Academic journal article Defense Counsel Journal

Emerging DTC Advertising of Prescription Drugs and the Learned Intermediary Doctrine

Academic journal article Defense Counsel Journal

Emerging DTC Advertising of Prescription Drugs and the Learned Intermediary Doctrine

Article excerpt

Even in the absence of a true physician-patient relationship, drug manufacturers can protect themselves by warning consumers directly

OWING to the influx of direct-toconsumer (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.


A. 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. ' 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 antiarthritis 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. …

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