Colacicco v. Apotex Inc

Opinions of the United
2008 Decisions States Court of Appeals
for the Third Circuit
4-8-2008
Colacicco v. Apotex Inc
Precedential or Non-Precedential: Precedential
Docket No. 06-3107
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PRECEDENTIAL
UNITED STATES COURT OF APPEALS
FOR THE THIRD CIRCUIT
No. 06-3107
JOSEPH C. COLACICCO,
INDIVIDUALLY AND AS EXECUTOR OF THE ESTATE
OF LOIS ANN COLACICCO, DECEASED,
Appellant
v.
APOTEX INC.; APOTEX CORP., AS SUBSIDIARY OF
APOTEX, INC.; SMITHKLINE BEECHAM,
d/b/a GLAXOSMITHKLINE
No. 06-5148
BETH ANN MCNELLIS,
ON BEHALF OF THE ESTATE OF
THEODORE DEANGELIS,
DECEASED AND IN HER OWN RIGHT
v.
PFIZER INC.; JOHN DOES 1-5; ABC DOE CORP.;
DEF DOE CORP.; GHI DOE CORP.
PFIZER INC.,
Appellant
No. 06-3107
On Appeal from the United States District Court
for the Eastern District of Pennsylvania
(D.C. No. 05-cv-05500)
District Judge: Honorable Michael M. Baylson
No. 06-5148
On Appeal from the United States District Court
for the District of New Jersey
(D.C. No. 05-cv-01286)
District Judge: Honorable Jerome B. Simandle
Argued December 10, 2007
Before: SLOVITER, AMBRO, Circuit Judges, and RESTANI* ,
Judge
(Filed April 8, 2008 )
_____
Harris L. Pogust
Derek T. Braslow (Argued)
T. Matthew Leckman
Pogust & Braslow
Conshohocken, PA l9428
Attorneys for Appellant, No. 06-3107
M. Karen Thompson
Norris, McLaughlin & Marcus
Sommerville, NJ 08876
Malcolm E. Wheeler (Argued)
Wheeler, Trigg & Kennedy
Denver, CO 80202
Attorneys for Appellant, No. 06-5148
*
Hon. Jane A. Restani, Chief Judge, United States Court of
International Trade, sitting by designation.
2
Charles A. Fitzpatrick, III
Arthur B. Keppel (Argued)
Rawle & Henderson
Philadelphia, PA l9l07
Attorneys for Appellee Apotex Corp., Apotex Corp.
as Subsidiary of Apotex, No. 06-3107
Chilton D. Varner (Argued)
Andrew T. Bayman
Erica M. Long
S. Samuel Griffin
King & Spalding
Atlanta, GA 30309
Joseph E. O’Neil
Lavin, O’Neil, Ricci, Cedrone & DiSipio
Philadelphia, PA l9l06
Attorneys for Appellee Smithkline Beecham, d/b/a
Glaxosmithkline, No. 06-3107
Gregory S. Spizer
Sol H. Weiss (Argued)
Anapol, Schwartz, Weiss, Cohan, Feldman & Smalley
Philadelphia, PA l9l03
Attorneys for Appellee Beth Ann McNellis, No. 06-5148
Allison Zieve
Public Citizen Litigation Group
Washington, DC 20009
Attorney for Amicus-Appellants Public Citizens
Litigation Group, Trial Lawyers for Public Justice and
Association of Trial Lawyers of America, No. 06-3107
Shanin Specter
David J. Caputo
Charles L. Becker (Argued)
3
Kline & Specter
Philadelphia, PA l9l02
Attorneys for Amicus-Appellant Pennsylvania Trial
Lawyers Association, No. 06-3107
Frederick S. Longer
Arnold Levin
Matthew C. Gaughan
Levin, Fishbein, Sedran & Berman
Philadelphia, PA l9l06
Attorneys for Amicus-Appellants Michael H. Alderman,
Jerry Avorn, Lisa Bero, Elizabeth A. Boyd, Adriane
Fugh-Berman, and Curt D. Furberg, No. 06-3107
Arnold A. Vickery
Vickery & Waldner
Houston, TX 77056
Attorney for Amicus-Appellants Steve Hulley, Richard A.
Kronmal, Kirby Lee, Arthur A. Levin, Bruce M.Psaty,
Wayne Ray, Jacquelyn Giles and Annabel Dobbs, No. 06-
3107
Michael A. Galpern
Law Offices of Gene Locks
Cherry Hill, NJ 08002
Attorney for Amicus-Appellees Association of Trial
Lawyers of America - New Jersey, No. 06-5148
Kenneth S. Geller
Mayer, Brown, Rowe & Maw
Washington, DC 20006
Attorney for Amicus-Appellees Product Liability
Advisory Council, Inc., No. 06-3107
Robert N. Weiner
4
Jeffrey L. Handwerker
Arnold & Porter
Washington, DC 20004
Attorneys for Amicus-Appellees Pharmaceutical
Research and Manufacturers of America, No. 06-3107
Michael X. Imbroscio
Covington & Burling
Washington, DC 20004
Attorney for Amicus-Appellees American Tort Reform
Association, No. 06-3107
Douglas N. Letter
Sharon Swingle (Argued)
United States Department of Justice
Washington, DC 20530
Attorneys for Amicus-Appellee United States,
No. 06-3107
OPINION OF THE COURT
SLOVITER, Circuit Judge.
The issue before us is one of preemption, an area of the
law that need delicately balance federal interests and those of the
states. It harks back to the very beginning of our republic, and
has continued to occupy us ever since. Preemption is not a
doctrine that lends itself to a black-letter rule. One size does not
fit all. The decision must be based on the circumstances
presented in the particular situation.
The plaintiffs in these consolidated cases are the husband
and daughter, respectively, of two adults who committed suicide
5
after taking medication from the class of antidepressants known
as selective serotonin reuptake inhibitors (“SSRIs”). The
common question presented by the cases is whether the plaintiffs
may maintain their state-law tort actions against the
manufacturers of two such drugs on the theory that the drugs’
labeling failed to warn of their association with an increased risk
of suicidality. The central issue is whether actions taken by the
Food and Drug Administration (“FDA”) pursuant to its authority
under the Federal Food, Drug, and Cosmetic Act (“FDCA”), 21
U.S.C. §§ 301-397, and the corresponding regulatory scheme
preempt the plaintiffs’ state-law failure-to-warn claims.
I.
SmithKline Beecham, d/b/a GlaxoSmithKline (“GSK”),
manufactures Paxil, an SSRI that is used to treat depression. On
October 6, 2003, Lois Colacicco’s physician prescribed Paxil for
her depression. After her prescription was filled with a generic
version of Paxil, Lois Colacicco began taking that medication.
Less than a month later, on October 28, 2003, at the age of fifty-
five, she committed suicide in her New York home.
At the time of Lois Colacicco’s death, the labeling for
Paxil included the following language in its “Precautions”
section:
Suicide: The possibility of a suicide attempt is inherent
in major depressive disorder and may persist until
significant remission occurs. Close supervision of high-
risk patients should accompany initial drug therapy.
Prescriptions for PAXIL should be written for the
smallest quantity of tablets consistent with good patient
management, in order to reduce the risk of overdose . . . .
Colacicco App. at 436. Apotex, Inc. and Apotex Corp.
(together, “Apotex”) manufacture and distribute the generic
version of paroxetine hydrochloride (the active ingredient in
Paxil) ingested by Lois Colacicco. The labeling for Apotex’s
generic paroxetine was identical to GSK’s labeling for Paxil.
6
After Lois Colacicco’s death, her husband, Joseph C.
Colacicco, filed suit against Apotex and GSK in the United
States District Court for the Eastern District of Pennsylvania,
alleging that those companies violated state common-law tort
rules and New York state consumer protection laws by selling
their products with labels that failed to warn consumers of the
increased risk of emergent suicidality and worsening depression
in adults taking paroxetine. On May 26, 2006, Apotex and GSK
moved to have Colacicco’s complaint dismissed on the ground
that it was preempted by federal law and, alternatively, that GSK
did not owe a duty of care to the consumers of generic
paroxetine, such as Lois Colacicco. The District Court
dismissed the complaint on the basis of preemption. Colacicco
v. Apotex, Inc., 432 F. Supp. 2d 514, 537-39 (E.D. Pa. 2006).
Pfizer is the manufacturer of Zoloft, another SSRI that is
used to treat depression. On January 22, 2003, sixty-four-year-
old Theodore DeAngelis was prescribed Zoloft for anxiety and
depression. DeAngelis ingested that drug in the days leading up
to his death by suicide on January 30, 2003. At the time of his
death, the suicide precaution on Zoloft’s labeling read as
follows:
Suicide - The possibility of a suicide attempt is inherent
in depression and may persist until significant remission
occurs. Close supervision of high risk patients should
accompany initial drug therapy. Prescriptions for Zoloft
(sertraline) should be written for the smallest quantity of
capsules consistent with good patient management, in
order to reduce the risk of overdose.
McNellis App. 499-500.
Following DeAngelis’ death, Beth Ann McNellis, his
daughter and the executrix of his estate, filed suit in New Jersey
state court, alleging that Pfizer violated various New Jersey
products liability and consumer fraud statutes by selling Zoloft
without warning consumers that it increased the risk of
suicidality in those ingesting the drug. Pfizer removed the action
to the United States District Court for the District of New Jersey
7
and moved for summary judgment on the ground that McNellis’
claim was preempted by federal law. The Court denied that
motion on December 29, 2005. McNellis ex rel. DeAngelis v.
Pfizer, Inc. (“McNellis I”), No. Civ. 05-1286 (JBS), 2005 WL
3752269, at *13 (D.N.J. Dec. 29, 2005). On September 29,
2006, following the dismissal of Colacicco’s complaint in the
Pennsylvania District Court, the New Jersey District Court
denied Pfizer’s motion to vacate its denial of the summary
judgment motion, but certified its order for interlocutory appeal.
The District Court framed the question for appeal as follows:
Whether . . . the United States Food and Drug
Administration’s requirements for the form and content of
the labeling for the prescription antidepressant Zoloft
preempted New Jersey’s failure-to-warn law, under the
doctrine of conflict preemption, where the FDA’s
regulations at 21 C.F.R. 201.57(e) [(2003)] and
314.70(c)(6)(iii) [(2007)] permit a manufacturer to
unilaterally enhance its warning when the manufacturer
has reasonable evidence of an association of a serious
hazard with a drug.
McNellis ex rel. DeAngelis v. Pfizer, Inc. (“McNellis II”), No.
Civ. 05-1286 (JBS), 2006 WL 2819046, at *13 n.9 (D.N.J. Sept.
29, 2006). We must decide which of the two fine opinions
authored by two of the ablest district judges in this circuit most
closely expresses our view of the difficult issue presented.
II.
The FDA is charged with “promot[ing] the public health
by promptly and efficiently reviewing [drug manufacturers’]
clinical research and taking appropriate action on the marketing
of regulated products in a timely manner” and “protect[ing] the
public health by ensuring that . . . drugs are safe and effective.”
21 U.S.C. § 393(b)(1), (b)(2)(B). In this capacity, the FDA
regulates the introduction of all new drugs. Id. § 355(a).
Persons intending to market a drug must first file a new drug
application (“NDA”) with the FDA. Id. § 355(b). An NDA
must include, inter alia, full reports of investigations into the
8
drug’s safety and effectiveness, the components and production
methods used to manufacture the drug, and “specimens of the
labeling proposed to be used for such drug.” Id. § 355(b)(1); see
also 21 C.F.R. § 314.50(c)(2)(i) (requiring manufacturers to
include “statements describing the reasons for omitting a section
or subsection of the labeling format in § 201.57 of this chapter”),
(e)(2)(ii).
Although “labeling” may be commonly understood as the
label affixed to a prescription bottle, in this context it also
encompasses the written material sent to the physician and
included with the drug provided to the patient.1 The FDA
regulations require prescription drug labeling to include “a
summary of the most clinically significant information . . .
critical to safe use of the drug,” including, inter alia, potential
safety hazards associated with use of the drug. 21 C.F.R. §
201.57a(10), (c)(6)(i). Applicants must also include a “summary
of the benefits and risks of the drug, including a discussion of
why the benefits exceed the risks under the conditions stated in
the labeling.” Id. § 314.50(d)(5)(viii).
