Case 6:20-cv-00176-JCB Document 86 Filed 02/26/21 Page 1 of 8 PageID #: 10281
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE EASTERN DISTRICT OF TEXAS
`TYLER DIVISION
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`CIVIL ACTION NO. 6:20-cv-00176
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`R.J. REYNOLDS TOBACCO COMPANY;
`SANTA FE NATURAL TOBACCO
`COMPANY, INC.; ITG BRANDS, LLC;
`LIGGETT GROUP LLC; NEOCOM, INC.;
`RANGILA ENTERPRISES INC.; RANGILA
`LLC; SAHIL ISMAIL, INC.; and IS LIKE
`YOU INC.;
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`Plaintiffs,
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`v.
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`UNITED STATES FOOD AND DRUG
`ADMINISTRATION;
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`UNITED STATES DEPARTMENT OF
`HEALTH AND HUMAN SERVICES;
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`JANET WOODCOCK,
`in her official capacity as Acting Commissioner
`of the United States Food and Drug
`Administration; and
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`NORRIS COCHRAN,
`in his official capacity as Acting Secretary of the
`United States Department of Health and
`Human Services;
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`Defendants.
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`PLAINTIFFS’ SECOND MOTION TO EXTEND POSTPONEMENT
`OF RULE’S EFFECTIVE DATE
`Plaintiffs respectfully request that the Court grant a second 90-day extension of the initial 120-
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`day postponement of the Rule’s effective date, without prejudice to Plaintiffs’ ability to seek additional
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`relief if it becomes necessary.1 In support of this request, Plaintiffs state as follows:
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`1 Two former Defendants—Stephen M. Hahn and Alex M. Azar II—have left their official
`positions. Accordingly, this Motion is directed to their successors, Janet Woodcock and Norris
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`Case 6:20-cv-00176-JCB Document 86 Filed 02/26/21 Page 2 of 8 PageID #: 10282
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`1.
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`On May 6, 2020, Plaintiffs and Defendants filed a joint motion requesting that the
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`Court postpone for 120 days the effective date of a Final Rule issued by the Food and Drug
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`Administration (“FDA”), which would require the use of eleven new graphic warnings on cigarette
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`packages and advertisements, see Tobacco Products; Required Warnings for Cigarette Packages and
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`Advertisements, 85 Fed. Reg. 15,638 (Mar. 18, 2020) (to be codified at 21 C.F.R. pt. 1141) (“the Rule”).
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`See Joint Mot., ECF No. 30, ¶¶ 1, 4, 7 (May 6, 2020). Defendants stipulated that, “[i]n light of the
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`disruptive effects of the global outbreak of COVID-19 on both the regulated community affected by
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`the Rule and on FDA, . . . justice require[d] a 120-day postponement of the Rule’s effective date, from
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`June 18, 2021, to October 16, 2021.” See id. ¶ 4. Plaintiffs explained that the Rule would cause
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`irreparable harm, including substantial compliance costs for the Manufacturer Plaintiffs. See id. ¶¶ 5–
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`6. Plaintiffs further noted that they would need to seek expedited relief from the Court if the joint
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`motion were not granted. See id. ¶ 5.
`2.
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`On May 8, 2020, the Court granted the parties’ joint motion. See Order, ECF No. 33
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`(May 8, 2020) (“Postponement Order”). The Court agreed that Plaintiffs would suffer “irreparable
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`injury absent postponement of the rule’s effective date” because they “would face imminent
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`compliance costs” and “those costs would not be reimbursed by the government if plaintiffs
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`prevail[ed] on the merits.” See id. at 1–2. The Court thus postponed the Rule’s effective date for 120
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`days—from June 18, 2021, to October 16, 2021—and set forth a briefing schedule to facilitate an
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`orderly and efficient resolution of this case. See id. at 1–4.
`3.
`Court’s May 8, 2020 order. See, e.g., Pls.’ Mot. for Summ. J. and a Prelim. Inj., ECF No. 34 (May 15,
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`The parties then proceeded to file merits briefs in accordance with the schedule in the
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`2020); Defs.’ Combined Cross-Mot. for Summ. J. and Opp. to Pls.’ Mot., ECF No. 37 (July 2, 2020).
