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ACTION ON SMOKING AND HEALTH (ASH)
A National Legal-Action Antismoking Organization 2013 H Street, NW / Washington, DC 20006 / (202) 659-4310 |
The tobacco industry has now appealed that portion of the decison by a North Carolina judge which held that the FDA does have jurisdiciton to regulate cigarettes as medical devices; i.e., devices for administering the "drug" nicotine.
A copy of their appeal is reprinted below.
IN THE UNITED STATES COURT OF
APPEALS
FOR THE FOURTH CIRCUIT
APPEAL NO.
BROWN & WILLIAMSON TOBACCO
CORPORATION, ET AL., v. UNITED STATES
FOOD & DRUG ADMINISTRATION, ET AL.
LORILLARD TOBACCO COMPANY, ET AL.,
v. UNITED STATES FOOD & DRUG
ADMINISTRATION, ET AL.
PHILIP MORRIS, INCORPORATED ET AL., v.
UNITED STATES FOOD & DRUG
ADMINISTRATION, ET AL.
R.J. REYNOLDS TOBACCO COMPANY, ET
AL. v. UNITED STATES FOOD & DRUG
ADMINISTRATION, ET AL.
PETITION FOR PERMISSION TO APPEAL
FROM AN INTERLOCUTORY ORDER OF
THE UNITED STATES DISTRICT COURT
FOR THE MIDDLE DISTRICT OF NORTH
CAROLINA, Civil Action, File Nos.
2:95CV00591
Of Counsel:
ARNOLD & PORTER
555 Twelfth Street, NW
Washington, DC 20004
COVINGTON & BURLING
1201 Pennsylvania Avenue, NW
Washington, DC 20004
WILEY, REIN & FIELDING
1776 K Street, NW
Washington, DC 20006
WILLIAMS & CONNOLLY
725 - 12th Street, NW
Washington, DC 20005
April 29, 1997
Keith W. Vaughan
NC State Bar No. 6895
WOMBLE CARLYLE SANDRIDGE &
RICE, PLLC
1600 BB&T Financial Center
200 West Second Street
P. O. Drawer 84
Winston-Salem, NC 27102
(910) 721-3600
Attorneys for Petitioners Brown & Williamson
Tobacco Corp., et al.
R. Noel Clinard
VSB No. 18303
HUNTON & WILLIAMS
Riverfront Plaza, East Tower
951 East Byrd Street
Richmond, VA 23219
(804) 788-8200
Attorneys for Petitioners Brown & Williamson
Tobacco Corp., et al.
DISCLOSURE OF CORPORATE
AFFILIATIONS AND OTHER ENTITIES
WITH A DIRECT FINANCIAL INTEREST IN
LITIGATION
Pursuant to FRAP 26.1 and Local Rule 26.1
BROWN & WILLIAMSON TOBACCO
CORPORATION, who is an appellant makes the
following disclosure:
1. Is the party a publicly held corporation or
other publicly held entity?
Answer: No.
2. Is the party a parent, subsidiary, or affiliate of,
or a trade association representing a publicly held
corporation, or other publicly held entity (see
Local Rule 26.1(b))?
Answer: Yes. Brown & Williamson Tobacco
Corporation is the indirect subsidiary of B.A.T.
Industries, P.L.C.
3. Is there any other publicly held corporation, or
other publicly held entity, that has a direct
financial interest in the outcome of the litigation
(see Local Rule 26.1(b))?
Answer: No.
DISCLOSURE OF CORPORATE
AFFILIATIONS AND OTHER ENTITIES
WITH A DIRECT FINANCIAL INTEREST IN
LITIGATION
Pursuant to FRAP 26.1 and Local Rule 26.1
LORILLARD TOBACCO COMPANY, who is
an appellant makes the following disclosure:
1. Is the party a publicly held corporation or
other publicly held entity?
Answer: No.
2. Is the party a parent, subsidiary, or affiliate of,
or a trade association representing a publicly held
corporation, or other publicly held entity (see
Local Rule 26.1(b))?
