Judge Leon Grants Preliminary Injunction- FDA’s Final Rule Requiring Graphic Warnings on Cigarette Packages Appears in Jeopardy

By David B. Clissold –

As we previously reported, a group of five tobacco companies (R.J. Reynolds Tobacco Company, Lorillard Tobacco Company, Commonwealth Brands, Inc., Liggett Group LLC, and Santa Fe Natural Tobacco Company, Inc.) filed a complaint against FDA in the U.S. District Court for the District of Columbia challenging the Agency’s June 22, 2011 final rule, promulgated pursuant to the Family Smoking Prevention and Tobacco Control Act (“Tobacco Control Act”), requiring the display of nine color graphic  “health warning” images on cigarette packages and in cigarette advertisements.  The Tobacco Control Act states that the new textual and graphic warnings, among other requirements, will become effective “15 months after the issuance of” FDA’s final rule.

In a memorandum opinion issued on November 7, 2011, Judge Richard Leon of the U.S. District Court for the District of Columbia granted plaintiff’s motion for a preliminary injunction to halt FDA from enforcing the rule until fifteen months after resolution of plaintiff’s claim on the merits.  Judge Leon first determined that the mandatory warnings, as compelled commercial speech, were subject to the “strict scrutiny” level of analysis.  He noted that the warnings were not the type of “purely factual and noncontroversial disclosures” permissible under the Constitution, but were instead designed “to evoke emotion” and intended to “provoke the viewer to quit, or never start, smoking.”  Under the strict scrutiny test, the government must show that the speech is “narrowly tailored” to meet a “compelling government interest.”  Judge Leon wrote:

[T]he sheer size and display requirements for the graphic images are anything but narrowly tailored . . . 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.” (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!

In addition, the opinion notes that the Government failed to provide sufficient evidence of a “compelling government interest” since in this case “the Government’s actual purpose is not to inform, but rather to advocate a change in consumer behavior.”  Judge Leon was also persuaded to grant the motion because the plaintiffs would be unable to recover economic damages from FDA, and “the harm flowing from a First Amendment violation is per se irreparable.”

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.

Finally, the government was unable to show that the public or the government would be unduly prejudiced as a result of preliminary injunctive relief.

[W]hen 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.

The government will now try to perfect its arguments, either in opposition to the plaintiffs’ motion for summary judgment (filed on the same day as the motion for preliminary injunction), or at trial.