Hillsborough County, Fla. v. Automated Medical Laboratories, Inc.
471 U.S. 707 (1985)
Premium Feature
Subscribe to Lexplug to listen to the Case Podcast.
Rule of Law:
State and local regulations concerning health and safety are not preempted by federal regulations unless that was the clear and manifest purpose of Congress or the federal agency. The mere comprehensiveness of federal agency regulations is insufficient to infer an intent to preempt an entire field traditionally occupied by the states.
Facts:
- Automated Medical Laboratories, Inc. operates a blood plasma center, Tampa Plasma Corporation (TPC), in Hillsborough County, Florida.
- TPC collects plasma from paid donors through a process called plasmapheresis and is subject to comprehensive federal regulations issued by the Food and Drug Administration (FDA).
- In 1980, Hillsborough County enacted ordinances requiring plasma centers to pay a license fee, submit to county inspections, and participate in a county-wide donor identification system.
- The county ordinances also imposed requirements beyond the federal regulations, such as mandatory hepatitis testing, a breath analysis test for alcohol, and a rule that donors could only donate at a single registered center.
- The county also instituted fees for donor identification cards and for each plasmapheresis procedure performed.
Procedural Posture:
- Automated Medical Laboratories, Inc. filed suit against Hillsborough County in the U.S. District Court for the Middle District of Florida, challenging the constitutionality of the local ordinances.
- Following a bench trial, the District Court upheld most of the ordinances, finding no preemption, but invalidated the breath-analysis requirement on Commerce Clause grounds.
- Automated Medical Laboratories, Inc., as appellant, appealed to the U.S. Court of Appeals for the Eleventh Circuit.
- The Court of Appeals reversed the District Court, holding that the FDA's regulations were so pervasive as to preempt the entire field, thus invalidating all of the county's ordinances.
- Hillsborough County, as appellant, appealed to the Supreme Court of the United States.
Premium Content
Subscribe to Lexplug to view the complete brief
You're viewing a preview with Rule of Law, Facts, and Procedural Posture
Issue:
Do federal regulations from the Food and Drug Administration governing the collection of blood plasma preempt local ordinances that impose additional health and safety requirements on plasma collection centers?
Opinions:
Majority - Justice Marshall
No, the federal regulations do not preempt the local ordinances. There is a strong presumption that state and local regulations of health and safety matters are valid, and this presumption is not overcome here. The Court found no evidence of federal intent to preempt. First, the FDA, when promulgating its regulations, explicitly stated that it did not intend to usurp the powers of state or local authorities. This statement is dispositive unless contradicted by clear congressional intent or subsequent agency action. Second, implied field preemption is not warranted. The Court is reluctant to infer preemption from the comprehensiveness of agency regulations alone, as agencies typically regulate in great detail; doing so would improperly federalize many areas of traditional local concern. Third, there is no conflict preemption. The appellee's claim that the ordinances would obstruct the federal goal of ensuring an adequate plasma supply by increasing costs and deterring donors was deemed 'too speculative' and was not supported by the district court's findings of fact.
Analysis:
This decision significantly reinforces the presumption against federal preemption in areas of traditional state police power, especially health and safety. It clarifies that an agency's express statement of non-preemptive intent carries great weight and will generally be upheld. The ruling sets a high bar for finding implied preemption based on the comprehensiveness of agency regulations, distinguishing them from congressional statutes and thereby preserving substantial regulatory authority for state and local governments. Consequently, states and localities retain considerable latitude to enact supplementary health and safety laws, so long as they do not create a direct conflict with federal requirements.
Unlock the full brief for Hillsborough County, Fla. v. Automated Medical Laboratories, Inc.