more emerges on Bush interference with prosecution

July 12, 2007 5:29 pm by krueger

This week Richard H. Carmona told a Congressional panel that when he was Surgeon General, the Bush administration repeatedly watered down or suppressed his public health efforts, including those on tobacco and secondhand smoke.

Dr. Carmona served as Surgeon General from 2002 to 2006. During that time he was invited to testify in the DoJ tobacco trial. But top Bush administration officials discouraged him from testifying — while at the same time they were telling the lead DoJ lawyer that he was not competent to testify.

Dr. Carmona also said that Bush administration officials delayed for years his report on secondhand smoke, and pressured him to water it down.

Dr. Carmona’s comments this week helped fill out the picture of Bush interference to help the tobacco industry in this trial. Comments from Sharon Eubanks and others have already shed light on how DoJ was forced to fight with their hands tied behind their backs. Carmona’s new information shows how this fits into a larger pattern. The Bush administration has been very tobacco-friendly.

Carmona’s revelations this week helped show how the Bush administration carried water for Big Tobacco.
However the real big picture is: most administrations are tobacco friendly, and so are most Congresses. A widely believed myth: the government is a big nanny, imposing health restrictions on people. The fact: the government more often does the bidding of Big Tobacco than does anything that would hurt it, like reducing smoking.

The sabotaging of the DoJ trial by the Bush administration is a good case in point. It is not suprising that the practical outcome of the trial, at least so far, has been that it hasn’t hurt Big Tobacco. The Bush administration was not going to let that happen.
The surprising thing is that despite everything that Big Tobacco could do, and everything that the Bush administration did to help it, the legal outcome was still conviction. Philip Morris is still an adjudicated racketeer. I attribute that to the strength of the evidence. No honest judge could conclude otherwise.

This brings us to the present: Big Tobacco has been found guilty– but it got a get out of jail free card. The court found that a massive 50-year long conspiracy led to the death of literally millions of people — but no penalty could be given that would stop it. In large part because of political interference in the trial.

This is an outstanding example illustrating why it’s a myth that the story of tobacco is a story of nanny government. On the contrary! In this example we see how government is more often the problem with tobacco than the solution, more often the protector of Big Tobacco’s interests than the protector of the public interest.

Eubanks Speaks out on Tobacco Case, Attorney Firings

March 23, 2007 7:00 am by Gene Borio

Followers of this blog have undoubtedly read Carol Leonnig’s Washington Post Page One story about lead prosecutor Sharon Eubanks’ allegations of political interference in the latter days of the tobacco trial.

However, the NPR audio interview by John Ydstie with Eubanks has several noteworthy segments which should be written down for posterity:

1. When asked if Gonzales was aware of administration appointees’ interference with the tobacco case, Eubanks said that Kyle Sampson was cc’d on their emails, so she was sure Gonzales was aware. ( Sampson, who resigned Monday over the fired-attorneys scandal, had been Gonzales’ chief of staff.)

2. As for the Office of Professional Responsibilty investigation, Eubanks flatly called it a “whitewash.”

–She said the OPD is not an independent office in the JD.

–She said that she had called then-Associate Attorney General Robert D. McCallum about one of the OPD issues and he said that he’d just call the head of OPD and address the issue himself. “If it’s an independent investigation, why would the subject of the investigation be in a position to call and to get changes made?”

–She said that she had never been asked a single question about White House interference, though “I had submitted emails, communications between the White House officials and Justice Department officials. I was not questioned about those documents.”

3. When asked why she was coming forward now, Eubanks said that a tobacco appeal is about to be filed. The same JD is in place now, she said, and various administration officials are still at Justice–including Peter Keisler, who is still the head of the Civil Division. These are the people who will be making decisions about the case and about what issues are going to be appealed.

Eubanks said there were many parallels between the tobacco case and the current fired-attorneys scandal. As a 22-year career attorney–not a political appointee (”I did not ’serve at the pleasure of the President’”)–she fears for the career attorneys at Justice. It is important, she said, to ensure that career people can do their jobs, so that there is continuity at the JD.

NB: The WP story names the three political appointees responsible for the last-minute shifts in the government’s tobacco case in June 2005: then-Associate Attorney General Robert D. McCallum, then-Assistant Attorney General Peter Keisler and Keisler’s deputy at the time, Dan Meron.

Washington Post item:

www.washingtonpost.com/wp…

NPR Interview:

www.npr.org/templates/sto…

Tobacco-on-Trial Interview with Sharon Eubanks, August, 2006:

www.tobacco-on-trial.com/…

fuller picture of Bush interference

March 22, 2007 8:33 am by krueger

An article in today’s Washingon Post provides a fuller and more detailed picture of the Bush administration’s political interference in the trial. Sharon Eubanks, the leader of the Justice team, provides new details on what happened and who did what.

The evidence that the Bush administration political interference, via political appointee, Robert D. McCollum, had forced Justice to weaken its monetary penalty, has already been presented.
What this article adds: Eubanks says that three Bush political appointees, McCallum, Peter Keisler, and Dan Meron, interfered with Justice’s case in 2005. They told key Justice witnesses to change their testimony. They demanded Justice drop its penalty recommendation that tobacco executives be removed from their corporate positions. And they ordered Eubanks to read verbatim a closing argument that they had written.
The occasion for Eubanks speaking now is eight-gate, the firing of eight U.S. attorneys for apparently political reasons. The common thread is what Eubanks calls the “overwhelming politicization” of Justice by the Bush administration. Eubanks sees this as the larger picture, and recommends that Congress therefore not limit its investigation to the dismissal of the eight U.S. attorneys.

“Political interference is happening at Justice across the department,” said Eubanks. “When decisions are made now in the Bush attorney general’s office, politics is the primary consideration . . . The rule of law goes out the window”.

How that figured into the case against Big Tobacco: Eubanks said the political appointees largely ignored the case until it became clear the government might win. Then in April 2005, in the last weeks of the case, the political inteference started.
The full Washingonton Post article is:

www.washingtonpost.com/wp…
Related material on Tobacco On Trial:

www.tobacco-on-trial.com/…

www.tobacco-on-trial.com/…

“LIGHT” AD RESTRICTIONS APPLY OUTSIDE US, KESSLER RULES

March 16, 2007 3:54 pm by Gene Borio

From Judge Kessler’s Memo on Order #1028, issued March 16, 2007:

In sum, the Court concludes that the provisions in the Remedial Order prohibiting the use of express or implied health messages or descriptors in Section II. A. 4. do apply to actions of the Defendants taken outside the United States. To rule otherwise would not only frustrate the salutary anti-fraud principles embodied in RICO, but would also allow the Defendants to spread fraudulent and misleading health messages and descriptors about their products throughout the world, even though they are prohibited from doing so in the United States. This Court sees no justification, either legal or ethical, for concluding that Congress intended to allow Defendants to continue to tell the rest of the world that “low tar/light” cigarettes are less harmful to health when they are prohibited from making such fraudulent representations to the American public. . . .

Under the “effects test,” RICO has extraterritorial effect where illegal activity abroad causes a “substantial effect” within the United States. Id. As to the effects test, there is no question that, as the Findings of Fact detail at great length (particularly in the sections on international organizations, committees, and groups (Section III. I.), environmental tobacco smoke (Section V. G. 6 and 7), destruction of documents and suppression of scientific research (Section V. H.)), the fraud perpetrated by Defendants involved extensive activity that occurred outside our national borders. For example, Defendants participated in an extraordinary number of international organizations and committees throughout the world, used scientists in countries as far apart as Switzerland, Japan, Finland, Germany, Sweden, Thailand, Argentina, and Brazil, engaged in document destruction in Australia, concealed and destroyed research documents in England, and supported extensive smoking and health research in both Germany and England.

All these activities, despite being carried out beyond our shores, were part of the Defendants’ scheme to defraud the American public about the adverse health effects of smoking and environmental tobacco smoke. The activities which took place abroad were all devoted to advancing and furthering the efforts of the Defendants to mislead and deceive American smokers and potential smokers about the lower health risks of “low tar,” “lite,” “ultra lite,” “mild” and “natural” cigarettes, as well as the dangers of smoking, nicotine addiction, and environmental tobacco smoke. . .

[I]n light of the extensive Findings of Fact and the lengthy Conclusions of Law, the actual nine month trial record, and the complexity of the scheme to defraud outlined in those Findings of Fact, Defendants have more than sufficient notice of the illegal conduct that is prohibited under the Sections of the Remedial Order relating to General Injunctive Relief.

Given the entire context of this case, “Rule 65(d) does not require the [D]istrict [C]ourt to ‘predict exactly what [the Defendants] will think of next.’”  . . .  Indeed, it would be impossible to foresee what the ingenuity and creativity of Defendants’ cadres of sophisticated lawyers could “think of next.” For all these reasons, the Defendants’ request for clarification regarding the General Injunction provisions at II. A. 1. and II. A. 3. is denied.

Note that requirements for “corrective statements” at retail counter displays do _not_ apply outside US.

Also note that the issue is moot for now, as all of Judge Kessler’s original order was stayed in October, pending appeal.

Text follows of:

03/16/2007 5799 ORDER #1028 granting in part and denying in part 5743 Certain Defendants’ Motion for Clarification or, in the Alternative, for Relief Under Rules 52, 59, and 60 with Respect to the Court’s August 17, 2006 Order. Signed by Judge Judge Gladys Kessler on 3/16/07. (CS, ) (Entered: 03/16/2007)

www.tobacco-on-trial.com/…

03/16/2007 5800 MEMORANDUM OPINION to Order #1028. Signed by Judge Gladys Kessler on 3/16/07. (CS, ) (Entered: 03/16/2007)

www.tobacco-on-trial.com/…

UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA

Civil Action No. 99-2496 (GK)

UNITED STATES OF AMERICA,
Plaintiff,

and

TOBACCO-FREE KIDS ACTION FUND,
AMERICAN CANCER SOCIETY,
AMERICAN HEART ASSOCIATION,
AMERICAN LUNG ASSOCIATION,
AMERICANS FOR NONSMOKERS’ RIGHTS,
and NATIONAL AFRICAN AMERICAN
TOBACCO PREVENTION NETWORK,

Intervenors,

v.

PHILIP MORRIS USA, INC.,
(f/k/a Philip Morris, Inc.), et al.,

Defendants.

ORDER #1028

Upon consideration of the Motion of Certain Defendants’1 for Clarification or, in the
Alternative, for Relief Under Rules 52, 59, and 60 with Respect to the Court’s August 17, 2006
Order, the Oppositions thereto, the Reply, the entire record in this case, and the applicable case law,
the Court concludes that the Motion should be granted in part and denied in part, as explained
in the accompanying Memorandum Opinion.

March 16, 2007 /s/

Gladys Kessler

United States District Judge

1

The Defendants joining in this Motion are: Philip Morris USA, Altria, R.J. Reynolds,
Brown & Williamson, Lorillard, and BATCo.

—————————————

ORDER #1028 granting in part and denying in part 5743 Certain Defendants’ Motion for Clarification or, in the Alternative, for Relief Under Rules 52, 59, and 60 with Respect to the Court’s August 17, 2006 Order.

www.tobacco-on-trial.com/…

—————————————

MEMORANDUM OPINION to Order #1028. Signed by Judge Gladys Kessler on 3/16/07.

www.tobacco-on-trial.com/…

UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA

Civil Action No. 99-2496 (GK)

UNITED STATES OF AMERICA,

Plaintiff,

and

TOBACCO-FREE KIDS ACTION FUND,
AMERICAN CANCER SOCIETY,
AMERICAN HEART ASSOCIATION,
AMERICAN LUNG ASSOCIATION,
AMERICANS FOR NONSMOKERS’ RIGHTS,
and NATIONAL AFRICAN AMERICAN
TOBACCO PREVENTION NETWORK,

Intervenors,

v.

PHILIP MORRIS USA, INC.,
(f/k/a Philip Morris, Inc.), et al.,

Defendants.

