Case 1:16-cv-01460-APM Document 221 Filed 08/26/20 Page 1 of 57
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`USCA Case #20-5266 Document #1859086 Filed: 08/31/2020 Page 1 of 57
`APPEAL,CONSOL,TYPE−C
`
`U.S. District Court
`District of Columbia (Washington, DC)
`CIVIL DOCKET FOR CASE #: 1:16−cv−01460−APM
`
`CIGAR ASSOCIATION OF AMERICA et al v. UNITED
`STATES FOOD AND DRUG ADMINISTRATION et al
`Assigned to: Judge Amit P. Mehta
` Case: 1:18−cv−01797−APM
`Case in other court: 18−05195
`Cause: 05:702 Administrative Procedure Act
`Plaintiff
`
`Date Filed: 07/15/2016
`Jury Demand: None
`Nature of Suit: 890 Other Statutory
`Actions
`Jurisdiction: U.S. Government Defendant
`
`CIGAR ASSOCIATION OF
`AMERICA
`
`represented by Mark S. Raffman
`GOODWIN PROCTER LLP
`1900 N St NW
`Washington, DC 20036
`202−346−4259
`Email: mraffman@goodwinlaw.com
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`Michael James Edney
`STEPTOE & JOHNSON LLP
`1330 Connecticut Avenue, NW
`Washington, DC 20036
`202−429−6488
`Email: medney@steptoe.com
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`Andrew Kim
`GOODWIN PROCTER LLP
`1900 N St NW
`Washington, DC 20036
`202−346−4000
`Email: andrewkim@goodwinlaw.com
`ATTORNEY TO BE NOTICED
`
`Mark A. Heller
`GOODWIN PROCTER, LLP
`901 New York Avenue, NW
`Washington, DC 20001
`(202) 346−4000
`Email: mheller@goodwinprocter.com
`ATTORNEY TO BE NOTICED
`
`Plaintiff
`
`INTERNATIONAL PREMIUM
`CIGAR AND PIPE RETAILERS
`
`represented by Mark S. Raffman
`(See above for address)
`
`1
`
`

`

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`USCA Case #20-5266 Document #1859086 Filed: 08/31/2020 Page 2 of 57
`ASSOCIATION
`LEAD ATTORNEY
`TERMINATED: 10/23/2019
`ATTORNEY TO BE NOTICED
`
`Michael James Edney
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`Andrew Kim
`(See above for address)
`ATTORNEY TO BE NOTICED
`
`Caroline M. Mew
`PERKINS COIE LLP
`700 13th Street, NW
`Suite 600
`Washington, DC 20005−3960
`(202) 654−1767
`Fax: (202) 624−9551
`Email: cmew@perkinscoie.com
`TERMINATED: 03/14/2018
`
`Ryan E. Meltzer
`NORTON ROSE FULBRIGHT US LLP
`98 San Jacinto Boulevard
`Suite 1100
`Austin, TX 78701−4255
`(512) 536−5234
`Fax: (512) 536−4598
`Email: ryan.meltzer@nortonrosefulbright.com
`PRO HAC VICE
`ATTORNEY TO BE NOTICED
`
`Mark A. Heller
`(See above for address)
`ATTORNEY TO BE NOTICED
`
`represented by Mark S. Raffman
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`Michael James Edney
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`Andrew Kim
`(See above for address)
`ATTORNEY TO BE NOTICED
`
`2
`
`Plaintiff
`
`CIGAR RIGHTS OF AMERICA
`
`

`

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`USCA Case #20-5266 Document #1859086 Filed: 08/31/2020 Page 3 of 57
`Caroline M. Mew
`(See above for address)
`TERMINATED: 03/14/2018
`
`Plaintiff
`
`EN FUEGO TOBACCO SHOP LLC
`18cv1797
`TERMINATED: 08/08/2019
`doing business as
`EN FUEGO TOBACCO SHOP
`TERMINATED: 08/08/2019
`
`Ryan E. Meltzer
`(See above for address)
`PRO HAC VICE
`ATTORNEY TO BE NOTICED
`
`Mark A. Heller
`(See above for address)
`ATTORNEY TO BE NOTICED
`
`represented by Michael James Edney
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`Clyde M. Siebman
`SIEBMAN FORREST BURG & SMITH,
`LLP
`Federal Courthouse Square
`300 N. Travis Street
`Sherman, TX 75090
`(903) 870−0070
`Fax: (903) 870−0066
`Email: clydesiebman@siebman.com
`PRO HAC VICE
`ATTORNEY TO BE NOTICED
`
`Elizabeth S. Forrest
`SIEBMAN FORREST BURG & SMITH,
`LLP
`Federal Courthouse Square
`300 N. Travis Street
`Sherman, TX 75090
`(903) 870−0070
`Fax: (903) 870−0066
`Email: elizabethforrest@siebman.com
`PRO HAC VICE
`ATTORNEY TO BE NOTICED
`
`Ryan E. Meltzer
`(See above for address)
`PRO HAC VICE
`ATTORNEY TO BE NOTICED
`
`Plaintiff
`
`CUBA LIBRE ENTERPRISES LLC
`18cv1797
`
`represented by Michael James Edney
`(See above for address)
`
`3
`
`

