United States District Court, M.D. Alabama, Northern Division
MEMORANDUM OPINION AND ORDER
CHARLES S. COODY UNITED STATES MAGISTRATE JUDGE
8, 2016, the plaintiffs filed this declaratory judgment
action against the United States Food and Drug Administration
(“FDA”), Robert Califf and Sylvia Burwell
(“collectively the government defendants”)
challenging the defendants' implementation of a final
rule related to e-cigarette devices and e-liquids. The
plaintiffs distribute e-cigarette devices and e-liquids, and
challenge the FDA's “Deeming Rule” which
places these products under the FDA's authority to
regulate pursuant to the Tobacco Control Act, 21 U.S.C.
§ 387a(b). According to the plaintiffs, the
defendants' Deeming Rule will subject their products to
“the premarket approval, reporting, recordkeeping,
inspection, labeling, manufacturing, testing and other
requirements” of tobacco products, and will
“severely and unnecessarily burden” their
businesses. (Doc. # 1 at 7, ¶ 30-31). The plaintiffs ask
the court to declare the Deeming Rule “an arbitrary and
capricious regulatory system” and vacate the rule.
(Id. at 16.) The court has jurisdiction of this
action pursuant to the Administrative Procedures Act, 5
U.S.C. § 500 et seq., the Administrative
Procedure Act Regulatory Flexibility Act, 5 U.S.C. § 601
et seq., the Declaratory Judgment Act, 28 U.S.C.
§§ 2201-02, and the court's federal question
jurisdiction, 28 U.S.C. § 1331.
December 13, 2016, the parties filed a joint motion for entry
of a briefing schedule asserting that because this case is
governed by the Administrative Procedures Act, “it will
be resolved on the basis of the administrative record
complied by the agency.” (Doc. # 15 at 1, ¶ 2. On
December 19, 2016, the court granted the parties' motion
and entered a scheduling order setting forth deadlines for
filing dispositive motions, cross motions and responses.
(Doc. # 20). On February 1, 2017, the plaintiffs filed a
motion for summary judgment. (Doc. # 21). On February 10,
2017, the Campaign for Tobacco-Free Kids filed a motion for
leave to file an amicus brief (doc. # 25) which the court
granted (doc. # 28).
March 1, 2017, the defendants filed a consent motion for an
extension of time to respond to the plaintiffs' motion
for summary judgment (doc. # 29) which the court granted.
(Doc. # 30). On May 1, 2017, the parties filed another joint
motion to amend the scheduling order (doc. # 31) which the
court also granted. (Doc. # 32).
24, 2017, the American Academy of Pediatrics, the American
Cancer Society Cancer Action Network, the American Heart
Association, the American Lung Association, the Campaign for
Tobacco-Free Kids, and the Truth Initiative (collectively
“the Public Health Intervenors”) filed a motion
to intervene pursuant to Fed.R.Civ.P. 24. (Doc. # 33). The
Public Health Intervenors seek to intervene as a matter of
right under Fed.R.Civ.P. 24(a)(2) or alteratively,
permissibly under Fed.R.Civ.P. 24(b)(1). The plaintiffs
oppose the motion to intervene (doc. # 67) arguing that the
motion is premature and untimely. The plaintiffs also argue
that the Public Health Intervenors have not demonstrated that
the government defendants would not adequately defend their
rights. The government defendants have filed a response in
which they reserve the right to oppose intervention but
suggest that the motion to intervene is premature. (Doc. #
pending before the court is the parties' joint motion to
stay the case and vacate the briefing schedule (doc. # 54)
pending the outcome of the appeal of Nicopure Labs LLC v.
FDA, 266 F.Supp.3d 360 (D.C. 2017) appeal
docketed No. 17-5196 (D.C. Cir. Aug. 31, 2017) which
addresses the very issues raised in this case.
to 28 U.S.C. § 636, this case is referred to the
undersigned for consideration and disposition or
recommendation of all pretrial matters. (Doc. # 19). The
court heard oral argument on the motion to intervene on
August 10, 2017. After careful consideration of the motion to
intervene, and the briefs filed in support of and in
opposition to the motion, the court concludes the motion to
intervene (doc. # 33) is due to be granted. The court further
concludes that the joint motion to stay the case (doc. # 54)
is due to be granted and the motion to vacate the briefing
schedule is due to be denied as moot.
Motion to Intervene
crux of this litigation involves the “Deeming
Rule” created by the FDA which determined that
e-cigarettes, e-liquids, and other related products were
deemed tobacco products and subject to FDA regulation.
According to the Public Health Intervenors the “Deeming
Rule” is necessary to permit the FDA to regulate
flavored e-cigarettes and products as well as marketing
strategies aimed at young people. The Public Health
Intervenors assert that “[s]etting aside the Deeming
Rule, as Plaintiffs request, would have a direct adverse
effect on public health, particularly among youth.”
(Doc.# 33 at 7). In opposition to the motion to
intervene, the plaintiffs assert that intervention by the
Public Health Intervenors at this juncture would
“unnecessarily encumber the litigation of the issues
raised in this lawsuit.” (Doc. # 67 at 6). The court
under Rule 24 can be either as of right or permissive.”
Salvors, Inc. v.Unidentified Wrecked & Abandoned
Vessel, 861 F.3d 1278, 1293 (11th Cir. 2017).
Fed.R.Civ.P. 24(a) allows a third party to intervene as a
matter of right if four requirements are met:
(1) [the] application to intervene is timely; (2) [the
applicant] has an interest relating to the property or
transaction which is the subject of the action; (3) [the
applicant] is so situated that disposition of the action, as
a practical matter, may impede or impair his ability to
protect that interest; and (4) [the ...