MEMORANDUM OPINION

1

Defendants have moved for Clarification or in the Alternative for Relief Under Rules 52,
59 and 60 with respect to the Court’s August 17, 2006 Order. Upon consideration of the Motion,
the Oppositions of the Plaintiff and Intervenors, the Replies, and the lengthy record herein, the Court
concludes that the Motion should be denied in part and granted in part.

First, Defendants seek clarification on two issues relating to Order #1015, the Final Judgment
and Remedial Order in this case. They seek clarification as to the meaning and applicability of the
General Injunctive Relief set forth in ¶¶ II. A. 1. and II. A. 3. of the Order. Second, Defendants seek

1

Defendants for purposes of this Motion are: Philip Morris USA, Altria, R.J. Reynolds,
Brown & Williamson, Lorillard, and BATCo.

clarification regarding the scope of the provisions in the Order, prohibiting the use of descriptors and
requiring corrective statements at retail point of sale.

I. Request for Clarification Regarding General Injunctive Relief

In § II. A. 1. of the Remedial Order, the Court has permanently enjoined Defendants

from committing any act of racketeering as defined in 18 U.S.C.
§ 1961(1), relating in any way to the manufacturing, marketing,
promotion, health consequences, or sale of cigarettes in the United
States.

In Section II. A. 3. of the Remedial Order, the Court has permanently enjoined Defendants

from making, or causing to be made in any way, any material false,
misleading, or deceptive statement or representation, or engaging in
any public relations or marketing endeavor that is disseminated to the
United States public and that misrepresents or suppresses information
concerning cigarettes. Such material statements include, but are not
limited to, any matter that: (a) involves health, safety, or other areas
with which a reasonable consumer or potential consumer would be
concerned; (b) a reasonable consumer or potential consumer would
attach importance to in determining whether to purchase or smoke
cigarettes; or (c) the Defendant, Covered Person or Entity making the
representation knows or has reason to know that its recipient regards
or is likely to regard as important in determining whether to purchase
cigarettes or to smoke cigarettes, even if a reasonable person would
not so regard it.

The RICO statute expressly authorizes the imposition of “reasonable restrictions on the future
activities . . . of any person, including, but not limited to, prohibiting any person from engaging in
the same type of endeavor as the enterprise engaged in, . . . .” 18 U.S.C. § 1964(a). As the Second
Circuit has pointed out in United States of America v. Carson, 52 F.3d 1173, 1184 (2d Cir. 1995),

“‘a [D]istrict [C]ourt has broad discretion to enjoin possible future violations of law where past
violations have been shown,”’ quoting SEC v. Manor Nursing Centers, Inc., 458 F.2d 1082, 1100
(2d Cir. 1972) (emphasis added). The prohibition against committing any racketeering activity, as

-2

defined in 18 U.S.C. § 1961(1), has been upheld in numerous cases, including Carson itself, 52 F.3d
at 1185 n. 10. See also S.C. Johnson & Son, Inc. v. The Clorox Co., 241 F.3d 232, 241 (2d Cir.
2001); Professional Association of College Educators, TSTA/NEA v. El Paso County Community
College District, et al., 730 F.2d 258, 273 (5th Cir. 1984).

Federal Rule of Civil Procedure 65(d) requires specificity in injunctions so that “those
enjoined will know what conduct the Court has prohibited,” Mayer v. Brown & Root Constr. Co.,
661 F.2d 369, 373 (5th Cir. 1981). Section II. A. 1. of the Remedial Order not only enjoins the
Defendants from committing any act of racketeering, but further specifies that the activity being
enjoined must relate to the “manufacturing, marketing, promotion, health consequences, or sale of
cigarettes in the United States.”

Section II. A. 3. of the Remedial Order covers the making of any “material false, misleading
or deceptive statement or representation, . . . .” That Section then sets forth that such material
statements which are enjoined include any material that “(a) involves health, safety, or other areas
with which a reasonable consumer or potential consumer of cigarettes would be concerned”; (b)
statements that a reasonable consumer would attach importance to; or (c) that the defendant knows
that the recipient would regard as important.

As the Fifth Circuit said in Professional Association of College Educators, 730 F.2d at 273,
“it is difficult to understand how the defendants could have legitimate difficulty understanding what
they are forbidden to do, or to imagine how the injunction could have more specificity without
attempting to catalog everyconceivable means bywhich they might be violating or seeking to violate
the injunction.”

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Finally, it must be noted that in determining whether injunctions do provide specific notice
of prohibited conduct to those affected, the courts have emphasized that such injunctions will be
evaluated “‘in the light of the circumstances surrounding (the injunction’s) entry: the relief sought
by the moving party, the evidence produced at the hearing on the injunction, and the mischief that
the injunction seeks to prevent.’” Common Cause v. Nuclear Regulatory Comm., 674 F.2d 921, 927

(D.C. Cir. 1982), quotingUnited States v. Christie Industries, Inc., 465 F.2d 1000, 1007 (3d Cir.
1972).

In this case, in light of the extensive Findings of Fact and the lengthy Conclusions of Law,
the actual nine month trial record, and the complexity of the scheme to defraud outlined in those
Findings of Fact, Defendants have more than sufficient notice of the illegal conduct that is prohibited
under the Sections of the Remedial Order relating to General Injunctive Relief.

Given the entire context of this case, “Rule 65(d) does not require the [D]istrict [C]ourt to
‘predict exactly what [the Defendants] will think of next.’” S.C. Johnson & Son, Inc., 241 F.3d at
240, quoting Sterling Drug v. Bayer AG, 14 F.3d 733, 748 (2d Cir. 1994). Indeed, it would be
impossible to foresee what the ingenuity and creativity of Defendants’ cadres of sophisticated
lawyers could “think of next.” For all these reasons, the Defendants’ request for clarification
regarding the General Injunction provisions at II. A. 1. and II. A. 3. is denied.

II.
Request for Clarification Regarding Application of the Remedial Order to
International Activities

Defendants request that the Court clarify that the provisions in the Remedial Order
prohibiting the use of express or implied health messages or descriptors in Section II. A. 4. apply
only to statements made by the Defendants in the United States and to cigarettes sold by them in the

-4

United States; Defendants also request that the Court clarify that the provisions in Section II. B.(7)(b)
of the Remedial Order, requiring corrective statements at counter top displays and header displays
used at retail points of sale, also apply only to conduct within the United States.

Initially, it must be noted that the issue of the extraterritoriality of statutes is a particularly
complex one. Surprisingly, and uncharacteristically, counsel for the parties have provided minimal
briefing on this difficult subject.2 In Small v. United States, 544 U.S. 385 (2005) and F. Hoffman-La
Roche Ltd v. Empagran S.A., 542 U.S. 155, 164-65 (2004), the Supreme Court enunciated the basic
principle to be considered in determining the extraterritorial scope of any statutory phrase. Because
“Congress generally legislates with domestic concerns in mind,” 544 U.S. at 388, the Court has
adopted “the legal presumption that Congress ordinarily intends its statutes to have domestic, not
extraterritorial application.” 544 U.S. at 388-89. See also Environmental Defense Fund, Inc. v.
Massey, 986 F.2d 528, 531 (D.C. Cir. 1993).

3

As to whether RICO, in particular, applies extraterritorially, the courts have expresseddiffering views. For example, compare Jose v. M/V Fir Grove, 801 F. Supp. 349, 354-58 (D. Ore. 1991) with United States v. Noriega, 746 F. Supp. 1506, 1516-17 (S.D. Fla. 1990). All courts agree,
however, that the key consideration is Congress’s intent. Moreover, it appears that our Circuit has
not yet been presented with this issue. See AGS Int’l Servs. S.A. v. Newmont USA Ltd., 346 F.
Supp.2d 64, 66 (D.D.C. 2004) (declining to consider the extraterritoriality of RICO because the
Court lacked personal jurisdiction over defendants); BCCI Holdings (Lux.) S.A. v. Khalil, 20 F.

2

Defendants’ Memorandum devotes barely two full pages to the issue, and the
Government devotes less than three pages.

3

There is extensive case law examining the extraterritorial impact of our anti-trust laws
and securities fraud laws.

-5

Supp.2d 1, 5-6 (D.D.C. 1997) (declining to decide the extraterritoriality of RICO because the case
required only domestic application of the statute).

As with any inquiry into Congressional intent, we always begin with an examination of the
statute. In this instance, that examination yields no useful results since “RICO itself is silent as to
its extraterritorial application,” Poulos v. Caesars World, Inc., 379 F.3d 654, 663 (9th Cir. 2004);
North South Fin. Corp. v. Al-Turki, 100 F.3d 1046, 1051 (2d Cir. 1996), Doe I v. State of Israel, 400
F. Supp.2d 86, 115 (D.D.C. 2005). Because of the absence of dispositive Supreme Court case law
on the subject of RICO’s extraterritoriality, the courts examining this issue have, in large part, been
guided by the two alternative tests used to determine the extraterritorial application of anti-trust and
securities fraud cases. Those two alternative tests are referred to as the “conduct test” and “effects
test.” North South Fin. Corp. v. Al-Turki, 100 F.3d at 1052; Poulos v. Caesars World, Inc., 379 F.3d
at 663.
Under the “conduct test,” RICO has an extraterritorial effect “if a defendant’s conduct in the
United States was more than merely preparatory to the fraud, and particular acts or culpable failures
to act within the United States directly caused losses to foreign investors abroad.” Alfadda v. Fenn,
935 F.2d 475, 478 (2d Cir. 1991). That test is not relevant or helpful given that the facts presented
in this case did not relate in any way to losses of foreign investors.

Under the “effects test,” RICO has extraterritorial effect where illegal activity abroad causes
a “substantial effect” within the United States. Id. As to the effects test, there is no question that,
as the Findings of Fact detail at great length (particularly in the sections on international
organizations, committees, and groups (Section III. I.), environmental tobacco smoke (Section V.
G. 6 and 7), destruction of documents and suppression of scientific research (Section V. H.)), the
-6

fraud perpetrated by Defendants involved extensive activity that occurred outside our national
borders. For example, Defendants participated in an extraordinary number of international
organizations and committees throughout the world, used scientists in countries as far apart as
Switzerland, Japan, Finland, Germany, Sweden, Thailand, Argentina, and Brazil, engaged in
document destruction in Australia, concealed and destroyed research documents in England, and
supported extensive smoking and health research in both Germany and England.

All these activities, despite being carried out beyond our shores, were part of the Defendants’
scheme to defraud the American public about the adverse health effects of smoking and
environmental tobacco smoke. The activities which took place abroad were all devoted to advancing
and furthering the efforts of the Defendants to mislead and deceive American smokers and potential
smokers about the lower health risks of “low tar,” “lite,” “ultra lite,” “mild” and “natural” cigarettes,
as well as the dangers of smoking, nicotine addiction, and environmental tobacco smoke.

In such circumstances, and taking into account the need to respect principles of international
comity,4 the Court concludes that there is no reason to believe that Congress intended to exclude
from a remedial injunctive order (in this case, Section II. A. 4 of the Remedial Order) activities by
Defendants, over whom the Court has personal jurisdiction, to the extent they fall within the Order’s
prohibitions because they adversely affect the health and welfare of American smokers, potential
smokers and passive smokers exposed to environmental tobacco smoke, merely because they occur
outside the physical boundaries of the United States.

4

Although Defendants warn of conflicts with the laws of other countries, they have
not cited to even one country whose statutes, case law, or regulatory policies would be violated by
operation of Section II. A. 4 of the Remedial Order.