Answer: Yes. Lorillard Tobacco Company is the
indirect subsidiary of Loews Corporation.
3. Is there any other publicly held corporation, or
other publicly held entity, that has a direct
financial interest in the outcome of the litigation
(see Local Rule 26.1(b))?
Answer: No.
DISCLOSURE OF CORPORATE
AFFILIATIONS AND OTHER ENTITIES
WITH A DIRECT FINANCIAL INTEREST IN
LITIGATION
Pursuant to FRAP 26.1 and Local Rule 26.1
PHILIP MORRIS INCORPORATED who is an
appellant makes the following disclosure:
1. Is the party a publicly held corporation or
other publicly held entity?
Answer: No.
2. Is the party a parent, subsidiary, or affiliate of,
or a trade association representing a publicly held
corporation, or other publicly held entity (see
Local Rule 26.1(b))?
Answer: Yes. Philip Morris Incorporated is the
indirect subsidiary of Philip Morris Companies
Inc.
3. Is there any other publicly held corporation, or
other publicly held entity, that has a direct
financial interest in the outcome of the litigation
(see Local Rule 26.1(b))?
Answer: No.
DISCLOSURE OF CORPORATE
AFFILIATIONS AND OTHER ENTITIES
WITH A DIRECT FINANCIAL INTEREST IN
LITIGATION
Pursuant to FRAP 26.1 and Local Rule 26.1
R.J. REYNOLDS TOBACCO COMPANY, who
is an appellant makes the following disclosure:
1. Is the party a publicly held corporation or
other publicly held entity?
Answer: No.
2. Is the party a parent, subsidiary, or affiliate of,
or a trade association representing a publicly held
corporation, or other publicly held entity (see
Local Rule 26.1(b))?
Answer: Yes. R.J. Reynolds Tobacco Company
is the indirect subsidiary of RJR Nabisco
Holdings Corp. (R.J. Reynolds Tobacco Company
is wholly owned by RJR Nabisco, Inc., which is
wholly owned by RJR Nabisco Holdings Corp.
which is publicly held). Nabisco Holdings Corp.
is the publicly held affiliate of R.J. Reynolds
Tobacco Co.
Is there any other publicly held corporation, or
other publicly held entity, that has a direct
financial interest in the outcome of the litigation
(see Local Rule 26.1(b))?
Answer: No.
CERTIFICATE OF TYPE SIZE AND STYLE
This Petition for Permission to Appeal has been
prepared in accordance with Local Rule 32(a)
regarding the typeface for briefs.
TABLE OF CONTENTS
DISCLOSURE OF CORPORATE
AFFILIATIONS AND OTHER ENTITIES
WITH A DIRECT FINANCIAL INTEREST IN
LITIGATION
CERTIFICATE OF TYPE SIZE AND STYLE
TABLE OF AUTHORITIES
ISSUES PRESENTED FOR REVIEW
I. INTRODUCTION
II. STATEMENT OF FACTS
STATEMENT OF THE MATTER BEFORE
THE COURT
ARGUMENT
I. THE DISTRICT COURT'S RULING
DENYING PETITIONERS' MOTION FOR
SUMMARY JUDGMENT IS PROPERLY
REVIEWABLE UNDER 28 U.S.C. Section
1292(b)
II. STATEMENT OF 28 U.S.C. Section 1292(b)
FACTORS WARRANTING INTERLOCUTORY
REVIEW
A. The District Court's Ruling Involves
Controlling Questions of Law as to Which
Substantial Grounds Exist for Difference of
Opinion
1. The Ruling Involves Controlling Questions of
Law
2. There Are Substantial Grounds for Difference
of Opinion About the District Court's Ruling
B. Review of the District Court's Order May
Materially Advance the Ultimate Termination of
this Challenge to the Agency's Action
CONCLUSION
TABLE OF AUTHORITIES
CASES
Consumer Product Safety Comm'n v Anaconda
Co., 593 F.2d 1314 (D.C.Cir. 1979)
Camacho v. Mancuso, 53 F.3d 48 (4th Cir.
