Comment by Kathy A. King-Cameron
Ethical, or prescription, drug products occupy a unique position in products liability law. Ordinarily, the manufacturer of a product is liable for injuries caused by a defect in its product even if the manufacturer has exercised all possible care in the manufacturing process. However, ethical drugs are classified by the Restatement (Second) of Torts as unavoidably unsafe products, because they are incapable of being made completely safe for their intended purpose. The overall societal benefit that they provide however, justifies their use and encourages their development. Weighing the risk and likelihood of its occurrence against this societal benefit strikes a balance in favor of marketing ethical drugs with certain limitations. According to the Restatement, if an unavoidably unsafe product, such as a prescription drug, is properly manufactured and is accompanied by both instructions for use and an adequate warning, the product is neither defective nor unreasonably dangerous. This rule, by restricting a manufacturer's exposure to liability, fosters the development of pharmaceutical products despite the impossibility of predicting or preventing all potential side effects or injuries. Nevertheless, requiring proper warnings serves two separate goals: the reduction of risk to the consumer and the protection of individual autonomy in the decisionmaking process. Therefore, attaching adequate warnings to prescription products insulates a manufacturer from liability for harm caused by the product. Conversely, the failure to provide adequate warning of inherent dangers, in and of itself, renders the product both defective and unreasonably dangerous, thereby exposing the manufacturer to liability.
In the context of ethical drugs, the primary issue in considering the duty to warn is to whom the warning must be given. Is sufficient for the manufacturer of an ethical drug to warn only the physician, or should the manufacturer be required to warn the patient, the ultimate consumer? In standard products liability law the manufacturer has a duty to warn the ultimate consumer of the dangers inherent in the use of its product, even if the ultimate consumer did not actually purchase the product from the manufacturer. This duty also extends to those that may be endangered by a reasonably foreseeable use of the product. By comparison, the prescription drug manufacturer generally does not have a duty to warn the ultimate user of the dangers of its product. With most ethical drugs, the manufacturer fulfills its duty when it provides an adequate warning to the prescribing and treating physicians.
This Comment traces the introduction and evolution of the learned intermediary doctrine, which restricts the ethical drug manufacturer'sduty to warn to the relevant physicians. The Comment then explores the major exceptions to the learned intermediary doctrine and examines whether they provide justification for abandoning the doctrine in the context of breast implants.
About the Author
Kathy A. King-Cameron.
Citation
68 Tul. L. Rev. 937 (1994)