`

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`USCA Case #20-5266 Document #1859086 Filed: 08/31/2020 Page 4 of 57
`TERMINATED: 08/08/2019
`LEAD ATTORNEY
`doing business as
`ATTORNEY TO BE NOTICED
`EL CUBANO CIGARS
`TERMINATED: 08/08/2019
`
`Clyde M. Siebman
`(See above for address)
`PRO HAC VICE
`ATTORNEY TO BE NOTICED
`
`Elizabeth S. Forrest
`(See above for address)
`PRO HAC VICE
`ATTORNEY TO BE NOTICED
`
`Ryan E. Meltzer
`(See above for address)
`PRO HAC VICE
`ATTORNEY TO BE NOTICED
`
`Plaintiff
`
`TEXAS CIGAR MERCHANTS
`ASSOCIATION
`18cv1797
`TERMINATED: 08/08/2019
`
`represented by Michael James Edney
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`Clyde M. Siebman
`(See above for address)
`PRO HAC VICE
`ATTORNEY TO BE NOTICED
`
`Elizabeth S. Forrest
`(See above for address)
`PRO HAC VICE
`ATTORNEY TO BE NOTICED
`
`Ryan E. Meltzer
`(See above for address)
`PRO HAC VICE
`ATTORNEY TO BE NOTICED
`
`Plaintiff
`
`PREMIUM CIGAR ASSOCIATION
`
`represented by Michael James Edney
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`V.
`
`Intervenor Plaintiff
`
`ALEC BRADLEY CIGAR
`DISTRIBUTORS, INC.
`
`represented by Michael James Edney
`(See above for address)
`
`4
`
`

`

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`USCA Case #20-5266 Document #1859086 Filed: 08/31/2020 Page 5 of 57
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`Intervenor Plaintiff
`
`ASHTON DISTRIBUTORS, INC.
`
`Intervenor Plaintiff
`
`HOLT CIGAR COMPANY, INC.
`
`Intervenor Plaintiff
`
`CROWNED HEADS, LLC
`
`Intervenor Plaintiff
`
`A. FUENTE & CO.
`
`Intervenor Plaintiff
`
`PILOTO CIGARS, INC.
`
`Intervenor Plaintiff
`
`ROCKY PATEL PREMIUM CIGARS
`
`Intervenor Plaintiff
`
`OLIVA CIGAR CO.
`
`V.
`
`Defendant
`
`represented by Michael James Edney
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`represented by Michael James Edney
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`represented by Michael James Edney
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`represented by Michael James Edney
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`represented by Michael James Edney
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`represented by Michael James Edney
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`represented by Michael James Edney
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`5
`
`

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`USCA Case #20-5266 Document #1859086 Filed: 08/31/2020 Page 6 of 57
`UNITED STATES FOOD AND DRUG
`represented by Eric B. Beckenhauer
`ADMINISTRATION
`U.S. DEPARTMENT OF JUSTICE
`Civil Division, Federal Programs Branch
`1100 L Street NW
`Washington, DC 20005
`202−514−3338
`Fax: 202−616−8470
`Email: eric.beckenhauer@usdoj.gov
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`Garrett Joseph Coyle
`U.S. DEPARTMENT OF JUSTICE
`Civil Division, Federal Programs Branch
`1100 L Street, NW
`Washington, DC 20005
`(202) 616−8016
`Email: garrett.coyle@usdoj.gov
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`Stuart Justin Robinson
`U.S. DEPARTMENT OF JUSTICE
`Civil Division, Federal Programs Branch
`450 Golden Gate Ave
`Suite 7−5395
`San Francisco, CA 94102
`(415) 436−6635
`Fax: (415) 436−6632
`Email: stuart.j.robinson@usdoj.gov
`TERMINATED: 06/26/2019
`
`Defendant
`
`UNITED STATES DEPARTMENT
`OF HEALTH AND HUMAN
`SERVICES
`
`represented by Eric B. Beckenhauer
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`Garrett Joseph Coyle
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`Stuart Justin Robinson
`(See above for address)
`TERMINATED: 06/26/2019
`
`Defendant
`
`SYLVIA MATHEWS BURWELL
`in her official capacity as Secretary of
`Health and Human Services
`
`represented by Eric B. Beckenhauer
`(See above for address)
`LEAD ATTORNEY
`
`6
`
`

`

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`USCA Case #20-5266 Document #1859086 Filed: 08/31/2020 Page 7 of 57
`TERMINATED: 01/22/2019
`ATTORNEY TO BE NOTICED
`
`Garrett Joseph Coyle
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`Stuart Justin Robinson
`(See above for address)
`TERMINATED: 06/26/2019
`
`Defendant
`
`ROBERT CALIFF
`M.D., in his official capacity as
`Commissioner of Food and Drugs
`TERMINATED: 01/22/2018
`
`represented by Eric B. Beckenhauer
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`Defendant
`
`SCOTT GOTTLIEB
`M.D., in his official capacity as
`Commissioner of Food and Drugs
`TERMINATED: 10/23/2019
`
`Defendant
`
`ALEX M. AZAR, II
`in his official capacity as Secretary of
`Health and Human Services
`
`Garrett Joseph Coyle
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`Stuart Justin Robinson
`(See above for address)
`TERMINATED: 06/26/2019
`
`represented by Eric B. Beckenhauer
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`Garrett Joseph Coyle
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`represented by Eric B. Beckenhauer
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`Garrett Joseph Coyle
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`Defendant
`
`represented by
`
`7
`
`

