### UNITED STATES DISTRICT COURT FORTHE DISTRICT OFCOLUMBIA
R.J. REYNOLDS TOBACCO COMPANY, LORILLARD TOBACCO COMPANY, COMMONWEALTHBRANDS, INC., LIGGETT GROUP LLC, and SANTAFE NATURAL TOBACCO COMPANY, INC., Plaintiffs,


### v. UNITED STATES FOODAND DRUG ADMINISTRATION, MARGARET HAMBURG, Commissionerofthe United States Food and DrugAdministration, and KATHLEEN SEBELIUS, Secretaryofthe United States DepartmentofHealth and Human Services, Defendants.

## ~ ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) Civil Case No. 11-1482 (RJL) ) ) ) ) ) ) ) ) ) ) ) ) ) ) 

### 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 manufacturerin 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 otherthings) the display ofnine new textual warnings

- along with certain graphic images1such as diseased lungs and a cadaver bearing chest staples on an autopsy table

- on the top 50% ofthe front and backpanels of every cigarettepackage manufactured and distributed in the United States on or after September22,2012. 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]. Allegingthat the Rule violates the First Amendment and the Administrative ProcedureAct ("APA"), 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 ofthe U.S. Department ofHealth and Human Services ("the Secretary"), and the Commissionerofthe FDA ("the Commissioner" and together, "defendants" or "the Government"), to enjoin enforcement ofthe Rule until fifteen months afterresolution ofplaintiffs' 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 whetherthe FDA'snew and mandatory graphic images, when combined with certain

The FDA conveniently refers to these graphic images as "graphic warnings." While characterizingthe mandatory textual statements as "warnings" seems to be a fair and accurate description, characterizingthese graphic images as "warnings" strikes me as inaccurate and unfair. At first blush, they appearto be more about shocking and repelling than warning. Accordingly, I will referto 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. # 1 0] on the same day they filed theirMotion for Preliminary Injunction [Dkt. #11]. The Motion for Summary Judgment, however, is not beforethe Courttoday. 2textual warnings on cigarette packaging, are unconstitutional underthe FirstAmendment. Upon review ofthe 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 oftheirposition thatthese mandatory graphic images unconstitutionally compel speech, and that they will suffer irreparable harm absent injunctive reliefpending ajudicial review ofthe constitutionality ofthe FDA'sRule. For that and the otherreasons stated herein, I hereby GRANTplaintiffs' Motion for Preliminary Injunction. 3 

### BACKGROUND I. Statutory and Regulatory History A. The Act The Family Smoking Prevention and Tobacco Control Act ("Act" or "theAct"), Pub. L. No. 111-31, 123 Stat. 1776 (2009), which President Obama signed into law on June 22, 2009, gives the FDAthe authority to regulate the manufacture and sale of tobacco products, including cigarettes.4 Defs.' Opp'n at 1. Pursuantto that authority,

Plaintiffs bring both First Amendment and APA claims. Atthe September 21, 2011 hearing, however, all parties agreedthat ifplaintiffs prevailed on theirFirst Amendment claim, resolution ofthe APA claim wouldbe superfluous. See Tr. 68:10-19 (Government), 71: 17-22 (plaintiffs). Because plaintiffs prevail on their First Amendment claim, an analysis ofthe APA claim is unnecessary. Plaintiffs note thatpreceding the Act, and indeed, "[f]ormore than 45 years, cigarettes sold in the United States have been accompanied by various Surgeon General Warnings," and that "Plaintiffs have neverbrought a legal challenge to any ofthem." CompI.**~** 1. 3Congress

