UNITED STATES DISTRICT COURT
FOR THE 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. ) Civil Case No. 11-1482 (RJL)
)
UNITED STATES FOOD AND DRUG )
ADMINISTRA TION, )
)
MARGARET HAMBURG, Commissioner of the )
United States Food and Drug Administration, )
)
and )
)
KATHLEEN SEBELIUS, Secretary of the )
United States Department of Health )
and Human Services, )
)
Defendants. )
~
MEMORANDUM OPINION
November !/-'
2011 [Dkt. # 11]
Plaintiffs in this case ("plaintiffs") are five tobacco companies, which include the
second-, third-, and fourth-largest tobacco manufacturers and the fifth-largest cigarette
manufacturer in the United States. Complaint ("Compl."), Aug. 16, 2011, ~~ 8-12 [Dkt.
#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 textual
warnings - along with certain graphic images 1 such as diseased lungs and a cadaver
bearing 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 after
September 22,2012. See FDA, Required Warnings for Cigarette Packages and
Advertisements, 76 Fed. Reg. 36,628 (June 22, 2011) ("the Rule"); see also PIs.' Mot. for
Preliminary Injunction ("Mot. for PI"), Aug. 19, 2011, at 1-3 [Dkt. # 11]. Alleging that
the Rule violates the First Amendment and the Administrative Procedure Act ("AP A"), 5
U.S.C. §§ 553(b)(3), 705, 706(2)(A), see CompI.,-r,-r 5-6, plaintiffs now seek a
preliminary injunction against the FDA, the Secretary of the U.S. Department of Health
and Human Services ("the Secretary"), and the Commissioner of the FDA ("the
Commissioner" 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 certain
The FDA conveniently refers to these graphic images as "graphic warnings."
While characterizing the mandatory textual statements as "warnings" seems to be a fair
and accurate description, characterizing these graphic images as "warnings" strikes me as
inaccurate and unfair. At first blush, they appear to be more about shocking and repelling
than warning. Accordingly, I will refer to them simply as graphic images, and set this
self-serving "warning" label aside for closer analysis on another day.
Plaintiffs filed a Motion for Summary Judgment [Dkt. # 10] on the same day they
filed their Motion for Preliminary Injunction [Dkt. # 11]. The Motion for Summary
Judgment, however, is not before the Court today.
2
textual warnings on cigarette packaging, are unconstitutional under the First Amendment.
Upon review of the pleadings, the parties' supplemental pleadings, oral argument, the
entire record, and the applicable law, the Court concludes that plaintiffs have
demonstrated a substantial likelihood that they will prevail on the merits of their position
that these mandatory graphic images unconstitutionally compel speech, and that they will
suffer irreparable harm absent injunctive relief pending a judicial review of the
constitutionality of the FDA's Rule. For that and the other reasons stated herein, I hereby
GRANT 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 on
June 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 First
Amendment 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 Amendment
claim, 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 General
Warnings," and that "Plaintiffs have never brought a legal challenge to any of them."
CompI. ~ 1.
3
Congress - following the lead of the Canadian governmentS - directed the Secretary to
"issue regulations that require color graphics depicting the negative health consequences
ofsmoking.,,6 See Pub. L. No. 111-31, § 201(a) (amending 15 U.S.c. § 1333(d)); Compl.
,-r 31; Defs.' Opp'n at 1. In addition, Congress required all cigarette packages
manufactured, packaged, sold, distributed, or imported for sale or distribution within the
United States to bear one of the following nine textual warnings:
"WARNING: Cigarettes are addictive.
WARNING: Tobacco smoke can harm your children.
WARNING: Cigarettes cause fatal lung disease.
WARNING: Cigarettes cause cancer.
WARNING: Cigarettes cause strokes and heart disease.
WARNING: Smoking during pregnancy can harm your baby.
WARNING: Smoking can kill you.
WARNING: Tobacco smoke causes fatal lung disease in nonsmokers.
WARNING: Quitting smoking now greatly reduces serious risks to your
health.,,7 Act § 201(a) (amending 15 U.S.C. § 1333(a)(l)).
It is no secret that the Congress was greatly influenced in the drafting and passage
of this aspect of the legislation by the example of our northerly neighbors. See, e.g.,
Defs.' Opp'n at 2,9, 11-13, 18-20.
6
The statute also vests a certain amount of discretion in the Secretary, who "may
adjust the type size, text and format of the label statements specified in subsections (a)(2)
and (b )(2) as the Secretary determines appropriate so that both the graphics and the
accompanying label statements are clear, conspicuous, legible and appear within the
specified area." Pub. L. No. 111-31, § 201 (amending 15 U.S.C. § 1333(d)).
The Act also imposes a number of related labeling requirements which require that
cigarette packages display specific information about, for example, the tobacco
4
Congress required that these new textual warnings and graphic images occupy the
top 50% of the front and back panels of all cigarette packages, Act § 201 (a) (amending
15 U. S. C. § 13 3 3(a)(2)), and the top 20% of all printed cigarette advertising, id.
(amending 15 U.S.c. § 1333(b)(2)). It gave the FDA "24 months after the date of
enactment" of the Act to issue regulations implementing the requirements of Section 201.
Act § 201(a) (amending 15 U.S.C. § 1333(d)); see also CompI. ~ 33. Finally, under the
Act, the new textual warnings and graphic-image labels (and the related requirements)
were scheduled to take effect 15 months after issuance of the Rule. Act § 201(b) (note on
amending 15 U.S.C. § 1333).
B. The Rule
1. Proposed Rule
On November 12,2010, the FDA submitted for public comment a Proposed Rule
unveiling therewith 36 graphic color images that could be displayed with the 9 new
textual warnings created by Congress. s Required Warnings for Cigarette Packages and
Advertisements, 75 Fed. Reg. 69,524; 69,534-69,535 (Nov. 12,2010) (to be codified at
21 C.F.R. Part 1141); see also CompI. ~~ 36,38; Defs.' Opp'n at 11. In addition, the
Proposed Rule required cigarette packaging and advertising to include "a reference to a
smoking cessation assistance resource" and set forth related requirements for what that
manufacturer and the quantity of tobacco contained in the product. See Act § 101(b); see
also Pis.' Mot. for PI at 2.
