Case 0:04-cv-02819-JMR-FLN

Document 151

Filed 07/20/2005

Page 1 of 14

UNITED STATES DISTRICT COURT
DISTRICT OF MINNESOTA
04-CV-2819(JMR/FLN)
Kimberly Kay Witczak

)
)
)
)
)

v.
Pfizer, Inc.

ORDER

Defendant, a prescription drug manufacturer, seeks summary
judgment claiming federal preemption bars plaintiff’s state law
failure-to-warn claim.
I.

Defendant’s motion is denied.

Background
On August 6, 2003, Timothy Michael Witczak committed suicide.

His suicide occurred shortly after he began taking Zoloft, a drug
manufactured by defendant.

Plaintiff is Mr. Witczak’s surviving

spouse, and claims his suicide was caused by known side effects ofZoloft.

She further claims defendant is liable for wrongful deathdamages because, among other things, it failed to warn of Zoloft’s
association with “suicidality.”
Zoloft is one of a class of drugs known as Selective Serotonin
Reuptake Inhibitors (“SSRIs”).

Defendant initially submitted the

product for Food and Drug Administration (“FDA”) approval in 1988.
In 1991, the FDA granted approval for the drug’s use in treating
adult depression.

The FDA-approved label did not warn of an

association between Zoloft and suicidality.
“Precautions”
depression.

sectionnoted

suicideasInstead, the label’saninherentriskofCase 0:04-cv-02819-JMR-FLN

Document 151

Filed 07/20/2005

Page 2 of 14

Since granting original approval, the FDA has reapproved
Zoloft several times for treatment of other disorders. As recently
as February, 2003, it approved Zoloft for treatment of Social
Anxiety Disorder.

During the reapprovals, the FDA never suggested

that Zoloft’s label was deficient for failing to warn of a link tosuicidality.1
Claims of an association between SSRIs and suicidality havebeen made since the drugs were first introduced.

In the past 15

years, the FDA has considered three petitions to remove Prozac,
another SSRI, from the market because of the claimed association.
Each petition was denied.2
The FDA changed its position on March 22, 2004, when it issued
a Public Health Advisory recommending that all SSRIs carry awarning calling for “close observation of adult and pediatricpatients treated with these agents for worsening depression or the
emergence of suicidality.”(Pl. Ex. 11 at 1.)

with the FDA’s recommendation.

Defendant complied

Later that year, an FDA panel

issued another Public Health Advisory directing that all SSRI
labels carry a “black-box warning” -- the most serious kind -1

For a more in-depth review of Zoloft’s FDA-approval
proceedings, see Cartwright v. Pfizer, 369 F. Supp. 2d 876 (E.D.
Tex. 2005).
2

In 2002, the FDA filed an amicus brief in a separate action.
See Motus v. Pfizer, 358 F.3d 659 (9th Cir. 2004). Its brief inthat case said any change in the warning to reflect a causal link
between Zoloft and suicidality would create a “false andmisleading” label, in violation of federal law.
2

Case 0:04-cv-02819-JMR-FLN

Document 151

Filed 07/20/2005

Page 3 of 14

warning of “increased risk of suicidality . . . in children andadolescents.”
II.

(Def. Ex. EE at 1.)

Legal Background
Defendant moves for summary judgment, claiming plaintiff’s

state law failure-to-warn claim -- upon which her other claims
allegedly depend -- is preempted by the federal Food, Drug, andCosmetics Act (“FDCA”), and FDA regulations promulgated pursuant to
it.

