Amicus Curiae Brief — Medtronic, Inc. v. Lohr
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Supseme Court, U8.
One, FILED
Nos. 95-754 & 95-886 |
RK
ee
MAR 18 1996
IN THE
SUPREME COURT OF THE UNITED STATES
OCTOBER TERM, 1995
MEDTRONIC, INC.,
Petitioner,
Vv.
LORA LOHR, et vir,
Respondent, and
Cross Petitioner.
On Writ of Certiorari to the
United States Court of Appeals
for the Eleventh Circuit
MOTION FOR LEAVE TO FILE A BRIEF AND
BRIEF FOR TWO PRODUCTS LIABILITY LAW PROFESSORS
AS AMICI CURIAE IN SUPPORT OF NEITHER PARTY
Richard N. Pearson”
Lars Noah
University of Florida
College of Law
P.O. Box 117625
Gainesville, FL 32611-7625
(352) 392-2211
March 11, 1996 * Counsel of Record
yi
mah
IN THE
SUPREME COURT OF THE UNITED STATES
OCTOBER TERM, 1995
Nos. 95-754 & 95-886
MEDTRONIC, INC.,
Petitioner,
On Writ of Certiorari to the
United States Court of Appeals
for the Eleventh Circuit
MOTION FOR LEAVE TO FILE A BRIEF
AS AMICI CURIAE IN SUPPORT OF NEITHER PARTY
The undersigned respectfully move for leave to file the
attached brief amicus curiae in support of neither party.
Counsel for Respondent Lora Lohr consented to the filing of
this brief, but Counsel for Petitioner Medtronic did not.”
The undersigned teach and write in the area of tort law
and products liability and are especially interested in the
rapidly accelerating use of federal preemption as a defense.”
v At the time that this motion and brief were finalized for printing,
counsel for Medtronic represented to the undersigned that he still had not
received final instructions from his client in response to our request of
January 29, 1996.
¥ E.g., Reconceptualizing Federal Preemption of Tort Claims as the
Government Standards Defense, 37 Wm. & Mary L. Rev. 903 (1996).
The attached brief offers an approach that neither Party
is likely to elaborate. Medtronic will argue that the
preemption provision in the Medical Device Amendments
(MDA), 21 U.S.C. § 360k(a), completely insulates manufac-
turers from products liability claims; Ms. Lohr will argue
that the MDA preempts no tort claims, at least not those
claims against manufacturers of medical devices subject to
premarket clearance. The proposed amicus brief suggests a
middle position, encouraging the Court to recognize a limited
preemption defense to tort claims. Although not consistent
with either Party’s ideal litigating position, this formulation
would be preferable to their opponent’s extreme alternative.
In addition, the proposed amicus brief addresses some
of the broader implications of the instant case. The Court's
resolution of these petitions will have immediate and
profound repercussions in other products liability litigation.
Respectfully submitted,
Richard N. Pearson’
Lars Noah
University of Florida
College of Law
P.O. Box 117625
Gainesville, FL 32611-7625
(352) 392-2211
March 11, 1996 " Counsel of Record
Nos. 95-754 & 95-886
S0007?03OooSS
IN THE
SUPREME COURT OF THE UNITED STATES
OCTOBER TERM, 1995
MEDTRONIC, INC..,
On Writ of Certiorari to the
United States Court of Appeals
for the Eleventh Circuit
BRIEF FOR TWO PRODUCTS LIABILITY LAW PROFESSORS
AS AMICI CURIAE IN SUPPORT OF NEITHER PARTY
Richard N. Pearson"
Lars Noah
University of Florida
College of Law
P.O. Box 117625
Gainesville, FL 32611-7625
(352) 392-2211
March 11, 1996 ” Counsel of Record
ee —_——_—_—_—eeeee———— eee
I. LOWER COURTS HAVE DEVELOPED
SEVERAL COMPETING CONCEPTIONS
OP PRE HUST oe cee See escceces
B. An Intermediate Version: Preemption as
Displacing State Tort Law Standards
C. The Weak Version: Proof of Compliance
as a Predicate for the Defense ......
Il. PREEMPTION SHOULD BE INTER-
PRETED AS THE GOVERNMENT
STANDARDS DEFENSE ............
CORMAN ccc ccc cece ccccedevece
10
14
17
TABLE OF AUTHORITIES
Cases:
Abbot v. American Cyanamid Co.,
844 F.2d 1108 (4th Cir.),
cert. denied, 488 U.S. 908 (1988) .......
Arkansas-Platte & Gulf Partnership
v. Van Waters & Rogers, Inc.,
959 F.2d 158 (10th Cir.),
vacated, 113 S. Ct. 314 (1992),
reinstated, 981 F.2d 1177 (10th Cir.),
cert. denied, 114 S. Ct. 60 (1993) ......
Atascadero State Hosp. v. Scanlon,
Ge MED We beoseiseccceccs
Bailey v. Johnson,
48 F.3d 965 (6th Cir. 1995) ..........
Bammerlin v. Navistar Int’l Transp. Corp.,
30 F.3d 898 (7th Cir. 1994) ..........
Bieneman v. City of Chicago,
864 F.2d 463 (7th Cir. 1988),
cert. denied, 490 U.S. 1080 (1989) ......
Butcher v. Robertshaw Controls Co..,
Caterpillar Inc. v. Williams,
GES U.S Gees oe Se Fae cw cee 8
Cipollone v. Liggett Group, Inc.,
— fF SS | Perr rrr passim
Cort v. Ash,
GB OB GB Gee VF 8 Sok bee Hews 18
CSX Transp., Inc. v. Easterwood,
5S. Ge. Fee Gee we’ do awed cee. 4
Daily Income Fund, Inc. v. Fox,
658 GE Ge eee ood iS. Ue oe twee 18
Davis v. Brunswick Corp..,
854 F. Supp. 1574 (N.D. Ga. 1994) ..... 11
Deford v. Soo Line R.R..,
867 F.2d 1080 (8th Cir.),
cert. denied, 492 U.S. 927 (1994)....... 8
Eimers v. Honda Motor Co.,
785 F. Supp. 1204 (W.D. Pa. 1992) ..... 12
English v. General Elec. Co..,
GS UB. Te Gees « 4 obs LO 1 8G 4
Ferebee v. Chevron Chem. Co..,
736 F.2d 1529 (D.C. Cir.),
cert. denied, 469 U.S. 1062 (1984) ...... 17
Fogal v. Steinfeld,
620 N.Y.S.2d 875 (Sup. Ct. 1994) ...... 9
Franchise Tax Bd. v. Construction Laborers
Vacation Trust, 463 U.S. 1 (1983) ......
