Vaccine Law

Mass Immunization Exception to the Learned Intermediary Defense - Davis v. Wyeth Laboratories, Inc., 399 F.2d 121 (9th Cir.(Idaho) Jan 22, 1968)

In Davis the plaintiff contracted polio after being vaccinated for that disease as part of a nationally sponsored immunization program, and sued the manufacturer of the vaccine for, among other things, failure to provide an adequate warning. The jury returned a verdict for the defendant, but the court of appeals reversed on the ground that "the manufacturer [had] a duty to warn the consumer (or make adequate provision for his being warned) as to the risks involved." 399 F.2d at 130.

The Davis court explained:

Ordinarily in the case of prescription drugs warning to the prescribing physician is sufficient. In such cases the choice involved is essentially a medical one involving an assessment of medical risks in the light of the physician's knowledge of his patient's needs and susceptibilities. Further it is difficult under such circumstances for the manufacturer, by label or direct communication, to reach the consumer with a warning. A warning to the medical profession is in such cases the only effective means by which a warning could help the patient.

Here, however, although the drug was denominated a prescription drug it was not dispensed as such. It was dispensed to all comers at mass clinics without an individualized balancing by a physician of the risks involved. In such cases ... warning by the manufacturer to its immediate purchaser will not suffice. The decision (that on balance and in the public interest the personal risk to the individual was worth taking) may well have been that of the medical society and not that of [the manufacturer]. But just as the responsibility for choice is not one that the manufacturer can assume for all comers, neither is it one that he can allow his immediate purchaser to assume. In such cases, then, it is the responsibility of the manufacturer to see that warnings reach the consumer, either by giving warning itself or obligating the purchaser to give warning.