Opposition Brief — Sowerby v. Prevo's Family Market, Inc.

Suprome Ceurt, US

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ii. EF D

No. 99-337 j er

IN THE

Supreme Court of the United States

JANIS SOWERBY, As Personal Representative of the Estate of

SCOTT MICHAEL HINKLEY, deceased, KAREN

BOULAHANIS, GEORGE BOULAHANIS, individually and as

next friend of BRIDGIT BOULAHANIS, a minor, KARA

BOULAHANIS, a minor and BRIAN BOULAHANIS, a minor,

Petitioners,

Vv.

PREVO’S FAMILY MARKET, INC. a Michigan Corporation;

I.B.P., INC. a Foreign Corporation and SPARTAN STORES, INC.,

a Michigan Corporation, Jointly and Severally,

Respondents.

ON PETITION FOR A WRIT OF CERTIORARI

TO THE MICHIGAN COURT OF APPEALS

BRIEF IN OPPOSITION FOR RESPONDENT

PREVO’S FAMILY MARKET, INC.

LANCE R. MATHER

Counsel of Record

SMITH, HAUGHEY, RICE & ROEGGE

Attorneys for Respondent

Prevo's Family Market, Inc.

200 Calder Plaza Building

250 Monroe, NW, Suite 200

Grand Rapids, MI 49503

(616) 774-8000

155029 @) Counsel Press LLC

FORMERLY LUTZ APPELLATE SERVICES

(800) 274-3321 + (800) 359-6859

i

STATEMENT OF QUESTION INVOLVED

Whether the Federal Meat Inspection Act, 21 U.S.C.

§§ 601 et seg., preempts the petitioners’ state law claims for

negligence and breach of warranty and the respondents are,

therefore, entitled to a summary disposition dismissing those

claims.

il

STATEMENT PURSUANT TO RULE 29.6

corporation and no publicly held company owns 10% or more

Respondent, Prevo’s Family Market, Inc., has no parent :

of its stock. |

iil

TABLE OF CONTENTS

Page

Statement of Question Involved ................ i

Statement Pursuant to Rule 29.6 ............... li

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Sp EI, ce Wweveseveecece l

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4. The Petitioners’ Claims. ................ l

5. Prevo’s Motions for Summary Disposition.

SET Ces pecc chs s50% a 60 see's l

6. The Trial Court's Decision. ............. 2

7. The Decision of the Michigan Court of

ss upline 3

8. The Decision of the Michigan Supreme

etic ccs Gl sane us Saks eb eeeeves 4

iv

Contents

Page

The Federal Meat Inspection Act, 21 U.S.C.

§§ 601 et seg., Preempts The Petitioners’

State Law Claims For Negligence And

Breach Of Warranty And The Responderits

Are, Therefore, Entitled To A Summary

Disposition Dismissing Those Claims. .... 4

1. The Preemption Doctrine. ........... 4

2. The Preemption Provision of the FMIA,

Be Wh Ee Sea vockbenaeeankes 5

3. The FMIA Has Preemptive Effect in this

GOOD. Keccecedovssvevceseeensevers 6

A. The Petitioners’ Arguments Rest on

an Incorrect Assumption and Are

Invalid for that Reason. ......... 6

B. The Michigan Supreme Court

Properly Decided Ryan vy.

Brunswick Corp, 454 Mich. 20, 557

N.W.2d 541 (1997), and the ,

Michigan Court of Appeals Properly

Relied on that Decision When It

Concluded that Federal Law

Preempts the Petitioners’ Claims.

Contents

Page

C. Even If the Federal Government

Had Not Established a Policy

Concerning Meat Contaminated

with E. Coli Prior to 1994, State

Regulation of Meat Containing

Such Bacteria Would Still Have

Been Preempted. ............... 12

D. The FMIA Was Intended by

Congress to Be Completely

FORTS Sxcevkssvedssuasee. 15

E. Michigan Did Not Have Concurrent

Jurisdiction to Make Laws and

Regulations Concerning the Meat

Involved in this Case............ 16

F. Given the Petitioners’ Failure to

Recognize that this Case Involves

Preemption Arising From

Congressional Mandate, Rather than

from the Mere Conflict Between

State and Federal Laws, Many of

Their Arguments Are Irrelevant.

phaviereed sede babebeies aac 17

4. The Petitioners’ Reliance on the Decisions

in the Medtronic and Freightliner Cases Is

Unfounded, and Those Cases Do Nothing to

Support Their Position in This Matter.

TUTTE er eee ee rere reer ae 19

vi

Contents

Page

5. Neither the Petitioners’ First Argument Nor

Their Unsubstantiated Claim that They Alone

Have Been Denied a Remedy for Exposure

to Meat Containing E. Coli States a Valid

Reason Why Their Claims Should Not Have

ree eres 26

6. The Petitioner’s Argument Based on What

This Court Might Have Done in Lewis v.

Brunswick, No. 97-288, Has No Merit.

vil

TABLE OF CITED AUTHORITIES

Page

Cases:

American Public Health Ass'n. v. Butz, 511 F.2d 331

COU Gals MEE wccieccckcthuvncebesueneeenien 8, 10

Armour & Co. v. Ball, 468 F.2d 76 (6th Cir. 1972),

cert. denied, 411 U.S. 981 (1973) . 13, 14, 15, 16, 17, 21

Cipollone v. Liggett Group, Inc., 505 U.S. 504

OE 0.5 kc vcuieeeeeeens ebeeeeeeciaee eee 11

Freightliner Corp. v. Myrick, 514 U.S. 280 (1995)

Pee ee TET ETT eT oe TT EP eee 19, 23, 25

Lewis v. Brunswick Corp., 197 F.3d 1494 (11th Cir.

PPE er ee ae ete: rata 27, 28

Medtronic, Inc v. Lohr, 518 U.S. 470, 116 S. Ct.