1995)
Consolidated Exp., Inc. v. New York Shipping
Assoc., 602 F.2d 494 (3d Cir. 1979)
Duane v. GEICO, 37 F.3d 1036 (4th Cir. 1994)
Farmer v. Employment Sec. Comm'n of North
Carolina 4 F.3d 1274 (4th Cir. 1993)
Ferguson v. United States, 712 F. Supp. 775
(N.D.Cal. 1989)
Foyle v. Lederle Labs., 674 F. Supp (E.D.N.C.
1987)
Hirsch v. Blue Cross & Blue Shield of Maryland.
Inc., 1991 U.S. Dist. LEXIS 20963 (D.Md. 1991)
J.P. Stevens Empys. Educ. Comm. v. NLRB, 582
F.2d 326 (4th Cir. 1978)
Klinghoffer v. SNC Achille Lauro, 921 F.2d 21
(2d Cir. 1990)
Lum v. City & Cty. of Honolulu, 963 F.2d 1167
(9th Cir.), cert. denied, 506 U.S. 1022, 113 S. Ct.
659, 121 L.Ed.2d 585 (1992)
Madonia v. Blue Cross & Blue Shield of Va., 11
F.3d 444 (4th Cir. 1993) . .
Metrix Warehouse, Inc. v._Daimler-Benz AG,
716 F.2d 245 (4th Cir. 1983)
Palumbo v. Waste Technologies Inds., 989 F.2d
156 (4th Cir. 1993)
Rector v. Local Union No. 10, Int'1 Union of
Elevator Constructors, 625 F. Supp. 174 (D.Md
1985)
Reed v. United Transportation Union, 828 F.2d
1066 (4th Cir. 1987)
Scott v. Jones, 964 F.2d 314 (4th Cir. 1992) .
Sejman v. Warner-Lambert Co.. Inc., 845 F.2d
66 (4th Cir. 1988)
Shaw v. Stroud, 13 F.3d 791 (4th Cir. 1994) . .
In re Showa Denko K.K. L-Tryptophan Liability
Litigation TI, 953 F.2d 162 (4th Cir. 1992) .
Terry v. Chauffeurs. Teamsters & Helpers, Local
391, 676 F. Supp. 659 (M.D.N.C. 1994)
U.S. v. Sasser, 738 F. Supp. 177 (D.S.C. 1990)
Virginia Hosp. Ass'n v. Balls, 868 F.2d 653 (4th
Cir. 1989)
White v. National Steel Corp., 938 F.2d 474 (4th
Cir. 1991)
STATUTES
21 U.S.C. Section 326(h)
28 U.S.C. Section 1292(b)
Pub. L. No. 59-384, 34 Stat. 768 (1906)
Pub. L. No. 75-447, 52 Stat 111 (1938)
MISCELLANEOUS
61 Fed. Reg. 44,396, 44,615-618 (Aug. 28,
1996)
G.J. Moore, B. Ward & J.D. Lucas, Moore's
Federal Practice and Procedure, 110.22 t2] at 275
(2d ed. 1991)
ISSUES PRESENTED FOR REVIEW
Whether this Court should grant petitioners'
request for interlocutory review of the issues that
(i) were ruled upon by the district court in
denying in part plaintiffs' motions for summary
judgment, and (ii) were certified in the district
court's order as appropriate for review by this
Court under 28 U.S.C. Section 1292(b). Those
issues are:
(1) Whether Congress has withheld jurisdiction
from the Food and Drug Administration ("FDA")
over tobacco products as customarily marketed.
(2) Whether the Federal Food, Drug, and
Cosmetic Act ("FDCA") applies to tobacco
products as customarily marketed.
(3) Whether such products can be regulated as
medical "devices" within the scope of the FDCA.
(4) Whether 21 U.S.C. Section 360j(e)
authorizes any of FDA's restrictions on tobacco
product.
I. INTRODUCTION.
The district court has ruled in a matter of vast
public importance on four issues of law that will
need to be determined in this case, and that can
be decided now. The district court has sue sponte
certified the case under 28 U.S.C. Section
1292(b) stating:
"This order involves controlling questions of law
as to which there is substantial ground for
difference of opinion. Furthermore, an immediate
appeal from this order may materially advance
the ultimate termination of the litigation.