Freightliner Corp. v. Myrick,
Se ee UE cee cc ce ccese
Gile v. Optical Radiation Corp.,
22 F.3d 540 (3d Cir.),
cert. denied, 115 S. Ct. 429 (1994) ......
Ginochio v. Surgikos, Inc.,
864 F. Supp. 948 (N.D. Cal. 1994)......
Gonzales v. Surgidev Corp.,
899 P.2d 576 (N.M. 1995) ...........
Helms v. Sporicidin Int’l,
871 F. Supp. 837 (E.D.N.C. 1994) ......
Hernandez-Gomez v. Leonardo, 884 P.2d 183
(Ariz. 1994), vacated sub nom. ,
Volkswagen of Am., 115 S. Ct. 1819 (1995)
Hodges v. Delta Airlines, Inc. ,
44 F.3d 334 (Sth Cir. 1995) ..........
Hunsaker v. Surgidev Corp.,
818 F. Supp. 744 (M.D. Pa. 1992),
aff'd mem., 5 F.3d 1489 (3d Cir. 1993) ...
Hurley v. Lederle Lab.,
863 F.2d 1173 (Sth Cir. 1988).........
Hurt v. Dow Chem. Co.,
963 F.2d 1142 (8th Cir. 1992) .........
Vv
ICI Americas, Inc. v. Banks,
440 S.E.2d 38 (Ga. App. 1993),
aff'd in part, 450 S.E.2d 671 (Ga. 1994) .. bt
In re "Agent Orange” Prod. Liab. Litig.,
635 F.2d 987 (2d Cir. 1980),
cert. denied, 454 U.S. 1128 (1981) ...... 7
International Longshoremen’s Ass'n v. Davis,
oe ee 9
Jenkins v. James B. Day & Co.,
634 N.E.2d 998 (Ohio 1994) .......... 10
Kemp v. Pfizer, Inc.,
835 F. Supp. 1015 (E.D. Mich. 1993) .... 8, 18
King v. Collagen Corp.,
983 F.2d 1130 (ist Cir.),
cert. denied, 114 S. Ct. 84 (1993) ...... 7
Landgraf v. USI Film Products,
BOS &. Ge, SER GIT. oe eld bed coe 20
Little v. Dow Chem. Co..,
559 N.Y.S.2d 788 (Sup. Ct. 1990) ...... G
Lohr v. Medtronic, Inc.,
56 F.3d 1335 (11th Cir. 1995),
cert. granted, 116 S. Ct. 806 (1996) ..... 4
Lowe v. General Motors Corp.,
624 F.2d 1373 (Sth Cir. 1980) ......... 12
Lowe v. Sporicidin Int'l,
47 F.3d 124 (4th Cir. 1995) .......... 10, 14
Mears v. Marshall,
905 P.2d 1154 (Or. App. 1995) ........ 6
Mendes v. Medtronic, Inc..
18 F.3d 13 (Ist Cir. 1994) ........... 6, 18
Merrell Dow Pharmaceuticals, Inc. v. Thompson,
478 U.S. 804 (1986) .........50006- 7
Metropolitan Life Ins. Co. v. Taylor,
GO UE, See Sew ke He cee 8
Michael v. Shiley, Inc.,
46 F.3d 1316 (3d Cir.),
cert. denied, 116 S. Ct. 67 (1995) ...... 7,8
Miller v. E.1. DuPont de Nemours & Co.,
880 F. Supp. 474 (S.D. Miss. 1994) ..... ie
Ministry of Health v. Shiley, Inc.,
858 F. Supp. 1426 (C.D. Cal. 1994) ..... 11, 21
Montauk-Caribbean Airways, Inc. v. Hope,
784 F.2d 91 (2d Cir.),
cert. denied, 479 U.S. 872 (1986) ....... 7
Moss v. Parks Corp.,
985 F.2d 736 (4th Cir.),
cert. denied, 113 S. Ct. 2999 (1993) ..... 10, 11
Mulhern v. Outboard Marine Corp.,
432 N.W.2d 130 (Wis. App. 1988) ...... 9
vii
i al |
National Bank of Commerce v. Kimberly-Clark
Corp., 38 F.3d 988 (8th Cir. 1994) ...... 11
Papas v. Upjohn Co.,
985 F.2d 516 (11th Cir.),
cert. denied, 114 S. Ct. 300 (1993) ...... 7
Reeves v. AcroMed Corp.,
44 F.3d 300 (Sth Cir.),
cert. denied, 115 S. Ct. 2251 (1995) ..... 6, 8
Reiter v. Zimmer, Inc..,
830 F. Supp. 199 (S.D.N.Y. 1993) ...... 12
Richardson v. Advanced Cardiovascular Sys., Inc.,
865 F. Supp. 1210 (E.D. La. 1994)...... 8
Rinehart v. International Playtex, Inc..,
688 F. Supp. 475 (S.D. Ind. 1988) ...... 12
Ryan v. Brunswick Corp.,
531 N.W.2d 793 (Mich. App. 1995) ..... 9
Sandoz Pharmaceuticals Corp. v. Richardson-Vicks,
Inc., 902 F.2d 222 (3d Cir. 1990). ...... 14
Sheridan v. United States,
969 F.2d 72 (4th Cir. 1992) .......... 12
Shots v. CSX Transp., Inc.,
38 F.3d 304 (7th Cir. 1994) .........., 7
Shumaker v. C.R. Bard, Inc..,
1996 U.S. Dist. LEXIS 822 (D. Mass. 1996) 8
Silkwood v. Kerr-McGee Corp.,
464 U.S. 238 (1984) .............
Slater v. Optical Radiation Corp. ,
961 F.2d 1330 (7th Cir.),
cert. denied, 113 S. Ct. 327 (1992) ....
Stanton v. Astra Pharmaceutical Prods., Inc. ,
718 F.2d 553 (3d Cir. 1983) ........
Stewart v. International Playtex, Inc..,
672 F. Supp. 907 (D.S.C. 1987) .....
St. Louis S.W. Ry. v. Malone Freight Lines,
39 F.3d 864 (8th Cir. 1994),
cert. denied, 115 S. Ct. 1963 (1995) ...
Strong v. Telectronics Pacing Sys., Inc..,
891 F. Supp. 401 (W.D. Mich. 1994) ....
Suter v. Artist M.,
ee ee ee
Swift v. United States,
866 F.2d 507 (Ist Cir. 1989)........
Talbott v. C.R. Bard, Inc.,
865 F. Supp. 37 (D. Mass. 1994),
aff'd, 63 F.3d 25, 29-30 (Ist Cir. 1995) ...
