Opinion ID: 1897541
Heading Depth: 2
Heading Rank: 1

Heading: Direct advertising of drugs to consumers alters the calculus of the learned intermediary doctrine.

Text: In Reyes, supra, the respected Judge John Minor Wisdom explained the rationale behind the learned intermediary doctrine. His perspective reflects the then-prevalent attitude about doctor-patient relationships: This special standard for prescription drugs is an understandable exception to the Restatement's general rule that one who markets goods must warn foreseeable ultimate users of dangers inherent in [the] products.... 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 [the] patient. [The physician's] task [is to weigh] the benefits of any medication against its potential dangers. The choice [the physician] makes is an informed one, an individualized medical judgment bottomed on a knowledge of both patient and palliative. Pharmaceutical companies then, who must warn ultimate purchasers of dangers inherent in patent drugs sold over the counter, in selling prescription drugs are required to warn only the prescribing physician, who acts as a learned intermediary between manufacturer and consumer. [498 F. 2d at 1276 (footnote and citation omitted).] A more recent review summarized the theoretical bases for the doctrine as based on four considerations. First, courts do not wish to intrude upon the doctor-patient relationship. From this perspective, warnings that contradict information supplied by the physician will undermine the patient's trust in the physician's judgment. Second, physicians may be in a superior position to convey meaningful information to their patients, as they must do to satisfy their duty to secure informed consent. Third, drug manufacturers lack effective means to communicate directly with patients, making it necessary to rely on physicians to convey the relevant information. Unlike [over the counter products], pharmacists usually dispense prescription drugs from bulk containers rather than as unit-of-use packages in which the manufacturer may have enclosed labeling. Finally, because of the complexity of risk information about prescription drugs, comprehension problems would complicate any effort by manufacturers, to translate physician labeling for lay patients. For this reason, even critics of the rule do not suggest that pharmaceutical companies should provide warnings only to patients and have no tort duty to warn physicians. [Noah, supra, 32 Ga. L.Rev. at 157-59 (footnotes omitted).] These premises: (1) reluctance to undermine the doctor patient-relationship; (2) absence in the era of doctor knows best of need for the patient's informed consent; (3) inability of drug manufacturer to communicate with patients; and (4) complexity of the subject; are all (with the possible exception of the last) absent in the directto-consumer advertising of prescription drugs. First, with rare and wonderful exceptions, the `Norman Rockwell' image of the family doctor no longer exists. Id. at 180 n. 78 (citing Paul D. Rheingold, The Expanding Liability of the Drug Manufacturer to the Consumer, 40 Food Drug Cosm. L.J. 135, 136 (1985)). Informed consent requires a patient-based decision rather than the paternalistic approach of the 1970s. See Largey v. Rothman, 110 N.J. 204, 206, 540 A. 2d 504 (1988) (discussing Canterbury v. Spence, 464 F. 2d 772 (D.C.Cir.), cert. denied, 409 U.S. 1064, 93 S.Ct. 560, 34 L.Ed. 2d 518 (1972)). The decision to take a drug is not exclusively a matter for medical judgment. See Teresa Moran Schwartz, Consumer-Directed Prescription Drug Advertising and the Learned Intermediary Rule, 46 Food Drug Cosm. L.J. 829, 831 (1991) (citing Margaret Gilhooley, Learned Intermediaries, Prescription Drugs, and Patient Information, 30 St. Louis. U. L.J. 633, 652 (1986)). Second, because managed care has reduced the time allotted per patient, physicians have considerably less time to inform patients of the risks and benefits of a drug. Sheryl Gay Stolberg, Faulty Warning Labels Add to Risk in Prescription Drugs, N.Y. Times, June 4, 1999, at A27. In a 1997 survey of 1,000 patients, the F.D.A. found that only one-third had received information from their doctors about the dangerous side effects of drugs they were taking. Ibid. Third, having spent $1.3 billion on advertising in 1998, supra at 12-13, 734 A. 2d at 1251 - 52, drug manufacturers can hardly be said to lack effective means to communicate directly with patients, Noah, supra, 32 Ga. L.Rev. at 158, when their advertising campaigns can pay off in close