The proposed images were not only in color, but some were also cartoon images,
as opposed to staged photographs; and some were at least arguably enhanced, using either
actors or technological augmentation to achieve the desired effect. See CompI. ~ 38.
5
resource must provide. 75 Fed. Reg. 69,564 (proposing 21 C.F.R. § 1141.16(a)); see also
Compl. ~ 39. Finally, as part of its preliminary benefits analysis, the FDA estimated that
"the U.S. smoking rate will decrease by 0.212 percentage points" as a result of the
Proposed Rule,9 75 Fed. Reg. 69,543 (emphasis added), a statistic the FDA admits is "in
general not statistically distinguishable from zero."IO Id. at 69,546; see also Compl.
2. Final Rule
After a period of notice and comment in which the FDA reviewed more than 1,700
comments, it published a Final Rule on June 22, 2011. See 76 Fed. Reg. 36,628-36,629;
9 The FDA prefaced its calculation with the following statement: "Estimation of the
effectiveness of the proposed rule (on reducing the future U.S. smoking rate) is subject to
a large uncertainty that is not fully reflected in the benefits estimates appearing in the
preceding sections, which only reflect different estimates of the value of a statistical life
year." 75 Fed. Reg. 69,546. Yet despite whatever statistical uncertainty may have
existed, the FDA nevertheless calculated and relied upon a 0.212 percentage-point
change in the smoking rate as part of its justification for the Proposed Rule.
10 Indeed, the FDA's estimated reduction in U.S. smoking rates decreased from
.212% in the Proposed Rule to .088% in the Final Rule. Compare 75 Fed Reg. 69,543
with 76 Fed. Reg. 36,721. See also 76 Fed. Reg. 36,724 (further explaining the "FDA's
estimate of a 0.088 percentage point reduction in the U.S. smoking rate"). Plaintiffs
suggest that the decrease could be attributed to the FDA considering (for the first time) a
confounding factor - the difference between Canadian and U.S. tax rates - in the Final
Rule analysis. See Compl. ~ 62.
II The Proposed Rule is replete with additional research and statistics on which the
FDA relied to formulate its proposal. But a merits evaluation of that information - such
as research regarding similar graphic warnings in Canada, see Compl. ~~ 40-46; Defs.'
Opp'n at 18-20,22-26, and an FDA-sponsored study assessing the effectiveness of its
proposed graphic warnings, see Compl. ~~ 47-54; Defs.' Opp'n at 11,27-30 - is not
necessary here, where the threshold issue is whether injunctive relief is warranted based
on plaintiffs' First Amendment claim - not whether defendants prevail on the merits.
6
CompI. ~ 57. Of the 36 graphic images originally proposed, the FDA chose 9 for
publication. See CompI. ~~ 57-58. The new graphic images, which will rotate according
to an agency-approved plan, Act § 201(a) (amending 15 U.S.C. § 1333(c)(2)); Compi.
~ 30, include color images of a man exhaling cigarette smoke through a tracheotomy hole
in his throat; a plume of cigarette smoke enveloping an infant receiving a kiss from his or
her mother; a pair of diseased lungs next to a pair of healthy lungs; a diseased mouth
afflicted with what appears to be cancerous lesions; a man breathing into an oxygen
mask; a bare-chested male cadaver lying on a table, and featuring what appears to be
post-autopsy chest staples down the middle of his torso; a woman weeping
uncontrollably; and a man wearing a t-shirt that features a "no smoking" symbol and the
words "I Quit." See CompI. ~~ 57, 59. An additional graphic image appears to be a
stylized cartoon (as opposed to a staged photograph) of a premature baby in an incubator.
Id. Plaintiffs allege, on information and belief, that many of these images are
technologically manipulated,12 enhanced, or animated, or that they depict actors to
achieve the desired image. See id. ~ 59; see also Tr. at 11: 17-20. And indeed, the FDA
cited these nine images' "salience" - defined at various points as a warning's ability to
evoke emotion - as a primary selection criterion. 13 76 Fed. Reg. at 36,639.
12 The FDA does not dispute that "some of the photographs were technologically
modified to depict the negative health consequences of smoking," although it insists that
"the effects shown in the photographs are, in fact, accurate depictions of the effects of
sickness and disease caused by smoking." Defs.' Opp'n at 26 (quoting 76 Fed. Reg. at
36,696).
13 The Rule reads, in pertinent part: "First, many of the proposed required warnings
elicited significant impacts on the salience measures (emotional and cognitive measures),
7
In addition to being paired with one of the nine new textual warnings introduced
by Congress, each of the graphic images prominently displays "1-800-QUIT-NOW": a
telephone number the FDA selected to fulfill its own regulatory obligation to offer
smoking cessation assistance on each package. 76 Fed. Reg. 36,686-36,687, 36,754-
36,755; see also CompI. ~~ 57,60. Based on the 15-month implementation period set out
by Congress, see Act § 201(a) (amending 15 U.S.C. § 1333), the new textual warnings
and graphic images are scheduled to take effect for all cigarette packages manufactured
on or after September 22, 2012, and for all cigarette packages introduced into commerce
on or after October 22,2012. See Act § 201(b) (note on amending 15 U.S.c. § 1333); see
also Mot. for PI at 3. In response to the Final Rule, plaintiffs filed a Motion for
Preliminary Injunction on August 19,2011; defendants responded on September 9,2011;
and oral argument was held on September 21, 2011.
ANALYSIS
I. Standard of Review
The factors a court must consider in determining whether to grant injunctive relief
which the research literature suggests are likely to be related to behavior change (Ref.
51). For example, the literature suggests that risk information is most readily
communicated by messages that arouse emotional reactions (see Ref. 45), and that
smokers who report greater negative emotional reactions in response to cigarette
warnings are significantly more likely to have read and thought about the warnings and
more likely to reduce the amount they smoke and to quit or make an attempt to quit (Ref.
44). The research literature also suggests that warnings that generate an immediate
emotional response from viewers can result in viewers attaching a negative affect [sic] to
smoking (i.e., feel bad about smoking), thus undermining the appeal and attractiveness of
smoking (Ref. 45 and Ref. 40 at pp. 37-38)." 76 Fed. Reg. at 36,639 (emphasis added).
