Take two of these and sue me in the morning: efficacy of the learned intermediary doctrine in prescription drug failure to warn cases.

• Author: Friedman, Robert J.

1. Introduction II. The Learned Intermediary Doctrine: The Doctrine Explored III. The Learned Intermediary Doctrine: Policy Explored IV. The Learned Intermediary Doctrine: Exceptions to the Rule V. The Role of Warnings in Tort Law Generally VI. Shortcomings of the Learned Intermediary Approach VII. Solutions--How to Improve Upon the Current Learned Intermediary VIII. Conclusion I. INTRODUCTION

   Consider Rex, (2) who wakes up one morning to find he suffers from an ailment and therefore pays a visit to his doctor's office. His physician, Dr. Pharm, discusses Rex's symptoms, examines Rex, and then prescribes Drug X. Rex picks up his prescription via the drive-thru window at his local drug-store chain. Rex takes the medication as instructed on the bottle whereupon he suffers an undesired side-effect--known to affect a small percentage of users--rendering him even more severely ill....

   Under the Learned Intermediary Doctrine--elaborated below and representing the majority approach to manufacturer liability in prescription drug cases (3)--Rex holds no recourse against the pharmaceutical manufacturer of Drug X. While logic would seem to impose a manufacturer duty to the ultimate user, for purposes of tort liability in prescription drug cases it is the physician, not the patient, deemed to be the consumer. (4) Thus, so long as the manufacturer conveys sufficient warning of possible side effects to the prescribing physician Dr. Pharm alone, a learned intermediary, the pharmaceutical manufacturer is absolved from any liability to Rex--the ultimate user of the drug. (5)

   Representing an exception to ordinary tort doctrines of manufacturer-to-consumer duty, (6) the reasoning and policy behind the Learned Intermediary Doctrine will be explored below. (7) Common exceptions to the doctrine, as well as the role of warnings generally in tort law, will be discussed. (8) Shortcomings of the doctrine--causing the public to be put at unnecessary risk--will be related, and novel solutions will be presented for shoring up the flaws, ultimately leading to a doctrine better serving of its intended policy aims, and more protective of the general public. (9)

   Back to our legally powerless ailing patient Rex, who has suffered an unintended side effect from the medication he was prescribed--should any of the following altered scenarios have an effect on his ability to hold the pharmaceutical manufacturer liable? Whether Rex merely telephoned his doctor to receive the prescription instead of visiting in person? Whether he telephoned his doctor's office but only spoke to a doctor's assistant instead of the doctor? Whether he went inside the pharmacy to pick up his prescription instead of utilizing the drive-thru? Whether, once inside the store, the pharmacist informs Rex of the medication's common possible side effects? Whether the pharmacist does not convey this information? Whether the bottle containing the medication conveys the medication's common possible side effects, or whether along with the medication Rex is provided a thick packet of literature which somewhere inside conveys the medication's common possible side effects? Whether a television or radio commercial advertising the medication commonly aired and such advertisement was seen or heard by Rex? These quandaries will similarly be explored below. (10)

2. THE LEARNED INTERMEDIARY DOCTRINE: THE DOCTRINE EXPLORED

   As related above, the Learned Intermediary Doctrine absolves a pharmaceutical manufacturer from any duty to warn the ultimate user of its prescription drug--the patient. (11) Rather, the doctor--the learned intermediary--and not the patient, is viewed by law as the consumer. (12) The manufacturer's duty to warn, therefore, extends only as far as the doctor. (13) One of the earliest cases formally adopting the concept of the Learned Intermediary Doctrine is the Eighth Circuit decision Sterling Drug, Inc. v. Cornish. (14) Sterling Drug involved a suit against a pharmaceutical manufacturer for failure to warn when a patient suffered permanent eye injury as a side-effect to a prescribed drug. (15) The patient contended the pharmaceutical manufacturer was negligent for failing to warn prescribing doctors of the side effect--chloroquine retinopathy--resulting in retina blindness in a small percentage of users. (16) The appellant, the pharmaceutical manufacturer, argued the doctor instead deserved liability for "negligently fail[ing] to keep up with medical literature, including appellant's literature." (17) In upholding the verdict for the plaintiff, the court found the pharmaceutical manufacturer held a duty to properly warn the doctor of the risk of the side effect--a duty not met. (18) Limiting its decision to the arena of prescription drugs alone, rather than an over the counter product, the court explained the uniquely limited duty imposed on the pharmaceutical manufacturer:

   [In the realm of prescription drugs] the purchaser's doctor is a learned intermediary between the purchaser and the manufacturer. If the doctor is properly warned of the possibility of a side effect in some patients, and is advised of the symptoms normally accompanying the side effect, there is an excellent chance that injury to the patient can be avoided. (19) In a later case, Johnson v. American Cyanamid Co., (20) the Kansas Supreme Court similarly applied the Learned Intermediary Doctrine in determining liability for an infant's contraction of polio resulting from a vaccination. (21) The court overturned a lower ruling for the patient, finding "under such circumstances the 'learned intermediary' concept comes into play." (22) The court found that, in effect, the concept dictates the pharmaceutical "manufacturer's duty is to adequately warn the physician of a known risk," (23) and that such duty was met. (24)

   Application of the Learned Intermediary Doctrine became more widespread to the degree that a Federal District Court noted, in 1995, that the doctrine "clearly reflects the law in an overwhelming number of jurisdictions." (25) It is therefore safe to say the doctrine represents the majority position in the realm of pharmaceutical manufacturer duty to warn. (26) And while the doctrine was not part of the Second Restatement of Torts, (27) it is incorporated directly into the Third Restatement of Torts, adopted in 1998. (28)

   The rationale behind the Learned Intermediary Doctrine, as noted above, states that "for purposes of determining consumer expectations and risk-utility" (29) in the context of prescription drugs, the doctor is deemed the consumer. (30) Ironically, therefore, the patient is not considered, by law, to be the consumer despite the reality that the patient is the ultimate user of the drug. (31) Thus, a warning to the doctor alone will suffice under most circumstances. (32) The Supreme Court of Alaska explained away the doctrine's perceived irony in this way:

   [P]rescribing doctors are the consumers of prescription drugs. It is the doctor's evaluation of the patient's condition and consideration of the available treatment alternatives which leads to the choice of a specific prescription drug product. Also, the doctor has ready access to the FDA-approved warning information contained in the package insert and the Physicians' Desk Reference. Thus it is the doctor's expectation, and not that of the patient, regarding the performance and safety of prescription drugs which is the relevant inquiry.... (33) Therefore, the pharmaceutical manufacturer's duty to warn the doctor alone stems from the doctor's professional knowledge of medicine and the doctor's unique position as a liaison between the pharmaceutical manufacturer and the patient. (34) From a legal perspective, the doctor's unique position makes her the party responsible for determining the patient's use of the drug. Therefore, under ordinary circumstances it seems the patient's ability to make an informed choice to take a given prescription drug is deemed non-existent or too negligible to factor into the calculus of tort duties to warn. (35)

   As has been seen, the Learned Intermediary Doctrine limits a pharmaceutical manufacturer's duty to warn to a doctor alone--not a patient. (36) Even this limited duty, however, has at times been interpreted narrowly--to the benefit of the manufacturer. (37) In Swayze v. McNeil Laboratories, Inc., (38) the Fifth Circuit went as far as finding that a manufacturer had no duty to limit the improper use of its product. (39) Such a ruling came in the face of a common practice by which certified registered nurse anesthetists (CRNA)--not doctors--were given sole discretion to determine dosage and ultimately administer anesthetic to patients. (40) An improperly high dosage of anesthetic, by a CRNA, amounted to an overdose causing the plaintiff cardiorespiratory arrest and ultimately permanent brain damage. (41) The Swayze Court found that the manufacturer held no duty to combat this practice and thereby "intervene" in the doctor-patient relationship, which the court found did exist in this case. (42)

   Moreover, a manufacturer's duty to warn a doctor may be limited further to the extent that experts generally need not even receive warning in the first place regarding "dangers commonly associated with the use of products about which he has expert knowledge." (43) For example in York v. Union Carbide Corp., (44) a state court of appeals found the defendant, who was a supplier of argon--a potentially deadly gas used in the production of steel--held no duty to warn the individual employees of the purchaser steel company. (45) Rather, the purchaser was deemed a "sophisticated user of argon," and could therefore be counted on to properly convey warnings in order to properly train employees as to the dangers of argon--thereby discharging the defendant's duty to warn. (46) Additionally, in Smith v. Walter C. Best, Inc. (47) the Third Circuit found that the seller of sand held no duty to warn the...