The FDA must deny an NDA if it finds that:
(1) the investigations [discussed above] do not include
adequate tests by all methods reasonably applicable to
show whether or not such drug is safe for use under the
conditions prescribed, recommended, or suggested in the
proposed labeling thereof;
(2) the results of such tests show that such drug is unsafe
1
“Labeling” is defined by statute as “all labels and other
written, printed, or graphic matter (1) upon any article or any of its
containers or wrappers, or (2) accompanying such article.” 21
U.S.C § 321(m). Thus, labeling “embraces advertising or
descriptive matter that goes with the package in which the articles
are transported,” Kordel v. United States, 335 U.S. 345, 350
(1948), in addition to any label that may be placed directly on a pill
bottle.
9
for use under such conditions or do not show that such
drug is safe for use under such conditions;
. . . . or
(7) based on a fair evaluation of all material facts, such
labeling is false or misleading in any particular.
21 U.S.C. § 355(d). The FDA shall otherwise approve the NDA.
Id. The “FDA will approve an application and issue the
applicant an approval letter . . . on the basis of draft labeling if
the only deficiencies in the application concern editorial or
similar minor deficiencies in the draft labeling.” 21 C.F.R. §
314.105(b). However, “[s]uch approval will be conditioned
upon the applicant incorporating the specified labeling changes
exactly as directed, and upon the applicant submitting to FDA a
copy of the final printed labeling prior to marketing.” Id.
The FDA’s post-approval oversight of drug labeling is
governed primarily by regulation.2 At the times relevant to this
litigation, 21 C.F.R. § 201.56 described the general requirements
for the content and format of drug labeling, while 21 C.F.R. §
201.57 set forth the specific requirements for such labeling.3
2
Because many of the relevant regulations were revised or
relocated after the dates relevant to this litigation (both DeAngelis
and Lois Colacicco were prescribed SSRIs and committed suicide
between January and October of 2003), we set forth the regulations
in effect during that time period in the text and, where applicable,
provide parallel citations to the current language and location of
those regulations in footnotes. Unless otherwise noted, the
substance of the regulations cited in this opinion have remained
consistent between January of 2003 and the present.
3
As part of the FDA’s amendments to its labeling
regulations in 2006, additional labeling requirements for recently
approved drugs were added to § 201.56 and that section was
retitled. See 21 C.F.R. § 201.56 (2007); see also 71 Fed. Reg.
3922, 3986 (Jan. 24, 2006). Meanwhile, the specific requirements
relating to drugs introduced prior to the amendments were amended
and redesignated as § 201.80. See 71 Fed. Reg. at 3988, 3996. Of
10
Section 201.57(e) required manufacturers to “describe serious
adverse reactions and potential safety hazards” under the
heading “Warnings.” 21 C.F.R. § 201.57(e) (2003). Moreover,
“[t]he labeling shall be revised to include a warning as soon as
there is reasonable evidence of an association of a serious hazard
with a drug; a causal relationship need not have been proved.”
Id. The same section states that “[s]pecial problems, particularly
those that may lead to death or serious injury, may be required
by the [FDA] to be placed in a prominently displayed box. . . . If
a boxed warning is required, its location will be specified by the
[FDA].” Id.
FDA regulations also govern the procedures for revising
drug labeling. At all times relevant to this litigation, an
applicant was required to notify the FDA of any changes to an
approved drug, including its labeling, by one of three methods,
depending on the magnitude of the intended change. See §
314.70(a)-(d) (2003). Section 314.70(b) covered “supplements
requiring FDA approval before the change is made.” Id. §
314.70(b). “Any change in labeling, except one described in
[subsections] (c)(2) or (d) of this section” required FDA pre-
approval. Id. § 314.70(b)(3)(i). Subsection (d) was limited to
minor changes that may be submitted with the drug
manufacturer’s annual report, and is not implicated by this
litigation. See id. § 314.70(d). Subsection (c), however,
described “changes that may be made before FDA approval.”
Id. § 314.70(c). In particular, “[a]n applicant shall submit a
supplement at the time the applicant makes” a change to its
labeling “[t]o add or strengthen a contraindication, warning,
precaution, or adverse reaction.” Id. § 314.70(c)(2)(i). The
supplemental submissions by which § 314.70(c) changes are
accomplished are sometimes referred to as “changes being
primary importance to this litigation, the text formerly appearing at
§ 201.57(e) now appears at § 201.80(e). The relevant language
remains unchanged. Compare 21 C.F.R. § 201.57(e) (2003), with
21 C.F.R. § 201.80(e) (2007). See also 71 Fed. Reg. at 3996.
11
effected” or “CBE” supplements.4
4
The FDA also amended § 314.70 in 2006. The regulation
now refers to changes under subsections (b), (c), and (d) as
“major,” “moderate,” and “minor” changes, respectively. 21
C.F.R. § 314.70(b), (c), (d) (2007). For the purposes of this
litigation, subsections (b) and (d) are not materially different.
Subsection (c), however, is now titled “Changes requiring
supplement submission at least 30 days prior to distribution of the
drug product made using the change (moderate changes).” Id. §
314.70(c). Nonetheless, that subsection also states that the FDA
“may designate a category of changes for the purpose of providing
that, in the case of a change in such category, the holder of an
approved application may commence distribution of the drug
product involved upon receipt by the agency of a supplement for
the change.” Id. § 314.70(c)(6). The listed categories include
changes in labeling “[t]o add or strengthen a contraindication,
warning, precaution, or adverse reaction.” Id. §
314.70(c)(6)(iii)(A). Thus, for all practical purposes, subsection
(c)(2)(i) has simply been relocated to subsection (c)(6)(iii)(A), but
the FDA may determine that products incorporating such labeling
changes may not be distributed until the agency has received the
CBE supplement or thirty days thereafter. Finally, the FDA now
provides express notice that if it “disapproves the supplemental
application, it may order the manufacturer to cease distribution of
the drug product(s) made with the manufacturing change.” Id. §
314.70(c)(7).
After oral argument, the FDA submitted a proposed rule that
would further limit the type of changes that may be effected
pursuant to § 314.70(c)(6)(iii). See 73 Fed. Reg. 2848 (Jan. 16,
2008). Specifically, that regulation would be limited to: “Changes
in the labeling to reflect newly acquired information, except for
changes to the information required in § 201.57(a) of this chapter
(which must be made under paragraph (b)(2)(v)(C) of this section),
to accomplish any of the following: (A) To add or strengthen a
contraindication, warning, precaution, or adverse reaction for
which the evidence of a causal association satisfies the standard for
inclusion in the labeling under 201.57(c) of this chapter . . . .” 73
12
Drug manufacturers have continuing obligations to report
adverse drug experiences, id. § 314.80(c), and any “significant
new information . . . that might affect the safety, effectiveness,
or labeling of the drug product,” id. § 314.81(b)(2)(i). Failure to
abide by these obligations may result in withdrawal of an
approved drug. Id. §§ 314.80(j), 314.81(d).
Although regulations describe the particulars of the
FDA’s oversight of drug labeling, the FDCA describes the
primary penalties for a drug manufacturer’s failure to comply
with those regulations. The FDA must withdraw approval of a
drug if it finds “on the basis of new information before [it,] . . .
that there is a lack of substantial evidence that the drug will have
the effect it purports or is represented to have under the
conditions of use prescribed, recommended, or suggested in the
labeling thereof.” 21 U.S.C. § 355(e). The FDA may withdraw
approval of a drug if, “on the basis of new information before
[it,] . . . the labeling of such drug, based on a fair evaluation of
all material facts, is false or misleading in any particular and was
not corrected within a reasonable time after receipt of written
notice from the [FDA] specifying the matter complained of.” Id.
The distribution of “misbranded” drugs is also prohibited
by the FDCA. Id. § 331(a), (b). A drug is misbranded if its
“labeling is false or misleading in any particular,” id. § 352(a), if
its labeling lacks “adequate warnings against use . . . where its
use may be dangerous to health,” id. § 352(f), or if “it is
dangerous to health when used in the . . . manner . . . prescribed,
recommended, or suggested in the labeling thereof,” id. § 352(j).
The FDA has the authority to enforce the prohibition on
misbranding by initiating injunction proceedings, see id. § 332,
criminal prosecutions, see id. § 333(a), and the seizure of
misbranded drugs, see id. § 334.
Once a drug has been approved, it is included in the
FDA’s published list of approved drugs. See 21 U.S.C. §
Fed. Reg. at 2853.
13
355(j)(7). Such a drug is then referred to as a “listed drug.” Id.
§ 355(j)(2)(A)(i). A listed drug is sometimes also referred to as
an “innovator” or “pioneer” drug. See, e.g., Bristol-Myers
Squibb Co. v. Shalala, 91 F.3d 1493, 1494, 1497-98 (D.C. Cir.
1996). Although the manufacturers of listed drugs, such as GSK
and Pfizer in this case, are governed by all of the requirements
associated with NDAs, the manufacturers of generic drugs, such
as Apotex, are not required to submit an NDA. Rather, such
manufacturers must abide by certain statutes and regulations that
are based on the equivalence of generic drugs to the listed drugs.
The Drug Price Competition and Patent Term Restoration
Act of 1984 (the Hatch-Waxman Amendments) relaxed the
approval procedures for generic drug manufacturers, allowing
them to submit an abbreviated NDA (“ANDA”). Pub. L. No.
98-417, 98 Stat. 1585 (codified at 21 U.S.C. § 355(j), 35 U.S.C.
§§ 156, 271, 281). An ANDA must contain information
showing the generic drug’s bioequivalency to the listed drug and
that “the labeling proposed for the new drug is the same as the
labeling approved for the listed drug . . . .” 21 U.S.C. §
355(j)(2)(A)(iv) & (v).5 FDA regulations also provide that the
agency may seek withdrawal of a generic drug, pursuant to
notice and the opportunity for a hearing, if “the labeling for the
[generic drug] is no longer consistent with that for the listed drug
referred to in the [ANDA].” 21 C.F.R. § 314.150(b)(10).
III.
The District Courts had jurisdiction over the plaintiffs’
claims under 28 U.S.C. § 1332. We have jurisdiction over
Colacicco’s appeal pursuant to 28 U.S.C. § 1291 following the
entry of the order of the Pennsylvania District Court dismissing
Colacicco’s complaint; we have jurisdiction over Pfizer’s appeal
from the New Jersey District Court’s interlocutory order denying
5
The FDA states that generic drug manufacturers may not
add new warnings to the approved labeling for the listed drug. 57
Fed. Reg. 17,950, 17,953, 17,955, 17,961 (April 28, 1992).
14
Pfizer’s motion for summary judgment in McNellis’ case
because the District Court certified that order pursuant to 28
U.S.C. § 1292(b).
The issue underlying the District Courts’ orders presents a
question of law. We apply plenary review over their preemption
determinations. See Pennsylvania Employees Benefit Trust
Fund v. Zeneca Inc., 499 F.3d 239, 242 (3d Cir. 2007) (motion
to dismiss); Horn v. Thoratec Corp., 376 F.3d 163, 166 (3d Cir.
2004) (motion for summary judgment).
IV.
The doctrine of preemption is rooted in the Supremacy
Clause, U.S. Const. art. VI, cl. 2, which provides that the
“Constitution, and the Laws of the United States which shall be
made in Pursuance thereof . . . shall be the supreme Law of the
Land.” Early in our constitutional history, the Supreme Court
interpreted this language to invalidate state laws that “interfere
with, or are contrary to,” federal law, the genesis of the
preemption doctrine. Gibbons v. Ogden, 22 U.S. (9 Wheat.) 1,
211 (1824). The Supreme Court has identified three major
situations where there is preemption. They were described in
Hillsborough County v. Automated Med. Labs., Inc. as: (1)
“express” preemption, applicable when Congress expressly
states its intent to preempt state law; (2) “field” preemption,
applicable when “Congress’ intent to pre-empt all state law in a
particular area may be inferred [because] the scheme of federal
regulation is sufficiently comprehensive” or “‘the federal interest
is so dominant that the federal system will be assumed to
preclude enforcement of state laws on the same subject;’” and
(3) “conflict” preemption, applicable when “state law is nullified
to the extent that it actually conflicts with federal law,” even
though Congress has not displaced all state law in a given area.6
6
Both field and conflict preemption are sometimes referred
to as forms of implied preemption. See, e.g., Geier v. Am. Honda
Motor Co., 529 U.S. 861, 884 (2000); Freightliner Corp. v. Myrick,
514 U.S. 280, 287 (1995). However, the Supreme Court has also
15
471 U.S. 707, 713 (1985) (quoting Rice v. Santa Fe Elevator
Corp., 331 U.S. 218, 230 (1947)).
