Overview

In a far-reaching decision that will benefit prescription drug manufacturers, the Texas Supreme Court, in Centocor, Inc. v. Hamilton, No. 10-0223 (Tex. June 8, 2012), adopted the “learned intermediary doctrine.” The court held that a prescription drug manufacturer fulfills its duty to warn an end user by providing the prescribing physician with an adequate warning. The court declined the invitation to create an exception for direct-to-consumer (DTC) advertising.

Background

In a prescription drug product liability case, the plaintiff typically alleges that the manufacturer failed to provide adequate warnings of risks that may be associated with a drug. Typically, plaintiffs argue that they would not have taken the drug if an adequate warning had been provided. Often, plaintiffs also contend that a warning would have led them to seek an alternative drug from the physician.

Under the learned intermediary doctrine, a drug manufacturer will not be liable so long as it provided adequate warnings to the plaintiff’s physician. While a majority of states now recognize the doctrine, courts still struggle over its application. In particular, some courts have shown reluctance to apply the doctrine in cases where the plaintiff alleges that he or she received information about the drug through DTC advertising in print media, television ads or informational videos.

Issues

In Centocor, the Texas Supreme Court considered three issues: (1) whether to recognize the learned intermediary doctrine; (2) whether to apply the doctrine in cases where DTC advertising has occurred; and (3) whether the doctrine applies to claims for fraud by omission or negligent misrepresentation that are based on an alleged failure to warn.

Decision

By formally adopting the learned intermediary doctrine, the court placed Texas in line with the majority of states. The Supreme Court explained that, while it had not previously announced its position on the learned intermediary doctrine, lower Texas courts had followed the rule for several years. The court also noted that the majority of other states have adopted the learned intermediary doctrine in some form. In fact, according to the court, West Virginia is the only state that has rejected the doctrine in its entirety.

While the plaintiffs argued that the doctrine should not apply based on the DTC exception, the court declined to adopt that exception on the facts presented. The court noted that only a few states have recognized a DTC exception. The court, however, left open the possibility for an exception where a manufacturer has used DTC to convey intentionally misleading information.

The court further held that the learned intermediary doctrine applies to claims for negligence and common law fraud by omission. In reality, the court explained, these claims were nothing more than failure to warn claims. The plaintiffs could not evade the learned intermediary doctrine by pleading their claims under a different legal theory.

Of additional interest to defendants, the court clarified that the learned intermediary doctrine is not an affirmative defense that the manufacturer must plead and prove. Rather, the doctrine is a common law rule that imposes a duty on the drug manufacturer to direct its warnings to the physician.

Comment

In short, the Supreme Court’s decision in Centocor will provide an effective shield for drug manufacturers who convey appropriate warnings to physicians.

The fact that the court declined the invitation to adopt a DTC exception is an important development. Given the pervasiveness of DTC advertising of prescription drugs, such an exception could eviscerate the learned intermediary doctrine. By declining to adopt this exception, the Supreme Court reaffirmed the principle that the physician (the “learned intermediary”) is in the best position to evaluate a treatment and weigh the potential risks and benefits of a drug. In fact, the physician is the individual in the best position to make an informed treatment decision. While DTC advertising serves to alert patients to the existence of a treatment option, it is not a forum for conveying information about risks posed by the drug. The appropriate forum for discussing the risks of a drug is in the physician’s office, between doctor and patient. Texas, therefore, has joined the majority of states that recognize the learned intermediary doctrine without an exception for DTC advertising.

The court correctly held that the doctrine applies to claims for fraud by omission, negligent misrepresentation and other legal theories. In actuality, all of these theories are based on a claim that warnings or instructions are inadequate. Thus, applying the doctrine to these claims is a matter of common sense.