United States: Deeming Regulations Litigation Update — Decisions Remain Pending On Health And Advocacy Groups' Intervention To Defend Deeming Regulations

Decisions remain pending on the adequacy of the FDA's defense in two cases challenging the Deeming Regulations. Those cases are Cigar Association of America v. FDA, No. 1:16-cv-01460 (D.D.C.), and Cyclops Vapor 2, LLC v. FDA, No. 2:16-cv-00556 (M.D. Ala.). The issue arose in Motions to Intervene filed by the American Academy of Pediatrics, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association, the Campaign for Tobacco-Free Kids, and the Truth Initiative on July 24, 2018.

In these Motions, the health and advocacy groups seek to enter the litigation as co-defendants alongside the FDA and other government defendants. Although there are other arguments at issue, in each case the crux of the matter may very well be whether the FDA is adequately defending the Deeming Regulations.

The Positions on Intervention

Questioning the adequacy of the FDA's advocacy, the would-be intervenors have cited various extensions in each case. The extensions have owed to the need for new leadership in the Department of Health and Human Services to review the cases and, more recently, for the existing plaintiffs and defendants to reconsider the claims in light of the FDA's July 28, 2017, announcement of a new comprehensive plan for focusing its regulatory efforts regarding nicotine.

In each case, plaintiffs have opposed the Motions. They have countered the would-be intervenors' assertions, arguing (among other things) that the would-be intervenors are merely speculating as to the alleged inadequacy of the FDA's representation of their interests and that intervention is unnecessary given that the would-be intervenors could participate in the cases as amici curiae. (By way of background, each Court earlier allowed the Campaign for Tobacco-Free Kids to file briefs as amicus curiae. In Cigar Association of America, notably, the Campaign for Tobacco-Free Kids' Motion was unopposed, and it anticipated that "several other public health and medical groups w[ould] join . . . as signatories to this brief.")

As for the FDA's views, it has taken no position on the possible intervention. The FDA has noted, however, that

  • the respective Courts "may wish to defer resolution of this question, as it is at least premature to conclude that the government will not adequately represent the interests at stake, and it is not yet clear what claims, if any, Plaintiffs intend to continue pursuing in this litigation;"
  • the would-be intervenors, short of intervention as Codefendants, may be allowed to participate as amici curiae; and
  • any intervention should be limited (guarding against the litigation's becoming too unwieldy, perhaps) to briefing on pending Motions for Summary Judgment.

As the FDA's July 28 announcement came after the would-be intervenors' original filings, afterward they sought to participate in further conferences with the existing parties and the Court as to the anticipated scope and schedule for the litigation. These efforts were met with resistance and were ultimately denied by the respective Courts.

Where the Motions Stand

The courts have not yet ruled on the respective Motions to Intervene.

In the Cigar Association of America case, on August 18, 2017, the Court announced that, "in the interest of judicial economy, it w[ould] defer ruling on the Motion until after the parties . . . submitted [their] Joint Status Report." Among other justifications were "the parties' ongoing efforts to narrow the issues in dispute, and the potential relief sought." The Court expected that the result of these efforts was "likely to materially influence [its] intervention decision." The existing parties having since updated the Court as to these and other logistical matters, on September 12, 2017, the Court ordered that "the parties shall file supplemental briefing on the issue of intervention. All Supplemental Briefs on this issue are due on or before September 20, 2017."

In the Cyclops Vapor 2 case, the would-be intervenors filed their Reply Brief on August 18, 2017. Briefing has closed, and a decision is forthcoming.

What to Watch For

On motions to intervene on the side of a government party defending a duly-enacted law, courts generally assume that the government adequately represents the would-be intervenor's interest in the defense of the law. However, the presumption may be rebutted if the would-be intervenor clearly shows otherwise.

Given the unique development of the challenges to the Deeming Regulations, it will be interesting to see how the various deadline extensions, proposed rulemaking, lingering uncertainties, and ongoing scheduling issues figure into the Courts' assessment of the FDA's defensive litigation. At the very least, it can be expected that the would-be intervenors will get their word in on the merits, through the Campaign for Tobacco-Free Kids' briefs as amicus curiae.

Stay tuned for further developments.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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