## Facts

- In September 1986, R.F. received a blood transfusion during surgery and later tested positive for HIV.
- The donor blood had been screened at a community blood center using Abbott Laboratories’ first-generation HIV antibody screening test, the first commercially available test of its kind (marketed roughly from 1985 to 1987).
- The test and its labeling were subject to intensive federal oversight. The FDA licensed the test, directed key aspects of development and validation, and approved the package insert (labeling) that accompanied the test.
- The FDA informed Abbott that changes to the package insert required FDA approval, and the agency also distributed information about the test to the medical community.
- Plaintiffs (R.F. and her husband) sued Abbott under New Jersey products-liability law, alleging the test was defective in design and/or warnings because the package insert did not instruct blood banks to retest “borderline” negative samples—those with results close to the FDA-defined cutoff value.
- Abbott denied liability and argued that plaintiffs’ state-law claims were preempted because the FDA controlled the test’s design and warnings, leaving no room for additional state-law requirements.
- After other defendants settled, the case proceeded to a jury trial against Abbott. The jury returned a verdict for Abbott, finding the warnings adequate and the test not defective.
- The Appellate Division affirmed on preemption grounds. After an earlier certification and remand for reconsideration in light of other preemption developments, the Appellate Division again affirmed, relying on the FDA’s close supervision of the test and the warning insert.
- The Supreme Court of New Jersey granted certification and reviewed whether federal regulation barred plaintiffs’ state-law causes of action.

## Issues

1. Are plaintiffs’ New Jersey products-liability claims alleging defective design and inadequate warnings for Abbott’s FDA-licensed HIV blood-screening test preempted by federal law due to the FDA’s control over the test and its labeling?

## Decision

- The Supreme Court of New Jersey held that plaintiffs’ state-law design-defect and failure-to-warn claims were impliedly preempted by federal law.
- The Court reasoned that the FDA’s regulation of the test and its labeling was so specific that imposing additional or different state-law duties—such as requiring a warning to retest borderline negatives—would conflict with the federal scheme.
- Because Abbott could not unilaterally change the package insert without FDA approval, a state-law verdict imposing different warning obligations would create an impermissible conflict (including “impossibility” and “obstacle” conflict) with federal requirements and objectives.
- The Court affirmed the judgment in Abbott’s favor, leaving intact the defense verdict.

## Legal Principles

- Federal preemption can arise not only from statutes but also from federal regulatory action when state law conflicts with federal requirements or federal purposes.
- Implied conflict preemption applies when compliance with both federal and state duties cannot be achieved, or when state law would interfere with the operation of a federal regulatory program.
- When a federal agency approves and controls a medical product’s labeling and requires agency permission for material label changes, state-law claims that would require different warnings may be barred as conflicting with federal control.
- State-law design-defect and warning theories may be treated as preempted when, in practice, they seek to impose additional safety requirements beyond those set by the federal regulator for the same product and use.

## Conclusion

In *R.F. and R.F. v. Abbott Laboratories*, the New Jersey Supreme Court concluded that federal regulation of Abbott’s FDA-licensed HIV blood-screening test—especially the FDA’s approval and control of the package insert—barred plaintiffs from using state products-liability law to impose additional or different design and warning duties, and it therefore affirmed the judgment for Abbott.


R.F. and R.F. v. Abbott Laboratories, 745 A.2d 1174 (2000)