Doctors, drugs, and duties to warn: protections afforded medical device and drug manufacturers under the learned intermediary doctrine may be threatened.

• Author: Graham, David P.

MEDICAL device and drug manufacturers have always been vulnerable to plaintiffs' allegations that defects in a product's design, manufacture, or warnings violate the manufacturers' common law duties, obligations, or warranties. Traditionally, manufacturers were subject to such tort claims as negligence (failure to warn, manufacturing defect, or design defect), strict liability, breach of express or implied warranties, concert of action, alternative liability, negligent misrepresentation, and fraud. However, over the past decade, manufacturers have become increasingly threatened with expanding theories of liability as plaintiffs recast traditional common law tort claims into state consumer protection statute violations.

Unlike conventional common law claims, state consumer protection statutes often afford plaintiffs the luxury of imposing liability on manufacturers without first proving that the plaintiff either relied on, or suffered actual harm as a result of, the manufacturers' representations or warranties. Recently, plaintiffs have further sought the shelter of consumer protection statutes in order to circumvent the learned intermediary doctrine, which routinely provides manufacturers with a primary defense against failure to warn claims. (1) To date, courts have yet to foreclose this form of strategic pleading by unequivocally holding that the learned intermediary doctrine equally applies to consumer protection claims. Nevertheless, manufacturers have ample incentive and sufficient support to insist that adequate warnings given to medical professionals regarding a product's dangers are sufficient to fulfill their duty to warn even though patients may have failed to receive those warnings from their doctors.

The Learned Intermediary Doctrine

The learned intermediary doctrine provides that medical device or drug manufacturers discharge their duty to warn patients who use their device or take their medicine if and when it provides an adequate warning to patients' prescribing physicians. (2) The doctrine seeks to impose practical limitations upon the obligations of manufacturers of pharmaceutical drugs or medical devices to adequately warn the ultimate consumer of the dangers inherent in the use of their product. The assumptions that underlie the doctrine are that patients rely upon the advice of their physicians, and physicians, in light of their experience and expertise, are in a better position than their patients to evaluate and communicate the manufacturers' warnings directly to the patients. (3) The doctrine thus imposes upon physicians the duty to balance the risks of a particular drug or device with the benefits that may accrue to patients through their product use. As a result, medical device or drug manufacturers are held to have satisfied their warning obligations by providing the prescribing physician with the relative risks and benefits of the drug or device so that, in light of a physician's assessment of his or her patient's needs, the physician can exercise discretion in prescribing the particular therapy. (4)

Due to courts' demonstrated willingness to apply the learned intermediary doctrine to both pharmaceutical drug and medical device cases, plaintiffs have understandably begun to regularly challenge the applicability of the doctrine, particularly in the context of alleged violations of consumer protection statutes. (5) In particular, plaintiffs have sought to undermine the assumptions on which the doctrine rests. For instance, there are numerous examples of plaintiffs arguing that the learned intermediary doctrine should not apply in cases involving intrauterine devices (IUDs) because, they argue, the physician does not act as a true intermediary due to the intensely personal and private nature of the selection of a birth control method. (6) Indeed, several courts have refused to apply the learned intermediary doctrine to an IUD case on precisely those grounds. (7) For example, in Hill v. Searle Laboratories, the court noted:

Recognizing that these factors limit the role that a physician plays in determining the necessity and desirability of birth control, and the fact that physicians are inundated with information about various prescription drug products, [the court held] that in the case of IUDs, prescribing physicians do not make an individualized medical judgment. (8) Similarly, in one jurisdiction, plaintiffs successfully argued for an exception to the learned intermediary doctrine when a manufacturer markets and advertises a drug or device directly to consumers. (9) In those situations, plaintiffs argued and courts have agreed that so-called direct-to-consumer (DTC) advertising bypasses the physician intermediary and empowers consumers to take a more active role in selecting an appropriate drug or device. Accordingly, courts have held that when a manufacturer engages in DTC advertising for a drug or device, they are no longer entitled to the protection of the learned intermediary doctrine. Instead, manufacturers must directly and adequately warn consumers of the potential dangers of the drug or device. (10)

Learned Intermediary Doctrine Exception: Perez v. Wyeth Laboratories, Inc.

In Perez v. Wyeth Laboratories, Inc., plaintiffs brought a products liability suit alleging that they experienced multiple and severe side effects resulting from their use of the surgically implanted Norplant contraceptive. (11) Plaintiffs alleged that the Norplant contraceptive had been extensively marketed directly to women rather than to doctors, with advertisements appearing in such magazines as Glamour, Mademoiselle, and Cosmopolitan. Plaintiffs further alleged that, in those advertisements, the Norplant manufacturer failed to warn of the side effects that...