There

are,

broadly

speaking,

three

kinds

of

preemption:

express preemption, field preemption, and conflict preemption.3
Defendant claims plaintiff’s case is barred by conflict preemption.
Conflict preemption can be either direct or indirect.
conflict(or“impossibility

preemption”)

occurs“whereDirectitisimpossible for a private party to comply with both state andfederal requirements”; indirect conflict (or “obstacle preemption”)
exists “where state law stands as an obstacle to the accomplishment
and execution of the full purposes and objectives of Congress."
English v. General Elec. Co., 496 U.S. 72, 79 (1990) (internal
quotation omitted).
3

Express preemption exists when Congress states a clear intent
to preempt state law. See, e.g., 29 U.S.C. § 1144(a) (ERISA)(“[T]his chapter shall supersede any and all State laws insofar as
they may now or hereafter relate to any employee benefit
plan . . . .”).
Field preemption arises when “Congress haslegislated comprehensively, thus occupying an entire field of
regulation and leaving no room for the States to supplement federal
law.” Louisiana Public Service Comm’n v. F.C.C., 476 U.S. 355, 368(1986). Neither party suggests either express or field preemption
applies here.
The many express preemption cases cited in thebriefs are therefore of limited relevance.
3

Case 0:04-cv-02819-JMR-FLN

Document 151

Filed 07/20/2005

Page 4 of 14

Because conflict preemption is based on the presumed (rather
than stated) intent of Congress, courts are advised to apply it
sparingly.

According to the Supreme Court, “a court should not

find pre-emption too readily in the absence of clear evidence of aconflict.”Geier v. American Honda Motor Co., Inc., 529 U.S. 861,

885 (2000); see also Gade v. Nat’l Solid Wastes Mgmt. Ass’n, 505
U.S. 88, 110 (1992) (Kennedy, J., concurring) (“Any conflict mustbe irreconcilable.
conflictis

The existence of a hypothetical or potential

insufficienttowarrant

preemptionofstatute.”) (internal omission and quotation omitted).

the

state

Rather, a

court should presume “that the historic police powers of the States
were not to be superseded by the Federal Act unless that was theclear and manifest purpose of Congress.” New York State Conferenceof Blue Cross & Blue Shield Plans v. Travelers Ins. Co., 514 U.S.
645, 655 (1995) (internal quotation omitted).

The Supreme Court

has recognized “the historic primacy of state regulation of mattersof health and safety.”

Medtronic, Inc. v. Lohr, 518 U.S. 470, 485(1996).
III.

Discussion
According to defendant, plaintiff’s failure-to-warn claim

conflicts both directly and indirectly with federal food and druglaws.

Defendant first argues that the state law duty-to-warn

requirement directly conflicts with both the FDA’s requirement thatit use “verbatim” the label specified by the agency, and with the4Case 0:04-cv-02819-JMR-FLN

Document 151

Filed 07/20/2005

Page 5 of 14

FDA’s prohibition on “false and misleading” labels.

Defendant

alternatively argues that the failure-to-warn claim indirectly
conflicts with the FDCA’s goal of providing only scientificallyaccurate drug-label information.

Defendant’s contentions arewithout merit.
a.

Direct Conflict
1.

“Verbatim”

Defendant argues that if it had warned of an association
between Zoloft and suicidality, it would have violated the FDA’sorder to use the FDA-approved warning-label language “verbatim.”4
But FDA regulations explicitly permitted defendant to unilaterally
strengthen its warning label at any time without regulatory preapproval.

21 C.F.R. § 314.70(c)(6)(iii)(A).5

This particularregulation

wasdrug-makers

promulgatedprecisely

to

allow

to

quickly strengthen label warnings when evidence of new side effects
are discovered.

See 30 Fed. Reg. 993 (Jan. 30, 1965).

Thus, asthe FDA has noted, the regulation “permits the addition to the
drug’s labeling or advertising of information about a hazard

4

The word “verbatim” appears only in the FDA “approvableletter” to Pfizer -- not in any of the misbranding statutes orregulations. (See Def. Ex. F at 1 (“Please use the proposed text
verbatim.”).)
5

The regulation was originally codified at 21 C.F.R. §130.9(d); it then became 21 C.F.R. § 314.8(d), before finallybecoming 21 C.F.R. § 314.70(c).
See 56 Fed. Reg. 59288, 59290(Nov. 25, 1991).
5Case 0:04-cv-02819-JMR-FLN

Document 151

Filed 07/20/2005

Page 6 of 14

without advance approval” by the FDA. 44 Fed. Reg. 37447 (June 26,1979).
Defendant denies that § 314.70 defeats preemption because it
gives manufacturers only temporary authority to strengthen theirlabels.