- following the lead ofthe Canadian governmentS

- directed the Secretaryto "issueregulations 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 cigarettepackages manufactured, packaged, sold, distributed, or imported for sale or distribution within the United States to bear one ofthe 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 duringpregnancy 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)). Itis no secretthat the Congress was greatly influenced in the drafting andpassage ofthis aspect ofthe legislation by the example ofour northerly neighbors. See, e.g., Defs.' Opp'nat 2,9, 11-13, 18-20.
6 The statute also vests a certain amount ofdiscretion in the Secretary, who "may adjust the type size, text and format ofthe 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 appearwithin the specified area." Pub. L. No. 111-31, §201 (amending 15 U.S.C. § 1333(d)). The Act also imposes a number ofrelated labelingrequirements which require that cigarettepackages display specific information about, for example, the tobacco 4Congress required that these new textual warnings and graphic images occupy the top 50% ofthe front and back panels ofall cigarettepackages, Act § 201(a) (amending 15 U.S.C. § 133 3(a)(2)), and the top 20% ofall printed cigarette advertising, id. (amending 15 U.S.c. § 1333(b)(2)). Itgavethe FDA "24 months after the date of enactment" ofthe Actto issue regulations implementingthe requirements ofSection 201. Act § 201(a) (amending 15 U.S.C. § 1333(d)); see also CompI.**~** 33. Finally, underthe Act, the new textual warnings and graphic-image labels (and the related requirements)
were scheduledto take effect 15 months after issuance ofthe Rule. Act § 201(b) (note on amending 15 U.S.C. § 1333). 

### B. TheRule 1. 

### Proposed Rule OnNovember 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 cigarettepackaging and advertising to include "areference to a smoking cessation assistance resource" and set forth related requirements for what that
manufacturer and the quantity oftobacco contained in the product. See Act § 101(b); see also Pis.' Mot. for PI at 2. Theproposed images were not only in color, but some were also cartoon images, as opposed to stagedphotographs; and some were at least arguably enhanced, using either actors or technological augmentation to achieve the desired effect. See CompI.**~** 38. 5resource mustprovide. 75 Fed. Reg. 69,564 (proposing 21 C.F.R. § 1141.16(a)); see also Compl.**~** 39. Finally, as part ofits preliminarybenefits analysis, the FDA estimatedthat "the U.S. smokingrate will decrease by 0.212 percentagepoints" as a result ofthe 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 ofnotice and comment in which the FDAreviewed morethan 1,700 comments, it published a Final Rule on June 22, 2011. See 76 Fed. Reg. 36,628-36,629;

9 The FDAprefaced its calculation withthe following statement: "Estimation ofthe effectiveness ofthe proposed rule (on reducing the future U.S. smokingrate) is subjectto a large uncertainty that is not fully reflected in the benefits estimates appearing in the preceding sections, which only reflect different estimates ofthe value ofa statistical life year." 75 Fed. Reg. 69,546. Yet despite whatever statistical uncertainty mayhave existed, the FDA nevertheless calculated and relied upon a 0.212 percentage-point change in the smokingrate as part ofitsjustification for the ProposedRule.

10 Indeed, the FDA's estimated reduction in U.S. smokingrates 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 explainingthe "FDA's estimate ofa 0.088 percentagepointreduction in the U.S. smokingrate"). Plaintiffs suggestthat the decrease could be attributed to the FDA considering (forthe first time) a confounding factor

- the difference between Canadian and U.S. taxrates
- in the Final Rule analysis. See Compl.**~** 62.

II The Proposed Rule is replete with additional research and statistics onwhichthe FDArelied to formulate its proposal. But a merits evaluation ofthat 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 ofits proposed graphic warnings, see Compl.**~~** 47-54; Defs.' Opp'n at 11,27-30

- is not necessary here, where thethreshold issue is whether injunctive reliefis warranted based onplaintiffs' FirstAmendment claim

- notwhetherdefendantsprevail onthe merits. 6CompI.**~** 57. Ofthe 36 graphic images originallyproposed, the FDA chose 9 for publication. See CompI.**~~** 57-58. The new graphic images, which will rotate according to an agency-approvedplan, Act §201(a) (amending 15 U.S.C. § 1333(c)(2)); Compi.**~** 30, include color images ofa man exhaling cigarette smoke through a tracheotomy hole in his throat; aplume ofcigarette smoke enveloping an infantreceiving a kiss from his or her mother; a pair ofdiseased lungs nextto a pair ofhealthy 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 ofhis torso; a woman weeping uncontrollably; and a man wearing at-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 stagedphotograph) ofa premature baby in an incubator. Id. Plaintiffs allege, on information and belief, that many ofthese images are technologically manipulated,12 enhanced, or animated, orthatthey 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 ofthe photographs were technologically modified to depictthe negative health consequences ofsmoking," although it insists that "the effects shown in the photographs are, in fact, accurate depictions ofthe 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 pertinentpart: "First, many ofthe proposedrequired warnings elicitedsignificant impacts on the salience measures (emotional andcognitive measures), 7In addition to beingpaired with one ofthe nine newtextual warnings introduced by Congress, each ofthe graphic images prominently displays "1-800-QUIT-NOW": a telephone numberthe FDA selectedto fulfill its own regulatory obligationto 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 implementationperiod set out by Congress, see Act § 201(a) (amending 15 U.S.C. § 1333), the newtextual warnings and graphic images are scheduled to take effect for all cigarettepackages manufactured
on or after September22, 2012, and for all cigarettepackages 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 ofReview The factors a court must consider in determining whetherto grant injunctive relief

