# Appellees Brief — Hillsborough County v. Automated Medical Laboratories, Inc.

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## Record

- **Collection:** Supreme Court brief
- **Document type:** Appellees Brief
- **Published:** January 1, 1985
- **Citation:** 471 U.S. 707

## Text

NO. 83-1925 AN ed

in the =

Supreme Court
uf the
United States

OCTOBER TERM, 194

HILLSBOROUGH COUNTY, FLORIDA AND
HILLSBOROUGH COUNTY HEALTH DEPARTMENT
1 ppe llants

AUTOMATED MEDICAL LABORATORIES, INC.,

Appellee,
APPELLEE'S BRIEF ON THE MERITS

LARRY A. STUMPI FINLEY, Kl MBLE, WAGNER,
Counse t Record HEINE, UNDERBERG, MANLEY
VICTORIA L. BADEN ~« CASEY

Members, United States ( imset for 1 pp

Supreme Court Bat Suite 1000, Flagship C

ti Brickell] Ave!

Miami, Florida 33131

(305) 371-2600

CHARLES F. JOHNS
On the Brief

QUESTIONS PRESENTED

A. Where the federal legislation and attendant
regulation in a given field is pervasive, what is the
proper test to be applied in determining whether local
legislation in the same field is pre-empted?

B. Does application of the appropriate test for
pre-emption mandate a holding that the subject
Hillsborough County ordinances regulating the
plasmapheresis procedure are pre-empted by federal
regulation of the plasmapheresis procedure under the
Public Health Service Act?

TABLE OF CONTENTS

Zante of Authovtiles ... .....0 26
Nag en 26
41 Fed. Reg. (1976)
I a et aS Eines ols ele ede’ 26
rte ee al Bi ite ries at 26

NO. 83-1925

in the
Supreme Court

of the
United States

OCTOBER TERM, 1984

HILLSBOROUGH COUNTY, FLORIDA AND
HILLSBOROUGH COUNTY HEALTH DEPARTMENT
Appellants,

vs.

AUTOMATED MEDICAL LABORATORIES, INC.,
Appellee,

APPELLEE’S BRIEF ON THE MERITS

OPINIONS AND JUDGMENTS BELOW

The opinion (JA 40-46)’ and final judgment (JA 47)
of the United States District Court for the Middle

‘References to the Joint Appendix are indicated by (JA _)},
the Jurisdictional Statement Appendix by (JSA__), and the Transcript
by (TR ).

District of Florida, William J. Castagna, J., are not
reported. The opinion (JA 48-59) of the United States
Court of Appeals for the Eleventh Circuit is reported
at 722 F.2d 1526. The final judgment (JA 60) is not
reported.

JURISDICTION

The judgment of the Court of Appeals was entered
on January 16, 1984 (JSA 21). A petition for rehearing
by panel was denied on February 23, 1984 (JSA 22-26)
and a notice of appeal was filed on April 20, 1984 (JSA
27). This Court noted probable jurisdiction on January
14, 1985. The jurisdiction of this Court rests upon 28
U.S.C. §1254(2).

CONSTITUTIONAL AND STATUTORY PROVISIONS
INVOLVED

1. This Constitution, and the Laws of the
United States which shall be made in Pursuance
thereof; and all Treaties made, or which shall
be made, under the Authority of the United
States, shall be the supreme Law of the Land;
and the Judges in every State shall be bound
thereby, any Thing in the Constitution or
Laws of any State to the Contrary
notwithstanding. United States Constitution,
Article VI, clause 2.

2. Public Health Service Act, Sections 351 &
361, 42 U.S.C. §§262 & 264.

3. Federal Food, Drug and Cosmetic Act, 21
U.S.C. §321, et. seq.

4. 21 C.F.R. §600.3-680.26 (1983).

5. Hillsborough County Ordinances 80-11 and
80-12 and the rules and regulations promulgated
thereunder (JA 21-34).

STATEMENT OF THE CASE

On November 26, 1980, Appellant, HILLSBOROUGH
COUNTY, FLORIDA (“County”), adopted Ordinances
80-11 and 80-12 (JA 21-31), purporting to regulate
plasmapheresis establishments and the eligibility of
donors of blood plasma.’ Ordinance 80-11 (JA 21-23)
imposed a license tax on blood plasma centers, and
required licensees, among other things, to permit
inspection of blood plasma centers by Appellant
HILLSBOROUGH COUNTY HEALTH DEPARTMENT
(“Department”). Ordinance 80-11, in addition, required
blood plasma centers located within Hillsborough County
to provide continuously updated information to the
Department regarding their ownership, employees,
equipment and facilities.

Ordinance 80-12 (JA 24-31), and the rules and
regulations promulgated thereunder (JA 32-34), required
that a blood plasma donor, prior to donating plasma,
undergo a medical examination and obtain a certificate
of good health, and to obtain from the Department an
identification card, which identification card would have

‘Plasmapheresis is a process whereby, during a single procedure,
blood is removed from a human donor, the plasma is removed
from the whole blood, and the red blood cells are returned to the
donor (JA 50; 722 F.2d at 1527-1528; see also, 21 C.F.R. §606.3(e) ).

permitted the potential donor to undergo plasmapheresis
for a period of six months only, and only at a single
specified plasma center within Hillsborough County.
Ordinance 80-12 also required licensee plasma centers
to submit to the Department, on a daily basis, and as to
each procedure performed, detailed information regarding
the donor, reports of testing, and results of the procedure.
Ordinance 80-12 also required licensee plasma centers
to pay to the Department a fee of $1.00 for each procedure
performed.