`

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`NORMAN E. SHARPLESS
`Eric B. Beckenhauer
`(See above for address)
`M.D., in his official capacity as
`Commissioner of Food and Drugs
`LEAD ATTORNEY
`TERMINATED: 02/24/2020
`ATTORNEY TO BE NOTICED
`
`Defendant
`
`STEPHEN HAHN
`In his official capacity as Commissioner
`of Food and Drugs
`
`Movant
`
`STATE OF ARIZONA
`
`Movant
`
`STATE OF MICHIGAN
`
`Movant
`
`STATE OF LOUISIANA
`
`Movant
`
`LINDA GOLDSTEIN
`
`Garrett Joseph Coyle
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`represented by Garrett Joseph Coyle
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`represented by Keith Joseph Miller
`OFFICE OF THE ATTORNEY
`GENERAL
`1275 W. Washington Street
`Phoenix, AZ 85007
`(602) 542−3333
`Email: Keith.Miller@azag.gov
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`represented by Keith Joseph Miller
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`represented by Keith Joseph Miller
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`represented by Jeffrey B. Dubner
`DEMOCRACY FORWARD
`FOUNDATION
`1333 H Street NW
`Washington, DC 20005
`(202) 448−9090
`Email: jdubner@democracyforward.org
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`8
`
`

`

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`Amicus
`
`CAUSE OF ACTION INSTITUTE
`
`Amicus
`
`CAMPAIGN FOR TOBACCO−FREE
`KIDS
`
`represented by Patrick Joseph Massari
`CAUSE OF ACTION INSTITUTE
`1875 I Street, NW
`Suite 800
`Washington, DC 20006
`(202) 499−4232
`Fax: 202−330−5842
`Email: patrick.massari@causeofaction.org
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`Eric R. Bolinder
`CAUSE OF ACTION INSTITUTE
`1310 N. Courthouse Rd
`Suite 700
`Washington, VA 22079
`571−329−3324
`Email: eric.bolinder@causeofaction.org
`ATTORNEY TO BE NOTICED
`
`represented by Mark E. Greenwold
`CAMPAIGN FOR TOBACCO−FREE
`KIDS
`1400 I Street, NW
`Suite 1200
`Washington, DC 20005
`(202) 481−9560
`Fax: (202) 296−5427
`Email: mgreenwold@gmail.com
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`Ari Holtzblatt
`WILMER CUTLER PICKERING HALE
`& DORR, LLP
`1875 Pennsylvania Avenue, NW
`Washington, DC 20006
`(202) 663−6964
`Email: ari.holtzblatt@wilmerhale.com
`ATTORNEY TO BE NOTICED
`
`Javier M. Guzman
`DEMOCRACY FORWARD
`FOUNDATION
`P.O. Box 34553
`Washington, DC 20043
`(202) 448−9090
`Email: jguzman@democracyforward.org
`ATTORNEY TO BE NOTICED
`
`9
`
`

`

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`
`Amicus
`
`AMERICAN ACADEMY OF
`PEDIATRICS
`
`Jeffrey B. Dubner
`(See above for address)
`ATTORNEY TO BE NOTICED
`
`Lynn Eisenberg
`WILMER CUTLER PICKERING HALE
`AND DORR, LLP
`1875 Pennsylvania Avenue, NW
`Washington, DC 20006
`(202) 663−6848
`Email: lynn.eisenberg@wilmerhale.com
`ATTORNEY TO BE NOTICED
`
`represented by Kelly P. Dunbar
`WILMER CUTLER PICKERING HALE
`AND DORR
`1875 Pennsylvania Avenue, N.W.
`Washington, DC 20006
`(202) 663−6262
`Fax: (202) 663−6363
`Email: kelly.dunbar@wilmerhale.com
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`Ari Holtzblatt
`(See above for address)
`ATTORNEY TO BE NOTICED
`
`Dennis A. Henigan
`CAMPAIGN FOR TOBACCO−FREE
`KIDS
`1400 Eye Street, NW
`Suite 1200
`Wasington, DC 20005
`(202) 481−9366
`Fax: (202) 295−5427
`Email: dhenigan@tobaccofreekids.org
`ATTORNEY TO BE NOTICED
`
`Javier M. Guzman
`(See above for address)
`ATTORNEY TO BE NOTICED
`
`Jeffrey B. Dubner
`(See above for address)
`ATTORNEY TO BE NOTICED
`
`Kevin Matthew Lamb
`WILMER, CUTLER, PICKERING, HALE
`& DORR, LLP.
`
`10
`
`

