in the united states court of appeals - khlaw.com oppo to... · no. 19-2130 (l), no. 19-2132, no....

No. 19-2130 (L), No. 19-2132, No. 19-2198, No. 19-2242

In The United States Court of Appeals

For the Fourth Circuit

No. 19-2132 (8:18-cv-00883-PWG)

AMERICAN ACADEMY OF PEDIATRICS; MARYLAND CHAPTER – AMERICAN ACADEMY OF PEDIATRICS; AMERICAN CANCER SOCIETY CANCER ACTION NETWORK; AMERICAN HEART ASSOCIATION; AMERICAN LUNG ASSOCIATION; CAMPAIGN FOR TOBACCO-FREE KIDS; TRUTH INITIATIVE; DR. LEAH BRASCH, MD; DR. CYNTHIA FISHMAN, MD; DR. LINDA GOLDSTEIN, MD; DR. STEVEN HIRSCH, MD; DR. DAVID MYLES, MD

Plaintiffs – Appellees

v.

AMERICAN E-LIQUID MANUFACTURING STANDARDS ASSOCIATION; AMERICAN VAPING ASSOCIATION; SMOKE-FREE ALTERNATIVES TRADE ASSOCIATION- CALIFORNIA; ARIZONA SMOKE FREE BUSINESS ALLIANCE; SMOKE-FREE ALTERNATIVES TRADE ASSOCIATION- CONNECTICUT; INDIANA SMOKE FREE ASSOCIATION; SMOKE-FREE ALTERNATIVES TRADE ASSOCIATION- HAWAII; IOWANS FOR ALTERNATIVE TO SMOKING AND TOBACCO; SMOKE-FREE ALTERNATIVES TRADE ASSOCIATION- LOUISIANA; KENTUCKY SMOKE FREE ASSOCIATION; SMOKE-FREE ALTERNATIVES TRADE ASSOCIATION- RHODE ISLAND; MARYLAND VAPOR ALLIANCE; SMOKE-FREE ALTERNATIVES TRADE ASSOCIATION- TEXAS; NEW YORK STATE VAPOR ASSOCIATION; SMOKE-FREE ALTERNATIVES TRADE ASSOCIATION- WISCONSIN; OHIO VAPOR TRADE ASSOCIATION; RIGHT TO BE SMOKE-FREE COALITION; SMOKE FREE ALTERNATIVES TRADE ASSOCIATION; TENNESSEE SMOKE FREE ASSOCIATION; TEXAS VAPOR COALITION

Intervenors – Appellants

PLAINTIFFS-APPELLEES’ OPPOSITION TO INTERVENORS-APPELLANTS’ MOTION TO STAY

(caption continued on inside pages)

USCA4 Appeal: 19-2132 Doc: 39 Filed: 12/31/2019 Pg: 1 of 32

and

UNITED STATES FOOD AND DRUG ADMINISTRATION; NORMAN E. SHARPLESS, in his official capacity as Acting Commissioner of Food and Drugs; UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES; ALEX M. AZAR, II, in his Official capacity as Secretary of Health and Human Services

Defendants ______________________________

No. 19-2242 (8:18-cv-00883-PWG)

______________________________

In re: AMERICAN E-LIQUID MANUFACTURING STANDARDS ASSOCIATION; AMERICAN VAPING ASSOCIATION; ARIZONA SMOKE FREE BUSINESS ALLIANCE; INDIANA SMOKE FREE ASSOCIATION; IOWANS FOR ALTERNATIVE TO SMOKING AND TOBACCO; KENTUCKY SMOKE FREE ASSOCIATION; MARYLAND VAPOR ALLIANCE; NEW YORK STATE VAPOR ASSOCIATION; OHIO VAPOR TRADE ASSOCIATION; RIGHT TO BE SMOKE-FREE COALITION; SMOKE FREE ALTERNATIVES TRADE ASSOCIATION; SMOKE-FREE ALTERNATIVES TRADE ASSOCIATION- CALIFORNIA; SMOKE-FREE ALTERNATIVES TRADE ASSOCIATION- CONNECTICUT; SMOKE-FREE ALTERNATIVES TRADE ASSOCIATION- HAWAII; SMOKE-FREE ALTERNATIVES TRADE ASSOCIATION- LOUISIANA; SMOKE-FREE ALTERNATIVES TRADE ASSOCIATION- RHODE ISLAND; SMOKE-FREE ALTERNATIVES TRADE ASSOCIATION- TEXAS; SMOKE-FREE ALTERNATIVES TRADE ASSOCIATION- WISCONSIN; TENNESSEE SMOKE FREE ASSOCIATION; TEXAS VAPOR COALITION

Appellants _________________________________________________________

AMERICAN ACADEMY OF PEDIATRICS; AMERICAN CANCER SOCIETY CANCER ACTION NETWORK; AMERICAN HEART ASSOCIATION; AMERICAN LUNG ASSOCIATION; LEAH BRASCH; CAMPAIGN FOR TOBACCO-FREE KIDS; CYNTHIA FISHMAN; LINDA GOLDSTEIN; STEVEN HIRSCH; DAVID MYLES; MARYLAND CHAPTER- AMERICAN ACADEMY OF PEDIATRICS; TRUTH INITIATIVE

Plaintiffs – Appellees

v.


