The learned intermediary doctrine and patient package inserts: a balanced approach to preventing drug-related injury.

• Author: Paytash, Catherine A.

In this note, Catherine Paytash examines the validity of the learned intermediary doctrine as it is applied in the context of prescription drug therapy. She explores and analyzes the rationales advanced to support the rule and the criticisms that have been leveled against its application to prescription drugs. Paytash identifies two roles that the learned intermediary doctrine is intended to play in relation to prescription drugs: 1) a role that provides a reasonable and efficient legal system of warning about side effects and appropriate use, and 2) a role that encompasses a system for informing patients. Paytash concludes that the learned intermediary doctrine, though justified as a legal standard of liability for warnings provided by prescription drug manufacturers, is inadequate as a system for informing patients about the prescription medications they use. She proposes that the most efficient way of preventing prescription drug related injury is a hybrid solution comprised of the learned intermediary doctrine as the legal standard for liability for product warnings and an FDA-mandated system of patient package inserts as a supplemental means of providing prescription drug users with information.

INTRODUCTION

Debate about the wisdom of the learned intermediary doctrine has been fueled by the emergence of a new Restatement (Third) of Torts and recent proposals by the Food and Drug Administration (FDA) to require patient package inserts (PPIs) for all prescription drugs.(1) The learned intermediary doctrine holds that a prescription drug manufacturer fulfills its legal duty to warn a patient by providing an adequate warning to the prescribing physician.(2) The duty to warn only the physician is an exception to the general rule of law that an adequate warning must reach the ultimate consumer in order for a manufacturer to avoid liability for harm caused by a product.(3) The learned intermediary doctrine is firmly entrenched in the vast majority of states and has recently been affirmed by the Restatement (Third) of Torts.(4) Critics, however, argue that the rule is not the best way to ensure safe and effective drug therapy.(5) They advocate the expansion of legal requirements for warnings that reach a patient directly.

The debate focuses on determining the best legal standard for adequate warnings by prescription drug manufacturers. It is generally assumed that the best legal rule will automatically encompass the best system for informing patients. The ultimate goal is to prevent drug-related injury. The subsidiary goals of discovering a legal rule for warning and finding the best system for informing patients, however, need not be merged. In this note, I will argue that the most effective way of promoting safe and effective prescription drug therapy involves a hybrid solution comprised of 1) the learned intermediary doctrine as the legal standard of liability for drug manufacturers, and 2) an FDA-mandated system of PPIs for all prescription drugs to supplement information that a patient receives from his or her physician.

Part I of this note will outline the learned intermediary doctrine, discussing its rationales and treatment by the Restatement (Third) of Torts. Part II will discuss the critiques of the doctrine, examining arguments favoring exceptions to the rule and exploring more generalized critiques. Part III will synthesize the material presented in the previous sections and propose that the most effective way to avoid drug-related injury is through the implementation of a learned intermediary rule complemented by a comprehensive PPI program mandated by the FDA.

1. THE LEARNED INTERMEDIARY DOCTRINE

   1. The Legal Rule

      The learned intermediary doctrine has been a well-established legal rule for decades. First articulated in 1966, the modern version of the rule exempts prescription drug manufacturers from the general legal duty, to warn consumers directly about their products.(6) The rule states that drug manufacturers must adequately warn only the medical community of the risks associated with the use of a prescription drug.(7) The prescribing physician then acts as a learned intermediary between the manufacturer and the consumer. A warning to a physician is adequate if it clearly conveys any risk or contraindication that the manufacturer knows or should know is associated with the use of the prescription drug.(8) The duty to warn is continuous, and the manufacturer must notify the medical community of risks or side effects subsequently discovered.(9) The prescription drug manufacturer, moreover, is directly liable to the patient for a breach of its duty to warn the physician.(10)

   2. The Rationales

      The rationale most commonly used to support the learned intermediary rule is that expressed by Judge Wisdom in Reyes v. Wyeth Laboratories:(11)

      Prescription drugs are likely to be complex medicines, esoteric in formula and varied in effect. As a medical expert, the prescribing physician can take into account the propensities of the drug, as well as the susceptibilities of his patient. His is the task of weighing the benefits of any medication against its potential dangers. The choice he makes is an informed one, an individualized medical judgement bottomed on a knowledge of both patient and palliative.(12) Judge Wisdom's discussion underscores the physician's unique capability--based on education, expertise, and awareness of an individual patient's needs--to properly assess and weigh the risks and benefits associated with prescription drug therapy.