which the research literature suggests are likely to be related to behavior change (Ref. 51). For example, the literature suggests thatrisk information is most readily communicatedby messages thatarouse emotionalreactions (see Ref. 45), and that smokers who report greaternegative 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 amountthey smoke and to quit ormake 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). 8are, ofcourse, familiar: 14 "(1) whetherthere is a substantial likelihood ofsuccess on the merits; (2) whether the movant will suffer irreparable harm ifthe injunction is not granted; (3) whether the injunction will substantially injure other interestedparties; and (4) whetherthe public interestwouldbe 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) (citingMova Pharm. Corp. v. Shalala, 140 F.3d 1060,1066 (D.C. Cir. 1998)). Importantly, "[t]he party seeking apreliminary injunction need not prevail on each factor." SmokingEverywhere, 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 ifthe arguments in other areas are rather weak." SmokingEverywhere, 680 F. Supp. 2d at 66 (quoting CityFedFin. Corp. v. Office a/ThriftSupervision, 58 F.3d 738, 747 (D.C. Cir. 1995)). A "very strong showing ofirreparable harm," for example, absent "substantial harm to the non-movant" may warrant application of"acorrespondingly lower standard
... for likelihood ofsuccess." Davis, 571 F.3d at 1292. Similarly, "agreater likelihood of[the movant's] success will militate for apreliminary injunction unless particularly strong equities favor the [nonmoving] parties." FTCv. 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 orAPA review. See 5 U.S.C. §705; Fed. R. Civ. P. 65; see alsoAffinityHealthcare Servs., Inc. v. Sebelius, 720 F. Supp. 2d 12, 15 n.4 (D.D.C. 2010) ("Motions to stay agency action pursuantto these provisions are reviewed under the same standards used to evaluate requests for interim injunctive relief."). 9injunctive reliefin this case atall. See, e.g., Defs.' Opp'n at 3, 35-37; Tr. at 38-4l. Becauseplaintiffs ask the Court to postpone the effective date ofthe Rule for aperiod after finaljudgment

