# Amicus Curiae Brief — Warner-Lambert Co. v. Kent

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URL: https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385016_0541%3A20

## Record

- **Collection:** Supreme Court brief
- **Document type:** Amicus Curiae Brief
- **Published:** January 1, 2008
- **Citation:** 552 U.S. 440

## Text

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@ NOV 28 2597
ZEPY _ No. 06-1498 Shoes Count Ue

IN THE

Supreme Court of the United States

WARNER-LAMBERT COMPANY LLC and PFIZER INC.,

Petitioners,
Vv.

KIMBERLY KENT, ET AL.,

Respondents.

On Writ of Certiorari to the
United States Court of Appeals
for the Second Circuit

BRIEF OF WASHINGTON LEGAL FOUNDATION
AS AMICUS CURIAE IN SUPPORT OF PETITIONERS

Daniel J. Popeo Eric G. Lasker

Richard A. Samp Counsel of Record
Washington Legal Foundation James M. Sullivan

2009 Massachusetts Ave. N.W. Spriggs & Hollingsworth
Washington, DC 20036 1350 I Street N.W.

(202) 588-0302 Washington, DC 20005

(202) 898-5800

Dated: November 28, 2007

WiILSON-EPES PRINTING Co., INC. — (202) 789-0096 — WASHINGTON, D. C. 20002

TABLE OF CONTENTS

Page

TABLE OF CITED AUTHORITIES ................ ili

INTEREST OF AMICUS CURIAE ............0.045: l
INTRODUCTION AND SUMMARY

ET ei eee cidteduseecescedseecnnees 2

TT (pict cchinh de penindaereeeey aieeees 3

I. THE FEDERAL PRESENCE IN’ THE
REGULATION AND APPROVAL OF
PRESCRIPTION DRUGS IS FAR MORE
SIGNIFICANT THAN THE FEDERAL
PRESENCE THAT LED THIS COURT TO
REJECT THE PRESUMPTION AGAINST
PREEMPTION IN BUCKMAN ................ 3

Il. THERE IS NO PRESUMPTION AGAINST
PREEMPTION WHERE A STATE LAW CLAIM
INTRUDES UPON A FEDERAL AGENCY’S
PRIMARY JURISDICTION ................. 10

Il. THERE IS NO PRESUMPTION AGAINST
IMPLIED CONFLICT PREEMPTION ......... 14

DET Whdeckes ben eesenstcaceusseeses 21

TABLE OF CITED AUTHORITIES

Page(s)

Cases:
Bates v. Dow AgroSciences LLC,

tek euieeseues sesso 1, 16, 17
Brown v. Hotel and Restaurant Employees and

Bartenders INT’L Union Local 54,

EEE eves ceancsencces 10, 11, 15, 20
Buckman Co. v. Plaintiffs’ Legal Comm. ,

EE wind cbecneeenscecescces passim
California v. ARC America Corp.,

CE 15
Chicago & Northwest Transp. Co. v. Kalo Brick

ee ES A ) ) re 20
CIBA Corp. v. Weinberger,

cies teed eseeseeecees 14
Cipollone v. Liggett Group, Inc.,

Need h say éah eee ees 15, 16
Conference of State Bank Supervisors v. Conover,

po 17
Crosby v. Nat'l Foreign Relations Trade Council,

EE 15
DeCanas v. Bica,

EE Se 15
Engine Mfrs. Ass'n v. S. Coast Air Quality

Mgmt. Dist., 541 U.S. 246 (2004) ................. 3
Far Eastern Conference v. United States,

ee 11
Fidelity Fed. Sav. and Loan Ass'n v. de la Cuesta,

i bo KMS oben 6c deca sa 15, 16

Florida Lime & Avocado Growers, Inc. v. Paul,
A Se 16

1V

Page(s)

Free v. Bland,

6 hsb os abs 40600-00802 66 15
Gade v. Nat’l Solid Wastes Mgmt. Ass'n,

rks dct wh nes eeseu awed 15
Geier v. Am. Honda Motor Co.,

PPE ED occ cece cccccsess 1, 8, 16, 17, 20
Gibbons v. Ogden,

yeh SS) | Crake a hae ae eee pera eae 14
Heckler v. Chaney,

es eed aeddeetedee dees 12
Hines v. Davidowitz,

ee ee teh eéséke bees eaceuen 16
Int'l Paper Co. v. Ouellette,

in coh 806) dak eeeeees 20
Irving v. Mazda Motor Co.,

136 F.3d 764 (11th Cir.),

cert. denied, 525 U.S. 1018 (1998) ............... 16
Kanter v. Warner Lambert Co.,

SP OEE POE occ ceccccscncccvence 3
Medtronic v. Lohr,

i ch cee cecus bee seccciecs 5, 8,17
Merck KGAA v. Integra Lifesciences I, Ltd.,

ee eet ets ehh sebccs vsesee 13
Penn. Employees Benefit Trust Fund v. Zeneca

Inc., 499 F.3d 239 (3d Cir. 2007) ................. 8
Rice v. Santa Fe Elevator Corp.,

EE 15
Rutherford v. United States,

S06 F.2d 1455 (10th Cir. 1966) ........... 000000, 14
Sandoz Pharms. Corp. v. Richardson-Vicks, Inc.,