UNITED STATES FOOD AND DRUG ADMINISTRATION; SCOTT GOTTLIEB, in his Official capacity as Commissioner of Food and Drugs; NORMAN E. SHARPLESS, in his Official capacity as Commissioner of Food and Drugs; UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES; ALEX M. AZAR, II, in his Official capacity as Secretary of Health and Human Services; AMERICAN ASSOCIATION FOR RESPIRATORY CARE

Defendants


i

TABLE OF CONTENTS

Page(s)

Section

Introduction ................................................................................................................ 1

Background ................................................................................................................ 3

I. The Tobacco Control Act .................................................................................. 3

II. The Rise of E-Cigarettes .................................................................................. 4

A. FDA’s Announcement of Intention to Regulate E-Cigarettes ..................... 4

B. Growth of Youth E-Cigarette Use in the Absence of Regulation ................ 5

C. FDA’s Issuance of the Final Deeming Rule ................................................. 6

D. The August 2017 Guidance and the Youth E-Cigarette Epidemic ............................................................................................................ 7 III. This Lawsuit ................................................................................................... 8

Legal Standard ......................................................................................................... 12

Argument ................................................................................................................. 13

I. The E-Cigarette Associations Have No Likelihood of Success on the Merits ............................................................................................................ 13

II. The E-Cigarette Associations Have Not Shown A Likelihood of Irreparable Harm ................................................................................................. 16

IV. Plaintiffs Will Be Substantially Harmed by a Stay ...................................... 19

V. The Public Interest Weighs Heavily Against a Stay ...................................... 20

Conclusion ............................................................................................................... 21


ii

TABLE OF AUTHORITIES

Page(s)

Cases

Andrulis Research Corp. v. U.S. Small Bus. Admin., No. 90-cv-2569, 1990 WL 169318 (D.D.C. Oct. 19, 1990)) ............................. 14

Coal. for Gov’t Procurement v. Fed. Prison Indus., Inc., 365 F.3d 435 (6th Cir. 2004) ........................................................................ 13, 14

Direx Israel, Ltd. v. Breakthrough Med. Corp., 952 F.2d 802 (4th Cir. 1991) ........................................................................ 16, 17

In re Fidelity Mortg. Investors, 690 F.2d 35 (2d Cir. 1982) ................................................................................. 16

Hilton v. Braunskill, 481 U.S. 770 (1987) ........................................................................................... 14

Long v. Robinson, 432 F.2d 977 (4th Cir. 1970) .............................................................................. 13

N.C. Fisheries Ass’n v. Gutierrez, 550 F.3d 16 (D.C. Cir. 2008) .............................................................................. 15

Nicopure Labs, LLC v. FDA, 944 F.3d 267 (D.C. Cir. 2019)..................................................................... passim

Nken v. Holder, 556 U.S. 418 (2009) ..................................................................................... 12, 13

Personhuballah v. Alcorn, 155 F. Supp. 3d 552 (E.D. Va. 2016) ................................................................. 12

Sierra Club v. U.S. Army Corps of Eng’rs, 909 F.3d 635 (4th Cir. 2018) .............................................................................. 15

Sottera, Inc. v. FDA, 627 F.3d 891 (D.C. Cir. 2010).............................................................................. 4

Thompson v. U.S. Dep’t of Hous. & Urban Dev., 2006 WL 581260 (D. Md. Jan. 10, 2006) .................................................... 13, 14


iii

Zambrana v. Califano, 651 F.2d 842 (2d Cir. 1981) ............................................................................... 14

Statutes, Regulations, and Rules

5 U.S.C.§ 551(1) ...................................................................................................... 15

21 U.S.C. § 387a ........................................................................................................ 4

21 U.S.C. § 387b ........................................................................................................ 1

21 U.S.C. § 387j................................................................................................ passim

Tobacco Control Act, Pub. L. No. 111-31, 123 Stat. 1776 (2009) ................................................... passim 79 Fed. Reg. 23,142 (Apr. 25, 2014 ................................................................ 6, 8, 13

81 Fed. Reg. 28,973 (May 10, 2016) ................................................................. 5, 6, 8

Fed. R. App. P. 8(1)(A) ............................................................................................ 17

Other Authorities

Anna Edney, “Judge Gives E-Cigarette Makers 10 Months to Seek FDA Review,” Bloomberg, July 12, 2019, https://tinyurl.com/y2wnfb6x ............................................................................. 17

April Roeseler, et al., “Assessment of Underage Sales Violations in Tobacco Stores and Vape Shops,” JAMA Pediatrics, June 24, 2019, https://tinyurl.com/yczqwkhu ............................................................................. 21

CDC, “Quick Stats: Cigarette Smoking Status Among Current Adult E-Cigarette Users, by Age Group—National Health Interview Survey, United States, 2015,” Oct. 28, 2016, https://tinyurl.com/uh8ulx4 ....................... 8

CDC, “Dual Use of Tobacco Products,” https://tinyurl.com/yczqwkhu ................... 8

Chris Kirkham, “FDA Targets E-Cigs That Hook Teens But Don’t Help Smokers Quit,” Reuters, Dec. 18, 2019, https://tinyurl.com/rl8xcpp ............................................................................. 8, 18

Donald Trump, President, Remarks by President Trump in Meeting on E-Cigarettes, Sept. 11, 2019, https://tinyurl.com/y3gl6tag ................................ 20


iv

FDA, Youth Tobacco Use: Results from the National Youth Tobacco Survey, Nov. 18, 2019, https://tinyurl.com/veseqtw ............................. 7 FDA, Statement from FDA Commissioner Scott Gottlieb, M.D., on

new steps to address epidemic of youth e-cigarette use, Sept. 11, 2018, https://tinyurl.com/y32z4yb2 ...................................................................... 7

Jennifer Maloney, “Reynolds Files for FDA Review of Vuse E-Cigarettes,” Wall St. Journal, Oct. 11, 2019, https://tinyurl.com/y4fkqqbv .............................................................................. 18

Juliet Chung & Jennifer Maloney, “E-Cigarette Maker NJOY Changes Funding Plan After Vaping Ban,” Wall St. Journal, Sept. 13, 2019, https://tinyurl.com/y4oufdkr; .............................................................................. 18

JUUL, “Our Commitment to the PMTA Process,” Aug. 20, 2019, https://tinyurl.com/y49swsma ............................................................................ 18

Letter from Lawrence Deyton, Dir., FDA Ctr. For Tobacco Prods. & Janet Woodcock, Dir., FDA Ctr. for Drug Evaluation & Research, Regulation of E-Cigarettes and Other Tobacco Products (Apr. 25, 2011), https://tinyurl.com/yx6xdsak ..................................................................... 4


1

The Intervenors-Appellants (“E-Cigarette Associations”) are trade

associations whose members sell highly addictive e-cigarettes that cannot be sold

lawfully. The Family Smoking Prevention and Tobacco Control Act (“Act” or

“TCA”), Pub. L. No. 111-31, 123 Stat. 1776 (2009), prohibits the sale of any “new

tobacco product”—i.e., any tobacco product introduced after February 15, 2007—

without a marketing order from the Food and Drug Administration (“FDA”), issued

through a process known as “premarket review.” 21 U.S.C. §§387b(6), 387j(a). The

e-cigarettes at issue are “new tobacco products” that have not received a marketing

order and it is thus illegal to market them.