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`Cochran, as well as the two agency defendants. Although Defendants have not filed a substitution
`notice relating to the two new officer defendants, such substitution occurs automatically under the
`Federal Rules of Civil Procedure. Fed. R. Civ. P. 25(d) (“An action does not abate when a public
`officer who is a party in an official capacity . . . ceases to hold office while the action is pending. The
`officer’s successor is automatically substituted as a party. Later proceedings should be in the
`substituted party’s name . . . . The court may order substitution at any time, but the absence of such
`an order does not affect the substitution.”).
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`Case 6:20-cv-00176-JCB Document 86 Filed 02/26/21 Page 3 of 8 PageID #: 10283
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`In addition, Defendants filed a motion to dismiss for improper venue. Defs.’ Mot. to Dismiss, ECF
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`No. 36 (July 2, 2020). These motions remain pending before the Court.
`4.
`120-day postponement of the Rule’s effective date. See Pls.’ Mot. to Extend Postponement of Rule’s
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`On November 23, 2020, Plaintiffs filed a motion seeking a 90-day extension of the
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`Effective Date, ECF No. 76 (Nov. 23, 2020). Plaintiffs explained that “199 days ha[d] elapsed since
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`the Court postponed the Rule’s effective date, and the Manufacturer Plaintiffs [were again] . . . facing
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`the same imminent compliance costs that the original postponement was designed to address.” See id.
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`¶ 4. Specifically, Plaintiffs noted that the Manufacturer Plaintiffs would have to redesign packaging,
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`modify the printing process, purchase and engrave printing cylinders, print compliant packages, and
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`redesign, modify, and replace point-of-sale advertisements at hundreds of thousands of retailers. See
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`id. ¶ 4(a)–(d). Plaintiffs further explained that these steps would cost millions of dollars and thousands
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`of employee hours, which would be unrecoverable if Plaintiffs prevailed, and that the balance of
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`equities strongly favored granting a stay. See id. ¶¶ 4–6. Defendants opposed the motion. See Defs.’
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`Opp. to Mot. to Extend Postponement of Rule’s Effective Date, ECF No. 79 (Nov. 25, 2020).
`5.
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`Based on the “equitable reasons given in plaintiffs’ motion” and “the reasons stated in
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`the court’s [previous] order . . . postponing the effective date of the challenged rule,” the Court granted
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`Plaintiffs’ motion for an extension of the original postponement. See Order, ECF No. 80 (Dec. 2,
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`2020) (“Extension Order”). Accordingly, the Court postponed the Rule’s effective date and related
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`requirements for “an additional 90 days, until January 14, 2022.” Id. at 1 (“The court orders that the
`effective date of the rule is postponed for an additional 90 days, until January 14, 2022. Any obligation
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`to comply with the Tobacco Control Act’s warning requirements, [1]5 U.S.C. § 1333(a)(1) and (b)(1),
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`and the additional requirements in 21 U.S.C. §§ 387c(a)(2) and 387t(a), is also postponed for an
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`additional 90 days, as is any other obligation to comply with a deadline tied to the effective date of the
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`rule.”). The Court further ordered that oral argument on the merits motions would occur on
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`December 11, 2020. See id.
`6.
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`At that December 11 hearing, the Court asked Plaintiffs when they would “again face
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`imminent compliance cost[s] that will prompt them, if there is no merits ruling at that point and no
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`Case 6:20-cv-00176-JCB Document 86 Filed 02/26/21 Page 4 of 8 PageID #: 10284
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`injunction, . . . to seek another stay of the rule’s effectiveness.” Tr. of Merits Hr’g (Dec. 11, 2020), at
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`8:18–22. Plaintiffs’ counsel informed the Court that, if there was no merits ruling and no injunction,
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`Plaintiffs would again face imminent compliance costs requiring them to seek a further extension of
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`the postponement in March 2021—90 days after the December 2020 date on which they would have
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`started to incur engraving costs if not for the extension of the original postponement. See id. at 8:23–
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`9:3; Tr. of Status Hr’g (Nov. 19, 2020), at 10:7–18.