The Court does not agree.

The FDA’s regulations do grant

it the power to later disapprove a label strengthened pursuant to§ 314.70.

21 C.F.R. § 314.70(c)(7).

But the regulation “does not

require that FDA take any action when a manufacturer” makes achange pursuant to § 314(c); if the FDA does nothing, the changeremains in effect.

See 56 Fed. Reg. 59290 (Nov. 25, 1991).

Further, even if exercised, the power to disapprove does not
retroactively

make

the

violation of any law.

manufacturer’s

strengthened

label

a

Rather, if the FDA exercises its power todisapprove, the manufacturer simply stops distributing the newlabel.

21 C.F.R. § 314.70(c)(7).

Thus, the Court finds no absolute duty to use the FDA-approved
label “verbatim.”

Pursuant to § 314.70(c), defendant could havestrengthened its label to warn of the alleged association between
Zoloft and suicidality at any time.

Accordingly, it was not“impossible for [defendant] to comply with both state and federal
requirements.”
2.

English, 496 U.S. at 79.
“False and Misleading”

Defendant next asserts that a unilateral change in its warninglabel which suggested a link between SSRIs and suicidality would
6

Case 0:04-cv-02819-JMR-FLN

Document 151

Filed 07/20/2005

Page 7 of 14

have rendered the label “false and misleading,” and in directconflict

with

21

U.S.C.

§

355(e),

themisbranding

statute.

Defendant bolsters this argument by pointing to a series of FDA
pronouncements.

The flaw in defendant’s argument is that, as set

forth below, none of the FDA’s statements has the force of law.

Sonone made it “impossible” for defendant to comply with Minnesota’s
failure-to-warn law.
A.

The Motus Amicus Brief

Defendant proffers the FDA’s amicus brief in Motus v. Pfizerin support of its position.

358 F.3d 659 (9th Cir. 2004) brief

available at 2002 WL 32303084.6

There, the FDA -- which has sincemodified its own position -- avers that it would have deemed any
warning of a causal link between Zoloft and suicidality to be false
and misleading. (Brief at p. 14.) These assertions do not preempt
state law.
The FDA is authorized to promulgate regulations which have thepreemptive force of law, so long as the regulations are properly
adopted and in accord with its statutory authority.
New York v. F.C.C., 486 U.S. 57, 63-64 (1988).

E.g. City of

And an agency’s

interpretations of its own regulations are ordinarily entitled togreat deference.

See generally Chevron U.S.A., Inc. v. Natural

Resources Defense Council, Inc., 467 U.S. 837 (1984).
6

Plaintiff moved to strike evidence of the Motus brief.
Defendant also brought a motion to strike evidence of certain FDA
statements. Both motions were denied at the hearing.
7

Case 0:04-cv-02819-JMR-FLN

Document 151

Filed 07/20/2005

Page 8 of 14

The Court, however, declines to treat statements from a single
FDA legal brief as declarations afforded the preemptive force oflaw.

First, the propositions defendant cites from the Motus brief

were not even addressed or considered by the Motus court itself.
See Motus, 358 F.3d at 661 (affirming district court’s holding thatplaintiff

could

not

establish

causality

without

reachingthepreemption issue). Second, the FDA has since distanced itself fromthe substance of the Motus brief by recommending labeling changes
that, in fact, reflect concerns about the association between SSRIs
and suicidality.

Thus, the Court has “reason to suspect that the[Motus brief’s] interpretation does not reflect the agency’s fairand considered judgment on the matter in question.”

Auer v.

Robbins, 519 U.S. 452, 462 (1997).
Furthermore, even if the Court credited the Motus brief as an
attempt by the FDA to articulate an official agency position, it
would still fail to preempt plaintiff’s claim. This is because the
FDA has no authority to declare, ipse dixit, that a label is false
andmisleading.