2240, 135 L. Ed. 2d 700 (1996) ..............

cubes eowaeaeen heed ae 2, 19, 20, 21, 22, 23, 25

Ray v. Atlantic Richfield Co., 435 U.S. 151 (1978)

Ryan v. Brunswick Corp, 454 Mich. 20, 557 N.W.2d

Dee CHOee icbdsbcwncsessenueereee 3, 10, 11, 12

vill

Cited Authorities

Page

San Diego Bldg. Trades Council v. Garmon, 359

Ef POPPER T TTT TTT P Tee TT Te Tory 11

Texas Food Industry Ass'n. v. Espy, 870 F. Supp.

Pe PO SUED ocd cpe ds edeencstdeenne 9,10

Statutes and Rules:

Se Se Oe OG cb. d0 soos sb eneenssveses 23

Pa OEE xo csaenekueadcneseuns eee 24

ee ees SRE, eens cenasendiessacnses 19

Pe Sr ED 3.9 ax Uke bop ones toeceenees 19

Oe Ss Se I. gk tev évececscereseades i, 2,4

co er rrr rr rer re 8, 10

ae SD 6 6 00.00 Kennet etekeceeens 16

ee eat PE ev decdavedonsceceeeesoees 2

re Pere e ee 5, 7, 11, 12, 14, 16

Se SEED cena xed0eernsnseseuseeei 13,14

Pern MEPUUUUEEEED cctevectscccersettpndeus 13

ee ee non ner enemr Ts

ix

Cited Authorities

Page

Se PEED fcc cuoceus tvvervsibeesus 13, 14

8 ee rrr 13

EE ce Gccevensnseeusseneaeabas 1,2

1

STATEMENT OF THE CASE

1. The Boulahanis Case.

The Boulahanis case arises out of injuries to several minor

petitioners allegedly caused by their consumption of ground

beef infected with the bacteria Escherichia coli 0157:H7

(“E. coli”). That beef was allegedly purchased at respondent

Prevo’s Family Market, Inc. (“Prevo’s”).

2. The Sowerby Case.

The Sowerby case arises out of the death of petitioner’s

son. As in Boulahanis, this injury allegedly resulted from the

consumption of ground beef infected with E. coli bacteria. Once

again that beef was allegedly purchased at Prevo’s.

3. The Respondents.

Respondent Prevo’s Family Market, Inc., is an individually-

owned chain of stores in the northwest region of Michigan that

Operates a supermarket in Mason County, Michigan. The two

remaining respondents are I.B.P., Inc., a slaughterhouse and

Spartan Stores, Inc., a distributor of food products.

4. The Petitioners’ Claims.

As a consequence of their injuries, the petitioners filed suit

against the respondents in the Circuit Court for Mason County

Michigan. The petitioners in both cases asserted claims for

breach of implied warranty of merchantability and various forms

of negligence.

5. Prevo’s Motions for Summary Disposition.

In response to the petitioners’ complaints in both

Boulahanis and Sowerby, respondent Prevo’s filed motions for

summary disposition pursuant to Michigan court rule MCR

2

2.116(C)(10). Those motions were based on the following

contentions:

A. The petitioners’ claims in both cases were based on

allegations that Prevo’s had sold ground round steak

that was contaminated with E. coli bacteria.

B. The Federal Meat Inspection Act, 21 U.S.C. §§ 601

et seq., as amended by the Wholesome Meat Act, 21

U.S.C. § 601-695, (“FMIA” or “the Act”) specifically

prohibits Michigan from imposing conflicting

standards or requirements on a retail establishment

for adulterant determination, inspection, labeling, or

warning.

C. E.coli bacteria was not deemed to be an “adulterant”

in July 1993 within the meaning of the FMIA.

D. Michigan law is preempted by the FMIA and under

the FMIA the petitioners have no valid claim against

Prevo’s.

6. The Trial Court’s Decision.

The trial court heard Prevo’s motion for summary

disposition on April 22, 1996. After the court heard oral

argument and later reviewed supplemental briefs it had requested

concerning the so-called “Jack-in-the-Box” cases, the court

concluded that Prevo’s motion should be granted; and it did so

in an order entered on June 25, 1996.

The petitioners subsequently filed a Motion for Rehearing

and Reconsideration, claiming that the decision of the United

States Supreme Court in Medtronic, Inc. v. Lohr, 518 U.S. 470

(1996) required a different conclusion on the question of

preemption; but the trial court disagreed with that contention

and denied the petitioners’ motions in an order entered August

12, 1996.

3

The petitioners then appealed from the orders granting

Prevo’s a summary disposition and denying their Motion for

Rehearing and Reconsideration.

7. The Decision of the Michigan Court of Appeals.

The Michigan Court of Appeals issued its decision in this

matter on June 2, 1998 (Petitioners’ Appendix A). In that

decision the court concluded that the federal government’s

refusal to declare E. coli an “adulterant” until 1994 had the

force of a positive determination that inspection of meat for

E. coli was not required. Thus, the Court of Appeals concluded

that the petitioners* claims were preempted by federal law and

that all of the respondents were entitled to a summary disposition

of those claims.

In Ryan [v Brunswick Corp, 454 Mich. 20; 557

N.W.2d 541 (1997)] p 35, the Supreme Court made

it clear that when a federal agency “has deliberately

concluded that regulation is not appropriate in a

given area, federal inaction will preempt state law

not identical to it.” That principle applies here. As

previously noted, until 1994, the USDA did not

consider E. coli to be an “adulterant.” Therefore, the

Department did not consider it necessary to inspect

for E. coli and allowed the distribution of E. coli

contaminated meat. The justification was that the

painstaking microscopic inspection of meat for

pathogens such as E. coli and salmonella was not

feasible and not warranted when any bacteria would

eventually be destroyed by the consumer upon

proper preparation and cooking of the meat. See

American Public Health Ass'n v Butz, 167 U.S. App.

D.C. 93; 511 F.2d 331, 332, 334 (1974). This

intentional decision, not to regulate the presence of

E. coli because it was not considered an adulterant,

carries the force of a positive enactment. Ryan,

4

supra. Holding defendants liable for failing to detect

the presence of E. coli bacteria in the meat purchased

by petitioners in 1993 would run contrary to the

USDA's then-existing determination that inspection

for E. coli bacteria was not required. The trial court

therefore properly concluded that petitioner’s claims

were preempted by federal law.

Boulahanis v. Prevo’s Family, Market, Inc., 230 Mich. App.

