The learned intermediary doctrine has been a fixture in American products liability law for decades. The doctrine relieves a prescription-drug manufacturer from the general duty imposed upon product manufacturers to warn ultimate consumers about the dangers inherent in the use of a product. In light of the fact that a prescription drug may be used by a consumer only upon the orders of the consumer's physician, the learned intermediary doctrine provides that a drug manufacturer discharges its duty to warn by issuing an adequate warning to a patient's prescribing physician.

In a recent and, in many ways, stunning decision, the West Virginia Supreme Court has unequivocally rejected the incorporation of the learned intermediary doctrine into West Virginia products liability law. See State ex rel. Johnson & Johnson Corp. v. Karl, 2007 WL 1888777 (W. Va. June 27, 2007). Karl was an action by the estate of a deceased patient against a prescription-drug manufacturer, alleging that the patient's sudden death after taking the drug Propulsid was caused by inadequate warnings about the dangerous side effects of the drug. The defendant manufacturer filed a motion in limine in the trial court, seeking to exclude evidence suggesting that the manufacturer had a duty to provide warnings directly to the patient personally. The defendant relied upon the learned intermediary doctrine in support of its motion, although the doctrine had never been adopted as part of West Virginia law. The trial court denied the drug manufacturer's motion, and the manufacturer sought immediate relief by filing a petition for a writ of prohibition in the West Virginia Supreme Court.

The most illuminating portion of the court's opinion is its rejection of the justifications for the learned intermediary doctrine in light of the reality of present-day prescription-drug marketing, which relies upon direct-to-consumer saturation advertising. The court noted that the traditional justifications for the learned intermediary doctrine are (1) the difficulty that manufacturers would encounter in attempting to provide warnings to the ultimate users of prescription drugs, (2) patients' reliance upon their treating physicians' judgment in selecting appropriate prescription drugs, (3) the fact that physicians exercise their professional judgment in selecting appropriate drugs, (4) the belief that physicians are in the best position to provide appropriate warnings to their patients, and (5) the concern that direct warnings to ultimate users would interfere with doctor-patient relationships.

In the view of the court, the justifications for the learned intermediary doctrine are outdated and unpersuasive in this age of incessant, ubiquitous direct-to-consumer marketing of prescription drugs. The court noted that such direct-to-consumer advertising has largely eviscerated the traditional physician-patient relationship, replacing a patient's doctor with a drug company having ostensibly unlimited advertising resources as the primary source of an individual patient's information about a drug and motivation to use it. Indeed, the court noted that one of the arguments against direct-to-consumer advertising is that "[p]hysicians complain that it is impossible to compete with pharmaceutical companies' massive advertising budgets, and resign themselves to the fact that if consumers make enough noise, they will eventually relent to patient pressure." Id. at *9. Critics of direct-to-consumer advertising also note that drug advertisements ignore other medications, alternative treatments, and the wisdom of doing nothing. Id. In this environment, the family doctor has all but disappeared, requiring a patient-based decision about the use of drugs, rather than one informed by professional medical judgment. Moreover, given the prevalence of managed care, physicians now have far less time to educate patients about the risks of a drug. Id.

Ultimately, the court's decision to reject the learned intermediary doctrine was based upon both the reality of the mass-marketing of prescription drugs directly to consumers, and the fairness of requiring drug manufacturers, who find it easy enough to bombard consumers directly with the asserted benefits of their products and who "spend millions to make millions more . . . [by] pushing their products onto the general public like never before," to reach the same consumers with the truth about the adverse effects of their products. Id. at *13.

The Karl court's decision to join the half of the American jurisdictions that have not adopted the learned intermediary doctrine is important not only because one more state now requires drug manufacturers to warn those who have been directly induced by the manufacturers to use the manufacturers' products, but because of the clarity and force of the reasoning in reaching this decision. No other segment of the product-manufacturing-and-distribution economy has benefitted from a rule, like the learned intermediary doctrine, which provides blanket absolution from the obligation to warn those consumers whom the industry has specifically targeted for the marketing of its product. While the learned intermediary doctrine may have made sense both as law and public policy at a time when physicians selected drugs for their patients and the manufacturers directed their informational activities toward physicians, in the current climate where patients select the drugs for their physicians to administer to them, as a direct result of the drug manufacturers' prodigious direct-to-consumer marketing campaigns, the Karl court may have it right that the learned intermediary doctrine has outlived its relevance and usefulness.