- instead ofrequesting a stay ofagency actionpendingfinal judgment

- defendants contend thatplaintiffs' request for preliminary injunctive reliefis, 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) (recognizingparty's ability to challenge the validity ofa law before its enforcementto avoid irreparable injury as deriving from "equitypractice with abackground ofseveral hundred years"). Like plaintiffs, I reject the notion that this Court does not have the inherent equitablepowerto issue reliefin this case. See, e.g., Fed. R. Civ. P. 65; FriendsforAll Children, Inc. v. LockheedAircraft Corp., 746 F.2d 816,834 (D.C. Cir. 1984) (a district court may "properly employ [] its inherent equitablepowers ...to preventplaintiffs from suffering irreparable injury"); see also Reply at 22-23. Indeed, this Court's equitable powers extend even farther, "beyondthe matters immediately underlying its equitable jurisdiction"to "decide whatever other issues and give whatever otherreliefmay be necessary under the circumstances" and to "do complete rather than truncatedjustice." 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 injunctivereliefin this
case. That said, Iturn to an analysis ofplaintiffs' claims under the balancing test used to evaluate injunctive relief. II. First Amendment Claim Atthe outset, it is importantto note thatplaintiffs do not quarrel with the 10substance ofthe nine new textual messages Congress createdby statute. Tr. 16:11-12. Indeed, plaintiffs insist that they would not contestreplacing the Surgeon General's warning, currently displayed on the side ofcigarette packages, with any ofCongress's nine new textual warnings. Id. at 9:24-25-10:1-3,15:11-12. Plaintiffs do, however, oppose the placement oftextual warnings which "confiscate" the front and backportions ofcigarette packaging. Id. at 9: 1-3. They further arguethatthe 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 FirstAmendment. Id. at 10:20-23. In particular, plaintiffs argue thatthe 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 evaluatedunder a less restrictive standard, seeZauderer v. Office of Disciplinary Counsel for Sup. Ct. of Ohio, 471 U.S. 626,651 (1985); see also Mot. for PI at 11-13. As aresult, 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 ofscrutiny. While plaintiffs advocate for application ofstrict scrutiny, they also argue that the Rulefails 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 CentralHudson Gas & Elec. Corp. v. Public Servo Comm In, 447 U.S. 557, 566 (1980), (but more likely a less restrictive review underZauderer), they also insist that the Rule withstands any level of scrutiny. Defs.' Opp'n at 15.
11Defendants, not surprisingly, disagree, contendingthat this case is so similarto a
case filed and decided in the Western District ofKentucky thatthis Court's decision should be, in essence, dictated by the determinations made by thejudgein that case. See Commonwealth Brands, Inc. v. UnitedStates ("Commonwealth Brands"),678 F. Supp. 2d 512, 530 (W.D. Ky. 2010) (considering, and rejecting, application ofstrict 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 Governmentthat even decisions from other district courts in our Circuithave no binding effect on this Court. This case is, indeed, one offirst impression in our Circuit

- and one wholly separate, both factually and legally, from the Commonwealth Brands case. Forthat reason and for the

16 Although three ofthe currentplaintiffs

- 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 ofthis 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 ofgraphic warnings in general

- but unlike plaintiffs in this case, they were incapable ofchallenging any ofthe nine graphic warnings the FDA ultimately selected. Moreover, because this case turns on facts that were not available to the Commonwealth Brands plaintiffs, itpresents new questions oflaw and fact

- and new applications oflaw 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 (ifany) "[a]tthis preliminaryjuncture"). 12others described below, the analysis and ruling in the Commonwealth Brands case is of little value here. A. Plaintiffs Have a SubstantialLikelihood ofSuccess on the Merits. 1. Applicable Level ofScrutiny Put simply, plaintiffs' likelihood ofsuccess 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 ofconstitutionaljurisprudence is thatthe 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 speakertypically "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 itthe choice ofwhat notto 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 speakerwould not otherwise make,' that statute 'necessarily alters the content ofthe speech.", EntertainmentSoftwareAss 'n v. Blagojevich, 469 F.3d 641, 651 (7th Cir. 2006) (quoting Rileyv. Nat'lFed'n o/theBlind o/N.C, Inc., 487 U.S. 781, 795 (1988)). As the Supreme Court itselfhas noted, this type ofcompelled speech is "presumptively unconstitutional." Rosenbergerv. Rector & Visitors ofUniv. ofVa., 515 U.S. 819, 830 (1995). In the arena ofcompelled commercial speech, however, narrow exceptions do allowthe Governmentto require certain disclosures to protect consumers from "confusion or deception." Zauderer, 471 U.S. at 651 (quotingIn Re R.MJ, 455 U.S. 13191,201 (2002». Indeed, courts apply a lesser standard ofscrutiny to this narrow category ofcompelled speech, through which the Governmentmay 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 FirstAmendment ifthey are "unjustified orunduly burdensome." 

