RICHARD J. LEON, District Judge.
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
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.
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. § 1333(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 Compl. ¶ 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).
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.
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; Compl. ¶ 57. Of the 36 graphic images originally proposed, the FDA chose 9 for publication. See Compl. ¶¶ 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)); Compl. ¶ 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
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 Compl. ¶¶ 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.
The factors a court must consider in determining whether to grant injunctive relief are, of course, familiar:
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]f the 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 of 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 Mkt., Inc., 548 F.3d 1028, 1035 (D.C.Cir.2008).
As an initial matter, defendants challenge this Court's authority to award injunctive relief in this case at all. See, e.g., Defs.' Opp'n at 3, 35-37; Tr. at 38-41. 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; Friends for 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 Holding Co., 328 U.S. 395, 398, 66 S.Ct. 1086, 90 L.Ed. 1332 (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.
At the outset, it is important to note that plaintiffs do not quarrel with the 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
In particular, plaintiffs argue that the new Rule unconstitutionally compels speech, see Wooley v. Maynard, 430 U.S. 705, 714, 97 S.Ct. 1428, 51 L.Ed.2d 752 (1977); Hurley v. Irish-Am. Gay, Lesbian & Bisexual Grp. of Boston, Inc., 515 U.S. 557, 573-74, 115 S.Ct. 2338, 132 L.Ed.2d 487 (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 of Disciplinary Counsel of Sup. Ct. of Ohio, 471 U.S. 626, 651, 105 S.Ct. 2265, 85 L.Ed.2d 652 (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.
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").
Not only do I reject the Government's suggestion that this case is factually analogous to Commonwealth Brands,
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 tenet 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, 97 S.Ct. 1428. A speaker typically "has the autonomy to choose the content of his own message." Hurley, 515 U.S. at 573, 115 S.Ct. 2338. And, in fact, "[f]or 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, 106 S.Ct. 903, 89 L.Ed.2d 1 (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 of the Blind of N.C., Inc., 487 U.S. 781, 795, 108 S.Ct. 2667, 101 L.Ed.2d 669 (1988)). As the Supreme Court itself has noted, this type of compelled speech is "presumptively unconstitutional." Rosenberger v. Rector & Visitors of Univ. of Va., 515 U.S. 819, 830, 115 S.Ct. 2510, 132 L.Ed.2d 700 (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, 105 S.Ct. 2265 (quoting In Re R.M.J., 455 U.S. 191, 201, 102 S.Ct. 929, 71 L.Ed.2d 64 (1982)). 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, 105 S.Ct. 2265. 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.
Moreover, the disclosures in this case are unlike those that the Government endorsed in Nat'l 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 under which [an attorney's] services w[ould] be available." 471 U.S. at 651, 105 S.Ct. 2265. 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.
To withstand strict scrutiny, the Government carries the burden of demonstrating that the FDA's Rule is narrowly tailored to achieve a compelling government interest. See, e.g., A.N.S.W.E.R. Coal. v. Kempthorne, 537 F.Supp.2d 183, 195-96 (D.D.C.2008) (citing Boos v. Barry, 485 U.S. 312, 322, 108 S.Ct. 1157, 99 L.Ed.2d 333 (1988) and Rosenberger v. Rector & Visitors of the Univ. of Va., 515 U.S. 819, 829, 115 S.Ct. 2510, 132 L.Ed.2d 700 (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.
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.
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
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.
It is undisputed that our Circuit "has set a high standard for irreparable injury." Chaplaincy of 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 of 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 15-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,
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 of 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 determined that the FDA's APA violation resulted in irreparable 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.
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, 96 S.Ct. 2673, 49 L.Ed.2d 547 (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, 91 S.Ct. 2140, 29 L.Ed.2d 822 (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'l Treas. Emps. Union v. United States, 927 F.2d 1253, 1254-55 (D.C.Cir.1991) and quoting Wagner v. Taylor, 836 F.2d 566, 577 n. 76 (D.C.Cir.1987) and Elrod, 427 U.S. at 373, 96 S.Ct. 2673), there is more than a sufficient showing of irreparable
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 "[e]ach 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.
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 of 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 Pls.' Supp. Memo. In Supp. of Pls.' 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 First Amendment implications of these changes or of the warnings requirement generally.").
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
For the reasons set forth in the accompanying Opinion, it is this 7th day of November, 2011 hereby
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!
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.