## Facts

- An infant, Mark Ezagui, was vaccinated by Dr. Jack Sherman in January 1961 with either Quadrigen (Parke-Davis) or Compligen (Dow).
- Days later, the child developed an extremely high fever and was diagnosed with post-vaccinal encephalopathy, allegedly causing severe and permanent injuries and death.
- The plaintiff (mother and estate representative) sued vaccine manufacturers for products liability (defect, inadequate warnings, and misbranding/mislabeling) and sued the physician and public hospital/County for malpractice and related negligence.
- Evidence indicated Quadrigen used a preservative associated with endotoxin leakage in the pertussis component, which could cause high fever and subsequent neurological injury; adverse reaction reports were being received and investigated before the vaccination, and Quadrigen was later withdrawn from the market.
- The case was tried in federal court under diversity jurisdiction; at the close of the plaintiff’s case, the district court dismissed all claims against all defendants.

## Issues

1. Whether claims against Dow could reach the jury absent sufficient proof that Dow’s vaccine was the one administered and caused the injury.
2. Whether the plaintiff’s evidence was sufficient to submit to the jury products-liability theories against Parke-Davis, including defect, causation, and inadequate warning/misbranding-based negligence.
3. Whether the plaintiff’s expert and factual proof was sufficient to submit to the jury malpractice claims against the pediatrician.
4. Whether the evidence (and applicable statutory prerequisites) was sufficient to proceed against the County and the hospital.

## Decision

- Affirmed dismissal of claims against Dow Chemical Company.
- Affirmed dismissal of claims against the County of Nassau and Meadowbrook Hospital.
- Reversed dismissal of claims against Parke-Davis Company and remanded for a new trial.
- Reversed dismissal of claims against Dr. Jack Sherman and remanded for a new trial.

## Legal Principles

- A products-liability claim fails as a matter of law when the plaintiff cannot present sufficient evidence that the defendant’s product was actually used and was a cause of the injury.
- Under New York law, a drug manufacturer may face liability where proof supports a defective product and inadequate warnings; when evidence permits competing inferences on defect, knowledge, warning adequacy, and causation, those questions generally belong to the jury.
- A claimed violation of federal drug labeling/misbranding standards can supply a negligence-per-se theory under New York law if causation and injury are supported by the evidence.
- In medical malpractice, where expert and factual evidence could allow a reasonable jury to find a departure from accepted practice and proximate cause, dismissal at the close of the plaintiff’s case is improper.

## Conclusion

The Second Circuit held that the case could not proceed against a manufacturer without proof its vaccine was administered, but that the plaintiff presented enough evidence of a defective vaccine and inadequate warnings (and enough malpractice proof against the physician) to require jury resolution; claims against the public hospital and County were properly dismissed.


Ezagui v. Dow Chem. Corp., 598 F.2d 727 (2d Cir. 1979)