### Id. Unfortunately for the Government, the evidence here overwhelmingly suggests thatthe Rule's graphic-image requirements are notthe type ofpurely factual and uncontroversial disclosures that are reviewable underthis less stringent standard. Indeed, the fact alone that some ofthe graphic images here appearto be cartoons, and others appearto be digitally enhanced or manipUlated, would seemto contravene the very definition of"purely factual." Thatthe 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 argumentthat 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 calculatedto provokethe viewerto quit, or neverto 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 theirbriefing and at the September21 hearing, what does the image ofabody on an autopsy table convey? See Mot. for PI at 3; 14permissible dissemination offactual information and the impermissible expropriation ofa 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 thephone number "I-800-QUIT"

- the line seems quite clear. Moreover, the disclosures in this case are unlike those that the Government endorsed in Nat 'IElec. 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 certainproducts' 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 believethe Government intends to promote, and one that the Governmenthas not demonstrated to be accurate. Once again, the Government relies on emotion

- that "smokingkills 443,000 Americans each year" and thatthe "autopsy image underscores this factual, noncontroversial information and is a good deal less 'disturbing' than photographs ofthe most common ravages ofthe diseases caused by [cigarettes]," Defs.' Opp'n at 26

- instead ofoffering a single shred ofevidence to support the proposition that smoking causes autopsies. Ironically, the Government would likely fare betterunder constitutional scrutiny (at least with respect to the content ofits warnings) by depicting the factual and accurate images it belittles in its brief.

19 The Governmentrepeatedly failed to answer this Court's question during oral argument about when the dissemination ofpurely 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 ofwhy the Rule isn't "advocacy as opposed to simply a statement of fact that relates to the product so that people aren'tin some way deceived"), 15under 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'sreasoning in Blagojevich is particularly instructive. There, athree-judge panel applied strict scrutiny to a state law which required videogame retailers to affix a four-square-inch stickerwith 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 "farmore opinion-based than the question of whether aparticularchemical is within any given product,"Blagojevich, 469 F.3d at 652 (referencingSorrell), so too are the graphic images promulgated as part ofthe FDA'srule
a more subjective vision ofthe horrors oftobacco addiction. Indeed, neitherthe stickers in Blagojevich northe 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 otherwiseinto the Zauderer exception for purely factual and uncontroversial information. As such, these images must withstand the strict-scrutiny analysis the Supreme Court imposes on Governmentregulations which compel commercial speech. 2. Analysis Under Strict Scrutiny To withstand strict scrutiny, the Government carries the burden ofdemonstrating

20 While Iby 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. 16thatthe FDA'sRule 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) (citingBoos v. Barry, 485 U.S. 312, 322 (1988) and Rosenberger v. Rector & Visitors of the Univ. ofVa., 515 U.S. 819, 829 (1995)). Unfortunately, the Government fails to do
so here. First, an analysis ofthe 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 ofits 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 ofsmoking 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 ofeducation" 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 statedpurpose does not seem to comport with the thrust of its arguments, orwith 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 subjectto 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 smokingrates, butthe extentto 17fact, its own words

- evinces a purpose wholly separate from education. In particular, the Government spends much ofits briefdiscussing the 18,000-consumer study that the FDA commissioned to help determine which ofthe 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 notdesigned to assess whetherthe proposed graphic images would have a statistically significant impact on consumer awareness ofsmokingrisks, but rather to "assess[] the relative impact ofdifferentwarnings based onparticipants' 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 ofwhether any singular graphic warning was effective on its own terms.22 This fundamental failure, coupledwith the Government's emphasis on the images' ability to provoke emotion, strongly suggests thatthe 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 evidencepointing to the FDA's attempt to measure improvement in this area, much less whether the warnings actually achieved the purported goal ofincreasing consumer awareness. Needless to say, generalized scientific literature and the "experiences ofcountries such as Canada, Australia, and the United Kingdom" (none ofwhich afford First Amendmentprotections like those found in ourConstitution), id. at 24, say nothing about the nine graphic images at issue in this case.

22 To be sure, the Government'sreliance on Canadian studies or scientific studies of graphic warnings in generaldoes not speak to the effectiveness (howeverthat is measured), and certainly notto the constitutionality, ofthe 36 proposed graphic images or the 9 images ultimately selected. See, e.g., Defs.' Opp'n at 27-30. 18purpose is not to inform, but ratherto advocate a change in consumerbehavior.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 ofthe 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% ofthe front and backpanels ofall cigarettepackages and the top 20% ofprinted advertising, Act § 201(a) (amending 15 U.S.c. § 1333(a)(2),(b)(2»), and charged the FDAwith 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% ofthe 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[] ahighly emotional response,' trigger 'greaternegative emotional reactions,' or 'confernegative feelings about smoking.'" Pis.' Reply at 7 (quoting 76 Fed. Reg. at 36,638-36,639). 24 Suffice itto say that a Government interest in disseminating information to consumers is more easily deemed "compelling"than is an interest in changing consumer behavior.