131, 137, 583 N.W. 2d 509 (1998).

8. The Decision of the Michigan Supreme Court.

The petitioners then sought to have the Michigan Supreme

’ Court review the decision rendered by the Court of Appeals,

but the Supreme Court denied their request for such review in

an order issued on March 30, 1999 (Petitioners’ Appendix F).

REASON FOR DENYING THE WRIT

THE FEDERAL MEAT INSPECTION ACT, 21 U.S.C.

§§ 601 et seqg., PREEMPTS THE PETITIONERS’ STATE

LAW CLAIMS FOR NEGLIGENCE AND BREACH OF

WARRANTY AND THE RESPONDENTS ARE,

THEREFORE, ENTITLED TO A SUMMARY

DISPOSITION DISMISSING THOSE CLAIMS.

1. The Preemption Doctrine.

There are three circumstances in which federal law

preempts state law:

First, Congress can define explicitly the extent to

which its enactments pre-empt state law. * * *

Second, in the absence of explicit statutory language,

state law is pre-empted where it regulates conduct

in a field that Congress intended the Federal

Government to occupy exclusively. * * * Finally,

state law is pre-empted to the extent that it actually

5

conflicts with federal law. Thus, the Court has found

pre-emption where it is impossible for a private party

to comply with both state and federal requirements

or where state law “stands as an obstacle to the

accomplishment and execution of the full purposes

and objectives of Congress.”

English v. General Electric Co., 496 U.S. 72, 78-79 (1990).

2. The Preemption Provision of the FMIA, 21 U.S.C.

§ 678.

21 U.S.C. § 678 contains the preemption provision of the

FMIA. It provides as follows:

Requirements within the scope of this chapter

with respect to premises, facilities and operations

of any establishment at which inspection is

provided under subchapter I of this chapter, which

are in addition to, or different than those made

under this chapter may not be imposed by any

State * * *. Marking, labeling, packaging, or

ingredient requirements in addition to, or different

than, those made under this chapter may not be

imposed by any State * * * but any State * * *

may, consistent with the requirements under this

chapter, exercise concurrent jurisdiction * * * for

the purpose of preventing the distribution for

human food purposes of any such articles which

are adulterated or misbranded and are outside of

such an establishment * * * . This chapter shall

not preclude any State *** from making

requirements or taking other action, consistent

with this chapter, with respect to any other matters

regulated under this chapter.

21 U.S.C. § 678 (emphasis added).

6

It is clear from this material that the FMIA forbids the states

to impose inspecting, marking, labeling, or packaging

requirements that are “in addition to or different than” those

contained in the Act. !

It is also clear that the instant cases involve the first type of

preemption described above — preemption resulting from an

express Congressional declaration that the FMIA and any

regulations based on it shall have preemptive effect.

The petitioners consistently overlook this fact; and, as a

consequence of their doing so, virtually all of their arguments

fail to discuss the issues actually involved in this appeal. The

petitioners’ arguments might be suitable in cases involving

preemption that results from the mere conflict of state and

federal laws, but those arguments say nothing that is relevant to

cases in which preemption is expressly mandated by the federal

statute itself.

3. The FMIA Has Preemptive Effect in this Case.

A. The Petitioners’ Arguments Rest on an Incorrect

Assumption and Are Invalid for that Reason.

The petitioners’ petition is largely devoted to a single

argument which they restate a number of times in somewhat

different fashion. The argument asserts that the doctrine of

preemption does not apply in this case because prior to 1994

the federal government had supposedly failed to make any

regulations concerning meat containing E. coli bacteria. The

following statements from the petitioners’ petition are illustrative

of their repeated claims to that effect.

* * * Thus, where the condition of which the

Petitioners complain, and as to which the

Petitioners assert common law theories of

recovery, is not federally regulated, and is the

7

subject to no federal requirements, either directly

under the statute or by regulation, state law claims

should be allowed.

(Petition, pp. 13-14.)

* * *

* * * That the Federal government had not yet

determined, at the time of Petitioners’

consumption of the meat, that the meat was

adulterated for having E. coli within it does not

mean that it was not, in fact and in law, adulterated

prior to that time.

(Petition, p. 15.)

* * *

* * * There was no Federal regulation or

regulatory action by the Federal Meat Inspection

Agency prior to 1994, * * *

(Petition, p. 17.)

The arguments the petitioners base on the alleged failure

of the federal government to regulate meat containing E. coli

bacteria are erroneous for several reasons.

First of all, they are irrelevant to the issues involved in this

appeal because the preemption involved in the underlying cases

is mandated by 21 U.S.C. § 678. The preemptive effect of the

FMIA thus does not depend in any way on the existence of a

conflict between state and federal laws; and it is consequently

immaterial whether, prior to 1994, the federal government had

decided whether meat containing E. coli was adulterated. The

FMIA has preemptive effect because it is a federal statute and

says that it preempts state law. Nothing more is needed.

8

The petitioners further err in claiming that prior to 1994

the federal government had not spoken on the issue of E. coli in

meat. Thus, the fundamental assumption underlying virtually

all of their arguments is simply wrong.

The fact that, prior to 1994, the United States Department

of Agriculture (“USDA”) declined to classify meat containing

E. coli bacteria as “adulterated” was fully equivalent to an

affirmative decision that such meat was not “adulterated” and

could be sold for human consumption. The petitioners’ attempt

to transform this obviously deliberate decision by the USDA

into a failure to act is nonsense.

After all, 1993 was not that long ago; and the dangers

associated with the contamination of food by E. coli were well

known at that time. 1994 was not the year when the USDA first

become aware of the dangers posed by meat containing E. coli,

and it had undoubtedly considered the status of E. coli as an

adulterant before that time. As long ago as 1975 the status of

salmonella bacteria as an “adulterant” was litigated, and it was

decided that the presence of salmonella in meat did not constitute

adulteration within the definition established by 21 U.S.C.

§ 601(m). American Public Health Ass'n. v. Butz, 511 F.2d 331,

334 (Sth Cir. 1975). The presence of bacteria in meat was clearly

an issue that has occupied the USDA for many years, and the

petitioners’ repeated assertions that the USDA never gave any

thought to the status of E. coli as an adulterant and made no

decision on that question prior to 1994 is clearly wrong.