Appellee, AUTOMATED MEDICAL LABORATO-
RIES, INC. (“AML”), a Florida corporation which, through
a wholly owned subsidiary corporation known as Tampa
Plasma Center, operates a blood plasma center in Tampa,
Hillsborough County, Florida, filed a civil action against
the County and the Department in the United States
District Court for the Middle District of Florida,
challenging the constitutionality of the Ordinances (JA
5-34). AML’s complaint challenged the County regulatory
scheme on the grounds that it was pre-empted by
regulations of the United States Food and Drug
Administration (“FDA”) (21 C.F.R. Subchapter F-Biologics),
that it imposed an undue burden on interstate commerce,
that it denied AML its right to equal protection of the
law, and for other reasons.

After a non-jury trial, the United States District
Court for the Middle District of Florida entered its
opinion (JA 40-46) and final judgment (JA 47), on
November 1, 1982, holding §7 of Ordinance 80-12 and §4
of the rules and regulations (dealing with required
breathalyzer tests) unconstitutional, as impermissibly
burdening interstate commerce, and upholding the
remainder of the County regulatory scheme.

AML appealed to the United States Court of Appeals
for the Eleventh Circuit, and the County cross-appealed
with respect to the portions of the Ordinances invalidated
by the District Court.

The Eleventh Circuit held that Ordinances 80-11
and 80-12 were invalid, because the County regulatory
scheme was wholly pre-empted by federal regulation
of the area, under the tests enunciated in Pennsylvania
v. Nelson, 350 U.S. 497, 76 S.Ct. 477 (1956) (JA 48-59:
722 F.2d 1526 (1984) ). Accordingly, the Eleventh Circuit
did not decide the other questions raised on the appeal.

Hillsborough County petitioned for rehearing by
panel (JSA 22-25). In its petition, the County explicated
its view that the Eleventh Circuit had erred in holding
that federal law pre-empted its Ordinances, had ignored
record evidence and had misapplied the law. The Eleventh
Circuit denied the petition for rehearing (JSA 26).

SUMMARY OF ARGUMENT

Pursuant to the Supremacy Clause of the United
States Constitution, the laws of the United States are
“the supreme Law of the Land.” Accordingly, local
legislation that interferes with, or is contrary to, federal
law is invalid under the doctrine of federal pre-emption.

In interpreting and applying the Supremacy Clause,
and in establishing and defining the doctrine of federal
pre-emption, this Court consistently has held that where
Congress intends, either expressly or impliedly, that a
federal regulatory system covering an area of permissible
federal regulation is the exclusive regulatory system,
local legislation in that area is pre-empted.

It is equally well-settled that, when promulgated
with appropriate legislative authority, federal regulations
have pre-emptive effect equal to that of federal statutes.

The first step, then, in a proper pre-emption analysis
is an examination of the statutory and regulatory
framework. In the case at bar, the system of federal
regulation of the plasmapheresis industry is grounded
upon the Public Health Service Act, 42 U.S.C. §262, et
seq. (and, to a much lesser degree, upon the Federal
Food, Drug and Cosmetic Act, 21 U.S.C. §321, et seg.).°

The relevant portions of the Public Health Service
Act provide that no person shall sell any blood component
or derivative (including blood plasma collected by
plasmapheresis) unless the product was propagated or
manufactured at an establishment holding a valid license
from the Food and Drug Administration (“FDA”). Licenses
for plasmapheresis establishments are, in turn, granted
pursuant to extensive FDA regulations promulgated
to ensure the safety and purity of blood components, to
ensure the safety of the (paid) donors of plasma who
undergo the plasmapheresis procedure, and to ensure
the continued adequate supply of plasma, collected by
the plasmapheresis procedure and subsequently
manufactured into vitally important pharmaceutical
products.

Acting pursuant to the statutory authority of Section
361 of the Public Health Service Act, the FDA has

*The statutory framework for the federal regulation of the
plasmapheresis industry is described at pages 1-4 of the Brief for
the United States, as Amicus Curiae. AML finds that description
to be accurate.

promulgated comprehensive regulations,‘ found by the |
United States Court of Appeals for the Eleventh Circuit
in this case to be pervasive, to be broad in scope and to
“cover virtually every phase of the plasmapheresis
process” (JA 56; 722 F.2d at 1531). There is no dispute
among the parties as to the comprekensiveness of the
regulations.

In its analysis of the doctrine of federal pre-emption
as applied to the facts of the case at bar, the Eleventh
Circuit carefully considered the correct, well-settled
and recently restated principles of pre-emption analysis.
The Eleventh Circuit concluded that, while the statutes
and regulations involved do not expressly pre-empt
local legislation, the federal system of regulation has,
by implication, pre-empted local legislation.

More specifically, the Eleventh Circuit carefully
applied the tests for determining the issue of implied
pre-emption, as articulated in Pennsylvania v. Nelson,
350 U.S. 497, 76 S.Ct. 477 (1956), and concluded that (i)
the federal regujations are comprehensive and fill the
entire field of regulation, (ii) the federal law concerns a
field of dominant federal interest and (iii) enforcement
of the County legislation would present a serious danger
of conflict with the administration of the federal system.
(JA 55-59; 722 F.2d at 1531-1533). Accordingly, the
Eleventh Circuit held the Hillsborough County Ordinances
to be invalid, because local regulation in the field had
been pre-empted.

‘The FDA regulations are found at 21 C.F.R. Parts 600, 601,
606, 607, 610 and 640, Subpart G.

The County’s brief indicates substantial agreement
with AML on the correct principles of pre-emption
analysis applicable to the case at bar. However, without
advancing persuasive reasons in support of their position,
the County argues that the Eleventh Circuit misapplied
the principles of pre-emption analysis.

Amici curiae supporting the County argue that
the Eleventh Circuit applied incorrect principles of
pre-emption analysis in finding that the federal regulatory
system pre-empts local legislation. More specifically,
the National Association of Counties, et al., with misplaced
reliance upon Fidelity Federal Savings & Loan Assn.
v. de la Cuesta, 458 U.S. 141, 102 S.Ct. 3014 (1982) and
Capital Cities Cable, Inc. v. Crisp, ___. U.S. ___, 104
S.Ct. 2694 (1984), argue that, in the absence of explicit
statutory language of pre-emption, a finding of express
agency intent to pre-empt is required before agency
regulations preempt state law. The United States argues
that this Court cannot find implied pre-emption where
the agency initially indicated a lack of intent to pre-
empt local legislation.