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In sum, the Court concludes that the provisions in the Remedial Order prohibiting the use of
express or implied health messages or descriptors in Section II. A. 4. do apply to actions of the
Defendants taken outside the United States. To rule otherwise would not only frustrate the salutary
anti-fraud principles embodied in RICO, but would also allow the Defendants to spread fraudulent
and misleading health messages and descriptors about their products throughout the world, even
though they are prohibited from doing so in the United States. This Court sees no justification, either
legal or ethical, for concluding that Congress intended to allow Defendants to continue to tell the rest
of the world that “low tar/light” cigarettes are less harmful to health when they are prohibited from
making such fraudulent representations to the American public.5

March 16, 2007 /s/

Gladys Kessler

United States District Judge

5 Defendants have also asked the Court to clarify whether the provisions in Section

II. B.(7)(b) of the Remedial Order apply extraterritorially to require corrective statements at counter
top and header displays used at retail points of sale. Extensive, detailed factual evidence was
presented during the course of this trial regarding advertisements and marketing at retail points of
sales in the United States. Based on that evidence, the Court fashioned the specific provisions for
corrective statements contained in Section II. B.(7)(b) of the Remedial Order. No such factual
evidence was presented regarding retail marketing outside the United States. Consequently, the
remedy fashioned in Section II. B.(7)(b) was not based on any evidence pertaining to foreign
marketing of cigarettes. Therefore, it would be inappropriate to give Section II. B.(7)(b)
extraterritorial effect.

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DR. LANE MAKES HIS CASE FOR AFLATOXIN

December 19, 2006 2:07 pm by Gene Borio

Dr. Kerry Lane has been investigating the link between the cigarette ingredient aflatoxin and cancer for many years now. On December 4, 2006, he set forth his case in an accompanying brief to his request to file the brief as amicus curiae.

Dr. Lane’s brief is unlikely to be accepted. It’s certainly late(!), and aflatoxin has not been a part of the evidence presented at trial. Even during the trial, Judge Kessler refused to deal with the fire-safe cigarette issue when DOJ tried to call Dr. Michael Watkins to the stand in February, 2005. Judge Kessler ruled that Dr. Watkins’ testimony at this point was largely irrelevant–fire-safe science never having come up before–and overly time-consuming. She expressed no excitement whatsoever for getting into the “coal drop-off” issue. That would undoubtedly go at least double for the aflatoxin issue, 15 months after the end of the trial and 5 months after her final order and judgement.

However, Dr. Lane in his brief certainly does make his most clear and referenced argument yet for aflatoxin’s toxicity.

From:

Lane Brief for Aflatoxin review, December 4, 2006

This brief contains evidence that Defendants knew, or should have known, of one particular method of making a safer cigarette but suppressed this information. Indeed, but for documents uncovered in this and related litigation, the information would likely have remained suppressed.

This Brief shows that Defendants knew, or should have known, that aflatoxin, a potent carcinogen, was a contaminant of tobacco products; that aflatoxin was a substantial source of the harm caused by tobacco products; and, that methods of neutralizing aflatoxin would have made tobacco products safer. While other issues before this Court are now under appellate review, this Brief urges the Court to consider aflatoxin contamination. Otherwise this highly significant public health issue will escape judicial review. Defendants have, and will continue, to make unsafe tobacco products by failing to publicly recognize and neutralize aflatoxin contamination.

**———————————————————

Texts follow of:

Lane Motion for Aflatoxin review, December 4, 2006

Lane Brief for Aflatoxin review, December 4, 2006

**———————————————————

Lane Motion for Aflatoxin review, December 4, 2006

**———————————————————

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

UNITED STATES OF AMERICA,

Plaintiff,

v. PHILIP MORRIS USA INC., f/k/a PHILIP MORRIS INC., et al

Defendants

Civil Action No. 99-CV-2496 (GK)

MOTION FOR LEAVE TO FILE BRIEF AS AMICUS CURIAE

Comes Now, Dr. Kerry M. Lane, and seeks leave to file a Brief, attached, as Amicus Curiae in connection with the above referenced litigation.

Dr. Lane is a medical physician who, through research and study, has acquired substantial background information and knowledge with respect to the subject of aflatoxin and tobacco and its effect on tobacco as a carcinogen. Dr. Lane believes that information regarding aflatoxin and its carcinogenic effect on tobacco was known and suppressed by one or more Joint Defendants and further believes that this information is relevant to the Court’s consideration of the subject litigation and necessary for the Court to form a complete response to the Joint Defendants actions. Otherwise a serious public health issue will escape judicial review.

1

**———————————————————

The parties consent for this filing has been sought in accordance with Local Civil Rule 7(m). The Joint Defendants oppose this filing. The Plaintiff, in view of government policy, has no comment. A proposed order is also attached.

Respectfully Submitted,

/s/

Bradford E. Kile DC Bar No. 66811 Kile Goekjian Reed & McManus, PLLC 1200 New Hampshire Ave. NW Suite 570 Washington DC 20036

Attorney for Amicus Curiae Dr. Kerry Scott Lane

2

**———————————————————

Lane Brief for Aflatoxin review, December 4, 2006

**———————————————————

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

UNITED STATES OF AMERICA,

Plaintiff,

v.

PHILIP MORRIS USA INC.,

f/k/a PHILIP MORRIS INC., et al

Defendants

Civil Action No. 99-CV-2496 (GK)

BRIEF FOR AMICI CURIAE

December 4, 2006

Kerry Scott Lane M.D.

St. Mary’s Medical Center

901 45th Street

West Palm Beach FL 33407

(561) 844-6300

**———————————————————

TABLE OF CONTENTS

I. INTRODUCTION……… 1

II. BACKGROUND……… 2

A. Tobacco, Aflatoxin, Fungal Toxins, Ammonia, and Human Disease……… 2

B. Defendants’ Experts Remain Silent About Aflatoxin Danger……… 7

1. Publications of B.S. Appleton Ph.D.- Head Scientist at RJR……… 7

2. Testimony of B.S. Appleton Ph.D. in the Tobacco Trial……… 7

3. Retention of Dr. Wogan of MIT……… 8

4. Testimony of David E. Townsend……… 8

C. Analysis of Retrieved Tobacco Documents in the Context of Aflatoxin Contamination……… 10

D. Suppression of Knowledge of Harmful Health Effects and Emerging Diseases-AIDS……… 28

E. The toxicology of aflatoxins as a basis for public health decisions……… 29

F. Aflatoxins and Smoke Studies……… 30

G. Aflatoxin Remediation by Ammoniation……… 30

H. p53 Tumor Suppressor Gene Mutated by Aflatoxin and Industry Deception….31

III. CONCLUSION ……… 32

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TABLE OF AUTHORITIES

Statutes

Racketeer Influenced and Corrupt Organizations Act (“RICO”) 18 U.S.C. § 1961, et seq. ……… 1

Other Authorities

Alvord ET, Cardon SZ. The Inhibition of Formation of 3-4 Benzpyrene in Cigarette Smoke. Brit J Cancer. 1956; 10: 498-503 ………16

Appleton, B.S., and Campbell, T.C. (1983). Effect of high and low dietary protien on the dosing and post dosing periods of aflatoxin B1-induced hepatic preneoplastic lesion development in the rat. Cancer Res. 43, 2150-2154………7

Appleton, B.S., Goetchius, M.P., and Campbell, T.C. (1982). Linear dose response curve for the hepatic macromolecular binding of aflatoxin B1 in rats in very low exposures. Cancer Res. 42, 3569-3662………7

Austin K. Substances in tobacco alleged to be causes of cancer, respiratory and other diseases. In: RJ Reynolds Center for Tobacco Research memo. June 8, 1966; RJR Website Doc. No. 502429578:1………19

Autrup H, Essigman JM, Croy RG, Trump BF, Wogan GN, Harris CC. Metabolism of aflatoxin B and identification of the major aflatoxin B1-DNA adducts formed in culture…….1

bronchus and colon. Cancer Res. 1979; 39:694-698 ………14

Blackmore R. Aflatoxin: Food Toxin. In: Phillip Morris memo; May 24, 1965; PM Website Doc. No. 2021551782………11, 12

Burg WR, Shotwell OR, Saltzman BE. Measurements of airborne aflatoxins during the handling of contaminated corn. Ann Ind Hyg. 1981; 42:1-11………14

Chapman R. Method for detoxifying foodstuffs. USPO. 1992; 1/21:U.S. Patent 5,082,679….. 27

Cherpillod P, Amstad PA. Benzo(a)pyrene-induced mutagenesis of p53 hot-spot condons 248 and 249 in human hepatocytes. Molecular Carcinogenesis 1995;13:15-20………3

Cordesman A. Weapons of mass destruction in Iraq: a summary of biological, chemical, nuclear and delivery efforts and capabilities. In: Middle East Program at the Center for Strategic and International Studies; Nov. 14, 1996; Washington, D.C………23

Cullen JM, Newberne PM. Acute Hepatotoxicity of Aflatoxins. In: Eaton DL, Groopman JD, eds. The Toxicology of Aflatoxins. San Diego, Ca: Academic Press; 1994: 3-26 ………22

DeBardeleben F. The Structure and Synthesis of Aflatoxin B and G1. In: Phillip Morris Project Report. Dec. 9, 1966; PM Website Doc. No. 2021551728. ………20

Denning DW, Allen R, Wilkinson, AP, Morgan MRA. Transplacental transfer of aflatoxin in humans. Carcinogenesis. 1990; 11:1033-1035………27

Dickens F, Jones HEH, Waynforth HB. Oral, Subcutaneous and Intratracheal Administration of Carcinogenic Lactones and Related Substances: the Intratracheal Administration of Cigarette Tar in the Rat. Br J Cancer. 1966; 20:134-144. RJR Website Doc. No. 500291239. ………19

Donnelly P, Stewart R, Ali S, Conlan A, Reid K, Petsikas D, et al. Biotransformation of

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aflatoxin B1 in human lung. Carcinogenesis 1996; Vol.17 No.11:2487-2494. ………4

Dvorackova I, Stora C, Ayraud N. Evidence of Aflatoxin B1 in Two Cases of Lung Cancer in Man. J Can Res. 1981; 100:221-224 ………14

Dvorackova I. Aflatoxins and Human Health. Boca Raton, Fl: CRC Press; 1990:135-150 …… 14

Editorial. Tobacco’s outrageous, unethical tactics a threat to public health. In: Sun Sentinel Editorial; Fort Laud, Fl.; Feb. 10, 98. The Secret of Marlboro is Ammonia…. Ammonia does many good things………26

Flalles D. Food toxins of fungal origin: Methodology and regulatory aspects. Food Technology. 1966; 20:61-pages unknown. PM Website Doc. No. 1000340451. ………12

Garner RC, Dvorackova I, Tursi F. Immunoassay procedures to detect exposure to aflatoxin B1 and benzo(a)pyrene in animals and man at the DNA level. Int Arc Occup Environ Health. 1988; 60:145-150………15

Glantz S, Slade J, Bero L, Hanauer P, Barnes D. The Cigarette Papers. Univ. of Calif. Press. Online; Berkley, Ca. 1966; Doc. ID 1165.03 Brown and Williamson Collection. www.library.ucsf.edu/toba…

Glantz SA, Slade J, Bero L, Hanauer P, Barnes. The Cigarette Papers. Univ. of Calif. Press. 1996, p.215 ………19

Griffith R. Importance of benzpyrene versus other PAH’s in Project Janus. The Brown and Williamson Collection. Online; Univ. Calif., San Francisco. 1967; Doc. ID 1101.1. ………19

Griffith R. Report to executive committee. The Brown and Williamson Collection. Online; Univ. Calif., San Francisco. 1965; Doc ID 1105.01………16

Harris CC. 1995 Deichmann lecture — p53 tumor suppressor gene: at the crossroads of molecular carcinogenesis, molecular epidemiology and cancer risk assessment. Toxicology Letters 1995; Vol.82/83:1………4

Hempfling W. Are mycotoxins present in cured tobaccos? In: Phillip Morris USA Confidential memo; March 31, 1994; PM Website Doc. No. 2024111027. ………12

Hendrickse RG, Maxwell SM. Heroin addicts, AIDS, and aflatoxins. Brit Med J. 1988; 296:1257………28