SU PEI BED occ cccccccccccescess 13

Schering Corp. v. Heckler,
FO ee is We SUED ccc ccc cc ccecccecees 12

Page(s)
Sprietsma v. Mercury Marine,
8 re 16, 17
Tutoki v. Celebrezze,
oo eT EB PP 14
United States v. Locke,
i esas od bese nse dene Ree 1,4
Weinberger v. Bentex Pharms., Inc.,
>. 8 rer rere 13
Constitutional Provisions:
Re a 8S ae 17, 20
Statutes:
Food and Drug Administration Modernization Act
of 1997, S. Rep. 105-43, 1997 WL 394244 .......... 6
Food, Drug, and Cosmetic Act (FDCA),
Oe EL, 6.66 ct ceesenvvceeeeuns passim
Se EE 60-6. 66 esnnn450nee dee eu 6
ee ED i646: tin'n wn anes dknue ee 7
MICH. COMP. LAWS § 600.2946(5) .............. 12, 13

MICH. ComP. LAWS § 600.2946(5)(a) ............... 4

Page(s)
Regulations:
WO GPE BOIDS «oo... cccccccccccccccccecccccccs 7
EE Ee 7
sk reece enedsebsceeeees 7
Be es GREED occ ccccvcccccccccccces 7
rds dbedecececteseteonteees 6
ie veccevededececedbeutieseoes 6
i cer ides cee eens beesecceenéeues 7
21 CFR. § 314.81(b)(3) 2.0. ccc ccc eee eee 7
Ey 7
ees ee kee eeneteenceets 7
SEEN EA are 7
eee ieec ie thaneoecetiees 7
Other Authorities:
71 Fed. Reg. 3922 (Jan. 24, 2006) .................. 9
TT cates bande We ond cseveedceecs 18, 20

Page(s)
J.A. DiMasi, et al., The Price of Innovation:
New Estimates of Drug Development Costs,
22 J. Health Economics 151-85 (2003) ............. 6
The Records of the Federal Convention of 1787,
(M. Farrand ed., rev. ed. 1937) ............... 18, 19

Trends in FDA Drug Enforcement 2006: An Expert
Analysis of the Latest Warning Letters,
(FDAnews Management Report 2006) ............. 8

INTEREST OF AMICUS CURIAE

The Washington Legal Foundation (“WLF”) is a non-
profit, public-interest law and policy center based in
Washington, D.C., with supporters in all 50 states.’ WLF
devotes a substantial portion of its resources to defending free
enterprise principles, individual rights, a limited and
accountable government, and the proper use of our state and
federal judicial systems. To that end, WLF has frequently
appeared as amicus curiae in this and other federal courts in
cases involving preemption issues, to point out the economic
inefficiencies often created when multiple layers of
government seek simultaneously to regulate the same business
activity. See, e.g., Bates v. Dow Agrosciences LLC, 544 U.S.
431 (2005); Buckman Co. v. Plaintiffs’ Legal Comm. , 531 U.S.
341 (2001) Geier v. Am. Honda Motor Co., 529 U.S. 861
(2000); United States v. Locke, 529 U.S. 89 (2000).

WLIF is particularly concerned that individual freedom
and the American economy both suffer when state law,
including state tort law, imposes upon industry an unnecessary
layer of regulation that frustrates the objectives or operation of
specific federal regulatory regimes, such as the Federal Food,
Drug, and Cosmetic Act (FDCA) at issue here.

WLF has no direct interest, financial or otherwise, in the
outcome of this case. It is filing due solely to its interest in the
important preemption issues raised by this case.

' WLKF hereby affirms that no counsel for either party authored
any part of this brief, and that no person or entity other than amicus
curiae and its counsel provided financial support for the preparation and
submission of this brief. By blanket letters of consent, all parties have
consented to the filing of this brief.

2

INTRODUCTION AND SUMMARY OF ARGUMENT

In Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S.
341 (2001), this Court unanimously held that plaintiffs’ claims
that a medical device manufacturer secured FDA approval for
a § 510{k) medical device through fraud on the FDA were
impliedly preempted because such claims “inevitably conflict
with the FDA’s responsibility to police fraud consistently with
the Administration’s judgments and objectives.” Jd. at 350.
In so ruling, this Court rejected plaintiffs’ assertion that it
should apply a presumption against preemption to such claims,
explaining that “[pJolicing fraud against federal agencies is
hardly ‘a field which the States have traditionally occupied’”
and noting that “the relationship between a federal agency and
the entity it regulates is inherently federal in character because
the relationship originates from, is governed by, and terminates
according to federal law.” Jd. at 347.

Just six years after its clear ruling in Buckman, this Court
is again faced with the issue of whether fraud-on-the-FDA
claims are preempted. In its ruling below, the Second Circuit
rejected the core holding of Buckman and held that fraud-on-
the-FDA claims asserted by plaintiffs to meet the exception to
Michigan’s product liability statute are not preempted. The
Second Circuit reached this contrary result based in large part
on its holding that it should apply the very same presumption
against preemption this Court rejected. See Pet. App. 18a-19a.