An express preemption situation is exemplified by the
Supreme Court’s recent decision in Riegel v. Medtronic, Inc., ---
U.S. ----, 128 S. Ct. 999 (2008), where it considered the effect of
the express preemption provision of the Medical Device
Amendments of 1976 (“MDA”) to the FDCA.7 It held that in
light of that provision, plaintiffs’ claims that an arterial catheter
was designed, labeled, and manufactured in a way that violated
New York common law were preempted. Id. at 1003, 1005,
1011. See also Horn, 376 F.3d at 166.
In the Colacicco case, the Pennsylvania District Court
noted that GSK and Apotex conceded that express and field
preemption are not implicated, and proceeded exclusively under
a conflict preemption analysis. 432 F. Supp. 2d at 523. After
reviewing the applicable principles and relevant precedent, and
according considerable deference to the FDA’s position, the
Court held that Colacicco’s claims are preempted. Id. at 537-38.
In so holding, the Court rejected Colacicco’s argument that the
asserted that these three categories are not “rigidly distinct;” for
example, “field pre-emption may be understood as a species of
conflict preemption: A state law that falls within a pre-empted field
conflicts with Congress’ intent (either express or plainly implied)
to exclude state regulation.” English v. Gen. Elec. Co., 496 U.S.
72, 79-80 n.5 (1990).
7
The statutory language provides that:
no State or political subdivision of a State may establish or
continue in effect with respect to a device intended for
human use any requirement (1) which is different from, or
in addition to, any requirement applicable under [the MDA]
to the device, and (2) which relates to the safety or
effectiveness of the device or to any other matter included
in a requirement applicable to the device under [the Act].
21 U.S.C. § 360(k)(a).
16
FDA’s position should not be accorded deference because it was
inconsistent with the FDA’s prior statements. The Court
concluded that “after 2000, the FDA has been very consistent.”
Id. at 531-32.
A directly contrary conclusion was reached by the New
Jersey District Court in the McNellis case. In the first of two
opinions on the issue, the Court denied defendant Pfizer’s
motion for summary judgment, holding that it was unwilling to
find that Congress intended to obviate the state laws upon which
McNellis’ complaint was based. McNellis I, 2005 WL 3752269,
at *10. The Court held that discovery was needed on whether
Pfizer had reasonable evidence of an association between Zoloft
and suicidality. Id. at *11. In its opinion the following year, the
Court declined to vacate its earlier opinion, and instead
determined that “there can be no conflict preemption because the
FDA’s regulations do not conflict with New Jersey’s failure to
warn laws.” McNellis II, 2006 WL 2819046, at *5. The Court
held that the interpretation of the FDA was not entitled to the
substantial deference accorded by the Pennsylvania District
Court, and certified its order to this court for interlocutory
appeal. Id. at *10, *13.
The pharmaceutical companies do not seriously argue that
this is a case of express preemption 8 or field preemption. We
8
Apotex and GSK briefly argue that this is a case of express
preemption because the 1962 Amendments to the FDCA stated:
“Nothing in the amendments made by this Act to the [FDCA] shall
be construed as invalidating any provision of State law which
would be valid in the absence of such amendments unless there is
a direct and positive conflict between such amendments and such
provision of State law.” Drug Amendments of 1962, Pub. L. No.
87-781, § 202, 76 Stat. 780, 793 (Oct. 10, 1962). Of course, the
plain language of this provision states that the Amendments do not
preempt state law in the absence of a conflict. Thus, to the extent
that this provision affects our analysis, it merely states that conflict
preemption applies. In other words, this “express preemption”
provision simply leads us to a conflict preemption analysis, which
17
therefore limit our consideration to whether the plaintiffs’ state-
law claims conflict with the federal scheme.
A.
We consider first whether there is a presumption against
preemption applicable in this case. The existence vel non of
such a presumption is contested. The Supreme Court has stated:
“[i]n all pre-emption cases, and particularly in those in which
Congress has legislated in a field which the States have
traditionally occupied, we start with the assumption that the
historic police powers of the States were not to be superseded by
the Federal Act unless that was the clear and manifest purpose of
Congress.” Medtronic, Inc. v. Lohr, 518 U.S. 470, 485 (1996)
(hereafter referred to as “Lohr”) (citation, internal quotation
marks, and alterations omitted). Colacicco and McNellis
emphasize this “presumption against preemption,” and both
District Courts recognized the existence of that presumption.
See Colacicco, 432 F. Supp. 2d at 524; McNellis I, 2005 WL
3752269, at *3. Although a presumption against preemption is
commonly acknowledged, the Supreme Court has made clear
that the application of such a presumption is not always
appropriate. See Buckman Co. v. Plaintiffs’ Legal Comm., 531
U.S. 341, 347-48 (2001) (declining to apply a presumption
against preemption where the plaintiff alleged fraud on the
FDA).
Apotex and GSK argue that a presumption against
preemption does not apply in the circumstances presented here
because the states have not traditionally been involved in the
regulation of drug labeling, whereas the federal government has
regulated that area for over a hundred years. Pfizer takes an
even broader position, arguing that the presumption against
preemption does not apply at all in conflict preemption cases.9
may be applied independently of an express preemption analysis.
9
Pfizer also argues that it has overcome the presumption
were it applicable. Where appropriate, we have not hesitated to find
a conflict even after applying the presumption against preemption.
18
The Supreme Court’s decision in Hillsborough County
undermines both of these arguments. In that case, the Court
stated that the “presumption that state or local regulation of
matters related to health and safety is not invalidated under the
Supremacy Clause,” 471 U.S. at 715, and then proceeded to
analyze whether local regulations imposed on blood plasma
centers “conflict with the federal scheme,” id. at 720. The Court
concluded that the County’s ordinances and regulations, which
imposed donor testing and requirements beyond those contained
in the federal regulations, and which were designed to protect
the health of the donors, to ensure the quality of the plasma, and
to protect the recipients of the plasma, id. at 715-16, were not
preempted by the federal regulatory scheme because the
County’s requirements “do not imperil the federal goal of
ensuring sufficient plasma,” id. at 722.
The Supreme Court later addressed the presumption
against preeemption in Lohr, where the plaintiff, who was
injured by the failure of her pacemaker, filed a “common-law
negligence action against the manufacturer of an allegedly
defective medical device.” 518 U.S. at 474. The manufacturer
argued that the claim was preempted by a provision in the MDA
that bars state or local requirements different from those
applicable under the MDA and which relate to the safety or
effectiveness of any device covered by the Act.10 Id. at 481.
The Court referred to the states’ police powers to protect the
health and safety of their citizens, id. at 485, the premise of the
presumption against preemption, in holding that plaintiff’s
negligence action was not preempted. A plurality of the Court
noted that the statutory language precluded any additional
“requirement,” not any “remedy,” under state law, id. at 487, and
concluded, by reference to the legislative history, that the statute
“was not intended to pre-empt most, let alone all, general
common-law duties enforced by damages actions.” Id. at 491.
We note, however, that the Court did not discuss the
See Fasano v. Fed. Reserve Bank of New York, 457 F.3d 274, 283,
290 (3d Cir. 2006).
10
See supra note 7.
19
presumption against preemption in its recent opinion in Riegel
considering the same provision of the MDA at issue in Lohr.
There are, as the pharmaceutical companies argue,
relevant Supreme Court decisions where the Court explicitly
declined to apply any presumption against preemption. In
Buckman, plaintiffs, who claimed injuries from the use of
orthopedic bone screws, brought suit against the consultant to
the manufacturer on the theory that its statements defrauded the
FDA and led the agency to approve a device that caused the
plaintiffs’ injuries. See 531 U.S. at 343, 347-48. The Supreme
Court held that plaintiffs’ fraud claims were preempted. It
rejected plaintiffs’ argument that there was a “virtually
irrefutable presumption against implied preemption of private
damage remedies predicated on an alleged conflict with a federal
remedial scheme.” Id. at 351 (internal quotation marks omitted).
Because “the relationship between a federal agency and the
entity it regulates . . . originates from, is governed by, and
terminates according to federal law,” the Court concluded that
the plaintiffs’ claims did not implicate the traditional state
interest in the regulation of public health and safety, and thus it
did not apply the presumption against preemption. Id. at 347-48.
Similarly, in United States v. Locke, 529 U.S. 89, 94, 108
(2000), the Supreme Court considered whether Washington State
laws governing oil tanker operations and designs enacted after
the oil spill caused by the Exxon Valdez were preempted by a
comprehensive federal regulatory scheme governing oil tankers.
The Court declined to apply a presumption against preemption
because the case concerned “national and international maritime
commerce,” a field in which “Congress has legislated . . . from
the earliest days of the Republic.” Id. The Court noted that “an
‘assumption’ of nonpre-emption is not triggered when the State
regulates in an area where there has been a history of significant
federal presence.” Id.
While the decisions in Buckman and Locke are
distinguishable from the cases before us, they do make clear that
it is “the purpose of Congress [as] the ultimate touchstone of
pre-emption analysis,” Cipollone v. Liggett Group, Inc., 505
20
U.S. 504, 516 (1992) (citations, internal quotation marks, and
alterations omitted), to which we must turn. See also Rice, 331
U.S. at 230; Fasano v. Fed. Reserve Bank of New York, 457
F.3d 274, 284 (3d Cir. 2006). Colacicco and McNellis argue
that preemption is inappropriate because Congress has never
expressed its intent to preempt state-law tort actions challenging
drug labeling. McNellis notes that the New Jersey District Court
concluded that it was “unwilling to find . . . that Congress
intended to obviate the very state laws that provide remedies to
consumers harmed by dangerous products and deceptive
marketing in the absence of a clear and compelling
Congressional statement.” McNellis I, 2005 WL 3752269, at *10
(citing Bates v. Dow Agrosciences LLC, 544 U.S. 431, 450
(2005)).
The pharmaceutical companies respond by quoting the
Supreme Court’s statement that “in a situation where state law is
claimed to be pre-empted by federal regulation, a ‘narrow focus
on Congress’ intent to supersede state law [is] misdirected,’ for
‘[a] pre-emptive regulation’s force does not depend on express
congressional authorization to displace state law.’” City of New
York v. FCC, 486 U.S. 57, 64 (1988) (quoting Fid. Fed. Sav. &
Loan Ass’n v. de la Cuesta, 458 U.S. 141, 154 (1982)). In fact,
the Supreme Court has found that even where an express
preemption saving clause demonstrated Congress’ intent to
exempt common-law tort actions from preemption, the language
of the saving clause did not suggest an intent to “bar the ordinary
working of conflict pre-emption principles” or preserve
“state-law tort actions that conflict with federal regulations.”
Geier v. Am. Honda Motor Co., 529 U.S. 861, 869 (2000). The
Court held that federal regulations may preempt common-law
tort actions under a conflict preemption analysis despite a
statutory provision stating that “‘[c]ompliance with’ a federal
safety standard ‘does not exempt any person from any liability
under common law.’” Id. at 868 (quoting 15 U.S.C. § 1397(k)
(1988 ed.)). Thus, the Court concluded that plaintiff’s tort action
against the automobile manufacturer for failing to install airbags
was preempted under conflict preemption principles although
expressly saved from preemption by statute. Id. at 881.
21
It follows that in this case, which is also one of conflict
preemption, the lack of a Congressional directive expressly
approving or rejecting preemption in the context of drug labeling
regulations is not determinative. Rather, the conflict preemption
analysis is designed to determine the propriety of preemption
where Congress has not explicitly stated its intent. Seen in this
light, Pfizer’s argument that the presumption against preemption
is inapplicable in the context of implied conflict preemption has
more force. Although the Supreme Court applied the
presumption in Hillsborough County, a decision in which it
engaged in a conflict preemption analysis, that analysis followed
the Court’s consideration of field preemption principles. 471
U.S. at 716-20.11 Therefore, the extent to which the Court relied
on the presumption in the context of its conflict analysis is not
clear. Here, we recognize the applicability of the presumption
against preemption, but note the tension between such a
presumption, which emphasizes the “clear and manifest purpose
of Congress,” Lohr, 518 U.S. at 485 (internal quotation marks
omitted), and implied conflict preemption, which analyzes
preemption in the absence of any explicit intent, cf. Geier, 529
U.S. at 885 (failing to formally apply the presumption against
preemption, but “assum[ing] that Congress or an agency
ordinarily would not intend to permit a significant conflict”).
B.
A conflict between state and federal law “arises when
compliance with both federal and state regulations is a physical
impossibility or when state law stands as an obstacle to the
accomplishment and execution of the full purposes and
11
Although both field and conflict preemption are generally
thought of as forms of implied preemption, a focus on
Congressional intent is of greater value in the context of field
preemption, where Congress’ mere presence in a given field
indiscriminately nullifies all state law in the field, than in the
context of conflict preemption, which excludes state law only to the
extent that it requires individuals to act contrary to conflicting
federal obligations.