The authorities relied upon by the National
Association of Counties, et al. and by the United States
do not, upon proper analysis, stand for the propositions
being urged by the amici curiae supporting the County.
Proper determination of this case does not require a
departure from established principles of pre-emption

analysis.

For the reasons stated above, and fully discussed
in Point II below, the Eleventh Circuit applied the
proper legal standard in concluding that the Hillsborough
County ordinances at issue are pre-empted by the federal

regulatory system authorized by the Public Health
Service Act and effectuated by regulations of the FDA.

For the reasons summarized below and fully
discussed in Part III, application of well-settled principles
of pre-emption analysis mandates a holding that the
conclusion reached by the Eleventh Circuit, that the
challenged ordinances are wholly pre-empted and cannot
stand, was correct.

As recently as June 1984, this Court restated the
three possible bases for a determination that local
legislation has been pre-empted by federal law: (1) in
enacting a federal statute, Congress may explicitly
state that it intends to pre-empt state law (express
pre-emption); (2) in the absence of language expressly
pre-empting state legislation,» Congress may, nevertheless,
indicate its intent to occupy an entire field of regulation,
thereby precluding the states from regulating in that
area (implied pre-emption); and (3) even in the absence
of express or implied congressional intent to displace
state law in its entirety, state law may be pre-empted
to the extent that the state law actually conflicts with
federal law, either when compliance with both state
and federal law is impossible, or when the state law

presents an obstacle to the purposes and objectives of

Congress (obstacle). Capital Cities Cable, Inc. v. Crisp,
supra, ____ U.S. at ___, 104 S.Ct. at 2700-01.

The principles enunciated in Capital Cities are
consistent with, and follow, an established line of decisions

‘Local ordinances are treated as are state statutes for these
purposes. City of New Orleans v. Dukes, 427 U.S. 297, 96 S.Ct.
2513 (1976).

of this Court. See, e.g., Michigan Canners & Freezers
Ass'n. v. Agricultural. Marketing and Bargaining Board.
____ ~-U.S. ___, 104 S.Ct. 2518 (1984); Jones v. Rath
Packing Co., 430 U.S. 519, 97 S.Ct. 1305 (1977); Rice v.
Santa Fe Elevator Corp., 331 U.S. 218, 67 S.Ct. 1146
(1947); Bethlehem Steel Co. v. New York State Labor
Relations Bd., 330 U.S. 767, 67 S.Ct. 1026 (1947). Federal
regulations can have the same pre-emptive effect as do
federal statutes. Fidelity Federal v. de la Cuesta, supra,
___ US. at ___, 102 S.Ct. at 3022; Capital Cities
Cable, Inc. v. Crisp, __. U.S. at ___, 104 S.Ct. at 2700.

The case at bar is not an instance in which Congress
or the FDA has explicitly stated an intent to pre-empt.
Therefore, the first possible basis for a finding of pre-
emption is inapplicable.

In the absence of express pre-emption, an analysis
of whether Congress or the appropriate federal agency
has impliedly pre-empted local law is required. There
are two instances in which implied pre-emption will be
found: (i) where the federal system of regulation is so
pervasive as to fill the field of regulation, or (ii) where
the federal interest in the area regulated is dominant
over any local interest.

The first test for implicit federal pre-emption is
met in the case at bar because the federal system for
regulation of blood and blood products, established
pursuant to Section 35] of the Public Health Service
Act (“the Act”), is so pervasive as to leave no room for
state regulation of the plasmapheresis industry. Section
351 of the Act requires federal licensing of each

10

establishment producing a biological product, federal
licensing of each product to ensure safety, purity and
potency, and federal standards for packing and labeling
of the product. The FDA regulations implementing the
Act contain a section dealing specifically with “Source
Plasma (Human),” as well as more general sections
which apply to the plasmapheresis procedure itself.
The federal regulatory system is so comprehensive
and extensive as to compel the conclusion that Congress
and the FDA have left no room for state regulation in the
field of plasmapheresis.

The second test for implicit pre-emption is met, in
that at least in the areas of product purity, donor
safety and adequate plasma supply, the federal interest
in the plasmapheresis field is so dominant that local
legislation is precluded. Section 351 of the Act prohibits
the sale or transportation of any blood or blood product
which has not been propagated or manufactured and
prepared at a federally licensed establishment. Section
361 of the Act (42 U.S.C. §264) authorizes the FDA to
promulgate such regulations as are necessary to prevent
the introduction, transmission, or spread of blood related
communicable disease from one state to another. This
necessarily requires the FDA to exercise its authority
to regulate a potential disease-causing substance from
the source of its collection through its subsequent
processing (or manufacture) and shipment. The FDA,
in promulgating the regulations concerning biological
products, established a comprehensive National Blood
Policy and employed the full regulatory authorities
vested in the federal government to assure uniform
adherence to the highest attainable standards of practice
in blood banking, including plasmapheresis. The statutory

11

language and the regulatory framework indicate that
Congress intended uniform national standards to promote
product purity, donor safety and an adequate plasma

supply.

The County concedes that the concern of its local
legislation is the source of the blood product, that is,
the donor. The concern for donor safety, then, is shared
by the County and the FDA. However, given the federal
congressional and regulatory intent to establish a uniform,
comprehensive national program in the area, and the
FDA's duty to issue all regulations it deems necessary
to effect that goal, it is apparent that Congress intended
uniform national standards that would foreclose the
imposition of different or more stringent local
requirements.