`

`Case 1:16-cv-01460-APM Document 221 Filed 08/26/20 Page 11 of 57
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`USCA Case #20-5266 Document #1859086 Filed: 08/31/2020 Page 11 of 57
`1875 Pennsylvania Ave., NW
`Washington, DC 20006
`(202) 663−6000
`Email: kevin.lamb@wilmerhale.com
`ATTORNEY TO BE NOTICED
`
`Lynn Eisenberg
`(See above for address)
`ATTORNEY TO BE NOTICED
`
`Mark E. Greenwold
`(See above for address)
`ATTORNEY TO BE NOTICED
`
`Amicus
`
`AMERICAN CANCER SOCIETY
`CANCER ACTION NETWORK
`
`represented by Kelly P. Dunbar
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`Mark E. Greenwold
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`Ari Holtzblatt
`(See above for address)
`ATTORNEY TO BE NOTICED
`
`Javier M. Guzman
`(See above for address)
`ATTORNEY TO BE NOTICED
`
`Jeffrey B. Dubner
`(See above for address)
`ATTORNEY TO BE NOTICED
`
`Kevin Matthew Lamb
`(See above for address)
`ATTORNEY TO BE NOTICED
`
`Lynn Eisenberg
`(See above for address)
`ATTORNEY TO BE NOTICED
`
`Amicus
`
`AMERICAN HEART ASSOCIATION
`
`represented by Kelly P. Dunbar
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`11
`
`

`

`Case 1:16-cv-01460-APM Document 221 Filed 08/26/20 Page 12 of 57
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`USCA Case #20-5266 Document #1859086 Filed: 08/31/2020 Page 12 of 57
`Mark E. Greenwold
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`Ari Holtzblatt
`(See above for address)
`ATTORNEY TO BE NOTICED
`
`Javier M. Guzman
`(See above for address)
`ATTORNEY TO BE NOTICED
`
`Jeffrey B. Dubner
`(See above for address)
`ATTORNEY TO BE NOTICED
`
`Kevin Matthew Lamb
`(See above for address)
`ATTORNEY TO BE NOTICED
`
`Lynn Eisenberg
`(See above for address)
`ATTORNEY TO BE NOTICED
`
`Amicus
`
`AMERICAN LUNG ASSOCIATION
`
`represented by Kelly P. Dunbar
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`Mark E. Greenwold
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`Ari Holtzblatt
`(See above for address)
`ATTORNEY TO BE NOTICED
`
`Javier M. Guzman
`(See above for address)
`ATTORNEY TO BE NOTICED
`
`Jeffrey B. Dubner
`(See above for address)
`ATTORNEY TO BE NOTICED
`
`Kevin Matthew Lamb
`(See above for address)
`ATTORNEY TO BE NOTICED
`
`12
`
`

`

`Case 1:16-cv-01460-APM Document 221 Filed 08/26/20 Page 13 of 57
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`USCA Case #20-5266 Document #1859086 Filed: 08/31/2020 Page 13 of 57
`Lynn Eisenberg
`(See above for address)
`ATTORNEY TO BE NOTICED
`
`Amicus
`
`TRUTH INITIATIVE
`
`represented by Kelly P. Dunbar
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`Mark E. Greenwold
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`Ari Holtzblatt
`(See above for address)
`ATTORNEY TO BE NOTICED
`
`Javier M. Guzman
`(See above for address)
`ATTORNEY TO BE NOTICED
`
`Jeffrey B. Dubner
`(See above for address)
`ATTORNEY TO BE NOTICED
`
`Kevin Matthew Lamb
`(See above for address)
`ATTORNEY TO BE NOTICED
`
`Lynn Eisenberg
`(See above for address)
`ATTORNEY TO BE NOTICED
`
`Amicus
`
`CAMPAIGN FOR TOBACCO−FREE
`KIDS
`
`represented by Kelly P. Dunbar
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`Mark E. Greenwold
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`Ari Holtzblatt
`(See above for address)
`ATTORNEY TO BE NOTICED
`
`Javier M. Guzman
`
`13
`
`

`

`Case 1:16-cv-01460-APM Document 221 Filed 08/26/20 Page 14 of 57
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`USCA Case #20-5266 Document #1859086 Filed: 08/31/2020 Page 14 of 57
`(See above for address)
`ATTORNEY TO BE NOTICED
`
`Jeffrey B. Dubner
`(See above for address)
`ATTORNEY TO BE NOTICED
`
`Kevin Matthew Lamb
`(See above for address)
`ATTORNEY TO BE NOTICED
`
`Lynn Eisenberg
`(See above for address)
`ATTORNEY TO BE NOTICED
`
`represented by Jeffrey B. Dubner
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`represented by Jeffrey B. Dubner
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`represented by Jeffrey B. Dubner
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`represented by Jeffrey B. Dubner
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`represented by Jeffrey B. Dubner
`(See above for address)
`LEAD ATTORNEY
`ATTORNEY TO BE NOTICED
`
`Amicus
`
`MARYLAND
`CHAPTER−AMERICAN ACADEMY
`OF PEDIATRICS
`
`Amicus
`
`LEAH BRASCH
`
`Amicus
`
`CYNTHIA FISHMAN
`
`Amicus
`
`STEVEN HIRSCH
`
`Amicus
`
`DAVID MYLES
`
`Date Filed
`
`#
`
`Page Docket Text
`
`07/15/2016
`
`1
`
`COMPLAINT against SYLVIA M. BURWELL, in her official capacity as
`Secretary of Health and Human Services, Robert Califf, M.D., in his official
`
`14
`
`