25 Forthis reason, the Government's argument thatthe "FDAhad 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 Governmentto argue thatthe FDAhad 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». 19back ofall 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). Tothe contrary, the dimensions alone strongly suggestthat the Rule was designed to achieve the very objective articulatedby the Secretary ofHealth and Human Services: to "rebrand[] our cigarette packs," treating (as the FDA Commissioner announced last year) "every singlepack ofcigarettes 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 ifthe Seventh Circuit determined in Blagojevichthat a four-squareinch sticker "literally fail[ed] to be narrowly tailored" because it "cover[ed] a substantial portion ofthe 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 ofthe graphic images chosen are not likely to survive a "narrowlytailored" analysis. Defendants, for theirpart, argue that plaintiffs objectto any type ofgraphic images whatsoever. See, e.g., Defs.' Opp'n at 22. Butthat is not actually so. And although plaintiffs may, in fact, object to any graphic image ofthe 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 compelledto comply with the intricacies ofour First Amendmentjurisprudence.

27 As Blagojevich nicely summarized, "[c]ertainly we would not condone a health department's requirement that halfofthe space on a restaurant menu be consumedby the raw shellfish warning. Nor will we condone the State's unjustified requirement ofthe four square-inch'18' sticker." 469 F.3d at 652. 20reasonable means ofdisseminating accurate information in a more narrowly tailored way. First, they could publish a graph demonstrating the difficulty ofquitting smokingby showing the correlation between the number ofpeople whotry to quit and the percentage who actually do. See Tr. at 20:5-8. Or, for example, plaintiffs couldpublish a "graphic that depicts the types ofharms that befall children ifthey are exposedto secondhand smoke or the types ofbirth defects that arise, and their likelihood, ifmothers smoke during the course ofpregnancy." Id. at 20: 18-2l. Though other alternatives surely exist,
aprolonged examination ofthose arguments is not necessary at this point, where it is quite clear that the Rule's graphic-image requirements in no way suggestthe slightest attempt to narrowly tailorthe display or presentation ofthe graphic images Congress mandated. 28 In short, the Governmenthas neither carried its burden ofdemonstrating a compelling interest, nor demonstrated how the Rule is narrowly tailoredto achieve a constitutionally permissible form ofcompelled 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 ofthe warnings are, individually, evidencethat 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 enhancesplaintiffs' 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 challengedto craft tailored images that pass constitutional muster, that does not excusethem from striving to do so in the first instance. Indeed, ourFirst Amendmentjurisprudence in this area of compelled commercial speech shouldhave compelledthem to at least try! 21B. Plaintiffs Offer Sufficient Evidence ofIrreparable Harm Absent Injunctive Relief. Itis undisputed that ourCircuit "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 showthat the injury complained ofis ofsuch imminence thatthere is a 'clear and present'" need for equitable reliefto prevent irreparable harm." Id. (quoting Wisc. Gas Co. v. FERC, 758 F.2d 669, 674 (D.C. Cir. 1985)). Indeed, aplaintiffmust showthat it will sufferharm that is "morethan simply irretrievable; it must also be serious in terms of its effect on the plaintiff." GulfOil Corp. v. Dep'ta/Energy, 514 F. Supp. 1019, 1026 (D.D.C.1981). Plaintiffs here offer two main arguments to supporttheir claim ofirreparable 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 attestingto the tens ofmillions ofdollars they will be forced to spendredesigning existing cigarette packaging,29 purchasing and engravingblankprinting 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 ofemployee hours

29 PlaintiffRJ. Reynolds avers that it alone must modify 480 distinctpackage designs. See Mot. for PI at 14 (citing O'BrienDecl.**~** 5). 22the 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 proofofeven tens ofmillions ofdollars 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 ofcompliance represents approximately "twelve one-hundredths ofone percent ofplaintiffs' 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

- argumentto demonstrate irreparable harm: their inability to recover costs from the FDA. Indeed, if this Court denies preliminary injunctivereliefand another court overturns that decision,
or even ifthis Court denies preliminary injunctive reliefbut later grants relieffor 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 ofirreparable harm that I previously recognized and described in 

### SmokingEverywhere, 680 F. Supp. 2d at 77 n.19. There, I detenninedthat the FDA's APA violation resulted in irreparable

30 For example, piaintiffRJ. Reynolds alone anticipates expending over 4,000 hours ofemployeetime to ensure compliance with the Rule. Mot. for PI at 16. 