Texas Indus., Inc. v. Radcliff Materials, Inc..,
oe 8 EF ee ee ee
Violette v. Smith & Nephew Dyonics, Inc..,
62 F.3d 8 (ist Cir. 1995) ..........
ix
10
12
10
15
- 18
12
Von Anhalt v. Delta Air Lines, Inc..,
735 F. Supp. 1030 (S.D. Fla. 1990) ..... 11
Weinberger v. Bentex Pharmaceuticals, Inc.,
S12 U.S. GS (9979). Po eee ek 14
Worm v. American Cyanamid Co..,
> F356 PS GR Ce. 0 Fo. ek 10
Statutes and Regulations:
15 U.S.C. § 1334(b) (1994) .. 2.2... 02 LL, 19
21 U.S.C. § 360k(a) (1994) ..... 22.0002. 2
42 U.S.C. §§ 300aa-22(b), 300aa-23(d) ...... 19
Miscellaneous:
James A. Henderson, Jr., Richard N. Pearson &
John A. Siliciano, The Torts Process (4th ed. 1994) l
Lars Noah, Reconceptualizing Federal Preemption of
Tort Claims as the Government Standards Defense,
37 Wm. & Mary L. Rev. 903 (March 1996) ... 1, 18
Lars Noah, Amplification of Federal Preemption
in Medical Device Cases,
49 Food & Drug L.J. 183 (1994) .......... l
Richard N. Pearson, The Florida Medicaid Third-
Party Liability Act, 46 Fla. L. Rev. 609 (1994) . l
Rest. (3d) Torts: Prods. Liab. (1995)........ 10
IN THE
SUPREME COURT OF THE UNITED STATES
OCTOBER TERM, 1995
Nos. 95-754 & 95-886
Petitioner,
BRIEF FOR TWO PRODUCTS LIABILITY LAW PROFESSORS
AS AMICI CURIAE IN SUPPORT OF NEITHER PARTY
INTEREST OF AMICI CURIAE
Amici teach and write in the area of tort law and
products liability,” and are especially interested in the rapidly
accelerating use of federal preemption as a defense.”
Y ‘See, e.g., James A. Henderson, Jr., Richard N. Pearson & John
A. Siliciano, The Torts Process (4th ed. 1994); Richard N. Pearson, The
Florida Medicaid Third-Party Liability Act, 46 Fla. L. Rev. 609 (1994).
¥ See, e.g., Lars Noah, Reconceptualizing Federal Preemption of
Tort Claims as the Government Standards Defense, 37 Wm. & Mary L.
Rev. 903 (March 1996); Lars Noah, Amplification of Federal Preemption
in Medical Device Cases, 49 Food & Drug L.J. 183 (1994).
This case presents an important opportunity to clarify
how courts should apply the preemption provisions that
appear in a variety of federal safety statutes to tort litigation.
The questions presented by the parties broadly ask the Court
to determine whether and to what extent federal law preempts
tort claims against manufacturers of medical devices. Amici
have filed this brief to explain some of the notable difficulties
that lower courts have encountered when addressing the
increasingly popular preemption defense. The Court’s
resolution of the instant petitions will have significant
consequences for numerous products liability cases.
SUMMARY OF ARGUMENT
The courts below correctly recognized some of the
difficulties that attend the application of the preemption
defense. The district court granted summary judgment for
defendant, dismissing all of the plaintiffs’ claims against
Medtronic, Inc., the manufacturer of the allegedly defective
pacemaker implanted in Ms. Lohr. The United States Court
of Appeals for the Eleventh Circuit accepted Medtronic’s
primary argument that the Medical Device Amendments
(MDA) preempted tort claims under Florida state law.
Nonetheless, the court reversed judgment with regard to
plaintiffs’ negligent design and strict liability claims because
it held that the Food and Drug Administration (FDA) had not
imposed any particular design requirements when it cleared
this device for commercial marketing. The Eleventh Circuit,
however, affirmed dismissal of the plaintiffs’ negligent
sd See 21 U.S.C. § 360k(a) (1994).
2
manufacture and failure-to-warn claims, rejecting Ms. Lohr’s
argument that the preemption defense should not apply
insofar as these claims were premised on violations of
applicable federal statutory standards. Pet. App. 13a-14a.
As illustrated by the instant case, there are several still
unresolved questions concerning the proper application of
the preemption defense under the MDA and similar safety
Statutes. Because the scope of federal preemption turns
primarily on matters of statutory construction, the subject
defies simple unitary treatment. Indeed, as applied by the
courts, the preemption defense lacks any single, coherent
meaning. Nonetheless, these statutory provisions pose
important recurring problems. Armici suggest alternatives
to the exaggerated reading of Cipollone that has been adopted
by a number of courts and was suggested by the Eleventh
Circuit in this case. In particular, this Court should clarify
that Cipollone announced a federal common law rule
accepting the "government standards” defense, a defense that
would absolve a company of liability only upon a showing
of compliance with all relevant safety requirements.
ARGUMENT
Federal preemption arguments in tort actions have
proliferated over the last few years. This Court’s decision
in Cipollone v. Liggett Group, Inc.,* triggered a notable
upsurge in the successful use of preemption as a defense to
: 505 U.S. 504 (1992).
products liability lawsuits. During the decade preceding
Cipollone, the Court expressed a marked reluctance to find
preemption of tort claims,* but its decisions from the last
several Terms suggest a significant reversal in this attitude.*
A number of lower courts apparently have viewed Cipollone
and its progeny as a mandate to dismantle the protections of
State tort law, even in extreme situations where a defendant
has not complied with the federal requirements that are being
given preemptive effect. |
Almost four years now have elapsed since Cipollone
was decided. As feared by a number of the Justices in that
case, lower courts have struggled when applying the plural-
ity’s judgment in other contexts. Preemption provisions
appear in statutes regulating, inter alia, medical devices,
pesticides and other hazardous chemicals, and various modes
of transportation. Because these provisions express Congres-
sional intent in different terms, and in some cases are
accompanied by savings clauses of varying breadth, lower
courts have encountered difficulties interpreting the proper
scope of federal preemption. A number of courts have read
Cipollone quite expansively, however, finding preemption of
most or all tort claims, sometimes even where the defendants
have not complied with the applicable federal safety require-
ments.