8
are, of course, familiar: 14 "( 1) whether there is a substantial likelihood of success on the
merits; (2) whether the movant will suffer irreparable harm if the injunction is not
granted; (3) whether the injunction will substantially injure other interested parties; and
(4) whether the public interest would be furthered by the injunction." Ivax Pharms., Inc.
v. FDA, No. 04-1603, 2004 U.S. Dist. LEXIS 29223, at *1-2 (D.D.C. Sept. 17,2004)
(citing Mova Pharm. Corp. v. Shalala, 140 F.3d 1060,1066 (D.C. Cir. 1998)).
Importantly, "[t]he party seeking a preliminary injunction need not prevail on each
factor." Smoking Everywhere, Inc. v. FDA, 680 F. Supp. 2d 62, 66 (D.D.C. 2010).
Indeed, courts may apply the factors on a "sliding scale," Davis v. Pension Benefit Guar.
Corp., 571 F.3d 1288, 1291 (D.C. Cir. 2009), and "[i]fthe arguments for one factor are
particularly strong, an injunction may issue even if the arguments in other areas are rather
weak." Smoking Everywhere, 680 F. Supp. 2d at 66 (quoting CityFed Fin. Corp. v.
Office a/Thrift Supervision, 58 F.3d 738, 747 (D.C. Cir. 1995)). A "very strong showing
of irreparable harm," for example, absent "substantial harm to the non-movant" may
warrant application of "a correspondingly lower standard ... for likelihood of success."
Davis, 571 F.3d at 1292. Similarly, "a greater likelihood of [the movant's] success will
militate for a preliminary injunction unless particularly strong equities favor the [non-
moving] parties." FTC v. Whole Foods MIa., Inc., 548 F.3d 1028, 1035 (D.C. Cir. 2008).
As an initial matter, defendants challenge this Court's authority to award
14 The factors are the same under constitutional or APA review. See 5 U.S.C. § 705;
Fed. R. Civ. P. 65; see also Affinity Healthcare Servs., Inc. v. Sebelius, 720 F. Supp. 2d
12, 15 n.4 (D.D.C. 2010) ("Motions to stay agency action pursuant to these provisions are
reviewed under the same standards used to evaluate requests for interim injunctive
relief.").
9
injunctive relief in this case at all. See, e.g., Defs.' Opp'n at 3, 35-37; Tr. at 38-4l.
Because plaintiffs ask the Court to postpone the effective date of the Rule for a period
after final judgment - instead of requesting a stay of agency action pending final
judgment - defendants contend that plaintiffs' request for preliminary injunctive relief is,
by definition, inappropriate. Id. I disagree. See, e.g., Fed. Trade Comm 'n v.
Weyerhaeuser Co., 665 F .2d 1072, 1084 (D.C. Cir. 1981) (recognizing party's ability to
challenge the validity of a law before its enforcement to avoid irreparable injury as
deriving from "equity practice with a background of several hundred years").
Like plaintiffs, I reject the notion that this Court does not have the inherent
equitable power to issue relief in this case. See, e.g., Fed. R. Civ. P. 65; Friendsfor All
Children, Inc. v. Lockheed Aircraft Corp., 746 F.2d 816,834 (D.C. Cir. 1984) (a district
court may "properly employ [] its inherent equitable powers ... to prevent plaintiffs from
suffering irreparable injury"); see also Reply at 22-23. Indeed, this Court's equitable
powers extend even farther, "beyond the matters immediately underlying its equitable
jurisdiction" to "decide whatever other issues and give whatever other relief may be
necessary under the circumstances" and to "do complete rather than truncated justice."
Porter v. Warner Holdings Co., 328 U.S. 395, 398 (1946); see also Reply at 22. Thus,
there is no genuine question about this Court's authority to issue injunctive relief in this
case. That said, I turn to an analysis of plaintiffs' claims under the balancing test used to
evaluate injunctive relief.
II. First Amendment Claim
At the outset, it is important to note that plaintiffs do not quarrel with the
10
substance of the nine new textual messages Congress created by statute. Tr. 16:11-12.
Indeed, plaintiffs insist that they would not contest replacing the Surgeon General's
warning, currently displayed on the side of cigarette packages, with any of Congress's
nine new textual warnings. Id. at 9:24-25-10:1-3,15:11-12. Plaintiffs do, however,
oppose the placement of textual warnings which "confiscate" the front and back portions
of cigarette packaging. Id. at 9: 1-3. They further argue that the graphic images (and
related placement requirements) promulgated in the FDA's Final Rule, alone and in
combination with Congress's new textual warnings, violate the First Amendment. Id. at
10:20-23.
In particular, plaintiffs argue that the new Rule unconstitutionally compels speech,
see Wooley v. Maynard, 430 U.S. 705, 714 (1977); Hurley v. Irish-Am. Gay, Lesbian &
Bisexual Grp. of Boston, Inc., 515 U.S. 557, 573-74 (1995), and that such speech does
not fit within the "commercial speech" exception under which certain types of
Government-mandated, informational disclosures are evaluated under a less restrictive
standard, see Zauderer v. Office ofDisciplinary Counsel for Sup. Ct. of Ohio, 471 U.S.
626,651 (1985); see also Mot. for PI at 11-13. As a result, they argue, the Government's
conduct must be analyzed under the strict scrutiny standard. IS Mot. for PI at 11-13.
15
The parties fundamentally disagree on the applicable level of scrutiny. While
plaintiffs advocate for application of strict scrutiny, they also argue that the Rule fails
under any constitutional standard. See Mot. for PI at 11. And as defendants argue that
the Rule is subject to no more than intermediate scrutiny, see Central Hudson Gas &
Elec. Corp. v. Public Servo Comm In, 447 U.S. 557, 566 (1980), (but more likely a less
restrictive review under Zauderer), they also insist that the Rule withstands any level of
scrutiny. Defs.' Opp' n at 15.
11
Defendants, not surprisingly, disagree, contending that this case is so similar to a
case filed and decided in the Western District of Kentucky that this Court's decision
should be, in essence, dictated by the determinations made by the judge in that case. See
Commonwealth Brands, Inc. v. United States ("Commonwealth Brands "),678 F. Supp.