`

`Case 1:16-cv-01460-APM Document 221 Filed 08/26/20 Page 15 of 57
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`USCA Case #20-5266 Document #1859086 Filed: 08/31/2020 Page 15 of 57
`capacity as Commissioner of Food and Drugs, UNITED STATES FOOD
`AND DRUG ADMINISTRATION, UNITED STATES DEPARTMENT OF
`HEALTH AND HUMAN SERVICES ( Filing fee $ 400 receipt number
`0090−4605334) filed by CIGAR ASSOCIATION OF AMERICA, CIGAR
`RIGHTS OF AMERICA, INTERNATIONAL PREMIUM CIGAR AND PIPE
`RETAILERS ASSOCIATION. (Attachments: # 1 Civil Cover Sheet, # 2
`Summons United States Food and Drug Administration, # 3 Summons United
`States Department of Health and Human Services, # 4 Summons Sylvia M.
`Burwell, # 5 Summons Robert Califf, M.D.)(Heller, Mark) (Entered:
`07/15/2016)
`
`07/19/2016
`
`Case Assigned to Judge Amit P. Mehta. (dr) (Entered: 07/19/2016)
`
`07/19/2016
`
`2
`
`07/19/2016
`
`3
`
`07/26/2016
`
`4
`
`08/18/2016
`
`08/18/2016
`
`08/18/2016
`
`08/18/2016
`
`5
`
`6
`
`7
`
`8
`
`09/30/2016
`
`9
`
`REQUEST FOR SUMMONS TO ISSUE as to the United States Attorney
`General and the United States Attorney's Office for the District of Columbia
`filed by CIGAR ASSOCIATION OF AMERICA, CIGAR RIGHTS OF
`AMERICA, INTERNATIONAL PREMIUM CIGAR AND PIPE
`RETAILERS ASSOCIATION.(Heller, Mark) (Entered: 07/19/2016)
`
`SUMMONS (6) Issued Electronically as to SYLVIA M. BURWELL,
`ROBERT CALIFF, UNITED STATES DEPARTMENT OF HEALTH AND
`HUMAN SERVICES, UNITED STATES FOOD AND DRUG
`ADMINISTRATION, U.S. Attorney and U.S. Attorney General (Attachments:
`# 1 Consent Form)(zsb) (Entered: 07/19/2016)
`
`NOTICE of Appearance by Mark S. Raffman on behalf of CIGAR
`ASSOCIATION OF AMERICA, CIGAR RIGHTS OF AMERICA,
`INTERNATIONAL PREMIUM CIGAR AND PIPE RETAILERS
`ASSOCIATION (Raffman, Mark) (Entered: 07/26/2016)
`
`RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed.
`SYLVIA M. BURWELL served on 8/1/2016 (Raffman, Mark) (Entered:
`08/18/2016)
`
`RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed.
`UNITED STATES DEPARTMENT OF HEALTH AND HUMAN
`SERVICES served on 7/26/2016 (Raffman, Mark) (Entered: 08/18/2016)
`
`RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed
`on United States Attorney General. Date of Service Upon United States
`Attorney General 7/26/2016. (Raffman, Mark) (Entered: 08/18/2016)
`
`RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed
`as to the United States Attorney. Date of Service Upon United States Attorney
`on 7/26/2016. Answer due for ALL FEDERAL DEFENDANTS by 9/24/2016.
`(Raffman, Mark) (Entered: 08/18/2016)
`
`RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed
`as to the United States Attorney. Date of Service Upon United States Attorney
`on 9/27/2016. Answer due for ALL FEDERAL DEFENDANTS by
`11/26/2016. (Attachments: # 1 Affidavit of Alexis D. Fernandez)(Heller,
`Mark) (Entered: 09/30/2016)
`
`10/26/2016
`
`10
`
`ANSWER to Complaint by SYLVIA M. BURWELL, ROBERT CALIFF,
`UNITED STATES DEPARTMENT OF HEALTH AND HUMAN
`
`15
`
`

