Learned Intermediary Doctrine

Ordinarily, product manufacturers have a duty to make and sell products that are reasonably safe and not defective. If that is not reasonably possible, then the manufacturer has a duty to warn about defects or danger. The learned intermediary doctrine says that drug manufacturers owe no duty to warn consumers about the risks of consuming prescription drugs because the manufacturers can rely on the prescribing physician to do so. Over twenty states follow this doctrine. Tennessee adopted the doctrine in Pittman v. Upjohn Co., 890 S.W.2d 425, 431 (Tenn. 1994)

But that ain’t the law in West Virginia no more. In Johnson & Johnson Corporation v. Karl, No. 33211 (W.Va. June 27, 2007), a majority of the Supreme Court of Appeals said this:

In rejecting the application of the learned intermediary doctrine to drugs that had been the subject of direct-to-consumer advertising, the Supreme Court of New Jersey opined, and we agree, that such advertising obviates each of the premises upon which the doctrine rests:

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 direct-to-consumer advertising of prescription drugs.

First, with rare and wonderful exceptions, the “’Norman Rockwell’ image of the family doctor no longer exists.” [Lars Noah, Advertising Prescription Drugs to Consumers: Assessing the Regulatory and Liability Issues, 32 Ga. L. Rev. 141, 180 n.78 (1997)] (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 warn the ultimate consumer should apply.

And then added this:

Public policy dictates that the manufacturer should warn the ultimate user of the harmful effects of its pharmaceuticals since it involves a person’s health. The knowledge of pharmaceutical side effects goes well beyond the scope of the average individual. The benefit in warning the consumer directly is far outweighed by the costs. It is not as though the manufacturer must incur costs to discover the risks as they are already known. It is only a matter of adding the consumer to the list of who to warn. . . .

. . . Since the early 1980’s, direct-to-consumer advertising has boomed into a very profitable venture for
pharmaceutical manufacturers. Yet, consumers’ exposure to harm has increased as a result. They are surrounded by various prescription advertisements in all forms of print and broadcast media. Advertisements directed to consumers, however, often supply partial or incomplete information. Additionally, self-diagnosis by the consumer has resulted from these advertisements, as well as patient-demand for the brand-name drugs. It is in the best interest of the general public that manufacturers have a duty to warn the ultimate user of side effects and risks. Courts are increasingly motivated to protect the consumer, and require manufacturers to warn more than just the physician.

. . . .

Pharmaceutical manufacturers spend millions to make millions more. They are pushing their products onto the general public like never before. Consequently, consumers need more protection. As a response to the changing times, courts have diminished the manufacturer’s shield of the learned intermediary doctrine. They have imposed a duty to warn the consumer in addition to the physician. In doing so, the goal of product liability to protect the ultimate user from harm, is more attainable. In the end, the burden should be on the one producing health care, not the one consuming it.

Bordes, supra, 81 U. Det. Mercy L. Rev. at 286-87 (emphasis added). West Virginia physicians naturally have duties and responsibilities regarding their role in providing prescription medicines to consumers. It would be unreasonable not to require the manufacturers of those medicines to accept similar responsibilities

Read the majority opinion here. Go here to read the concurring and dissenting opinions.