Herrold KM. Aflatoxin induced lesions in Syrian hamsters. Br J Cancer. 1969:23; 655-660. .. 22

Hesseltine CW, Shotwell OL, Kwolek WF, Lillehoj EB, Jackson WK, Bothast RJ. Aflatoxin occurrence in 1973 corn at harvest. II. Mycological studies. Mycologia. 1976; 68:341353 ……… 14

Hitchcock R, Willoughby, Cardon SZ, Alvord RT. Cigarette wrapper material and method for making same. USPO. 1958; U.S. Patent 2,859,753. ………17

Hockett RC. Elimination of Benzpyrene from Tobacco Smoke. In: Phillip Morris memo; May 14, 1956; PM Website Doc. No. 2000756765-67. ………17

Husgafvel-Pursiainen K, Benhamou S, Kannio A, Nyberg F, Mukeria A, Constantinescu V, et al. p53 mutations in lung cancer among non-smokers exposed to environmental tobacco smoke. Proc Amer Assoc Can Res 1998;39. ………5

Karja VJ, Syrjanen KJ, Kurvinen AK, Syrjanen SM. Expression and Mutations of p53 in Salivary Gland Tumors. J of Oral Path & Med. 1997; 26/5: 217-23. ………15

Lane K. Method and system for continuous assay and removal of harmful toxins during processing of tobacco products. 1997; U.S. Patents 6,058,940, 6,637,438, 6,786,221 and pending. ………7

Langer AM, Nolan RP, Bowes DR, Shirey SB. Inorganic Particles Found in Cigarette Tobacco, Cigarette Ash, and Cigarette Smoke. In: Wehner AP, Felton D. Biological

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interaction of inhaled mineral fibers and cigarette smoke. Proceedings of an International Symposium/Workshop. Columbus, OH: Battelle Press; 1989: 430………24

Lasky T, Silbergeld E. p53 mutations associated with breast, colorectal, liver, lung, and ovarian cancers. Env Health Persp 1996; Vol.104 No.12: 1324-1334………4, 10

Lofroth G, Zebuhr Y. Polychlorinated dibenzo-p-dioxins (PCDDs) and dibenzofurans (PCDFs) in mainstream and sidestream cigarette smoke. Env Contam and Tox. 1992; 48:789-794… 24

Lola N. On the Health Conditions of female tobacco workers: an investigation of a modern factory. Italian Tobacco. 1959; 693:431-433. ………12

Ma X, Gibbons J, Babish J. Benzo(e)pyrene pretreatment of immature, female C57BL/6J mice results in increased bioactivation of aflatoxin B1 in vitro. Toxicology Letters. 1991; 59:51-58……… 15

McGlynn KA, Rosvold EA, et al. Susceptibility to hepatocellular carcinoma is associated with genetic variation in the enzymatic detoxification of aflatoxin B1. Proc Natl Acad Sci. 1995; 92:2384-2387………15

McMillian WW, Widstrom NW, Beaver RW, Wilson DM. Aflatoxin in Georgia: Factors associated with its formation in corn. In: Aflatoxin in Corn–New Perspectives; Iowa Agri and Home Eco Exper Sta; Iowa St Univ. 1991; 599:329-334………14

Michelson I. Method of making a cigarette of reduced biological damage capability. USPO. 1974;U.S Patent 3,782,393………25

Michelson I. Smoking composition of reduced toxicity and method of making same. USPO. 1970;U.S Patent 3,631,865………25

Mitchell GF, et.al. The Total Synthesis of Racemic Aflatoxin B1. Jour of Am Chem Soc. 85: 19, Oct.5, 1966, PM Website Doc. No.2021551735-37………20

Newberne PM, Butler WH. Acute and Chronic Effects of aflatoxin on the liver of domestic and laboratory animals. A review. Cancer Res. 1969; 29: 236-250 ………22

Norred W, Morrissey R. Effects of long-term feeding of ammoniated aflatoxin-contaminated corn to Fischer 344 rats. Tox and App Pharm. 1983; 70:96-104 ………25

O’Donohue C. Literature Survey: Aflatoxin. In: Phillip Morris Incorporated Research Center report; November 11, 1966; PM Website Doc. No. 1000340449. ………12

O’Neill IK. Relevance to Human Cancer of N-Nitroso compounds, tobacco smoke and mycotoxins. Lyon, France: International Agency for Research on Cancer; 1991. ………27

Park DL, Lee LS. New perspectives on the ammonia treatment for decontamination of aflatoxins. In: A Perspective on Aflatoxin in Field Crops and Animal Food Products in the US: A Symposium; National Technical Information Services, Springfield, VA. 1990; 127-137……… 25

Park J, Ren Q, et al. p53 mutations in oral tumors are associated with specific CYP1A1 and GSTM1 polymorphic genotypes and patient tobacco use. Proc Amer Assoc Cancer Res. 1998; 39 # 1250………15

Peedin G, Smith D, Yelverton F, Melton T, Boyette M. Flue cured tobacco. N Carolina Coop Ex Svc 1993;145-148. ………5, 13

Pier AC, McLoughlin ME. Mycotoxic suppression of immunity. In: Lacey J. ed. Trichothecenes and Other Mycotoxins; John Wiley & Sons, Chichester; 1985: Pages 507-519………28

Prochaska HJ, Yeh Y, Baron P, Polsky B. Oltipraz, an inhibitor of human immunodeficiency virus type 1 replication. Proc Natl Acad Sci. USA. 1993; 90:3953-3957………28

Puisieux A, Lim S, Groopman J, Ozturk M. Selective targeting of p53 gene mutational hotspots in human cancers by etiologically defined carcinogens. Cancer Res 1991;51:6185-6189.4, 14

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Rodgman A. Biological Studies on Tobacco Products: Role of Animal Experimentation in Cancer Research. In: Phillip Morris study; Oct. 1, 1959; PM Website Doc. No.2025018236, 2025018276, 2025018713, 2025018279, 2025018286 ………18

Roe FJC, Salamon MM, Cohen I, Surgon LG. Role of 3,4-benzopyrene in experimental tobacco carcinogenisis. In: Abstracts of Papers, VII International Cancer Congress, 1962; Great Britain, London; PM Website Doc. No. 1005087287………18

Roebuck BD, Liu YL, Rogers AE, Groopman JD, Kensler TW. Protection against aflatoxin B1induced hepatocarcinogenesis in F344 rats by 5-(2-pyrazinyl)-4-methyl-1, 2-dithiole-3thione (oltipraz), predictive role for short-term molecular dosimetry. Cancer Res. 1991; 5501-5506………28

Salmon WD, Newberne PM. Occurrence of hepatomas in rats fed diets containing peanut meal as a major source of protein. Cancer Res. 1963; 23:571-575………22

Stewart LL. Total particulate matter delivery and nicotine delivery of cigarettes…treated with Ammonia, (versus) Untreated Tobacco. In: Phillip Morris study; Dec. 23, 1958; PM Website Doc. No. 1001920430……… 17

Townsend R. In: Minnesota Medicaid trial transcripts. March 29-30, 1998. ………26 US Dept. Labor, OSHA. Indoor air quality: proposed rule. Federal Register. 1994; 59/65:15988………24

Walsh AA, Hsieh DPH, Whitehead WE, Rice RH. Aflatoxin toxicity in cultured epidermal cells: Stimulation by TCDD. Toxicologist. 1992; 12: 207 ………24

Weider R, Wogan GN, Shimkin MB. Pulmonary tumors in strain “A” mice given injections of aflatoxin B1. J Natl Cancer Inst. 1968; 40:1195-1197………22

Weissman G. Benzpyrene research. In: Phillip Morris Interoffice Correspondence; Sept. 16, 1959; PM Website Doc. No. 1001882395………18

Wild CP, Pionneau F, Montesano R, Muitiro CF, Chetsanga CJ. Aflatoxin detected in human breast milk by immunoassay. Int J Cancer. 1987; 40:328-333………27

Wild CP, Umbenhauer D, Chapot B, Montesano R. Monitoring of individual human exposure to aflatoxins (AF) and N-nitrosamines (NNO) by immunoassays. J Cell Biochem. 1986; 30:171-179………27

Wogan GN, Newberne PM. Dose-response characteristics of aflatoxin B1 carcinogenesis in the rat. Cancer Res. 1967; 27:2370-2376………22 Wogan, G.N. (1966). Chemical nature and biological effects of the aflatoxins. Bacteriol. Rev. 30, 460-470………8

Wogan, G.N. (1973). Aflatoxin carcinogenesis. Methods Cancer Res. 7, 303-344………8

Wogan, G.N., and Paglialunga, S. (1974). Carcinogenicity of synthetic aflatoxin M1 in rats. Food Cosmet. Toxicol. 12, 381-384………8

Wogan, G.N., Edwards, E.S., and Shank, R.C. (1967). Excretion and tissue distribution of radioactivity from aflatoxin B1-14-C in rats. Cancer Res. 27, 1729-1736. ………8

Wogan, G.N., Edwards, G.S., and Newberne, P.M. (1971). Structure-activity relationships in toxicity and carcinogenicity of aflatoxin and analogs. Cancer Res. 31, 1936-1942………8

Wood NB, Caldarelli DD, et al. Mutation of p53 in Squamous Cell Cancer of the Head and Neck: Relationship to Tumor Cell Proliferation. Laryngoscope. 1997; 107/6:827-33………15

Yao Y, Hoffer A, Chang C, Puga A. Dioxin activates HIV-1 gene expression by an oxidative stress pathway requiring a functional cytochrome P450 CYP1A1 enzyme. Env Health Persp. 1995; 366………28

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I. INTRODUCTION

After a nine month trial, this Court issued its Memorandum Opinion and Order (Op.) on August 17, 2006 finding Defendants liable for violations of the Racketeer Influenced and Corrupt Organizations Act (“RICO”). 18 U.S.C. § 1961, et seq. Among myriad unlawful activities, the Court found that Defendants had engaged in a deliberate, decades-long campaign to deceive the public concerning the adverse health effects of smoking, cigarette addictiveness and Defendants’ manipulation of cigarette contents to enhance addictiveness, the effects of secondhand smoke, and the true health effects of “light” cigarettes. Thus, the Court found that “each and every one of these Defendants repeatedly, consistently, vigorously – and falsely – denied the existence of any adverse health effects from smoking,” Op. at 330, and made similar findings on these other matters. In light of the Court’s findings that “Defendants have made false, deceptive, and misleading public statements about cigarettes and smoking from at least January 1954, when the Frank Statement was published up until the present,” id. at 1632, among other remedies the Court has ordered:

Defendants to make corrective statements about addiction (that both nicotine and cigarette smoking are addictive); the adverse health effects of smoking (all the diseases which smoking has been proven to cause); the adverse health effects of exposure to [environmental tobacco smoke] ETS (all the diseases which exposure to ETS has been proven to cause); their manipulation of physical and chemical design of cigarettes (that Defendants do manipulate design of cigarettes in order to enhance the delivery of nicotine); and light and low tar cigarettes (that they are no less hazardous than full-flavor cigarettes).

Id. at 1636. The final judgment and remedial order have been stayed pending appeal. No. 065267 (D.C. Cir., Oct. 31, 2006).

While Defendants were producing the misinformation described above, Defendants legal counsel were advising against producing a “safer” cigarette, “as that would create

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substantial legal concerns.” Op. at 1413. This brief contains evidence that Defendants knew, or should have known, of one particular method of making a safer cigarette but suppressed this information. Indeed, but for documents uncovered in this and related litigation, the information would likely have remained suppressed.

This Brief shows that Defendants knew, or should have known, that aflatoxin, a potent carcinogen, was a contaminant of tobacco products; that aflatoxin was a substantial source of the harm caused by tobacco products; and, that methods of neutralizing aflatoxin would have made tobacco products safer. While other issues before this Court are now under appellate review, this Brief urges the Court to consider aflatoxin contamination. Otherwise this highly significant public health issue will escape judicial review. Defendants have, and will continue, to make unsafe tobacco products by failing to publicly recognize and neutralize aflatoxin contamination.