`

`Case 1:16-cv-01460-APM Document 221 Filed 08/26/20 Page 16 of 57
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`USCA Case #20-5266 Document #1859086 Filed: 08/31/2020 Page 16 of 57
`SERVICES, UNITED STATES FOOD AND DRUG
`ADMINISTRATION.(Beckenhauer, Eric) (Entered: 10/26/2016)
`
`10/27/2016
`
`11
`
`10/27/2016
`
`11/03/2016
`
`12
`
`11/03/2016
`
`13
`
`11/14/2016
`
`14
`
`11/15/2016
`
`11/15/2016
`
`11/18/2016
`
`15
`
`11/18/2016
`
`16
`
`11/22/2016
`
`17
`
`ORDER: Both a Complaint and an Answer are now before the court in this
`APA case. It is hereby ordered that the parties shall meet and confer and file a
`Joint Status Report on or before November 14, 2016. Please see the attached
`Order for additional details. Signed by Judge Amit P. Mehta on 10/27/2016.
`(lcapm3) (Entered: 10/27/2016)
`
`Set/Reset Deadlines/Hearings: Joint Status Report due by 11/14/2016. (cdw)
`(Entered: 10/28/2016)
`
`NOTICE of Appearance by Michael James Edney on behalf of CIGAR
`RIGHTS OF AMERICA, INTERNATIONAL PREMIUM CIGAR AND PIPE
`RETAILERS ASSOCIATION (Edney, Michael) (Entered: 11/03/2016)
`
`NOTICE of Appearance by Caroline M. Mew on behalf of CIGAR RIGHTS
`OF AMERICA, INTERNATIONAL PREMIUM CIGAR AND PIPE
`RETAILERS ASSOCIATION (Mew, Caroline) (Entered: 11/03/2016)
`
`Joint STATUS REPORT and MOTION for Extension of Time by SYLVIA
`M. BURWELL, ROBERT CALIFF, UNITED STATES DEPARTMENT OF
`HEALTH AND HUMAN SERVICES, UNITED STATES FOOD AND
`DRUG ADMINISTRATION. (Attachments: # 1 Text of Proposed
`Order)(Beckenhauer, Eric) Modified on 11/15/2016 (znmw). (Entered:
`11/14/2016)
`
`MINUTE ORDER granting 14 Motion for Extension of Time. The parties
`shall file another Joint Status Report that proposes a schedule for this case on
`or before November 18, 2016. Signed by Judge Amit P. Mehta on 11/15/2016.
`(lcapm3) (Entered: 11/15/2016)
`
`Set/Reset Deadlines/Hearings: Joint Status Report due by 11/18/2016. (cdw)
`(Entered: 11/15/2016)
`
`Joint STATUS REPORT and Proposed Scheduling Order by SYLVIA M.
`BURWELL, ROBERT CALIFF, UNITED STATES DEPARTMENT OF
`HEALTH AND HUMAN SERVICES, UNITED STATES FOOD AND
`DRUG ADMINISTRATION. (Attachments: # 1 Text of Proposed
`Order)(Beckenhauer, Eric) (Entered: 11/18/2016)
`
`NOTICE of Filing of Certified Index to Administrative Record by SYLVIA M.
`BURWELL, ROBERT CALIFF, UNITED STATES DEPARTMENT OF
`HEALTH AND HUMAN SERVICES, UNITED STATES FOOD AND
`DRUG ADMINISTRATION (Attachments: # 1 Certified Index to
`Administrative Record)(Beckenhauer, Eric) (Entered: 11/18/2016)
`
`ORDER: Having considered the parties' 15 Joint Status Report and Proposed
`Scheduling Order, the court sets the following schedule for further
`proceedings in this matter: Plaintiffs' Motion for Summary Judgment shall be
`filed on or before February 13, 2017; Briefs of any amici granted leave to file
`in support of Plaintiffs shall be filed on or before February 20, 2017;
`Defendants' Opposition and Cross−Motion for Summary Judgment shall be
`filed on or before March 30, 2017; Briefs of any amici granted leave to file in
`support of Defendants shall be filed on or before April 6, 2017; Plaintiffs'
`
`16
`
`

`

`Case 1:16-cv-01460-APM Document 221 Filed 08/26/20 Page 17 of 57
`
`USCA Case #20-5266 Document #1859086 Filed: 08/31/2020 Page 17 of 57
`Reply and Opposition shall be filed on or before May 15, 2017; Defendants'
`Reply shall be filed on or before June 14, 2017; and Plaintiffs' appendix
`containing excerpts of the administrative record shall be filed on or before
`June 28, 2017. Oral argument is scheduled for July 28, 2017 at 10:00 a.m. in
`Courtroom 10. Please see the attached Order for additional details, and please
`note bolded additions to the Order. Signed by Judge Amit P. Mehta on
`11/22/2016. (lcapm3) (Entered: 11/22/2016)
`
`11/22/2016
`
`12/12/2016
`
`18
`
`12/13/2016
`
`19
`
`02/03/2017
`
`20
`
`02/06/2017
`
`02/06/2017
`
`02/06/2017
`
`21
`
`02/07/2017
`
`Set/Reset Deadlines/Hearings: Plaintiffs' Summary Judgment motion due by
`2/13/2017. Response to Motion for Summary Judgment due by 3/30/2017.
`Reply to Motion for Summary Judgment due by 5/15/2017. Plaintiffs' Brief of
`any amici due by 2/20/2017. Defendant's Cross Motion due by 3/30/2017.
`Response to Cross Motion due by 5/15/2017. Reply to Cross Motion due by
`6/14/2017. Defendants' Brief of any amici due by 4/6/2017. Plaintiffs'
`appendix due by 6/28/2017. Oral argument scheduled for 7/28/2017 at 10:00
`AM in Courtroom 10 before Judge Amit P. Mehta. (cdw) (Entered:
`12/05/2016)
`
`Joint MOTION for Protective Order by CIGAR RIGHTS OF AMERICA,
`INTERNATIONAL PREMIUM CIGAR AND PIPE RETAILERS
`ASSOCIATION (Attachments: # 1 Text of Proposed Order)(Edney, Michael)
`(Entered: 12/12/2016)
`
`ORDER granting 18 Joint Motion for Protective Order. Please see the attached
`Order for additional details. Signed by Judge Amit P. Mehta on 12/13/2016.
`(lcapm3) (Entered: 12/13/2016)
`
`MOTION for Leave to File Excess Pages , MOTION to Expedite by CIGAR
`ASSOCIATION OF AMERICA, CIGAR RIGHTS OF AMERICA,
`INTERNATIONAL PREMIUM CIGAR AND PIPE RETAILERS
`ASSOCIATION (Attachments: # 1 Text of Proposed Order)(Edney, Michael)
`(Entered: 02/03/2017)
`
`MINUTE ORDER. It is hereby ordered that Defendants shall file a Response
`to Plaintiffs' 20 Motion to Exceed Page Limits and for Expedited
`Consideration of Motion by noon on Tuesday, February 7. Signed by Judge
`Amit P. Mehta on 02/06/2017. (lcapm3) (Entered: 02/06/2017)
`
`Set/Reset Deadlines/Hearings: Response to 20 due by 2/7/2017. (cdw)
`(Entered: 02/06/2017)
`
`RESPONSE re 20 MOTION for Leave to File Excess Pages MOTION to
`Expedite filed by SYLVIA MATHEWS BURWELL, ROBERT CALIFF,
`UNITED STATES DEPARTMENT OF HEALTH AND HUMAN
`SERVICES, UNITED STATES FOOD AND DRUG ADMINISTRATION.
`(Beckenhauer, Eric) (Entered: 02/06/2017)
`
`MINUTE ORDER granting Plaintiffs' 20 Motion to Exceed Page Limits.
`Plaintiffs' Memorandum in Support of their Motion for Summary Judgment
`shall not exceed 65 pages. Signed by Judge Amit P. Mehta on 02/07/2017.
`(lcapm3) (Entered: 02/07/2017)
`
`02/13/2017
`
`22
`
`MOTION for Summary Judgment by CIGAR ASSOCIATION OF
`AMERICA, CIGAR RIGHTS OF AMERICA, INTERNATIONAL
`PREMIUM CIGAR AND PIPE RETAILERS ASSOCIATION (Attachments:
`
`17
`
`