Despite the TCA’s clear language, the FDA decided “to hold in abeyance

enforcement of mandatory provisions of a statute that Congress viewed as integral

to address public dangers that the agency itself acknowledges are alarming for five

or more years … all the while affording those manufacturers responsible for the

public harm a holiday from meeting the obligations of the law.” ECF 36-2 (“Summ.

J. Op.”) at 46. This decision was memorialized in a “Guidance” issued without

notice or comment in August 2017. Id. at 10. Plaintiffs-Appellees (“Plaintiffs”),

several public health organizations and individual pediatricians, challenged this

abdication in the U.S. District Court for the District of Maryland (Grimm, J.) and

prevailed: the District Court found that the Guidance (1) violated the TCA and (2)

violated the Administrative Procedure Act’s (“APA”) requirement of notice and

comment. See Summ. J. Op. at 42-53. Because the previous deadline for submitting


2

premarket review applications (“PMTAs”) had passed, the District Court issued a

remedial order extending that deadline to May 12, 2020. ECF 36-3 (“Remedial

Order”) at 12.

The E-Cigarette Associations ask this Court to stay the Remedial Order, but

not the Summary Judgment Opinion. They desire an order from this Court that will

let them continue marketing their products illegally without having to show the

FDA that their products are “appropriate for the protection of public health,” as

Congress required. 21 U.S.C. § 387j(c)(2)(A). The putative injury they seek to

avoid is the risk of being found liable for continuing to violate the law. They seek

this extraordinary result despite the fact that e-cigarette use among youth has

become an unprecedented epidemic addicting a new generation to nicotine.

The E-Cigarette Associations’ motion fails all four requirements for the

extraordinary relief of a stay pending appeal. First, their arguments have no

likelihood of success. Given the passage of the pre-Guidance deadline, FDA’s

abdication of its statutory obligation, and the epidemic of youth e-cigarette usage,

the District Court had remedial discretion to extend the lapsed deadline for filing

PMTAs. Second, the Associations have not shown irreparable harm because (a)

there is no legally cognizable harm in being prohibited from selling products

without the authorization required by law; and (b) without the Remedial Order, the

Summary Judgment Order (which the Associations have never challenged) would

permit no compliance period at all. Third, the relief sought by the Associations


3

would harm Plaintiffs, making it more difficult to counsel and treat the victims of

the epidemic of youth usage. Fourth, the public interest weighs heavily against a

stay, because (1) the e-cigarette industry’s holiday from the TCA’s requirements

has caused an epidemic of youth e-cigarette use; and (2) there is no risk that the

Remedial Order will remove all e-cigarette products from the market. Moreover,

given the public health consequences of a continued failure to enforce the law, this

Court should not consider nullifying the well-reasoned decision of the district court

before full briefing and argument on the merits.

BACKGROUND

I. The Tobacco Control Act

In 2009, Congress enacted the TCA to authorize and require FDA to regulate

tobacco products. Congress found that “nicotine is an addictive drug” and that “use

of tobacco products by the Nation’s children is a pediatric disease of considerable

proportions that results in new generations of tobacco-dependent children and

adults.” TCA §§ 2(1), 2(3), 123 Stat. at 1777. Recognizing the impracticality of

immediately banning all tobacco products, “Congress instead took the then-current

tobacco product market as a baseline from which to ratchet down tobacco products’

harms to public health.” Nicopure Labs, LLC v. FDA, 944 F.3d 267, 271 (D.C. Cir.

2019). Congress immediately subjected cigarettes and smokeless tobacco products

to the TCA and gave FDA authority to issue regulations “deem[ing] other products


4

that meet the statutory definition of a tobacco product” subject to the Act. 21 U.S.C.

§ 387a(b).

The TCA required that “all new tobacco products [subject to the Act] must be

cleared by the FDA before they can be marketed and sold in the United States.”

Nicopure, 944 F.3d at 276 (citing 21 U.S.C. § 387j). To obtain authorization to

market a product, its manufacturer must prove that it is “appropriate for the

protection of the public health.” 21 U.S.C. § 387j(c)(2).1 Congress did not give

FDA discretion to waive these requirements. Nicopure, 944 F.3d at 281.

II. The Rise of E-Cigarettes

A. FDA’s Announcement of Intention to Regulate E-Cigarettes

When the TCA was enacted, e-cigarettes had virtually no market. In early

2011, after the D.C. Circuit barred its efforts to regulate e-cigarettes as drugs under

the Food, Drug and Cosmetic Act, Sottera, Inc. v. FDA, 627 F.3d 891 (D.C. Cir.

2010), FDA announced its intention to issue a rule “deeming” e-cigarettes subject to

the TCA.2

1 The TCA also created a significantly easier “substantial equivalence” pathway to authorization, but the E-Cigarette Associations acknowledge that their products can only satisfy the PMTA pathway. ECF 41 at 6-7. 2 Letter to Stakeholders from Lawrence Deyton, Dir., FDA Ctr. for Tobacco Prods. & Janet Woodcock, Dir., FDA Ctr. for Drug Evaluation & Research, Regulation of E-Cigarettes and Other Tobacco Products (Apr. 25, 2011), https://tinyurl.com/yx6xdsak.


5

FDA’s decision to subject e-cigarettes to the TCA was based on its

recognition that e-cigarettes are addictive and harmful to the user’s health. An e-

cigarette “delivers nicotine by vaporizing a liquid that includes other chemicals and

flavorings. The device heats the liquid until it generates an aerosol—or ‘vapor’—

that can be inhaled.” Nicopure, 944 F.3d at 270. But rather than water vapor, users

inhale “ultrafine particulate aerosols”—“atomized chemicals” that “are often not

safe for inhalation in the lungs.” D.Ct. Dkt. 145-1 ¶ 7; see Nicopure, 944 F.3d at

274-76.

