## Facts

- Lucy McDonald received a swine influenza vaccination on November 14, 1976 under the federal immunization program.
- She later developed a serious and permanent neurological impairment.
- McDonald sued the United States under the Federal Tort Claims Act and the National Swine Flu Immunization Program of 1976, seeking compensatory damages for vaccine-related injuries.
- The principal factual dispute was the medical diagnosis of her condition and, as a result, whether the vaccine caused it.
- McDonald contended she suffered Guillain-Barré Syndrome (GBS) (or a related variant) caused by the vaccination, relying on clinical findings, expert testimony, and data associating the 1976 vaccine with GBS.
- The United States contended her condition was transverse myelitis (TM), emphasizing spinal cord involvement and arguing TM had no causal relationship to the swine flu vaccine.
- The court heard competing expert testimony concerning symptom progression, electrophysiological testing, cerebrospinal fluid findings, and other diagnostic studies, including debate over whether spinal cord involvement can be consistent with GBS.

## Issues

1. Whether McDonald’s post-vaccination neurological condition was GBS (or a GBS-spectrum disorder) rather than TM.
2. Whether, under the Swine Flu Act/FTCA applying Pennsylvania tort law, the swine flu inoculation was a proximate cause of McDonald’s neurological injury.
3. If liability was established, what compensatory damages were supported by the evidence (including medical expenses, lost earnings, and pain and suffering).

## Decision

- The court entered judgment for McDonald after a bench trial.
- The court found McDonald suffered a GBS-type neurological disorder (within the GBS spectrum).
- The court found the swine flu vaccination was a proximate cause of her neurological injury under the Swine Flu Act/FTCA framework.
- The court awarded compensatory damages, including amounts for medical expenses and other proven loss.

## Legal Principles

- The Swine Flu Act makes the United States the exclusive defendant for covered immunization-program injuries and channels claims through FTCA procedures and standards.
- Under the FTCA, liability and causation are determined by the tort law of the place of the relevant act or omission; here, Pennsylvania law required proof by a preponderance of the evidence.
- When expert testimony reflects competing medical views, the factfinder may credit the diagnosis better supported by the clinical course, diagnostic evidence, and the overall weight of credible expert opinion.
- Epidemiological and medical literature evidence may support causation when combined with expert medical testimony and case-specific timing and symptom progression.
- Under Pennsylvania damages law, recoverable damages must be supported by evidence providing a reasonable basis for calculation; speculation is insufficient, though exact certainty is not required.

## Conclusion

The court held the United States liable under the Swine Flu Act and FTCA after finding that McDonald suffered a GBS-spectrum disorder proximately caused by her swine flu vaccination, and it awarded compensatory damages supported by non-speculative proof.


McDonald v. United States, 555 F. Supp. 935 (M.D. Pa. 1983)