WLIF files this amicus brief because the Second Circuit’s

confusion over the proper scope of a presumption against
preemption highlights the need for further guidance on the

3

issue by this Court.? While the claims here should be held
preempted even if a presumption applied, the arguments
contrary to a presumption against preemption here are in fact
far stronger than they were in Buckman, because the degree of
federal involvement in the approval of prescription drugs
dwarfs that at issue in the approval of § 510(k) medical
devices. More fundamentally, however, a presumption against
preemption is completely inapplicable here because plaintiffs’
fraud-on-the-FDA claims (1) intrude upon regulatory
determinations within the primary jurisdiction of FDA and (2)
conflict directly with federal law. WLF respectfully requests
that the Court clarify that no anti-preemption presumption can
be applied in such circumstances.

ARGUMENT

I. THE FEDERAL PRESENCE IN THE
REGULATION AND APPROVAL OF
PRESCRIPTION DRUGS IS FAR MORE
SIGNIFICANT THAN THE FEDERAL PRESENCE
THAT LED THIS COURT TO REJECT THE
PRESUMPTION AGAINST PREEMPTION IN
BUCKMAN

In applying a presumption against preemption, the
Second Circuit failed to recognize the longstanding, extensive
role that the federal government plays in the approval of the
safety and efficacy of prescription drugs. “[A]Jn ‘assumption’
of nonpre-emption is not triggered when the State regulates in

? As the Court has recently noted, the proper application of a
“presumption against preemption” is an issue “on which not all
Members of this Court agree.” Engine Mfrs. Ass'n v. S. Coast Air
Quality Mgmt. Dist., 541 U.S. 246, 256 (2004).

4

an area where there has been a history of significant federal
presence.” United States v. Locke, 529 U.S. 89, 108 (2000).

In rejecting any presumption against preemption in
Buckman, this Court focused on the federal interest in
maintaining control over the FDA regulatory process by which
medical device applicants secure approval for Section 510(k)
medical devices. As the Court explained, “the § 510(k)
process sets forth a comprehensive scheme for determining
whether an applicant has demonstrated that a product is
substantially equivalent to a predicate device.” Buckman, 531
U.S. at 348. Accordingly, the Court concluded that policing
fraud against the FDA in the Section 510(k) process “is
inherently federal in character because the relationship
originates from, is governed by, and terminates according to
federal law.” Jd. at 347.’

For prescription drug manufacturers pursuing a new drug
application (NDA), far more even than for manufacturers of
Section 510(k) devices, the manufacturers’ “dealings with the
FDA [a]re prompted by the [FDCA], and the very subject of
[the applicants’] statements [are] dictated by that statute’s
provisions.” /d. at 347-48. This Court recognized in Buckman
that the Section 510(k) process “lacks the . . . rigor” of FDA’s
premarket approval (PMA) review of Class III medical
devices, id. at 348, a process modeled after and substantially

> Like the fraud-on-the-FDA claims at issue in Buckman, under
the Michigan statutes, plaintiffs seeking to bring claims against a
prescription drug manufacturer must establish that the manufacturer
“[ijntentionally withholds from or misrepresents to the [FDA]
information concerning the drug that is required to be submitted under
the [FDCA]” and “the drug would not have been approved, or the
[FDA] would have withdrawn approval for the drug if the information
were accurately submitted.” Mich. Comp. Laws § 600.2946(5)(a),
reprinted at Pet. App. 42a.

5

identical to FDA’s NDA process for prescription drugs.* As
the Court previously had noted in Medtronic, Inc. v. Lohr:

The § 510(k) notification process is by no means
comparable to the PMA process; in contrast to the 1,200
hours necessary to complete a PMA review, the § 510(k)
review is completed in an average of only 20 hours. . . .
As one commentator noted: “The attraction of
substantial equivalence to manufacturers is clear.
Section 510(k) notification requires little information,
rarely elicits negative response from the FDA, and gets
processed very quickly.

518 U.S. 470, 478-79 (1996) (citations omitted).

Nevertheless, the Buckman Court rejected a presumption
against preemption because “to achieve its limited purpose, the
§ 510(k) process imposes upon applicants a variety of
requirements that are designed to enable the FDA to make its
statutorily required judgment as to whether the device qualifies
under this exception.” 531 U.S. at 348-49.

The requirements imposed by FDA on manufacturers of
prescription drugs and the corresponding scope of the federal
presence mandating the inapplicability of a presumption
against preemption here are far more detailed and substantial.
Like PMA-approved Class III medical devices, prescription
drugs are subject to perhaps the most extensive federal
regulatory scheme governing any consumer product. As the

* See Kanter v. Warner-Lambert Co., 99 Cal. App. 4th 780, 794
(2002) (“The substantial similarity between the premarket approval
process {for medical devices} and new drug application processes
compels the conclusion that the latter also establishes a federal
requirement with respect to labeling that can have preemptive effect.”).

6

United States Congress recognized a decade ago, the NDA
process is rigorous; new drug applications “typically run to
hundreds of thousands of pages,” and the process of securing
NDA approval for a prescription drug “takes an average of 15
years and costs in the range of $5(0 million.” Food and Drug
Administration Modernization Act of 1997, S. Rep. 105-43,
available at 1997 WL 394244, at *6. These costs have only
increased since. See Joseph A. DiMasi et al., The Price of
Innovation: New Estimates of Drug Development Costs, 22 J.
Health Economics 151-85 (2003) (calculating that total R&D
costs per new drug brought to market in the United States have
now reached $802 million).