E-cigarettes also contain nicotine, “one of the most addictive substances used

by humans.” 81 Fed. Reg. at 28,988. Adolescents are “uniquely susceptible to …

becom[ing] addicted to tobacco products,” id. at 29,047, an addiction that often

becomes permanent, Nicopure, 944 F.3d at 274. Moreover, nicotine can have

“lasting adverse consequences for brain development,” 81 Fed. Reg. at 29,034

causing “detrimental effects on the cardiovascular system and potentially

disrupt[ing] the central nervous system,” id. at 29,033—effects to which

adolescents are “particularly vulnerable,” id. at 29,029.

B. Growth of Youth E-Cigarette Use in the Absence of Regulation

Although FDA announced its intention to regulate e-cigarettes in early 2011,

it did not issue a proposed rule to do so until 2014 and a final rule until May 2016.

In that five-year interval, while e-cigarettes were totally unregulated, youth use

increased exponentially. Key to the increase in youth use were youth-oriented


6

advertising and the introduction and promotion of youth-friendly flavors. E-

cigarette manufacturers “introduced many sweet flavors particularly appealing to

children, including ‘gummy bear’ and ‘bubblegum,’” Nicopure, 944 F.3d at 274-

275 (citing 79 Fed. Reg. at 23,157), gave them names like “Cherri Bombz” and

“Cereal Treats Loopz,” D.Ct. Dkt. 125 at 3, and sometimes marketed them in

packaging resembling juice boxes or candy, Summ. J. Op. at 3. FDA found

“substantial evidence that manufacturers have specifically targeted youth, both with

kid-friendly fruit and candy flavors and youth-directed advertising.” D.Ct. Dkt. 125

at 8.

As a result, between the time FDA announced its intention to regulate e-

cigarettes and the time it actually proposed the Deeming Rule, “e-cigarette use

among high school students rose ‘nearly 800 percent from 1.5 percent in 2011 to

13.4 percent in 2014.’” Nicopure, 944 F.3d at 275 (quoting 81 Fed. Reg. at 28,984).

C. FDA’s Issuance of the Final Deeming Rule

After notice-and-comment rulemaking, FDA issued the final Deeming Rule

on May 10, 2016, making it effective August 8, 2016. 81 Fed. Reg. at 28,974.

Although the Deeming Rule subjected e-cigarettes to premarket review, FDA

announced that it would establish a “compliance period” during which it would not

enforce the premarket review requirements for two years (i.e., until August 8, 2018)

against products on the market on the effective date. Id. at 29,011. Moreover, e-


7

cigarettes for which PMTAs were filed by August 8, 2018 would receive an

additional one-year compliance period while FDA reviewed their applications. Id.

The Deeming Rule—and particularly the application of premarket review to

e-cigarettes—has been upheld on judicial review, see Nicopure, 944 F.3d 267, and

the validity of the Rule has not been challenged in this case.

D. The August 2017 Guidance and the Youth E-Cigarette Epidemic

In August 2017, FDA, without notice-and-comment rulemaking, issued a

Guidance extending the compliance period for e-cigarettes by four years, from

August 2018 to August 2022, and replacing the one-year post-filing compliance

period with a policy of permanent non-enforcement unless an application was

rejected. Summ. J. Op. at 10.

Following the Guidance, youth e-cigarette use exploded to unprecedented

levels. E-cigarette use more than doubled among high schoolers and tripled among

middle schoolers from 2017 to 2019 (to 27.5% and 10.5%, respectively).3 In 2019,

five million people age 18 and under used e-cigarettes, with 1.6 million of them

reporting using e-cigarettes frequently—an indication of addiction.4 FDA has

widely characterized this level of usage as an “epidemic.”5

3 D.Ct. Dkt. 59-1 at 9; FDA, Youth Tobacco Use: Results from the National Youth Tobacco Survey, Nov. 18, 2019, https://tinyurl.com/veseqtw (“NYTS”). 4 NYTS, supra n. 3. 5 E.g., FDA, Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to address epidemic of youth e-cigarette use, Sept. 11, 2018, https://tinyurl.com/y32z4yb2.


8

Moreover, “studies show that youth who use e-cigarettes are more likely to

smoke conventional cigarettes.” Nicopure, 944 F.3d at 275 (quoting 81 Fed. Reg. at

28,985, 29,040-41). E-cigarettes provide “a trendy on-ramp to tobacco use for

people who otherwise might never have used it.” Id. (citing 81 Fed. Reg. at 29,036-

37).

By contrast, “[e]-cigarettes have not been shown to reduce the incidence of

conventional smoking.” Id. (citing 81 Fed. Reg. at 29,041 and 79 Fed. Reg. at

23,147, 23,152). Although youth use of e-cigarettes has exploded since 2017, adult

use of e-cigarettes has not increased6 and many adults who use e-cigarettes also use

combusted tobacco products concurrently,7 a practice that eliminates any potential

health benefit.8 In short, suspending premarket review has produced a public health

catastrophe.

III. This Lawsuit.

In response to the Guidance, Plaintiffs—seven leading public health

organizations that educate the public about the consequences of tobacco use and aid

physicians in treating and counseling patients, along with six individual

pediatricians—filed this lawsuit, raising three claims. First, the Guidance

6 Chris Kirkham, “FDA Targets E-Cigs That Hook Teens But Don’t Help Smokers Quit,” Reuters, Dec. 18, 2019, https://tinyurl.com/rl8xcpp. 7 CDC, “Quick Stats: Cigarette Smoking Status Among Current Adult E-Cigarette Users, by Age Group—National Health Interview Survey, United States, 2015,” Oct. 28, 2016, https://tinyurl.com/uh8ulx4. 8 CDC, “Dual Use of Tobacco Products,” https://tinyurl.com/yczqwkhu.