Therefore, the court certifies this order for an
interlocutory appeal pursuant to 28 U.S.C.
Section 1292(b). N Petitioners hereby petition
this Court to decide (1) whether Congress has
withheld from the Food and Drug Administration
("FDA") jurisdiction over tobacco products as
customarily marketed; (2) whether the Federal
Food, Drug, and Cosmetic Act ("FDCA") applies
to tobacco products; (3) whether such products
can be regulated as medical "devices" within the
meaning of the FDCA; and (4) whether 21
U.S.C. Section 360j(e) authorizes any of FDA's
restrictions on tobacco products. These questions
arise from a ruling by the U.S. District Court for
the Middle District of North Carolina on April
25, 1997 that denied in part petitioners' motions
for summary judgment that FDA has no
jurisdiction over tobacco products as customarily
marketed, and that all of FDA's tobacco
regulations are invalid. The district court's
decision accompanies this petition as Exhibit 1.
See Appendix (hereinafter "Exh. ")
The April 25, 1997 Order granting and denying
relief and certifying that ruling for interlocutory
review (the "Order") also accompanies this
petition (Exh. 2).
Prompt appellate review of these issues will
effectively and efficiently resolve several of the
important legal aspects of petitioners' challenge
to FDA's tobacco regulations, and could very well
resolve the entire case. Thus, the appeal will
present "controlling question[s] of law as to
which there [are] substantial ground[s] for
difference of opinion," and because resolution of
the issues now "may materially advance the
ultimate termination of the litigation, n
interlocutory review is warranted. 28 U.S.C.
Section 1292(b). II. STATEMENT OF FACTS.
No disputed issues of fact were decided by the
district court, and none is presented for review in
this Court. The issues presented are purely legal.
STATEMENT OF THE MATTER BEFORE
THE COURT
The legal issues presented for review arise in a
challenge to FDA's assertion of jurisdiction over
the entire cigarette and smokeless tobacco
industry, and to FDA's tobacco regulations
promulgated under the asserted authority of the
FDCA.
On August 28, 1996, FDA issued a final rule, in
which it asserted plenary jurisdiction over
tobacco products (cigarettes and smokeless
tobacco). 61 Fed. Reg. 44,396, 44,61518 (Aug.
28, 1996) (Exh. 3). FDA's unprecedented
regulations cover, inter alia, tobacco
manufacturing, product names, the labels and
other aspects of tobacco packages, and the sale,
distribution, advertising, and promotion of
tobacco products. FDA's assertion of jurisdiction
over these products may also presage attempts by
FDA to regulate the design and content of
tobacco products.
Two FDA regulations relating to the retail sale
of tobacco products to persons under 18 years of
age (proof of age and related matters) went into
effect on February 28, 1997, during the pendency
of petitioners' motions for summary judgment.
Under the district court's Order, those two
regulations remain in effect. FDA's other tobacco
regulations were scheduled to go into effect on
August 28, 1997 and August 28, 1998. The
effectiveness of all of those regulations has been
enjoined or stayed by the district court. *1
Petitioners' Complaints challenged these
regulations on many grounds. In support of their
motions for summary judgment, petitioners
contended that (1) Congress has withheld from
FDA jurisdiction to regulate tobacco products as
customarily marketed; (2) the FDCA does not
authorize FDA to exercise jurisdiction over
tobacco products at all ; (3) it does not authorize
FDA to regulate them as medical "devices"; (4)
21 does not authorize any U.S.C. Section 360j(e),
a provision of the FDCA, of FDA's restrictions on
tobacco products, (5) Section 360j(e) does not
authorize FDA to regulate their advertising or
promotion; and (6) FDA's restrictions on tobacco
advertising and promotion violate the First
Amendment to the United States Constitution, by
impermissibly restricting substantially more
speech than is necessary in pursuit of FDA's
asserted regulatory goals.