Furthermore, the Supreme Court of the United States has

expressly recognized that a decision not to regulate is itself

regulation whenever the federal government intended to

centralize all authority over the regulated area in one decision

maker; and that is precisely the situation where the USDA and

regulation of standards for meat are concerned. Ray v. Atlantic

Richfield Co., 435 U.S. 151 (1978).

9

Unfortunately for the petitioners’ arguments in this case,

until 1994 the USDA held the view that meat containing E. coli

bacteria was not adulterated; but its doing so is obviously far

different from making no decision at all on that question.

The court in Texas Food Industry Ass'n. vy. Espy, 870

F. Supp. 143 (W.D. Tex. 1994) properly interpreted the USDA's

decision in 1994 to declare E. coli an adulterant and labeled

that decision a change in its prior policy of viewing meat

containing E. coli as not adulterated.

* ** Prior to this announcement, the USDA

had treated pathogen-contaminated meat as

unadulterated under the FMIA.

870 F. Supp. 143, 145.

*** Finally, the Court finds that the

Defendants’ changing policy is a rational response

to an emerging problem.

870 F. Supp. 143, 148.

The court in Texas Food also pointed out that the USDA

had been sampling and testing meat for E. coli bacteria for

several years before declaring that bacteria an adulterant

(870 F. Supp. 143, 146, fn. 6), and obviously the presence of

E. coli in meat had been a matter of concern to the USDA for a

considerable amount of time before it declared such bacteria an

adulterant in 1994,

A decision not to label certain meat as adulterated is a

decision even though it results in no action; and when, prior to

1994, the USDA declined to label meat containing E. coli as

adulterated it made a decision that such meat was not, in fact,

10

adulterated. The petitioners’ repeated claims to the contrary have

no merit and are clearly wrong.

B. The Michigan Supreme Court Properly Decided Ryan

v. Brunswick Corp, 454 Mich. 20, 557 N.W.2d 541

(1997), and the Michigan Court of Appeals Properly

Relied on that Decision When It Concluded that

Federal Law Preempts the Petitioners’ Claims.

The decision in Ryan v. Brunswick Corp., 454 Mich. 20,

557 N.W.2d 541 (1997) shows quite clearly that federal law

preempts the petitioners’ claims. Ryan properly concluded that

a refusal to regulate can itself be considered a form of regulation,

especially where no federal standards or requirements are

imposed even after a particular problem has been identified and

studied. That portion of Ryan’s holding is based on solid federal

precedent and is consistent with well-established law. 454 Mich.

20, 35-36.

This part of Ryan's holding provides the answer to the

petitioners’ repeated assertions that no preemption can occur in

this case because prior to 1994 the USDA did not consider

E. coli bacteria to be an adulterant. The USDA certainly knew

that the presence of such bacteria in meat presented a possible

problem, and it studied that problem for several years before

declaring E. coli an adulterant. See Texas Food Industry Ass'n.

v. Espy, 870 F. Supp. 143 (W.D. Tex. 1994). See also American

Public Health Ass'n. v. Butz, 511 F.2d 331, 334 (Sth Cir. 1975).

(Salmonella bacteria was not an adulterant in meat as that term

is defined in 21 U.S.C. § 601(m)).

Given this awareness of the possible problem posed by

E. coli in meat and the study of that problem prior to 1994, the

USDA's decision not to declare E. coli an adulterant was fully

equivalent to an express decision that it was not then an

adulterant. Thus, even if it were necessary for the federal

government to exert its regulatory power in this area for

1]

preemption to occur (a clearly incorrect assumption given the

nature of the express preemption provision found in 21 U.S.C.

§ 678), such regulation did in fact occur; and the decision in

Ryan strongly supports that conclusion. The petitioners’ claims

to the contrary are clearly wrong.

Ryan also holds that “state law” includes common law

actions for damages. This conclusion is also clearly correct and

is, once again, based on established federal precedent. A

common law action may be a form of state law or regulation

that is preempted by federal law because the possibility of a

damage award can compel someone to do something federal

law does not require. See Cipollone v. Liggett Group, Inc., 505

U.S. 504, 521 (1992); San Diego Bldg. Trades Council v.

Garmon, 359 U.S. 236 (1959).

This portion of Ryan answers the petitioners’ claims that

their common law claims somehow fall outside the scope of

the preemption doctrine and survive despite it.

The petitioners’ analysis of Ryan is furthermore dead wrong

because it ignores the nature of the preemption provision

involved in that case. By doing so it fails to comprehend the

question actually presented in that case.

Given the preemption provision and saving clause involved

in the Federal Boat Safety Act, the Supreme Court of Michigan

in Ryan concluded that preemption occurred only when a state

law or regulation was not identical to an existing federal

regulation (454 Mich. 20, 30, fn. 12). Thus, in Ryan it was

necessary for a federal regulation inconsistent with a state law

or regulation to exist before preemption could take place. It

was for that reason that the Michigan Supreme Court considered

the intention of Congress in deciding not to require guards on

boat propellers. In order to answer the preemption question

presented in Ryan it was necessary to determine whether the

refusal of Congress to require such guards was equivalent to an

express determination that such guards were not necessary.

12

This case necessitates no such inquiry. The preemption

provision involved in this matter expressly prohibits a state from

enacting any requirement “in addition to” those imposed by

the FMIA, and thus it is not necessary to find a conflict between

a state law or regulation and an existing federal regulation before

preemption occurs. The preemption provision in 21 U.S.C.

§ 678 invalidates any state law or regulation that imposes an

additional “marking, labeling, packaging, or ingredient”

obligation on any entity subject to the FMIA regardless of

whether the federal government has enacted any regulations in

that area or not. The petitioners’ claim that a Ryan-type analysis

of Congressional intent is required in this case thus has no merit.

C. EvenIf the Federai Government Had Not Established

a Policy Concerning Meat Contaminated with E. Coli

Prior to 1994, State Regulation of Meat Containing

Such Bacteria Would Still Have Been Preempted.