Because federal regulation of plasma and
plasmapheresis is so pervasive, and because the federal
interest in regulating the field is so dominant as to
preclude enforcement of local laws on the subject, the
federal regulatory system implicitly pre-empts
enforcement of the County’s ordinances.

Even if Congress and the FDA have not implicitly
pre-empted state regulation of the plasmapheresis
industry, enforcement of the challenged local legislation
would result in both an irreconcilable conflict with
federal regulations and a substantial obstacle to the
full attainment of congressional objects and purposes
in regulating blood and blood products. The County
ordinances, including a restrictive donor registration
requirement, a pre-registration hepatitis test, a pre-
donation breath analysis for alcohol content and detailed
recordkeeping and reporting requirements, impose

12

burdensome and expensive requirements in addition to
the extensive federal regulatory system. If enforced,
the County’s legislation would conflict with federal
regulation authorizing the collection of hepatitis plasma
for vaccine manufacture and would frustrate the
congressional goals of ensuring a safe and adequate
blood supply and ensuring a continued supply of healthy
donors.

ARGUMENT
POINT I

THE DECISION OF THE UNITED STATES
COURT OF APPEALS FOR THE ELEVENTH
CIRCUIT SHOULD BE SUMMARILY
AFFIRMED.

AML filed its Motion to Affirm with this Court on
June 27, 1984. For the reasons stated therein, this
Court should now, AML respectfully submits, summarily
affirm the decision of the United States Court of Appeals
for the Eleventh Circuit.

The controlling issues have now been fully briefed
in this Court, and, under the current and well-settled
state of the law of pre-emption, it is abundantly clear,
for the reasons fully discussed in Point II below, that
the Eleventh Circuit applied the appropriate legal
principles in determining that Hillsborough County
Ordinances 80-11 and 80-12 are pre-empted by federal
law. For the reasons fully discussed in Points III and
IV below, the Eleventh Circuit correctly determined,
under the tests set forth in Pennsylvania v. Nelson, 350
U.S. 497, 76 S.Ct. 477 (1956), that the Hillsborough

13

County ordinances were pre-empted by the federal
regulatory system.

POINT I

THE COURT OF APPEALS APPLIED THE
PROPER LEGAL STANDARD IN DETER-
MINING THAT THE CHALLENGED LOCAL
LEGISLATION WAS PRE-EMPTED.

A. The basic principles of pre-emption analysis
are well settled and free of doubt.

It is axiomatic that the doctrine of federal pre-
emption is grounded upon the Supremacy Clause of the
United States Constitution, Article VI, clause 2:

This Constitution, and the Laws of the United
States which shali be made in Pursuance thereof;
... Shall be the supreme Law of the Land; ...

Since as early as 1824, the Supremacy Clause, as
the foundation for the doctrine of federal pre-emption,
has been interpreted and applied to invalidate local
laws that “interfere with, or are contrary to” federal
law. Gibbons v. Ogden, 9 Wheat. 1, 211 (1824).

It is also firmly established that “(federal regulations
have no less pre-emptive effect than federal statutes.”
Fidelity Federal v. de la Cuesta, supra, 458 U.S. at
153-54, 102 S.Ct. at 3022; Capital Cities Cable, Inc. v.
Crisp, __. U.S. at , 104 S.Ct. at 2700:

14

. . . Under the Supremacy Clause, U.S. Const.,
Art. VI, cl. 2, the enforcement of a state
regulation may be pre-empted by federal! law
in several circumstances: first, when Congress,
in enacting a federal statute, has expressed a
clear intent to pre-empt state law, Jones wu.
Rath Packing Co., 430 U.S. 519, 525, 97 S.Ct.
1305, 1309, 51 L.Ed.2d 604 (1977); second, when
it is clear, despite the absence of explicit pre-
emptive language, that Congress has intended
by legislating comprehensively, to occupy an
entire field of regulation and has thereby “left
no room for the States to supplement” federal
law, Rice vu. Santa Fe Elevator Corp., 331 U.S.
218, 230, 67 S.Ct. 1146, 1152, 91 L.Ed. 1447
(1947); and, finally, when compliance with both
state and federal law is impossible, Florida
Lime & Avocado Growers, Inc. v. Paul, 373
U.S. 132, 142-143, 83 S.Ct. 1210, 1217-1218, 10
L.Ed.2d 248 (1963), or when the state law “stands
as an obstacle to the accomplishment and
execution of the full purposes and objectives
of Congress.” Hines v. Davidowitz, 312 U.S.
52, 67, 61 S.Ct. 399, 404, 85 L.Ed 581 (1941).
See also Michigan Canners & Freezers Assn.
u Agricultural Marketing and Bargaining Board,
oan : , 104 S.Ct. 2518, ___, 80
L.Ed.2d ___(1984).

And, as we made clear in Fidelity Federal
Savings and Loan Assn. v. De La Cuesta, 458
U.S. 141, 102 S.Ct. 3014, 78 L.Ed.2d 664 (198?).

“Federal regulations have no less pre-
emptive effect than federal statutes

15

The cases cited above flow consistently in a long
stream of cases expressing these now familiar principles.
See, e g.: Bethlehem Steel Co. vu. Allegheny Ludlum
Steel Corp., 330 U.S. 767, 67 S.Ct. 1026, (1947); Rice wv.
Santa Fe Corporation., 331 U.S. 218, 67 S.Ct. 1146
(1947); Jones v. Rath Packing Co., 430 U.S. 519, 97 S.Ct.
1305 (1977); Michigan Canners, supra, _.. U.S. ___.,
104 S.Ct. 2518 (1984).

B. Contrary to the position advanced by the
National Association of Counties, a finding of express
agency intent to pre-empt is not a prerequisite to a
holding that the federal regulatory system governing
the plasmapheresis industry pre-empts the challenged
Hillsborough County ordinances.

Although the principles set forth above would appear
to be certain, the primary substantive disagreements
among the parties (and amici curiae) in this case arise
at this point in the pre-emption analysis.