A drug manufacturer seeking approval to market a
prescription drug is subject to specific FDA regulatory
determinations at every stage of the pre-approval development,
approval, labeling, marketing, and post-marketing approval
process. To obtain FDA approval of a prescription drug, a
pharmaceutical company must submit voluminous scientific
evidence to the agency in accordance with the statutory
requirements set forth in Section 355 of the Federal Food,
Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301 et seq.

Pursuant to a broad grant of regulatory authority under
the Act, FDA has enacted detailed regulatory reporting
requirements for New Drug Applications addressing, inter
alia, the format and organization of the application,
pharmacologic and toxicologic studies, clinical investigation
data, case reports forms, patent information, and marketing-
exclusivity issues. See 21 C.F.R. § 314.50. Once a drug has
received FDA approval, FDA continues to subject drug
manufacturers to extensive regulatory requirements mandating
frequent submissions of adverse drug experience reports, see
21 C.F.R. § 314.80, and regular submissions of new studies
and other information relevant to the continued approval of the

7

drug, see 21 C.F.R. § 314.81. FDA may also require Phase IV
post-marketing studies to gather additional information
regarding the drug’s safety, efficacy, or optimal use. See 21
U.S.C. § 356b. FDA retains continuing regulatory control
over the content and format of drug labels. See 21 C.F.R.
§ 201.57; see also 21 C.F.R. Part 201. FDA’s postmarketing
authority has been enhanced further through the recent
enactment of the Food and Drug Administration Amendments
Act of 2007, Pub. L. No. 110-85, §§ 901-21, 121 Stat. 823
(2007).

FDA also imposes strict regulatory requirements on drug
manufacturers in their direct communications with physicians.
See 21 C.F.R. § 200.5 (“mailing of important information
about drugs”); § 201.57 and Part 201 (labeling); Part 202
(“Prescription Drug Advertising”); Part 203 (“Prescription
Drug Marketing”). In seeking to market a drug to physicians,
pharmaceutical companies also are required to “submit
specimens of mailing pieces and any other labeling or
advertising devised for promotion of the drug product at the
time of initial dissemination of tHe labeling and at the time of
initial publication of the advertivement for a prescription drug
product.” 21 C.F.R. § 314.81(b)(3). If the company fails to
submit such information to the FDA, the agency “may
withdraw approval of the application and, thus, prohibit
continued marketing of the drug product.” Jd. § 314.81(d).

FDA comprehensively regulates the content and format
of prescription drug advertising, including requiring that the
advertisement “present a ‘true statement’ of information in
brief summary relating to side effects, contraindications, and
effectiveness,” id. § 202.1(e)(5), and _ prohibiting
advertisements that — as defined in detail in the regulations —
are or may be “false, lacking in fair balance, or otherwise
misleading,” id. § 202.1(e)(6) & (7). The FDA vigorously

monitors Grug company communications with the medical
community and takes regulatory action where it deems such
action is appropriate.° See also Penn. Employees Benefit Trust
Fund v. Zeneca Inc., 499 F.3d 239 (3d Cir. 2007) (holding
consumer fraud claims against prescription drug manufacturers
impliedly preempted); id. at 250 (Supreme Court opinions in
“Medtronic and Geier add to the preemption analysis by
suggesting that state laws are preempted when they frustrate
regulations that have been promulgated following a specific
inquiry into a particular area of agency authority”).

The federal presence here is also stronger than that in
Buckman because the federal government’s role in the
approval of prescription drugs substantially predates its role in
the regulation of medical devices. In discussing the competing
state and federal interests in the safety of Section 510(k)
medical devices in Lohr, this Court noted that “[dJespite the
prominence of the States in matters of public health and safety,
in recent decades the Federal Government has played an
increasing role in the protection of the health of our people.”
Lohr, 518 U.S. at 475. The Court explained, however, that the
FDA had not been authorized to regulate the approval of
medical devices until the enactment of the Medical Device
Amendments of 1976, some twenty years before. Jd. at 475-
76. In sharp contrast, FDA began regulating the approval of
prescription drugs with the enactment of the Food and Drug
Act of 1906. The federal government has thus played a central
role in ensuring the safety of prescription drugs for over one
hundred years.

* For example, in 2005, FDA issued 102 drug warning letters to
drug manufacturers in connection with promotional activity. See
Trends in FDA Drug Enforcement 2006: An Expert Analysis of the
Latest Warning Letters (FDAnews Management Report 2006).

9

The federal interest in maintaining control over the
relationship between FDA and prescription drug manufacturers
in the NDA process is substantial and would be significantly
impeded if courts could misuse a presumption against
preemption to allow fraud-on-the-FDA claims under the
Michigan statute. The substantial nature of the federal interest
in the disclosures to FDA as part of the regulation of
prescription drugs was clearly explained in January 2006,
when the FDA promulgated a Final Rule on labeling for
prescription drugs. Requirements on Content and Format of
Labeling for Human Prescription Drug and Biological
Products, 71 Fed. Reg. 3922 (Jan. 24, 2006).