2d 512, 530 (W.D. Ky. 2010) (considering, and rejecting, application of strict scrutiny to
plaintiffs' First Amendment facial challenge to the graphic-warning statute); see also
Defs.' Opp'n at 2 ("Plaintiffs' new suit reprises arguments already considered and
rejected in Commonwealth Brands."). 16 I disagree.
Not only do I reject the Government's suggestion that this case is factually
analogous to Commonwealth Brands, 17 but I would remind the Government that even
decisions from other district courts in our Circuit have no binding effect on this Court.
This case is, indeed, one of first impression in our Circuit - and one wholly separate, both
factually and legally, from the Commonwealth Brands case. For that reason and for the
16 Although three of the current plaintiffs - R.1. Reynolds Tobacco, Lorillard, and
Commonwealth Brands, were plaintiffs in Commonwealth Brands (in addition to other
manufacturers and retailers not involved in this litigation), current plaintiffs Liggett
Group and Santa Fe were not. Compi. ~ 24 n.3.
17 The facts of this case are readily distinguishable from those in Commonwealth
Brands, which was briefed and decided after the Act was passed, but before the FDA's
Rule was promulgated. Compi. ~ 24, n.3. The Commonwealth Brands plaintiffs, as a
result, made a facial challenge to the constitutionality of graphic warnings in general -
but unlike plaintiffs in this case, they were incapable of challenging any of the nine
graphic warnings the FDA ultimately selected. Moreover, because this case turns on
facts that were not available to the Commonwealth Brands plaintiffs, it presents new
questions of law and fact - and new applications of law to facts. That the Government
does not argue for issue preclusion undermines its attempt to characterize these two cases
as functionally equivalent. See PIs.' Reply at 4, n.6; see also Defs.' Opp'n at 14, n.7
(alluding to issue preclusion but discouraging the Court from deciding preclusive effect
(if any) "[a]t this preliminary juncture").
12
others described below, the analysis and ruling in the Commonwealth Brands case is of
little value here.
A. Plaintiffs Have a Substantial Likelihood of Success on the Merits.
1. Applicable Level of Scrutiny
Put simply, plaintiffs' likelihood of success on the merits turns on the level of
constitutional scrutiny which governs the FDA's Rule mandating textual warnings and
graphic images on cigarette packaging and advertisements.
A fundamental tenant of constitutional jurisprudence is that the First Amendment
protects "both the right to speak freely and the right to refrain from speaking at all."
Wooley, 430 U.S. at 714. A speaker typically "has the autonomy to choose the content of
his own message." Hurley, 515 U.S. at 573. And, in fact, "[f1or corporations as for
individuals, the choice to speak includes within it the choice of what not to say." Pac.
Gas & Elec. Co. v. Pub. Utils. Comm 'n of Cal., 475 U.S. 1,16 (1986) (plurality opinion).
Thus, where a statute '''mandates speech that a speaker would not otherwise make,' that
statute 'necessarily alters the content of the speech. ", Entertainment Software Ass 'n v.
Blagojevich, 469 F.3d 641, 651 (7th Cir. 2006) (quoting Riley v. Nat'l Fed'n o/the Blind
o/N.C, Inc., 487 U.S. 781, 795 (1988)). As the Supreme Court itselfhas noted, this type
of compelled speech is "presumptively unconstitutional." Rosenberger v. Rector &
Visitors ofUniv. of Va., 515 U.S. 819, 830 (1995).
In the arena of compelled commercial speech, however, narrow exceptions do
allow the Government to require certain disclosures to protect consumers from
"confusion or deception." Zauderer, 471 U.S. at 651 (quoting In Re R.MJ, 455 U.S.
13
191,201 (2002». Indeed, courts apply a lesser standard of scrutiny to this narrow
category of compelled speech, through which the Government may require disclosure
only of "purely factual and uncontroversial information." Zauderer, 471 U.S. at 651.
Even under this paradigm, however, compelled disclosures containing "purely factual and
uncontroversial information" may still violate the First Amendment if they are
"unjustified or unduly burdensome." Id.
Unfortunately for the Government, the evidence here overwhelmingly suggests
that the Rule's graphic-image requirements are not the type of purely factual and
uncontroversial disclosures that are reviewable under this less stringent standard. Indeed,
the fact alone that some of the graphic images here appear to be cartoons, and others
appear to be digitally enhanced or manipUlated, would seem to contravene the very
definition of "purely factual." That the images were unquestionably designed to evoke
emotion - or, at the very least, that their efficacy was measured by their "salience," which
the FDA defines in large part as a viewer's emotional reaction, see Compl. ~ 58 (citing 76
Fed. Reg. at 36,638-36,639) - further undercuts the Government's argument that the
images are purely factual and not controversial, see, e.g., Defs.' Opp'n at 22-29.
Moreover, it is abundantly clear from viewing these images that the emotional response
they were crafted to induce is calculated to provoke the viewer to quit, or never to start,
smoking: an objective wholly apart from disseminating purely factual and
uncontroversial information. 18 Thus, while the line between the constitutionally
18 For example, and as plaintiffs suggested in their briefing and at the September 21
hearing, what does the image of a body on an autopsy table convey? See Mot. for PI at 3;
14
permissible dissemination of factual information and the impermissible expropriation of a
company's advertising space for Government advocacy can be frustratingly blurry, 19 here
- where these emotion-provoking images are coupled with text extolling consumers to
call the phone number "I-800-QUIT" - the line seems quite clear.
Moreover, the disclosures in this case are unlike those that the Government
endorsed in Nat 'I Elec. Mfrs. Ass 'n v. Sorrell, 272 F.3d 104, 114-16 (2d Cir. 2001),
where the Second Circuit applied a rational basis test to a Vermont statute which
compelled manufacturers to include informational text on certain products' labels to
advise consumers about mercury content. Nor do they fit, more importantly, the
Zauderer paradigm - to which the Government adamantly clings, see Defs.' Opp'n at 15-
17 - under which the Supreme Court upheld a state requirement that attorney
advertisements disclose "purely factual and uncontroversial information about the terms
Defs.' Opp'n at 26; PIs.' Reply at 5-6; Tr. at 11: 14-17, 12: 1-10. A reasonable inference,
based on the images and the text, would be that smoking leads to autopsies: a conclusion
I do not believe the Government intends to promote, and one that the Government has not
demonstrated to be accurate. Once again, the Government relies on emotion - that
"smoking kills 443,000 Americans each year" and that the "autopsy image underscores
this factual, noncontroversial information and is a good deal less 'disturbing' than
photographs of the most common ravages of the diseases caused by [cigarettes]," Defs.'