Any Michigan law concerning meat containing E. coli

would have been preempted in 1993 even if the federal

government had failed to determine that such meat was not

adulterated. The FMIA does not merely prohibit state laws and

regulations that are “different than” those established by the

federal government. It also prohibits laws and regulations “in

addition to” those set forth in the FMIA. This fact is fatal to the

petitioners’ arguments.

Any Michigan provision that concerned the marking,

labeling, packaging, or ingredient requirements of the meat

involved in this case would necessarily have been “in addition

to” the requirements of the FMIA and would have been

preempted for that reason. This conclusion is independent of

any federal statute or regulation concerning meat containing

E. coli and does not depend upon the existence of federal action

concerning such meat.

The fact that the FMIA prohibits any state regulation “in

addition to” its own provisions demonstrates a fundamental error

13

in the petitioners’ arguments. They have treated this case as

one that involves only an actual conflict between federal and

state law; and, having supposedly demonstrated that there is no

conflict, they claim that preemption has not occurred.

There are two errors inherent in the petitioners’ approach.

First, there is an actual conflict because, prior to 1994, the federal

refusal to label meat containing E. coli as adulterated was fully

equivalent to an affirmative decision that such meat was not

adulterated. Second, given the FMIA’s prohibition against state

provisions “in addition to” its own, no actual conflict between

state and federal law was necessary for preemption to occur.

Preemption took place because the FMIA specifically said it

did, and that expression of Congressional will was more than

sufficient to effect preemption in this case.

The preemptive effect of the FMIA on state law and

regulations “in addition to” its own is also made clear by the

decision in Armour & Co. v. Ball, 468 F.2d 76 (6th Cir. 1972),

cert. denied, 411 U.S. 981 (1973), which struck down major

portions of Michigan’s Comminuted Meat Law.

Although certain portions of the Comminuted Meat Law

conflicted directly with federal regulations, a number of its

provisions did not do so. That fact notwithstanding, even the

provisions that did not establish requirements different from

federal regulations were found to be preempted.

For example, the federal regulations governing the

ingredients in sausage did not establish a requirement for overall

moisture or protein content (468 F.2d 76, 87). The Comminuted

Meat Law did so, however. M.C.L. 289.582(a)(1); M.S.A.

12.964(2)(a)(1). (These provisions are now found in M.C.L.

289.582(1)(e); M.S.A. 12.964(2)(1)(e).)

Despite the absence of any direct conflict between the

federal regulations and Michigan law, the portions of M.C.L.

14

289.582(a)(1); M.S.A. 12.964(2)(a)(1) establishing the

standards for overall moisture and protein content were held to

be preempted (468 F.2d 76, 85).

The same conclusion must be reached in this case. Even if

the USDA had not taken the position that meat containing

E. coli was unadulterated, a state law or regulation declaring

such meat adulterated would necessarily have been preempted

because the FMIA and the federal regulations based on it

establish the only standards for determining whether such meat

is, in fact, adulterated.

Although the petitioners’ arguments concern only meat

containing E. coli, those arguments obviously would apply just

as well to any characteristic of meat that has not been regulated

by the federal government. If the petitioners’ arguments were

correct, then a state could pass laws and enact regulations

affecting any such characteristic simply because the federal

authorities had not yet done so. Is such a conclusion possibly

correct? Of course not. If a state passed such laws and

regulations, they would necessarily be “in addition to” the

standards imposed by the FMIA and would be preempted by

reason of 21 U.S.C. § 678. Such laws and regulations would

fare no better than the portions of Michigan’s Comminuted Meat

Law concerning overall moisture and protein content that were

found to be preempted in Armour & Co. v. Ball, 468 F.2d 76

(6th Cir. 1972), cert. denied, 411 U.S. 981 (1973).

The petitioners’ arguments completely overlook the fact

that the FMIA prohibits state laws and regulations “in addition

to” its own, and their petition contains no discussion at all of

that prohibition. By failing to recognize that the FMIA has

preemptive force by its own terms, the petitioners have missed

one of the most important points in this case.

15

D. The FMIA Was Intended by Congress to Be Completely

Preemptive.

In addition to the language of the FMIA itself, the case law

interpreting it demonstrates that Congress intended the FMIA

to have completely preemptive effect. This conclusion is clearly

set forth in Armour & Co. v. Ball, 468 F.2d 76 (6th Cir. 1972),

cert. denied, 411 U.S. 981 (1973). The decision in that case

States in the most definite terms that the FMIA completely

preempts state law within its sphere of operation.

* * * Thus, by prohibiting a state’s imposition

of “marking, labeling ... or ingredient

requirements” which are “in addition to or

different than [those made by the Secretary],”

Congress has “unmistakably ... ordained” that

the Federal Act fixes the sole standards. * * *

468 F.2d 76, 84.

* * *

Congressional debates are devoid of any

discussion of Section 408 of the Act (21 U.S.C.

§ 678). However, in view of its unambiguous

language, Section 408 reflects unequivocal

legislative purpose to make the Federal Act

preemptive.

468 F.2d 76, 84-85.

* * *

* * * Nevertheless, in view of the clear and

complete preemption ordained by Congress, this

Court must enforce the Supremacy Clause and

declare that the Federal Act preempts certain

provisions of the Michigan law. * * *

468 F.2d 76, 85.

16

In this case, as in Armour, the FMIA established the “sole

standards” and effected a “clear and complete preemption” of

any Michigan law or regulation “in addition to, or different than”

the FMIA’s own provisions.

E. Michigan Did Not Have Concurrent Jurisdiction to

Make Laws and Regulations Concerning the Meat

Involved in this Case.

The petitioners err in claiming that 21 U.S.C. § 678 granted

Michigan “concurrent jurisdiction” to regulate the meat involved

in this case. Admittedly, 21 U.S.C. § 678 does say that “ * * *

any State may, consistent with the requirements under this

chapter, exercise concurrent jurisdiction * * * for the purpose

of preventing the distribution for human food purposes of any

such articles which are adulterated or misbranded * * *.”

However, that provision did not apply to the meat involved in

this case and could not possibly have conferred any jurisdiction

on Michigan to regulate it.