      Numerous other rationales are routinely advanced to support the learned intermediary rule. Proponents of the doctrine emphasize that it is the doctor, not the patient, who ultimately decides whether or not a prescription drug should be taken.(13) Furthermore, to the extent that patients are involved in drug therapy decisions, it is the duty of the physician--under the legal doctrine of informed consent--to provide them with the necessary information.(14) The physician, unlike an objective written warning, can tailor discussion of risks to a patient's individual condition and can answer any questions the patient might have.(15) Patients, moreover, are unlikely to be able to understand the highly technical medical jargon that is contained in a warning that adequately discloses a prescription drug's risks.(16) Such a warning, if read at all, might interfere with the doctor/patient relationship and deter patients from taking their prescribed medication.(17) Finally, proponents of the learned intermediary rule argue, it would be insurmountably difficult to fashion a prescription drug warning in lay language that adequately conveys risks and benefits that are so inherently varied, complex, and dependent upon an individual patient' s susceptibilities.(18)

   3. The Mass Vaccination Exception

      The learned intermediary doctrine is, however, not without exceptions.(19) Courts have commonly held that the learned intermediary rule cannot apply when there is no physician involved in the dispensing of a prescription drug. When a manufacturer knows or has reason to know that a drug will be dispensed without the participation of a doctor, a legal duty exists to warn the consumer directly.(20) This exception developed in the context of mass immunizations where there is no "individualized balancing by a physician of the risks involved" and where vaccines are dispensed to "all-comers" on request.(21) The immunization process is thus viewed as analogous to the acquisition of over-the-counter drugs.(22)

   4. The Restatement Approach

      The Restatement (Third) of Torts follows the vast majority of jurisdictions in embracing the learned intermediary doctrine and the mass immunization exception.(23) Section 6(d) of the Restatement on Products Liability states:

      A prescription drug or medical device is not reasonably safe because of inadequate instructions or warnings if reasonable instructions or warnings regarding foreseeable risks of harm are not provided to: 1. prescribing and other health care providers who are in a position to reduce the risks of harm in accordance with the instructions or warnings; or 2. the patient when the manufacturer knows or has reason to know that health care providers will not be in a position to reduce the risks of harm in accordance with the instructions or warnings.(24) II. CRITIQUES OF THE LEARNED INTERMEDIARY DOCTRINE

      Many have sharply criticized the learned intermediary doctrine, particularly in recent years. Some attack the form of the rule adopted by most jurisdictions and by the recent Restatement, advocating the expansion of exceptions to the rule.(25) Others question the wisdom of the doctrine in general, pointing to recent changes in the provision of health care and arguing that the current system of warning does not effectively prevent prescription drug-related injury.(26)

   1. The Push for More Exceptions

      1. Oral contraceptives.

         Since 1985, the value of the learned intermediary doctrine in reproductive health has been the subject of an extensive body of case law. Despite the one-on-one doctor/patient contact that occurs in the course of prescribing an oral contraceptive, several courts have found a number of reasons to reject the application of the learned intermediary doctrine in this context.(27) Three primary rationales are advanced to justify the exception. First, consumers of oral contraceptives actively participate in the decision to use this method of birth control instead of available alternatives.(28) Such heightened participation contrasts with the patient's generally minimal involvement in the decision to take prescription drugs to treat illness.(29) Second, unlike most prescription drugs, patients use oral contraceptives over long periods of time without regular contact with their doctors.(30) Physicians typically examine a patient and then prescribe a year's supply of oral contraceptives, requiring only annual examinations...