The learned intermediary doctrine in Florida: courts wrestle with claimed exceptions to the doctrine in drug and device litigation.

• Author: Camp, John A.

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The learned intermediary doctrine (LID) is a widely recognized defense in pharmaceutical failure-to-warn litigation. Under the LID, a pharmaceutical manufacturer has a duty to warn the learned intermediary--the patient's prescribing physician--of risks associated with its product. The manufacturer does not have a duty to warn the patient directly. Virtually every state recognizes the LID in prescription drug litigation, and many courts have applied the LID in medical device litigation as well. Plaintiffs have sought to circumvent the LID by advancing alternative theories of recovery against manufacturers in addition to the traditional negligent failure to warn cause of action, including common law negligent misrepresentation and fraud claims as well as claims based on statutory consumer protection legislation. Additionally, plaintiffs in a variety of contexts have advocated for courts to recognize exceptions to the doctrine, including an "overpromotion" exception and a "direct-to-consumer" (DTC) advertising exception.

Two opinions issued in June 2007 addressed theories advanced by plaintiffs seeking to avoid the application of the LID. In one, the West Virginia Supreme Court rejected the LID in its entirety. In the other, the U.S. District Court for the Southern District of Florida reaffirmed the LID under Florida law and resolved in the manufacturer's favor several issues of first impression in this state, including whether the LID applies to medical devices and whether it applies to Florida's consumer fraud statute. Additionally, this court examined whether the overpromotion or DTC advertising exceptions applied to the case before it under Florida's LID framework.

This article traces the evolution of the LID generally and tracks its adoption and implementation in Florida. The authors then discuss the national trends in LID jurisprudence based on a landmark 1999 New Jersey Supreme Court opinion and the recent West Virginia Supreme Court opinion. Finally, in the wake of these decisions, the authors examine the June 2007 LID opinion from the Southern District of Florida and analyze the impact of this case on future LID cases in Florida.

Evolution of the Doctrine

The term "learned intermediary" was coined in 1966 in Sterling Drug, Inc. v. Cornish, 370 F.2d 82 (8th Cir. 1966). The Sterling court articulated the doctrine as follows: "[W]e are dealing with prescription drugs rather than a normal consumer item. In such a case the purchaser's doctor is the learned intermediary between the purchaser and the manufacturer. If the doctor is properly warned of the possibility of a side effect, there is an excellent chance that injury to the patient can be avoided." (1) Virtually every jurisdiction now recognizes the LID essentially as the Sterling court articulated it 40 years ago. (2)

The LID creates an exception to the general rule that a manufacturer owes its consumers a duty to warn of the risks associated with its products. Under the LID, a drug or medical device manufacturer's duty to warn consumers of the dangers associated with its prescription product extends only to the prescribing physician who acts as a "learned intermediary" between the manufacturer and the ultimate consumer and assumes responsibility for advising individual patients of the risks associated with the drug. (3) As long as adequate information has been provided to the patient's physician, the manufacturer will be deemed to have discharged its duty to warn and will not be held liable if the physician fails to pass that information on to the patient.4

The Learned Intermediary Doctrine in Florida

The LID developed in Florida in the context of prescription drug failure-to-warn cases. It was first recognized by the Fifth District Court of Appeal in Buckner v. Allergan Pharmaceuticals, Inc., 400 So. 2d 820 (Fla. 5th DCA 1981). The Florida Supreme Court adopted the LID eight years later in Felix v. Hoffman-LaRoche, Inc., 540 So. 2d 102 (Fla. 1989). (5) In Felix, a mother sued the manufacturer of a prescription acne drug, Accutane, for the wrongful death of her son, which she attributed to her ingestion of the drug while she was pregnant. Her child was born with severe birth defects, which led to his early death. At issue in Felix was whether the manufacturer furnished adequate warnings of the dangers of using Accutane during pregnancy.

The court stated that the manufacturer's duty to warn of the risks associated with Accutane was directed to the physician, not to the patient, because "the prescribing physician, acting as a 'learned intermediary' between the manufacturer and the consumer, weighs the potential benefits against the dangers in deciding whether to recommend the drug to meet the patient's needs." Thus, the court concluded, the drug manufacturer had discharged its duty to warn and could not be penalized if the physician failed to impart his knowledge of the dangers of the drug to his patient. (6)

Rationale

Courts have articulated a number of rationales for the LID, all of which are based on the concept of the traditional doctor-patient relationship. First is the notion that the physician, not the patient, is in the best position to weigh the risks and benefits of a particular drug, taking into account the patient's presentation, medical history, and the like. It is the physician, after all, who exercises his or her independent professional judgment in selecting the appropriate drug for the patient. Second, the physician is in a better position than the manufacturer to provide the appropriate warning to his or her patient of the risks associated with the drug. As a practical matter, because the manufacturer lacks effective means to communicate directly with consumers of its product, it would be virtually impossible for a drug manufacturer to warn each patient. Third, requiring manufacturers to provide warnings directly to the ultimate consumers would interfere with doctors' relationships with their patients.

Critics of the LID have suggested that these rationales may have made sense in the era of the "Norman Rockwell image of the family doctor," when pharmaceutical companies directed their sales efforts entirely to physicians, and patients relied entirely on their doctors to choose and prescribe the drugs best suited for their needs. But, these critics argue, that world no longer exists, and the LID no longer applies in today's healthcare environment.

Advocates for the continued viability of the LID argue that the basic rationale for the doctrine still applies, even in the face of the changing healthcare landscape. For example, they maintain, whether a drug is advertised directly to a consumer or not, the physician who prescribes the drug is still the intermediary between the manufacturer and the consumer. It is the physician's duty after all to become informed about the qualities and characteristics of those products he or she prescribes and to exercise independent judgment, taking into account his or her knowledge of the patient and the product. The patient is expected to and, presumably, does place primary reliance upon that judgment. Even if information about a drug is readily available to the patient, it is the doctor who must make the final decision as to the appropriateness of that drug for the patient. Thus, if the product is properly labeled and carries the necessary instructions and warnings to fully apprise the physician of the proper procedures for use and the risks involved, the manufacturer can reasonably assume that the physician will exercise his or her informed judgment that information in conjunction with his or her own independent learning, in the best interest of the patient. (7) Even in the current healthcare environment, where product labels are set forth in their entirety in print advertisements, where drug companies tout the benefits of their products on radio and television, and where the Internet allows patients to thoroughly research the benefits and risks of drugs, patients still must rely on their physician to make decisions regarding the safety, efficacy, and appropriateness of the drugs they prescribed.

Challenges to the Application of the LID

In 1999, the New Jersey Supreme Court recognized for the first time an exception to the LID in the case of drugs that are advertised directly to consumers. In Perez v. Wyeth Laboratories, Inc., 734 A.2d at 1248 (N.J. 1999), the plaintiffs claimed that Wyeth failed to properly warn consumers about the side effects of the contraceptive Norplant. The plaintiffs alleged, among other things, that Wyeth undertook a widespread advertising campaign directed at...