II. BACKGROUND

A. Tobacco, Aflatoxin, Fungal Toxins, Ammonia, And Human Disease

Aflatoxins are toxins produced by fungi that invade agricultural commodities under warm and wet storage conditions after harvesting. Aflatoxin was first identified in 1960 as one of the most potent carcinogens known, and has been recognized as a teratogen (agent causing malformation of embryos), mutagen, carcinogen, immunosuppressant, and potent inhibitor of protein synthesis. The US Food and Drug Administration (FDA) began regulating aflatoxin on agricultural commodities, such as peanuts, corn, and grains, in 1966. Federal and state laws prohibit interstate shipment of contaminated aflatoxin commodities exceeding 20 parts per billion (ppb) (0.5 ppb for milk).

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Aflatoxin causes mutations in the p53 tumor-suppressor gene as well as ras mutations, which are involved in the majority of human cancers. A link between aflatoxin and tobacco products is suggested by their similar effects on human subjects. Tobacco-related cancers, including those associated with environmental tobacco smoke (ETS), often show the same p53 mutations associated with aflatoxin exposure. Another link is the use of ammonia, used in neutralizing aflatoxin contamination and used by the tobacco industry. This is explained below.

The mycotoxin aflatoxin B1 (AFB1) is known to mutate the p53 tumor-suppressor gene and to cause ras mutations. Dietary exposure to AFB1 indicates it is a hepatotoxin and hepatocarcinogen, specifically causing p53 mutations at codon 249. Aflatoxin has the potential in primary and secondary smoke to be a potent carcinogen, mutating the p53 tumor suppressor gene that is often associated with smoking- and chewing tobacco-related cancers.

Aflatoxin has been shown to cause cancer in every animal model and cellular system studied, and to form adducts in the p53 tumor-suppressor gene that mutates in approximately half of all human cancers. Cherpillod and Amstad showed that AFB1 binds to the middle and third positions of p53 codon 248, inducing G-T transversions associated with lung cancer, and binds strongly to the third base pair of codon 249, generating a G-T transversion in a liver cancer mutational hotspot. Cherpillod P, Amstad PA. Benzo(a)pyrene-induced mutagenesis of p53 hot-spot condons 248 and 249 in human hepatocytes. Molecular Carcinogenesis 1995;13:15-20. Benzopyrene has been shown to bind to positions in codon 248, but has not been shown to target codon 249. These codons are adjacent, and carcinogenic targeting is presently not well-understood; it has been suggested that targeting is affected by the positions of different nucleotides in short sequence. Puisieux A, Lim S, Groopman J, Ozturk M.

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Selective targeting of p53 gene mutational hotspots in human cancers by etiologically defined carcinogens. Cancer Res 1991; 51:6185-6189.

“G:C to T:A transversions are the most frequent substitutions observed in cancers of the lung, breast, esophagus and liver,” states Dr. Curtis C. Harris of the National Cancer Institute (NCI). “G to T transversion is more common in lung cancers from smokers when compared to never smokers.” Harris CC. 1995 Deichmann lecture — p53 tumor suppressor gene: at the crossroads of molecular carcinogenesis, molecular epidemiology and cancer risk assessment. Toxicology Letters 1995; Vol.82/83:1. Donnelly and coworkers state, “In addition to being a potent hepatocarcinogen, aflatoxin B1 (AFB1) is a pulmonary carcinogen in experimental animals, and epidemiological studies have shown an association between AFB1 exposure and lung cancer in humans.” Donnelly P, Stewart R, Ali S, Conlan A, Reid K, Petsikas D, et al. Biotransformation of aflatoxin B1 in human lung. Carcinogenesis 1996; Vol.17 No.11:24872494. In their study, lung tumor samples collected from 76 mice treated with doses of AFB1 showed 100% K-ras mutations.

Lasky and Silbergeld suggest, through study of p53 mutations, that environmental carcinogens are a cause of breast, esophageal, lung, ovarian, pancreatic, prostate, and skin cancers. They state, “In lung cancer p53 mutations have been found in 56% of tissue samples, and in colorectal, esophageal, ovarian, pancreatic, and skin cancers, prevalences of 44-50% have been reported.” Lasky T, Silbergeld E. p53 mutations associated with breast, colorectal, liver, lung, and ovarian cancers. Env Health Persp 1996; Vol.104 No.12: 1324-1334. They suggest G to T transversions in breast and lung cancers are caused similarly by exogenous mutagenic chemicals. Aflatoxin from primary smoke and ETS is the likely carcinogen, as these cancers are more often associated with tobacco use.

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More recently, p53 mutations have been found in ETS lung cancer patients. A study done by Husgafvel-Pursiainen and associates investigated the presence of mutations in the p53 gene in samples of lung cancer patients who had never smoked, but who had reported a detailed history of exposure to ETS. “Although based on a relatively small number of mutated lung cancer cases among non-smokers, our findings are consistent with a carcinogenic effect of ETS on the human lung,” the authors state. Husgafvel-Pursiainen K, Benhamou S, Kannio A, Nyberg F, Mukeria A, Constantinescu V, et al. p53 mutations in lung cancer among nonsmokers exposed to environmental tobacco smoke. Proc Amer Assoc Can Res 1998;39.

As mentioned above, the FDA regulates aflatoxin in food commodities. With respect to tobacco crops, however, neither the FDA or any other organization monitors aflatoxin levels. Ignorance with respect to the level of tobacco contamination by aflatoxin and lack of a clear FDA role in regulating the aflatoxin levels has contributed to the public health catastrophe.

The tobacco industry heavily imports cheaper tobacco from tropical countries such as Brazil and Zimbabwe, in which the level of aflatoxin contamination is also unknown. Presently, in North Carolina alone, the flue-cured tobacco stabilization board has 195 million pounds of tobacco stored for sale, where it may remain for years and become contaminated. Peedin G, Smith D, Yelverton F, Melton T, Boyette M. Flue cured tobacco. N Carolina Coop Ex Svc 1993; 145-148. Contamination of tobacco may occur during extended storage time as well as during the curing process, yet there is little agricultural literature on this subject.

Since the mid-1950s, the tobacco companies have been aware that ammonium-based compounds neutralize benzpyrene compounds. Upon the discovery of aflatoxin in 1960, and chemosynthesis by Phillip Morris in 1966, the tobacco industry was likely aware that ammonia

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neutralized aflatoxin as well. Aflatoxin is 200 times more carcinogenic than benzpyrene and decomposes at 269°C, well above the combustion temperature of an idling cigarette.

RJR documents indicate that as early as 1968, collaborating researchers at the Wisconsin Alumni Research Foundation found a 100% carryover of aflatoxin from combusted tobacco.1 The heat stability of aflatoxin may explain studies showing related compounds, polychlorinated dibenzofurans, in ETS at levels two to ten times higher than those in mainstream smoke, which is combusted at higher temperatures. Aflatoxins are chemically classified as dibenzofurofurans, which are highly oxygenated heterocyclic compounds, and as such easily would be amenable to deactivation by a catalyst such as palladium. Significantly, the Liggett Group developed a less hazardous cigarette in 1977 using a palladium catalyst that essentially reduced the biological activity of the smoke condensate to zero, but it was never marketed (see p. 26 below).

Aflatoxin is metabolized to the active carcinogen — the epoxide — by benzpyrene, a product of combustion. Use of smokeless tobacco products often leads to oral cancers in a few years, indicating that benzpyrene is not the responsible compound in these cases. Uncombusted aflatoxin may be a causal agent or promoter of the early onset of oral malignancies, as p53 mutations have been found in tumors in proximity to the oral cavity.

The above described studies strongly suggest that the genetic mutations known to be associated with aflatoxin are the same mutations often associated with the use of tobacco products. Aflatoxin is more than likely a causal agent or promoter of tobacco-associated cancers. The advancing technology of molecular epidemiology will presumably confirm this

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1 Senkus M. Re: meeting with Mr. P. Derse, Director, Wisconsin Alumni Research Foundation (WARF), Madison, Wisconsin. In: R.J. Reynolds report. 1968; Bates No. 501868781:1

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theory in the near future, with significant repercussions for public health and the tobacco industry. From Medscape General Medicine, September 1999. Kerry Scott Lane M.D.

Technology to prevent, remediate, and terminally test for these toxins, developed by the author of this Brief, is currently available for a fraction of the cost of the morbidity and mortality it will prevent. Lane K. Method and system for continuous assay and removal of harmful toxins during processing of tobacco products, 1997; U.S. Patents 6,058,940, 6,637,438, 6,786,221 and pending. The author also believes tobacco can be made safer simply by FDA regulation of levels of mycotoxin and aflatoxin contamination. The FDA currently regulates all other susceptible agricultural commodities.

B. Defendants’ Experts Remain Silent About Aflatoxin Danger

Defendants’ experts Drs. Townsend and Appleton had knowledge of aflatoxin’s harmful effects. Dr. Townsend learned of this during his years of employ (see below). Dr. Appleton had extensive knowledge about aflatoxin, having multiple publications in the field. Both remained silent about aflatoxin. A leading expert in aflatoxin research, Dr. Wogan, had been retained by Defendants in the past but did not testify in this trial.

1. Publications of B.S. Appleton Ph.D.- Head Scientist at RJR

a. Appleton, B.S., and Campbell, T.C. (1983). Effect of high and low dietary protein on the dosing and post dosing periods of aflatoxin B1-induced hepatic preneoplastic lesion development in the rat. Cancer Res. 43, 2150-2154.

b. Appleton, B.S., Goetchius, M.P., and Campbell, T.C. (1982). Linear dose response curve for the hepatic macromolecular binding of aflatoxin B1 in rats in very low exposures. Cancer Res. 42, 3569-3662.

2. Testimony of B.S. Appleton Ph.D. in the Tobacco Trial

See www.altria.com, Department of Justice Trial, Live Witness Filings. 7

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3. Retention of Dr. Wogan of MIT

Another of Defendants’ experts, Dr. Wogan of MIT, was one of the individuals who first isolated aflatoxin in 1960 after an outbreak of “Turkey X” disease in England in which 100,000 turkey poults died from ingesting aflatoxin contaminated peanut meal. Dr. Wogan is recognized as the world’s foremost authority on aflatoxin and has authored textbooks and dozens of articles on the subject. While Dr. Wogan was not called to testify, the fact that he has been retained strongly suggests the industry is aware of the problem. Listed below are representative scholarly articles of Dr. Wogan’s work from the text “The Toxicology of Aflatoxins” edited by Groopman and Eaton.

a. Wogan, G.N., and Newberne, P.M. (1967). Dose-response characteristics of aflatoxin B1 carcinogenesis in rats. Cancer Res. 27, 2370-2376.

b. Wogan, G.N., Edwards, E.S., and Shank, R.C. (1967). Excretion and tissue distribution of radioactivity from aflatoxin B1-14-C in rats. Cancer Res. 27, 1729-1736.

c. Wogan, G.N., Edwards, G.S., and Newberne, P.M. (1971). Structure-activity relationships in toxicity and carcinogenicity of aflatoxin and analogs. Cancer Res. 31, 1936-1942.

d. Wogan, G.N. (1966). Chemical nature and biological effects of the aflatoxins. Bacteriol. Rev. 30, 460-470.

e. Wogan, G.N. (1973). Aflatoxin carcinogenesis. Methods Cancer Res. 7, 303344.

f. Wogan, G.N., and Paglialunga, S. (1974). Carcinogenicity of synthetic aflatoxin M1 in rats. Food Cosmet. Toxicol. 12, 381-384.

4. Testimony of David E. Townsend

Dr. Townsend spent 27 years with his employer and was obviously familiar with the evolution of scientific thought in the causality of tobacco related diseases. The associations with the individuals listed below which he cites in his deposition illustrate his certain knowledge of aflatoxin issues.