22
objectives of Congress.” Hillsborough County, 471 U.S. at 713
(citations and internal quotation marks omitted); see also City of
New York, 486 U.S. at 64 (“The statutorily authorized
regulations of an agency will pre-empt any state or local law that
conflicts with such regulations or frustrates the purposes
thereof.”).
There are not many examples of instances where it is
impossible to comply with both federal and state law,
presumably because state legislatures and regulators do not
readily seek confrontation with federal authority. One such
example is provided by the Court’s 1913 decision where it
considered the effect of a 1907 Wisconsin statute providing that
mixtures or syrups offered for sale “shall have upon them no
designation or brand . . . other than that required by the state law
. . . .” McDermott v. Wisconsin, 228 U.S. 115, 127 (1913). The
federal food and drugs act passed in 1906 barred false and
misleading labels on product packages. Id. at 127, 129. When
the issue came before the Supreme Court, it stated that “the State
may not, under the guise of exercising its police power or
otherwise, . . . enact legislation in conflict with the statutes of
Congress passed for the regulation of the subject . . . .” Id. at
131-32. The Court held that the state statute was invalid because
“[t]he legislative means provided in the Federal law for its own
enforcement may not be thwarted by state legislation having a
direct effect to impair the effectual exercise of such means.” Id.
at 137.
The scarcity of actual conflict cases has led the Justices to
pose hypothetical conflicts. In Florida Lime & Avocado
Growers, Inc. v. Paul, 373 U.S. 132, 143 (1963), the Supreme
Court hypothesized the existence of an impossibility conflict
where “federal orders forbade the picking and marketing of any
avocado testing more than 7% oil, while the California test
excluded from the State any avocado measuring less than 8% oil
content.” Under those circumstances, it would be a “physical
impossibility” for avocado growers to comply with both federal
and state law because California law would require them to do
what federal law forbade, that is, pick their avocados after they
surpassed the 7% ceiling established by federal law. Id.
23
In another case, where the issue was whether a federal
statute that permits national banks to sell insurance in small
towns preempts a state statute that forbids them to do so, Justice
Breyer discussed the impossibility situation:
In this case we must ask whether or not the Federal and
State Statutes are in “irreconcilable conflict.” The two
statutes do not impose directly conflicting duties on
national banks-as they would, for example, if the federal
law said, “you must sell insurance,” while the state law
said, “you may not.”
Barnett Bank of Marion County, N.A. v. Nelson, 517 U.S. 25, 31
(1996).
Most of the preemption cases falling within the conflict
category are cases that present the second scenario discussed in
Hillsborough County - when “state law stands as an obstacle to
the accomplishment and execution of the full purpose and
objectives of Congress.” 471 U.S. at 713 (internal quotation
marks omitted). In his opinion in Barnett Bank, Justice Breyer
continued,
the Federal Statute authorizes national banks to engage in
activities that the State Statute expressly forbids. Thus,
the State’s prohibition of those activities would seem to
“stan[d] as an obstacle to the accomplishment” of one of
the Federal Statute’s purposes – unless, of course, that
federal purpose is to grant the bank only a very limited
permission, that is, permission to sell insurance to the
extent that state law also grants permission to do so.
517 U.S. at 31 (quoting Hines v. Davidowitz, 312 U.S. 52, 67
(1941)). After deciding that the McCarran-Ferguson Act anti-
preeemption rule did not govern the case, id. at 38, the Court
held that the federal statute preempted the state statute, id. at 42.
It is not only state statutes that may stand as obstacles to
the achievement of federal objectives. It is now established that
law suits based on state tort law, as well as on state statutes, may
24
be viewed as presenting obstacles to the federal objectives and
hence barred as preempted. In Geier, the Court held that an
action against American Honda based on its failure to provide a
driver’s side airbag was preempted by a federal regulation. The
Court adopted the principle that ordinary preemption principles
apply to a state tort action where an actual conflict with a federal
objective is at stake. Geier, 529 U.S. at 871-72. The majority
stated that in the absence of such a principle:
state law could impose legal duties that would conflict
directly with federal regulatory mandates, say, by
premising liability upon the presence of the very
windshield retention requirements that federal law
requires. See, e.g., 49 CFR § 571.212 (1999). Insofar as
petitioners’ argument would permit common-law actions
that “actually conflict” with federal regulations, it would
take from those who would enforce a federal law the very
ability to achieve the law’s congressionally mandated
objectives that the Constitution, through the operation of
ordinary pre-emption principles, seeks to protect. To the
extent that such an interpretation of the saving provision
reads into a particular federal law toleration of a conflict
that those principles would otherwise forbid, it permits
that law to defeat its own objectives, or potentially, as the
Court has put it before, to “‘destroy itself.’”
Id. (quoting Am. Tel. & Tel. Co. v. Cent. Office Tel., Inc., 524
U.S. 214, 228 (1998)).
A similar consideration was noted in Lohr where Justice
Breyer, in his separate opinion concurring in part and dissenting
in part, stated that “ordinarily, insofar as [federal law] pre-empts
a state requirement embodied in a state statute, rule, regulation,
or other administrative action, it would also pre-empt a similar
requirement that takes the form of a standard of care or behavior
imposed by a state-law tort action.” 518 U.S. at 504-05. In
Horn, which dealt with the same express preeemption provision
as in Lohr, we quoted from the FDA’s letter brief stating, inter
alia,
25
State common law tort actions threaten the statutory
framework for the regulation of medical devices,
particularly with regard to FDA’s review and approval of
product labeling. State actions are not characterized by
centralized expert evaluation of device regulatory issues.
Instead, they encourage, and in fact require, lay judges
and juries to second-guess the balancing of benefits and
risks of a specific device to their intended patient
population - the central role of FDA - sometimes on
behalf of a single individual or group of individuals.
376 F.3d at 178.
State common-law tort actions based on the
manufacturers’ failure to warn present the pharmaceutical
manufacturers with particular difficulties. State standards of
care undoubtedly differ from state to state. Absent a
determination that the FDA-approved labeling and the FDA’s
refusal to require the warnings suggested by plaintiffs in this
case preempt state tort actions, the manufacturers may be
subjected to considerable liability based on varying standards,
with no benchmark that they should follow.
In holding the tort action based on the failure to provide
airbags was preempted, the Court in Geier reviewed the history
of the consideration of passive restraints by the federal agency,
there the Department of Transportation. Similarly, in this case,
before we can hold that a federal regulation or, as in Geier, the
failure to regulate as extensively as plaintiffs sought, has
preemptive force, we must review the record of the FDA’s
treatment of the desired warning at issue here.
As discussed above, a new drug may not be marketed
until it has received FDA approval. The FDA will not approve a
drug if its “labeling is false or misleading in any particular.” 21
U.S.C. § 355(d)(7). Even after a drug has been approved, a drug
will be deemed misbranded if the “labeling is false or misleading
in any particular” and the FDA may withdraw approval of that
drug and prosecute the manufacturer. See id. §§ 331(b)
(prohibition on misbranding), 355(e)(3) (withdrawal authority),
26
352(a), (f), (j) (definition of misbranding), 332 (injunction
proceedings), 333(a) (criminal prosecutions), 334 (seizure).
Thus, the FDCA vests the FDA with significant authority over
drug labeling. FDA regulations further implement this authority.
Under its regulations, the FDA may withdraw approval of
a drug if the manufacturer disregards its obligation to submit
periodic reports notifying the FDA of adverse drug experiences
and other new information that might affect the drug labeling.
21 C.F.R. §§ 314.80(c), (j), 314.81(b)(2)(i), (d). FDA
regulations detail the information that must be included in the
warnings section of drug labeling and instruct that such “labeling
shall be revised to include a warning as soon as there is
reasonable evidence of an association of a serious hazard with a
drug . . . .” Id. § 201.57(e) (2003); id. § 201.80(e) (2007).
There are three distinct procedures by which
manufacturers may revise their drugs’ labeling, each of which
requires the manufacturer to notify the FDA of its proposed
revision. See id. § 314.70(a)-(d). Generally, labeling changes
require FDA pre-approval. See id. § 314.70(b)(3)(i) (2003).
However, changes that “add or strengthen a contraindication,
warning, precaution or adverse reaction,” may be implemented
prior to the manufacturer’s receipt of FDA approval. Id. §
314.70(c)(2)(i) (2003); id. § 314.70(c)(6)(iii)(A) (2007).
Colacicco and McNellis argue that because § 314.70(c)
allows drug manufacturers to strengthen and augment warnings
on drug labeling without prior FDA approval, the FDA labeling
requirements constitute mere minimum standards for the
information that may be required in their labeling. See, e.g.,
Sprietsma v. Mercury Marine, 537 U.S. 51, 58-59 (2002).
Therefore, they argue that state-law failure-to-warn claims that
would require manufacturers to strengthen or augment a warning
do not conflict with FDA regulations, and are in fact
complementary to those regulations.
The pharmaceutical companies respond that even though
labeling changes made pursuant to § 314.70(c) do not require
prior approval, the legality of those changes remains within the
27
FDA’s control. They state that because the FDA is directly
involved with balancing the benefits and risks of a drug’s
labeling, see, e.g., 21 C.F.R. § 314.50(d)(5)(viii), and has the
statutory authority to order the manufacturer to discontinue
distribution of any products incorporating the manufacturer’s
labeling change, the FDA-approved labeling reflects the FDA’s
expert judgment about the information that must be included in a
drug’s labeling.12
Of course, in this case we must focus on the effect of the
FDA’s failure to require a warning that plaintiffs argue was the
cause of their injury rather than the effect of a positive
regulation. It is always easier to evaluate the effect of a conflict
created by a positive regulation than the effect created by
inaction. It is difficult to know whether the absence of a
regulation may reflect a wait-and-see approach or mere inertia.
We are guided to some extent by Geier where the Court held that
the failure of the Department of Transportation to require auto
manufacturers to equip their 1997 vehicles with a specific form
of passive restraint system, i.e. airbags, preempted the state “no
airbag” tort suit. 529 U.S. at 874, 881.
In this case we need not speculate on the rationale of the
FDA for its failure to require the adult suicidality warnings. Not
only has the FDA filed an amicus brief in the Colacicco action
but it has repeatedly rejected the scientific basis for the warnings
that Colacicco and McNellis argue should have been included in
the labeling. The FDA has actively monitored the possible
association between SSRIs and suicide for nearly twenty years,13
12
Apotex, for its part, argues that tort actions against generic
drug manufacturers are preempted because the Hatch-Waxman
Amendments and the FDA’s implementing regulations require such
manufacturers to maintain labeling identical to that of the innovator
drug.
13
Colacicco, whose complaint was dismissed prior to
discovery, argues that the District Court improperly relied on
evidence of the FDA’s past actions and that we are prohibited from
considering that information. This problem does not arise in the
28
and has concluded that the suicide warnings desired by plaintiffs
are without scientific basis and would therefore be false and
misleading.
In 1991, after considering whether antidepressants caused
or intensified suicidal thoughts, the FDA’s
Psychopharmacological Drugs Advisory Committee concluded
that no such warning should be added to Prozac (an SSRI similar
to Paxil and Zoloft) or other antidepressants. The FDA
specifically rejected citizen petitions in 1991, 1992, and 1997
which sought to either withdraw approval of Prozac as a result of
its asserted association with suicide or to include a suicide
warning on the labeling of that drug. In each instance, the FDA
concluded that there was insufficient evidence to take the actions
requested.
DeAngelis committed suicide on January 22, 2003. The
FDA approved the Zoloft suicide precaution seven separate
times before and after that date, in each instance requiring Pfizer
to market the drug with the precise labeling approved.14 Further,
McNellis case, which is before us following summary judgment
proceedings. Of course, courts may place limited reliance on
public records in the context of a motion to dismiss. See Anspach
ex rel. Anspach v. City of Philadelphia, Dep’t of Pub. Health, 503
F.3d 256, 273 n.11 (3d Cir. 2007). Thus, in Anspach, we took
notice of FDA public records “not for the truth of [their] contents,
but rather as evidence of the information provided by the federal
government” to the relevant regulated parties. Id. Our recognition
of the records contested here, all of which are publicly available,
is similarly limited. See also Jean Alexander Cosmetics, Inc. v.
L’Oreal USA, Inc., 458 F.3d 244, 256 n.5 (3d Cir. 2006)
(recognizing that courts may take judicial notice of prior judicial
proceedings).