The concurrent jurisdiction described in the quoted

language applies only to “adulterated or misbranded” articles;

and furthermore those terms must be given the meaning they

have under federal, not state, law. This conclusion is clear from

the decision in Armour & Co. v. Ball, 468 F.2d 76 (6th Cir.

1972), cert. denied, 411 U.S. 981 (4973) in which the Court

said this about the language quoted above.

The concurrent action of a state, permitted by

this language, only applies to adulterated or

misbranded articles. These words are necessarily

used as defined in the act. * * * Permissible

concurrent enforcement by a state under Section

678 would apply only to meat food products that

satisfy this definition of misbranding [i.e., the

definition in 21 U.S.C. § 601(n)(7)]. In its

concurrent enforcement a state would not be

17

permitted to prevent the distribution in commerce

of any article that “conforms” to the “definition

and standard of identity or composition.” Thus,

Congress is ordaining uniform national ingredient

requirements prescribed by the Secretary.

468 F.2d 76, 84.

At the time the meat involved in this case was sold and

consumed, federal regulations did not classify meat containing

E. coli bacteria as adulterated. Given that fact, Michigan had

no concurrent jurisdiction to regulate the handling, inspection,

labeling or sale of such meat because it was not adulterated as

that term is used in the FMIA. At the times relevant to these

cases, Michigan likewise had no power to prevent the

distribution of meat containing E. coli bacteria because such

meat was then in full compliance with the requirements imposed

by the FMIA. The petitioners’ arguments to the contrary are

clearly incorrect.

F. Given the Petitioners’ Failure to Recognize that this

Case Involves Preemption Arising From

Congressional Mandate, Rather than from the Mere

Conflict Between State and Federal Laws, Many of

Their Arguments Are Irrelevant.

Because the petitioners have misconstrued the reason why

federal law has preemptive effect in these cases, many of their

arguments are irrelevant to the issues actually involved in this

appeal. It is, for example, immaterial whether-the USDA’s

regulations are comprehensive or not (Petition, p. 19). The FMIA

does not preempt Michigan law because of any particular

characteristic of the regulations based on it. It preempts

Michigan law because it is a federal statute and expressly says

that it has preemptive effect.

It is likewise immaterial whether the petitioners have a

remedy to replace the one being precluded by the federal statute

18

(Petition, p. 11). The absence of such an alternative remedy is

relevant only when preemption arises because of a perceived

conflict between state and federal law. Where a federal statute

expressly provides for preemption, there can be no doubt about

the effect of that statute; and the absence of some other remedy

is, therefore, irrelevant.

As the petitioners themselves admit in their petition:

*** Where there is a specific preemption

provision in a Federal statute, there is no need to

consider whether preemption should be implied

from the law or from Federal regulations. The

question at that point is the proper interpretation

of the express preemption provision. Cipollone v

Liggett Group, Inc, 505 US 504; 112 SCt 2608;

120 LEd 2d 407, 423 (1992). As noted in

Cipollone (id):

When Congress has considered the issue

of preemption and has included in the

enacted legislation a provision explicitly

addressing that issue, and when the

provision provides a “reliable indicium

of congressional intent with respect to

State authority,” * * * “there is no need

to infer congressional intent to preempt

state law from the substantive

provisions of the legislation” (citations

omitted).

(Petition, p. 11).

Respondent Prevo’s agrees fully with the quoted material

from the petition. The situation present in this appeal is

furthermore identical to the one described in that material, and

thus it applies directly to this matter.

19

The FMIA contains a “specific preemption provision,” and

in light of that fact there is no question that it preempts state

law. All of the petitioners’ arguments about what might possibly

be presumed or inferred from the nature of the regulations based

on the FMIA, from the absence of some other remedy to replace

the one precluded by the FMIA, or from the alleged failure of

the federal government to regulate meat containing E. coli until

1994 are, therefore, irrelevant.

4. The Petitioners’ Reliance on the Decisions in the

Medtronic and Freightliner Cases Is Unfounded, and

Those Cases Do Nothing to Support Their Position

in This Matter.

In their petition the petitioners place significant reliance

on the decisions in Medtronic, Inc. y. Lohr, 518 U.S. 470 (1996)

and Freightliner Corp. v. Myrick, 514 U.S. 280 (1995). That

reliance is unfounded. Neither of those decisions supports the

petitioners’ arguments in this matter.

Medtronic involved claims for personal injury allegedly

caused by a defective pacemaker lead. The defendant

manufacturer responded with an argument that the claim was

preempted by federal law because 21 U.S.C. § 360k(a) provides

that no state may establish or continue in effect, with respect to

a device intended for human use, any requirement that is

different from, or in addition to, any requirement applicable to

the device under the Federal Food, Drug, and Cosmetic Act of

1938 (FDCA), 21 U.S.C. § 301 er seq.

The Supreme Court disagreed and held that the petitioners’

claim was not preempted. It did so for a number of reasons, not

one of which applies to this case.

First and foremost, the Court’s decision was based in large

part on the fact that the Food and Drug Administration (FDA)

has broad power to determine when and to what extent a statute

20

in the FDCA or a regulation based on such a statute has

preemptive effect. The FDA, unlike many other agencies, has

even passed regulations that place significant restrictions on

the extent to which preemption occurs.

The FDA regulations interpreting the scope

of § 360k’s preemptive effect support the Lohrs’

view, and our interpretation of the pre-emption

Statute is substantially informed by those

regulations. * * * In addition, Congress has given

the FDA a unique role in determining the scope

of § 360k’s pre-emptive effect. Unlike the statute

construed in Cipollone, for instance, pre-emption

under the MDA [Medical Devices Act] does not

arise directly as a result of the enactment of the

Statute; rather, in most cases a state law will be

pre-empted only to the extent that the FDA has

promulgated a relevant federal “requirement.”

** *

Medtronic, Inc v. Lohr, 518 U.S. 470, __, 116 S. Ct. 2240,

2255, 135 L. Ed. 2d 700, 722 (1996).

The regulations enacted by the FDA furthermore provide

that preemption does not occur unless the FDA has enacted its

own regulations speaking to the very same subject as the state

law that is supposedly preempted or some unavoidable conflict

between state and federal law is certain to result.