Opp'n at 26 - instead of offering a single shred of evidence to support the proposition
that smoking causes autopsies. Ironically, the Government would likely fare better under
constitutional scrutiny (at least with respect to the content of its warnings) by depicting
the factual and accurate images it belittles in its brief.
19 The Government repeatedly failed to answer this Court's question during oral
argument about when the dissemination of purely factual, uncontroversial information
crosses the line into advocacy, see, e.g., Tr. at 50:9-11,52:12,53:8-9 (failing to answer
the Court's question of why the Rule isn't "advocacy as opposed to simply a statement of
fact that relates to the product so that people aren't in some way deceived"),
15
under which [an attorney's] services w[ould] be available." 471 U.S. at 651. To the
contrary, the disclosures mandated in this case are much more similar in form and
function to those at issue in Blagojevich, 469 F.3d at 643, 652. 20 Although only
persuasive, the Seventh Circuit's reasoning in Blagojevich is particularly instructive.
There, a three-judge panel applied strict scrutiny to a state law which required video-
game retailers to affix a four-square-inch sticker with the number" 18" (representing age
18) on any game deemed "sexually explicit" under the statute. 469 F.3d at 643,652. Just
as the Seventh Circuit recognized that a compelled video-game label based on what the
state deemed to be "sexually explicit" was "far more opinion-based than the question of
whether a particular chemical is within any given product," Blagojevich, 469 F .3d at 652
(referencing Sorrell), so too are the graphic images promulgated as part of the FDA's rule
a more subjective vision of the horrors of tobacco addiction. Indeed, neither the stickers
in Blagojevich nor the graphic images here can be characterized as mere "disclaimers that
deliver cold, hard facts." Tr. at 18:6. Thus, the Rule does not fit - neatly or otherwise-
into the Zauderer exception for purely factual and uncontroversial information. As such,
these images must withstand the strict-scrutiny analysis the Supreme Court imposes on
Government regulations which compel commercial speech.
2. Analysis Under Strict Scrutiny
To withstand strict scrutiny, the Government carries the burden of demonstrating
20 While I by no means intend to suggest that a case about video-game regulations
carries the serious healthcare implications present in a case regarding cigarette warning
labels, the constitutional analysis is the same where, as here, the disclosure is neither
purely factual nor uncontroversial.
16
that the FDA's Rule is narrowly tailored to achieve a compelling government interest.
See, e.g., A.N.S. WE.R. Coal. v. Kempthorne, 537 F. Supp. 2d 183, 195-96 (D.D.C. 2008)
(citing Boos v. Barry, 485 U.S. 312, 322 (1988) and Rosenberger v. Rector & Visitors of
the Univ. of Va., 515 U.S. 819, 829 (1995)). Unfortunately, the Government fails to do
so here.
First, an analysis of the Government's compelling interest - which is normally a
perfunctory step in the strict-scrutiny analysis - has been seriously clouded by the
Government's own explanation of its goals, which are, to say the least, unclear. To start,
the Government professes that its primary purpose is '''to effectively convey the negative
health consequences of smoking on cigarette packages and in advertisements. '" Defs.'
Opp'n at 23 (citing 76 Fed. Reg. at 36,697). This is particularly important, the
Government argues. because "consumers with low levels of education" have trouble
recalling text-only health information. Defs.' Opp'n at 16,24; see also 75 Fed. Reg. at
69,531-69,532.
Yet the Government's stated purpose does not seem to comport with the thrust of
its arguments, or with the evidence it offers to support the Rule. Indeed, the Government
appears to have chosen this "informational" goal as its official purpose because it most
closely mirrors the Zauderer exception and would thus be subject to a lesser standard of
scrutiny. As best as I can discern, however, the Government's primary purpose is not, as
it claims, merely to inform. 21 Instead, the Government - through its own data and, in
21 For example, the Government argues that "[tJthe most relevant metric in
evaluating the warnings is not their short-term impact on smoking rates, but the extent to
17
fact, its own words - evinces a purpose wholly separate from education. In particular, the
Government spends much of its brief discussing the 18,000-consumer study that the FDA
commissioned to help determine which of the 36 proposed graphic images it would
ultimately select. See Defs.' Opp'n at 27-30. In so doing, the Government acknowledges
that the study was not designed to assess whether the proposed graphic images would
have a statistically significant impact on consumer awareness of smoking risks, but rather
to "assess[] the relative impact of different warnings based on participants' exposure to
one graphic warning on one occasion." Id. at 29 (emphasis in original). Thus, instead of
focusing on its own alleged primary goal - providing information to consumers - the
Government effectively admits that it looked only to relative impact, thus side-stepping
the basic question of whether any singular graphic warning was effective on its own
terms. 22 This fundamental failure, coupled with the Government's emphasis on the
images' ability to provoke emotion, strongly suggests that the Government's actual
which they more effectively convey information about health risks to consumers and
potential customers." Defs.' Opp'n at 23. Yet it offers no evidence pointing to the
FDA's attempt to measure improvement in this area, much less whether the warnings
actually achieved the purported goal of increasing consumer awareness. Needless to say,
generalized scientific literature and the "experiences of countries such as Canada,
Australia, and the United Kingdom" (none of which afford First Amendment protections
like those found in our Constitution), id. at 24, say nothing about the nine graphic images
at issue in this case.
22 To be sure, the Government's reliance on Canadian studies or scientific studies of
graphic warnings in general does not speak to the effectiveness (however that is
measured), and certainly not to the constitutionality, of the 36 proposed graphic images
or the 9 images ultimately selected. See, e.g., Defs.' Opp'n at 27-30.