In the preamble to this Final Rule, FDA warned that in
recent years, state law “product liability lawsuits have directly
threatened the [FDA’s] ability to regulate manufacturer
dissemination of risk information for prescription drugs in
accordance with the [FDCA].” Jd. at 3934. FDA explained
that “[s]tate law actions can rely on and propagate
interpretations of the [FDCA] and FDA regulations that
conflict with the agency’s own interpretations and frustrate the
agency’s implementation of its statutory mandate.” Jd. FDA
thus stressed that “[i]f State authorities, including judges and
juries applying State law, were permitted to reach conclusions
about the safety and effectiveness information disseminated
with respect to drugs for which FDA has already made a series
of regulatory determinations based on its considerable
institutional expertise and comprehensive statutory authority,
the federal system for regulation would be disrupted.” Jd. at
3969.

It cannot be disputed that “there has been a history of
significant federal presence” in the regulation and approval of
prescription drugs, a federal presence far more significant than
that which led this Court to reject a presumption against

10

preemption in Buckman. Whereas the Buckman Court
confronted the adverse consequences of fraud-on-the-FDA
claims only in the context of a limited Section 510(k) review,
in this case, the Court is faced with claims that would interfere
with scores if not hundreds of different FDA submission
requirements that are routinely imposed on drug manufacturers
during each stage of the multi-year NDA process and during”
FDA’s subsequent oversight of approved drugs. The Second
Circuit’s reliance on a presumption against preemption below
was in error, and this Court should so hold.

Il. THERE IS NO PRESUMPTION AGAINST
PREEMPTION WHERE A STATE LAW CLAIM
INTRUDES UPON A FEDERAL AGENCY’S
PRIMARY JURISDICTION

The Second Circuit’s reliance on a presumption against
preemption is also in error because it fails to account for the
fact that the questions that must be resolved under the
Michigan statute fraud on the FDA exception would require a
court to intrude upon the primary jurisdiction of FDA. A
presumption against preemption is not appropriate where it
would undercut the discretion and expertise entrusted by
Congress to the federal agencies, which this Court has
consistently protected. See, e.g., Buckman, 531 U.S. at 347-53
(no presumption against preemption given FDA’s primary
responsibility to police fraud against the Agency); Brown v.
Hotel & Rest. Employees & Bartenders Int'l Union Local 54,
468 U.S. 491, 502 (1984) (NLRB’s primary jurisdiction
protected by special “presumption [in favor] of federal
preemption [that] applies even when the state law regulates

11

conduct only arguably protected by federal law.”);° Far East
Conference v. United States, 342 U.S. 570, 574-75 (1952)
(action should be dismissed to afford agency with primary
jurisdiction opportunity to review in first instance).

The Court explained the need to not lightly intrude on a
federal agency’s primary jurisdiction over fifty years ago:

[I]n cases raising issues of fact not within the
conventional experience of judges or cases requiring the
exercise of administrative discretion, agencies created by
Congress for regulating the subject matter should not be
passed over. This is so even though the facts after they
have been appraised by specialized competence serve as
a premise for legal consequences to be judicially defined.
Uniformity and consistency in the regulation of business
entrusted to a particular agency are secured, and the
limited functions of review by the judiciary are more
rationally exercised, by preliminary resort for
ascertaining and interpreting the circumstances
underlying legal issues to agencies that are better
equipped than courts by specialization, by insight gained
through experience, and by more flexible procedure.

Far East Conference, 342 U.S. at 574-75.

Each of the two showings necessary to invoke the fraud
on the FDA exception in the Michigan products liability
statute requires a factfinder under state law to intrude upon
FDA’s primary jurisdiction:

* While Brown addressed a special preemption doctrine applicable
to matters within the primary jurisdiction of NLRB, the principles
behind the Court’s rejection there of any presumption against
preemption are equally applicable here.

12

First, the factfinder is required to determine that the drug
manufacturer has intentionally withheld from or
misrepresented information to the FDA concerning its drug
that is required to be submitted under the FDCA. See MICH.
ComP. LAWS § 600.2946(5), reprinted at Pet. App. 42a. But
as this Court recognized in Buckman, “the federal statutory
scheme amply empowers the FDA to punish and deter fraud
against the Administration, and . . . this authority is used by
the Administration to achieve a somewhat delicate balance of
statutory objectives” that “can be skewed by allowing fraud-
on-the-FDA claims under state tort law.” 531 U.S. at 348; see
also id. at 349 (“The FDA thus has at its disposal a variety of
enforcement options that allow it to make a measured response
to suspected fraud upon the Administration.”). Thus, for
example, this Court has held that courts may not review FDA
determinations whether to take enforcement action with regard
to prescription drugs. See Heckler v. Chaney, 470 U.S. 821
(1985). The Court explained that “an agency decision not to
enforce often involves a complicated balancing of a number of
factors which are peculiarly within its expertise” and that
“[t]he agency is far better equipped than the courts to deal with
the many variables involved in the proper ordering of its
priorities.” Jd. at 831-32; see also Schering Corp. v. Heckler,
779 F.2d 683, 685-86 (D.C. Cir. 1985) (decision by FDA
whether to exercise its enforcement authority “involve a
complex balancing of an agency’s priorities, informed by
judgments ‘peculiarly within its expertise,’ and they are
therefore ill-suited for judicial review”) (internal citation
omitted).