The Lohrs’ theory is supported by the FDA

regulations, which provide that state requirements

are preempted “only” when the FDA has

established “specific counterpart regulations or

* ** other specific requirements applicable to a

particular device.” 21 CFR § 808.1(d)(1995). * * *

116 S. Ct. 2240,

Medtronic, Inc v. Lohr, 518 U.S. 470

2257, 135 L. Ed. 2d 700, 723 (1996).

21

»* * *

** * The regulations even go so far as to state

that § 360k(a) generally “does not preempt a state

or local requirement prohibiting the

manufacturing or adulterated or misbranded

devices” unless “such a prohibition has the effect

of establishing a substantive requirement for a

specific device. § 808.1(d)(6)(ii) * * *”

Medtronic, Inc v. Lohr, 518 U.S. 470 116 S. Ct. 2240,

2257, 135 L. Ed. 2d 700, 724 (1996).

* * *

Although we do not believe that this statutory

and regulatory language necessarily precludes

“general” federal requirements from ever pre-

empting state requirements, or “general” state

requirements from ever being pre-empted, see Part

VI, infra, it is impossible to ignore its overarching

concern that preemption occur only where a

particular state requirement threatens to interfere

with a specific federal interest. * * *

Medtronic, Inc v. Lohr, 518 U.S. 470, __, 116 S. Ct. 2240,

2257, 135 L. Ed. 2d 700, 724 (1996).

This case involves nothing that is even close to the

preemption doctrine that applies to the FDCA. The FMIA was

intended by Congress to set the sole standards within its sphere

of operation, and preemption occurs under the FMIA even if

the federal government has not enacted laws or regulations

concerning a particular question. Armour & Co. v. Ball, 468

F.2d 76 (6th Cir. 1972), cert. denied, 411 U.S. 981 (1973).

In Medtronic the Court also found preemption inapplicable

because the petitioners were, in effect, seeking to use a state

remedy to enforce a requirement that already existed under

22

federal law. In other words, the petitioners were looking to state

law only for their remedy, not for the basis of their claim.

Nothing in § 360k denies Florida the right to

provide a traditional damages remedy for

violations of common-law duties when those

duties parallel federal requirements. Even if it may

be necessary as a matter of Florida law to prove

that those violations were the result of negligent

conduct, or that they created an unreasonable

hazard for users of the product, such additional

elements of the state-law cause of action would

make the state requirements narrower, not broader,

that the federal requirement. * * * The presence

of a damages remedy does not amount to the

additional or different “requirement” that is

necessary under the statute; rather, it merely

provides another reason for manufacturers to

comply with identical existing “requirements”

under federal law.

Medtronic, Inc v. Lohr, 518 U.S. 470

2255, 135 L. Ed. 2d 700, 722 (1996).

116 S. Ct. 2240,

in this case the situation is completely different. When the

petitioners’ claims arose in 1993, federal law did not consider

meat containing E. coli bacteria adulterated; and thus the

petitioners had no possible claim against respondent Prevo's

under federal law. Indeed, the petitioners have even admitted

that fact. See Part 4, supra.

The petitioners in this matter, unlike the petitioners in

Medtronic, were not seeking a state remedy for violation of a

federal requirement. They were likewise not seeking a state

remedy for violation of a state requirement that was no broader

than and essentially identical to one already existing under

federal law.

23

To the contrary, they were seeking a state remedy for

violation of a state requirement that was “in addition to” and

“different than” the federal standard in effect at the time. Given

that fact, the decision in Medtronic, based as it is on the fact

that federal law established a requirement identical to the one

under which the petitioners there sought to recover, does nothing

to show that there is no preemption in this case.

The decision in Medtronic is obviously based on a statute

and doctrine of preemption that are quite different from the ones

involved in this case, and for that reason Medtronic simply does

not apply to this matter. The petitioners’ reliance on that decision

is thus unfounded.

The decision in Freightliner Corp. v. Myrick, 514 U.S. 280

(1995) likewise fails to support the petitioners’ arguments, and

it does so for reasons similar to those affecting the decision in

Medtronic.

Freightliner involved claims that certain tractor-trailers were

negligently designed because they did not have antilock brake

systems (ABS’s). The manufacturer argued that these state law

claims were preempted by the National Traffic and Motor

Vehicle Safety Act of 1966 (the “Safety Act”), 15 U.S.C. § 1381

et seq. and its implementing regulations.

The Supreme Court disagreed and found no preemption. It

did so for two reasons, neither of which exists in this-case. First,

the preemption provision in the Safety Act specifically provided

that preemption occurred only when state and federal safety

standards regulated the same aspect of performance of a vehicle

or item of equipment and the standards were not identical.

Whenever a Federal motor vehicle safety

standard established under this subchapter is in

effect, no State or political subdivision of a State

shall have any authority either to establish, or to

24

continue in effect, with respect to any motor

vehicle or item of motor vehicle equipment any

safety standard applicable to the same aspect of

performance of such vehicle or item of equipment

which is not identical to the Federal standard.

** *

15 U.S.C. § 1392(d).

Second, at the relevant times, previously enacted federal

standards concerning the required stopping distances for trucks

had been suspended by order of the Ninth Circuit Court of

Appeals.

Given the language of the Safety Act allowing preemption

only when a federal standard regulating the same subject matter

was in effect and the suspension of the federal standard for

stopping distances, the Supreme Court found the requirements

of the statute had not been satisfied.

Despite the fact that Standard 121 remains

suspended, petitioners maintain that defendants’

lawsuits are expressly pre-empted. We disagree.

The Act's pre-emption clause applies only

“[w]henever a Federal motor vehicle safety

standard * * * is in effect” with respect to “the

same aspect of performance” regulated by the a

state standard. 15 U.S.C. § 1392(d) [15 U.S.C.S.

§ 1391(d)]. There is no express federal standard

addressing stopping distances or vehicle stability

for trucks or trailers. No NHTSA regulation

currently establishes a “minimum standard for

*** motor vehicle equipment performance,”

§ 1391(2), nor is any standard “stated in objective

terms,” § 1392(a). There is simply no minimum,

objective standard stated at all. Therefore, States

remain free to “establish, or to continue in effect,”

25

their own safety standards concerning those

“aspects of performance.” § 1392(d).