# See, e.g., English v. General Elec. Co., 496 U.S. 72, 80-86
(1990); Silkwood v. Kerr-McGee Corp., 464 U.S. 238, 251-56 (1984),
¥ See Freightliner Corp. v. Myrick, 115 S. Ct. 1483, 1487-88
(1995); CSX Tramsp., Inc. v. Easterwood, 113 S. Ct. 1732, 1740-43
(1993); Cipollone, SOS U.S. at 524 (plurality).
4
Increasingly, defendants assert federal preemption as a
defense in tort litigation involving, for example, medical
devices and pesticides. This trend represents a departure
from the traditional application of preemption as a barrier
only to conflicting state and local legislation and regulation,
and, more disturbingly, the use of the preemption defense in
tort litigation sometimes immunizes defendants from liability
irrespective of their conduct. Indeed, as argued herein,
lower courts have misinterpreted Cipollone by finding broad
preemption of tort claims under other federal safety statutes
when this Court really had nothing more than the government
standards defense in mind.
I. LOWER COURTS HAVE DEVELOPED SEVERAL
COMPETING CONCEPTIONS OF PREEMPTION.
Although preemption of tort claims under various
Statutory provisions generally has been accepted, at |vast
under some circumstances, important questions remain to be
resolved. One of the most immediate quandaries concerns
the practical consequence of a finding that one or more
claims are preempted in a particular case. For instance,
does preemption mean that failure-to-warn or other tort
claims may never be brought against companies, or instead
may a plaintiff sustain such a claim by introducing evidence
of noncompliance with agency regulations? If the latter is
true, then who bears the burden of proof if noncompliance
is alleged; must the defendant prove compliance as a
predicate for invoking a preemption defense, or does it
become an element of the plaintiff's burden when attempting
to assert a claim in the face of such a defense? More
fundamentally, is such a defense even properly characterized
as one based on “preemption”?
$
The lower courts have offered varying answers to these
questions, suggesting three different conceptions of federal
preemption as applied in the context of tort litigation. As
more fully developed in the following sections, it is possible
to differentiate between a “strong,” “intermediate,” and
"weak" version of the preemption defense based in part on
whether compliance with federal safety standards is relevant
and which party shoulders the burden of proof on that issue.
The choice of one among these competing conceptions of
the preemption defense will have profound consequences for
litigants in future tort cases.
A. The Strong Version: Preemption as
Foreclosing Tort Remedies Altogether.
In the wake of Cipollone, several lower courts have
suggested that preemption would completely cut off common
law claims whenever federal safety requirements apply,
whether or not a particular company has strictly complied
with those requirements. This view is most noticeable in
medical device decisions, including the instant case.”
Under this extreme approach, a plaintiff could not seek
compensatory damages for injuries resulting from a
manufacturer's failure to abide by federal requirements.
Plaintiffs would have no recourse under state tort law, and
v See, e.g., Lohr v. Medtronic, Inc., 56 F.3d 1335, 1343 (11th Cir.
1995), cert. granted, 116 S. Ct. 806 (1996); Talbott v. C.R. Bard, Inc..
63 F.3d 25, 27-30 (1st Cir. 1995), petition for cert. filed, No. 95-1321
(Feb. 16, 1996); Reeves v. AcroMed Corp., 44 F.3d 300, 307 (Sth Cir.),
cert. denied, 115 S. Ct. 2251 (1995); Gile v. Optical Radiation Corp.
22 F.3d S40, 544 (3d Cir.), cert. denied, 115 S. Ct. 429 (1994); Mendes
v. Medtronic, Inc., 18 F.3d 13, 17-19 (ist Cir. 1994); Mears v.
Marshall, 905 P.2d 1154, 1166-67 (Or. App. 1995).
aaadbaudietlaatakcmmnel
* See Merrell Dow Pharmaceuticals, Inc. v. Thompson, 478 U.S.
804, 810 (1986) (assuming without deciding that Congress intended
prohibit private enforcement of the Food, Drug and Cosmetic Act); Bailey
v. Johnson, 48 F.3d 965, 967-68 (6th Cir. 1995); Montauk-Caribbean
Airways, Inc. v. Hope, 784 F.2d 91, 97 (2d Cir.), cert. denied, 479 U.S.
872 (1986); In re “Agent Orange” Prod. Liab. Litig., 635 F.2d 987, 991-
92 n.9 (2d Cir. 1980), cert. denied, 454 U.S. 1128 (1981).
‘gu
* ‘See, ¢.g., Miller v. E.1. DuPont de Nemours & Co., 880 F. Supp.
474, 480(S.D. Miss. 1994); Helms v. Sporicidin Int’!, 871 F. Supp. 837,
839 (E.D.N.C. 1994).
2 See, ¢.g., Michael v. Shiley, Inc., 46 F.3d 1316, 1328-29 (3d
Cir.), cert. denied, 116 S. Ct. 67 (1995); Shots v. CSX Transp., Inc.,
38 F.3d 304, 308 (7th Cir. 1994); King v. Collagen Corp., 983 F.2d
1130, 1139-40 (1st Cir.) (Aldrich, J., concurring), cert. denied, 114 S.
Ct. 84 (1993); Papas v. Upjohn Co., 985 F.2d 516, 519 (11th Cir.) (per
curiam), cert. denied, 114 S$. Ct. 300 (1993).
7
defense, in part because otherwise such allegations would
become routine and difficult to resolve.”
The strong conception of the defense resembles so-
called “complete” preemption, a doctrine that has developed
under the federal labor statutes. Complete preemption means
that the displacement of state law by federal statute is such
that a defendant could remove an action from state court
under federal question jurisdiction, creating an exception to
the well-pleaded complaint rule that would otherwise ignore
federal issues raised defensively.” Although the existence
of a parallel federal remedy originally was regarded as a
prerequisite for complete preemption of a state law claim,
such substitution apparently is no longer necessary to support
removal.” Courts initially rejected arguments that federal
safety statutes establish complete preemption, but several
now have granted removal petitions on such a theory.
“See Talbott, 63 F.3d at 29-30; Michael, 46 F.3d at 1329, Reeves,
44 F.3d at 307; Kemp v. Pfizer, Inc., 835 F. Supp. 1015, 1021-22
(E.D. Mich. 1993); ICI Americas, Inc. v. Banks, 440 $.E.2d 38, 42-
43 (Ga. App. 1993), aff'd in relevant part, 450 $.E.2d 671 (Ga. 1994).
2 See, é.g., Metropolitan Life Ins. Co. v. Taylor, 481 U.S. 58, 63-
67 (1987); Franchise Tax Bd. v. Construction Laborers Vacation Trust,
463 U.S. 1, 24-28 (1983).
@ See, ¢.g., Caterpillar Inc. v. Williams, 482 U.S. 386, 391 n.4
(1987); Deford v. Soo Line R.R., 867 F.2d 1080, 1086 (8th Cir.), cert.
denied, 492 U.S. 927 (1994).
