March 10, 2008
In a three to two decision, the highest appellate court in West Virginia recently rejected the learned intermediary doctrine as an exception to the general duty of manufacturers to warn consumers about the risks of their products.1 In dissent, Justice Albright called the majority decision “exceptionally shortsighted.”
The Karl case arose from a May, 1999 prescription for Propulsid by Dr. Daniel Wilson. Dr. Wilson prescribed the medication to his patient, Nancy Gellner. Three days after taking the medication, allegedly along with other medications, Ms. Gellner became ill and died. A products liability/medical malpractice action was brought by her estate against the manufacturer (Janssen Pharmaceuticals) and the treating physician (Dr. Wilson). As trial approached, Janssen filed a motion in limine seeking to exclude evidence or argument suggesting that Janssen had a duty to provide any warnings regarding the medication directly to Ms. Gellner. The trial court denied the motion. Janssen then sought a writ of prohibition from the West Virginia Supreme Court of Appeals seeking to prohibit enforcement of the trial court’s order, contending that the trial court exceeded its “legitimate powers” by refusing to apply the learned intermediary doctrine.
Courts in the United States have long recognized that if pharmaceutical manufacturers warn the physician of any reasonable risk associated with taking a prescribed drug the duty to warn the patient is thereby relinquished.2 This concept was introduced as early as 1948 when a New York court found that a manufacturer was not directly liable because it had neither held itself or its product out to the patient directly.3
The rationale underlying the doctrine has been that the physician was in the best position to make an informed decision by assessing the risks involved with taking the drug in relation to the medical history of the individual patient. Therefore, a pharmaceutical manufacturer discharged its duty when it provided an FDA approved warning to the physician. The learned intermediary doctrine has long been infused into modern tort law.4
In Karl, West Virginia’s highest appellate court rejected the learned intermediary doctrine, finding that the justifications for the doctrine are largely “outdated and unpersuasive.” Despite the requirement that precedent be respected in the development of the common law and despite the fact that a majority of courts, including federal courts in West Virginia, had adopted the doctrine, the court found that the learned intermediary doctrine is “not a modern doctrine.” According to the court, “the very age of the doctrine requires us to pause.” The court concluded that “[u]nder West Virginia products liability law, manufacturers of prescription drugs are subject to the same duty to warn consumers about the risks of their products as other manufacturers.”
The court pointed to the increased use of direct-to-consumer advertising by pharmaceutical companies as evidence of significant changes in the prescription drug industry since the doctrine’s origin. The court asserted that the very premise underlying direct-to-consumer advertising is that consumers are direct and active participants in their prescription drug choices, “invalidating the concept that it is the doctor, not the patient, who decides whether a drug or device should be used.”
The rejection of this long held doctrine should be a matter of some concern for practitioners and pharmaceutical manufacturers. This development clearly should be monitored to determine whether the decision by the West Virginia court is an isolated anomaly or represents a trend.
1State ex rel. Johnson & Johnson Corp. v. Karl, 647 S.E.2d 899 (W. Va. 2007).
3Marcus v. Specific Pharm., Inc., 77 N.Y.S.2d 508 (N.Y. App. Div. 1948).
4See Jack B. Harrison and Mina J. Jefferson, "Some Accurate Information is Better than No Information At All": Arguments Against an Exception to the Learned Intermediary Doctrine Based on Direct-to-Consumer Advertising, 78 Or. L. Rev. 605 (1999); Restatement (Second) of Torts 402A cmt. K (1965).