Freightliner Corp. v. Myrick, 514 U.S. 280, 286 (1995).

The FMIA contains no provision like the one in the Safety

Act that limits preemption to situations where state and federal

standards speak to the same subject matter. The FMIA provides

just the opposite, in fact, by providing that preemption occurs

whenever any state law or regulation is “in addition to, or

different than” the provisions of the Act itself. Thus, under the

FMIA, a state law or regulation is preempted if it is simply “in

addition to” the provisions of the Act, regardless of whether

any portion of the FMIA regulates the same subject as the state

enactment. The situation in Freightliner was quite different;

and, therefore, the decision in that matter Says nothing about

whether preemption occurred in this case.

In addition, the decision of the USDA not to label meat

containing E. coli bacteria adulterated was fully equivalent to

an affirmative decision that such meat was not, in fact,

adulterated; and thus preemption would occur in this case even

if the FMIA contained the sort of restrictive preemption

provision found in the Safety Act at issue in Freightliner.

The petitioners’ arguments thus find no support in

Medtronic or Freightliner. The petitioners’ discussion of those

decisions fails even to mention, much less take account of, the

fact that each of them involved a preemption provision that is

far more restrictive than the one involved in this case and that

the decisions in those matters were direct (and necessary)

consequences of the restrictive preemption provisions they were

applying.

26

5. Neither the Petitioners’ First Argument Nor Their

Unsubstantiated Claim that They Alone Have Been

Denied a Remedy for Exposure to Meat Containing

E. Coli States a Valid Reason Why Their Claims

Should Not Have Been Dismissed.

The petitioners misdirect their first argument. If the current

regulatory procedures for meat products present problems

(Prevo's denies that they do), the petitioners should direct their

complaints at Congress, which placed an express preemption

provision in the FMIA, and the USDA, which is allegedly not

acting quickly enough in identifying new pathogens and labeling

them as adulterants.

The petitioners’ complaints and “parade of horribles’” do

not provide any reason, much less justification, for any court to

refuse enforcement of an express preemption provision in a

federal statute. Congress has clearly stated that the FMIA shall

have preemptive effect, and that fact cannot be changed by any

problems the petitioners claim they have identified in the

inspection and labeling procedures the FMIA establishes.

The E. Coli problems associated with the Jack-in-the- Box

hamburger chain have no relevance to this case, and the

petitioners’ discussion of them proves nothing. Jack-in-the-Box

is a fast food retailer, and its liability in the various cases brought

against it was based on improper cooking of the hamburgers it

served. The express preemption provision of the FMIA is

concerned with “marking, labeling, packaging, and ingredient

requirements”; and it has nothing at all to do with cooking.

Thus, the preemption provision of that act did not apply to

Jack-in-the-Box in any way. The decision in this case thus has

no effect whatsoever on the possible liability of a retailer selling

hamburgers or other finished food products for claims based

on improper cooking. It is misleading of the petitioner to suggest

otherwise.

27

The petitioners’ claim that they are the only victims of

E. coli poisoning in the United States to be denied a tort remedy

is both undemonstrated and irrelevant. It is undemonstrated

because the petitioners have not cited one single case in which

someone injured before 1994 by meat containing E. coli was

allowed to recover from an entity covered by the preemption

provision of the FMIA. In other words, the petitioners have

failed to show that any other jurisdiction has refused to give

preemptive effect to the FMIA for an E. coli injury that occurred

before the USDA declared E. coli to be and adulterant in meat.

The petitioners’ claim is irrelevant for at least two reasons.

First, to the extent that it is based on claims asserted against

fast food retailers such as Jack-in-the-Box for improper cooking,

it proves nothing because the preemption provision of the FMIA

does not apply to cooking. Second, if other states have failed to

recognize the preemptive effect of the FMIA, they have clearly

erred by doing so. Their errors certainly provided no valid reason

why the courts of Michigan should have repeated their mistakes.

6. The Petitioner’s Argument Based on What This Court

Might Have Done in Lewis v. Brunswick, No. 97-288,

Has No Merit.

The petitioners’ final argument is based on a claim that

this Court might have reversed the decision Lewis v, Brunswick

Corp., 197 F.3d 1494 (11th Cir. 1997) if the case had not been

settled prior to the release of an opinion. That argument has no

merit.

The opinion of petitioner’s counsel about what this Court

might have done in a case in which no decision was ever

rendered is speculative and totally irrelevant to any question

involved in this case.

Furthermore, even if the Court had modified the decision

of the Eleventh Circuit Court of Appeals in Lewis v. Brunswick

ee

28

Corp., 197 F.3d 1494 (11th Cir. 1997), its decision would have

had little, if any, relevance to this matter because of the different

express preemption provisions contained in the Federal Meat

Inspection Act (FMIA) and the Federal Boating Safety Act

(FBSA).

The petitioners also place reliance on the amicus curiae

brief of the Solicitor General submitted to this Court in Lewis.

That reliance is unfounded. The arguments set forth in that brief

are clearly statute specific, and their reasoning could not possibly

apply to the express preemption provision in the FMIA because

it differs significantly from the preemption provision in the

FBSA.

In addition, it is axiomatic that the law is stated by the

courts, not by the Department of Justice, the Solicitor General,

or anyone else who takes a position on a particular issue for

undisclosed reasons that may well have no connection

whatsoever with the merits of that issue. The petitioners’ attempt

to use the position taken by the Solicitor General in the Lewis

case as “authority” for their position thus necessarily fails.

CO SSSSST-C:~Ss=

29

CONCLUSION

For the reasons set forth above, respondent, Prevo’s Family

Market, Inc., respectfully requests the Court to deny the petition

for a writ of certiorari.

Respectfully submitted,

Lance R. MATHER

Counsel of Record

SmitH, HauGuey, Rice & RoEGGE

Attorneys for Respondent

Prevo's Family Market, Inc.

200 Calder Plaza Building

250 Monroe, NW, Suite 200

Grand Rapids, MI 49503

(616) 774-8000