* See, ¢.g., Shumaker v. C.R. Bard, Inc., 1996 U.S. Dist. LEXIS
822, at “6-9 (D. Mass. Jan. 3, 1996); Richardson v. Advanced
Cardiovascular Sys., Inc., 865 F. Supp. 1210, 1213-16 (E.D. La. 1994);
Strong v. Telectronics Pacing Sys., Inc., 891 F. Supp. 401. 402-03
(W.D. Mich. 1994). But see Hurt v. Dow Chem. Co., 963 F.2d 1142,
1144-45 (8th Cir. 1992)
Similarly, according to some courts, preemption
deprives them of subject matter jurisdiction over all tort
actions within the preempted domain, apparently in the sense
that a federal agency has been given exclusive jurisdiction
over the matter.” This is similar to the effect of preemption
claims to the NLRB, federal preemption strips state courts
of their subject matter jurisdiction to hear claims of this
sort.“ This Court has emphasized, however, that its
decision to vest exclusive jurisdiction in the NLRB “does not
apply to pre-emption claims generally but only to those
preemption claims that go to the State’s actual adjudicatory
or regulatory power as opposed to the State’s substantive
laws." Nonetheless, some state courts have accorded a
comparable effect to preemption provisions in federal safety
Statutes, treating these provisions as divesting them of
jurisdiction over tort claims against products or activities that
are subject to federal regulation.”
Of course, even if not properly regarded as an objection
to jurisdiction or a basis for removal, the strong version of
@ See, ¢.g., Talbott v. C.R. Bard, Inc., 865 F. Supp. 37, 40 (D.
Mass. 1994), aff'd, 63 F.3d 25, 29-30 (ist Cir. 1995).
— See \nternational Longshoremen’s Ass'n v. Davis, 476 U.S. 380,
391 (1986).
2 id. wa 391 2.9.
& See, e.g., Ryan v. Brunswick Corp., 531 N.W.2d 793, 796 (Mich.
App. 1995); Fogal v. Steinfeld, 620 N.Y .S.2d 875, 880 (Sup. Ct. 1994);
Little v. Dow Chem. Co., 559 N.Y.S.2d 788, 790 (Sup. Ct. 1990);
Mulhern v. Outboard Marine Corp., 432 N.W.2d 130, 134 (Wis. App.
1988).
preemption would support a defendant’s motion to dismiss
for failure to state a claim, and no set of proffered evidence
or amended allegations could save any claims that fall within
the preempted domain. Thus, the strong version of the
preemption defense effectively forecloses tort remedies
altogether.
B. An Intermediate Version: Preemption as
Displacing State Tort Law Standards.
Under a less extreme view, federal preemption of tort
claims would not completely cut off actions for damages, at
least not in the event of noncompliance with federal
standards.” For example, several courts in earlier medical
device cases explained that only the substantive duties
imposed under state law are preempted.” Under this view,
preemption does not foreclose the availability of compen-
satory damages for personal injuries or other common law
remedies, but it does mean that federal regulatory standards
will trump tort law standards such as the general duty of
care under negligence. Plaintiffs would not be able to invite
judges and juries to second-guess, under the guise of
@ See, ¢.g., Lowe v. Sporicidin Int'l, 47 F.3d 124, 130 (4th Cir.
1995); Worm v. American Cyanamid Co., 5 F.3d 744, 748 (4th Cir.
1993); Moss v. Parks Corp., 985 F.2d 736, 740 (4th Cir.), cert. denied,
113 S. Ct. 2999 (1993); Jenkins v. James B. Day & Co., 634 N.E.2d
998, 1003-05 (Ohio 1994).
@ See, ¢.g., Slater v. Optical Radiation Corp., 961 F.2d 1330, 1334
(7th Cir.), cert. denied, 113 S. Ct. 327 (1992); Hunsaker v. Surgidev
Corp., 818 F. Supp. 744, 751 (M.D. Pa. 1992), aff'd mem., 5 F.3d
1489 (3d Cir. 1993); Stewart v. International Playtex, Inc., 672 F. Supp.
907, 910 (D.S.C. 1987); see also Res:. (3d) Torts: Prods. Liab. § 7,
cmt. e (1995), at 198.
10
applying a manufacturer's common law duty of care, an
agency’s safety and utility determinations for products whose
design and labeling the agency has either dictated by
regulation or individually reviewed and approved.
Because many of the preemption provisions prohibit
only “different” state requirements, courts reason that claims
premised on noncompliance with the federal standard would
not impose a different obligation under state tort law.” The
possibility that a company may be liable for violation of
federal standards has provided courts with one way of
reconciling statutory savings clauses (which preserve existing
rights or remedies at common law) with express preemption
provisions.“ The intermediate version of preemption may,
therefore, be understood as nothing more than a choice-of-
law principle, directing courts to select federal rather than
state standards when resolving tort claims.”
Plaintiffs would be able to recover under state law for
injuries in the event that a manufacturer violated the
conditions contained in any applicable product license or
w See, ¢.g., National Bank of Commerce v. Kimberly-Clark Corp..,
38 F.3d 988, 993 (8th Cir. 1994); Moss, 985 F.2d at 740-41; Ministry
of Health v. Shiley, Inc., 858 F. Supp. 1426, 1439 (C.D. Cal. 1994).
2 See, e.g., Bieneman v. City of Chicago, 864 F.2d 463, 471 (7th
Cir. 1988), cert. denied, 490 U.S. 1080 (1989); Davis v. Brunswick
Corp., 854 F. Supp. 1574, 1581 (N.D. Ga. 1994); Von Anhalt v. Delta
Air Lines, Inc., 735 F. Supp. 1030, 1031 (S.D. Fla. 1990).
® See Violette v. Smith & Nephew Dyonics, Inc., 62 F.3d 8, 10-
12 (ist Cir. 1995); Gonzales v. Surgidev Corp., 899 P.2d 576, 582-83
(N.M. 1995). Although a failure to state a claim objection may be made
as late as the trial on the merits, preemption understood merely as a
regulation.“ Indeed, in many jurisdictions, violations of
federal requirements constitute negligence per se, though
not all jurisdictions recognize this rule. Under the inter-
mediate version of preemption being described here, courts
essentially would allow only such negligence per se claims
to go forward. Similarly, a fraud-on-the-agency claim might
escape federal preemption, assuming it is otherwise available
under state law.”