`7.
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`Eighty-six days have now elapsed since this Court’s order granting a 90-day extension.
`The Manufacturer Plaintiffs are once again on the threshold of incurring the same irreparable and
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`imminent compliance costs that were identified in the previous joint motion for a stay, the first motion
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`to extend postponement of Rule’s effective date, and the merits briefs and supporting declarations,
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`and that the previous postponement orders were designed to address. See Joint Mot. ¶¶ 5–6; Pls.’ Mot.
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`to Extend Postponement ¶¶ 4–5; Pls.’ Mot. for Summ. J. and Prelim. Inj. at 59–64; Decl. of Lamar
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`W. Huckabee, ECF No. 34-5 (May 15, 2020) (attached as Exhibit A); Decl. of Kim Reed, ECF No.
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`34-6 (May 15, 2020) (attached as Exhibit B); Decl. of Francis G. Wall, ECF No. 34-7 (May 15, 2020)
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`(attached as Exhibit C); Pls.’ Combined Reply and Resp., ECF No. 59, at 39–40. The legal analysis
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`and balance of the equities are indistinguishable from the previous extension motion, which this Court
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`granted in December 2020. See Extension Order at 1; Pls.’ Mot. to Extend Postponement ¶¶ 5–6.
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`Another extension is therefore warranted under 5 U.S.C. § 705.
`8.
`the Rule’s effective date and related requirements, from January 14, 2022 to April 14, 2022. See
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`Accordingly, Plaintiffs request an additional 90-day extension of the postponement of
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`Extension Order at 1. Plaintiffs further request that the additional 90-day extension be granted
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`without prejudice to Plaintiffs’ right to move for additional relief at a later date, including another
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`motion requesting a further postponement of the Rule’s effective date, and without prejudice to
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`Plaintiffs’ pending motions.
`9.
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`As detailed in the certificate of conference, counsel for Plaintiffs and Defendants have
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`discussed Plaintiffs’ intention to file this motion, and Defendants’ counsel has informed Plaintiffs’
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`Case 6:20-cv-00176-JCB Document 86 Filed 02/26/21 Page 5 of 8 PageID #: 10285
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`counsel that Defendants oppose this motion for substantially the same reasons set forth in
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`Defendants’ opposition to Plaintiffs’ previous motion for a 90-day extension.
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`Case 6:20-cv-00176-JCB Document 86 Filed 02/26/21 Page 6 of 8 PageID #: 10286
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`Respectfully submitted,
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`/s/Ryan J. Watson
`Ryan J. Watson*
`D.C. Bar No. 986906
`Lead Attorney
`Christian G. Vergonis*
`D.C. Bar No 483293
`Alex Potapov*
`D.C. Bar No. 998355
`JONES DAY
`51 Louisiana Avenue, N.W.
`Washington, DC 20001-2113
`Telephone: 202-879-3939
`Facsimile: 202-626-1700
`rwatson@jonesday.com
`cvergonis@jonesday.com
`apotapov@jonesday.com
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`Autumn Hamit Patterson
`Texas Bar No. 24092947
`JONES DAY
`2727 North Harwood Street, Suite 500
`Dallas, TX 75201-1515
`Telephone: 214-220-3939
`Facsimile: 214-969-5100
`ahpatterson@jonesday.com
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`Counsel for Plaintiffs R.J. Reynolds Tobacco Co.,
`Santa Fe Natural Tobacco Co., Neocom, Inc.,
`Rangila Enterprises Inc., Rangila LLC, Sahil
`Ismail, Inc., and Is Like You Inc.