Rather,totheestablish

government

enforcement

actionthatthemisbranded.

See 21 U.S.C. §§ 331-37, 352.

must

initiate

drug

is

in

an
fact

For all of thesereasons, the statements in the Motus brief are insufficient topreempt plaintiff’s failure-to-warn claim.

8Case 0:04-cv-02819-JMR-FLN

B.

Document 151

Filed 07/20/2005

Page 9 of 14

The Reapprovals

Defendant next suggests the FDA would have regarded any
unilateral label change to be “false and misleading” by pointing to
the FDA’s frequent reapproval of Zoloft without any changes to its
warnings or its label.

This suggestion fails to recognize that

“FDA regulations are generally minimum standards of conduct” unless
Congress has expressed clear intent to preempt state common law,which it has not done here.

Hill v. Searle Laboratories, 884 F.2d1064, 1068 (8th Cir. 1989); see also Wells v. Ortho Pharm. Corp.,
788 F.2d 741, 746 (11th Cir. 1986) (“An FDA determination that awarning is not necessary may be sufficient for federal regulatory
purposes

but

still

purposes.”).

not

be

sufficient

for

state

tort

law

As a result, rather than acting as a mandate, thereapprovals merely confirmed the minimum labeling requirements.
They

do

not

prove

that

a

label

strengthened

pursuant

to§ 314.70(c)(6)(iii)(A) would necessarily be “false and misleading.”
In sum, Pfizer’s claim of direct conflict rests on its own
assumptions of what the FDA would have done if defendant had
unilaterally strengthened its warning label.

The validity andauthority of state law, however, does not depend on speculative
hypotheticals.
concurring).

See

Gade,

505

U.S.

at

110

(Kennedy,J.,

The Court cannot find that defendant has establisheda direct conflict.

9

Case 0:04-cv-02819-JMR-FLNb.

Document 151

Filed 07/20/2005

Page 10 of 14

Indirect Conflict

Defendant also claims that complying with Minnesota’s duty-towarn regime would have created an indirect conflict. It claims any
warning of a possible link between Zoloft and suicidality would
have frustrated Congress’s goal of ensuring the scientific validityof drug label information.

Specifically, defendant posits that

failure-to-warn laws pressure drug manufacturers to paper theirlabels with unsubstantiated warnings in order to avoid lawsuits.
Defendant claims this undercuts the FDA’s mission to provide only
scientificallyvalidefficacious drugs.

warnings,

andover-deters

the

use

of

The Court considers this a public policy

argument gone awry.
It is obvious that state failure-to-warn laws do not pressure
manufacturers to include false or invalid warnings.

Instead, theygive drug manufacturers every incentive to warn of real, known
risks as soon as they are discovered -- even before any FDA action.
This does not conflict with the FDCA’s purposes and objectives. To
thecontrary,

FDA

regulations

allow

drug

manufacturers

tostrengthen warning labels “in the interest of drug safety” at any
time without FDA pre-approval precisely so that new warnings can be“placed into effect at the earliest possible time” and “to enable

10Case 0:04-cv-02819-JMR-FLN

Document 151

prompt adoption of such changes.”

Filed 07/20/2005

Page 11 of 14

30 Fed. Reg. 993 (Jan. 30,1965).7
This regulation underscores the crucial flaw in defendant’s
argument:

Congress certainly did not intend to bar drug companies

from protecting the public when enacting the FDCA; its goal was toprotect the public.

See, e.g., F.D.A. v. Brown & Williamson

Tobacco Corp., 529 U.S. 120 (2000) (“The labeling requirements
currently imposed by the FDCA . . . require the FDA to regulate thelabeling

of

drugs

and

devices

toprotect

thesafetyofconsumers.”); United States v. Sullivan, 332 U.S. 689, 696 (1948)(“[T]he Act as a whole was designed primarily to protect consumers
fromdangerous

products.”).