9

contradicted the TCA and violated the Executive Branch’s obligation to “take care

that the Laws be faithfully executed.” D.Ct. Dkt. 1 ¶¶ 93-102. Second, the Guidance

was a substantive rule requiring, but issued without, notice and opportunity to

comment. Id. ¶¶ 104-10. Third, the Guidance was not supported by reasoned

explanation and therefore was arbitrary and capricious. Id. ¶¶ 112-18. The parties

cross-moved for summary judgment, with FDA vigorously opposing Plaintiffs’

claims. See D.Ct. Dkt. 36-1 & 43.

While the summary judgment motions were pending, in March 2019, FDA

proposed to replace the 2017 Guidance with a draft guidance under which FDA

would terminate compliance periods within 30 days of issuance for some flavored

e-cigarettes unless sold in adult-only facilities and shorten the compliance period to

August 8, 2021 for flavored products sold in such facilities (but make no changes in

compliance periods for other flavored products and retain the indefinite post-filing

compliance period established by the 2017 Guidance). See D.Ct. Dkt. 59-1. FDA

has yet to finalize this draft guidance.

The District Court initially denied the cross-motions sua sponte in light of

this draft guidance. D.Ct. Dkt. 62. It subsequently reconsidered this decision based

on the substantial uncertainty regarding when—if ever—FDA would finalize the

Draft Guidance. See Summ. J. Op. at 6. The Court granted summary judgment to

Plaintiffs, finding that the 2017 Guidance conflicted with the TCA and exceeded


10

FDA’s statutory authority, id. at 41-46, and required, but was issued without, notice

and opportunity to comment, id. at 47-53.9

Accordingly, the Court vacated the Guidance. Id. at 53. Vacating the

Guidance reinstated the deadlines established by the Deeming Rule—but, as the

Court recognized, those deadlines had passed. Summ. J. Op. at 53. Thus, after the

Summary Judgment Order, manufacturers no longer had any assurance that FDA

would not enforce the TCA against them for marketing e-cigarettes without

premarket review. The Court therefore directed the parties to submit additional

briefing regarding further remedies.

The day after Plaintiffs’ remedial brief was due, the E-Cigarette Associations

for the first time sought leave to intervene. See D.Ct. Dkt. 80. The District Court

found that the Associations and other proposed intervenors had not made the

requisite “‘strong showing’ that the Government cannot adequately represent [their]

interest,” nor “that the protection of their interests would be impaired without

intervention.” D.Ct. Dkt. 84 at 1 (quoting Stuart v. Huff, 706 F.3d 345, 352 (4th Cir.

2013)). It further denied permissive intervention because “delay in determining a

remedy for [FDA’s] violation would not be in the public interest.” Id. at 3. Instead,

it permitted the E-Cigarette Associations and the other proposed intervenors to file

9 Because these failings were established by “undisputed evidence,” the Court did not consider Plaintiffs’ “arbitrary and capricious” claim. Summ. J. Op. at 42 n.10.


11

an amicus brief, ensuring that the Court would have their views when considering a

remedy.

The Court considered three options for additional remedy:

• Plaintiffs proposed a 120-day deadline for manufacturers to submit PMTAs for products to remain on the market without threat of enforcement, and the resumption of the Deeming Rule’s one-year post-filing compliance period. D.Ct. Dkt. 78 at 8.10

• FDA opposed any additional remedy, arguing that “[t]he Court should not go beyond vacating the August 2017 guidance.” D.Ct. Dkt. 120 at 2. FDA further proposed that, if the District Court established a remedy, it set a deadline no sooner than 10 months, based on a detailed affidavit from the Director of the Center for Tobacco Products explaining that such a deadline would allow manufacturers to submit quality applications and FDA to prepare adequately to review them. Id. at 11-13.

• The E-Cigarette Associations proposed that the Court “remand[] th[e] Guidance to FDA without vacatur,” D.Ct. Dkt. 113 at 2, leaving manufacturers free to sell these addictive products unlawfully and indefinitely with impunity, based on the supposed need for FDA “to complete essential regulatory steps.” Id. at 3. (In response, FDA strongly disputed that further steps were needed before it could enforce the premarket review requirement. See D.Ct. Dkt. 125 at 2-5.)

With the pre-Guidance deadlines having passed, the Court concluded that it

was appropriate to adjust those deadlines. Remedial Order at 10. It rejected the

four-month deadline Plaintiffs had proposed, adopting instead the ten-month

deadline proposed by FDA. Id. It also rejected the E-Cigarette Associations’

proposal, finding the industry’s argument “that it cannot complete … applications

10 The State of Maryland filed an amicus brief in support of Plaintiffs’ proposal. D.Ct. Dkt. 97.


12

without further formal guidance” to be “disingenuous[]” and holding that “remand

without vacatur is not appropriate under the circumstances of this case.” Id. at 7-8

& n.6.

The E-Cigarette Associations moved to intervene for purposes of appeal and

for a stay of the Remedial Order pending appeal, making largely the same

arguments they raise here. ECF 36-6. Notably, the E-Cigarette Associations did not

seek to stay the Summary Judgment Order. Id. The District Court granted their

motion to intervene, but denied their motion to stay, finding that “there simply is no

pressing need” because “[t]he Remedy Order does not impose an immediate

deadline.” ECF 36-8.

LEGAL STANDARD

A stay pending appeal “is considered extraordinary relief for which the

moving party bears a heavy burden.” Personhuballah v. Alcorn, 155 F. Supp. 3d

552, 558 (E.D. Va. 2016), stay denied sub. nom. Wittman v. Personhuballah, 136 S.

Ct. 998 (Mem) (quotations omitted). “A stay is an intrusion into the ordinary

processes of administration and judicial review, and accordingly is not a matter of

right, even if irreparable injury might otherwise result to the appellant.” Nken v.