In its decision, the district court ruled against
petitioners on issues (1)-(4); it ruled in their favor
on issue (5); and it did not reach issue (6). Thus,
the issues tendered in this petition are issues (1)-
(4). *2 These issues relate to FDA's jurisdiction
over tobacco products at all, to FDA's treatment
of these products as medical "devices," which is
the basis for all of FDA's tobacco regulations, and
to the applicability of Section 360j(e) in
circumstances where, in FDA's view, restrictions
under that provision would not prevent the
regulated products from being unsafe.
ARGUMENT
I. THE DISTRICT COURT'S RULING
PARTIALLY DENYING PETITIONERS'
MOTIONS FOR SUMMARY JUDGMENT IS
PROPERLY REVIEWABLE UNDER 28 U.S.C.
Section 1292(b).
Title 28 U.S.C. Section 1292(b) provides that, if
a district judge
in making in a civil action an order not
otherwise appealable under this section, shall be
of the opinion that such order involves a
controlling question of law as to which there is
substantial ground for difference of opinion and
that an immediate appeal may materially advance
the ultimate termination of the litigation, he shall
so state in writing such order. 28 U.S.C. Section
1292(b). The section further states:
The Court of Appeals which would have
jurisdiction of an appeal of such action may
thereupon, in its discretion, permit an appeal to
be taken from such order, if application is made
to it within ten days after the entry of the order[.]
Id. An order denying a motion for summary
judgment in whole or in part is just much an
otherwise non-final order, non-appealable as of
right, but in appropriate circumstances suitable
for certification under section 1292(b). Shaw v.
Stroud, 13 F.3d 791, 797-98 (4th Cir. 1994);
Lum v. City & Cty. of Honolulu, 963 F.2d 1167,
1169-70 (9th Cir.) ("the appropriate forum to
review the denial of a summary judgment motion
is through interlocutory appeal under [Section
1292(b)]"), cert. denied, 506 U.S. 1022, 113 S.
Ct. 659, 121 L.Ed.2d 585 (1992); Consolidated
Exp., Inc. v. New York Shipping Assoc., 602
F.2d 494, 501 (3d Cir. 1979) (same; certification
granted where review of issue could make
summary judgment appropriate).
Here, the district court's Order states the findings
required by Section 1292(b). Under Section
1292(b), this Court thus has the discretion to
review the issues certified in the district court's
Order.
II. STATEMENT OF 28 U.S.C. Section 1292(b)
FACTORS WARRANTING INTERLOCUTORY
REVIEW.
Section 1292(b) identifies three determinations
for the Court regarding the propriety of
interlocutory review: (1) the presence of
controlling questions of law; (2) the existence of
substantial grounds for difference of opinion on
those questions; and (3) the possibility of material
advancement of the litigation through
interlocutory review of the district court's ruling.
In the instant case, as the district court has
determined, all three of these requirements -- as
applied in this Circuit and elsewhere -- are
satisfied.
First, the district court has decided questions of
law that are controlling. They are pure questions
of statutory construction; no issues of fact were
raised or decided. The issues of congressional
intent and statutory authorization with respect to
FDA jurisdiction over tobacco products as
customarily marketed at all and, in particular, as
medical "devices" are controlling as to
petitioners' challenge to FDA's assertion of
jurisdiction over petitioners' tobacco products and
as to the statutory validity of all of FDA's tobacco
regulations. Resolution of either of these sets of
issues in petitioners' favor would fully resolve the
litigation.
Second, as demonstrated by the authorities cited
by the petitioners and the government in the
district court -- and the diametrically opposed,
competing interpretations of those authorities
offered by the parties -- there exist substantial
grounds for difference of opinion on these issues.
Indeed, the district court so stated. See Exh. 2.
Third, interlocutory review of these legal issues
may well materially advance the termination of
this litigation. Such review would be much more
efficient than proceeding in the district court to
the next phase of petitioners' challenge to the
regulations. *3 The legal issues raised have the
potential to end the litigation swiftly and finally.
The district court's decision on the remaining
issues would almost certainly be appealed to this
Court, however the district court decides them.