Preemption would not, however, depend on proof of
compliance with federal standards; instead, a defendant may
be found liable only in the event (and only to the extent)
that the plaintiff can demonstrate noncompliance with those
standards. After all, the argument continues, preemption of
positive state enactments does not vary depending on each
manufacturer’s proof of compliance with federal rules.
“See Reiter v. Zimmer, Inc., 830 F. Supp. 199, 204 (S.D.N.Y.
1993); Rinehart v. International Playtex, Inc., 688 F. Supp. 475, 477-
78 (S.D. Ind. 1988).
See, e.g., Stanton v. Astra Pharmaceutical Prods., Inc., 718 F.2d
553, 565 (3d Cir. 1983); Lowe v. General Motors Corp., 624 F.2d
1373, 1380 (Sth Cir. 1980).
See, e.g., Sheridan v. United States, 969 F.2d 72, 75 (4th Cir.
1992); Swift v. United States, 866 F.2d 507, 508-09 (1st Cir. 1989);
Eimers v. Honda Motor Co., 785 F. Supp. 1204, 1208 (W.D. Pa. 1992).
al See Cipollone, 505 U.S. at 528 (1992) (plurality) (noting that the
preemption provision would not foreclose recovery on a fraud claim
alleging a failure “to disclose material facts about smoking and health to
an administrative agency” if state law created a duty to disclose such
information); id. at 555 (per Scalia, J.) (conceding that "the hypothetical
law requiring disclosure to a state regulatory agency would seem to
survive” even a sweeping interpretation of the preemption provision).
Since the other Justices would have found no claims preempted, id. at
543 (per Blackmun, J.), the Court was unanimous in this regard.
12
Instead, plaintiffs attempting to sustain claims affected by
this type of preemption would have to prove any alleged
failures to comply with federal requirements. Thus, rather
than supporting either an objection to subject matter
jurisdiction or a removal petition, preemption in these cases
would be regarded as grounds for either a motion for
summary judgment or a motion to dismiss for failure to state
a claim if plaintiffs have not alleged any failure to comply.
With the proliferation of more or less detailed (and
often ambiguous) regulatory requirements, compliance may
be difficult to gauge. Questions of compliance with the
statutory labeling requirements for cigarettes can be resolved
with relative ease, but efforts to determine whether a medical
device manufacturer has fully complied with the requirements
found in a premarket approval and any generally applicable
FDA regulations could present serious difficulties. The
matter would, of course, be simpiified greatly if an agency
successfully had prosecuted the defendant for a regulatory
infraction. Although less clearly probative of noncom-
pliance, formal citations alleging a violation also may
support a negligence per se claim. At the other extreme, a
plaintiff may argue that the defendant has failed to comply
with an applicable regulation notwithstanding the agency’s
apparent acquiescence. In some situations, courts should
@ See, e.g., Talbott v. C.R. Bard, Inc., 865 F. Supp. 37, 47 (D.
Mass. 1994) (noting, however, that some ambiguity remained over the
precise infractions to which the manufacturer had pled guilty), aff'd, 63
F.3d 25 (ist Cir. 1995), petition for cert. filed, No. 95-1321 (Feb. 16,
1996).
13
ee
experience little difficulty resolving such questions, but often
the inquiry will be quite complicated.”
Because of such difficulties, courts generally recognize
that agencies should exercise primary jurisdiction over
regulatory matters within their special expertise.“ Indeed,
this is one of the premises underlying the strong version of
preemption discussed in the previous section. Short of
avoiding the compliance issue altogether through complete
preemption, however, courts might differentiate between
situations where a regulatory infraction is apparent, as when
the agency undertakes enforcement action, and other cases
where plaintiff has only alleged some failure to comply with
an ambiguous requirement. In any case, under the
intermediate version of the preemption defense, claims
premised on noncompliance would provide plaintiffs with
their sole avenue for relief.
C. The Weak Version: Proof of Compliance
as a Predicate for the Defense.
Under the weakest version of preemption suggested by
courts in the wake of Cipollone, defendants would shoulder
the burden of proving compliance as a predicate for
2 See, e.g., Lowe v. Sporicidin Int’l, 47 F.3d 124, 130 (4th Cir.
1995); Bammerlin v. Navistar Int’l Transp. Corp., 30 F.3d 898, 900
(7th Cir. 1994); Sandoz Pharmaceuticals Corp. v. Richardson-Vicks,
Inc., 902 F.2d 222, 231 (3d Cir. 1990).
2 See, e.g., Weinberger v. Bentex Pharmaceuticals, Inc., 412 U.S.
645, 654 (1973).
14
successfully invoking the preemption defense.“ This
conception of preemption differs from the intermediate
version described in the previous section, which only
forecloses recovery on tort claims premised on state law
duties other than the duty to comply with any applicable
federal safety standards. Thus, rather than serving either as
a subject matter jurisdiction objection or as grounds for
dismissal (or summary judgment) for failure to state a claim,
preemption would constitute an affirmative defense.
Because the weak version is poorly elaborated in the
reported cases, though perhaps Cipollone itself is an
example, one must summarize it by comparison to the other
conceptions of the preemption defense described previously.
If compliance is undisputed, the outcome will be indistin-
guishable from the result under the other two versions
identified above. Under both the strong and intermediate
versions, the preemption defense is not dependent on proof
of compliance. Courts abiding by the intermediate version
recognize negligence per se claims, but there would be no
colorable basis for pursuing such claims in the event that
compliance is undisputed. Similarly, even if the weak
version of the defense is predicated on proof of compliance,
a defendant would escape potential tort liability where there
is no dispute that it complied with the applicable federal
requirements.
In the event of a dispute over compliance, however,
the weak version differs from the intermediate version by
placing the burden of proof on the defendant. Because the
intermediate version of preemption does not make the
defense hinge on compliance but only preserves negligence
Ww sSee, e.g., St. Louis S.W. Ry. v. Malone Freight Lines, 39 F.3d
864, 867 (8th Cir. 1994), cert. denied, 115 S. Ct. 1963 (1995).
15
per se claims, plaintiffs would have to carry the frequently
difficult burden of establishing noncompliance if they hope
to recover damages for their injuries, and even then recovery
may be unavailable if a particular jurisdiction does not
recognize negligence per se claims for violations of federal
standards as a matter of state law.
Under the weak version, by contrast, preemption does
not even come into play until the defendant has proven
compliance with federal requirements. In light of the
potential complexities posed by questions of compliance, this
difference in the allocation of the burden may be quite
important. Although the plaintiff still shoulders the burden
of proof on the underlying tort claims, the defendant’s failure
to carry the burden with regard to questions of compliance
would entirely remove federal preemption from the case (and
perhaps invite a negligence per se claim by the plaintiff).