Holder, 556 U.S. 418, 427 (2009) (quotations omitted). The party seeking a stay

must show “(1) that he will likely prevail on the merits of the appeal, (2) that he

will suffer irreparable injury if the stay is denied, (3) that other parties will not be

substantially harmed by the stay, and (4) that the public interest will be served by


13

granting the stay.” Long v. Robinson, 432 F.2d 977, 979 (4th Cir. 1970). “More than

a mere possibility of relief is required,” and “simply showing some possibility of

irreparable injury” is not enough; rather, a “strong showing that [movant] is likely

to succeed on the merits” is required.” Nken, 556 U.S. at 434-35.

ARGUMENT

I. The E-Cigarette Associations Have No Likelihood of Success on the Merits

The E-Cigarette Associations do not dispute that the District Court’s

Summary Judgment Order was correctly decided. Instead, they challenge only the

Remedial Order, arguing that “the District Court improperly imposed injunctive

relief without remand for notice and comment.” ECF 36-1 at 9. The District Court

had no power to do so, the Associations contend, because “the typical remedy” for

agency violation of law is “not for the court to issue injunctive relief, but rather to

remand to the agency.” ECF 36-1 at 9.

While remand may be typical, it is not always sufficient to “account for past

violations of … statutes or regulations.” Remedial Order at 5 (quoting Coal. for

Gov’t Procurement v. Fed. Prison Indus., Inc., 365 F.3d 435, 460 (6th Cir. 2004)).

As the District Court explained, “[f]ederal agencies are not immune from the

federal court’s traditional equitable powers.” Id. at 11 (quoting Thompson v. U.S.

Dep’t of Hous. & Urban Dev., No. 95-cv-309, 2006 WL 581260, at *9-10 (D. Md.

Jan. 10, 2006)). “Court[s] may craft declaratory and injunctive relief designed to


14

preclude a federal agency from acting in contravention of its statutory and

regulatory authority.” Id. at 4 (quoting Coal. for Gov’t Procurement, 365 F.3d at

460). Most relevant, courts frequently establish or alter deadlines where necessary

“to remedy improper agency delay.” Id. at 5 (quoting Andrulis Research Corp. v.

U.S. Small Bus. Admin., No. 90-cv-2569, 1990 WL 169318, at *2 (D.D.C. Oct. 19,

1990)) (collecting cases); see also, e.g. Zambrana v. Califano, 651 F.2d 842, 844

(2d Cir. 1981) (courts “may when appropriate set a time limit for action by the

[agency], and this is often done”).

The Associations barely acknowledge the main cases that the District Court

cited, relegating them to a single footnote, ECF 36-1 at 13 n.5, or (like Thompson)

ignoring them altogether. Instead, they assert three propositions, none of which

comes close to establishing a “strong showing that [they are] likely to succeed on

the merits.” Hilton v. Braunskill, 481 U.S. 770, 776 (1987).

First, they argue that the typical remedy “holds more true in cases involving

procedural error, like the failure to comply with the APA’s notice and comment

requirements.” ECF 36-1 at 10. This proposition weakens the Associations’

argument. The District Court did not vacate the Guidance solely, or even

principally, because FDA had violated the APA’s requirement of notice-and-

comment rulemaking; rather, it found that the Guidance “cannot fall within its

enforcement discretion” and was “inconsistent with the Tobacco Control Act and in

excess of its statutory authority.” Summ. J. Op. at 46. The Court found that FDA’s


15

actions constituted “a decision to hold in abeyance enforcement of mandatory

provisions of a statute that Congress viewed as integral to address public dangers

that the agency itself acknowledges are alarming for five or more years … all the

while affording those manufacturers responsible for the public harm a holiday from

meeting the obligations of the law.” Id. at 10.

Second, the Associations argue that the D.C. Circuit’s holding that

“extraordinary circumstances” may require a remedy beyond simple vacatur, see

N.C. Fisheries Ass’n v. Gutierrez, 550 F.3d 16, 20 (D.C. Cir. 2008), has not been

explicitly adopted by the Fourth Circuit. ECF 36-1 at 12. They do not, however,

identify even a single court that has questioned the validity of that rule, much less

disputed the equitable authorities cited above. A bare hope that an appellate court

will make an unprecedented ruling, without reference to any caselaw whatsoever,

does not demonstrate likelihood of success, much less the strong showing that a

stay requires.11

Third, they suggest the District Court could not adjust the previous deadline

without remanding for notice and comment. But the APA’s notice-and-comment

requirement does not apply to courts. See 5 U.S.C.§ 551(1)(B) (excluding “the

courts of the United States” from the definition of “agency” for purposes of the

11 Their argument is particularly ill-taken because their preferred remedy, remand without vacatur, not only has never been adopted by the Fourth Circuit but has been specifically questioned. Compare D.Ct. Dkt. 113 at 9-10 with Sierra Club v. U.S. Army Corps of Eng’rs, 909 F.3d 635, 655 (4th Cir. 2018).


16

APA); In re Fidelity Mortg. Investors, 690 F.2d 35, 38 (2d Cir. 1982) (“[I]t is clear

that Congress intended the entire judicial branch of the Government to be excluded

from the provisions of the Administrative Procedure Act.”). The Associations cite

no authority for their novel proposition that notice-and-comment rulemaking is

required when a court concludes injunctive relief is necessary; as far as Plaintiffs

can find, none exists.

II. The E-Cigarette Associations Have Not Shown A Likelihood of Irreparable Harm

The Associations have not made a “clear showing” that irreparable harm is

likely. Direx Israel, Ltd. v. Breakthrough Med. Corp., 952 F.2d 802, 812 (4th Cir.

1991). The only harm they claim is that some companies may be unable to submit

PMTAs within the 10-month extension of the compliance period, and thus may face

liability if they choose to continue selling new e-cigarettes. This putative harm falls

far short, for at least four reasons.

First, as explained above, the sale and marketing of the products at issue is

illegal. The E-Cigarette Associations do not and cannot dispute that marketing new

tobacco products without a premarket order is unlawful, whether or not FDA

withholds enforcement. See Nicopure, 944 F.3d at 281 (“It was Congress, not the

FDA, that imposed [the premarket authorization requirement] on new tobacco

products … .”). The relief they request is permission to violate the law with

impunity; the harm they declaim is the possibility of facing consequences. There


17

can be no irreparable harm in being placed at risk of an enforcement action if one

chooses to violate the law.