Interlocutory review may both expedite the
resolution of the case and preserve the federal
courts' resources, by obviating the need for
extensive further proceedings.
A. The District Court's Ruling Involves
Controlling Questions of Law as to Which
Substantial Grounds Exist for Difference of
Opinion.
1. The Ruling Involves Controlling Questions of
Law.
A "controlling question of law" is one that is
important or crucial to the case, and
determination of which would substantially
resolve the litigation. "Although the resolution of
an issue need not . . . terminate an action in order
to be 'controlling,"' "it is clear that a question of
law is controlling if reversal of the district court's
order would terminate the action." Klinghoffer v.
SNC Achille Lauro, 921 F.2d 21, 24 (2d Cir.
1990). "Controlling" may also be defined with
reference to an issue's importance to a wide
spectrum of cases and parties. See 1d.
As petitioners' memoranda in support of their
motions for summary judgment on statutory
grounds made clear (see Exh. 45), the questions
of congressional intent and statutory construction
with regard to FDA jurisdiction over tobacco
products in general and as medical devices in
particular and the structure of the FDCA and its
ability to accommodate regulatory authority over
tobacco products are all questions of law (no
issues of fact are raised), and all potentially
control the outcome of this litigation.
In their motions for summary judgment in the
district court, and now in this Court, petitioners
do not challenge any of the factual findings FDA
made in support of its assertion of jurisdiction
and its tobacco regulations (though petitioners do
challenge legal conclusions drawn from those
findings). *4 Thus, the issues that would be
presented on this appeal do not involve any
disputed issues of fact.
A ruling for petitioners on any one of the issues
of FDA jurisdiction, applicability of the FDCA to
tobacco products, or whether tobacco products
can be regulated as medical "devices" would
invalidate all of FDA's tobacco regulations, and
terminate the litigation.
Where such controlling questions of
congressional intent and statutory construction
are present, this Court regularly grants
interlocutory review. See, e.g., Duane v. GEICO,
37 F.3d 1036, 1037-38 (4th Cir. 1994)
(interlocutory review to determine whether 42
U.S.C. Section 1981 applies to private alienage
discrimination); Madonia v. Blue Cross & Blue
Shield of Va., 11 F.3d 444, 446 (4th Cir. 1993)
(ERISA preemption); Sejman v. Warner-Lambert
Co., 845 F.2d 66, 67 (4th Cir. 1988) (same);
Terry v. Chauffeurs. Teamsters & Helpers Local
391, 676 F. Supp. 659, 660-665 (M.D.N.C. 1994)
(right to jury trial on claim under Section 301 of
LMRA).
Here, FDA's interpretation of the FDCA (a
statute in effect since 1938 *5) to support its
assertion of jurisdiction over tobacco products is
unprecedented. This interpretation is at odds with
many decades of past interpretations of the FDCA
and its predecessor statute, *6 and a different
determination of its validity could end the
litigation. A question of agency jurisdiction under
an organic statute is particularly fit for
interlocutory review. See Consumer Product
Safety Comm'n v. Anaconda Co., 593 F.2d 1314,
1316 (D.C. Cir. 1979) (interlocutory review of
agency jurisdiction under Consumer Product
Safety Act).
The district court's ruling attempted to reconcile
FDA's interpretation of the FDCA with
Congress's comprehensive program of tobacco-
specific legislation. Such an attempt to reconcile
potentially conflicting statutes is well-suited for
certification and interlocutory review. See, e.g.,
Reed v. United Transp. Union, 828 F.2d 1066,
1066-67 (4th Cir. 1987) (interlocutory review of
question of whether limitations period from
NLRA applies to proceedings under LMRDA),
rev'd on the merits, 488 U.S. 319, 109 S. Ct. 621,
102 L.Ed.2d 665 (1989); White v. Nat'l Steel
Corp., 938 F.2d 474, 480 (4th Cir. 1991)
(interlocutory review of LMRA preemption,
relationship with other statutes).
