R.J. REYNOLDS TOBACCO COMPANY et al v. UNITED STATES FOOD AND DRUG ADMINISTRATION et al

Filing 32

SUPPLEMENTAL MEMORANDUM to re 11 MOTION for Preliminary Injunction filed by COMMONWEALTH BRANDS INCORPORATED, LIGGETT GROUP LLC, LORILLARD TOBACCO COMPANY, R.J. REYNOLDS TOBACCO COMPANY, SANTA FE NATURAL TOBACCO COMPANY, INC.. (Francisco, Noel)

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
R.J. REYNOLDS TOBACCO COMPANY,
LORILLARD TOBACCO COMPANY,
COMMONWEALTH BRANDS, INC.,
LIGGETT GROUP LLC, and SANTA FE
NATURAL TOBACCO COMPANY, INC.,

Civil Action No. 11-01482 (RCL)

Plaintiffs,
v.
UNITED STATES FOOD AND DRUG
ADMINISTRATION, MARGARET
HAMBURG, Commissioner of the United
States Food and Drug Administration, and
KATHLEEN SEBELIUS, Secretary of the
United States Department of Health and
Human Services,
Defendants.
SUPPLEMENTAL MEMORANDUM IN SUPPORT OF
PLAINTIFFS’ MOTION FOR PRELIMINARY INJUNCTION

Pursuant to the Court’s invitation at oral argument, this memorandum briefly addresses three
points relevant to Plaintiffs’ Motion for Preliminary Injunction that were raised by the Court at
argument.
1.

During oral argument, the Court asked both parties whether Congress had specifically

considered the First Amendment implications of the graphic warnings embodied in the Rule.
Plaintiffs have reviewed the Tobacco Control Act, Pub. L. No. 111-31, 123 Stat. 1776 (2009) (the
“Act”), and its legislative history, and have been unable to identify any indication that Congress
considered such First Amendment implications.
The Act was introduced in the 111th Congress as H.R. 1256. See H.R.1256, 111th Cong.
(Mar. 3, 2009). In its original form, the bill gave FDA discretion “to require color graphics to
accompany the text” and “increase the required label area from 30 percent up to 50 percent of the
front and rear panels of the package,” but required FDA to justify such warnings under the APA and
“find that such a change would promote greater public understanding of the risks associated with the
use of tobacco products.’’ Id. § 202(b). As introduced, however, the bill did not itself require the
new warnings to include graphic images or occupy 50 percent of the front and back of cigarette
packages. On June 10, 2009, H.R. 1256 was amended to expand the size of the warnings and
require the inclusion of color graphics. See 155 Cong. Rec. S6406-12 (June 10, 2009); Act § 201(a)
(June 11, 2009). The bill was enacted by the Senate the following day, June 11, 2009, and passed by
the House on June 12, 2009. See 155 Cong. Rec. S6501 (June 11, 2009); 155 Cong. Rec. H6660
(June 12, 2009).
We have been unable to identify any indication in the legislative history that Congress
considered the First Amendment implications of these changes or of the warnings requirement
generally. Nor does the Act include any congressional findings that the new warnings will: (1)
increase public understanding of the risks associated with tobacco use; (2) further the government’s
interest in reducing smoking rates, or (3) be more effective than the many less-restrictive warnings

possible (including, most obviously, the less obtrusive warnings contained in prior versions of the
bill). See Act § 2.
2.

During argument, the Court also inquired about the evidentiary record. As Plaintiffs

explained, the FDA’s Regulatory Impact Analysis and experimental study of 18,000 individuals
demonstrate that the warnings (1) have no statistically significant impact on smoking rates, (2) do not
increase the likelihood that smokers will quit or non-smokers will start smoking, and (3) do not
increase knowledge of the risks of smoking. The other evidence cited by the Government, moreover,
does not address any of these issues either. Instead, it simply tests “salience”—that is, whether
shocking graphics are more noticeable than the current warnings. This, however, is irrelevant absent
any empirical evidence that they change smoking behavior. After all, the Government does not have
an interest in shocking people just for the sake of shocking them.
In short, as the Surgeon General said back in 1994, because the risks of tobacco use are
universally known, anti-smoking strategies that, like the new warnings, are premised on the
“assumption” that “young people had a deficit of information that could be addressed by presenting
them with health messages in a manner that caught their attention and provided them with sufficient
justification not to smoke,” are “not effective” at reducing smoking. See SJ Mem. at 15. Or as Dr.
David Hammond, an anti-tobacco researcher that the Government regularly relies upon, recently
explained: “There is no way to attribute . . . declines [in smoking] to the new health warnings given
that [they] are typically introduced against a backdrop of other tobacco control measures, including
changes in price/taxation, mass media campaigns and smoke-free legislation.”1 The Government’s
own scientists therefore concede that there is no empirical evidence that the warnings are effective.
This is dispositive in a First Amendment case in which the Government bears the burden of proof.

1
Hammond D., Health Warnings Messages on Tobacco Products: A Review, 20 Tobacco Control 327, 331
(March 2011) available at http://tobaccocontrol.bmj.com/content/early/2011/05/23/tc.2010.037630.abstract.

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3.