In the case at bar, the Eleventh Circuit found that
the language of the statutes upon which the
comprehensive FDA regulatory system is based, the
Public Health Service Act and the Federal Food, Drug
and Cosmetic Act, does not support a finding of express
congressional intent to pre-empt (JA 54-55; 722 F.2d at
1530). From that finding, coupled with an unsound analysis
of Fidelity Federal u de la Cuesta, the National Association
of Counties asks this Court to adopt an entirely novel
approach to pre-emption analysis and to depart from
the well settled rules of law expressed above. The
National Association of Counties advances the position

16

that, in the absence of express congressional intent to
pre-empt, a finding of pre-emption by agency regulation
is proper only if the agency has expressly stated its
intent to pre-empt local legislation.’

It hardly merits stating that, in accordance with
modern day concepts of federalism, Congress frequently
provides the statutory basis for federal control over a
given field, and delegates to an agency the task of
promulgating and enforcing the detailed regulatory
system. Bethlehem Steel Co. v. New York State Labor
Relations Bd., 330 U.S. 767, 67 S.Ct. 1026 (1947). This, of
course, is the context of the case at bar, namely, a
congressional enactment stating essential federal
principles and policy, with appropriate authority granted
to the proper agency to enact controlling regulations.
This gives rise to the issue of whether the system of
federal regulation has pre-empted local legislation in
the field.

In such circumstances, this Court has repeatedly
found local regulation to be pre-empted, even without
a finding of express agency intent to pre-empt. Capital
Cities Cable, Inc. v. Crisp ___. U.S. ____, 104 8.Ct. 2694
(1984) (Federal Communications Commission regulations
promulgated under Communications Act of 1934); Jones
v. Rath Packing Co., 430 U.S. 519, 97 S.Ct. 1305 (1977)
(Secretary of Agriculture regulations promulgated under
Federal Meat Inspection Act); Ray v. Atlantic Richfield
Co., 435 U.S. 151, 98 S.Ct. 988 (1978) (Department of
Transportation regulations promulgated under Ports
and Waterways Safety Act of 1972); Franklin National

"Brief of the National Association of Counties, et. al, as Amici
Curiae, p. 16.

17

Bank v. New York, 347 U.S. 373, 74 S.Ct. 550 (1954)
(Federal Reserve Board Regulations promulgated under
Federal Reserve Act).

In short, the National Association of Counties’
position represents a radical departure from the
established precedent of this Court.

In addition, Fidelity Federal v. de la Cuesta simply
does not stand for the proposition advanced —that a
finding of pre-emption “requires a clear expression of
administrative intent to preempt all state efforts, including
non-conflicting laws, to regulate the same subject.”* In
fact, Fidelity Federal v. de la Cuesta restates the classic
principles of pre-emption analysis and explicitly recognizes
that “federai regulations have no less pre-emptive effect
than federal statutes.” ____ U.S. at ___., 102 S.Ct. at
3022. The issue in Fidelity Federal v. de la Cuesta was
whether the agency expressing the intent to pre-empt
did so with proper congressional authority. Fidelity
Federal v. de la Cuesta cannot be construed to stand
for the proposition asserted by the National Association
of Counties.

C. The position advanced by the United States is
contrary to controlling precedent.

The position advanced by the United States appears
to differ from the position of AML in only one, but one
quite substantial, respect. The United States
acknowledges, as indeed it must, that the subject FDA
regulations are “comprehensive” and that:

"Brief of National Association of Counties, et. al, as Amici
Curiae, p. 16.

18

[t]he purpose of the FDA regulations is to
establish nationwide standards necessary to
provide an adequate supply of safe, pure and
potent blood, blood components, and blood
products, as well, as to protect the health of
blood donors.’

The United States argues, however, that because
a comment made at the time the initial regulations
were proposed indicates a lack of intent to pre-empt,
this Court cannot find implied pre-emption despite the
facts that the regulations are comprehensive in scope,
and concern an area in which the federal interest is
dominant, and the County ordinances have the same
goal as the federal regulations. However, later comments
by the Commissioner indicate that the agency soon
thereafter felt constrained to take steps to ensure that
the plasmaphleresis regulations were uniform,
comprehensive and applicable nationwide. See e.g., 39
Fed. Reg. 18614-15 (1974). The present scope of the
federal regulations should be considered by the Court
in determining if a finding of pre-emption is now
appropriate. Edgar v. MITE Corp., 457 U.S. 624, 633,
102 S.Ct. 2629, 2636 (1982).

AML's position, that a federal regulatory system
impliedly pre-empts the entire field of regulation when
(i) the federal law fills the field by its pervasiveness or
(ii) the federal law regulates a field of dominant federal
interest, is fully supported by the cases cited in Point
II, B above. The fact that the United States concedes

the pervasiveness of the FDA plasmapheresis regulations,

"Brief for the United States, as Amicus Curiae, p. 7 (emphasis
supplied).

19

and the importance of the national interest thusly served,
adds substantial weight to AML’s position that the
Eleventh Circuit's holding of implicit federal pre-emption
of the field of plasmapheresis was sound and should be
affirmed.

Of particular importance is the fact that the United
States admits that the federal regulations have as one
of their purposes the same purpose as the County
ordinances, namely the protection of the health of the
donors. The law is well settled that when local legislation
has the same purpose as a comprehensive federal
regulatory system, local legislation in any area of that
field is pre-empted. Ray v. Atlantic Richfield Company,
435 U.S. 151, 98 S.Ct. 988 (1978).

