Thoughts on Informed Consent in the Era of Direct-to-Consumer Marketing of Pharmaceuticals

By Phyllis Griffin Epps

Direct-to-consumer marketing of prescription drugs is altering the balance between doctor and patient.  With information from commercial advertisements, the patient-consumer is equipped with more knowledge than ever.  In fact, the presumption underlying the consumer as target audience is the idea that patient preference should influence the judgment of the prescribing physician in matters related to drug therapy. In the recent Perez case, a state supreme court addressed these issues with results that, if adapted, would signal a revolution within the relationship between patient-consumer, provider, and pharmaceutical manufacturer. Perez v. Wyeth Lab. Inc., 161 N.J. 1, 734 A.2d 1245 (1999). But see In re Norplant Contraceptive Products Liability Litigation, 215 F. Supp. 2d 795 (E.D. Tex. 2002)(declining to adapt exception to learned intermediary doctrine articulated by Perez court).  The empowerment of the patient-consumer under direct-to-consumer marketing raises the question how the imbalance of power that prompted legal theory such as the learned intermediary doctrine and ethical notions of informed consent can remain intact. The process of informed consent is costly, but ultimately some form of additional counseling may be necessary to balance the judgment of the provider with that of the patient without undue paternalism or injury.

The process of obtaining informed consent respects the autonomy of the patient as an individual capable of making decisions in her interest and expressing her will.  Within the context of negligence theory, the adequacy of informed consent has been assessed under one of three standards: the “reasonable professional”, the “reasonable patient”, and the subjective.  The reasonable professional standard has been rejected as overly paternalistic; the “reasonable patient” standard holds sway in most jurisdictions.  The shift from one standard to the other reflects changes in the perception of the balance of power in the patient-physician relationship.

The “learned intermediary” doctrine arises in claims by a patient following injury by a drug product.  See Norplant, 215 F. Supp. 2d at 803-04 (citing Porterfield v. Ethicon, Inc., 183 F. 3d 464 (5th Cir. 1999)).  The drug manufacturer is shielded from liability by the presence of the physician, a learned intermediary competent to exercise judgment as to the suitability of a drug.  Several researchers have discussed the implications of direct-to-consumer marketing of prescription drugs for the learned intermediary doctrine, which is likely to remain intact.  Regardless of legal constraints, one must ask whether the empowerment of the patient-consumer has increased the danger of undue paternalism in drug therapy as an ethical matter.  If, however, the consumer preference is nearly as great a factor as the judgment of the physician (also subject to commercial information) in the selection of prescription drugs, should health service providers respect the autonomy of the consumer by recognizing the education via commercial as adequate or valuable?  As pharmacogenomics yields diagnostic tests and drug products, how might the heightened standard of care affect the balance of power and responsibility between all parties given the importance of post-approval safety reporting?  At what point does the empowerment of the consumer translate into responsibility for consequences of his preferences?

Informed consent is not customary in drug therapy.  Moreover, the purpose of the consent process should not be viewed as an opportunity to disclaim liability for bad results.  Nevertheless, the influence of direct-to-consumer marketing increases the need for greater counseling or “extra-education” of the patient.