The unavoidable intrusion upon FDA’s primary
jurisdiction required for purposes of determining whether FDA
has been defrauded is particularly significant because of the
complexity of FDA regulations regarding the information that
should be provided to FDA by drug companies and FDA’s

13

discretion in many instances in determining whether or not
certain types of information should be submitted. Thus, “it
will not always be clear to parties setting out to seek FDA
approval for their new product exactly which kinds of
information, and in what quantities, it will take to win that
agency’s approval.” Merck KGaA v. Integra Lifesciences I,
Lid., 545 U.S. 193, 207 (2005); cf Sandoz Pharms. Corp. v.
Richardson-Vicks, Inc., 902 F.2d 222, 231 (3d Cir. 1990)
(“agency decisions are frequently of a discretionary nature or
frequently require expertise,” resulting in “administrative
agencies’ responsibility for interpreting and enforcing
potentially ambiguous regulations”).

Second, under Michigan’s fraud on the FDA exception,
the factfinder must determine that the drug would not have
been approved or would have had its approval withdrawn if
the information had been accurately submitted. See MICH.
ComP. LAWS § 600.2946(5), reprinted at Pet. App. 42a. This
Court has recognized FDA’s primary jurisdiction over the
NDA approval of prescription drugs. See Weinberger v.
Bentex Pharms., Inc., 412 U.S. 645, 654 (1973). “The
determination whether a drug is generally recognized as safe
and effective . . . necessarily implicates complex chemical and
pharmacoiogical considerations. Threshold questions within
the peculiar expertise of an administrative agency are.
appropriately routed to the administrative agency, while the
court stays its hand.” Jd.

Under the Michigan statute, plaintiffs must establish that
“the drug would not have been approved, or the [FDA] would
have withdrawn approval for the drug if the information were
accurately submitted.” MICH. COMP. LAWS § 600.2946(5),
reprinted at Pet. App. 42a. Thus, “an essential element of
proof... would be a showing that if the FDA had passed upon
[a prescription drug] according to statutory and constitutional

14

standards, it would have been approved or exempted.” Tutoki
v. Celebrezze, 375 F.2d 105, 107 (7th Cir. 1967). As the
United States Court of Appeals for the Seventh Circuit has
explained, “[t]his determination is a matter within the primary
jurisdiction of the FDA. /d. “The possible conflict of a
judicial determination of this question with a[n] ... FDA
determination on [the drug] strengthens our view that the
doctrine of primary jurisdiction should be applied.” Jd.; cf.
Rutherford v. United States, 806 F.2d 1455, 1461 (10th Cir.
1986) (“[T]he intent behind the [FDCA] was to give the
agency the primary jurisdiction to determine evidentiary
matters concerning drugs about which it has a special
expertise. See also CIBA Corp. v. Weinberger, 412 U.S. 640,
643-44 (1973).”).

By failing to recognize FDA’s primary jurisdiction over
both steps in the Michigan statute’s fraud on the FDA
exception, the Second Circuit erroneously hinged its opinion
on a presumption against preemption. No such presumption
applies here.

Ill. THERE IS NO PRESUMPTION AGAINST
IMPLIED CONFLICT PREEMPTION

Thirdly, the Second Circuit erred in relying on a
presumption against preemption because such presumption, if
ever appropriate, is not appropriate in cases giving rise to
implied conflict preemption. Rather, the sole question for the
courts in determining whether implied conflict preemption
applies is the existence of a conflict between federal and state
law.

The Court repeatedly has made clear that “‘[t}he relative
importance to the State of its own law is not material when
there is a conflict with a valid federal law, for the Framers of

15

our Constitution provided that the federal law must prevail.’”
Fidelity Fed. Sav. and Loan Ass'n v. de la Cuesta, 458 U.S.
141, 153 (1982) (principle that “state law is nullified to the
extent that it actually conflicts with federal law” is “not
inapplicable here simply because real property law is a matter
of special concern to the States”); Brown, 468 U.S. at 502-03
(same with respect to local interest in crime control). Indeed,
even where the State has a “compelling interest” in
preservation of its law, “under the Supremacy Clause, for
which our preemption doctrine is derived, any state law, . . .
clearly within a State’s acknowledged power, which interferes
with or is contrary to federal law, must yield.” Gade v. Nat'l
Solid Wastes Mgmt. Ass'n, 505 U.S. 88, 108 (1992) (internal
quotations and citations omitted); DeCanas v. Bica, 424 U.S.
351, 357 (1976) (“[E]}ven state regulation designed to protect
vital state interests must give way to paramount federal
legislation.”); Free v. Bland, 369 U.S. 663, 666 (1962)(same)
(citing Gibbons v. Ogden, 22 U.S. 1 (1824)).’

? Counsel has found no case in which the Court has relied on a
presumption against preemption in the face of an actual conflict
between state and federal law. In California v. ARC Am. Corp., 490
U.S. 93, 101-06 (1989), the Court suggested a presumption against
preemption, but any such presumption played no ascertainable part in
the Court's holding. See id. (mentioning presumption as something to
“overcome,” but finding no federal-state conflict for the presumption
to overcome); see also Crosby v. Nat'l Foreign Trade Council, 530 U.S.
363, 374 n.8 (2000) (deferring on question whether presumption against
preemption applies in context of implied conflict preemption). This
Court has, by contrast, applied a presumption against preemption in
cases involving express preemption, e.g., Cipollone v. Liggett Group,
Inc., 505 U.S. 504, 517-18 (1992), or field preemption, e.g., Rice v.
Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947). However, even in
preemption” has not been consistently applied and is not free from
controversy. It has been ignored in many recent express preemption

(continued...)