`

`Case 1:16-cv-01460-APM Document 221 Filed 08/26/20 Page 18 of 57
`
`USCA Case #20-5266 Document #1859086 Filed: 08/31/2020 Page 18 of 57
`# 1 Declaration of Cecil Reynolds, Ph.D., # 2 Exhibit 1 to Reynolds Decl., # 3
`Exhibit 2 to Reynolds Decl., # 4 Declaration of Rocky Patel, # 5 Exhibit A to
`Patel Decl., # 6 Exhibit B to Patel Decl., # 7 Declaration of Janelle Rosenfeld,
`# 8 Exhibit A to Rosenfeld Decl., # 9 Declaration of John Anderson, # 10 Text
`of Proposed Order)(Edney, Michael) (Entered: 02/13/2017)
`
`02/16/2017
`
`02/21/2017
`
`23
`
`02/21/2017
`
`24
`
`MINUTE ORDER resetting briefing deadline in this case. Briefs of any amici
`granted leave to file in support of Plaintiffs shall be filed on or before February
`21, 2017. The court hereby vacates the previous deadline of February 20,
`2017, due to the federal holiday. Signed by Judge Amit P. Mehta on
`02/16/2017. (lcapm3) (Entered: 02/16/2017)
`
`MOTION for Leave to File Amicus Brief and Statement of Points &
`Authorities In Support Thereof by CAUSE OF ACTION INSTITUTE
`(Attachments: # 1 Exhibit Brief of Amicus Curiae Cause of Action Institute, #
`2 Text of Proposed Order)(Massari, Patrick) (Entered: 02/21/2017)
`
`ENTERED IN ERROR.....NOTICE Brief of the Amici Curiae States in
`Support of Plaintiffs by ARIZONA (Miller, Keith) Modified on 2/22/2017 (jf).
`(Entered: 02/21/2017)
`
`02/21/2017
`
`25
`
`AMICUS BRIEF by STATE OF ARIZONA, STATE OF LOUISIANA,
`STATE OF MICHIGAN. (jf) (Entered: 02/22/2017)
`
`02/22/2017
`
`03/17/2017
`
`26
`
`03/20/2017
`
`03/21/2017
`
`27
`
`03/21/2017
`
`28
`
`NOTICE OF ERROR re 24 Notice (Other); emailed to
`Keith.Miller@azag.gov, cc'd 9 associated attorneys −− The PDF file you
`docketed contained errors: 1. Incorrect document/case, 2. Parties must file a
`motion for amicus with attachment(s) (jf, ) (Entered: 02/22/2017)
`
`MOTION for Extension of Time to File Response/Reply , MOTION to
`Expedite by SYLVIA MATHEWS BURWELL, ROBERT CALIFF, UNITED
`STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES,
`UNITED STATES FOOD AND DRUG ADMINISTRATION (Attachments:
`# 1 Text of Proposed Order)(Beckenhauer, Eric) (Entered: 03/17/2017)
`
`MINUTE ORDER. Plaintiffs' Opposition, if any, to 26 Defendants' Motion to
`Extend Deadlines shall be filed by close of business on March 21, 2017.
`Signed by Judge Amit P. Mehta on 03/20/2017. (lcapm3) (Entered:
`03/20/2017)
`
`Joint MOTION to Amend/Correct 17 Scheduling Order by SYLVIA
`MATHEWS BURWELL, ROBERT CALIFF, UNITED STATES
`DEPARTMENT OF HEALTH AND HUMAN SERVICES, UNITED
`STATES FOOD AND DRUG ADMINISTRATION (Attachments: # 1 Text of
`Proposed Order)(Beckenhauer, Eric) (Entered: 03/21/2017)
`
`NOTICE OF WITHDRAWAL OF MOTION by SYLVIA MATHEWS
`BURWELL, ROBERT CALIFF, UNITED STATES DEPARTMENT OF
`HEALTH AND HUMAN SERVICES, UNITED STATES FOOD AND
`DRUG ADMINISTRATION re 26 MOTION for Extension of Time to File
`Response/Reply MOTION to Expedite (Beckenhauer, Eric) (Entered:
`03/21/2017)
`
`03/22/2017
`
`VACATED PURSUANT TO COURT'S ORDER OF
`5/2/2017............MINUTE ORDER granting 27 the parties' Joint Motion to
`
`18
`
`

