Conning the IADC Newsletters.

Recognizing that a wide range of practical and helpful material appears in the newsletters prepared by committees of the International Association of Defense Counsel, this department highlights interesting topics covered in recent newsletters and presents excerpts from them.

New Restatement and the Learned Intermediary Doctrine

Writing in the January newsletter of the Drug, Device and Biotech Committee, Janet H. Smith of Arter & Hadden, Cleveland, looks at the future of the learned intermediary doctrine:

The learned intermediary doctrine relieves drug and medical device manufacturers of the duty to warn a patient when the manufacturer has provided an adequate warning to the patient's physician. What will be impact of the newly promulgated Restatement (Third) of Torts on the learned intermediary doctrine--now and in the future?

Persuasive authority

Although the new Restatement is not approved by any legislature and is not binding on any court, it is undisputed that the persuasive authority of the Restatement (Second) of Torts greatly influenced--if not created--the present state of product liability law based on strict liability/defect. Section 402A of Restatement (Second), adopted in 1965, states that a plaintiff may recover if injured by a "unreasonably dangerous" product.

Comment k to Section 402A laid the groundwork for the learned intermediary doctrine when it stated that:

Such a product properly prepared, and accompanied by proper directions and warnings, is not defective, nor is it unreasonably dangerous.... The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, when the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use. While only alluded to in Comment k, the learned intermediary doctrine, based on proper and adequate warnings to physicians, developed on a parallel course with the growing acceptance of Section 402A. Since 1966, when the term "learned intermediary" was first coined in Sterling Drug v. Cornish, 370 F.2d 82, 85 (8th Cir. 1966), courts have acknowledged the common sense reasoning behind this bright line no duty rule.

The oft-cited case of Reyes v. Wyeth Laboratories, 498 F.2d 1264 (5th Cir. 1974), explains the rationale:

Prescription drugs are likely to be complex medicines, esoteric in formula and varied in effect. As a medical expert, the prescribing physician can take into account the propensities of the drug as well as the susceptibilities of his patient. His is the task of weighing the benefits of any medication against its potential dangers. The choice he makes is an informed one, an individualized medical judgment bottomed on a knowledge of both patient and palliative. [498 F.2d at 1276] A review of case law reveals that in the vast majority of product liability actions brought against manufacturers of drugs and medical devices, courts have rightfully continued to uphold the learned intermediary doctrine.

Enter: New Restatement

Since the overwhelming majority of cases involving prescription drugs and medical devices are "inadequate warning" cases, the new Restatement (Third) of Torts has attempted to bring some order to the now well-established concepts of product defect and the learned intermediary doctrine. Section 6(d) of the new Restatement provides:

(d) A prescription drug or medical device is not reasonably safe because of inadequate instructions or warnings if reasonable instructions or warnings regarding foreseeable risks of harm are not provided to: (1) prescribing and other health care providers who are in a position to reduce the risks of harm in accordance with the instructions or warnings; or (2) the patient when the manufacturer knows or has reason to know that healthcare providers will not be in a position to reduce the risks of harm in accordance with the instructions or warnings. While Section 6(d)(1) essentially follows the learned intermediary doctrine, it adds the unfortunate requirement that the manufacturer must warn "other healthcare providers" who are "in a position to reduce the risks of harm" in addition to warning prescribing physicians. Several cases are cited in the Reporters' Notes, one of which basically extends this duty to "all members of the medical profession who come into contact with a patient in a decision-making capacity." See McEwen v. Ortho Pharmaceutical Corp., 528 P.2d 522, 529 (Or. 1974); Holley v. Burroughs Wellcome Co., 330 S.E.2d 228 (N.C.App. 1985) (duty to warn nurse anesthetist).

It is unclear exactly how far this requirement will extend. Manufacturers now must consider (1) whether there are other healthcare professionals (such as nurse anesthetists) who generally operate in decision-making capacities with regard to particular drags or devices; (2) what type of warning would be reasonable and adequate; (3) under what circumstances should warnings be disseminated; and (4) the appropriate type and method of warning.