14
The FDA first approved Zoloft for the treatment of
depression in adults on December 30, 1991, conditioning its
approval on Pfizer’s incorporation of specifically indicated labeling
revisions. In 1996, the FDA approved Zoloft for a new indication,
the treatment of obsessive compulsive disorder (“OCD”), with that
29
just months before DeAngelis’ death, the FDA filed an amicus
brief in an action before the Court of Appeals for the Ninth
Circuit, stating that it had concluded that there was no scientific
basis for a warning suggesting that Zoloft causes suicidality.
See Brief for the United States as Amicus Curiae, Motus v.
Pfizer Inc., 358 F.3d 659 (9th Cir. 2004) (Nos. 02-55372, 02-
55498), 2002 WL 32303084 (brief submitted September 10,
2002).15
The FDA also repeatedly approved the Paxil labeling in
effect at the time of Lois Colacicco’s prescription of Paxil on
October 6, 2003, and her death on October 28, 2003, approving
it for a new indication, the treatment of generalized anxiety
approval again conditioned on Pfizer’s incorporation of a series of
labeling revisions. The FDA proceeded to approve the use of
Zoloft for panic disorder and pediatric OCD in 1997, post-
traumatic stress disorder in 1999, premenstrual dysphoric disorder
in 2002, and, on February 7, 2003, social anxiety disorder. Each
time the FDA approved Zoloft for a new indication, it required that
the final printed labeling be identical to the labeling attached to the
FDA’s approval.
15
The New Jersey District Court acknowledged the FDA’s
position in Motus, but decided that it was not appropriate to defer
to that litigation position. See McNellis I, 2005 WL 3752269, at
*10. However, we distinguish between the agency’s legal position
in its amicus brief and its factual representations. In the Motus
brief, the FDA stated not just its legal conclusions with respect to
the applicability of preemption, but it also reported its view of the
state of scientific research regarding Zoloft and antidepressants at
that time. The FDA’s summary of its scientific determinations
must be distinguished from the agency’s construction of a statute,
as the review of scientific information is strictly within its
expertise. The FDA asserted facts in support of its legal position,
and we take notice of its statement of those facts, rather than its
legal position.
30
disorder, just a year before those events.16 The FDA approved
Apotex’s application to market generic paroxetine on June 30,
2003, concluding that “the drug is safe and effective for use as
recommended in the submitted labeling,” which included the
suicide precaution discussed above, rather than a warning. See
Letter from Gary Buehler, Director, Office of Generic Drugs,
Center for Drug Evaluation and Research, FDA, to Apotex Corp.
3 (July 30, 2003), available at
http://www.fda.gov/cder/foi/appletter/2003/75356ap.pdf (last
visited January 8, 2008). Significantly, on June 19, 2003, the
FDA issued a public statement to address reports associating the
pediatric use of Paxil with suicidality, in which it stated: “There
is no evidence that Paxil is associated with an increased risk of
suicidal thinking in adults.” FDA Talk Paper, FDA Statement
Regarding the Anti-Depressant Paxil for Pediatric Population
(June 19, 2003), available at
http://www.fda.gov/bbs/topics/answers/2003/ans01230.html (last
visited Nov. 8, 2007).
On October 27, 2003, the FDA issued a Public Health
Advisory regarding increased suicidality in pediatric users of
antidepressants. This advisory was limited to pediatric patients;
a warning for adult patients was not issued. In that advisory, the
FDA announced that it would continue to research the reports of
suicidality in pediatric patients treated with antidepressants,
explaining that “[s]uch reports are very difficult to interpret, in
the absence of a control group, as these events also occur in
untreated patients with depression.” FDA, FDA Public Health
Advisory (Oct. 27, 2003), available at
16
As with its approvals of Zoloft, the FDA approved Paxil
for new indications on the condition that the final drug labeling be
identical to the labeling approved by the FDA. See, e.g., Letter
f ro m R u s s e ll K a tz , M .D ., D ire ctor, D iv is io n o f
Neuropharmacological Drug Products, Office of Drug Evaluation
I, Center for Drug Evaluation and Research, FDA, to
G laxoSm ithK line (O ct. 2, 2002), available at
http://www.fda.gov/cder/foi/appletter/2002/20031se8-035ltr.pdf
(last visited January 8, 2008).
31
http://www.fda.gov/cder/drug/advisory/mdd.htm (last visited
January 8, 2008).
Thus, even when it began to reevaluate its position
regarding the association of antidepressants with pediatric and
adolescent suicidality, the FDA continued to announce its
rejection of adult suicidality warnings for SSRIs as it had for the
decade before the prescriptions and deaths at issue in this
litigation. Just months prior to Lois Colacicco’s death, the FDA
publicly stated that Paxil was not associated with a risk of
suicidality in adults. Similarly, four months before DeAngelis’
death, the FDA filed a public brief stating its position that
scientific evidence did not support the addition of a suicide
warning on Zoloft’s labeling.
Although preemption is commonly thought of in terms of
statutes and regulations, a federal agency’s action taken pursuant
to statutorily granted authority may also have preemptive effect
over state law. See Chicago & N. W. Transp. Co. v. Kalo Brick
& Tile Co., 450 U.S. 311, 327 (1981) (“These findings by the
[Interstate Commerce] Commission, made pursuant to the
authority delegated by Congress, simply leave no room for
further litigation over the matters respondent seeks to raise in
state court.”); NCNB Texas Nat’l Bank v. Cowden, 895 F.2d
1488, 1497-99 (5th Cir. 1990) (finding that Federal Deposit
Insurance Corporation’s action taken pursuant to statutory
authority preempted state law); cf. Sprietsma, 537 U.S. at 66-67
(recognizing that an agency’s refusal to regulate may be
construed as a determination that no such regulation is
appropriate and have preemptive force). Because the standard
for adding a warning to drug labeling is the existence of
“reasonable evidence of an association of a serious hazard with a
drug,” 21 C.F.R. § 201.57(e), and the FDCA authorizes the FDA
to prohibit false or misleading labeling, a state-law obligation to
include a warning asserting the existence of an association
between SSRIs and suicidality directly conflicts with the FDA’s
oft-repeated conclusion that the evidence did not support such an
association. Therefore, under the circumstances of this case, the
plaintiffs’ failure-to-warn claims are preempted by the FDA’s
actions taken in accordance with its statutory authority.
32
The FDA clearly and publicly stated its position prior to
the prescriptions and deaths at issue here. Therefore, we need
not decide whether preemption would be appropriate under
different facts--such as where the FDA had not rejected the
substance of the warning sought or where the FDA only stated
its position after a lawsuit had been initiated--or under the
broader theories of preemption argued by the parties. Thus, we
do not decide whether the FDA’s mere approval of drug labeling
is sufficient to preempt state-law claims alleging that the
labeling failed to warn of a given danger, whether FDA approval
of drug labeling constitutes minimum standards in the absence of
the FDA’s express rejection of a specific warning, or whether
actions against generic drug manufacturers are preempted on the
basis of their obligations under the Hatch-Waxman
Amendments.17 Our holding is limited to circumstances in
which the FDA has publicly rejected the need for a warning that
plaintiffs argue state law requires. Cf. Dowhal v. Smithkline
Beecham Consumer Healthcare, 88 P.3d 1, 11 (Cal. 2004)
(concluding that an FDA “letter established a federal policy
prohibiting defendants from giving consumers any warning other
than the one approved by the FDA in that letter, and that the use
of a [warning required by state law] would conflict with that
policy”).
17
In contrast to our decision, the Supreme Court of Vermont
has held that plaintiffs’ negligence and failure-to-warn claims
alleging inadequate warnings on the labeling of an anti-nausea drug
“did not conflict with the FDA’s labeling requirements for [the
drug] because [Wyeth] could have warned against [the danger
alleged by plaintiffs] without prior FDA approval, and because
federal labeling regulations create a floor, not a ceiling, for state
regulation.” Levine v. Wyeth, --- A.2d ----, 2006 WL 3041078, ¶
6 (Vt. 2006), cert. granted, 128 S. Ct. 1118 (2008). The Vermont
Court found that there was “no evidence that the FDA intended to
prohibit defendant from strengthening the [drug] label pursuant to
[§] 314.70(c)” and thus it was not impossible for Wyeth to comply
with both state and federal obligations. Id. ¶ 23. The facts in these
cases are otherwise.
33
The plaintiffs raise two primary objections to this
conclusion. First, they argue that nothing less than the FDA’s
explicit rejection of a drug manufacturer’s request to add a
contested warning to its drug labeling should suffice to establish
conflict preemption. Second, they contend that the
pharmaceutical companies failed to provide the FDA with
sufficient information for it to make a valid decision regarding
the necessity of a suicidality warning. Neither argument is
persuasive.
As we previously noted, the FDA is authorized by statute
to reject an NDA if the labeling is false or misleading in any
particular and may withdraw its approval of a drug upon the
same findings. See 21 U.S.C. § 355(d)(7), (e)(3). Plaintiffs
argue, however, that the FDA’s actions were insufficient to
manifest such a rejection here. They ask us to overlook the
FDA’s various public statements rejecting the existence of an
association between SSRIs and adult suicidality because they
were not made in the context of the FDA’s formal rejection of a
CBE supplement submitted by one of the defendant
pharmaceutical companies.
We agree that a court could more easily determine the
preemption issue if the FDA had formally rejected such a CBE
supplement, but we cannot compel the defendant companies to
suggest a CBE supplement that they believe is unnecessary. Nor
do we favor encouraging regulated parties to submit CBE
supplements for the sole purpose of insulating themselves from
potential liability. Cf. 44 Fed. Reg. 37,434, 37,435 (June 26,
1979) (cautioning, in the context of medical malpractice liability,
that “it would be inappropriate to require statements in drug
labeling that do not contribute to the safe and effective use of the
drug, but instead are intended solely to influence civil litigation
in which the agency has no part”). Thus, we reject the notion
that, in order to rise to the level of a conflict in this situation, the
FDA’s rejection of a warning must be imbued with the formality
proposed by the plaintiffs.
Colacicco further argues that the FDA’s failure to require
an adult suicidality warning cannot be seen as a rejection of the
34
warning that his lawsuit would require because “GSK
manipulated or withheld information from the FDA.” Colacicco
Reply Br. at 9. This contention borders on the charge that GSK
defrauded the FDA by manipulating or withholding such
information. Cf. Buckman, 531 U.S. at 346-47. Such a claim, if
supported by sufficient evidence, should be brought before the
FDA. As far as we know from the record, Colacicco has not
done so.
In the New Jersey action, McNellis opposed Pfizer’s
motion for summary judgment by submitting copies of research
studies that were made public, which McNellis argued showed a
link between SSRIs and suicidality. McNellis does not argue
that the FDA was unaware of this material. Our focus is on the
period before the two deaths that are the subject of the actions
before us. We note, however, that the FDA has continued its
close scrutiny of the effect of SSRI drugs on suicidality of
adults. In March of 2004, the FDA directed GSK and nine other
manufacturers of SSRIs to include stronger warnings on drug
labels about the need to monitor adult patients for signs of
worsening depression or suicidality, but noted that it had “not
concluded that these drugs cause worsening depression or
suicidality in adult patients.” 18 Br. for the United States as
Amicus Curiae at 13 (citing FDA Talk Paper, FDA Issues Public
Health Advisory on Cautions for Use of Antidepressants in
Adults and Children (March 22, 2004), available at
http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01283.htm
l).
18
In April 2006, GSK, after reviewing studies that disclosed
a higher incidence of suicidal behavior in young adults treated with
Paxil, modified its Paxil label to include a warning that young
adults “especially those with [major depressive disorder], may be
at an increased risk of suicidal behavior when treated with” Paxil.
Br. for the United States as Amicus Curiae at 14 (citing Paxil
Label, available at http://us.gsk.com/products/assets/US_paxil.pdf
(last visited Feb. 27, 2008)). It made this change only after filing
the proposed change with the FDA and waiting the required 30
days.
35
More recently, the FDA, after its review of the aggregated
data from all SSRI manufacturers, reaffirmed its conclusion that
there is insufficient evidence demonstrating that SSRIs are
associated with adult suicidality. In its widely distributed notice
on Antidepressant Use in Children, Adolescents and Adults
dated May 2, 2007, available at
http://www.fda.gov/cder/drug/antidepressants/default.htm (last
visited Feb. 22, 2008), the FDA incorporated its conclusions that
“[s]hort-term studies did not show an increase in the risk of
suicidality with antidepressants compared to placebo in adults
beyond age 24” and that adults ages 65 and older taking
antidepressants have a decreased risk of suicidality. Revisions to
Product Labeling, available at
http://www.fda.gov/cder/drug/antidepressants/antidepressants_la
bel_change_2007.pdf (last visited Feb. 22, 2008); see also FDA
News, FDA Proposes New Warnings About Suicidal Thinking,
Behavior in Young Adults Who Take Antidepressant
Medications,
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01624.html
(May 2, 2007).19 The FDA Revisions to Product Labeling
directed the drug companies (including manufacturers of Paxil
and Zoloft) to make changes in the warnings included at the
beginning of the package inserts that confirm that
antidepressants increase the risk of suicidality in children,
adolescents, and young adults but that the studies did not show
an increase in the risk of suicidality in adults older than age 24.20
19
We may, of course, take judicial notice of this
development “which [took] place after the judgment appealed
from.” Werner v. Werner, 267 F.3d 288, 295 (3d Cir. 2001).
