## Facts

- Jane Stevens filed a petition under the National Vaccine Injury Compensation Program in the U.S. Court of Federal Claims, alleging that a hepatitis B vaccination caused neurological defects.
- Because the claimed injury was not a Vaccine Injury Table injury for the hepatitis B vaccine, Stevens proceeded under an off-Table causation-in-fact theory.
- As part of the Vaccine Program process, the Department of Health and Human Services reviewed the petition and filed a report recommending denial due to inadequate proof that the hepatitis B vaccine caused Stevens’s condition.
- Stevens moved for summary judgment on entitlement, arguing that the record established causation based on scientific plausibility, clinical assessments, the absence of other causes, and a temporal relationship between vaccination and diagnosis.
- The Secretary opposed summary judgment, arguing Stevens had not shown adequate proof of injury and contending that Stevens needed evidence of direct causation—such as dispositive epidemiologic studies or pathological markers (“footprints”) showing the vaccine caused injury in Stevens’s body.

## Issues

1. In an off-Table Vaccine Act claim, can a petitioner obtain summary judgment on entitlement based on medical reasoning and circumstantial proof (including timing and exclusion of alternative causes), or must the petitioner present more direct scientific evidence such as epidemiology or biological “footprints”?
2. Did Stevens’s record eliminate genuine disputes of material fact on causation so that she was entitled to judgment as a matter of law?

## Decision

- The special master denied Stevens’s motion for summary judgment.
- The special master concluded that, on this record, Stevens had not carried her burden to show vaccine causation as a matter of law, emphasizing the lack of direct scientific proof (such as epidemiologic support or individualized pathological “footprints”) tying the hepatitis B vaccine to Stevens’s neurological condition.

## Legal Principles

- In an off-Table Vaccine Act case, the petitioner bears the burden to prove causation-in-fact by a preponderance of the evidence.
- A petitioner seeking summary judgment must show there is no genuine dispute of material fact and that the petitioner is entitled to judgment as a matter of law; contested medical causation questions commonly involve fact disputes not suitable for summary judgment.
- In this decision, the special master treated the absence of direct scientific proof—such as dispositive epidemiologic studies or objective pathological markers in the petitioner—as a central deficiency in Stevens’s effort to establish entitlement on summary judgment for an off-Table hepatitis B claim.

## Conclusion

In *Stevens v. Secretary of Department of Health and Human Services*, a Vaccine Act special master denied Stevens’s motion for summary judgment on an off-Table claim alleging neurological injury from the hepatitis B vaccine, determining that Stevens’s causation showing was insufficient for judgment as a matter of law without stronger direct scientific evidence, such as epidemiology or biological “footprints,” linking the vaccine to her condition.


Stevens v. Secretary of Department of Health and Human Services, 2001 WL 387418 (unpublished opinion) (2001)