UNITED STATES
DISTRICT COURT
FORTHE
DISTRICT
OF
COLUMBIA
R.J. REYNOLDS
TOBACCO
COMPANY,
LORILLARD TOBACCO
COMPANY,
COMMONWEALTH
BRANDS, INC.,
LIGGETT
GROUP
LLC,and
SANT A
FE
NATURAL
TOBACCO
COMPANY, INC.,Plaintiffs,
v.
UNITED STATES FOOD AND DRUGADMINISTRA TION,MARGARET HAMBURG, Commissioner
of
theUnited States Food
and Drug
Administration,
andKATHLEEN
SEBELIUS, Secretary
of
theUnited States
Department
of
Health
and Human
Services,Defendants.
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) Civil Case
No.
11-1482
(RJL)
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MEMORANDUMOPINION
November
!/-'
2011 [Dkt.
#
11]
Plaintiffs in this case ("plaintiffs") are five tobacco companies, which include thesecond-, third-, and fourth-largest tobacco manufacturers and the fifth-largest cigarettemanufacturer in the United States. Complaint ("Compl."), Aug. 16, 2011,
~~
8-12 [Dkt.
Case 1:11-cv-01482-RJL Document 38 Filed 11/07/11 Page 1 of 29
#1]. In June 2011, defendant United States Food and Drug Administration ("FDA")published a Final Rule requiring (among other things) the display
of
nine new textualwarnings -along with certain graphic images
1
such as diseased lungs and a cadaverbearing chest staples on an autopsy table -on the top 50%
of
the front and back panels
of
every cigarette package manufactured and distributed
in
the United States on or afterSeptember
22,2012.
See
FDA, Required Warnings for Cigarette Packages andAdvertisements, 76 Fed. Reg. 36,628 (June 22, 2011) ("the Rule");
see also
PIs.' Mot. forPreliminary Injunction ("Mot. for PI"), Aug. 19, 2011, at
1-3
[Dkt. # 11]. Alleging thatthe Rule violates the First Amendment and the Administrative Procedure Act ("AP A"), 5U.S.C.
§§
553(b)(3), 705, 706(2)(A),
see
CompI.,-r,-r
5-6, plaintiffs now seek apreliminary injunction against the FDA, the Secretary
of
the U.S. Department
of
Healthand Human Services ("the Secretary"), and the Commissioner
of
the
FDA
("theCommissioner" and together, "defendants" or "the Government"), to enjoin enforcement
of
the Rule until fifteen months
after
resolution
of
plaintiffs' claims on the merits.
2
Mot.for PI at
1,
5-6. As such, plaintiffs raise for the first time in our Circuit the question
of
whether the
FDA's
new and mandatory graphic images, when combined with certainThe FDA conveniently refers to these graphic images as "graphic warnings."While characterizing the mandatory textual statements as "warnings" seems to be a fairand accurate description, characterizing these graphic images as "warnings" strikes me asinaccurate and unfair. At first blush, they appear to be more about shocking and repellingthan warning. Accordingly, I will refer to them simply as graphic images, and set thisself-serving "warning" label aside for closer analysis on another day.Plaintiffs filed a Motion for Summary Judgment [Dkt. # 1
0]
on the same day theyfiled their Motion for Preliminary Injunction [Dkt. # 11]. The Motion for SummaryJudgment, however, is not before the Court today.
2
Case 1:11-cv-01482-RJL Document 38 Filed 11/07/11 Page 2 of 29
textual warnings on cigarette packaging, are unconstitutional under the First Amendment.Upon review
of
the pleadings, the parties' supplemental pleadings, oral argument, theentire record, and the applicable law, the Court concludes that plaintiffs havedemonstrated a substantial likelihood that they will prevail on the merits
of
their positionthat these mandatory graphic images unconstitutionally compel speech, and that they willsuffer irreparable harm absent injunctive relief pending a judicial review
of
theconstitutionality
of
the
FDA's
Rule. For that and the other reasons stated herein, I herebyGRANT plaintiffs' Motion for Preliminary Injunction.
3
BACKGROUND
I.
Statutory and Regulatory History
A.
The Act
The Family Smoking Prevention and Tobacco Control Act ("Act" or "the Act"),Pub. L. No. 111-31,
123
Stat. 1776 (2009), which President Obama signed into law onJune 22, 2009, gives the FDA the authority to regulate the manufacture and sale
of
tobacco products, including cigarettes.
4
Defs.'
Opp'n
at
1.
Pursuant to that authority,Plaintiffs bring both First Amendment and APA claims. At the September 21,2011 hearing, however, all parties agreed that
if
plaintiffs prevailed on their FirstAmendment claim, resolution
of
the APA claim would be superfluous.
See
Tr. 68:10-19(Government), 71:
17
-22 (plaintiffs). Because plaintiffs prevail on their First Amendmentclaim, an analysis
of
the AP A claim
is
unnecessary.Plaintiffs note that preceding the Act, and indeed, "[f]or more than
45
years,cigarettes sold in the United States have been accompanied by various Surgeon GeneralWarnings," and that "Plaintiffs have never brought a legal challenge to any
of
them."CompI.
~
1.
3
Case 1:11-cv-01482-RJL Document 38 Filed 11/07/11 Page 3 of 29
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Judge Extinguishes Cigarette Warning Label Law
A federal district court judge in Washington D.C. has issued a preliminary injunction blocking enforcement of new rules by the Food and Drug Administration that require cigarette manufacturers to display graphic warning labels on every pack…
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