20
The entire text of the revised warning reads as follows:
Antidepressants increased the risk compared to placebo of
suicidal thinking and behavior (suicidality) in children,
adolescents, and young adults in short-term studies of major
depressive disorder (MDD) and other psychiatric disorders.
Anyone considering the use of [Insert established name] or
any other antidepressant in a child, adolescent, or young
adult must balance this risk with the clinical need. Short-
36
In light of the FDA’s continued review of existing scientific
studies, we reject plaintiffs’ arguments that the FDA lacked
information that would have dissuaded it from rejecting an adult
suicidality warning for Zoloft, Paxil, or generic paroxetine in
2003.
The FDA has taken the position, both in the preamble to
the 2006 amendments revising the drug labeling regulations and
in its amicus brief in the Colacicco case, that plaintiffs’ claims
are preempted as a result of the actions taken by the FDA
pursuant to its regulatory authority. The preamble specifically
states that preemption applies to “claims that a [manufacturer]
term studies did not show an increase in the risk of
suicidality with antidepressants compared to placebo in
adults beyond age 24; there was a reduction in risk with
antidepressants compared to placebo in adults aged 65 and
older. Depression and certain other psychiatric disorders are
themselves associated with increases in the risk of suicide.
Patients of all ages who are started on antidepressant
therapy should be monitored appropriately and observed
closely for clinical worsening, suicidality, or unusual
changes in behavior. Families and caregivers should be
advised of the need for close observation and
communication with the prescriber. [Insert Drug Name] is
not approved for use in pediatric patients. [The previous
sentence would be replaced with the sentence, below, for
the following drugs: Prozac: Prozac is approved for use in
pediatric patients with MDD and obsessive compulsive
disorder (OCD). Zoloft: Zoloft is not approved for use in
pediatric patients except for patients with obsessive
compulsive disorder (OCD). Fluvoxamine: Fluvoxamine is
not approved for use in pediatric patients except for patients
with obsessive compulsive disorder (OCD).] (See
Warnings: Clinical Worsening and Suicide Risk,
Precautions: Information for Patients, and Precautions:
Pediatric Use). Revisions to Product Labeling, available at
http://www.fda.gov/cder/drug/antidepressants/antidepress
ants_label_change_2007.pdf (last visited Feb. 22, 2008).
37
breached an obligation to warn by failing to include a statement
in labeling or in advertising, the substance of which had been
proposed to FDA for inclusion in labeling, if that statement was
not required by FDA at the time plaintiff claims the
[manufacturer] had an obligation to warn.” 71 Fed. Reg. 3922,
3936 (Jan. 24, 2006). The FDA explains in the amicus brief that
“the basis for federal preemption is not the [labeling] guidelines
themselves . . ., but rather FDA’s repeated determinations prior
to October 2003 that there was insufficient scientific evidence of
an association between adult use of SSRI and suicide or
suicidality to permit a warning on the labeling for those drugs . .
. .” Br. for the United States as Amicus Curiae at 28.
We would ordinarily be leery of an agency’s view of what
is essentially a legal issue, but we note that in Geier the Supreme
Court recently addressed the weight to be given to an agency’s
position on preemption. The Court “place[d] some weight” on a
Department of Transportation interpretation, as set forth in an
amicus brief, of a rule that it had promulgated. Geier, 529 U.S.
at 883. The Court considered that Congress had delegated the
agency “authority to implement the statute; the subject matter is
technical; and the relevant history and background are complex
and extensive.” Id. The Court stated that the agency was
“‘uniquely qualified’ to comprehend the likely impact of state
requirements.” Id. (quoting Lohr, 518 U.S. at 496). The Court
also noted the consistency of the agency’s position over time, id.,
and the coherence of the agency’s views, id. at 885. Although
the Court did not rely solely on the agency’s position, it noted
that “a specific expression of agency intent to pre-empt, made
after notice-and-comment rulemaking” was not necessary to find
conflict preemption. Id.
From Geier’s discussion of an agency’s informal position
regarding preemption, we conclude (1) that an agency’s position
concerning preemption need not be contained in a formal
regulation in order to be considered, and (2) that such a position
is subject to a level of deference approximating that set forth in
Skidmore v. Swift & Co., 323 U.S. 134 (1944). Cf. Christensen
v. Harris County, 529 U.S. 576, 587 (2000) (quoting Skidmore,
323 U.S. at 140) (holding that agency interpretations contained
38
in statements that “lack the force of law” are “‘entitled to
respect’” only to the extent they have the “‘power to
persuade’”).21
“The fair measure of deference to an agency
administering its own statute has been understood to vary with
circumstances, and courts have looked to the degree of the
agency’s care, its consistency, formality, and relative expertness,
and to the persuasiveness of the agency’s position.” United
States v. Mead Corp., 533 U.S. 218, 228 (2001) (alterations
omitted) (citing Skidmore, 323 U.S. at 139-40).
It is important to consider the rationale given by the
agency for its position that its actions preempt state law in the
particular situation. In the case of the SSRI drugs at issue, Paxil,
Zoloft, and the generic paroxetine manufactured by Apotex, the
FDA has explained that “[u]nder-use of a drug based on
dissemination of unsubstantiated warnings may deprive patients
of efficacious and possibly lifesaving treatment. Further,
allowing unsubstantiated warnings would likely reduce the
impact of valid warnings by creating an unnecessary distraction
and making even valid warnings less credible.” Br. for the
United States as Amicus Curiae at 16-17. The FDA’s view that
“the imposition of liability under state law for defendants’
alleged failure to warn would interfere with FDA’s
accomplishment of regulatory objectives,” id. at 22, is in our
21
Counsel for GSK suggested that a combination of
Skidmore and Auer deference was appropriate. Under Auer v.
Robbins, 519 U.S. 452, 461 (1997) (citations and internal quotation
marks omitted), an agency’s interpretation of its own regulation is
“controlling unless plainly erroneous or inconsistent with the
regulation.” However, because the FDA purports to interpret both
the statutory structure and regulatory framework, we believe it
more prudent to apply Skidmore deference, which is the weaker of
the two. This is also consistent with Geier, wherein the Court
considered an agency’s interpretation of its own regulation under
a less deferential standard than that suggested by Auer. 529 U.S.
at 883.
39
view entitled to at least as much deference, if not more, as the
FDA’s view of its preemption authority. The Pennsylvania
District Court accorded the FDA’s views “significant”
deference, Colaciccio, 432 U.S. at 529, and we agree that in at
least this respect the FDA’s view is entitled to some degree of
deference.
In light of the circumstances in this case, we agree that
the FDA’s rejection of the warning plaintiffs proffer preempts a
state-law action premising liability on a drug manufacturer’s
failure to include such a warning in the drug labeling
notwithstanding that the agency’s view was not subject to notice-
and-comment rulemaking.
The Supreme Court has recently acknowledged the
FDA’s expertise in the context of the medical devices covered
by the MDA. It stated, “[b]ecause the FDA is the federal agency
to which Congress has delegated its authority to implement the
provisions of the Act, the agency is uniquely qualified to
determine whether a particular form of state law ‘stands as an
obstacle to the accomplishment and execution of the full
purposes and objectives of Congress,’ and, therefore, whether it
should be pre-empted.” Lohr, 518 U.S. at 496 (citing Hines, 312
U.S. at 67). Justice Breyer, concurring in that decision, also
noted that the Court has “suggested that, in the absence of a clear
congressional command as to pre-emption, courts may infer that
the relevant administrative agency possesses a degree of leeway
to determine which rules, regulations, or other administrative
actions will have pre-emptive effect.” Id. at 505 (Breyer, J.,
concurring) (emphasis added) (citing cases). Of course, the
FDA is equally expert, if not more so, with respect to regulation
of drugs, with which it has had a longer experience than with
medical devices.
We need not decide whether the FDA’s position in this
case is inconsistent, as plaintiffs argue, with the FDA’s 2000
rule proposal. We see no inconsistency between the FDA’s
preamble to the 2006 amendments and its long-held position that
it has the responsibility to determine whether a warning is
required. Compare 44 Fed. Reg. at 37,447 (stating, in 1979, that
40
“the decision as to whether a warning is legally required for the
labeling of a drug must rest with the agency”), with 71 Fed. Reg.
at 3934 (“In fact, the determination whether labeling revisions
are necessary is, in the end, squarely and solely FDA’s under the
act.”).
In conclusion, based on our own review of the FDCA, the
FDA’s regulations, and the FDA’s actions taken pursuant to its
statutory authority, we conclude that the failure-to-warn claims
brought by Colacicco and McNellis conflict with, and are
therefore preempted by, the FDA’s regulatory actions. It is
important to note that we express no view as to the merits of the
issue whether SSRIs contribute to adult suicidality. We are not
scientists and we do not purport to have any expertise on that
issue. That is within the FDA’s authority. This decision is
based on the record before us.
V.
For the above-stated reasons, we will affirm the judgment
of the United States District Court for the Eastern District of
Pennsylvania dismissing Colacicco’s complaint and we will
reverse the order certified by the United States District Court for
the District of New Jersey with instructions that judgment be
entered in favor of the defendants. In light of our decision with
respect to preemption, we need not reach the other issues
considered by the District Courts.
41
Colacicco v. Apotex Inc., et al. McNellis v. Pfizer Inc.
Nos. 06-3107/5148
AMBRO, Circuit Judge, dissenting
The majority opinion describes these cases as situations
calling for preemption: the expert agency, the Food and Drug
Administration (“FDA”), consults scientific data to generate the
optimal warnings (not too lax, not too alarmist) for drug
labels—and state tort lawsuits would disrupt this fine system.
But there is an important contrary view that has prevailed until
recently: state tort law complements FDA provisions on drug
warnings, in part by eliciting more information than the FDA
would glean otherwise from pharmaceutical manufacturers. This
contrary view has, I believe, the better argument in terms of legal
doctrine on preemption, congressional intent, and the history of
state tort law alongside federal law. Although the majority
opinion is well-crafted and responsibly narrow, I would not
move even the short distance my colleagues go toward
preemption of state-law torts. I thus respectfully dissent.
I. Presumption Against Preemption
The majority opinion begins its analysis where I would,
by examining whether we are to apply a presumption against
preemption. State tort law, dealing with failure-to-warn claims
(like those brought by the plaintiffs in our cases), addresses
health and safety and thus falls within the states’ traditional
police powers. See Medtronic, Inc. v. Lohr, 518 U.S. 470, 485
(1996) (describing the presumption against preemption and
asserting “the historic primacy of state regulation of matters of
health and safety”). As the majority recognizes, the presumption
does not always apply; for example, it does not apply to claims
alleging fraud on the FDA. See Buckman Co. v. Plaintiffs’ Legal
Comm., 531 U.S. 341, 347–48 (2001). That the presumption
there does not apply—where common sense points to federal law
42
governing exclusively those who seek to defraud a federal
agency—is no surprise, and hardly weakens the presumption
when it does apply.
The presumption against preemption must inform our
analysis of both “whether Congress intended any pre-emption at
all” and “the scope of its intended invalidation of state law.”
Lohr, 518 U.S. at 485 (emphasis omitted). When the
presumption applies, rebutting it requires a clear expression that
Congress intended to preempt. Bates v. Dow Agrosciences LLC,
544 U.S. 431, 449 (2005) (“In areas of traditional state
regulation, we assume that a federal statute has not supplanted
state law unless Congress has made such an intention clear and
manifest.”) (citations and internal quotation marks omitted).
In my view, the majority opinion under-emphasizes
congressional intent as the “ultimate touchstone of pre-emption
analysis.” Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516
(1992) (citations and internal quotations marks omitted). Our
inquiry is “guided” by a focus on gaining “ ‘a fair understanding
of congressional purpose.’ ” Lohr, 518 U.S. at 485–86 (quoting
Cipollone, 505 U.S. at 530) (emphasis in original). As the
majority opinion rightly recognizes, the defendants in our cases
do not make a serious argument that this case involves express
preemption or field preemption. But I would place more
significance on the fact that the key conflict preemption cases
that the majority opinion relies on involve express statutory
preemption provisions. Geier v. American Honda Motor
Company, 529 U.S. 861, 864–65 (2000) (evaluating viability of
state-tort-law claims in light of a preemption provision, 15
U.S.C. § 1392(d), and a savings provision, id. § 1397(k), within
the National Traffic and Motor Vehicle Safety Act of 1966);
Lohr, 518 U.S. at 481 (evaluating viability of state-tort-law
claims in light of the preemption provision of the Medical
Devices Act, 21 U.S.C. § 360k(a)).