18
purpose is not to inform, but rather to advocate a change in consumer behavior.23
Fortunately, however, identifying the Government's precise interest - and evaluating
whether it is "compelling,,24 - is not, in fact, essential at this preliminary stage of the
litigation, because under any scenario the Rule hardly appears to be narrowly tailored to
achieve the Government's purpose. How so?
First, the sheer size and display requirements for the graphic images are anything
but narrowly tailored. Although it is true that Congress mandated the new images to
occupy the top 50% of the front and back panels of all cigarette packages and the top
20% of printed advertising, Act § 201(a) (amending 15 U.S.c. § 1333(a)(2),(b)(2»), and
charged the FDA with implementing a final rule consistent with its mandate, see id.
(amending 15 U.S.C. § 1333(d)), doing so does not enable this requirement to somehow
automatically pass constitutional muster. 25 Appropriating the top 50% of the front and
23 As plaintiffs point out, the Government's intent is "irreconcilable with its own
admissions on the record that it chose warnings that scored high on the FDA Study for
'salience,' defined as an image's tendency to make viewers 'depressed, discouraged, and
afraid,' 'arouse fear,' 'provoke[] a highly emotional response,' trigger 'greater negative
emotional reactions,' or 'confer negative feelings about smoking. '" Pis.' Reply at 7
(quoting 76 Fed. Reg. at 36,638-36,639).
24 Suffice it to say that a Government interest in disseminating information to
consumers is more easily deemed "compelling" than is an interest in changing consumer
behavior.
25 For this reason, the Government's argument that the "FDA had no authority to
second-guess [Congress's] legislative determination," Defs.' Opp'n at 32, does not
advance its case. The FDA may not promulgate Rules that violate the Constitution, even
as it attempts to comply with legislative requirements. Moreover, it is disingenuous for
the Government to argue that the FDA had no discretion in formulating this rule;
Congress specifically vested the Secretary with sufficient discretion to allow narrower
tailoring in the Final Rule. See, e.g., Act § 201 (amending 15 U.S.C. § 1333(d».
19
back of all cigarette packages manufactured and distributed in the United States is hardly
a directive narrowly designed to achieve the Government's purpose (whatever it might
be). To the contrary, the dimensions alone strongly suggest that the Rule was designed to
achieve the very objective articulated by the Secretary of Health and Human Services: to
"rebrand[] our cigarette packs," treating (as the FDA Commissioner announced last year)
"every single pack of cigarettes in our country" as a "mini-billboard.,,26 Mot. for PI at 6
(citing a June 2001 press briefing with Sec. Sebelius, and an FDA Tobacco Strategy
Announcement). A "mini-billboard," indeed, for its obvious anti-smoking agenda!
Suffice it to say that if the Seventh Circuit determined in Blagojevich that a four-square-
inch sticker "literally fail [ed] to be narrowly tailored" because it "cover[ ed] a substantial
portion of the box," 469 F.3d at 652, plaintiffs are highly likely to prevail on the same
argument here.27
Similarly, it is easy to conclude that the content of the graphic images chosen are
not likely to survive a "narrowly tailored" analysis. Defendants, for their part, argue that
plaintiffs object to any type of graphic images whatsoever. See, e.g., Defs.' Opp'n at 22.
But that is not actually so. And although plaintiffs may, in fact, object to any graphic
image of the size or placement mandated by the Final Rule, they do, at least, concede two
26 One can only wonder what the Congress and the FDA might conjure for fast food
packages and alcohol containers if, like the Canadian government, they were not
compelled to comply with the intricacies of our First Amendment jurisprudence.
27 As Blagojevich nicely summarized, "[ c]ertainly we would not condone a health
department's requirement that half of the space on a restaurant menu be consumed by the
raw shellfish warning. Nor will we condone the State's unjustified requirement of the
four square-inch' 18' sticker." 469 F.3d at 652.
20
reasonable means of disseminating accurate information in a more narrowly tailored way.
First, they could publish a graph demonstrating the difficulty of quitting smoking by
showing the correlation between the number of people who try to quit and the percentage
who actually do. See Tr. at 20:5-8. Or, for example, plaintiffs could publish a "graphic
that depicts the types of harms that befall children if they are exposed to secondhand
smoke or the types of birth defects that arise, and their likelihood, if mothers smoke
during the course of pregnancy." Id. at 20: 18-2l. Though other alternatives surely exist,
a prolonged examination of those arguments is not necessary at this point, where it is
quite clear that the Rule's graphic-image requirements in no way suggest the slightest
attempt to narrowly tailor the display or presentation of the graphic images Congress
mandated. 28
In short, the Government has neither carried its burden of demonstrating a
compelling interest, nor demonstrated how the Rule is narrowly tailored to achieve a
constitutionally permissible form of compelled commercial speech. As a result,
plaintiffs are likely to succeed on the merits and this factor weighs heavily in favor of
awarding injunctive relief.
28
To be sure, the ineffectiveness, size, placement, and content of the warnings are,
individually, evidence that the graphic warnings are not narrowly tailored. Combined,
these factors significantly increase the likelihood that the graphic warnings cross the line
from information to advocacy. That each warning brandishes the "1-800-QUIT-NOW"
smoking-cessation hotline only enhances plaintiffs' argument that the FDA has
"conscript[ed] [tobacco manufacturers] into an anti-smoking brigade." Tr. at 33:19-20.
And while the Congress and the FDA might be genuinely challenged to craft
tailored images that pass constitutional muster, that does not excuse them from striving to
do so in the first instance. Indeed, our First Amendment jurisprudence in this area of
compelled commercial speech should have compelled them to at least try!
21
B. Plaintiffs Offer Sufficient Evidence of Irreparable Harm Absent
Injunctive Relief.
It is undisputed that our Circuit "has set a high standard for irreparable injury."
Chaplaincy 0/ Full Gospel Churches v. England, 454 F.3d 290, 297 (D.C. Cir. 2006). In
addition to demonstrating an injury that is "both certain and great," the moving party
"must show that the injury complained of is of such imminence that there is a 'clear and
present'" need for equitable relief to prevent irreparable harm." Id. (quoting Wisc. Gas
Co. v. FERC, 758 F.2d 669, 674 (D.C. Cir. 1985)). Indeed, a plaintiff must show that it
will suffer harm that is "more than simply irretrievable; it must also be serious in terms of
its effect on the plaintiff." Gulf Oil Corp. v. Dep't a/Energy, 514 F. Supp. 1019, 1026
(D.D.C.1981).