to billions in dividends. Consumer-directed advertising of pharmaceuticals thus belies each of the premises on which the learned intermediary doctrine rests. First, the fact that manufacturers are advertising their drugs and devices to consumers suggests that consumers are active participants in their health care decisions, invalidating the concept that it is the doctor, not the patient, who decides whether a drug or device should be used. Second, it is illogical that requiring manufacturers to provide direct warnings to a consumer will undermine the patient-physician relationship, when, by its very nature, consumer-directed advertising encroaches on that relationship by encouraging consumers to ask for advertised products by name. Finally, consumer-directed advertising rebuts the notion that prescription drugs and devices and their potential adverse effects are too complex to be effectively communicated to lay consumers. Because the FDA requires that prescription drug and device advertising carry warnings, the consumer may reasonably presume that the advertiser guarantees the adequacy of its warnings. Thus, the common law duty to warm the ultimate consumer should apply. [Susan A. Casey, Comment, Laying an Old Doctrine to Rest: Challenging the Wisdom of the Learned Intermediary Doctrine, 19 Wm. Mitchell L.Rev. 931, 956 (1993) (footnotes omitted).] When all of its premises are absent, as when direct warnings to consumers are mandatory, the learned intermediary doctrine, itself an exception to the manufacturer's traditional duty to warn consumers directly of the risk associated with any product, simply drops out of the calculus, leaving the duty of the manufacturer to be determined in accordance with general principles of tort law. Edwards v. Basel Pharms., 116 F. 3d 1341, 1343 (10th Cir. 1997) (discussing question of adequacy of nicotine patch warning under Texas law certified in Edwards v. Basel Pharms., 933 P. 2d 298 (Okla.1997)). We acknowledge that the Fifth Circuit recently held that under Texas law, the learned intermediary doctrine does apply in the context of Norplant. In re Norplant Contraceptive Products Liab. Litig., 165 F. 3d 374, 379-80 (1999). Nonetheless, we agree with the Tenth Circuit's approach. Concerns regarding patients' communication with and access to physicians are magnified in the context of medicines and medical devices furnished to women for reproductive decisions. In MacDonald v. Ortho Pharmaceutical Corp., 394 Mass. 131, 475 N.E. 2d 65, cert. denied, 474 U.S. 920, 106 S.Ct. 250, 88 L.Ed. 2d 258 (1985), the plaintiff's use of oral contraceptives allegedly resulted in a stroke. The Massachusetts Supreme Court explained several reasons why contraceptives differ from other prescription drugs and thus warrant the imposition of a common law duty on the manufacturer to warn users directly of associated risks. Id. at 136-37, 475 N.E. 2d 65. For example, after the patient receives the prescription, she consults with the physician to receive a prescription annually, leaving her an infrequent opportunity to explore her questions and concerns about the medication with the prescribing physician. Id. at 137, 475 N.E. 2d 65. Consequently, the limited participation of the physician leads to a real possibility that their communication during the annual checkup is insufficient. Id. at 138, 475 N.E. 2d 65. The court also explained that because oral contraceptives are drugs personally selected by the patient, a prescription is often not the result of a physician's skilled balancing of individual benefits and risks but originates, instead, as a product of patient choice. Id. at 137, 475 N.E. 2d 65. Thus, the physician is relegated to a ... passive role. Ibid. Patient choice is an increasingly important part of our medical-legal jurisprudence. New Jersey has long since abandoned the professional standard in favor of the objectively-prudent-patient rule, recognizing the informed role of the patient in health-care decisions. Largey, supra, 110 N.J. at 212, 540 A. 2d 504. Accordingly, a patient must be informed of material risks, which exist when a reasonable patient, in what the physician knows or should know to be the patient's position, would be `likely to attach significance to the risk or cluster of risks' in deciding whether to forego the proposed therapy or to submit to it. Id. at 211-12, 540 A. 2d 504 (quoting Canterbury, supra, 464 F. 2d at 787). When a patient is the target of direct marketing, one would think, at a minimum, that the law would require that the patient not