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. a. Retention Of Gerald Wogan Ph.D.-The individual who first identified Aflatoxin. Townsend deposition pg. 135, line 22.

b. Citation of Dr. Tso-Author of one of the early aflatoxin articles published in the journal Beitr.Tabakforschung in 1967 in German where it was not seen by the English speaking media. Townsend deposition pg. 12, line 11.

c. Citation of Ernest Wynder-. Wynder wrote many of the now revealed documents in the early 1960s when tobacco scientists where looking at tobacco disease causality. He wrote in 1963 Benzpyrene (Bzp) cannot be a cause of cancer from tobacco. By 1964 tobacco lawyers attempted to limit work linking aflatoxin to tobacco disease.

Townsend deposition pg.50, line 1.

d. Citation of Murray Senkus- Senkus authored many of these similar documents including the WARF study showing 100 % carryover of aflatoxin in combustion studies. (see below). Townsend deposition pg.120, line 23.

e. Citation of Thomas Osdene Ph.D., Former Director R&D, PM. Originator of many aflatoxin documents dating to 1966 when he ordered a literature survey on the subject. Days later he received a document with 163 citations. In the Minnesota Medicaid trial he took the Fifth Amendment 135 times. Townsend deposition pg 121, line 3

f. Citation of p53 tumor suppressor gene, K-ras, DNA adducts. P53 was discovered in the late 1980s by Lane at the University of Dundee in Scotland. It is called the “Guardian of the Genome” as it instructs cells that have turned cancerous to die. When it is mutated cancer cells run amok and spread. Aflatoxin is the most prolific chemical to mutate p53. Surely the tobacco scientists know this fact. Townsend deposition pg. 166, Chart.

g. Citation concerning ammonia and tobacco by Townsend. Ammonia is used to decontaminate feedstuffs that have been contaminated with aflatoxin. Ammonia was experimented with by the tobacco companies in 1967. In the early 1970s Philip Morris was using ammonia on Marlboro. Townsend deposition pg. 169, line 22.

h. Citation concerning use of ammonia for other than taste. Generally tobacco companies claim they use ammonia for taste and they vehemently deny they use it to speed nicotine to the brain. This is a contentious argument. What other use could they be using it for?

Townsend deposition pg. 170, line 10.

i. Citation concerning use of ammonia on Winston. Many premium tobacco products are ammoniated. Many are not. Which ones have aflatoxin and

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aflatoxin and mycotoxin producing spores on them?

Townsend deposition pg. 174, line 1.

j. Citation concerning use of ammonia- “we do not use ammonia for that purpose”, concerning free-base ammonia effect. Why do they use it and why did they not explicitly state the reason? Townsend deposition pg.176, line 13.

C. Analysis Of Retrieved Tobacco Documents In The Context Of Aflatoxin Contamination

Aflatoxin, Tobacco, and Ammonia: Cancer’s Missing Link? Tobacco use in the United States today is estimated to account for 450,000 premature deaths annually, and the worldwide toll is increasing ever rapidly as American style marketing takes hold overseas. Approximately half of all tobacco deaths are due to cancers of many types, the predominant being cancer of the lung. Tobacco use is also associated with an increased incidence of breast, colon, pancreas, bladder, mouth, larynx and esophageal cancer, among others. Lasky T, Silbergeld E. p53 mutations associated with breast, colorectal, liver, lung, and ovarian cancers. Env Health Persp, 1996; 104/12:1324-1334. It is generally accepted that prevention of tobacco use coupled with the production of a considerably safer tobacco product would be the single greatest public health measure of our time.

Yet, despite these laudable but difficult to achieve goals, a serious but preventable hazard associated with the use of tobacco has been overlooked. Moreover, the tobacco industrial complex has suppressed and denied the fact that their product is regularly contaminated by one of the most potent carcinogens known, aflatoxin.

The recent legal and legislative attempts to address the issue of tobacco use in this Country have been a step in the right direction but are far from satisfactory. However, one positive result with the advent of the information age and the Internet, is the rapid dissemination of knowledge and the heretofore-concealed tobacco company documents. When

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these documents are pieced together with respect to the role of aflatoxin contamination of tobacco products, the following picture emerges. The industry has known of the potential for their product to be contaminated by mycotoxins, indeed the likelihood that it was and still is, at least as far back as 1965. Blackmore R. Aflatoxin: Food Toxin, In: Phillip Morris memo; May 24, 1965; PM Website Doc. No. 2021551782. Yet tobacco industry lawyers and their outside legal counsel have kept this knowledge suppressed.

There is more evidence. An internal company document from a British American Tobacco R &D Conference of October 26, 1967 stated “concern is expressed over microbiological contamination in concern that the government will require tobacco manufacturers to have conformed to standards similar to those in the food industries.” (To Glantz’ knowledge this never happened.) Glantz S, Slade J, Bero L, Hanauer P, Barnes D. The Cigarette Papers, Univ. of Calif. Press, Online; Berkley, Ca. 1996; Doc. ID 1165.03 Brown and Williamson Collection. www.library.ucsf.edu/toba… cigpapers/.

Still more Phillip Morris documents show an internal memo from 1965 entitled “Aflatoxin: Food Toxin.” The memo goes on to state that aflatoxin, the food toxin produced by the Aspergillus flavus mold, still is of major concern to the Food and Drug officials of the United States and that Aspergillus flavus has not been reported present in moldy tobacco. However, according to the memo, it is possible that this species of Aspergillus could be found in tobacco since this organism has been found in more than one cultivated crop (peanuts or groundnuts, small grains, corn, etc.). An Italian report indicated that Aspergillus flavus spores were present in minor numbers in the air of a tobacco processing plant. The memo concludes: “We shall keep up with the literature on this subject and maintain a file on the mold hazards in

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U.S. food crops.” Blackmore R. Aflatoxin: Food Toxin. In: Phillip Morris memo; May 24, 1965; PM Website Doc. No. 2021551782.

It is significant to note that the Italian study cited was performed in 1959 and many of the fungal species found were capable of aflatoxin production. Lola N. On the Health Conditions of female tobacco workers: an investigation of a modern factory. Italian Tobacco, 1959; 693:431-433.

Significantly, many of the early aflatoxin documents disseminated from Phillip Morris internal memoranda were either written by or to Dr. Thomas Osdene, their lead researcher for some thirty plus years. On November 8, 1966, Dr. Osdene ordered a literature survey on the subject of aflatoxin. Three days later he received a package containing 163 citations, most describing the potent genetically disruptive and toxic effects of aflatoxin from a variety of crops in a myriad of animal models. O’Donohue C. Literature Survey: Aflatoxin. In: Phillip Morris Incorporated Research Center report; November 11, 1966; PM Website Doc. No. 1000340449. The third citation from 1966 was entitled “Food toxins of Fungal Origin. Methodology and Regulatory Aspects”, by an author from the Food and Drug Administration in the journal Food Technology. Flalles D. Food toxins of fungal origin: Methodology and regulatory aspects. Food Technology, 1966; 20:61-pages unknown. PM Website Doc. No. 1000340451.

Incredibly, in the Minnesota Medicaid trial in 1997, Dr. Osdene took the Fifth Amendment 135 times, answering little more than his name and title. He would answer virtually no questions posed to him, in spite of urgings by the present CEO of Phillip Morris, Geoffrey Bible, to be candid.

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It is unknown what Mr. Bible knows of efforts to remediate aflatoxin contaminated commodities and the role of ammonia in this process. However, the newly released documents and other readily available sources hint at the answer. Conspicuous by its absence is any significant study on this subject over the last thirty years.

As stated previously, aflatoxins are produced by fungi that invade agricultural commodities under warm and wet storage conditions after harvesting such as is often found, for instance, in the southeastern United States. Many of the fungal species commonly found worldwide are capable of producing mycotoxins, with aflatoxin the best studied, currently cited in Medline in over 8000 articles since 1966. Aflatoxin was first identified in 1960, and by 1966 was regulated by the Food and Drug Administration on peanuts, corn, grains and the like. Currently, the States and Federal government ban interstate shipment of contaminated aflatoxin commodities if they exceed 20 parts per billion (ppb), and for milk if the level exceeds 0.5 ppb.

Recently in North Carolina alone the flue-cured tobacco stabilization board has 195 millions pounds of tobacco warehoused for ultimate sale when price, supply and demand are harmonized. In addition there are over 50,000 bulk curing barns in North Carolina, yet there is not a word in the tobacco agricultural literature about the potential for aflatoxin contamination of this stored commodity. When tobacco is cured in a barn it may remain there for years and the state of disrepair of many tobacco barns is a matter of concern. Peedin G, Smith D, Yelverton F, Melton T, Boyette M, et al. Flue Cured Tobacc,. N. Carolina Coop Ex Svc, N. Carolina St. Univ. 1993; 145-148.

In 1996 the corn crop in North Carolina was stricken particularly hard by aflatoxin contamination and the State Agricultural extension service urged corn farmers to take their contaminated corn to the regional tobacco auction houses so it could be tested for aflatoxin.

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McMillian WW, Widstrom NW, Beaver RW, and Wilson DM. Aflatoxin in Georgia: Factors associated with its formation in corn. In: Aflatoxin in Corn–New Perspectives; Iowa Agri and Home Eco Exper Sta; Iowa St Univ. 1991; 599:329-334. To the tobacco insiders, the corn contamination would have been an unmistakable warning of aflatoxin contamination in tobacco. Like they do on corn, Aspergillus flavus and other mycotoxin producing fungi can inhabit a microbiological niche on tobacco.

Aflatoxin has been found to be a potent pulmonary carcinogen in grain handlers and others exposed to contaminated dusts, and DNA-aflatoxin adducts have been found in these patient’s lung tissue. Dvorackova I, Stora C, Ayraud N. Evidence of Aflatoxin B1 in Two Cases of Lung Cancer in Man. J Can Res. 1981; 100:221-224; Burg WR, Shotwell OR, Saltzman BE. Measurements of airborne aflatoxins during the handling of contaminated corn, Ann Ind Hyg. 1981; 42:1-11; Dvorackova I. Aflatoxins and Human Health, Boca Raton, Fl: CRC Press; 1990:135-150; Hesseltine CW, Shotwell OL, Kwolek WF, Lillehoj EB, Jackson WK, Bothast RJ. Aflatoxin occurrence in 1973 corn at harves,. II. Mycological studies. Mycologia. 1976; 68:341-353; Autrup H, Essigman JM, Croy RG, Trump BF, Wogan GN, Harris CC. Metabolism of aflatoxin B1 and identification of the major aflatoxin B1-DNA adducts formed in cultured human bronchus and colon, Cancer Res. 1979; 39:694-698.

Additionally, work by Groopman et.al. in 1991 showed DNA-carcinogen adducts at codon 249 of the p53 tumor suppressor gene in 45% of lung cancers. Puisieux A, Lim S, Groopman J, Ozturk M. Selective targeting of p53 gene mutational hotspots in human cancers by etiologically defined carcinogens, Cancer Res. 1991; 51:6185-6189; Garner RC, Dvorackova I, Tursi F. Immunoassay procedures to detect exposure to aflatoxin B1 and benzo(a)pyrene in animals and man at the DNA level. Int Arc Occup Environ Health. 1988;

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60:145-150. This same site is often mutated by aflatoxin in hepatomas, where liver cancer is believed to be caused often by aflatoxin. McGlynn KA, Rosvold EA, et al, Susceptibility to hepatocellular carcinoma is associated with genetic variation in the enzymatic detoxification of aflatoxin B1. Proc Natl Acad Sci. 1995; 92:2384-2387.