43
Even when considering a species of implied
preemption—as conflict preemption generally is, see Geier, 529
U.S. at 884—we should be asking whether Congress intended to
preempt. In our cases, we have no statutory preemption
provision to interpret that relates to drug labeling in the Food,
Drug and Cosmetic Act (“FDCA”). This fact should push us to
hold the presumption against preemption in place, as we lack the
best kind of evidence of congressional intent: statutory text.
The absence of a relevant preemption provision in the
FDCA does not, of course, resolve whether the presumption
against preemption is overcome by something else. The
Supreme Court has “held repeatedly that state laws can be
pre-empted by federal regulations as well as by federal statutes.”
Hillsborough County v. Automated Med. Labs., 471 U.S. 707,
713 (1985). Although initial approval of drug labeling involves
both statutory and regulatory provisions, FDA regulations
primarily govern the continuing oversight of drug-label
revisions. These regulations, at the time relevant to this
litigation, required drug manufacturers to revise labeling “to
include a warning as soon as there is reasonable evidence of an
assocation of a serious hazard with a drug,” 21 C.F.R. §
201.57(e), and to submit supplemental information in the event
that they “add or strengthen a contraindication, warning,
precaution, or adverse reaction,” id. § 314.70(c). The defendants
in our cases rely primarily on their continuing obligations under
these FDA regulations for their conflict-preemption argument.
Yet the mere presence of a comprehensive regulatory
scheme such as the FDA’s for drug labeling does not itself
unseat the presumption against preemption. Hillsborough
County, 471 U.S. at 717 (“We are even more reluctant to infer
pre-emption from the comprehensiveness of regulations than
44
from the comprehensiveness of statutes.”).22 Because our focus
must remain on congressional intent, we should remember in
deciding questions of regulatory preemption that any inferences
regarding congressional purpose typically will be indirect.
Congress enacted the FDCA, which in turn enabled the FDA to
adopt its regulations regarding continuing (i.e., post-approval)
drug labeling. To overcome the presumption against
preemption, the defendants in our cases must show that Congress
implicitly intended to allow the FDA to adopt regulations that
preempt failure-to-warn lawsuits under state law. Cf. Fidelity
Federal Sav. & Loan Ass’n v. de la Cuesta, 458 U.S. 141, 162
(1982) (holding that Federal Home Loan Bank Board regulations
preempted state law where “the statutory language suggests that
Congress expressly contemplated, and approved, the Board’s
promulgation of regulations superseding state law” after also
inquiring into the Board’s own intent to preempt).
The majority opinion closes its discussion of the
presumption against preemption by describing a “tension”
between the presumption as outlined in Lohr and some
seemingly contrary language in Geier. But the Geier side of this
doctrinal tug-of-war has slippery footing. The quoted
language—“[O]ne can assume that Congress or an agency
ordinarily would not intend to permit a significant conflict,”
22
The majority opinion suggests that, because Hillsborough
County considered field preemption in analyzing the municipal
ordinances at issue, the operation of the Supreme Court’s
application of the presumption against preemption in that case “is
not clear.” I disagree with this suggestion. Hillsborough County’s
discussion of the presumption against preemption appears in Part
III of that opinion. 471 U.S. at 714–16. The field-preemption
analysis in Sections IV.A and IV.B, and the conflict-preemption
analysis in Section IV.C, follow. Id. at 716–20. In my view, the
Court’s purpose in setting out the presumption against preemption
in Part III was to indicate that the presumption should guide the
analysis in all sections of Part IV.
45
Geier, 529 U.S. at 885—appears as a dictum in the context of a
larger discussion of whether an agency must adopt a clear
statement of preemptive intent for a conflict between federal
regulation and state law to exist.23 This sentence does not create
a counter-presumption in favor of preemption, for the very next
sentence in Geier states that “a court should not find pre-emption
too readily in the absence of clear evidence of a conflict.” Id.
That is a restatement of the presumption against preemption,
suggesting that we should not interpret Geier to muddy the
presumption or to dilute its effect.24
When a federal court undertakes a conflict-preemption
analysis, a “significant conflict” between federal and state law
might be the kind of “clear evidence” that could rebut the
presumption against preemption. Geier, 529 U.S. at 885. We
can assume Congress or the FDA had awareness of products-
liability law when legislating or regulating. So if we find a
genuine conflict, we may conclude that Congress intended to
preempt state law. But in situations involving less obvious
conflicts, the presumption against preemption will be more
difficult to overcome.
I would apply the presumption against preemption here.
23
That discussion in Geier settles the issue: an agency need
not do so for a conflict to exist. 529 U.S. at 884–85. Even without
express statutory preemption or a clear agency statement on
preemption, a court may find that state law “actual[ly] conflict[s]”
with federal law under the facts of a particular case. Id. at 884
(quoting English v. Gen. Elec. Co., 496 U.S. 72, 79 (1990)). I
address the broader issue of how much deference we owe an
agency’s position on preemption below. See infra Part II.
24
In contrast, the majority opinion never again mentions the
presumption against preemption after Section IV.A of its opinion,
suggesting that the presumption is performing virtually no
analytical work.
46
The plaintiffs’ failure-to-warn claims stand near the heart of the
states’ police powers over matters of health and safety. And the
existence and detailed nature of the federal scheme does not
change our imperative to require clear congressional intent
(whether expressed directly in a preemption provision or implied
by an authorizing statute enabling an agency to act) to preempt
state tort law.
II. Deference to the FDA’s View on Preemption
At the end of its conflict-preemption analysis—even after
addressing the plaintiffs’ arguments—the majority opinion
considers the FDA’s own view regarding the preemptive effect
of its drug-labeling regulations. In 2006, the preamble to an
FDA revision of its drug-labeling regulations stated that failure-
to-warn claims are preempted if, at the time of injury, the
substance of the alternative warning proposed by plaintiffs (1)
had already been submitted to the FDA and (2) had not been
adopted. 71 Fed. Reg. 3922, 3936 (Jan. 24, 2006). The FDA
also filed an amicus brief in the Colacicco case before us,
arguing that “federal law preempts a state tort claim arising out
of drug manufacturers’ alleged failure to provide a warning that
FDA determined was not scientifically supported.” FDA Br. 16.
The FDA emphasizes that it strives for the optimal strength of
warning. Anything less or more than the FDA-approved and
FDA-monitored warning, in the agency’s view, would be “false
or misleading.” See 21 U.S.C. §§ 331(a)–(b), 352(a); Br. of
Amicus Curiae United States at 2.
We must decide what weight we should give to these
FDA views before analyzing the purported conflict in this case.
I agree with the majority opinion that we should apply Skidmore
deference to the FDA’s informal position contained in its 2006
preamble and its amicus brief in Colacicco. See Geier, 529 U.S.
at 883 (placing “some weight” on the Department of
Transportation’s interpretation of its own airbag regulation);
47
Skidmore v. Swift & Co., 323 U.S. 134, 139 (1944) (giving the
Department of Labor’s “interpretive bulletin” regarding the
calculation of working hours a level of deference based on “all
those factors which give it power to persuade, if lacking power
to control”). The formulation in Mead, which cites Skidmore
and which the majority opinion quotes, designates the following
factors for consideration: “the degree of the agency’s care, its
consistency, formality, and relative expertness, and to the
persuasiveness of the agency’s position.” United States v. Mead
Corp., 533 U.S. 218, 228 (2001).
I disagree with the majority opinion, however, in its
application of the standards articulated in Skidmore and Mead.
Comparing FDA statements from 1979 and 2006, my colleagues
discern “no inconsistency” between them.25 I suggest a better
analysis of inconsistency would take a more detailed view of the
FDA’s position(s) during the 27 intervening years.26 For
25
Importantly, the majority opinion’s quote from the 1979
regulation is taken out of context. Rather than contemplating the
FDA’s relation to state courts, the quoted sentence discusses the
FDA’s relation to panels of experts from which the agency seeks
advice: “Although FDA often refers questions of whether a
warning should be included in the labeling of a drug to its standing
advisory committees, the decision as to whether a warning is
legally required for the labeling of a drug must rest with the
agency.” 44 Fed. Reg. 37,434, 37,447 (June 26, 1979) (emphasis
added). Thus there is no support I can find in the record for the
proposition that, in 1979, the FDA viewed its drug-labeling
regulations as preemptive of state tort law.
26
Some Supreme Court cases suggest that inconsistency is
no bar to deference. See, e.g., Motor Vehicle Mfrs. Ass’n v. State
Farm Mut. Auto Ins. Co., 463 U.S. 29. 42 (1983). But others have
language suggesting that inconsistency counts against the agency’s
position. See, e.g., Bates, 544 U.S. at 449 (finding a preemption
argument “particularly dubious” in light of the EPA’s change in
position within five years).
48
instance, only slightly more than seven years ago the FDA
disavowed any “federalism implications” or preemptive effect of
changes to its requirements for prescription drug labeling. 65
Fed. Reg. 81,082, 81,103 (Dec. 22, 2000). Rather than
maintaining a consistent position, the FDA now undertakes a
“180-degree reversal.” David A. Kessler & David C. Vladeck, A
Critical Examination of the FDA's Efforts to Preempt
Failure-to-Warn Claims, 96 Geo. L.J. 461, 474 n.59 (2008)
(internal quotation marks omitted). Its current position is novel
rather than longstanding. See id. at 462 (“For most of its
seventy-seven-year history [since receiving the name “Food and
Drug Administration” in 1930], the [FDA] has regulated the
drugs sold in the United States without any significant
interaction with the world of state-law damages litigation.”). I
thus conclude that the FDA’s position regarding preemption
deserves little deference by way of its inconsistency.
The majority opinion relies on another of the Skidmore
and Mead factors: agency expertise. Undoubtedly, the FDA has
special expertise in evaluating the scientific evidence on
pharmaceuticals’ safety and efficacy. That expertise should
contribute to any consideration of the proper mix of legal
institutions used to regulate drug labeling. But, as my colleagues
note, “[w]e would ordinarily be leery of an agency’s view of
what is essentially a legal issue.” The FDA is not an expert on
federalism concerns. Nor is the agency the only Government
institution that should bring its perspective to bear on the
relationship between the executive branch and state courts;
Congress, federal courts, and state courts each have a
constitutional responsibility under the Supremacy Clause to
evaluate such issues. Thus, I would consider the FDA’s
expertise only a mild positive in our calculation of how much
deference to apply in these cases.
The remaining factors listed in Mead weigh against
giving the FDA’s view on preemption much deference. With
49
respect to “formality,” the FDA has not engaged in notice-and-
comment rulemaking on this issue, instead promulgating its
views in a preamble to a regulation and a series of amicus briefs
in cases like these. As the majority notes, notice-and-comment
rulemaking is not required to find conflict preemption. See
Geier, 529 U.S. at 885. But the lack of notice-and-comment
rulemaking should, all else equal, reduce the level of deference
we give the FDA’s position. Similarly, the lack of institutional
formality suggests a relatively low “degree of care” taken to
outline its reasoning.27 In my view, a high degree of care on
issues of preemption would involve scholarly, scientific, and
public-health 28 research into the complex matters of law and
policy that these cases implicate. I see no evidence in the record
that the FDA conducted or commissioned independent research
of this nature in preparing the 2006 preamble.
In summary, the Mead factors counsel us to give the
FDA’s position a relatively low level of deference. The ultimate
test under Skidmore is nonetheless whether the FDA’s (and the
defendants’) view has the “power to persuade,” 323 U.S. at 139,
27
By making this point I do not mean to criticize FDA
counsel’s efforts in writing its amicus brief in this case or at oral
argument. On the contrary, counsel performed admirably in both
regards. My focus here is in-depth institutional research on law
and policy preceding the recent “about face” on agency
preemption.
28
A group of public health researchers writes that “[i]ndirect
regulation of the pharmaceutical industry by tort litigation is an
important complement to the regulation of drug safety by the
FDA.” Br. of Amicus Curiae Curt D. Furberg, M.D., Ph.D., et al.
at 6. This view—based on various scholarly, peer-reviewed
articles—does not receive any attention in the 2006 preamble or in
the FDA’s amicus brief. Notice-and-comment rulemaking would
provide a forum for such research to be considered, but, as noted,
the FDA has not undertaken that administrative process on the
issue of preemption of state tort law.
