En Fuego Tobacco Shop LLC, et al. v. U.S. Food and Drug Administration

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No. 4:18-cv-00028 (E.D. Tex.)
No. 1:18-cv-01797 (D.D.C.)

On January 11, 2018, En Fuego Tobacco Shop LLC, Cuba Libre Enterprises LLC, and the Texas Cigar Merchants Association, a cigar retailer, a manufacturer, and a trade association, filed suit in the Eastern District of Texas. The plaintiffs requested that the court issue a preliminary injunction barring enforcement of the rule while the litigation proceeds and asked the court to permanently strike down the rule. The FDA’s filed its answer on March 19, 2018 along with a motion to transfer the venue to the U.S. District Court for the District of Columbia. The motion to transfer highlights the fact that the plaintiffs in this litigation are a member of one of the organizations that is a plaintiff in Cigar Association of America, et al. v. FDA, the attorneys representing the plaintiffs in this lawsuit also represent the plaintiffs in that case, and that the claims made in this case are identical to the claims in that case. The transfer of venue would allow this case to be consolidated with Cigar Association of America. The plaintiffs filed a response in opposition to the motion to transfer on April 2, 2018. The FDA filed a reply on April 9, 2018. The plaintiffs filed a sur-reply on April 16, 2018.

On March 27, 2018, the plaintiffs amended their complaint and filed a motion for summary judgment which the court deemed filed on April 10, 2018. On April 16, 2018, the FDA filed a motion to stay briefing on the plaintiff’s motion for summary judgment pending the outcome of the FDA’s motion to transfer. On April 20, 2018, the court stayed the briefing on the plaintiff’s motion for summary judgment until the court ruled on the FDA’s motion to stay. The plaintiffs filed their response to the motion to stay on April 30, 2018. On May 22, 2018, the court denied the FDA’s motion to transfer and denied the FDA’s motion to stay briefing. On June 5, 2018, the FDA filed an appeal of the court’s denial of the agency’s motion to transfer and the plaintiffs filed their response to the FDA’s appeal on June 12, 2018.

While the appeal of the denial of the motion to transfer was pending, briefing continued on the plaintiffs’ motion for summary judgment. The FDA filed its response to the plaintiffs’ motion for summary judgment on June 19, 2018 and the plaintiffs filed their reply on June 22, 2018. A hearing on the motion was held on June 26, 2018.

On July 2, 2018, the court granted the FDA’s motion to transfer, overturning its previous decision to deny the motion. On July 5, 2018, the plaintiffs filed an appeal of that order and the FDA filed its response to the appeal on July 17, 2018. On July 30, 2018, the court denied the plaintiffs’ appeal and transferred the case to the District of Columbia.

On October 1, 2018, the plaintiffs filed a motion to retransfer the case to the Eastern District of Texas. On October 22, 2018, the FDA filed its opposition to the plaintiffs’ motion and on October 29, the plaintiffs’ filed their reply regarding the motion to retransfer. On January 11, 2019, the court denied the motion to retransfer and ordered the case to be consolidated with Cigar Association of America v. FDA.

The lawsuit alleges that:

  1. the required warning labels impermissibly restrict speech, a violation the First Amendment;
  2. the required warning labels unconstitutionally compel speech, a violation of the First Amendment;
  3. the required submission of warning plans is an unconstitutional prior restraint and unconstitutionally restricts speech, a violation of the First Amendment;
  4. the FDA did not make findings required by the Tobacco Control Act before imposing required warning labels;13
  5. the FDA did not make findings required by the Tobacco Control Act before imposing required warning labels, a violation of the APA.