Law360 (June 19, 2020, 9:24 PM EDT) -- A group of cigar associations snared in a battle over e-cigarette regulations asked the full Fourth Circuit to let them intervene in the case, saying the U.S. Food and Drug Administration hung them out to dry by acquiescing to an accelerated tobacco product approval timeline.
The Cigar Association of America and two other groups who sought to block vaping regulations that would also force them to seek product approvals on a tighter deadline, said Thursday that a Fourth Circuit panel was wrong to find their intervention untimely, arguing they had no way of knowing that the FDA would abandon its position.
The case made odd bedfellows of the FDA and the cigar groups as the agency sought to defend approval application deadlines for certain nicotine products, which Maryland health groups succeeded in moving up through a lawsuit. The FDA later abandoned an appeal, and a federal court blocked the vaping and cigar groups from stepping in.
The Fourth Circuit dismissed an appeal of that decision last month, saying January FDA guidance limiting the sale of flavored vapes rendered the case moot. The panel also found the Maryland court was free to block the cigar groups' intervention as untimely.
Affirming that decision could leave future litigants "reading tea leaves" when deciding whether or not to intervene, the cigar groups warned.
"If left to stand, the panel's decision will put future intervenors supporting the government in the same damned-if-you-do, damned-if-you-don't situation that the cigar associations here found themselves," they said.
The groups said it would have been unnecessary and wasteful to intervene before the FDA gave up, pointing to "long-standing" precedent holding that parties don't need to jump in until the government stops defending a rule that would benefit them. The panel was wrong to overlook this, they said.
"If the earliest sign of the government's wavering is the point at which a prospective intervenor must try to join the case, the panel decision provides no guidance on when that is, which only encourages future intervenors to intervene early and often," they said. "There is no reason to impose such a Hobson's choice on potential intervenors."
The groups said the panel's decision could unleash torrents of paper in litigation over future regulations, with interested parties leaping in early as intervenors lest the government abandon them by changing its legal position.
The appeal stems from a 2018 effort by public health groups to accelerate the FDA's regulation of vaping products under the Tobacco Control Act, citing vaping-related lung injuries that last year sickened thousands of people and left nearly 70 dead.
Those groups partially succeeded but landed the FDA in a multifront scrum with vape shops and e-cig manufacturers who fought the new regulatory timeline in two federal appeals courts. The cigar groups joined the fray as well, as some of their products were included in the regulations.
In July 2019, a Maryland district judge effectively allowed the FDA to set a May 2020 deadline, prompting appeals by the vaping and cigar groups.
Last month, a Maryland federal judge granted a 120-day extension to the May 12 deadline in light of the coronavirus pandemic, which the FDA said had significantly slowed clinical trials and product safety testing.
Counsel for the cigar groups and the FDA did not immediately respond to requests for comment Friday.
The cigar groups are represented by Mark S. Raffman, Andrew Kim and Benjamin Hayes of Goodwin Procter LLP and Michael J. Edney of Steptoe & Johnson LLP.
The FDA is represented by Joshua Revesz of the U.S. Department of Justice.
The case is In re: Cigar Association, case number 19-2130 in the U.S. Court of Appeals for the Fourth Circuit.
--Additional reporting by Sarah Jarvis, Emily Field and Hailey Konnath. Editing by Steven Edelstone.