### 23economic injury

- even absent a threat to plaintiffs' viability

- "becauseplaintiffs c[ould] not recover money damages against [the] FDA." Id; see also BraccoDiagnostics, 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 reliefthat can be provided at a later date, tipping the balance in favor ofinjunctive relief.") (internal citation and quotations omitted). Plaintiffs' harm is no different here. 31 Absent injunctive relief(and especially in light ofplaintiffs' likelihood ofsuccess on the merits), plaintiffs have thus demonstrated that they will suffer irreparable harm. In addition, plaintiffs appropriately argued at the September21, 2011 hearing that the harm flowing from a First Amendmentviolation isperse irreparable. See, e.g., Elrod
v. Burns, 427 U.S. 347, 373 (1976) (plurality opinion) ("The loss ofFirst Amendment freedoms, for even minimal periods oftime, unquestionably constitutes irreparable injury.") (citingN Y Times Co. v. UnitedStates, 403 U.S. 713 (1971»; see also Tr. at 24:6-7. Where, as here, plaintiffs are likely to prevail on the merits oftheir constitutional claim, and where their "FirstAmendment interests are eitherthreatened or in fact being impaired at the time reliefis sought," Chaplaincy of Full Gospel Churches, 454 F.3d at 301 (citingNat 'I Treas. Emps. Union v. UnitedStates, 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) andElrod,

31 Indeed, Wisconsin Gas implicitly endorses this concept in its discussion ofhow corrective reliefand recoverable loss militate against injunctive relief. See 758 F.2d at 674. 24427 U.S. at 373), there is more than a sufficient showing ofirreparable harm. 32 Tothat end

- and contrary to defendants' protestations otherwise, see Defs.' Opp'n at 39-40

- the harm plaintiffs suffer is, in fact, "serious in terms ofits effect," Coal. For Common Sense in Gov'tProcurement v. UnitedStates, 576 F. Supp. 2d 162, 168 (D.D.C. 2008), precisely because their First Amendmentrights have been abridged. Such harm is not, as defendants conveniently claim, merely "the ordinary costs ofcomplying with regulations." Defs.' Opp'n at 39. It is the residual effect ofunconstitutionally compelled commercial speech designed to advocate, at a company's expense, a competing policy agenda. Thus, plaintiffs have demonstrated thatthey will suffer irreparable harm in the absence ofpreliminary relief, and this factor also weighs in favor ofgranting an injunction.

32 The Government argues that even an alleged First Amendmentviolation is notper se irreparable harm where, as here, the FDA's Rule is operative, but where plaintiffs have not yetprinted the new warnings (and thus have not yet realized the costs associated with them). Specifically, the Government argues that "this isn'tthe case in which any speech either is happening or not happening within the comingyear," 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 ofaRule that violates the First Amendment

- until the point ofimplementation 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 ofeconomic recourse (aprinciple which I have already discussed), and the Rule would, in essence, escape the constitutional scrutiny and preliminary review that could afford anytype of meaningful relief. A system of justicepremised on this type ofreasoning defies common sense and is fundamentally unfair! Put simply, defendants cannot separate the Rule's effective date from the point at whichplaintiffs begin sufferingharm (whether constitutional or economic). Faced with aRule which compels speech andthreatens their First Amendment rights, plaintiffs are not required to sit idly and wait for irreparable and irretrievable harm to occurbeforethey may seekrelief. 25

### C. Injunctive ReliefWill Not Substantially Injure Other Interested Parties, Including the Public or the Government. Although the two most critical factors weigh in favor ofgranting injunctive relief, otherparties' interests

