speculation, Courts Consider Another Exception to the Learned Intermediary Rule

JurisdictionUnited States,Federal
CitationVol. 24 No. 01
Publication year2000

SEATTLE UNIVERSITY LAW REVIEWVolume 24, No. 2FALL 2000

Direct-to-Consumer Advertising of Prescription Drugs: After a Decade of Speculation, Courts Consider Another Exception to the Learned Intermediary Rule

Mae Joanne Rosok(fn*)

I. Introduction

The rising costs of health care have forced changes in institutions that provide health care services to patients. Doctors, hospitals, insurance companies, and drug manufacturers have changed business practices to trim costs and maximize profits. One practice exploited by pharmaceutical companies is the freedom to advertise prescription drug products.(fn1) Direct-to-consumer advertising can effectively increase product sales by reaching potential consumers through print and broadcast media.(fn2)

Direct-to-consumer advertising has prompted considerable legal comment regarding the liability of drug manufacturers to the ultimate consumer, the patient.(fn3) Unlike makers of nonpharmaceutical products, a drug manufacturer does not have a duty to warn a consumer(fn4) of the risks associated with a drug, rather, it owes a duty to warn the prescribing physician.(fn5) The physician is recognized as a learned intermediary between the drug manufacturer and the consumer.(fn6) As a result, the drug manufacturer is shielded from direct liability in failure to warn cases because the physician has the requisite skill to understand the risks described by the drug manufacturer, and the physician knows the health status of the patient far better than the manufacturer does.

Courts are reexamining policies supporting the learned intermediary doctrine in view of direct-to-consumer advertising by pharmaceutical companies. In a recent decision, the New Jersey Supreme Court advocated that when a manufacturer's advertisement misinforms a patient's choice of therapy, the court should recognize an exception to the learned intermediary rule.(fn7) In a factually similar case, the Fifth Circuit Court of Appeals ruled that it would not abandon the learned intermediary doctrine.(fn8)

This Comment will explore whether Washington courts should recognize direct-to-consumer advertising as an exception to the learned intermediary rule. With the ultimate goal of advocating the best protection for the consumer, the discussion will suggest that Washington courts should not create an exception. A review of other exceptions to the learned intermediary rule does not support abandoning the doctrine when a drug company advertises its product directly to consumers. Nevertheless, advertising does affect consumer purchases and does influence consumer choices, and drug companies should accept the responsibility to present balanced information. This responsibility should encompass more than meeting the minimum requirements for balanced advertising presently promulgated by the Food and Drug Administration (FDA).

The following section of this Comment presents a brief background of the learned intermediary doctrine, which provides an exception to the general rule that a product manufacturer is directly liable to a consumer of the product. Section III discusses decisions in which courts have created exceptions to the learned intermediary rule (exceptions to the exception). Next, Section IV presents a brief summary of the Washington court decisions that evaluate whether a pharmaceutical manufacturer should be directly liable to a patient. Section V discusses the role of the FDA and the weight courts give to the defense that drug manufacturers complied with FDA regulations. This section also presents the measures the FDA takes to regulate prescription drug advertising, as well as the challenges to these measures. Finally, Section VI reviews the recent court decision in Perez v. Wyeih Laboratories,(fn9) and the policies discussed therein regarding advertising and the learned intermediary rule. In this last section, the author concludes with a discussion of how health care product advertising impacts consumers.

