## Facts

- Eight-month-old Anita Reyes received Wyeth’s oral polio vaccine at a Texas public health clinic as part of a mass immunization program.
- The vaccine was administered in a clinic setting without a physician present and without individualized medical judgment directed to Anita.
- Anita’s mother primarily spoke Spanish and testified she received no warning that the live-virus vaccine could, in rare cases, cause paralytic polio in the recipient (or close contacts).
- Slightly more than two weeks after vaccination, Anita was diagnosed with paralytic poliomyelitis.
- Wyeth had distributed the vaccine through state health channels; warnings and labeling were directed to health authorities and medical professionals, not to recipients’ parents.
- Anita’s father sued Wyeth under Texas strict products-liability law, alleging the vaccine caused the injury and was unreasonably dangerous due to inadequate warnings.
- A federal jury returned a verdict for Reyes and awarded $200,000; Wyeth appealed.

## Issues

1. Whether, under Texas law, a prescription vaccine manufacturer may rely solely on warnings to medical professionals under the learned intermediary doctrine when the vaccine is administered in a mass immunization clinic without individualized physician involvement.
2. Whether failure to ensure that an adequate warning reached a child’s parents in that setting renders the product unreasonably dangerous and supports strict liability for failure to warn.
3. Whether the evidence and trial rulings sufficiently supported the jury’s findings on defect (inadequate warning) and causation.

## Decision

- The Fifth Circuit affirmed the judgment for Reyes and upheld the $200,000 verdict.
- The court held Wyeth had a duty to warn Anita’s parents directly (or ensure a warning reached them) because the vaccine was dispensed through a mass clinic program without a prescribing physician’s individualized assessment and counseling.
- The learned intermediary doctrine did not bar liability on these facts, because its rationale depends on a physician–patient relationship and individualized medical judgment.
- The court concluded the jury could find the vaccine unreasonably dangerous due to the absence of an adequate warning to the persons making the vaccination decision for the child.

## Legal Principles

- Under Texas strict products-liability principles, a product may be defective and unreasonably dangerous because of inadequate warnings or instructions, even if properly manufactured.
- For prescription drugs, a manufacturer ordinarily satisfies its duty to warn by adequately warning the prescribing physician, who then acts as the learned intermediary for the patient.
- When a manufacturer knows or should know its product will be dispensed in a mass immunization setting without individualized physician involvement, the learned intermediary rationale fails, and the manufacturer may have a duty to provide warnings that reach the ultimate consumer (or, for a minor, the parents or guardians).
- A known risk that is rare but severe can require disclosure so that recipients (or guardians) can make an informed choice; withholding such disclosure can support failure-to-warn liability.

## Conclusion

The Fifth Circuit affirmed strict liability against a vaccine manufacturer for failure to warn where a prescription vaccine was administered through a mass public clinic program without individualized physician judgment, holding that the learned intermediary doctrine did not excuse the manufacturer from ensuring that a meaningful warning reached the child’s parents.


Reyes v. Wyeth Lab'ys, 498 F.2d 1264 (5th Cir. 1974)