Second, the E-Cigarette Associations only asked the District Court to stay the

Remedial Order, and therefore could not obtain a stay of the Summary Judgment

Order even if they sought one (which they do not). See Fed. R. App. P. 8(1)(A)

(requiring a party to “move first in the district court” for “a stay of the … order of a

district court pending appeal”). But as explained above, the Summary Judgment

Order rendered all e-cigarettes immediately subject to the premarket review

requirement, and it is only the Remedial Order that deferred that consequence. The

Remedial Order that the E-Cigarette Associations seek to stay is the only order

standing between them and immediate enforcement of the TCA. The Remedial

Order thus does not cause them irreparable harm; to the contrary, it mitigates it.

Third, the E-Cigarette Associations suggest that FDA might, through notice-

and-comment rulemaking, create a longer compliance period. There is absolutely no

evidence that FDA would do any such thing. To the contrary, FDA publicly stated

that the Remedial Order “is an important step forward for public health” and that it

“stands ready to accelerate review of these products.”12 The mere possibility that

FDA might change its mind does not constitute the required “clear showing” of

harm that is “neither remote nor speculative.” Direx Israel, 952 F.2d at 812.

12 Anna Edney, “Judge Gives E-Cigarette Makers 10 Months to Seek FDA Review,” Bloomberg, July 12, 2019, https://tinyurl.com/y2wnfb6x.


18

Fourth, the E-Cigarette Associations cite supposed “uncertainties regarding

how manufacturers should test their products and gather information.” ECF 36-1 at

14; see id. at 14-18. The District Court found this contention “disingenuous[].”

Remedial Order at 8. As FDA and Plaintiffs explained below, FDA has issued

ample guidance concerning the PMTA process, and has consistently encouraged

manufacturers not to wait for further guidance before submitting applications or

contacting FDA with questions. See Remedial Order at 8 (summarizing FDA

actions). As the District Court found, the E-Cigarette Associations’ members

generally ignored these invitations, “a purposeful avoidance by the industry of

complying with the premarket requirements despite entreaties from the FDA that it

can do so.” Id. at 9. Tellingly, at least four manufacturers have already filed PMTAs

based on the existing guidance or have stated that they can do so by May 2020—

making clear that the supposed lack of guidance is no barrier to filing PMTAs.13

Congress made the right to market new tobacco products contingent on

demonstrating to the FDA that the marketing of the product was “appropriate for

the protection of the public health.” 21 U.S.C. §387j(c)(2)(A). Nowhere does the

TCA make that requirement depend on the issuance of FDA rules or guidance. As

13 See Kirkham, supra n. 6; Jennifer Maloney, “Reynolds Files for FDA Review of Vuse E-Cigarettes,” Wall St. Journal, Oct. 11, 2019, https://tinyurl.com/y4fkqqbv; Juliet Chung & Jennifer Maloney, “E-Cigarette Maker NJOY Changes Funding Plan After Vaping Ban,” Wall St. Journal, Sept. 13, 2019, https://tinyurl.com/y4oufdkr; JUUL, “Our Commitment to the PMTA Process,” Aug. 20, 2019, https://tinyurl.com/y49swsma.


19

the D.C. Circuit observed in rejecting a similar argument, “[t]he Industry’s

wholesale objection is to Congress’ design,” Nicopure, 944 F.3d at 281—not to the

Remedial Order.

III. Plaintiffs Will Be Substantially Harmed by a Stay

A stay allowing the E-Cigarette Associations’ members to continue

marketing their products with impunity would significantly harm Plaintiffs. The

District Court made extensive findings regarding the harm that the Guidance has

caused Plaintiffs—findings that the Associations do not challenge. See Summ. J.

Op. at 13-23; see also D.Ct. Dkt. 39-1 to 39-14 (Plaintiffs’ declarations). Industry’s

immunity from the premarket review requirement “interferes with … Plaintiffs’

missions of advancing the public health by allowing nearly 25,000 unreviewed

products to remain on the market—requiring Plaintiffs to expend more resources to

monitor the marketplace and to counsel and educate the public about e-cigarettes.”

Id. at 16.

The Associations’ claim that Plaintiffs’ “only alleged injury is a lack of

information from PMTAs,” ECF 36-1 at 19, is incorrect. Not only do Plaintiffs lack

the information that PMTAs would produce, they must cope with “the variable

contents of the unregulated products, and the sheer number of products on the

market.” Summ. J. Op. at 19 (quoting American Heart Association declaration).

“This situation forces [Plaintiffs] to invest considerably more resources in

monitoring the market and the products in the market so that [they] can determine


20

where the greatest risks to public health are arising.” Id at 17 (quoting American

Cancer Society declaration). Similarly, without information on the specific products

their patients use, individual pediatricians must conduct time-consuming research to

determine how best to counsel their patients on a given product—or provide less

effective counseling to their patients. See, e.g., D.Ct. Dkt. 39-8 ¶¶ 13-15, 39-10 ¶

14, 39-11 ¶ 6. For example, the recent outbreak of fatal disease due to the use of

unregulated vaping products was exacerbated by the difficulties that the unlimited

array of unregulated products caused for physicians and researchers trying to

understand and combat the outbreak. See D.Ct. Dkt. 145-1 ¶¶ 13-21.

IV. The Public Interest Weighs Heavily Against a Stay

Most importantly, the public interest weighs heavily against a stay. As FDA,

the District Court, and the President of the United States have all stated, the

availability of unauthorized e-cigarettes has fostered a public health crisis.14 The

explosion of youth usage and addiction is due in no small part to the August 2017

guidance, which “allowed the manufacturers … time to attract new, young users

and get them addicted to nicotine before any of their products, labels, or flavors are

pulled from the market.” Summ. J. Op. at 44.15 This epidemic is exactly what

14 See, e.g., D.Ct. Dkt. 59-2; Summ. J. Op. at 1-2; Donald Trump, President, Remarks by President Trump in Meeting on E-Cigarettes, Sept. 11, 2019, https://tinyurl.com/y3gl6tag. 15 The Associations claim that their members are “‘Mom and Pop’ shops” whose products do not “drive[] underage use.” ECF No. 36-1 at 7. To the contrary, small vape shops have the highest rates of sales to minors, with 45% of tobacco and vape


21

Congress sought to prevent by requiring all new tobacco products to be subject to

premarket review.