In Farmer v. Employment Sec. Comm'n of North
Carolina, 4 F.3d 1274 (4th Cir. 1993), an
interlocutory appeal, this Court was confronted
with the task of reconciling two federal statutes as
part of a comprehensive statutory scheme, (1) the
1988 Amendments to the 1968 Fair Housing Act,
and (2) the Immigration Reform and Control Act
of 1986. See i. at 1279. There were competing
statutory interpretations; no court had definitively
resolved the issue; and, although the district court
had ruled for the defendants, the plaintiffs'
reading had "in the abstract,. . . some merit,"
sufficient to support certification and
interlocutory review. See id. at 1281-83; see also
Metrix Warehouse, Inc. v. Daimler-Benz AG,
716 F.2d 245, 246 (4th Cir. 1983) (interpretation
of Robinson-Patman Act).
Here, the district court's ruling also addressed
FDA's construction of its statute taken by itself,
and whether that construction does violence to
the statute and whether it is in keeping with past
agency interpretations, as FDA claims. This set
of issues also is controlling, in that a decision for
the petitioners would end the case. The validity of
an interpretation of crucial provisions of a statute
is an issue well-suited for interlocutory review.
See Palumbo v. Waste Technologies Industries.,
989 F.2d 156, 158-59 (4th Cir. 1993)
(interpretation of "citizen suit" language of
RCRA in context of other statutory sections);
Scott v. Jones, 964 F.2d 314, 316 (4th Cir. 1992)
(meaning of "debt collector" under Federal Debt
Collection Practices Act).
2. There Are Substantial Grounds for Difference
of Opinion about the district court's Ruling.
Section 1292 (b) requires that there be
"substantial grounds for difference of opinion." In
giving meaning to thin phrase, courts have found
such grounds in a wide range of circumstances.
See, e.g., Camacho v. Mancuso, 53 F.3d 48, 49-
50 (4th Cir. 1995) (question of first impression in
the Circuit); Ferguson v. United States, 712 F.
Supp. 775, 786 (N.D.Cal. 1989) (no existing law
on the subject, and "[a] determination on this
critical, novel issue would aid the parties and the
court"); Rector v. Local Union No. 10, Int'1
Union of Elevator Constructors, 625 F. Supp.
174, 181 (D.Md. 1985) (disagreement between
district court and other courts demonstrates
substantial ground for difference of opinion);
U.S. v. Sasser, 738 F. Supp. 177, 180 (D.S.C.
1990) (substantial grounds for difference of
opinion even where district court followed Fourth
Circuit precedent and implications of Supreme
Court opinion); Virginia Hosp. Ass'n v. Baliles,
868 F.2d 653, 657 (4th Cir. 1989) (district court
in disagreement with two other courts of
appeals); Foyle v. Lederle Labs , 674 F. Supp
580, 533 (E.D.N.C. 1987) (district court joined
majority of circuits that had considered issue but
certified nonetheless).
Here, the substantial grounds for disagreement
with the district court's decision are set forth in
the petitioners' memoranda on the statutory
issues, filed below and submitted herewith (Exh.
4-5). These differences are actually spelled out to
some extent in the district court's opinion.
FDA's assertion of jurisdiction over tobacco
products as customarily marketed is
unprecedented and sweeping. Substantial
authority and authoritative indicia of
congressional intent conflict with this assertion of
jurisdiction, as set forth in Exhibits 4 and 5. The
district court's construction of Congress's
tobacco-specific statutes and of the FDCA
constitutes a dramatic break with long-
established understandings of these laws,
including prior interpretations by both FDA and
the courts.
The district court's interpretation of the FDCA to
include tobacco products even though they are
not represented to affect a structure or function of
the body is contrary to long-established principles
of food and drug law. Moreover, the district
court's upholding of FDA's determination that
these tobacco products are medical "devices" as
defined in the FDCA is contrary to the plain
meaning of Section 326(h) of the FDCA.
In sum, there are substantial grounds for
difference of opinion on the issues of law decided
by the district court.
B. Review of the district court's Order May
Materially Advance the Ultimate Termination of
this Challenge to the Agency's Action.