Furthermore, under the weak version of preemption, even
if the defendant establishes compliance, plaintiffs may be
able to rebut that showing by alleging some relevant fraud
on the agency.
Finally, if noncompliance is fairly apparent, the weak
version may differ from the intermediate version in the sense
that the federal safety standards completely drop out of sight
even if the defendant’s noncompliance is only partial. For
example, the failure to abide strictly by the FDA’s labeling
requirements in a premarket approval may expose the device
manufacturer to both failure-to-warn and design defect claims
even if there is no evidence that the medical device deviated
from design specifications in the product license. Under the
© See, e.g., Hurley v. Lederle Lab., 863 F.2d 1173, 1179-80 (Sth
Cir. 1988); Butcher v. Robertshaw Controls Co., 550 F. Supp. 692,
694-703 (D. Md. 1981).
16
intermediate version, by contrast, plaintiffs could pursue only
a negligence per se failure-to-warn claim under these
circumstances. Second, under the weak version, the defen-
dant’s conduct may be judged against a more stringent
standard of care in the event of noncompliance, so that even
trivial deviations from federal requirements may be regarded
as sufficiently extreme departures from the state law standard
of eae a care to support the imposition of punitive
damages.
Il. PREEMPTION SHOULD BE INTERPRETED AS
THE GOVERNMENT STANDARDS DEFENSE.
In the face of such confusion over the proper applica-
tion of statutory preemption provisions in tort litigation, one
might favor the simplicity of a clear statement rule,
demanding that Congress specifically enumerate tort claims
as preempted before displacing common law remedies.~
Because the plurality’s judgment in Cipollone has been fully
embraced by the Court, however, a clear statement rule
seems unrealistic at this juncture. Alternatively, courts
might reconsider implied private rights of action under
federal statutes that they have now given sweeping preemp-
* _sG&. Silkwood v. Kerr-McGee Corp., 464 U.S. 238, 243-44, 258
(1984) (even where violations of federal regulations were at most
inconsequential, jury could award punitive damages absent preemption).
* See Hernandez-Gomez v. Leonardo, 884 P.2d 183, 190 (Ariz.
1994), vacated sub nom. Volkswagen of Am., Inc. v. Hernandez-Gomez,
115 S. Ct. 1819 (1995) (remanded for further consideration in light of
Freightliner); Ferebee v. Chevron Chem. Co., 736 F.2d 1529, 1543
(D.C. Cir.), cert. denied, 469 U.S. 1062 (1984); of. Atascadero State
Hosp. v. Scanlon, 473 U.S. 234, 242 (1985).
17
es
tive effect.~ In a sense, this approach would attempt to fix
one arguable error in construing congressional intent--
namely, the recent tendency to find express preemption of
tort claims notwithstanding congressional silence--with what
might well be a second error.™ Instead, by understanding
preemption of tort claims as the government standards
defense, the Court could make sense of Cipollone without
giving it the extreme effect suggested by the strong version
of preemption.”
Although traditionally compliance with federal safety
standards has not protected companies from tort liability,
under the strong version of preemption companies are now
immunized from liability even if they have violated these
standards. Surely this is a remarkable turn of events.
Instead, courts should view preemption provisions as nothing
more than a decision by Congress to give companies a
defense to state tort liability if they have complied with
federal safety standards. Of the three different conceptions
of preemption that have emerged, Cipollone only supports
the weak version. Although denoted “preemption,” this
# ‘See, e.g., Suter v. Artist M., 112 S. Ct. 1360, 1370 & n.16
(1992); Daily Income Fund, Inc. v. Fox, 464 U.S. 523, 536 (1984);
Texas Indus. , Inc. v. Radcliff Materials, Inc., 451 U.S. 630, 639 (1981);
Cort v. Ash, 422 U.S. 66, 78 (1975).
See, ¢.g., Mendes v. Medtronic, Inc., 18 F.3d 13, 19 n.4 (ist
Cir. 1994); Gile v. Optical Radiation Corp., 22 F.3d 540, 544 (3d Cir.),
cert. denied, 115 S. Ct. 429 (1994); Ginochio v. Surgikos, Inc., 864 F.
Supp. 948, 956-57 (N.D. Cal. 1994); Kemp v. Pfizer, Inc., 835 F.
Supp. 1015, 1022 & n.5 (E.D. Mich. 1993).
ae For a more detailed treatment of these and other arguments
appearing herein, see Lars Noah, Reconceptualizing Federal Preemption
of Tort Claims as the Government Standards Defense, 37 Wm. & Mary
L. Rev. 903 (March 1996).
18
version of preemption more closely resembles the govern-
ment standards or approval defense.
Several aspects of Cipollone undergird the weak version
of preemption. First, the statutory provision at issue in the
case made compliance a predicate for invoking the defense.
This element of the preemption provision has received little
or no attention, however, in part because the tobacco
companies have conscientiously used the mandatory warning
Statements in their labeling. The statutory provision is
entitled “Preemption,” but, by demanding compliance as a
prerequisite for preemptior the cigarette labeling law more
closely resembles other federal statutes adopting a govern-
ment approval defense.” Second, because the statute itself
specifies the text of these statements, compliance should be
relatively simple to determine. Presumably, in the event of
noncompliance, a plaintiff alleging injuries from cigarettes
would be free to pursue failure-to-warn and related tort
claims on theories other than noncompliance with the federal
labeling requirement. Arguably, this weak version is not
really preemption at all.
Cipollone certainly cannot support the strong version of
preemption, in part because of the plurality’s distinction
between pre- and post-1969 failure-to-warn claims. If the
1969 amendments were understood as completely preempting
failure-to-warn claims, then the provision would foreclose
# = See 15 U.S.C. § 1334(b) (1994) (preempting the imposition of
requirements or prohibitions under state law with respect to cigarettes
“labeled in conformity with the provisions of this Act”).
” For example, the National Childhood Vaccine Injury Act provides
a compliance defense against failure-to-warn and manufacturing defect
claims. See 42 U.S.C. §§ 300aa-22(b), 300aa-23(d) (West Supp. 1995).