16

Such a federal-state conflict arises when “compliance
with both federal and state regulations is a physical
impossibility,” Fla. Lime & Avocado Growers, Inc. v. Paul,
373 U.S. 132, 142-43 (1963), or when state law “stands as an
obstacle to the accomplishment and execution of the full
purposes and objectives of Congress,” Hines v. Davidowitz,
312 U.S. 52, 67 (1941). E.g., de la Cuesta, 458 U.S. at 153.
“[Bjoth forms of conflicting state law are ‘nullified’ by the
Supremacy Clause, and [this Court] has assumed that Congress
would not want either kind of conflict.” Geier v. Am. Honda
Motor Co., 529 U.S. 861, 873 (2000) (internal citations
omitted). Thus, once a federal-state conflict is established,
preemption is “inescapable and requiv@s no inquiry into
congressional design.” Fla. Lime, 373 U.S. at 142-43; see also
Geier, 529 U.S. at 869 (“ordinary pre-emption principles . . .
instruct us to read statutes as pre-empting state laws (including
common-law rules) that ‘actually conflict’ with the statute or
federal standards promulgated thereunder’’).

As both the D.C. Circuit and Eleventh Circuit have
recognized, this Court’s teaching cannot coexist with a
presumption against preemption in implied conflict preemption
cases. See Irving v. Mazda Motor Co., 136 F.3d 764, 769
(11th Cir. 1998) (“When considering implied preemption, no

’(...continued)

cases, e.g., Sprietsma v. Mercury Marine, 537 U.S. 51, 63 (2002)
(relying on “natural{] read[ing]” of express preemption clause without
any mention of presumption), and squarely rejected as a guide to
interpreting express preemption clauses by at least two Members of this
Court, e.g., Cipollone, 505 U.S. at 544 (Scalia, J., joined by Thomas, J.,
concurring in the judgment in part and dissenting in part) (“Under the
Supremacy Clause, . . . our job is to interpret Congress’s decrees of pre-
emption neither narrowly nor broadly but in accordance with their
apparent meaning.”); Bates v. Dow Agrosciences LLC, 544 U.S. 431,
457 (2005) (opinion of Thomas, J.) (same).

17

presumption exists against preemption.”), cert. denied, 525
U.S. 1018 (1998); Conference of State Bank Supervisors v.
Conover, 710 F.2d 878, 882 (D.C. Cir. 1983) (“the
‘presumption [against preemption]’ inquiry is not relevant
here, for the only question before us is whether admittedly
conflicting regulations are valid”).*

Indeed, the Framers left no doubt that there can be no
presumption against preemption of conflicting state law, and
that federal law is supreme without need for a showing of a
Congressional preemptive intent, by placing that statement of
intent within the text of the Supremacy Clause. See US.
Const., art. VI, cl. 2 (“{T]he laws of the United Siates . . . shall
be the supreme Law of the Land . . . any Thing in the

* A close review of this Court’s recent preemption jurisprudence
in cases involving state tort law claims demonstrates that it is the
existence or non-existence of a conflict — rather than any presumption
— that has informed the Court’s rulings. See Bates, 544 U.S. 431 (2005)
(no express preemption of state tort law claims alleging inefficacy of
pesticide because EPA does not evaluate pesticide efficacy nor approve
pesticide labeling in that regard, but holding that fraud and failure-to-
warn claims might be preempted to the extent based on requirements
inconsistent with EPA regulation); Sprietsma, 537 U.S. 51 (2002) (no
implied preemption where federal coast guard had not taken position on
whether propeller guards should be required on motor boats); Buckman,
531 U.S. 341 (2001) (fraud-on-the-FDA claims impliedly preempted in
light of conflict with FDA regulatory authority); Geier, 529 U.S. 861
(2000) (state tort law claims for failure to install airbags impliedly
preempted due to conflict with federal law despite savings clause in
National Traffic and Motor Vehicle Act precluding finding of express
preemption); Lohr, 518 U.S. 470 (1996) (rejecting express preemption
of state tort law claims involving Section 510(k) medical device
because the generality of FDA requirements in approving such devices
did not provide basis for state-federal law conflict); see also id. at 504
(Breyer, J., in controlling concurrence, explaining that preemption
would be necessary if conflict existed).

18

Constitution or Laws of any State to the Contrary
notwithstanding.”) (emphasis added). During the
Constitutional Convention, the delegates specifically debated
whether the source of federal law supremacy should be an
affirmative assertion by Congress — i.e. some statement as
might be needed to rebut a presumption against preemption —
or the fundamental hierarchy between federal and state laws.
They decided on the latter and charged the courts to declare
conflicting state laws void without awaiting any statement of
preemptive intent by Congress. See id.; see also The
Federalist No. 78 (Alexander Hamilton) (“The interpretation
of the laws is the proper and peculiar province of the courts. .

[T]n regard to the interfering acts of a superior and
subordinate authority, . . . . it will be the duty of the judicial
tribunals to adhere to [the supreme law].”).