A litigant seeking interlocutory review must
show that such review may expedite resolution of
the case, nerve the goals of efficiency and
simplicity, and not prolong the case through
piecemeal appeals. 9 J. MOORE, B. WARD &
J.D. LUCAS, MOORE's FEDERAL PRACTICE
AND PROCEDURE 110.22[2], at 275 (2d ed.
1991). Here, a grant of interlocutory review
should make possible (though obviously not
certain) the conservation of resources through
avoidance of further district court proceedings.
Id.; cf. J.P. Stevens Empys. Educ. Comm. v.
NLRB, 582 F.2d 326, 327 (4th Cir. 1978).
"Material advance[ment]" may also be explored
in light of the amount of resources, number of
litigants, and persons affected by the ruling. In re
Showa Denko K.K. L-Tryptophan Liability
Litiqation II, 953 F.2d 162, 165 (4th Cir. 1992).
In this case, the efficiencies of interlocutory
review are not mere conjecture. Immediate review
of the district court's ruling may materially
advance the ultimate termination of this litigation
by (1) preventing further lower court proceedings
that may not be necessary if the legal issues are
resolved differently during interlocutory review;
and (2) expediting final resolution of the
controlling legal issues, thus allowing the courts
to resolve whether the regulations will be put in
place or the government must seek congressional
action with respect to FDA jurisdiction over
tobacco products.
A fact-intensive proceeding as to the sufficiency
of FDA's findings to support its regulations may
be avoided altogether if this Court resolves the
controlling legal question" in petitioners' favor. A
conclusion that FDA does not have jurisdiction
over tobacco products as customarily marketed,
for example, would terminate the case. Cf. J.P.
Stevens Empys. Educ. Comm. v. NLRB, 582 F.2d
at 327. Likewise, a conclusion that FDA has
impermissibly distorted the FDCA to try to make
it fit tobacco products would end this litigation.
These eventualities should be definitively
explored and resolved by this Court sooner rather
than later, to preserve the federal courts'
resources. Ferguson v. United States, 712 F.
Supp. 775, 786 (N.D.Cal. 1989).
An immediate appeal also does not represent an
additional expenditure of federal judicial
resources, because the issues for which
certification is urged will be appealed by one side
or the other regardless of the outcome of the
district court proceedings. Hirsch v. Blue Cross &
Blue Shield of Maryland Inc., 1991 U.S. Dist.
LEXIS 20963, *17-*19 (D.Md. 1991)
(certification appropriate where different legal
disposition would obviate later need for trial;
especially appropriate if legal issues are going to
be appealed regardless) (Exh. 6); Ferguson, 712
F. Supp. at 786 (same; government had expressed
intent to appeal legal issues, whatever the trial
outcome).
CONCLUSION
For the foregoing reasons, this Court should
grant petitioners' petition and allow an
interlocutory appeal with respect to the issues
certified by the district court.
Respectfully submitted,
/s/ R. Noel Clinard, Esq.
Hunton & Williams
VSB #18303
Riverfront Plaza, East Tower
951 East Byrd Street
Richmond, Virginia 23219
Attorneys for Appellants Brown & Williamson
Tobacco Corp., et al.
Dated: April 29, 1997
[Endnotes]
*1 The Order stayed FDA from implementing
"any of the additional Regulations set for
implementation on August 28, 1997, pending
further orders by the court." Exh. 2.
*2 If on an appeal by the Government this Court
were to reverse the district court's decision that
FDA has no statutory authority to regulate
tobacco advertising and promotion, the district
court would then need to reach the First
Amendment issues.
*3 The next phase would be a series of
challenges to individual regulations on a broad
range of grounds: e.g., FDA's lack of statutory
authority for particular regulatory provisions, a
lack of factual support in the record, procedural
irregularities in the rulemaking, and additional
constitutional infirmities in individual
regulations.
*4 If necessary, petitioners will challenge FDA's
findings at a later stage of the litigation. See n. 3,
supra.
*5 Pub. L. No. 75-447, 52 Stat Ill (1933).
*6 Pub L. No. 59-384, 34 Stat 768 (49O6)
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