19
ee tio
any tort actions founded on such claims that are brought after
1969, whether or not some of the defendant’s alleged
negligence pre-dated enactment of the statute.“ Instead, of
course, the Cipollone plurality distinguished between claims
grounded on conduct occurring before and after passage of
the preemption provision. Finally, by differentiating among
numerous tort claims and only finding preemption of a
limited class that was based on a failure to warn, the
plurality’s decision in Cipollone left a number of alternative
grounds for recovery available to plaintiffs, so the practical
result of preemption was not particularly harsh in that case. |
Although preemption provisions in the MDA and other
Statutes are broader than that applicable to cigarettes, it is
not clear that Cipollone really dictates the recognition of
more sweeping preemption defenses in those cases. None
of the other statutes include a similar compliance prere-
quisite in the text of the preemption provision, and com-
pliance with requirements imposed under those statutes is
also harder to determine, but these are reasons for narrow-
ing or distinguishing Cipollone rather than unthinkingly
giving it even greater effect in other contexts. In particular,
the absence of substitute remedies should incline courts
against finding preemption of tort law claims unless
congressional intent to foreclose such claims is unmistak-
* Although retroactive application of statutes generally is disfavored,
see Landgraf v. USI Film Products, 114 S. Ct. 1483, 1496-1504 (1994),
complete preemption (operating as a jurisdictional rule, id. at 1501-02)
would foreclose any claims filed after enactment even if premised on
conduct pre-dating the statute. See, ¢.g., Arkansas-Platte & Gulf
Partnership v. Van Waters & Rogers, Inc., 959 F.2d 158, 160-61 (10th
Cir.) (holding that FIFRA preempted failure-to-warn claims even though
defendant's allegedly negligent conduct entirely pre-dated enactment of
the preemption provision), vacated, 113 S. Ct. 314 (1992), reinstated,
981 F.2d 1177, 1178 (10th Cir.), cert. denied, 114 S. Cr. 6 (1993).
20
able. Interpreting preemption provisions as establishing a
government standards defense would promote the goal of
federal uniformity without foreclosing common law remedies
where federal safety standards have been violated.
In a sense, the Court would be recognizing a federal
common law defense against state tort claims when a product
or activity is subject to regulation under a federal statute
that contains a preemption provision. The Court recognized
an analogous defense against products liability claims for
government contractors supplying military equipment. Like
the weak version of preemption, a contractor first would
have to identify the government requirements that trigger the
defense, then demonstrate compliance with those specifica-
tions, and finally not be guilty of fraud or misrepresentation
in its dealings with the government.“ The case for recog-
nizing a government standards defense for compliance with
certain federal safety requirements is even stronger than for
the contractor defense because the Court can interpret the
express preemption provisions in the relevant statutes as
more directly justifying the recognition of such a defense as
a matter of federal common law. Although the develop-
ment of federal common law rules generally is reserved for
extraordinary circumstances, such interstitial lawmaking is
preferable to the tortured feats of statutory construction
© See, e.g., Hodges v. Delta Airlines, Inc., 44 F.3d 334, 338 & n.8
(Sth Cir. 1995) (en banc); Abbot v. American Cyanamid Co., 844 F.2d
1108, 1112 (4th Cir.), cert. denied, 488 U.S. 908 (1988); Ministry of
Health v. Shiley, Inc., 858 F. Supp. 1426, 1440 (C.D. Cal. 1994). Of
course, the plurality in Cipollone and the majority in Easterwood did not
construe the respective statutes so narrowly, but then only the weaker
versions of preemption discussed above seem appropriate.
2 Boyle v. United Technologies Corp., 487 U.S. 500, 512 (1988).
21
engaged in when lower courts find sweeping express
preemption of tort claims.
The theoretical difference between interpreting such
provisions as dictating preemption of tort claims or as
authorizing courts to fashion a government standards defense
may be inconsequential. Even so, courts could decide that
a provision preempting state law demonstrates a sufficiently
strong interest in uniformity (but not exclusivity) to support
application of the government standards defense against tort
claims. Whether the defense recognized in Cipollone is
styled as preemption or government standards, however, this
Court should more clearly articulate the prerequisites for
invocation of the defense. The three-part government
contractor defense suggests one useful formulation that could
be readily adapted to this end.
To be sure, significant controversy surrounds the use
of the government standards defense. Several justifications
are offered in support of its recognition. For instance,
allowing recovery of tort damages notwithstanding conscien-
tious adherence to carefully crafted safety standards is both
inefficient and unfair, and lay jurors are not qualified to
second-guess the safety determinations made by federal
regulators. Proponents also argue that the traditional
assumptions underlying the hesitancy to accept a govern-
ment standards defense are open to serious question in light
of the radical changes in the regulatory state. The relative
strength of these arguments may well vary across different
product categories.
Conversely, critics make a number of cogent arguments
against the recognition of such a defense to liability. For
example, the tort system has the virtue of encouraging
product manufacturers to discover and address health and
22
safety risks before they result in serious injuries, whereas
regulators generally can react only after such injuries
come to light. Opponents of the defense also express little
ption provisions is far better than the stronger versions of
preemption that have been adopted by a number of courts.
Furthermore, by deciding that preemption translates into the
government standards defense when raised in the context of
tort litigation, the Court could decouple the defense and
arguments about its desirability from the conceptually
different issue of federal preemption of positive state enact-
ments.
Cipollone was decided under the rubric of federal
preemption. Perhaps this was an unfortunate choice of
terminology by Congress because it has caused great
mischief in other contexts. Before 1992, the Court did not
accept preemption as a defense to tort liability, at least not
unless the statute provided a substitute remedy or otherwise
granted exclusive jurisdiction to a federal agency. The
plurality’s judgment in Cipollone, as refined in a pair of
subsequent decisions by this Court, signalled a new
willingness to accept preemption as a defense to tort claims.
A number of lower courts have read Cipollone and its
progeny as an invitation to cut off plaintiffs’ access to tort
23
remedies, even in extreme situations where a company has
not complied with the federal requirements that are being
given preemptive effect. This strong version of preemption
represents the least defensible reading of Cipollone. The
intermediate version, which does not preempt claims if they
are premised on violations of federal requirements, is
somewhat more sensible but arguably still more protective
than Cipollone demands (for instance, where negligence per
se claims are not available under state law). Instead, the
weak version of preemption, which is really indistinguishable
from the government standards defense, is more in keeping
with what the Court actually decided in that case. Under
this approach, proof of compliance is a predicate for
invoking this affirmative defense, and evidence of fraud on
the responsible agency could defeat it.
CONCLUSION
For the foregoing reasons, amici urge this Court to
clarify, in the course of resolving the instant petitions, the
limited nature of the preemption defense to tort claims.
Respectfully submitted,
Richard N. Pearson’
Lars Noah
University of Florida
College of Law
P.O. Box 117625
Gainesville, FL 32611-7625
(352) 392-2211
* Counsel of Record
March 11, 1996
This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.