Case 6:20-cv-00176-JCB Document 79 Filed 11/25/20 Page 1 of 4 PageID #: 10139
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE EASTERN DISTRICT OF TEXAS
`TYLER DIVISION
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`R.J. REYNOLDS TOBACCO COMPANY, et al.,
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`Plaintiffs,
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`v.
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`Civil Action No. 6:20-cv-00176
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`UNITED STATES FOOD AND DRUG
`ADMINISTRATION, et al.,
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` Defendants.
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`DEFENDANTS’ OPPOSITION TO MOTION TO EXTEND POSTPONEMENT
`OF RULE’S EFFECTIVE DATE
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`Defendants oppose Plaintiffs’ motion to further postpone the effective date of the Food and
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`Drug Administration’s (“FDA”) new cigarette health warnings rule, see Tobacco Products; Required
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`Warnings for Cigarette Packages and Advertisements, 85 Fed. Reg. 15,638 (Mar. 18, 2020) (“the
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`Rule”). The Rule’s effective date—originally slated for June 18, 2021, see id. at 15,638—has already
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`been postponed by 120 days to October 16, 2021. See Order at 2, ECF No. 33 (May 8, 2020). The
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`Court ordered that postponement following a joint motion in which the parties emphasized “the
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`extraordinary disruptions caused by the COVID-19 pandemic” and the desire “to facilitate the
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`efficient briefing and resolution of this case[.]” Joint Mot. for Entry of Stipulated Order at 1, ECF
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`No. 30 (“Joint Mot.”). Since that filing, the parties have briefed all of the motions contemplated in
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`their joint motion, including Plaintiffs’ motion for preliminary injunction, see Pls.’ Mot. for Summ. J.
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`& Prelim Inj. at 59, ECF No. 34 (“Pls.’ MSJ Br.”) (requesting that the Court “preliminarily enjoin the
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`Rule and postpone its effective date”).1
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`1 The parties have also briefed (and argued) Defendants’ Motion to Dismiss, ECF No. 36.
`Because Plaintiff Neocom lacks standing, which renders venue in this district improper, the Court
`should dismiss—or, in the alternative, transfer—this case. See id. at 14. Accordingly, the Court need
`only consider the arguments in this opposition if it denies, or has not yet resolved, the Motion to
`Dismiss.
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`Case 6:20-cv-00176-JCB Document 79 Filed 11/25/20 Page 2 of 4 PageID #: 10140
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`Plaintiffs’ motion seeks an additional 90-day postponement of the Rule’s effective date, until
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`January 14, 2022. See Pls.’ Mot. to Extend Postponement of Rule’s Effective Date at 5, ECF No. 76
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`(“Pls.’ Mot.”). To support that request, Plaintiffs rely exclusively on materials they already submitted
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`in support of their motion for preliminary injunction. See id. at 3-5 (citing the Huckabee, Reed, and
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`Wall declarations, ECF Nos. 34-5, 34-6, 34-7). But as Defendants explained in opposing that motion,
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`Plaintiffs have not set forth evidence sufficient to meet their “burden to demonstrate entitlement to
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`[an] ‘extraordinary remedy never awarded as of right[.]’” Defs.’ Combined Cross-Mot. for Summ. J.
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`& Opp. to Pls.’ Mot. at 73, ECF No. 37 (citation omitted); see also id. at 73-75.
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`The same analysis applies with force here. In particular, because the Court can now conclude
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`that Plaintiffs will not succeed on the merits by consulting the same briefs that address Plaintiffs’
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`motions for summary judgment and for a preliminary injunction, there is no basis for further
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`preliminary relief. Nor is there a basis for finding imminent irreparable harm. Plaintiffs’ primary
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`arguments about irreparable harm concern injuries they will allegedly suffer only once they have to
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`introduce cigarette packages and advertisements that comply with the Rule—i.e., not until the Rule is
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`in effect. See Pls.’ MSJ Br. 59-60 (alleging First Amendment injuries and loss of future business). And
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`none of the financial harms they allege approach the level of “threaten[ing] the very existence of some
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`of [Plaintiffs’] businesses,” unlike other injuries the Fifth Circuit has found warrant a stay of agency
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`action. Texas v. EPA, 829 F.3d 405, 434 (5th Cir. 2016).
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`Moreover, Plaintiffs’ arguments about allegedly “imminent compliance costs,” Pls.’ Mot. at 3,
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`do not support their assertion that the rushed relief of an effective-date extension must issue by
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`December 2020. Plaintiffs place considerable weight on the costs of “purchas[ing] additional blank
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`cylinder bases and tools,” id. at 4, but those costs do not appear to be imminent until January 2021—
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`i.e., ten months after the Rule was published on March 18, 2020. See Huckabee Decl. ¶ 11, ECF No.
