Emerging DTC advertising of prescription drugs and the learned intermediary doctrine: even in the absence of a true physician-patient relationship, drug manufacturers can protect themselves by warning consumers directly.

• Author: Matter, Monica Renee
• Position: Direct-to-consumer

OWING to the influx of direct-to-consumer (DTC) advertising for prescription medications, the learned intermediary doctrine should no longer absolve pharmaceutical manufacturers from liability for failure to warn claims because that advertising removes the physician from the role of a learned intermediary and gives the patients a more active role in the decision to use certain medications. While pharmaceutical manufacturers should W not be absolved of liability, defenses to liability should be available in situations where the manufacturer has provided sufficient warnings in accordance with U.S. Food and Drug Administration (FDA) and state law regulations regarding DTC advertising.

Section 402A of the Restatement (Second) of Torts 402A imposes strict liability on the manufacturer of an "unreasonably dangerous defective product, but certain products are considered to be "unavoidably unsafe because their social benefits outweigh their inherent dangers. Comment k to Section 402A relieves manufacturers for any injuries resulting from the use of such products if the products were properly manufactured and accompanied by adequate directions and warnings of the product's inherent dangers. Prescription drugs and various medical devices have been characterized as "unavoidably unsafe," thus manufacturers of prescription drugs have a duty to warn consumers of inherent dangers and provide directions on the proper use of the products.

An exception to the duty to warn consumers directly has been created for manufacturers of prescription drugs. The exception imposes the duty to warn not to the foreseeable user of the product--the patient--but rather to the prescribing physician. This exception is known as the learned intermediary doctrine.

DEVELOPMENT AND CASE LAW

1. What It Is

   The learned intermediary doctrine applies when a manufacturer provides adequate information about a certain drug's composition and effects to the prescribing physician. The benefit is that if the manufacturer provides an adequate warning to the prescribing physician, the manufacturer is immune from liability for any harm caused to the consumer from use of the drug, and the consumer may sue only the prescribing physician.

   The doctrine had its beginning in Marcus v. Specific Pharmaceuticals Inc. (1) and Love v. Wolf. (2) In Marcus, the New York Appellate division held that a drug manufacturer could not be found negligent for failing to warn the ultimate consumer of inherent dangers in a product that was only available by a physicians prescription. In Love, the California Court of Appeal held that a manufacturers common law duty to warn could be satisfied by providing an adequate warning to the physician, thus absolving it from liability to the consumer.

   The phrase "learned intermediary" was first used in Sterling Drug Inc. v. Cornish to illustrate the relationship of the physician as an intermediary between the patient and the pharmaceutical manufacturer. (3) The Eighth Circuit, in considering whether the drug manufacturer had a duty to warn of newly discovered side effects of an anti-arthritis medication, held that the manufacturer had a duty only to warn the prescribing physician. The policy behind this conclusion was that the physician was a learned intermediary between the purchaser of the drug and the manufacturer because the patient could receive the drug only with a prescription. The court reasoned that if the physician was sufficiently warned of the possible side effects and was made aware of the symptoms, it would be highly unlikely that a patient would be injured because the physician would take into consideration all this information in prescribing the medications.

   The doctrine was significantly broadened in Buckner v. Allergan Pharmaceuticals Inc. (4) There the Florida Court of Appeal held that a drug manufacturer had no duty to warn the patient directly despite the fact the manufacturer was aware that the medical community was not warning the patient of the adverse side effects associated with the use of the drug. The court's reasoning was that physicians do not have an absolute duty to inform patients of all possible side effects in every instance, and so the failure to warn in a particular instance should not give rise to a manufacturer's duty to warn.

   The current rule states that a pharmaceutical manufacturer has a duty only to warn the prescribing physician adequately of the risks and side effects associated with the use of a prescription drug. (5) This rule has been interpreted to encompass all physicians who may be involved with a patient in a decision making capacity. (6) A warning to the physician is considered adequate if it clearly discloses any risks, side effects or contraindications the manufacturer knew or should know are associated with the use of the drug. (7)

   If the manufacturer's warning to the physician is inadequate, the learned intermediary doctrine does not apply and the manufacturer may be liable for the failure to warn. (8) Even if the manufacturer's warning to the physician is inadequate, however, the manufacturer may be relieved of liability if the physicians actions in prescribing the drug would not have been altered even with the adequate warning. (9) The manufacturer's duty to warn the prescribing physician is continuous, requiring it to keep abreast of scientific developments touching on the manufacturer's product and to notify of any additional side effects discovered from its use. (10)

2. Rationales

   The several rationales on which the learned intermediary doctrine is based are: (1) the physician's training and experience; (2) the physician's evaluation of the patient's needs and wishes; (3) the assumption that the physician is better situated than the manufacturer to convey the appropriate and applicable warnings to the ultimate user; (4) the fact that warnings to consumers might interfere with the traditional physician-patient relationship; and (5) that it is difficult, if not impossible, to convey appropriate warnings to the consumer in view of the highly technical nature of the information and the variations in the needs of individual patient characteristics. (11)

   Of the rationales, the main focus is on the physician patient relationship and the ability of consumers to understand the information provided to them. (12)

   EXCEPTIONS TO DOCTRINE

   Courts have carved out exceptions to the learned intermediary doctrine in certain situations: (1) mass vaccinations, (2) oral contraceptives, (3) contraceptive devices and (4) over-promoted drugs. Of these, the most widely accepted and followed are those for mass immunizations and oral contraceptives.

1. Mass Immunizations

   This was first recognized in Davis v. Wyeth Laboratories Inc., (13) in which the plaintiff contracted polio as a result of vaccination at a mass immunization clinic. Because the vaccine was administered to everyone who requested it without any patient-by-patient assessment by a physician, the Ninth Circuit found the immunization process to be analogous to the sale of over-the-counter non-prescription drugs and held there was a common law duty to warn the consumer directly. Following Davis, the Fifth Circuit in Reyes v. Wyeth Laboratories (14) found mass immunization to be an exception when a manufacturer's product is dispensed without the sort of individualized balancing by a physician of the risks of the vaccine that is contemplated by the learned intermediary doctrine. Acceptance of this exception is further demonstrated by the fact that it had been adopted as Section 6(d) of the Restatement (Third) of Torts.

   This exception arose in a clinical setting, the crucial factor being not whether a large number of patients received the vaccine, but whether patients had their individual needs evaluated before treatment. Where a manufacturer knows or has reason to know that a drug will be dispensed without individualized evaluation, the manufacturer retains the...