The facts in Ray are strikingly similar to those in
the case at bar. Pursuant to statutory authority, the
Secretary of Transportation was to promulgate
“comprehensive minimum standards” for the design
and structure of certain cargo carrying vessels. After
promulgating such standards, the Secretary was to
then provide for inspection for compliance with the
minimum requirements, and to issue certificates if the
federal standards were satisfied. The State of Washington
attempted to impose additional and more stringent
requirements to accomplish the same goal as the
Secretary's, namely vessel safety. Applying well
established principles of pre-emption analysis, this Court
held that “[t}he Supremacy Clause dictates that the
federal judgment that a vessel is safe to navigate United
States waters prevails over the contrary state judgment.”
Ray v. Atlantic Richfield Co., 435 U.S. at 165, 98 S.Ct.
at 998. This Court went on to find that to allow the
state to impose additional and more stringent

20

requirements on vessel design and safety would frustrate
the congressional purpose of establishing uniform national
standards, which if met, allow a vessel to operate.
Thus, because Hillsborough County has admittedly
“enacted a regulatory scheme governing [the area covered
by the FDA regulations]’,"” and that scheme imposes
additional and more stringent requirements than those
imposed by federal law, the local legislation is pre-
empted entirely.

D. The Court of Appeals applied the proper legal
standard in determining that the Hillsborough County
ordinances are pre-empted.

Thus, for the reasons stated above, the correct
legal standard was utilized by the Eleventh Circuit in
its analysis of this case. And, as will be demonstrated
in Point III below, application of those well established
pre-emption standards compels the conclusion that the
challenged County ordinances are pre-empted.

POINT Ill

PROPER APPLICATION OF WELL-
SETTLED PRINCIPLES OF IMPLIED PRE-
EMPTION ANALYSIS MANDATES THE
CONCLUSION THAT THE CHALLENGED
ORDINANCES ARE WHOLLY PREEMPTED
AND CANNOT STAND.

The Eleventh Circuit, in determining that the federal
system for regulating blood plasma and plasmapheresis

“Brief for the United States, as Amicus Curiae, p. 7.

implicitly pre-empted the County’s regulation of the
area, applied the tests set forth in Pennsylvania v.
Nelson, 350 U.S. 497, 76 S.Ct. 477 (1956), the identical
tests recently restated by this Court in Fidelity Federal
v. de la Cuesta, supra, 458 U.S. 141, ___, 102 S.Ct.
3014, 3022 (1982): (i) whether the federal scheme is so
pervasive as to make reasonable the inference that
Congress left no room for the states to supplement it,
or (ii) whether the federal system of regulation controls a
field in which the federal interest is so dominant that
the federal system must be assumed to preclude
enforcement of state laws on the same subject.

The Eleventh Circuit was eminently correct in
holding that, based upon the criteria set forth in
Pennsylvania v. Nelson, as restated in Fidelity Federal
v. de la Cuesta, the County regulation of plasma and
plasmapheresis is implicitly pre-empted by the federal
system regulating the area.

A. Federal regulation of blood plasma and
plasmapheresis is so pervasive as to leave no room for
local regulation of the area.

The first test for determining the existence of
implied federal pre-emption is whether federal regulation
of the area is so pervasive as to make reasonable the
inference that Congress left no room for the states to
supplement it. Pennsylvania v. Nelson, 350 U.S. at 502,
76 S.Ct. at 480. In the case at bar, the federal system
for regulation of plasmapheresis is so extensive as to
require such an inference.

As the Eleventh Circuit noted, Section 351 of the
Public Health Service Act (the “Act”) requires federal
licensing of each establishment producing a biological
product, federal licensing of each such product to ensure
safety, purity and potency, and federal standards for
packaging and labeling of the product. 42 U.S.C. §262
(1982). Section 351 and Section 361 (42 U.S.C. §264) of
the Act delegate to the FDA the authority to promulgate
the rules and regulations required to implement the
Act. (JA 56; 722 F.2d at 1531).

The regulations implementing the Act include a
section dealing specifically with “Source Plasma (Human),”
which is defined as the fluid portion of human blood
collected by plasmapheresis and intended as source
material for further manufacturing use. 21 C.F.R.
§640.60-640.76 (1983). Other portions of the regulations
promulgated pursuant to the Act also apply to, and
regulate, virtually every aspect of the plasmapheresis
industry.” Jd.

"The regulations prescribe rules as to consent of a prospective
donor, medical supervision of the procedure, suitability of donors,
method of collection, requirements of the plasmapheresis procedure,
immunization of donors, testing for hepatitis, processing of the
blood, pooling, inspection, labeling, manufacturing responsibility,
records, reporting of fatal donor reactions, modification of source
plasma, alternate procedures, and products stored or shipped at
unacceptable temperatures (JA 56, fn.4; 722 F.2d at 1531, fn.4).

“The subjects included within the remaining regulations are
establishment standards and inspections, 21 C.F.R. §§600.3-22 (1983);
licensing, 21 C.F.R. §§601.1-601.33 (1983); good manufacturing practices
for blood and blood components, 21 C.F.R. §§606.3-606.170 (1983)
(with specific sections relating to personnel, facilities, equipment,
supplies and reagents, standard operating procedures, finished
product and laboratory controls, labeling, records, and reports);

23

Clearly, as found by the Eleventh Circuit, the federal
regulations are broad in their scope and cover virtually
every phase of the plasmapheresis process. The federal
regulatory system is so comprehensive and extensive
that the only reasonable inference that may be drawn
is that Congress and the FDA have left no room for
local regulation in the plasmapheresis field.

B. At least in the areas of product purity, donor
safety and adequate plasma supply, the federal interest
is so dominant that local legislation is precluded.

The second basis for a finding of implicit federal
pre-emption is a finding that the federal regulatory
system covers a field in which the federal interest is so
dominant that the federal system must be assumed to
preclude enforcement of state laws on the same subject.
Pennsylvania v. Nelson, 350 U.S. at 504, 76 S.Ct. at 481.
In the case at bar, the federal interest in ensuring a
safe and adequate supply of blood and blood components,
and in ensuring the safety of the donors, as demonstrated
by congressional act and federal agency regulation,
dominates over any local interest in those areas.

