Vaccine Law

Court Rejects Nurses as Learned Intermediaries for Mass Immunizations - Reyes v. Wyeth Laboratories, 498 F.2d 1264 (5th Cir. 07/31/1974)

In Reyes the court of appeals adopted the reasoning of Davis on similar facts. The plaintiff in that case contracted polio slightly more than two weeks after she was vaccinated for that disease at a county health clinic. The vaccine was administered by a registered nurse; no physician was present. The nurse who administered the vaccine said that she read the package circular accompanying the vaccine, but did not warn the plaintiff of the risks of vaccination.
The plaintiff sued the manufacturer of the vaccine for, among other things, failure to warn. The defendant argued that it met its duty to warn by inserting an adequate warning--the package circular--in the vials of vaccine, and that Davis was distinguishable because (1) whereas the plaintiff in Davis was vaccinated as part of a mass immunization program, the plaintiff in Reyes was vaccinated at her parents' request; (2) whereas the plaintiff in Davis was vaccinated by a pharmacist, the plaintiff in Reyes was vaccinated by a "public health nurse"; (3) compared to the defendant in Davis, it "played a relatively passive role" in the national immunization program; and (4) unlike the defendant in Davis, it "had no knowledge that the vaccine would not be administered as a prescription drug." 498 F.2d at 1277.

The Reyes court found the defendant's arguments unpersuasive. Embracing the rationale of Davis, the court first observed that "[w]here there is no physician to make an 'individualized balancing ... of the risks,' ... the very justification for the [learned intermediary rule] evaporates." Id. at 1276 (quoting Davis, 399 F.2d at 131). The court then rejected the defendant's attempt to distinguish Davis on the facts presented.