Anycontrary

interpretationofCongress’s intent is perverse.
The FDA itself vindicated Congress’s protective intent when it
issued its March 22, 2004, Public Health Advisory, recommendingthat SSRI labels be modified to reflect potential suicide risks.
The FDA noted in the Advisory that it had “not concluded that [SSRI
side effects] are a precursor to either worsening of depression or
the emergence of suicidal impulses,” but it still recommended thelabel change to alleviate “concern.”words:(Pl. Ex. 11 at 1.)

In other“Safety first.”

7

Prior to 1965, FDA regulations prohibited drug companies fromstrengthening their warnings without prior regulatory approval.
See Caraker v. Sandoz Pharm. Corp., 172 F. Supp. 2d 1018, 1034-35(S.D. Ill 2001) (citing 25 Fed. Reg. 12,592, 12,595 (Dec 9, 1960)).
11

Case 0:04-cv-02819-JMR-FLN

State

Document 151

consumer-protectionlaw

Filed 07/20/2005

Page 12 of 14

compliments,

ratherfrustrates, the FDA’s protective regime.

thanThis is especiallyapparent when one considers that prescription drugs were once
marketedprimarily

totrainedhealthsophisticated and discerning intermediaries.

care

providers--

Today, on the other

hand, pill-rolling apothecaries and the mortar and pestle havedisappeared.

They have been replaced by drug manufacturers whourge the use of their drugs in mass-market print and television
advertisements targeted directly at the public.

Defendant, forexample, advertises the drug involved in this case by personifying
it as a happy, bouncing-oval cartoon character.
This new drug-marketing environment calls out for enhanced
consumer protection.

But defendant urges the Court to findCongress intended to obviate the very state laws that provide
remedies to consumers harmed by dangerous products and deceptive
marketing.

The Court finds this proposition untenable in theabsence of a clear and compelling Congressional statement.

See

Bates v. Dow Agrisciences LLC, 125 S. Ct. 1788, 1802 (2005) (“IfCongress

hadintendedtodepriveinjuredparties

of

a

long

available form of compensation, it surely would have expressed that
intent more clearly.”).
Defendant’s extended argument -- that too many warnings will
dilute the effectiveness of warnings in general, and thereby underdeter the use of dangerous drugs -- is similarly unavailing.
12

Drug

Case 0:04-cv-02819-JMR-FLN

Document 151

Filed 07/20/2005

Page 13 of 14

companies’ pursuit of the public is sufficient to deter them fromrecklessly warning of unsubstantiated associations between theirproducts and dire risks to health. State law need not be preemptedto accomplish this.
Finally, defendant’s argument that it should not be exposed to
fifty-one separate tort-law regimes also rings hollow.

Most massmerchants in this nation’s economy sustain this burden as a cost of
doing business. If Congress intends to create a class of protectedbusinesses, it has the means and ability to do so.

The Court finds

no proof that it has done so here.
IV.

Conclusion
Defendant’s preemption argument has a surface appeal:

Shouldit face state law liability for a failure to warn even though its
label fully complied with federal law? But the argument fails upon
scrutiny. Federal labeling laws are minimum standards; they do notnecessarily shield manufacturers from state law liability.

The

primary purpose of both the FDCA and the FDA’s regulatory scheme isto protect the public. State-law protections reinforce and enhance
this objective.
Defendant’s

preemption

argument

ultimately

fails

becauseCongress has not expressed a specific intent to preempt state
consumer-protection laws in the area of prescription-drug labeling.
In the absence of Congress’s express statement, defendant mustovercome the presumption against implying Congressional preemptive
13

Case 0:04-cv-02819-JMR-FLN

intent.

Document 151

It has not done so.

Filed 07/20/2005

Page 14 of 14

As a result, plaintiff’s state law

claims remain viable.
Accordingly, for all of the foregoing reasons, IT IS ORDERED
that:
1.

Defendant’s motion for summary judgment [Docket No. 15]
is denied.

2.
Dated:The motions to strike [Docket Nos. 66 & 97] are denied.
July 20, 2005s/ James M. Rosenbaum
JAMES M. ROSENBAUM
United States Chief District Judge

14