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`34-5 (“[T]he work to engrave the cylinders will take several months and must begin within ten months
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`after the Rule is published[.]”); Reed Decl. ¶ 10, ECF No. 34-6 (“[T]he work to engrave the cylinders
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`will take at least five months and must begin within ten months after the Rule is published.”). And
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`although one declarant for one brand (Liggett) has stated that “engraving [of the cylinders] would
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`2
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`Case 6:20-cv-00176-JCB Document 79 Filed 11/25/20 Page 3 of 4 PageID #: 10141
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`need to begin by December 2020,” Wall Decl. ¶ 19, ECF No. 34-7, that assertion appears to be based
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`on simply taking the longer of two estimates for how long the engraving process will take. Compare
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`id. (“Under ideal circumstances, the engraving process would take approximately five or six months,
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`meaning engraving would need to begin by December 2020.” (emphasis added)), with Reed Decl. ¶ 10
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`(suggesting engraving will take “at least five months” and therefore must begin in January 2021).
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`Absent any evidence that one estimate is more likely than the other, Plaintiffs have not carried their
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`burden to make “a clear showing” that irreparable harm is imminent before this Court can reach a
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`decision on the merits. See Elite Rodeo Ass’n v. Prof’l Rodeo Cowboys Ass’n, Inc., 159 F. Supp. 3d 738, 748
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`(N.D. Tex. 2016); see also Parks v. Dunlop, 517 F.2d 785, 787 (5th Cir. 1975) (noting that “the central
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`purpose of a preliminary injunction . . . is to prevent irreparable harm . . . before the merits are fully
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`determined”).2
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`If, however, the Court disagrees with the foregoing arguments and further extends the Rule’s
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`effective date over Defendants’ objection, then Defendants agree with Plaintiffs that the statutory
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`deadlines “tied to the issuance of the Rule” should move in conjunction with the Rule’s effective date.
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`Pls.’ Mot. at 5 n.1. In other words, if (and only if) the Court extends the Rule’s effective date by 90
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`days, it should also extend the statutory deadlines tied to the issuance of the Rule by 90 days as well.3
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`2 With respect to the work that allegedly needs to be done “before . . . the engraving of the
`printing cylinders,” Pls.’ Mot. at 3, Plaintiff have introduced no evidence as to how much—if any—
`of that work remains outstanding.
`3 Those deadlines are identified in the parties’ prior joint motion, see Joint Mot. at 4 n.1, and
`reiterated in Plaintiffs’ instant motion, see Pls.’ Mot. at 5 & n.1. Separate and apart from those statutory
`deadlines, the Rule addresses the timeframe for cigarette manufacturers to submit compliance plans.
`But rather than establish a fixed deadline for those plans, FDA “strongly encourage[d] entities to
`submit cigarette plans as soon as possible after publication of this final rule, and in any event within
`five months after the publication of this final rule.” 85 Fed. Reg. at 15,695. Because there is just an
`agency recommendation regarding compliance plans, there is no statutory or regulatory deadline for this
`Court to potentially alter. FDA can consider, in its discretion, whether its own non-binding
`recommendations should be modified. Accordingly, any relief this Court orders need not and should
`not address the submission of compliance plans. See Joint Mot. at 4 n.1 (directing a request to the
`Court regarding “any obligation to comply with the[] additional [statutory] requirements,” but
`separately noting that the timeframe for “manufacturers [to] submit compliance plans” would be the
`subject of an understanding between the parties).
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`3
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`Case 6:20-cv-00176-JCB Document 79 Filed 11/25/20 Page 4 of 4 PageID #: 10142
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`For these reasons, Defendants respectfully request that the Court deny Plaintiffs’ motion to
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`extend the postponement of the Rule’s effective date.
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`Dated: November 25, 2020
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` Respectfully submitted,
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`JEFFREY BOSSERT CLARK
`Acting Assistant Attorney General
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`STEPHEN J. COX
`United States Attorney
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`ERIC B. BECKENHAUER
`Assistant Branch Director
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`/s/ Michael H. Baer
`MICHAEL H. BAER (New York 5384300)
`STEPHEN M. PEZZI (Virginia 84311)
`Trial Attorneys
`United States Department of Justice
`Civil Division, Federal Programs Branch
`1100 L Street, NW
`Washington, DC 20005
`Tel: (202) 305-8576
`Fax: (202) 616-8470
`Email: stephen.pezzi@usdoj.gov
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`4
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