317 F.Supp.3d 555
D.D.C.2018Background
- In May 2016 the FDA’s "Deeming Rule" extended tobacco regulation to cigars and pipe tobacco, requiring specified health warnings on packaging and ads effective August 10, 2018 (21 C.F.R. §§ 1143.3, 1143.5).
- Plaintiffs (Cigar Association of America et al.) sued, alleging the warnings violate the TCA, the APA, and the First Amendment; Counts VI and VII challenged the warnings on First Amendment grounds.
- The district court issued a May 15, 2018 memorandum opinion rejecting Plaintiffs’ TCA/APA claims and upholding the warnings under Zauderer, and entered final judgment for the FDA on June 27, 2018. Plaintiffs appealed.
- Plaintiffs moved under Federal Rule of Civil Procedure 62(c) for an injunction pending appeal (or a postponement), arguing the warnings compel government speech beyond what Zauderer permits and impose unrecoverable compliance costs.
- The court found Plaintiffs’ appeal presents "serious legal questions," that Plaintiffs would suffer irreparable First Amendment and financial injury if forced to comply, and that equities and public interest favor a stay.
- The court enjoined enforcement of the cigar and pipe tobacco warning requirements until 60 days after final disposition of Plaintiffs’ appeal.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether an injunction pending appeal is warranted under Rule 62(c) | The warnings raise serious First Amendment questions; immediate compliance would cause irreparable speech and financial harm | The court already ruled on the merits; Plaintiffs cannot show likelihood of success | Granted: injunction pending appeal warranted under sliding-scale test because of serious legal questions and other factors favoring Plaintiffs |
| Whether the warnings are permissible compelled disclosures under Zauderer | Warnings exceed Zauderer because they are broader than reasonably necessary and unduly burdensome (crowd out protected commercial speech) | Warnings are factual, uncontroversial, reasonably tailored and not unduly burdensome | Court concluded issue presents a serious legal question for appeal (did not finally resolve in favor of Plaintiffs here) |
| Whether Plaintiffs will suffer irreparable harm absent injunctive relief | Compliance would force speech Plaintiffs contest and impose millions in unrecoverable redesign costs | FDA asserted public health interest and need for timely enforcement | Held Plaintiffs showed irreparable harm (First Amendment injury and unrecoverable monetary costs) |
| Whether public interest and balance of equities favor a stay | Protecting free-speech rights and avoiding enforcement that may be overturned serve the public interest; little harm from delay | Public has interest in FDA communicating health risks and prompt enforcement | Held balance and public interest favor injunction pending appeal |
Key Cases Cited
- Winter v. Natural Res. Def. Council, 555 U.S. 7 (2008) (standard for preliminary injunctions: likelihood of success, irreparable harm, balance of equities, public interest)
- Zauderer v. Office of Disciplinary Counsel, 471 U.S. 626 (1985) (compelled disclosures of factual, uncontroversial information may be permissible under relaxed First Amendment scrutiny)
- National Institute of Family and Life Advocates v. Becerra, 138 S. Ct. 2361 (2018) (Supreme Court clarified limits on compelled disclosures under Zauderer and emphasized disclosures must be no broader than reasonably necessary)
- Washington Metro. Area Transit Comm’n v. Holiday Tours, 559 F.2d 841 (D.C. Cir. 1977) (district courts may issue injunctions pending appeal under a sliding-scale analysis where serious legal questions exist)
- Chaplaincy of Full Gospel Churches v. England, 454 F.3d 290 (D.C. Cir. 2006) (First Amendment losses can constitute irreparable harm)