Again, as found by the Eleventh Circuit, Congress
and the FDA have maintained extensive and
comprehensive control over the nation’s blood collection
system since 1946. 38 Fed. Reg. 2966 (1973). The collection

(Footnote 12 Continued)

establishment registration and product listing, 21 C.F.R. §§607.3-607.65
(1983); general biological products standards, 21 C.F.R. §610.65
(1983) (including standards of potency, hepatitis requirements,
dating periods, and labeling standards) (JA 56, fn.5; 722 F.2d at

1531, fn.5).

of blood is an area of nationa! concern, for “{hjuman
blood is a priceless resource.” 39 Fed. Reg. 18614 (1974)
(JA 57; 722 F.2d at 1531).

Section 351 of the Act prohibits the sale or
transportation of any blood or blood product that has
not been propagated (or manufactured) and prepared
at a federally licensed establishment. Pursuant to Section
361 of the Act (42 U.S.C. §264) and under the authority
delegated under 21 C.F.R. §20.21, the FDA is authorized
to promulgate such regulations as are necessary to
prevent the introduction, transmission, or spread of
blood related communicable disease from one state to
another, necessarily requiring the FDA to exercise its
authority to regulate a potential disease-causing substance
from the source of its collection through its subsequent
processing (or manufacture) and shipment. 39 Fed. Reg.
18614 (1974).

In promulgating regulations concerning good
manufacturing practices for blood and blood components,
the Commissioner of Food and Drugs stated that:

The promulgation of standards for these
biological drugs is part of an existing effort to
increase the quality of blood related health
care in this country. Pursuant to the findings
of a special Task Force in Blood Banking, the
Secretary of Health, Education, and Welfare
has established a comprehensive National Blood

‘In 1974, the FDA expressly acknowledged that the inspection
or licensing provisions »nacted by approximately ten states were
inadequate to protect against the spread of hepatitis in blood
products. 39 Fed. Reg. 18614-18615 (1974).

Policy. One of the fundamental methods
prescribed by the Secretary to implement the
policy is to “employ the full regulatory
authorities now vested in the Federal
Government * * * for the purpose of assuring
uniform adherence to the highest attainable
standards of practice in blood banking, including
plasmapheresis and plasma fractionation.”

39 Fed. Reg. 18614 (1974) (emphasis supplied).

The FDA, therefore, has developed a “comprehensive
regulatory program” concerning blood and blood
products. The FDA's express purposes in promulgating
regulations to implement that program are to ensure a
safe and adequate supply of blood and blood products
and to ensure a continuous and healthy donor population.
41 Fed. Reg. 10762-10763 (1976); 39 Fed. Reg. 26161-26162
(1974); 39 Fed. Reg. 18615 (1974).

The United States, in its Brief, acknowledges that,
insofar as those goals are concerned, the federal interest
so dominates as to foreclose local legislation on the
subject.

The federal government has required vendors
nationwide to be subject to the same minimum
product and donor safety standards to further
the two-fold interest in ensuring that the national
supply of safe, pure, and potent blood plasma
remains adequate to meet the nation’s health
care needs and in protecting the health of

“See, supra, fn. 12 and 13.

donors for their own sake and to provide a
healthy donor population. To that extent, the
federal interest in plasmapheresis is dominant
and the states are foreclosed from promoting
a contrary policy.”

The County attempts to create a distinction between
the purposes of the federal regulation and those of the
local ordinances, asserting that the purpose of the local
legislation is to protect the health of the donor of the
plasma, while the purpose of the federal regulations is
to ensure the purity and adequacy of supply of the
product (Appellant’s Brief on the Merits, p. 10). However,
as demonstrated above, the distinction sought to be
made by the County is illusory.

The federal regulatory system aims at ensuring
an adequate supply of blood and blood products,
maintaining product safety and protecting and maintaining
a sufficient supply of healthy donors. Congress, insofar
as those aims are concerned, has entrusted to the FDA
the duty of promulgating all regulations necessary to
meet those ends. Section 351 of the Act, and the attendant
regulatory framework, cleariy demonstrates that
Congress intended uniform national standards in the
areas of product safety and supply and donor protection
that would foreclose the imposition of more stringent
local requirements in those areas. Ray u Atlantic Richfield
Co., 435 U.S. at 164, 98 S.Ct. at 998 (1978).

AML does not, of course, assert that, by reason of
the federal regulatory system, it is free to ignore local

“Brief of the United States, as Amicus Curiae, p. 23.

regulation in areas not covered by the federal regulations,
such as local occupational licensing or general health
and safety requirements. See, e.g., Huron Portland
Cement Co. v. City of Detroit, Michigan, 362 U.S. 440,
80 S.Ct. 813 (1960) (federal approval and licensing of
vessels to ensure seagoing safety did not preclude
enforcement of municipal smoke abatement ordinance);
Pacific Gas & Electric Co. v. State Energy Resources
Conservation & Development Comm'n., 461 U.S. 190,
103 S.Ct. 1713 (1983) (federal regulation of radiological
safety in construction and operation of nuclear power
plants did not preclude state regulation concerning
need, reliability and cost). However, the local ordinances
at issue in this case relate only to the precise areas
encompassed by the federal regulations.

The County attempts to regulate in areas which
have been identified as being of dominant federal concern.
The County is precluded from imposing requirements
which are different from, or more stringent than those
dictated to promote the comprehensive national program
in that area, and, thus the County ordinances, are
impliedly pre-empted by the federal regulatory system.

POINT IV

BECAUSE ENFORCEMENT OF THE
CHALLENGED LOCAL LEGISLATION
WOULD RESULT IN BOTH AN IRRECONCI-
LABLE CONFLICT WITH FEDERAL REGU-
LATIONS AND A SUBSTANTIAL OBSTACLE
TO FULL ATTAINMENT OF CONGRESSION.-
ALLY MANDATED OBJECTS AND
PURPOSES, THE LOCAL LEGISLATION IS
PRE-EMPTED.

