R.J. Reynolds Tobacco Co. v. U.S. Food & Drug Admin.

• Decision Date: 29 February 2012
• Docket Number: Civil Case No. 11–1482 (RJL).
• Citation: 845 F.Supp.2d 266
• Parties: R.J. REYNOLDS TOBACCO COMPANY, Lorillard Tobacco Company, Commonwealth Brands, Inc., Liggett Group LLC, and Santa Fe Natural Tobacco Company, Inc., Plaintiffs, v. UNITED STATES FOOD AND DRUG ADMINISTRATION, 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.
• Court: U.S. District Court — District of Columbia

845 F.Supp.2d 266

R.J. REYNOLDS TOBACCO COMPANY, Lorillard Tobacco Company, Commonwealth Brands, Inc., Liggett Group LLC, and Santa Fe Natural Tobacco Company, Inc., Plaintiffs,

v.UNITED STATES FOOD AND DRUG ADMINISTRATION, 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.

Civil Case No. 11–1482 (RJL).

United States District Court, District of Columbia.

Feb. 29, 2012.

Held Unconstitutional

21 C.F.R. §§ 1141.1, 1141.3, 1141.10, 1141.12, 1141.14, 1141.16

Geoffrey Kres Beach, Womble, Carlyle, Sandridge & Rice, LLP, Winston–Salem, NC, Noel John Francisco, Warren Postman, Jones Day, Patricia Anne Barald, U.S. Commodity Futures Trading Commission, Scott Darren Danzis, Covington & Burling LLP, Philip Jonathan Perry, Latham & Watkins, Jonathan D. Hacker, O'Melveny & Myers, LLP, Washington, DC, Floyd Abrams, Joel L. Kurtzberg, Kayvan Sadeghi, Cahill Gordon & Reindel LLP, New York, NY, for Plaintiffs.

Drake S. Cutini, Daniel K. Crane–Hirsch, U.S. Department of Justice, Washington, DC, for Defendants.

MEMORANDUM OPINION

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 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 Mem. in Supp. of Pls.' Mot. for Summ. J. and Permanent Inj. (“Pls.' Mot.”), Aug. 19, 2011, at 3–5 [Dkt. # 10]. Alleging that the Rule violates the First Amendment and the Administrative Procedure Act (“APA”), 5 U.S.C. §§ 553(b)(3), 705, 706(2)(A), see Compl. ¶¶ 5–6, plaintiffs moved for a preliminary injunction on August 19, 2011, enjoining the enforcement of the Rule until fifteen months after resolution of plaintiffs' claims on the merits. See Pls.' Mot. at iii. As such, plaintiffs raised for the first time in our Circuit the question of whether the FDA's new and mandatory graphic images, when combined with certain textual warnings on cigarette packaging, are unconstitutional under the First Amendment. The Court granted plaintiffs' motion on November 7, 2011. See R.J. Reynolds Tobacco Co. v. FDA, 823 F.Supp.2d 36, 39, n. 1 (D.D.C.2011). Since then both parties have moved for summary judgment on the same issues.² Upon review of the pleadings, oral argument, the entire record, and the applicable law, the Court concludes that these mandatory graphic images violate the First Amendment by unconstitutionally compelling speech. For that and the other reasons stated herein, the Court GRANTS plaintiffs' Motion for Summary Judgment and DENIES the Cross–Motion for Summary Judgment.³

BACKGROUND⁴

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. Mem. in Support of Defs.' Mot. for Summ. J. and in Opp'n to Pls.' Mot. for Summ. J. (“Defs.' Opp'n”), Oct. 21, 2011, at 1 [Dkt. # 34]. Pursuant to that authority, Congress directed the Secretary of the U.S. Department of Health and Human Services (“the Secretary”) to “issue regulations that require color graphics depicting the negative health consequences of smoking.” ⁵SeePub.L. No. 111–31, § 201(a) (amending 15 U.S.C. § 1333(d)); Compl. ¶ 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.” Act § 201(a) (amending 15 U.S.C. § 1333(a)(1)).

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)); 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).

B. The Rule

1. Proposed Rule

On November 12, 2010, the FDA submitted for public comment a Proposed Rule unveiling 36 graphic color images that could be displayed with the 9 new textual warnings created by Congress.⁶Required 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); Compl. ¶¶ 36, 38; Defs.' Opp'n at 10–11. 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 resource must provide. 75 Fed. Reg. 69,564 (proposing 21 C.F.R. § 1141.16(a)); 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, 75 Fed. Reg. 69,543 (emphasis added), a statistic the FDA admits is “in general not statistically distinguishable from zero.” ⁷Id. at 69,546;see also Compl. ¶ 41.

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. See76 Fed. Reg. 36,628–36,629; Compl. ¶ 57. Of the 36 graphic images originally proposed, the FDA chose 9 for publication. Compl. ¶ 57. 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 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 Compl. ¶¶ 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,⁸ enhanced, or animated, or that they depict actors to achieve the desired image. See id. ¶ 59. And indeed, the FDA cited these nine images' “salience”—defined as a warning's ability to evoke emotion—as a primary selection criterion.⁹76 Fed. Reg. 36,639.

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). In response to the Final Rule, plaintiffs filed a Motion for Preliminary Injunction, which this Court granted on November 7, 2011. Plaintiffs also filed a Motion for Summary Judgment and Permanent Injunction on August 19, 2011; defendants responded and filed a Cross–Motion for Summary Judgment on October 21, 2011; and oral argument was held on February 1, 2012.

ANALYSIS

I. Standard of Review

Summary judgment is appropriate when the movant demonstrates that there is no genuine issue of material fact in dispute and that the moving party is entitled to judgment as a matter of law. Fed.R.Civ.P. 56(a). The moving party bears the burden, and the court will draw “all justifiable inferences” in the favor of the non-moving party. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). Nevertheless, the non-moving party “may not rest upon the mere allegations or denials of his pleading, but ... must set forth specific facts showing that there is a genuine issue for trial.” Id. at 248, 106 S.Ct. 2505 (internal quotations omitted). Factual assertions in the moving party's...