The Food and Drug Administration filed notice (PDF) this afternoon that it intends to appeal U.S. District Judge Richard Leon's Nov. 7 order granting a preliminary injunction to delay enforcement of new cigarette package label requirements.
The government's notice of appeal to the U.S. Court of Appeals for the D.C. Circuit marks an expected next step in the case following Leon's decision - during oral arguments before Leon on Sept. 21, he even noted that regardless of how he ruled, he anticipated the losing side would appeal.
The agency is fighting to defend the constitutionality of the new regulations, which would require cigarette manufacturers to print labels that include graphic color images meant to depict the health risks associated with smoking. The manufacturers claim the new labels run afoul of the First Amendment.
The plaintiffs in the case, five of the largest cigarette manufacturers in the United States, filed suit against the agency on Aug. 16 in U.S. District Court for the District of Columbia. The companies are arguing that the new labels cross the line from factual warnings to unconstitutional compelled speech promoting the government’s anti-smoking platform.
Without a preliminary injunction, the manufacturers had argued that they would have to spend millions of dollars preparing for the new regulations, which go into effect next September. The government countered that the companies hadn’t shown that they were likely to win on the merits, and also that the harm would be minimal.
In the opinion granting the preliminary injunction, Leon wrote that the cigarette manufacturers had demonstrated “a substantial likelihood that they will prevail on the merits of their position." When it comes to commercial businesses, the government can compel speech as long as it is "purely factual and uncontroversial," Leon wrote.
In this case, Leon found, the proposed graphic labels aren't purely fact – some are cartoons and some appear to be digitally altered or enhanced. He added that all of them are "unquestionably designed to evoke emotion," or at least that was a standard the agency used to consider which images to use.
The injunction will delay enforcement for 15 months after the court issues a final ruling in the case. Leon has yet to rule on the manufacturers’ motion for summary judgment.
Floyd Abrams of New York's Cahill, Gordon & Reindel, a lead counsel for the manufacturers declined to comment on the notice of appeal. Co-lead counsel, Jones Day partner Noel Francisco, could not immediately be reached. An FDA spokeswoman declined to comment on the case, citing the pending litigation.