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In a victory for anti-smoking activists, a federal court ruled Wednesday that the U.S. Food and Drug Administration must provide a schedule for issuing a graphic-warnings rule for cigarette packaging by late September, years after being required to do such by federal law.

In her Wednesday ruling, U.S. District Judge Indira Talwani of the District of Massachusetts wrote that the FDA “unlawfully withheld” or “unreasonably delayed” the promulgation of graphic warnings and a rule for regulating their implementation after being tasked with the oversight of such with Congress' 2009 passing of the Tobacco Control Act. The FDA's most recent estimation for issuing a “final rule,” the order said, would be November 2021 “at the earliest.”

“The remaining question is the proper time frame for the agency to act. The court orders that, no later than September 26, 2018, the FDA shall provide to this court an expedited schedule,” Talwani wrote. Among her requirements for such are the publication of a “final rule” on the implementation of graphic warning labels for cigarettes as well as “the completion of outstanding studies” that the agency had cited as among the reasons for its initial delay.

The court, Talwani added, intends to take any necessary further action upon review of the schedule, for which plaintiffs may submit a response “no later than 14 days” after it's filed.

The case began in 2016 when a complaint was filed on behalf of the American Academy of Pediatrics and other groups that partake in health or anti-smoking efforts. Representing plaintiffs in the effort along with Anderson & Kreiger partner Scott Lewis was Mark Greenwold, a consultant for plaintiff Campaign for Tobacco-Free Kids, admitted pro hac vice.

“We didn't realize at the time we brought the lawsuit how little the FDA had done and the fact that instead of developing graphics for the textual warnings … they decide to take several years to rewrite the text. And that came out after we filed the lawsuit,” Greenwold told the NLJ. “They had every chance to move forward, and we found out after we filed the lawsuit they were years and years away, and they weren't even developing graphics they were required to use.”

The FDA's trial attorney, Daniel Crane-Hirsch of the U.S. Department of Justice, didn't respond to a request for comment, nor did plaintiffs attorney Lewis.

Tobacco companies challenged the Tobacco Control Act on two separate occasions. The first was in the U.S. Court of Appeals for the Sixth Circuit, where the court in 2012 rejected the companies' facial challenge to the packaging rules. In the second, however, the D.C. Circuit vacated prior graphic warning requirements. Then-Attorney General Eric Holder in a letter to Congress said the FDA planned to undertake research for new graphic warnings and seek review of the D.C. Circuit decision. The FDA then worked with outside consultants to come up with an image and new warning statements, conducting qualitative testing on them in 2015, and set to recruit focus groups for testing in early February. However, the FDA identified additional steps that would take three years to complete.

In the case presided over by Talwani, plaintiffs argued the FDA “unlawfully withheld” action by “unreasonably delaying” the issuance of such warnings via their timeline, with the court finding that they're entitled to relief under either argument. Regarding “unlawfully withheld” specifically, plaintiffs argued that Congress' previous establishment of a “firm, enforceable deadline” for rule issuance and the FDA's failure to meet it compelled agency action, and requested that the court apply a previous Tenth Circuit ruling that sets a distinction between unlawfully withheld and unreasonably delayed, contingent on “whether Congress imposed a date-certain deadline agency action.”

“The court concluded that in the absence of a new rule more than four years past Congress' deadline, the agency 'unlawfully withheld' a new rule,” Talwani wrote. “Here, the FDA's duty to promulgate a rule is non-discretionary,” she noted, adding that the law required the issuance of regulations over the cigarette package graphics no later than 24 months following June 22, 2009.

The FDA for its part asked the court to apply “TRAC factors”—factors set forth in a Telecommunications Research and Action Center case against the FCC—to demonstrate the agency didn't unreasonably delay rule promulgation. However, Talwani said the court “finds that even utilizing the TRAC factors,” the agency “has 'unreasonably delayed' in promulgating a final rule,” describing its current trajectory as “extraordinary.”

“The FDA, of its own accord, decided to revise the texts for two years and delay work on the images until 2015,” Talwani wrote. “Moreover, even more troubling is the gaps of time where little to no work was completed on the graphic images. From 2013 to 2015, the record does not indicate any work on the graphic images. Aside from the drawings completed by the certified medical illustrator, the record does not indicate any work on the images from June 2016 to October 2017.”

Plaintiffs attorney Greenwold noted that while his side didn't believe TRAC factors “ought to be applied” in this case, they did believe the factors might actually work in their favor.

“We thought if you did apply them, we'd certainly win,” he said. “And that's exactly what the court ruled.”