There is no known safe dose of aflatoxin. Levels below one part per billion can cause cancer. Aflatoxin is more actively metabolized to the active carcinogen, the epoxide, by benzpyrene, the carcinogen heretofore suspected of being most likely responsible for cancer associated with tobacco use. Ma X, Gibbons J, Babish J. Benzo(e)pyrene pretreatment of immature, female C57BL/6J mice results in increased bioactivation of aflatoxin B1 in vitro, Toxicology Letters. 1991; 59:51-58. Yet aflatoxin is 200 times more carcinogenic than benzpyrene, a product of combustion.

Benzpyrene has been considered a principal carcinogen in tobacco. Uncovered Brown and Williamson documents suggest aflatoxin, not benzpyrene, as the causative agent. Is has been known that oral use of tobacco products often leads to cancers after only several years. It is difficult to implicate benzpyrene in this phenomenon. Uncombusted aflatoxin, however, may be the cause as mutations of p53 are often found in cancers of the oral cavity and throat. Park J, Ren Q, et al. p53 mutations in oral tumors are associated with specific CYP1A1 and GSTM1 polymorphic genotypes and patient tobacco use, Proc Amer Assoc Cancer Res. 1998; 39 # 1250; Wood NB, Caldarelli DD, et al. Mutation of p53 in Squamous Cell Cancer of the Head and Neck: Relationship to Tumor Cell Proliferation, Laryngoscope. 1997; 107/6:827-33; Karja VJ, Syrjanen KJ, Kurvinen AK, Syrjanen SM. Expression and Mutations of p53 in Salivary Gland Tumors. J of Oral Path & Med. 1997; 26/5: 217-23.

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Brown and Williamson data strongly support this hypothesis but these data were kept secret. Documents from August 1967 state, “These results would certainly indicate that reduction of benzpyrene does not necessarily result in a decrease in mouse skin activity, even though Wynder and others might like to think this is true. Actually, the data from the initial Harrowgate experiment would indicate that the benzpyrene fraction can account for, at most, one third of the activity of the total condensate…” Griffith R. Report to executive committee. The Brown and Williamson Collection Online; Univ. Calif., San Francisco. 1965; Doc ID 1105.01. Benzpyrene research relative to tobacco began in earnest after it was reported by Alvord and Cardon in the British Journal of Cancer in 1955 that ammonium based compounds were able to neutralize the carcinogenic effects of benzpyrene in cigarette smoke condensates. Alvord ET, Cardon SZ. The Inhibition of Formation of 3-4 Benzpyrene in Cigarette Smoke, Brit J Cancer. 1956; 10: 498-503. On May 14, 1956, R.C. Hockett of Phillip Morris (PM) wrote “[H]e has received a letter from Sir Robert Sinclair in which he inquires whether active efforts are under way in this country to remove 3-4 benzpyrene from tobacco. He writes: “(he) does not believe there is any 3- 4benzpyrene in tobacco … except from soot… etc.… Another conceivable possibility…is some trace of benzpyrene might reach tobacco leaves during…fluecuring. The benzpyrene reported by the British and a few Americans is claimed to be present in the condensed smoke. It is presumed to be formed during smoking by the action of heat on some of the constituents on tobacco under conditions where the oxygen supply is not sufficient to burn these constituents completely to carbon dioxide gas and water. . . .Sir Robert speaks of neutralization of benzpyrene. So far as chemists know, there is no method of neutralizing a compound of this class. It is already neutral chemically and there is no accepted knowledge in general as to how the biological activity of a chemical carcinogen can be neutralized (though

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there are some claims). The only practical course of action open to the technical man at present are removal of benzpyrene from smoke, its destruction, or the prevention of its formation in the first instance. … The development of better biological assay methods for carcinogens, which might be used for purposes outlined above, is one of the main objectives of the Scientific Advisory Board in its present program. It is regarded as a difficult task.… Other possibilities exist. For example benzpyrene may eventually be found to arise on heating chiefly from some specific compound present on tobacco.” Hockett RC. Elimination of Benzpyrene from Tobacco Smoke, In: Phillip Morris memo; May 14, 1956; PM Website Doc. No. 2000756765-67.

A United States Patent was issued in 1958 entitled “Cigarette Wrapper Material and Method of Making Same” which described this technology of ammoniation to neutralize benzpyrene. Hitchcock R, Willoughby, Cardon SZ, Alvord ET. Cigarette wrapper material and method for making same. USPO, 1958; U.S. Patent 2,859,753. Research projects were undertaken by the individual tobacco companies and the Tobacco Institute to remediate this perceived benzpyrene problem. A December 23, 1958 Phillip Morris memo assessed the “Total Particulate Matter Delivery and Nicotine Delivery of Cigarettes…treated with Ammonia, (versus) Untreated Tobacco.” Stewart LL. Total particulate matter delivery and nicotine delivery of cigarettes…treated with Ammonia, (versus) Untreated Tobacco. In: Phillip Morris study; Dec. 23, 1958; PM Website Doc. No. 1001920430.

On Sept. 16, 1959, a document with the letterhead Phillip Morris Interoffice Correspondence on “Benzpyrene Research” states “Further to this, I discussed the problem …and I am in agreement with him that this is an important future area of work. It is basic in nature and is liable to plague us for years to come because of its fundamental aspect. Unless there is work about this which we are not aware, which lessens the likelihood of this becoming

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a major factor; I would think it most sound for the company to have a long-range research project in this area.” Weissman G. Benzpyrene research, In: Phillip Morris Interoffice Correspondence; Sept. 16, 1959; PM Website Doc. No. 1001882395.

On October 1, 1959, a memo was sent from Rodgman to Holtman which stated: “no specific carcinogen has previously been shown in such smoke… Benzpyrene…(is) only feebly (carcinogenic).” Wynder and Wright, by testing various fractions of tar, estimated that there can be no more than one part per million of 3,4-benzpyrene in the total condensate. They state, “We feel that as yet unestablished carcinogens or co-carcinogens are in tobacco tar, since the concentration in which benzpyrene seems to be in cigarette tar is insufficient to account for the observed carcinogenic activity to mouse epidermis.” Rodgman A. Biological Studies on Tobacco Products: Role of Animal Experimentation in Cancer Research. In: Phillip Morris study; Oct. 1, 1959; PM Website Doc. No.2025018236, 2025018276, 2025018713, 2025018279, 2025018286. Furthermore, subsequent researchers were not convinced benzpyrene was a significant contributor to the biological activity associated with tobacco use.

In 1962 Roe et.al, wrote in Abstracts of Papers, VII International Cancer Congress, 1962, Role of 3,4-Benzopyrene in Experimental Tobacco Carcinogenisis, “benzpyrene is a very weak carcinogen and may be, at most, responsible for a small fraction of the cancers associated with cigarette use.” Roe FJC, Salamon MM, Cohen I, Surgon LG. Role of 3,4-benzopyrene in experimental tobacco carcinogenisis, In: Abstracts of Papers, VII International Cancer Congress, 1962; Great Britain, London; PM Website Doc. No. 1005087287. Another document revealed “Most of the biological activity seems to be associated with the fraction containing the polynuclear hydrocarbons” which would include aflatoxin and benzpyrene but not the nitrosamine fraction. Griffith R. Importance of

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benzpyrene versus other PAH’s in Project Janus. The Brown and Williamson Collection, Online; Univ. Calif., San Francisco. 1967; Doc. ID 1101.1.

If these studies were credible one would have to conclude a polycyclic aromatic compound other than benzpyrene was responsible for the majority of biological activity of these cigarette condensate samples. Aflatoxin is the likely culprit. A subsequent study to prove this point by reducing or neutralizing benzpyrene was never performed because “if the experiment showed no protection, but benzo(a)pyrene levels were, in fact, lower, this result would suggest that other carcinogens in the smoke were responsible for the cigarettes’ carcinogenicity.” Glantz SA, Slade J, Bero L, Hanauer P, Barnes. The Cigarette Papers, Univ. of Calif. Press. 1996, p.215. The tobacco industry did not want this carcinogen publicly identified. In March of 1966 a journal article stated, “Aflatoxins by all routes tested (s.c., by mouth in drinking water, and intratrachealy) proved to be effective carcinogens. When aflatoxins were given intratrachealy, 3 of 6 rats developed squamous carcinoma of the trachea. Intratracheal benzpyrene did not lead to the formation of any tumors.” Dickens F, Jones HEH, Waynforth HB. Oral, Subcutaneous and Intratracheal Administration of Carcinogenic Lactones and Related Substances: the Intratracheal Administration of Cigarette Tar in the Rat. Br J Cancer, 1966; 20:134-144. RJR Website Doc. No. 500291239. This study was supported by the Tobacco Research Council and by The British Empire Cancer Campaign. On June 8, 1966, a memo was sent to the law firm representing the tobacco industry, Shook, Hardy, from K. Austin, where “aflatoxins” appeared at the top of the alphabetically arranged list. Austin K. Substances in tobacco alleged to be causes of cancer, respiratory and other diseases, In: RJ Reynolds Center for Tobacco Research memo. June 8, 1966; RJR Website Doc. No. 502429578:1.

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In 1968, a researcher for the Wisconsin Alumni Research Foundation met with RJ Reynolds and reported their work “has shown 100% carryover of aflatoxin from combusted tobacco.” Senkus, M. Meeting with Mr. P. Derse. RJ Reynolds, Feb. 27, 1968; RJR Website Doc. No. 501868781:1. Subsequent letters between RJR and their outside legal counsel, Shook Hardy, Ottman, Mitchell & Bacon reveal a significant level of concern with respect to this finding. Shinn WW. In: RJ Reynolds letter. July 20, 1968; RJR Website Doc. No. 501868751; Ramm HH. In: RJ Reynolds letter. July 25, 1968; RJR Website Doc. No. 501868750.

It is in this context that the revelations by documents posted on the Internet of Phillip Morris “Project 2500” and “Project 1801” can be understood. Project 2500 was produced by Phillip Morris in 1966. DeBardeleben F. The Structure and Synthesis of Aflatoxin B1 and G1, In: Phillip Morris Project Report. Dec. 9, 1966; PM Website Doc. No. 2021551728. Additionally, aflatoxin was synthesized at MIT in 1966, and was manufactured under contract to the Center for Tobacco Research (CTR) by Hoffman-Laroche in 1966. Mitchell GF, et.al. The Total Synthesis of Racemic Aflatoxin B1. Jour of Am Chem Soc, 85: 19, Oct.5, 1966, PM Website Doc. No. 2021551735-37.

Most likely, the tobacco industry required significant quantities of pure aflatoxin in order to learn a technique whereby it could be decontaminated from tobacco, much the same as the industry had done with benzpyrene some ten years previously. Once the chemists and toxicologists had an ample supply of this most deadly of carcinogens on hand, one of the first decontaminating agents they reached for was surely ammonia, as it had worked on benzpyrene. In 1967 a project was underway at Phillip Morris, which utilized ammonia to remove Tar Particulate Material (TPM), thought to contain most of the carcinogenic materials, including aflatoxin, from tobacco. A side effect of this process was removal of nicotine from the tobacco

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materials. Comes HA, Nichols DG, Liquid ammonia extracted bright tobacco. In: Phillip Morris report, Oct. 31, 1967; PM Website Doc. No. 1000704262. Thus, use of ammonia on tobacco was called a “denicotinization process” in what appears to have been a deliberate act of disinformation. In 1970, Phillip Morris Project 1801 demonstrated “that ammonia vapor saturated or impregnated tobacco was puffed successfully.” Deszyck EJ. Summary - Project 1801 activities. In: Phillip Morris memo, January 27, 1970; PM Website Doc. No. 2022232919. The tobacco industry would not call this an “aflatoxin-benzpyrene-neutralization process” as aflatoxin was at that time regulated by the FDA on corns, grains, and other commodities. The tobacco industry had no greater fear than regulation by the FDA, as is the case today some 39 years later. Indeed, even “Independent Counsel” Kenneth Starr represented the tobacco industry in 1995-1996 in an effort to prevent FDA jurisdiction over tobacco.