- and the prejudices otherparties might suffer

- must also be evaluated and weighed againstthe factors supporting an injunction. Defendants argue thatthe delay resulting from a grant ofinjunctive reliefharms thepublic because "[e Jach 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 Governmentunfortunately

- and once again

- trumpets its appeal to emotion instead offocusing on the discrete legal issue before the Court: whether the public will be prejudicedby atemporary delay in the Rule's implementation. 33 Notwithstanding its obvious desire to limit, ifnot eradicate, the use oftobacco, the Governmentutterly fails to address the real issue at hand, and in theprocess gives short shrift to Congress's own instruction for a IS-month implementationperiod. See 76 Fed. Reg. 36,703. Put simply: based on the existingrecord, Congress demonstrated no real urgency when itpassed the graphic-warning statute and vested the FDAwith authority to promulgate the graphic-warning rule. To the contrary, Congress provided a measured,

33 Ofcourse, the temporary delay caused by apreliminary injunction could ultimately tum into apermanent delay ifthis Court determines, on the merits, that the Rule is unconstitutional or violates the APA. Ifthat were the case, however, defendants could hardly argue that the public suffered prejudice from injunctive reliefsince that very relie/wouldpreserve the public's First Amendmentrights. 26multi-stage timeline in which the FDA had 

### up to twoyears to issue a Final Rule, and a 

### 15-month implementationperiod beforethe Final Rule and its related requirements took effect. Pis.' Mot. for PI at 19. The Government, for its part, has pointedto 

### no evidence supporting its bare assertion that "the fact that Congress gave 15 months doesn'tmean that every month ofthat is required." Tr. at 40:22-24. 34 Thus, I can afford little weight to defendants' argument that a delay specifically contemplated and mandatedby Congress couldprejudicethe public, or even the Government itself. Finally, and most importantly, the constitutional protections an injunction would afford plaintiffs far outweigh any incidental prejudicethe public (or indeed, the Government) could hypothetically suffer as a result ofpreliminary injunctive relief. After all, "thepublic clearly has an interest in free speech," andtherefore "thepublic interest
...will be servedby ensuring that plaintiffs' FirstAmendmentrights are not infringed before the constitutionality ofthe regulation has been definitively determined," 

### Stewart v. 

### District o/ColumbiaArmoryBd., 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 whetherthe statute orthe FDA's subsequent Rule might violate it. 

### See, e.g., Tr. at 72:1-23; 

### see also PIs.' Supp. Memo. In Supp. ofPIs.' 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 FDAused the full two-yearperiodto promulgate the Final Rule undercuts any argument that implementation is urgent. 

### See Mot. for PI at 19. 27First Amendment implications ofthese changes or ofthe warnings requirement generally.,,).35 And when one considers the logical extension ofthe Government's defense ofits 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 ofits citizens

- are best served by granting injunctive reliefat this preliminary stage. Thus, like the twobefore them, the final two factors weigh heavily in favor ofan injunction. CONCLUSION This case poses a constitutional challengeto a bold newtackby the Congress, and the FDA, in their obvious and continuing efforts to minimize, ifnot eradicate, tobacco
use in the United States. Notwithstandingthe potential legal and financial ramifications ofthis challenge, the Government, for reasons known only to itself, is unwilling to voluntarily stay the effective date ofthis Rule until the Judicial Branch can appropriately review the constitutionality ofthe Government's novel- and costly

- approach to regulating tobacco packaging and advertising. Thus, this Court must
- and will

- act to

35 Plaintiffs make several otherpersuasive arguments dispelling the notion that injunctive reliefwouldharm the public, butthose 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 oftobacco and thatthe Government offers no empirical evidence that the new graphic warnings "reduce consumption orchange smoking behavior"). 28preserve the status quo until it can evaluate, on the merits (and without incurring irreparableharm to those companies genuinely affected), the constitutionality ofthe 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 ofsuccess on the merits; (2) that they will suffer irreparable harm absent injunctive relief; (3) that neitherthe Government, northe public, will suffer any comparable injury as a result ofthe reliefsought; and (4) thatthe public's interest in the protection ofits First Amendmentrights 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 DistrictJudge



### 29