50
an evaluation I take up in Part III.
III. Conflict Preemption.
The defendants’ argument is that labeling that satisfies
the FDA is both the minimum and the maximum amount of
labeling they may do. Under this view, the FDA believes it has
struck the proper balance between safety and efficacy, that is,
between avoiding unintended injuries to patients because of
insufficient warnings while not deterring too many patients from
using drugs that would benefit them because of unjustified over-
warnings. Adding additional warnings unsupported by medical
evidence would subject the defendants to FDA sanctions for
false labeling. Conflict preemption must apply to block state-
law claims for failure to warn, according to the defendants, since
stronger warnings for Paxil and Zoloft—the drugs within the
category of selective seratonin reuptake inhibitors (“SSRIs”)
involved in these cases—would violate FDA regulations. This
makes it impossible, defendants continue, for them to have
complied with both state and federal law. Alternatively,
imposing an overlay of tort liability would frustrate the federal
objective of having the FDA strike the safety-efficacy balance.
For the reasons I describe below, I disagree with this
characterization of the interaction of FDA regulation and state
tort law. Informed by the presumption against preemption, I see
the federal and state constructs as complementary, as they have
been since the 1930s. The majority opinion’s holding of
preemption in these cases, despite an apparently narrow
construction, threatens the institutional framework we have for
balancing safety and efficacy in the pharmaceutical industry
while compensating victims of wrongful injuries.
A. Absence of an Actual Conflict
51
None of the drug manufacturers in these cases attempted
to enhance a warning and received an FDA sanction in response.
The majority opinion correctly states that hypothetical conflicts
can give rise to conflict preemption. But the hypothetical in
question must be convincing for us to allow this. The conflict
the defendants raise relies, at its heart, on the FDA punishing
drug manufacturers for over-warning. But a heightened warning
would likely have its source in new information that the FDA
had not previously known. Thus, I find it hard to believe that, if
a drug manufacturer augmented its warning in response to or in
anticipation of a state tort lawsuit, the FDA would sanction the
manufacturer for over-warning consumers under 21 U.S.C.
§§ 331(a)–(b) and 352(a).
Indeed, drug manufacturers have authority to strengthen
warnings without advance permission from the FDA. The plain
language of 21 C.F.R. § 314.70 permits unilateral additions to
warnings, subject to subsequent FDA approval: “[T]he holder of
an approved application may commence distribution of the drug
product involved upon receipt by the agency of a supplement for
the change,” including such changes as “add[ing] or
strengthen[ing] a contraindication, warning, precaution, or
adverse reaction.” 21 C.F.R. §§ 314.70(c)(6), (c)(6)(iii)(A). The
motivation for additional warnings, which the regulation does
not address, need not come from inside the pharmaceutical
company in question or FDA prodding. In particular, that
motivation may come from a failure-to-warn lawsuit or the threat
of one.
Drug manufacturers have the best information about the
safety of their products. The FDA does not conduct its own drug
trials and “does not have sufficient authority to require
additional clinical trials after drug approval.” Mary J. Davis,
The Battle Over Implied Preemption: Products Liability and the
FDA, 48 B.C. L. Rev. 1089, 1149 (2007). Thus, to avoid
discouraging the party with the best safety information from
52
coming forward, 21 C.F.R. § 314.70 permits a manufacturer to
alter a drug label before the FDA has evaluated and approved the
change.
The defendants and the FDA do not cite even one
example of the FDA punishing a drug manufacturer for over-
warning. See Oral Argument Tr. 82, Dec. 10, 2007 (statement of
FDA counsel that she was “not aware of any instance” in which
the FDA “told a manufacturer who added an increased warning
that that warning was unsubstantiated and caused the drug to be
misbranded”).29 At oral argument, counsel for GlaxoSmithKline
mentioned that, in 2004, the FDA required additional language
in response to a strengthened warning by Wyeth Pharmaceuticals
in a “changes being effected” supplement under 21 C.F.R. §
314.70. Merely requiring a clarification of or addition to
warning language does not strike me as close to being close to a
true conflict. On the contrary, the Wyeth example shows that the
FDA typically engages in a back-and-forth discussion with drug
manufacturers about warnings. In the event of a state tort
lawsuit resulting in a warning that conflicted with the FDA’s
previous judgment, a commonplace dialogue between the
manufacturer and the FDA could produce a warning complying
with both federal regulations and state tort law.
B. Harmony Between Tort Law and FDA Regulation
Tort law and FDA regulation do not have conflicting
29
The majority opinion emphasizes a different fact: that the
FDA, in response to citizen petitions and approvals of new uses for
existing SSRIs, considered requiring a strengthened warning and
declined. I agree that inaction of this kind is a form of agency
action. But more important to me is that the FDA may never have
sanctioned a drug manufacturer that strengthened a warning
without prior FDA approval. This additional example of FDA
inaction suggests that the conflict complained of is not an actual
conflict.
53
goals. Both seek to strike a safety–efficacy balance. Under a
negligence standard, most state courts balance the cost of care
owed to a patient against the prospective harm. See, e.g., La
Russa v. Four Points at Sheraton Hotel, 821 A.2d 1168,
1173–74 (N.J. Super. Ct. 2003) (quoting Judge Learned Hand’s
formula from United States v. Carroll Towing Co., 159 F.2d
169, 173, reh’g denied, 160 F.2d 482 (2d Cir.1947), which
compares the cost of precautions with the expected loss);
cf. Stephen G. Gilles, On Determining Negligence: Hand
Formula Balancing, The Reasonable Person Standard, and the
Jury, 54 Vand. L. Rev. 813, 816–22 (2001) (describing
widespread use of, as well as complications in applying, the
Hand formula).
Properly understood, the cost of additional warnings
includes the consequences of over-warning that the defendants
emphasize and that the FDA similarly takes into account.30 In
reaching its holding of conflict preemption, the majority focuses
on the hypothetical scenario of differing (and presumably
conflicting) results of the FDA regulatory process and state tort
lawsuits. Because we are dealing with hypothetical situations,
however, I would focus on the essential harmony of the
standards applied by the FDA and state courts rather than the
disharmony conjured about the results. Both institutions seek to
balance safety and efficacy. If it turns out those results actually
conflict, then it is time for Congress to step in or at least for the
FDA to propose a rule followed by public comment before
30
Advocates of preemption in these cases point to the
danger of “over-warning” and imply that over-warning will result
from jury decisions biased toward plaintiffs. Br. of Amicus Curiae
Product Liability Advisory Council, Inc. at 14–23. This argument
assumes that juries do not understand that the cost of care,
including the cost of taking too much care, is part of determining
negligence. I presume, for the purposes of analyzing a hypothetical
conflict between federal and state law, that state-court judges will
properly instruct juries about the negligence standard.
54
proclaiming preemption.
Allowing multiple institutions to investigate the difficult
question of how strong to make a warning can have important
benefits. State courts provide a check on agency power. Our
society relies on the FDA to an enormous degree to monitor the
safety of pharmaceuticals. But the FDA’s toolkit is imperfect
and incomplete by design. The FDA relies on the information
provided by drug manufacturers (to repeat, it does no
independent testing), and will always lack the inside perspective
on clinical trials and data analyses stemming from those trials.
Moreover, the FDA is limited as to the additional clinical trials it
may require post-approval, Davis, supra, at 1149 & n.444, and
even “the reporting process for postapproval adverse reaction
events . . . is too weak,” id. at 1149 & n.443. Also, as they play
their parts in the post-approval process the drug manufacturer
and the FDA will not necessarily ask the right questions. The
citizen-petition administrative process was used here
unsuccessfully to seek an FDA requirement of stronger warnings
for SSRIs. Discovery in state tort lawsuits provides a different
way for third parties to raise questions about new and existing
drugs. Given this context, I would not eliminate the potentially
valuable information-gathering tools of state tort law.
To make all this real, I would point out that the regulatory
process at the FDA, even if it allows for submission of citizen
petitions, does not compensate the families of alleged victims
like Lois Colacicco and Theodore DeAngelis. The availability
of damages in state tort lawsuits can give injured citizens the
incentive to come forward and share potentially valuable
information. Even if an injury or death turns out not to have
been caused by a drug or an insufficient warning, that
information, too, can have social value. And the prospect of
paying damages can sharpen drug manufacturers’ incentives to
place appropriate weight on safety as they strike the
safety–efficacy balance. We should not lightly assume this
55
balance now preempted—and by a single recently adopted
preamble at that.
C. Backdoor Federalization
The FDA’s position in these cases is an instance of
“backdoor federalization,” a descriptive term commentators have
recently used to describe a trend in the federal courts toward
finding state law preempted. On the positive side, centralized
federal control can facilitate uniform regulation of a national
market (like that for pharmaceuticals) and prevent states from
interfering with the affairs of other states. Samuel Issacharoff &
Catherine M. Sharkey, Backdoor Federalization, 53 UCLA L.
Rev. 1353 (2006).
Unfortunately, the trend toward federalization is not fully
benign. While the FDA seeks to keep private plaintiffs out of
state court (or federal court applying state law in diversity
actions), a separate line of jurisprudence has limited private
rights of action. There is a “troublesome” contrast in the way
courts now tend to “grant agencies expansive discretion to
interpret or declare the preemptive scope of the regulations they
promulgate, whereas agencies are not given corresponding
latitude to infer private rights of action under those same
regulations.” Catherine M. Sharkey, Preemption by Preamble:
Federal Agencies and the Federalization of Tort Law, 56 DePaul
L. Rev. 227, 258–59 (2007).
Although the FDA should have a strong voice in the
debate among government institutions about preemption of state
tort law, by executive order it must consult with state and local
governments about the consequences of its regulations. See id.
at 252–55 (citing Exec. Order No. 13,132, 64 Fed. Reg. 43,255,
43,257 (Aug. 10, 1999)). But nothing in the record suggests a
dialogue between federal and state officials has occurred
regarding preemption of failure-to-warn lawsuits.
56
I would interpret the absence of an express preemption
statute, the text of the actual FDA regulations, and the late
arrival of the FDA’s statement on preemption in a preamble, as
evidence that state tort law is not displaced. Tort lawsuits can
generate useful information that the FDA can inject into its
regulatory process. And tort damages can aid the FDA in
aligning drug manufacturers’ incentives to find the right balance
between safety and efficacy. In any event, the choice to preempt
state tort law is best left to Congress, should it wish to do so. In
these cases, I do not see the kind of conflict that implies
Congress has made that choice.
IV. Conclusion
The plaintiffs allege that SSRIs increase the risk of
patients committing suicide. They further allege that the drug
manufacturers knew or should have known this, but failed to
label their products appropriately. The defendants would have
us halt any inquiry into their alleged negligence before it starts.
They contend that, in the area of drug labeling, state tort law
renders compliance with federal provisions impossible, or at
least stands as an obstacle to federal objectives.
The FDA, which relies on information provided by
others, seeks to stop one avenue of information—that gathered
from suits under state tort law theories. But should an earlier
series of FDA decisions indicating that the previous warnings
were adequate, when they might be inadequate, preclude the
operation of state tort law? The majority suggests that the
plaintiffs’ claims border on claiming fraud on the FDA. But the
underlying issue in these preemption cases is the structure of
federal–state relations. We must decide whether the FDA will
be the sole decision-maker. Without a clear statement from
Congress or clear evidence that 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
57
(1941), I am reluctant to say that the defendants’ claim of a
conflict has scaled the presumption against preemption.
A holding of no preemption in these cases would not
suggest in any way that the defendant drug manufacturers should
be liable for plaintiffs’ injuries. Like my majority colleagues, I
express no view regarding the relationship between SSRIs and
adult suicide. Allowing the plaintiffs’ cases to proceed beyond
the motion-to-dismiss stage means instead that the state courts
and federal district courts applying state tort law may
evaluate—provide a check on—whether the FDA struck the
right balance in the precautions and warnings it required for
SSRIs.
To review the history of this issue, the FDA has for over
three-quarters of a century viewed state tort law as
complementary to its warning regulations. Only for the last two
years has it claimed otherwise. This “sea change,” Sharkey,
supra, at 242, in the FDA’s conception of the relationship
between federal and state law has not appeared in a regulation
subject to notice and comment, but in a preamble to a regulation.
With this background, I believe courts should fear to tread where
Congress has not given us a clear statement. Because I see
sound legal and policy reasons to hold that the presumption
against preemption is not overcome, I would allow the plaintiffs’
suits to go forward. I respectfully dissent.
58