Liability for direct-to-consumer advertising and drug information on the internet: while the learned intermediary doctrine still lives, drug manufacturers can take some precautionary measures if it is ruled inapplicable.

• Author: Heather, Justin Lee

Our medical-legal jurisprudence is based on images of health care that no longer exist.

--New Jersey Supreme Court in Perez v. Wyeth Laboratories Inc., 734 A.2d 1245, 1246 (1999).

THE INTERNET and the growing system of managed health care present opportunities and challenges not previously contemplated by the legal community or the judiciary. Manufacturers generally are liable in products liability claims for product defects, including failing to warn consumers of dangers associated with their products. For pharmaceutical drugs, a manufacturer is not liable when it warns physicians regarding the risks inherent in its products. This doctrine, the learned intermediary rule, shields manufacturers from liability to ultimate consumers based on inadequate instructions and warnings accompanying its products.

Created in the 1960s, the learned intermediary rule recognized the importance of the physician in providing patients with warnings associated with prescription drugs and the limited ability of manufacturers to provide warnings directly to consumer-patients. The changing nature of the doctor-patient relationship in an era of managed care and the availability of the Internet as a resource for providing information raises questions regarding the continuing vitality of the learned intermediary rule.

The doctrine, however, has continuing validity despite the changing nature of the provision of health care. There is a general framework for limiting a manufacturer's exposure to liability in the creation and maintenance of Internet web sites. Although it is unclear whether the learned intermediary rule continues to apply to products that manufacturers advertise directly to consumers, manufacturers may take steps to prevent the imposition of liability for failure to warn.

A LOOK AT THE RULE

Although not all states follow the Restatement (Third) of Torts: Products Liability, it provides a general framework for products liability claims regarding pharmaceutical drugs. (1) Under Sections 2 and 6(a)-(b) of the Restatement, a manufacturer generally is liable in products liability for (1) manufacturing defects, (2) design defects and (3) failure to warn of dangers associated with its products. According to Comment d to Section 6 of the Third Restatement, allegations of failure to warn of dangers associated with using prescription drugs are one of the primary theories of product liability in this field. The failure to warn theory of liability therefore warrants discussion.

Section 6(b) of the Third Restatement provides that "a prescription drug or medical service is defective if at the time of sale or other distribution of the drug or medical device ... (3) is not reasonably safe due to inadequate instructions or warnings." A manufacturer, however, can assert the learned intermediary rule as an affirmative defense, thereby avoiding the imposition of liability.

The learned intermediary rule limits a prescription drug manufacturer's duty to warn to an obligation to advise the prescribing physician of any potential dangers that may result from using the drug. The Third Restatement's version of the learned intermediary rule, stated in Section 6(d) is:

A prescription drug or medical device is not reasonably safe due to 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. A manufacturer discharges its duty to warn regarding the risks inherent in its pharmaceutical drugs by warning health care providers and physicians regarding those dangers. (2) This statement of the learned intermediary rule generally presumes the traditional doctor-patient relationship. The public policy concerns underlying the creation of the rule make sense within this traditional relationship.

Comment b to Section 6 of the Third Restatement declares that providing physicians with adequate information regarding the "relevant benefits and risks associated with various prescription drugs" allows health care providers to reach appropriate, informed decisions regarding which drug is best for a specific patient. In Reyes v. Wyeth Laboratories Inc., the Fifth Circuit stated succinctly the purpose of the learned intermediary rule:

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 judgment bottomed on a knowledge of both patient and palliative. (3) The complex nature of prescription drugs places the doctor in the unique position of evaluating the costs and benefits of a specific treatment modality in the context of a patient's needs and medical history.

Comments b and e to Section 6 of the Third Restatement recognize, however, that it is appropriate to impose a duty on the manufacturer to provide warnings directly to the consumer where the health care provider assumes a "much-diminished role as an evaluator or decision-maker." For example, where "manufacturers have advertised a prescription drug and its indicated use in the mass media." Although the Third Restatement adopts the learned intermediary rule generally, Comment e ultimately leaves the issue of liability for direct-to-consumer advertising "to developing case law." (4)

CASE LAW AND PUBLIC POLICY

Case law on the applicability of the learned intermediary rule for prescription drugs in the direct-to-consumer advertising context is in its infancy. There is no case law addressing whether information provided on the Internet constitutes direct-to-consumer advertising or the applicability of the learned intermediary rule in this situation. Because the Internet does not discriminate between physicians and lay consumers, information contained on a drug manufacturer's website likely is direct-to-consumer advertising. Although there is no definitive answer to the question whether the learned intermediary rule continues to apply in this situation, the policy reasons that compelled the creation of the rule remain.

1. Recent Case Law

   The New Jersey Supreme Court in 1999 adopted a new exception to the learned intermediary rule in Perez v. Wyeth Laboratories Inc., (5) In Perez, several bell-wether plaintiffs sought an early determination regarding the applicability of the learned intermediary doctrine to their claims alleging failure to warn of risks associated with Norplant, a surgically implanted contraceptive. The procedural posture is significant; it was the consolidation of 25 separate product liability actions.

   The court reviewed case law holding the learned intermediary rule inapplicable to contraceptives and to mass immunizations. For the purposes of evaluating the claims, the court assumed that "none of the Norplant advertisements warned of any inherent dangers or side effects posed by the drug." (6) It identified four...