Plaintiffs here offer two main arguments to support their claim of irreparable
harm. First, they point to the monetary harm they will incur during the IS-month
preparation period necessary to comply with the Rule. See Mot. for PI at 14-16. In
particular, plaintiffs offer sworn declarations attesting to the tens of millions of dollars
they will be forced to spend redesigning existing cigarette packaging,29 purchasing and
engraving blank printing cylinders, and embossing new packaging (among other costs).
Id. Specifically, and as defendants point out, plaintiffs submit declarations that estimate
the aggregate monetary harm somewhere around $20 million. Defs.' Opp'n at 42. In
addition, plaintiffs offer sworn declarations attesting to the thousands of employee hours
29 Plaintiff RJ. Reynolds avers that it alone must modify 480 distinct package
designs. See Mot. for PI at 14 (citing O'Brien Decl. ~ 5).
22
the companies will be forced to expend in preparation for full compliance with the
Rule. 3o Mot. for PI at 16.
Unfortunately for plaintiffs, however, the standard for irreparable economic harm
in our Circuit is so demanding that the proof of even tens of millions of dollars in
economic detriment does not necessarily suffice. Indeed, "[ r]ecoverable monetary loss
may constitute irreparable harm only where the loss threatens the very existence o/the
movant's business." Wisc. Gas. Co., 758 F.2d at 674 (emphasis added). And as
defendants note, plaintiffs' aggregate, estimated cost of compliance represents
approximately "twelve one-hundredths of one percent of plaintiffs' combined annual
sales as reported for 2010." Defs.' Opp'n at 42. Accordingly, plaintiffs do not
demonstrate irreparable injury based on economic harm alone.
Plaintiffs do, however, offer a second - and more persuasive - argument to
demonstrate irreparable harm: their inability to recover costs from the FDA. Indeed, if
this Court denies preliminary injunctive relief and another court overturns that decision,
or even if this Court denies preliminary injunctive relief but later grants relief for
plaintiffs on the merits, plaintiffs would be an injured party without legal recourse. See
Mot. for PI at 16.
As such, plaintiffs' argument here fits well within the definition of irreparable
harm that I previously recognized and described in Smoking Everywhere, 680 F. Supp. 2d
at 77 n.19. There, I detennined that the FDA's AP A violation resulted in irreparable
30 For example, piaintiffRJ. Reynolds alone anticipates expending over 4,000 hours
of employee time to ensure compliance with the Rule. Mot. for PI at 16.
23
economic injury - even absent a threat to plaintiffs' viability - "because plaintiffs c[ ould]
not recover money damages against [the] FDA." Id; see also Bracco Diagnostics, Inc. v.
Shalala, 963 F. Supp. 20, 29 (D.D.C. 1997) ("While the injury to plaintiffs is admittedly
economic, there is no adequate compensatory or other corrective relief that can be
provided at a later date, tipping the balance in favor of injunctive relief. ") (internal
citation and quotations omitted). Plaintiffs' harm is no different here. 31 Absent
injunctive relief (and especially in light of plaintiffs' likelihood of success on the merits),
plaintiffs have thus demonstrated that they will suffer irreparable harm.
In addition, plaintiffs appropriately argued at the September 21, 2011 hearing that
the harm flowing from a First Amendment violation is per se irreparable. See, e.g., Elrod
v. Burns, 427 U.S. 347, 373 (1976) (plurality opinion) ("The loss of First Amendment
freedoms, for even minimal periods of time, unquestionably constitutes irreparable
injury.") (citing N Y Times Co. v. United States, 403 U.S. 713 (1971»; see also Tr. at
24 :6-7. Where, as here, plaintiffs are likely to prevail on the merits of their constitutional
claim, and where their "First Amendment interests are either threatened or in fact being
impaired at the time relief is sought," Chaplaincy of Full Gospel Churches, 454 F.3d at
301 (citing Nat 'I Treas. Emps. Union v. United States, 927 F.2d 1253, 154-55 (D.C. Cir.
1991) and quoting Wagner v. Taylor, 836 F.2d 556, 577 n.76 (D.C. Cir. 1987) and Elrod,
31
Indeed, Wisconsin Gas implicitly endorses this concept in its discussion of how
corrective relief and recoverable loss militate against injunctive relief. See 758 F .2d at
674.
24
427 U.S. at 373), there is more than a sufficient showing of irreparable harm. 32 To that
end - and contrary to defendants' protestations otherwise, see Defs.' Opp'n at 39-40 - the
harm plaintiffs suffer is, in fact, "serious in terms of its effect," Coal. For Common Sense
in Gov't Procurement v. United States, 576 F. Supp. 2d 162, 168 (D.D.C. 2008),
precisely because their First Amendment rights have been abridged. Such harm is not, as
defendants conveniently claim, merely "the ordinary costs of complying with
regulations." Defs.' Opp'n at 39. It is the residual effect of unconstitutionally compelled
commercial speech designed to advocate, at a company's expense, a competing policy
agenda. Thus, plaintiffs have demonstrated that they will suffer irreparable harm in the
absence of preliminary relief, and this factor also weighs in favor of granting an
injunction.
32
The Government argues that even an alleged First Amendment violation is not per
se irreparable harm where, as here, the FDA's Rule is operative, but where plaintiffs have
not yet printed the new warnings (and thus have not yet realized the costs associated with
them). Specifically, the Government argues that "this isn't the case in which any speech
either is happening or not happening within the coming year," Tr. at 43 :4-6, and thus
plaintiffs' speech has not been compelled - at least not yet.