The Framers’ rejection of any presumption against
contlict preemption is made evident by the history behind the
drafting of the Supremacy Clause. Early in the Convention,
Governor Edmund Randolph proposed fifteen resolutions,
primarily drafted by James Madison, which became known as
the Virginia Plan. The sixth resolution dealt generally with the
affirmative powers of Congress — the functional equivalent
under the Virginia Plan of the Constitution’s Article I, Section
8. I The Records of the Federal Convention of 1787, at 21 (M.
Farrand ed., rev. ed. 1937). Among the powers allocated to
Congress under this resolution was the authority “to negative
all laws passed by the several States, contravening in the
opinion of the National Legislature the articles of Union.” See
id. In other words, under this proposal, Congress would be
required to declare whether conflicting state law would be

preempted.

In response to the Virginia Plan, William Patterson,
proposed nine alternative resolutions which became known as

19

the New Jersey Plan or the Small State Plan. The sixth of
Patterson’s resolutions was in substance and concept, if not in
form, similar to the current language of the Supremacy Clause.
See id. at 245. Patterson’s sixth resolution differed from
Randolph’s power to negative state laws in that the former was
not proposed as one of Congress’s affirmative powers. All
such powers under the Small State Plan were proposed in
Patterson’s second resolution. See.id. at 243. The supremacy
concept was instead offered as a separate resolution, distinct
from legislative powers and listed after the fifth resolution
establishing the federal judiciary. See id. at 244. That is, the
courts — not Congress — would determine whether there was a
preemptive conflict between federal and state law.

Resolution of the competing proposals came when the
Convention debated the report of the Committee of the whole
House. As he had done throughout the debates, see id. at 169
(June 8, 1787), 317 (June 19, 1787), James Madison warned
against the “propensity of the States to pursue their particular
interests in opposition to the general interest” and advocated
“the negative on the laws of the States as essential to the
efficacy & security of the Gen]. Govt,” 2 The Records of the
Federal Constitutional Convention of 1787, at 27 (M. Farrand
ed., rev. ed. 1937). Roger Sherman responded, “Such a power
involves a wrong principle, to wit, that a law of a State
contrary to the articles of the Union, would if not negatived, be
valid & operative.” Jd. Randolph’s proposal for a legislative
power to negative state laws was thereafter defeated by a vote
of three to seven. See id.

The Convention then immediately adopted by unanimous
consent an alternative proposal by Luther Martin which is in
substance similar to Patterson’s sixth resolution and in form
almost identical to the current Supremacy Clause. See id. at
28-29. Consistent with the structure of Patterson’s plan, the

20

adopted text that became the Supremacy Clause does not
mention any affirmative authority of Congress to repeal state
law, but rather made federal law supreme over conflicting state
law in all instances. See U.S. Const., art. VI, cl. 2; see also
The Federalist No. 78.

Conflict preemption cases thus represent the
paradigmatic operation of the Supremacy Clause to resolve
conflicts between state and federal law. In declining to find
preemption “[u]ntil and unless Congress states explicitly that
it intends invalidation of state common law claims,” Pet. App.
24a, the Second Circuit below contravened the fundamental
constitutional principles underlying implied conflict
preemption and departed from this Court’s unambiguous
teaching. See Geier, 529 U.S. at 884-85 (“[C]onflict pre-
emption . . . turns on the identification of ‘actual conflict,’ and
not on an express statement of preemptive intent. ... [T]he
Court has never before required a specific, formal agency [or
congressional} statement identifying conflict in order to
conclude that such a conflict in fact exists.”); Int'l Paper Co.
v. Ouellette, 479 U.S. 481 (1987) (“[I]t is not necessary for a
federal statute to provide explicitly that particular state laws
are pre-empted.”); Brown, 468 U.S. at 501 (“[e]ven in the
absence of such express language or implied congressional
intent to occupy the field, we may nevertheless find state law
to be displaced to the extent that it actually conflicts with
federal law”); Chicago & N.W. Transp. Co. v. Kalo Brick &
Tile Co., 450 U.S. 311, 317 (1981) (“[W]hen Congress has
chosen to legislate pursuant to its constitutional powers, then
a court must find local law pre-empted by federal regulation
whenever the ‘challenged state statute “stands as an obstacle
to the accomplishment and execution of the full purposes and
objectives of Congress.”””’) (citations omitted).

21

The Second Circuit’s application of a presumption
against preemption to avoid implied conflict preemption of
Respondent’s fraud-on-the-FDA claims was in error. No such
presumption exists against implied conflict preemption.

CONCLUSION

The Second Circuit’s rejection of this Court’s holding in
Buckman based on a misplaced “presumption against
preemption” highlights the need for further guidance from this
Court on the proper scope, if any, of such a presumption. For
the reasons set forth herein, WLF respecifully requests that this
Court make clear that no such presumption can be applied in
cases involving drug manufacturer regulatory submissions in
the approval and regulation of prescription drugs due to the
long-standing significant federal presence in that area. WLF
also requests that this Court confirm that no presumption
against preemption exists in cases intruding upon a federal
agency’s primary jurisdiction or in cases of implied conflict
preemption.

Respectfully submitted,
Daniel J. Popeo Eric G. Lasker
Richard A. Samp Counsel of Record

Washington Legal Foundation James M. Sullivan

2009 Massachusetts Ave. NW Spriggs & Hollingsworth

Washington, D.C. 20036 1350 I Street NW

(202) 588-0302 Washington, D.C. 20005
(202) 898-5800

November 28, 2007

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385016_0541%3A20. Public record. Not legal advice.