Even if the pervasiveness of the federal regulations
(Point iII, A) and the dominance of the federal interest
in the subject matter of those regulations (Point III, B)
were not enough to imply pre-emption of the County
ordinances, enforcement of the ordinances would conflict
with the federal regulations and stand as an obstacle to
the accomplishment and execution of the full purposes
and objectives of Congress in establishing a national
policy with regard to blood and blood products. These
circumstances alone compel a finding that the challenged
legislation is pre-empted. Capital Cities Cable, Inc. v.
Crisp, ___. U.S. at ___, 104 S.Ct. at 2700; Michigan
Canners, supra, ___._ U.S. at ___, 104 S.Ct. at 2523;
Fidelity Federal v. de la Cuesta, supra, ____ US. at
____., 102 3.Ct. at 3022.

The United States recognizes a conflict between
the County ordinances and the federal regulations. If
the County ordinances were to be enforced,
plasmapheresis centers in Hillsborough County would
be prevented from collecting plasma necessary for

&

production of hepatitis vaccine."* This conflict alone
mandates a holding of pre-emption.

More substantially, enforcement of the County
ordinances would stand as a serious obstacle to the
expressly stated federal goal to “insure there is a
continued healthy donor population to serve as a source
of plasma.” 37 Fed. Reg. 17420 (1972). In fact, AML’s
evidence at trial demonstrated that enforcement of the
County ordinances would render the continued existence
of AML’s plasma center in Tampa economically impossible
by substantially increasing costs of plasma production,
while, at the same time, substantially reducing the
donor population.

In particular, enforcement of the County ordinances
would have such a negative effect upon local plasma
centers that the donor population would be significantly
reduced, resulting, obviously, in a diminished supply of
available plasma. The evidence at trial indicated that
enforcement of the County ordinances would result in
an increase in direct costs of plasma production by
$1.50 per litre, and a total increase in production costs
(including both direct and indirect costs) of $7.00 per
litre of plasma, an increase of approximately 15% in
the total cost of production (TR 49-52; AML Trial Exhibit
19). In fact, prior experiences with a virtually identical
set of ordinances indicate that the number of plasma
centers would be reduced, in addition to reducing the
donor population. Similar ordinances have been in effect
in Miami, and since their enactment the number of
plasma centers has been reduced from eleven until
only two currently remain (AML Trial Exhibits 4 and

5).

“Brief of United States, as Amicus Curiae, pp. 29-30.

30

Donor population would be reduced by the complete
elimination of what is known as the “casual donor.” A
casual donor is a donor who does not regularly engage
in a systematic plasmapheresis program, but who does
so only occasionally, usually at times separated over
many months. Casual donors would be effectively excluded
from engaging in plasmapheresis under the County
ordinances because they would need County donor
identification cards, which would be burdensome to
obtain and would be valid for only six months.
Additionally, those donors who participate elsewhere
in a plasmapheresis program on a regular basis, but
who find themselves in Hillsborough County only for a
short period of time, would be effectively excluded
from continuing to participate as plasma donors while
in the County of Hillsborough (TR 54-55).

While it is true that the County has a legitimate
interest in protecting the health and safety of its citizens,
any such protection provided by the subject ordinances
is illusory. None of the features of the County regulations
accomplishes a. purpose that the federal regulatory
system does not accomplish, and none provides protection
to the people of Hillsborough County not afforded by
the comprehensive federal regulations.

Because enforcement of the County ordinances
would, in the above respects, stand as an obstacle to
the accomplishment and execution of the purposes of
Congress in establishing a national blood policy, the
ordinances are pre-empted by the federal regulatory
system.

31

CONCLUSION

The Eleventh Circuit properly determined, based
upon criteria set forth by this Court, that the subject
Ordinances are pre-empted by federal regulation. For
the reasons stated herein, the judgment below should

be affirmed. ‘

Respectfully submitted,

LARRY A. STUMPF
Counsel of Record
VICTORIA L. BADEN
Members, United States
Supreme Court Bar

FINLEY, KUMBLE, WAGNER, HEINE,
UNDERBERG, MANLEY & CASEY
Counsel for Appellee

Suite 1000, Flagship Center

777 Brickell Avenue

Miami, Florida 33131

(305) 371-2600

CHARLES F. JOHNS,
On the Brief

J

CERTIFICATE OF SERVICE

All parties required to be served have been se \ ed
by depositing on this 29th day of March, 1985 three
printed copies of this document in a U.S. Post Office,
with first class postage prepaid, addressed to counsel
of record at his or her post office address as follows:

Joe Horn Mount, Esq.
Hillsborough County Attorney
Counsel for Appellants

P.O. Box 1110

Tampa, Florida 33601

Paul J. Larkin, Jr., Esq.
Counsel for Amicus,
United States Government
Department of Justice
Solicitor General's Office
10th and Constitution Ave.
Room 5634

Washington, D.C. 20004

Joyce Holmes Benjamin, Esq.
Counsel for Amicus,
The Academy for State and
ae Government

tate and Local
Suite 208 Legal Center
444 North Capital Street, N.W.
Washington, D.C. 20001

$3

Landfield, Becker & Green
Counsel for Amicus,
American Blood Resources
Association

1220 Nineteenth Street, N.W.
Washington, D.C. 20036

/3/ Lamy A. Stumpt

LARRY A. STUMPF

Counsel of Record

Member, United States Supreme
Court Bar

FINLEY, KUMBLE, WAGNER, HEINE,
UNDERBERG, MANLEY & CASEY
Counsel for Appellee

Suite 1000, Flagship Center

777 Brickell Avenue

Miami, Florida 33131

(305) 371-2600

w

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385012_0778%3A10. Public record. Not legal advice.