Significant Cases

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In a nearly 250-page Memorandum Opinion and Order, the Honorable James O. Browning of the U.S. District Court for the District of New Mexico has granted in part and denied in part a Motion to Dismiss filed by Defendants Santa Fe Natural Tobacco Co., Reynolds American, Inc., and R.J. Reynolds Tobacco Co. The case is In re Santa Fe Natural Tobacco Co. Marketing & Sales Practices Litigation, No. 1:16-md-02695 (D.N.M.).

By way of background, this multidistrict litigation involves class actions filed by Plaintiffs across various states and under those various states’ respective laws, all directed toward the use of certain descriptors in Natural American Spirit (“NAS”) cigarettes’ packaging, labeling, and advertising.

Further briefing and deliberation are expected on a Motion to Intervene filed by several anti-tobacco advocacy and health groups in Nicopure Labs, LLC, v. FDA, No. 17-5196 (D.C. Cir.). The would-be intervenors include 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.

Recent filings in the cigar industry’s challenge to the FDA’s Deeming Regulations involve outside support and opposition. The case is Cigar Association of America v. FDA, No. 1:16-cv-01460 (D.D.C.).

After Plaintiffs in the cigar-industry challenge to the Deeming Regulations filed a Motion for Preliminary Injunction and a Motion for Partial Summary Judgment on October 3, 2017, filings of amici curiae have come on their side. Meanwhile, the Court has denied a Motion to Intervene filed by several anti-tobacco advocacy and public-health groups.

Activity on Motions for Summary Judgment seems to suggest different paths ahead for remaining trial litigation in Deeming Regulations challenges. This activity comes after delays owing 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. The 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.).

Expect about a year’s worth of new anti-tobacco messaging on television and in the newspaper as the result of a recent Consent Motion in United States v. Philip Morris USA Inc., et al., No. 1:99-cv-02496 (D.D.C.).

Over eighteen years ago, on September 22, 1999, the federal government filed this case under the Racketeer Influenced and Corrupt Organizations (“RICO”) Act. The trial court eventually found for the federal government in 2006, ordering (among other remedies) that Defendants issue “Corrective Statements” regarding previous representations as to their products. 

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.

On August 29, 2017, Plaintiffs Nicopure Labs and the Right to Be Smoke-Free Coalition appealed the adverse judgment of the U.S. District Court for the District of Columbia in Nicopure Labs, LLC, et al. v. Food & Drug Administration, et al., No. 1:16-cv-0878 (D.D.C. July 21, 2017). The District Court held for the FDA on competing Cross Motions for Summary Judgment, denying all of the plaintiffs’ statutory and constitutional challenges to the Deeming Regulation.

Several delays have come in a cigar industry challenge to the FDA’s Deeming Regulations. The case is Cigar Association of America, et al. v. U.S. Food & Drug Administration, et al., No. 1:16-cv-01460 (D.D.C.).

During the spring of 2017, there were several extensions of pending deadlines to “allow new leadership personnel at the Department of Health and Human Services to more fully consider the issues raised in this case and determine how best to proceed.” Another delay has come after the FDA’s most recent announcement of July 28, 2017, declaring a new comprehensive plan for focusing the FDA’s regulatory efforts regarding nicotine.