be misinformed about the product. It is one thing not to inform a patient about the potential side effects of a product; it is another thing to misinform the patient by deliberately withholding potential side effects while marketing the product as an efficacious solution to a serious health problem. Further, when one considers that many of these life-style drugs or elective treatments cause significant side effects without any curative effect, increased consumer protection becomes imperative, because these drugs are, by definition, not medically necessary. In the development of products liability law, the role of advertising has been a significant factor in defining the duties of sellers. An early, but important, example is Henningsen v. Bloomfield Motors Inc., [32 N.J. 358, 161 A. 2d 69 (1960) ] the seminal case marking the date of the fall of the citadel of privity, in which the Court recognized the advent of large scale advertising by manufacturers as a basis for reconsidering the long-standing privity rule in warranty cases. The general principle recognized in Henningsen that a manufacturer's duty runs directly to the consumer when it markets its products directly to the consumeris as applicable today to prescription drug manufacturers who advertise their products as it was to automobile manufacturers three decades ago in Henningsen. [Schwartz, supra, 46 Food Drug Cosm. L.J. at 840-41 (footnotes omitted).] Obviously, the learned intermediary doctrine applies when its predicates are present. In New Jersey, as elsewhere, we accept the proposition that a pharmaceutical manufacturer generally discharges its duty to warn the ultimate users of prescription drugs by supplying physicians with information about the drug's dangerous propensities. Niemiera, supra, 114 N.J. at 559, 555 A. 2d 1112. Had Wyeth done just that, simply supplied the physician with information about the product, and not advertised directly to the patients, plaintiffs would have no claim against Wyeth based on an independent duty to warn patients. The question is whether the absence of an independent duty to warn patients gives the manufacturer the right to misrepresent to the public the product's safety. D. Prescription drug manufacturers that market their products directly to consumers should be subject to claims by consumers if their advertising fails to provide an adequate warning of the product's dangerous propensities. In reaching the conclusion that the learned intermediary doctrine does not apply to the direct marketing of drugs to consumers, we must necessarily consider that when prescription drugs are marketed and labeled in accordance with FDA specifications, the pharmaceutical manufacturers should not have to confront state tort liability premised on theories of design defect or warning inadequacy. Note, A Question of Competence: The Judicial Role in the Regulation of Pharmaceuticals, 103 Harv. L.Rev. 773, 773 (1990). We draw much of this summary concerning the specifics of FDA pharmaceutical regulation from the brief of amicus curiae, the Pharmaceutical Research and Manufacturers of America. Because such regulations may change from day to day, our commentary concerning the current regulations may soon become moot. The FDA is authorized to regulate advertisements for prescription drugs pursuant to 21 U.S.C.A. Section 352(n) of the Food, Drug and Cosmetic Act, 21 U.S.C.A. Sections 301-397. Advertisements subject to Section 352(n) include advertisements in published journals, magazines, other periodicals, and newspapers, and advertisements broadcast though media such as radio, television, and telephone communication systems. 21 C.F.R. § 202.1( l. )(1). Although the FDA has regulated drug advertising since 1963, those regulations initially addressed only advertising directed at health-care providers. Noah, supra, 32 Ga. L.Rev. at 142-43. Aware of the potential threat to consumers when pharmaceutical companies first sought to advertise to non-health-care professionals, the FDA, in the early 1980s initially imposed a [voluntary] moratorium on such advertising so that it could study the issue more carefully; but, in 1985, it lifted the moratorium, content to apply its existing regulations to this new practice. Perhaps spurred by the rapid growth of direct consumer advertising and the inherent shortcomings of rules designed to control advertising to physicians, coupled with the emergence of brand new media such as the Internet for disseminating promotional messages, the Agency has now proposed to modify its approach.