During oral argument, this Court also asked both parties about its authority to enter

the preliminary injunction that Plaintiffs have requested. As Plaintiffs have explained, subject to the
balancing test governing preliminary relief, this Court has inherent equitable authority to issue an
injunction preventing irreparable injury pending review of Plaintiffs’ claims. See Porter v. Warner
Holding Co., 328 U.S. 395, 398 (1946) (“Power is … resident in the District Court … to do equity
and mould each decree to the necessities of the particular case…. In addition, the court may go
beyond the matters immediately underlying its equitable decision and decide whatever other issues
and give whatever other relief may be necessary under the circumstances. Only in that way can
equity do complete rather than truncated justice.”). Here, the relief Plaintiffs have requested is the
only relief capable of avoiding the irreparable harm they have identified; it therefore falls well within
this Court’s equitable power.
In light of the Court’s questioning at oral argument, Plaintiffs add that courts frequently
employ their broad equitable power to fashion interim relief appropriate to a variety of situations.
These remedies underscore the flexibility of the Court’s equitable power to tailor relief to the facts of
the case. For example, in Society of the Sisters of the Holy Names of Jesus and Mary v. Pierce, 296
F. 928, 933 (D. Or. 1924), the district court preliminarily enjoined a compulsory public education
law even though it was not scheduled to take effect for approximately two and half years. The court
explained that “although the time at which the act is to become effective is somewhat remote, it is
quite apparent, from the allegations of the bills, the work of destruction of complainants’ occupation
has already set in” (because the law deterred parents from enrolling in private schools). Id. On
review, the Supreme Court expressly approved of this reasoning, stating that “[i]f no relief had been
possible prior to the effective date of the Act, the injury would have become irreparable. Prevention
of impending injury by unlawful action is a well recognized function of courts of equity.” Pierce v.
Society of Sisters, 268 U.S. 510, 536 (1925). The same is true here: there is no dispute that, absent

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preliminary relief, Plaintiffs will be forced to expend millions of dollars and thousands of employee
hours to comply with warnings that are likely to be held unconstitutional.
Likewise, in Friends for All Children v. Lockheed Aircraft, 746 F. 2d 816 (D.C. Cir 1984),
the court granted a preliminary injunction that, rather than barring any party from taking a particular
action, affirmatively required Lockheed to create a $450,000 fund for accident victims, even though
there had been no determination of the amount of Lockheed’s liability. This unusual remedy was
within the courts’ inherent equitable power because “the delay inherent in trying the case to compute
the amount of the defendant’s liability w[ould] result in irreparable injury.” Id. at 831.
And in Northern Pipeline Construction Co. v. Marathon Pipe Line Co., 458 U.S. 50 (1982),
the Supreme Court held that the Bankruptcy Act of 1978 violated the constitution by vesting judicial
power in judges who lacked the protections of Article III. Yet the Court relied on its inherent
authority to stay its judgment for several months so that Congress could transition smoothly to a
constitutional bankruptcy system. Id. at 88 (plurality opinion) (“This limited stay will afford
Congress an opportunity to reconstitute the bankruptcy courts or to adopt other valid means of
adjudication, without impairing the interim administration of the bankruptcy laws.”). That is, the
Court gave the Government a reasonable compliance period following its decision even though the
Government had conclusively lost on its constitutional argument. A fortiori, this Court has the power
to give Plaintiffs a reasonable compliance period if, as Plaintiffs have argued, they have a strong
likelihood of success on their constitutional claim.
As the foregoing examples illustrate, this Court has broad authority to grant relief where
justified by the strength of Plaintiffs’ claims on the merits, the need to avoid irreparable injury, the
balance of the equities, and the public interest. Each of these factors likewise tips decisively in
Plaintiffs’ favor here.

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Respectfully Submitted,

Dated: September 30, 2011

/s/ Noel J. Francisco
Noel J. Francisco (D.C. Bar No. 464752)
Geoffrey K. Beach (D.C. Bar No. 439763)
Warren Postman (D.C. Bar No. 995083)

Floyd Abrams (admitted pro hac vice)
Joel Kurtzberg (admitted pro hac vice)
Kayvan Sadeghi (admitted pro hac vice)

JONES DAY
51 Louisiana Avenue, NW
Washington, D.C. 20001-2113
Telephone: [phone]
Facsimile: [phone]
[e-mail]
[e-mail]
[e-mail]

CAHILL GORDON & REINDEL LLP
80 Pine Street
New York, NY 10005-1702
Telephone: [phone]
Facsimile: [phone]
[e-mail]
[e-mail]
[e-mail]
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Counsel for Plaintiff R.J. Reynolds and
Santa Fe Natural Tobacco Company
Philip J. Perry (D.C. Bar No. 434278)
LATHAM & WATKINS LLP
555 11th Street, NW, Suite 1000
Washington DC 20004-1304
Telephone: [phone]
Facsimile: [phone]
[e-mail]

Counsel for Plaintiff Commonwealth Brands,
Inc.

Patricia A. Barald (D.C. Bar No. 218016)
Scott D. Danzis (D.C. Bar No. 481426)
COVINGTON & BURLING LLP
1201 Pennsylvania Avenue, NW
Washington, DC 20004-2401
Telephone: [phone]
Facsimile: 202.662.6291
[e-mail]
[e-mail]
Counsel for Plaintiff Lorillard
Tobacco Company

Jonathan D. Hacker (D.C. Bar No. 456553)
O’MELVENY & MYERS LLP
1625 Eye Street, NW
Washington, D.C. 20006-4061
Telephone: [phone]
Facsimile: [phone]
[e-mail]
Counsel for Plaintiff Liggett Group LLC

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