Hillsborough County v. Automated Medical Labs
Whether local ordinances enacted by Hillsborough County, Florida, regulating the collection of blood plasma within its borders were preempted by federal Food and Drug Administration (FDA) regulations governing the same subject.
The Decision
9-0 decision · Opinion by Thurgood Marshall · 1985
Majority Opinion— Thurgood Marshallconcurring ↓
The Supreme Court reversed the Eleventh Circuit and held, unanimously, that the Hillsborough County ordinances regulating blood plasma collection were not preempted by federal FDA regulations. The opinion was written by Justice Thurgood Marshall.
The Court's analysis began with a foundational principle: when a federal law or regulation does not expressly state that it preempts state or local law, courts should start with the assumption that Congress did not intend to displace state authority — especially in areas like health and safety that states and localities have traditionally regulated. This 'presumption against preemption' meant that AML bore a heavy burden in proving that the county's ordinances were impliedly preempted.
The Court then examined two forms of implied preemption. First, regarding 'field preemption' — the idea that the federal government has regulated a subject so thoroughly that it has implicitly claimed the entire field for itself — the Court found no such intent here. The FDA's own regulations contained provisions acknowledging that state and local governments could impose additional requirements. This was strong evidence that the federal agency did not view its regulations as occupying the entire field to the exclusion of all local rules.
Second, regarding 'conflict preemption' — the idea that it is physically impossible to comply with both local and federal rules, or that local rules stand as an obstacle to achieving federal objectives — the Court likewise found no impermissible conflict. The county's ordinances were generally more stringent than the federal requirements, but complying with the stricter local rules would not cause a plasma center to violate any federal regulation. The Court emphasized that federal regulations establishing minimum standards do not automatically preempt state or local rules that go further. The mere existence of more demanding local rules did not, by itself, frustrate any identifiable federal objective.
The decision established an important analytical framework for implied preemption cases, making clear that courts should not lightly infer that Congress or federal agencies intended to strip states and localities of their authority to supplement federal regulations with their own health and safety measures.
Concurring Opinions
Justice Brennan wrote a brief concurring opinion emphasizing that the presumption against preemption should carry particular weight when federal agencies — rather than Congress itself — promulgate the regulations at issue, since agencies lack the same democratic accountability as the national legislature and should not be readily assumed to have displaced the regulatory authority of elected state and local governments.
Background & Facts
Hillsborough County, Florida, adopted a series of local ordinances and regulations governing the practice of plasmapheresis — the process by which blood plasma is collected from donors. These local rules imposed various requirements on blood plasma collection centers operating in the county. Among other things, the ordinances required donors to present photographic identification, mandated certain testing of donors, and placed limits on how frequently individuals could donate plasma. The county argued these rules were a legitimate exercise of its traditional authority to protect local public health and safety.
Automated Medical Laboratories, Inc. (AML), a company that operated blood plasma collection centers in Hillsborough County, challenged the local ordinances in federal court. AML argued that the FDA had already comprehensively regulated the blood plasma collection industry under authority granted by the Public Health Service Act, and that the county's regulations were therefore preempted — meaning they were overridden — by federal law. In essence, AML claimed the federal government had already spoken on these issues, leaving no room for local rules.
The U.S. District Court agreed with AML and struck down the county's ordinances as preempted by federal regulations. The U.S. Court of Appeals for the Eleventh Circuit affirmed that ruling, holding that the FDA's extensive regulation of blood plasma collection indicated the federal government intended to occupy the entire field, leaving no room for local regulation.
Hillsborough County then petitioned the Supreme Court for review, arguing that the lower courts had been too quick to find preemption. The case raised an important question about how far federal regulatory authority reaches and when states and localities can impose additional health and safety rules on top of existing federal regulations. The Supreme Court agreed to hear the case to clarify the standards for determining when federal law impliedly preempts state and local regulations.
The Arguments
The county argued that its local ordinances regulating blood plasma collection were a valid exercise of its traditional power to protect the health and safety of its residents. These local rules supplemented, rather than conflicted with, federal FDA regulations and should be allowed to stand.
- Health and safety regulation is an area traditionally governed by state and local authorities, and there is a strong presumption against finding that federal law preempts such local regulation.
- The FDA's own regulations included statements indicating that its standards were minimum requirements, not a ceiling, and that states and localities remained free to impose additional or more stringent standards.
- The county ordinances did not make it impossible for plasma centers to comply with both local and federal requirements simultaneously — the two sets of rules could coexist without conflict.
AML argued that the FDA's comprehensive regulatory scheme for blood plasma collection occupied the entire field, leaving no room for local regulation. Allowing a patchwork of local rules would undermine the uniformity that the federal government sought to achieve in regulating blood products.
- The FDA had enacted an extensive and detailed set of regulations governing virtually every aspect of blood plasma collection, demonstrating its intent to fully occupy the regulatory field.
- Allowing different localities to impose their own varying standards could create confusion for companies operating across multiple jurisdictions and could interfere with the federal government's ability to ensure a consistent national blood supply.
- The county's more stringent local requirements could frustrate the federal regulatory objectives by imposing additional burdens that Congress and the FDA did not contemplate or intend.