This appendage to the learned intermediary doctrine may, indeed, open a Pandora's box, given the increased impact of third parties on decision making in connection with modern day managed health care delivery systems.

Unfortunate exception

The only exception to the learned intermediary doctrine is set forth in Section 6(d)(2), which recognizes that under certain circumstances no healthcare provider would be in a position to reduce the risk of harm in accordance with the instruction or warning. The example given in Comment e relates to "the administration of a vaccine in clinics where mass inoculations are performed."

This exception undoubtedly was applicable in the days of mass polio and childhood disease vaccinations. While the impact of this exception has been diluted by the National Childhood Vaccine Injury Act, it still might be argued that it should be applicable with regard to non-mandatory immunizations, such as flu vaccines, where inoculations are frequently given away from traditional healthcare settings. Thus, it remains a reasonable exception to the learned intermediary doctrine. Manufacturers should know what drugs would be applicable in this setting and take the suitable steps to warn consumers directly through patient information leaflets or informed consent forms, or both.

However, there are several arguments that can be made, if warranted by the facts, to show that this exception is inappropriate. In Hurley v. Lederle Laboratories Division of American Cyanimid Co., 851 F.2d 1536 (5th Cir. 1988), for example, the Fifth Circuit held that, although the nurse administered a vaccine in a "clinic-like" fashion and the physician did not see the patient at the actual time of vaccination, the "mass inoculation" exception to the learned intermediary doctrine did not apply because the physician had examined the patient in the past, and he was vaccinated under the doctor's direction.

Delegate the warning

Another defense in this situation would be to argue that the manufacturer can delegate its obligation to provide direct warnings to patients in "mass inoculation" situations. This issue was decided in opposite ways in two recent cases, Mazur v. Merck & Co., 964 F.2d 1348 (3d Cir. 1992), cert. denied, 113 S.Ct. 463 (1992), and Allison v. Merck & Co., 878 P.2d 948 (Nev. 1994). Both cases involved mass inoculations of children.

In Mazur, the vaccine manufacturer successfully argued that it could not be held liable because the school district had acquired the vaccine from the Centers for Disease Control. When the CDC bought the vaccine from the manufacturer, the sales contract obligated the CDC to provide warnings to the recipients of the vaccine. The manufacturer argued that it was entitled to summary judgment because it could not reasonably foresee that the CDC would fail to fulfill its contractual obligation to warn. The court agreed.

However, in Allison, a more recent decision, the Nevada Supreme Court expressly rejected Mazur, holding that "a manufacturer cannot be relieved of ultimate responsibility for assuring that its unsafe product is dispensed with proper warning."

Defendants should continue to argue that under these circumstances, the holding in Mazur is correct, for two reasons. First, manufacturers always must rely on delegation when distributing direct warnings to patients. The manufacturer cannot be held liable if the intermediary (in Mazur, the CDC) fails to provide the patient with the appropriate information. Second, since this was a childhood vaccination setting, the warning should not have made any difference, since the children were required to have the inoculations by law.

Potential exceptions

Comment e to Section 6(d) of the new Restatement goes on to note two other areas in which arguments have been advanced for exceptions to the learned intermediary rule. The first deals with government regulatory agencies, such as the Food and Drug Administration, mandating direct patient warnings with regard to select products. The second deals with warnings to consumers when manufacturers advertise their prescription drugs or medical devices directly through the mass media.

In both situations, direct patient warnings are mandated by the FDA. The new Restatement, while not acknowledging these two theories as bona fide exceptions to the learned intermediary doctrine, notes that the question then becomes "whether adequate warnings to the appropriate healthcare provider should insulate the manufacturer from tort liability" in these two situations.

The answer to that question should be a resounding "yes." Unfortunately, the Restatement leaves the answer to "developing case law," thus giving credence to theories that in most cases have been soundly rejected.

FDA-mandated warnings

With regard to FDA-mandated warnings, cases have dealt primarily with oral contraceptives. Several 1985 cases, notably MacDonald v. Ortho Pharmaceutical Corp., 475 N.E.2d 65 (Mass. 1985)...