The Government's argument, however, once again misses the mark. Under its
reasoning, plaintiffs would suffer no harm - even facing implementation of a Rule that
violates the First Amendment - until the point of implementation at which new printing
plates were designed and forged, or perhaps until every cigarette package in the country
were imprinted with the new graphic warnings and all related costs were incurred. At
that point, however, plaintiffs would have suffered harm with no possibility of economic
recourse (a principle which I have already discussed), and the Rule would, in essence,
escape the constitutional scrutiny and preliminary review that could afford any type of
meaningful relief. A system of justice premised on this type of reasoning defies common
sense and is fundamentally unfair! Put simply, defendants cannot separate the Rule's
effective date from the point at which plaintiffs begin suffering harm (whether
constitutional or economic). Faced with a Rule which compels speech and threatens their
First Amendment rights, plaintiffs are not required to sit idly and wait for irreparable and
irretrievable harm to occur before they may seek relief.
25
C. Injunctive Relief Will Not Substantially Injure Other Interested
Parties, Including the Public or the Government.
Although the two most critical factors weigh in favor of granting injunctive relief,
other parties' interests - and the prejudices other parties might suffer - must also be
evaluated and weighed against the factors supporting an injunction.
Defendants argue that the delay resulting from a grant of injunctive relief harms
the public because "[eJach day, nearly 4,000 Americans under the age of 18 experiment
with cigarettes for the first time, and approximately 1,000 children become new daily
smokers." Defs.' Opp'n at 43 (emphasis in original). Consistent with its briefing and
oral argument, the Government unfortunately - and once again - trumpets its appeal to
emotion instead of focusing on the discrete legal issue before the Court: whether the
public will be prejudiced by a temporary delay in the Rule's implementation. 33
Notwithstanding its obvious desire to limit, if not eradicate, the use of tobacco, the
Government utterly fails to address the real issue at hand, and in the process gives short
shrift to Congress's own instruction for a IS-month implementation period. See 76 Fed.
Reg. 36,703.
Put simply: based on the existing record, Congress demonstrated no real urgency
when it passed the graphic-warning statute and vested the FDA with authority to
promulgate the graphic-warning rule. To the contrary, Congress provided a measured,
33 Of course, the temporary delay caused by a preliminary injunction could
ultimately tum into a permanent delay if this Court determines, on the merits, that the
Rule is unconstitutional or violates the APA. If that were the case, however, defendants
could hardly argue that the public suffered prejudice from injunctive relief since that very
relie/would preserve the public's First Amendment rights.
26
multi-stage timeline in which the FDA had up to two years to issue a Final Rule, and a
15-month implementation period before the Final Rule and its related requirements took
effect. Pis.' Mot. for PI at 19. The Government, for its part, has pointed to no evidence
supporting its bare assertion that "the fact that Congress gave 15 months doesn't mean
that every month of that is required." Tr. at 40:22-24. 34 Thus, I can afford little weight
to defendants' argument that a delay specifically contemplated and mandated by
Congress could prejudice the public, or even the Government itself.
Finally, and most importantly, the constitutional protections an injunction would
afford plaintiffs far outweigh any incidental prejudice the public (or indeed, the
Government) could hypothetically suffer as a result of preliminary injunctive relief.
After all, "the public clearly has an interest in free speech," and therefore "the public
interest ... will be served by ensuring that plaintiffs' First Amendment rights are not
infringed before the constitutionality of the regulation has been definitively determined,"
Stewart v. District o/Columbia Armory Bd., 789 F. Supp. 402, 406 (D.D.C. 1992)
(Green, J.). Indeed, as plaintiffs noted during oral argument and again in their
supplemental pleading, Congress did not specifically contemplate the First Amendment
implications when formulating its statute, much less whether the statute or the FDA's
subsequent Rule might violate it. See, e.g., Tr. at 72:1-23; see also PIs.' Supp. Memo. In
Supp. of PIs.' Mot. for Prelim. Inj., Sept. 30,2011, at 1-2 [Dkt. #32] ("We have been
unable to identify any indication in the legislative history that Congress considered the
34 Moreover, that the FDA used the full two-year period to promulgate the Final Rule
undercuts any argument that implementation is urgent. See Mot. for PI at 19.
27
First Amendment implications of these changes or of the warnings requirement
generally.,,).35 And when one considers the logical extension of the Government's
defense of its compelled graphic images to possible graphic labels that the Congress and
the FDA might wish to someday impose on various food packages (i. e., fast food and
snack food items) and alcoholic beverage containers (from beer cans to champagne
bottles), it becomes clearer still that the public's interest in preserving its constitutional
protections - and, indeed, the Government's concomitant interest in not violating the
constitutional rights of its citizens - are best served by granting injunctive relief at this
preliminary stage. Thus, like the two before them, the final two factors weigh heavily in
favor of an injunction.
CONCLUSION
This case poses a constitutional challenge to a bold new tack by the Congress, and
the FDA, in their obvious and continuing efforts to minimize, if not eradicate, tobacco
use in the United States. Notwithstanding the potential legal and financial ramifications
of this challenge, the Government, for reasons known only to itself, is unwilling to
voluntarily stay the effective date of this Rule until the Judicial Branch can appropriately
review the constitutionality of the Government's novel- and costly - approach to
regulating tobacco packaging and advertising. Thus, this Court must - and will - act to
35 Plaintiffs make several other persuasive arguments dispelling the notion that
injunctive relief would harm the public, but those arguments do not merit full discussion
here. See id. at 19-21 (arguing that the Surgeon General's warnings sufficiently inform
consumers about the health risks of tobacco and that the Government offers no empirical
evidence that the new graphic warnings "reduce consumption or change smoking
behavior").
28
preserve the status quo until it can evaluate, on the merits (and without incurring
irreparable harm to those companies genuinely affected), the constitutionality of the
commercial speech that these graphic images compel. Therefore, for all the foregoing
reasons, this Court concludes that the plaintiffs have demonstrated: (1) a substantial
likelihood of success on the merits; (2) that they will suffer irreparable harm absent
injunctive relief; (3) that neither the Government, nor the public, will suffer any
comparable injury as a result of the relief sought; and (4) that the public's interest in the
protection of its First Amendment rights against unconstitutionally compelled speech will
be, in fact, furthered. Accordingly, the plaintiffs' Motion for Preliminary Injunction
[Dkt. # 11] is GRANTED. An order consistent with this decision is attached herewith.
RICHARDJ.
United States District Judge
29