The Associations claim vaguely that e-cigarettes have “enormous” potential

health benefits and “help [adult smokers] move away from more dangerous

cigarettes.” ECF 36-1 at 20-22. Rather than allowing marketing of new products on

the basis of such vague and generalized claims, Congress enacted the premarket

review provision to require proof that the health benefits of individual products are

real—and worth risking youth addiction. Nicopure, 944 F.3d at 281. E-cigarette

manufacturers have known since 2011, when FDA stated its intention to subject e-

cigarettes to the TCA, that they would have to demonstrate that their products are

“appropriate for the protection of the public health.” 21 U.S.C. § 387j(c)(2)(A). If,

after years of marketing their products and subjecting the public to the risks these

products create, manufacturers are still unable to demonstrate a public health

benefit, they have only themselves to blame.

Finally, even assuming there is a cognizable public interest in having

unlawfully marketed e-cigarettes on the market, there is no possibility that the

District Court’s orders will clear the market of all such products. At least four

manufacturers have already submitted PMTA applications or expressed their

shops making underage sales according to one study. April Roeseler, et al., “Assessment of Underage Sales Violations in Tobacco Stores and Vape Shops,” JAMA Pediatrics, June 24, 2019, https://tinyurl.com/yczqwkhu.


22

intention to do so by the May 2020 deadline, ensuring that e-cigarettes will remain

available for purchase until at least May 2021. See supra n.13.

CONCLUSION

For the foregoing reasons, the Court should deny the motion to stay.

Respectfully submitted,

Dated: December 31, 2019 /s/ Jeffrey B. Dubner Jeffrey B. Dubner DEMOCRACY FORWARD FOUNDATION 1333 H Street NW, 11th Floor Washington, D.C. 20005 [email protected] Tel: (202) 448-9090 Eve L. Hill BROWN GOLDSTEIN & LEVY, LLP 120 East Baltimore Street, Suite 1700 Baltimore, Maryland 21202 [email protected] Tel: (410) 962-1030 Fax: (410) 385-0869

Dennis A. Henigan Swati Rawani CAMPAIGN FOR TOBACCO-FREE KIDS 1400 I Street NW, Suite 1200 Washington, D.C. 20005 [email protected] Swati Rawani @tobaccofreekids.org Tel: (202) 296-5469 Mark E. Greenwold 3913 Highwood Court, N.W. Washington, D.C. 20007 [email protected]


23

Tel: 202-965-2728 Cell: 202-420-1895 Counsel for Plaintiffs


11/14/2016 SCC

UNITED STATES COURT OF APPEALS FOR THE FOURTH CIRCUITEffective 12/01/2016

No. ____________ Caption: __________________________________________________

CERTIFICATE OF COMPLIANCE WITH TYPE-VOLUME LIMITType-Volume Limit, Typeface Requirements, and Type-Style Requirements

Type-Volume Limit for Briefs: Appellant’s Opening Brief, Appellee’s Response Brief, and Appellant’s Response/Reply Brief may not exceed 13,000 words or 1,300 lines. Appellee’s Opening/Response Brief may not exceed 15,300 words or 1,500 lines. A Reply or Amicus Brief may not exceed 6,500 words or 650 lines. Amicus Brief in support of an Opening/Response Brief may not exceed 7,650 words. Amicus Brief filed during consideration of petition for rehearing may not exceed 2,600 words. Counsel may rely on the word or line count of the word processing program used to prepare the document. The word-processing program must be set to include headings, footnotes, and quotes in the count. Line count is used only with monospaced type. See Fed. R. App. P. 28.1(e),29(a)(5), 32(a)(7)(B) & 32(f).

Type-Volume Limit for Other Documents if Produced Using a Computer: Petition for permissionto appeal and a motion or response thereto may not exceed 5,200 words. Reply to a motion may not exceed 2,600 words. Petition for writ of mandamus or prohibition or other extraordinary writ may not exceed 7,800 words. Petition for rehearing or rehearing en banc may not exceed 3,900 words. Fed. R. App. P. 5(c)(1), 21(d), 27(d)(2), 35(b)(2) & 40(b)(1).

Typeface and Type Style Requirements: A proportionally spaced typeface (such as Times New Roman) must include serifs and must be 14-point or larger. A monospaced typeface (such as Courier New) must be 12-point or larger (at least 10½ characters per inch). Fed. R. App. P. 32(a)(5), 32(a)(6).

This brief or other document complies with type-volume limits because, excluding the parts of the document exempted by Fed. R. App. R. 32(f) (cover page, disclosure statement, table of contents, table of citations, statement regarding oral argument, signature block, certificates of counsel, addendum, attachments):

[ ] this brief or other document contains [state number of] words

[ ] this brief uses monospaced type and contains [state number of] lines

This brief or other document complies with the typeface and type style requirements because:

[ ] this brief or other document has been prepared in a proportionally spaced typeface using [identify word processing program] in [identify font size and type style]; or

[ ] this brief or other document has been prepared in a monospaced typeface using [identify word processing program] in

[identify font size and type style].

(s)

Party Name

Dated:

AAP, et al. v. FDA, et al.

✔ 5,150

19-2132

✔Word 2016Times New Roman, 14 pt. font

Jeffrey B. Dubner

AAP, et al.

12/31/2019


CERTIFICATE OF SERVICE

I certify that on December 31, 2019, I electronically filed the foregoing

document with the Clerk of the Court for the United States Court of Appeals for

the Fourth Circuit by using the CM/ECF system. I certify that all participants in

this case are registered CM/ECF users and that service will be accomplished by the

CM/ECF system.

s/ Jeffrey B. Dubner Jeffrey B. Dubner