`* admitted pro hac vice
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`February 26, 2021
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`Philip J. Perry (D.C. Bar No. 148696)*
`Monica C. Groat (D.C. Bar No. 1002696)*
`Nicholas L. Schlossman (D.C. Bar No. 1029362)*
`LATHAM & WATKINS LLP
`555 Eleventh Street NW
`Suite 1000
`Washington, DC 20004
`Tel: (202) 637-2200
`Fax: (202) 637-2201
`philip.perry@lw.com
`monica.groat@lw.com
`nicholas.schlossman@lw.com
`Attorneys for Plaintiff ITG Brands, LLC
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`Meaghan VerGow*
`D.C. Bar No. 977165
`Scott Harman-Heath*
`D.C. Bar No. 1671180
`O’MELVENY & MYERS LLP
`1625 Eye Street, N.W.
`Washington, D.C. 20006
`Telephone: 202-383-5504
`Facsimile: 202-383-5414
`mvergow@omm.com
`sharman@omm.com
`Leonard A. Feiwus*
`N.Y. Bar No. 2611135
`Nancy E. Kaschel*
`N.Y. Bar No. 2839314
`Deva Roberts*
`N.Y. Bar No. 5110846
`KASOWITZ BENSON TORRES LLC
`1633 Broadway
`New York, NY 10019
`Telephone: 212-506-1785
`Facsimile: 212-835-5085
`LFeiwus@kasowitz.com
`NKaschel@kasowitz.com
`DRoberts@kasowitz.com
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`Counsel for Plaintiff Liggett Group LLC
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`Case 6:20-cv-00176-JCB Document 86 Filed 02/26/21 Page 7 of 8 PageID #: 10287
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`CERTIFICATE OF SERVICE
`I hereby certify that on February 26, 2021, a true and correct copy of the foregoing was
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`electronically filed with the clerk of court for the U.S. District Court for the Eastern District of Texas,
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`using the CM/ECF system, which will send a notice of electronic filing to all counsel of record.
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`/s/Ryan J. Watson
`Ryan J. Watson*
`D.C. Bar No. 986906
`Lead Attorney
`JONES DAY
`51 Louisiana Avenue, N.W.
`Washington, DC 20001-2113
`Telephone: 202-879-3939
`Facsimile: 202-626-1700
`rwatson@jonesday.com
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`Counsel for Plaintiffs R.J. Reynolds Tobacco
`Co., Santa Fe Natural Tobacco Co.,
`Neocom, Inc., Rangila Enterprises Inc.,
`Rangila LLC, Sahil Ismail, Inc., and Is
`Like You Inc.
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`Case 6:20-cv-00176-JCB Document 86 Filed 02/26/21 Page 8 of 8 PageID #: 10288
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`CERTIFICATE OF CONFERENCE
`I hereby certify, pursuant to Local Rule CV-7(i), that (1) I complied with the meet and confer
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`requirement in Local Rule CV-7(h), and (2) this motion is opposed.
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`I have conducted the personal conference required by Local Rule CV-7(i). Specifically, I
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`emailed Defendants’ counsel on February 25, 2021, to inform them of Plaintiffs’ intention to seek an
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`additional postponement of 90 days. The next day, on February 26, 2021, I, along with Christian G.
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`Vergonis and Alex Potapov, had a telephone conference with Stephen M. Pezzi to discuss whether
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`Defendants would join or oppose Plaintiffs’ request for an additional postponement of the Rule’s
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`effective date. After a collegial discussion where both sides discussed the issues in good faith,
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`Defendants’ counsel stated that Defendants oppose the motion for substantially the same reasons that
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`Defendants opposed Plaintiffs’ first motion to extend the postponement. The conference participants
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`then concluded that the discussion had ended in an impasse, leaving an open issue for the Court to
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`resolve.
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`/s/Ryan J. Watson
`Ryan J. Watson*
`D.C. Bar No. 986906
`Lead Attorney
`JONES DAY
`51 Louisiana Avenue, N.W.
`Washington, DC 20001-2113
`Telephone: 202-879-3939
`Facsimile: 202-626-1700
`rwatson@jonesday.com
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`Counsel for Plaintiffs R.J. Reynolds Tobacco
`Co., Santa Fe Natural Tobacco Co.,
`Neocom, Inc., Rangila Enterprises Inc.,
`Rangila LLC, Sahil Ismail, Inc., and Is
`Like You Inc.
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