II. Background

A. Prescription Drugs Are Unavoidably Unsafe Products

Section 402A of the Restatement (Second) of Torts states that a manufacturer should be held strictly liable if it sells a product that is defective and as such presents an unreasonable danger to the user or consumer.(fn10) Most states, including Washington, have adopted the rule either by statute or by case law.(fn11)

Comment k to section 402A suggests that prescription drugs should be considered unavoidably unsafe products because these products are "quite incapable of being made safe for their intended and ordinary use."(fn12) Risks are inherent in taking most, if not all, pharmaceutical drugs. A drug may provide benefit to some people, yet the same drug may not be an appropriate treatment for others. For example, aspirin, a readily available nonprescription drug, is recommended for some patients to reduce the risk of heart attack.(fn13) Recognition of this property of aspirin, i.e., its effect on blood clotting, justifies its use by a particular population of patients with cardiovascular disease. This same property, however, prompts physicians to recommend another type of pain reliever for post-surgery patients.(fn14) Because most drugs pose some risk to some patients, drugs are considered unavoidably unsafe. Nevertheless, if a drug is not unreasonably unsafe or defective, then its benefit to many people justifies its sale.(fn15) The manufacturer should not be held strictly liable because it has supplied the public "with an apparently useful and desirable product, attended with a known but apparently reasonable risk."(fn16)

Comment k of 402A was reorganized in the Restatement (Third) of Torts: Product Liability.(fn17) If jurisdictions displace 402A with the rules of the Restatement (Third), courts may change how they determine drug manufacturer liability. In the provision of the Restatement (Third) that describes prescription drug manufacturing, design, and warning defects,(fn18) a prescription drug is no longer described as an unavoidably unsafe product. Instead, the Restatement (Third) providesA prescription drug or medical device is not reasonably safe due to defective design if the foreseeable risks of harm posed by the drug or medical device are sufficiently great in relation to its foreseeable therapeutic benefits that reasonable health-care providers, knowing of such foreseeable risks and therapeutic benefits, would not prescribe the drug or medical device for any class of patients.(fn19)

Commentators Michael Wagner and Laura Peterson note that the "reasonable health care provider" standard departs from comment k language, and they suggest it is a poorer test for judging the reasonableness of marketing a particular drug or device than a "reasonable manufacturer" standard.(fn20) Wagner and Peterson contend that requiring a physician to determine whether a product should be on the market is "nonsensical."(fn21) Consequently, this provision increases the risk that the judiciary will reject the Restatement (Third).(fn22) In the next few years, pharmaceutical companies and attorneys will closely follow whether, and to what extent, courts will follow the new restatement.

B. Duty to Warn

The Restatement (Second) advocates that a manufacturer should be held strictly liable if the manufacturer introduces an unreasonably unsafe product into the stream of commerce.(fn23) A product may be considered unreasonably unsafe if it is placed in the hands of the ultimate consumer without adequate warning of the dangers involved in the product's use.(fn24) Under comment k, the seller of prescription drugs is not to be held strictly liable for "unfortunate consequences" attending the use of unavoidably unsafe products provided that the products are "properly prepared and marketed" and that "proper warning is given."(fn25) To prevent inappropriate administration of a drug, the manufacturer properly warns when it identifies the characteristics of patient populations that may be adversely affected by the drug and discusses the consequent effects with those particular patients so that harm may be prevented.(fn26)

In failure to warn cases, the majority of jurisdictions has applied a negligence standard, a position also supported by the Restatement (Third).(fn27) The reporters for the Restatement (Third) reject the minority view that a company should be strictly liable for injuries caused by a drug it manufactures, and instead focus on the reasonableness of the manufacturer's conduct.(fn28) A reasonable drug manufacturer is one that knew or should have known about the risks of a prescription drug.(fn29) To impose liability upon a manufacturer for failing to warn of scientifically unknowable risks is unfair, inefficient, and impossible to insure against.(fn30)

C. The Learned Intermediary Rule-An Exception to a Manufacturer's Duty to Warn Consumers

To establish a claim of negligence, a plaintiff must show that the defendant had a duty to warn, the defendant breached that duty, and the breach was the proximate cause of the plaintiffs injury.(fn31) Generally, a manufacturer of a product can be held directly liable to a consumer who is injured by the product. In drug liability cases, the learned intermediary rule provides an exception to the duty owed by a drug manufacturer to the consumer of a product, the patient.(fn32) The manufacturer meets its duty to warn of the dangers...

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