`

`Case 1:16-cv-01460-APM Document 221 Filed 08/26/20 Page 19 of 57
`
`USCA Case #20-5266 Document #1859086 Filed: 08/31/2020 Page 19 of 57
`Amend Scheduling Order. The revised schedule is as follows: Defendants'
`Opposition to Plaintiffs' Motion for Summary Judgment and Cross−Motion for
`Summary Judgment shall be filed on or before May 1, 2017; briefs of any
`amici granted leave to file in support of Defendants shall be filed on or before
`May 8, 2017; Plaintiffs' Reply in Support of its Motion for Summary
`Judgment and Opposition to Defendants' Cross−Motion shall be filed on or
`before June 14, 2017; Defendants' Reply in Support of their Cross−Motion for
`Summary Judgment shall be filed on or before July 14, 2017; Plaintiffs shall
`file the appendix of excerpts of the administrative record on or before July 28,
`2017; and oral argument is scheduled for August 30, 2017, at 10 a.m. in
`Courtroom 10. Signed by Judge Amit P. Mehta on 03/22/2017. (lcapm3)
`Modified on 5/3/2017 (zcdw). (Entered: 03/22/2017)
`
`03/22/2017
`
`Set/Reset Deadlines/Hearings: Defendant's Response to Motion for Summary
`Judgment due by 5/1/2017. Reply to Motion for Summary Judgment due by
`6/14/2017. Defendants' Cross Motion due by 5/1/2017. Response to Cross
`Motion due by 6/14/2017. Reply to Cross Motion due by 7/14/2017. Briefs of
`amici due by 5/8/2017. Plaintiffs' appendix due by 7/28/2017. Motion Hearing
`set for 8/30/2017 at 10:00 AM in Courtroom 10 before Judge Amit P. Mehta.
`(cdw) (Entered: 03/23/2017)
`
`04/03/2017
`
`29
`
`MOTION for Leave to File by Campaign for Tobacco−Free Kids (Greenwold,
`Mark) (Entered: 04/03/2017)
`
`04/03/2017
`
`04/03/2017
`
`30
`
`04/03/2017
`
`31
`
`04/03/2017
`
`32
`
`04/05/2017
`
`33
`
`05/01/2017
`
`34
`
`05/02/2017
`
`35
`
`MINUTE ORDER granting 23 Cause of Action Institute's Motion for Leave to
`File Brief as Amicus Curiae. Signed by Judge Amit P. Mehta on 04/03/2017.
`(lcapm3) (Entered: 04/03/2017)
`
`ORDER granting 29 Unopposed Motion of Campaign for Tobacco−Free Kids
`for Leave to File Brief Amicus Curiae. See attached Order for additional
`details. Signed by Judge Amit P. Mehta on 04/03/2017. (lcapm3) (Entered:
`04/03/2017)
`
`NOTICE TO PARTIES. See attached Notice. Signed by Judge Amit P. Mehta
`on 04/03/2017. (lcapm3) (Entered: 04/03/2017)
`
`AMICUS BRIEF re 22 IN SUPPORT OF PLAINTIFFS MOTION FOR
`SUMMARY JUDGMENT by CAUSE OF ACTION INSTITUTE. (jf)
`(Entered: 04/03/2017)
`
`NOTICE in Response to the Court's Notice of April 3, 2017 by CAMPAIGN
`FOR TOBACCO−FREE KIDS (Greenwold, Mark) (Entered: 04/05/2017)
`
`Joint MOTION to Amend/Correct 17 Scheduling Order by SYLVIA
`MATHEWS BURWELL, ROBERT CALIFF, UNITED STATES
`DEPARTMENT OF HEALTH AND HUMAN SERVICES, UNITED
`STATES FOOD AND DRUG ADMINISTRATION (Attachments: # 1 Text of
`Proposed Order)(Beckenhauer, Eric) (Entered: 05/01/2017)
`
`VACATED PURSUANT TO ORDER FILED 9/19/2017.....ORDER granting
`34 the parties' Joint Motion to Amend Scheduling Order. The revised schedule
`in this matter is as follows: Defendants' opposition to Plaintiffs' motion for
`summary judgment and cross−motion for summary judgment shall be filed on
`or before August 1, 2017; briefs of any amici granted leave to file in support of
`Defendants shall be filed on or before August 8, 2017; Plaintiffs' reply in
`
`19
`
`

`

`Case 1:16-cv-01460-APM Document 221 Filed 08/26/20 Page 20 of 57
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`USCA Case #20-5266 Document #1859086 Filed: 08/31/2020 Page 20 of 57
`support of their motion for summary judgment and opposition to Defendants'
`cross−motion for summary judgment shall be filed on or before September 14,
`2017; Defendants' reply in support of their cross−motion for summary
`judgment shall be filed on or before October 16, 2017; Plaintiffs shall file the
`appendix of excerpts of the administrative record on or before October 3