To the detriment of the public health, the FDA has never had explicit jurisdiction over tobacco and the mycotoxin and aflatoxin contamination of tobacco products, yet an estimated half of all deaths annually associated with tobacco use are attributable to cancer. R.J. Reynolds documents obtained from the Minnesota Medicaid trial stated the “greatest fear” of the company’s top lawyer throughout the 1950s and 1960s “was that RJR would do something that would enable the FDA to assert jurisdiction over cigarettes.” RJ Reynolds Fact Team, Minnesota Medicaid Trial. In: RJ Reynolds Research and Development Activities Fact Team Memorandum; Vol. III; 1985; RJR Website Doc. No. 515873867. “The company’s external scientific research program is controlled, not by its scientists or R&D department, but by its lawyers.” RJ Reynolds Fact Team. Minnesota Medicaid Trial, In: RJ Reynolds Research and Development Activities Fact Team Memorandum; Vol. III; 1985; RJR Website Doc. No. 515873880. “Much of this control was exerted, apparently, through an outside law firm which

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for years has exercised extraordinary influence over RJR research, even to the point of deciding which species of rodent would be used in one research project.” RJ Reynolds Fact Team. Minnesota Medicaid Trial,. In: RJ Reynolds Research and Development Activities Fact Team Memorandum; Vol. III; 1985; RJR Website Bates Nos. 515873880-515873884. The decision of which species of rodent to use in experimental tobacco toxicology studies becomes relevant when one reviews the study undertaken and funded by CTR which engaged the services of Microbiological Associates of Bethesda, Maryland. This study utilized 10,000 mice over a ten- year period beginning in 1974, and cost CTR over $10 million dollars. It was designed to test for tumors in lungs and organs of mice following inhalation of whole cigarette smoke. Yet it is likely the lawyers for CTR knew mice were relatively resistant to the effects of aflatoxins as research on these subjects was published as early as 1967. Wogan GN, Newberne PM. Dose- response characteristics of aflatoxin B1 carcinogenesis in the rat, Cancer Res. 1967; 27:23702376; Cullen JM, Newberne PM. Acute Hepatotoxicity of Aflatoxin, In: Eaton DL, Groopman JD, eds. The Toxicology of Aflatoxins, San Diego, Ca: Academic Press; 1994: 3-26; Weider R, Wogan GN, Shimkin MB. Pulmonary tumors in strain “A” mice given injections of aflatoxin B1, J Natl Cancer Inst. 1968; 40:1195-1197; Salmon WD, Newberne PM. Occurrence of hepatomas in rats fed diets containing peanut meal as a major source of protein, Cancer Res, 1963; 23:571-575; Newberne PM, Butler WH. Acute and Chronic Effects of aflatoxin on the liver of domestic and laboratory animals, A review. Cancer Res. 1969; 29: 236-250; Herrold KM. Aflatoxin induced lesions in Syrian hamsters. Br J Cancer, 1969:23; 655-660.

These and other documents clearly indicate that the potential for aflatoxin contamination was known by the tobacco industry since 1965. In order to keep the FDA from exerting its jurisdiction over tobacco this knowledge of the possibility of contamination of

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tobacco by aflatoxin was suppressed both by neglect and by an active misinformation campaign. Indeed, even as of today, after the largest civil trial in history, aflatoxin is still not recognized as a carcinogen associated with tobacco use, in spite of knowledge of its potent carcinogenic properties. Cordesman, A. Weapons of mass destruction in Iraq: a summary of biological, chemical, nuclear and delivery efforts and capabilities. In: Middle East Program at the Center for Strategic and International Studies; Nov. 14, 1996; Washington, D.C (citing aflatoxin as a potential weapon of mass destruction manufactured and weaponized by Saddam Hussein).

As recently as 1994 internal Phillip Morris documents revealed a proposal for a project entitled “Are mycotoxins present in cured tobaccos?” Hempfling, W. March 31, 1994; Phillip Morris Website Doc. No. 2024111027, 2024111030. These documents place of origin are betrayed by the facsimile numbers on top of the document and the word Inbofan, the secret facility in Germany where Phillip Morris did most of their research which they wished to keep from the prying eyes of American trial lawyers. The proposal described a multi-million dollar effort to ascertain the level of aflatoxin and mycotoxin contamination of their product. Unfortunately, the results of this study are unavailable to health researchers at the present time, if indeed the project was ever undertaken. As with many of the tobacco industry’s deepest secrets, internecine competition, desire to secure market share and fear of catastrophic regulation have conspired to keep answers to many important questions from the public. Indeed, for many relevant subjects, researchers are not well versed enough in the ways of the industry to know which questions to ask.

Aflatoxins are relatively heat stable compounds, decomposing at 269 degrees centigrade, well above the combustion temperature of an idling cigarette. Langer AM, Nolan

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RP, Bowes DR, Shirey SB. Inorganic Particles Found in Cigarette Tobacco, Cigarette Ash, and Cigarette Smoke. In: Wehner AP, Felton D. Biological interaction of inhaled mineral fibers and cigarette smoke. Proceedings of an International Symposium/Workshop, Columbus, OH: Battelle Press; 1989: 430. Polychlorinated dibenzo-p-dioxins (PCDDs) and dibenzofurans (PCDFs) have been found in sidestream or environmental smoke (ETS) at levels two to ten times that of mainstream smoke, which is combusted at higher temperatures. Lofroth G, Zebuhr Y. Polychlorinated dibenzo-p-dioxins (PCDDs) and dibenzofurans (PCDFs) in mainstream and sidestream cigarette smoke. Env Contam and Tox, 1992; 48:789-794; US Dept. Labor, OSHA. Indoor air quality: proposed rule. Federal Register, 1994; 59/65:15988. These compounds have been shown to increase aflatoxin-DNA adducts in human epidermal cells twenty-fold, implicating dioxin in stimulation of the active metabolite of aflatoxin, the epoxide. Walsh AA, Hsieh DPH, Whitehead WE, Rice RH, Aflatoxin toxicity in cultured epidermal cells: Stimulation by TCDD. Toxicologist, 1992; 12: 207. Aflatoxins are chemically classified as dibenzofurofurans and are highly oxygenated heterocyclic compounds, and as such would be easily amenable to deactivation by a catalyst such as palladium. Liggett Corporation even had developed a safer cigarette in” Project XA” in 1977 which used a palladium catalyst which essentially reduced the biological activity of the smoke condensate to zero. This product was never developed because the companies with larger market share threatened retaliation as this might indicate the product in general was unsafe and might lead to unlimited litigation.

Generally, aflatoxin is decontaminated on foodstuffs by simple ammoniation, either in a liquid or gaseous form, or by contacting the product with a strong base or alkali. Park DL, Lee LS. New perspectives on the ammonia treatment for decontamination of aflatoxins, In: A Perspective on Aflatoxin in Field Crops and Animal Food Products in the US: A Symposium;

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National Technical Information Services, Springfield, VA. 1990; 127-137; Norred W, Morrissey R. Effects of long-term feeding of ammoniated aflatoxin-contaminated corn to Fischer 344 rats. Tox and App Pharm, 1983; 70:96-104. This technology dates to 1969 for foodstuffs as evidenced by U.S. Patent No.3, 429,709 assigned to the United States of America. Subsequent to this patents were granted in 1970 and 1974 for a technique whereby ammoniated cigarette paper was used to encircle the tobacco cylinder. Michelson I, Smoking composition of reduced toxicity and method of making same, USPO. 1970; U.S Patent 3,631,865; Michelson I, Method of making a cigarette of reduced biological damage capability, USPO. 1974; U.S Patent 3,782,393. This technology specifically claimed a 45% reduction in biological activity, a euphemism for cancer production ability, yet it is not apparent from the patent text if the cause of the biological activity was known to the inventor. Coincidentally, this 45% reduction in biological activity closely approximates the proportion of lung cancers which show the prototypical genetic change in p53 caused by aflatoxin.

Thus the technology to neutralize aflatoxin was generally known as of 1969 and indeed, the ammoniation of cigarette paper was patented as early as 1958. Clearly, ammoniation of tobacco products was initially performed in an effort to eliminate first benzpyrene, and subsequently aflatoxin, when it became apparent aflatoxin was the far more deadly of the two compounds. The tobacco industry apparently invented the aflatoxin-ammoniationneutralization process but did not patent this technology as patents require full disclosure of all relevant points. The industry dared not reveal their product was contaminated by the most potent carcinogen ever identified.

When these documents are viewed in a historical context in becomes strikingly clear the use of ammonia to enhance the nicotine delivery to the brain of the smoker was a secondary or

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tertiary goal after 1) detoxification of benzpyrene and aflatoxin, and 2) reduction of Tar Particulate Matter (TPM), which contained most of the carcinogens. A side effect of ammonia use resulted in “denicotinization.” Comes HA, Nichols DG, Liquid ammonia extracted bright tobacco. In: Phillip Morris report, Oct. 31, 1967; PM Website Doc. No. 1000704262. Consumer research had shown smoker satisfaction had been enhanced by a known ration of tar to nicotine. If tar was removed to eliminate some carcinogens, some proportion of nicotine needed to be removed also. This fact has important implications for future regulation of nicotine by the FDA. Neutralization of aflatoxin by ammonia results in loss of nicotine. The FDA should regulate the amount of nicotine that is added back in the reformulation process.

How widespread was ammonia use by the tobacco industry? Phillip Morris began using ammonia on tobacco in the late 1960s. A Brown and Williamson researcher stated “Ammonia does many good things, the secret to Marlboro is ammonia.” Editorial, Tobacco’s outrageous, unethical tactics a threat to public health, In: Sun Sentinel Editorial; Fort Laud, Fl.; Feb. 10, 98. By 1984, the tobacco industry was utilizing 5 million pounds of ammonia annually, and by 1989 usage had climbed to ten million pounds. Covington and Burling (Attorneys) to Phillip Morris Legal Dept. 4/17/86, Ammonia use. Phillip Morris Website Doc. No. 2056136056 pg. 2 of 11. In the Minnesota Medicaid trial when a lead researcher for RJ Reynolds was asked when RJR began using ammonia on tobacco products he acknowledged “from ‘74 to ‘79, the only brand that had any ammoniated reconstituted sheet was Camel Filter.” When asked what proportion of their product was ammoniated as of late, the researcher responded, “In 1994… thirty nine per cent of our products we sold had ammoniated reconstituted tobacco.” Townsend R. In: Minnesota Medicaid trial transcripts. March 29-30, 1998. The prevailing sentiment among the lay media is that ammoniation was performed to increase the free base of

26

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the nicotine, thus allowing a quicker and more intense high from a given amount of nicotine. Nicotine was coincidentally the addictive component of their product. The fact that ammonia neutralized aflatoxin was the prime intent of its use, with the nicotine boost a fortuitous effect, that also had significant implications for these companies final product design. Chapman R. Method for detoxifying foodstuffs. USPO, 1992; 1/21:U.S. Patent 5,082,679.

Thus the tobacco industry can no longer credibly deny their product does not cause cancer, and that aflatoxin does not play a substantial or possibly majority role in tobacco induced carcinogenesis. Wild CP, Umbenhauer D, Chapot B, Montesano R. Monitoring of individual human exposure to aflatoxins (AF) and N-nitrosamines (NNO) by immunoassays. J Cell Biochem, 1986; 30:171-179; O’Neill IK. Relevance to Human Cancer of N-Nitroso compounds, tobacco smoke and mycotoxins. Lyon, France: International Agency for Research on Cancer; 1991. The secondhand smoke controversy should similarly end at once as the entire civilian population of the United States may be inhaling aflatoxin in unknown but potentially harmful quantities when exposed to this toxin in enclosed spaces.

The Defendant’s suppression of aflatoxin in tobacco has also left unanswered other questions of paramount importance to the future health of the hundreds of millions of smokers worldwide, their dependents and their unborn children. Wild CP, Pionneau F, Montesano R, Muitiro CF, Chetsanga CJ. Aflatoxin detected in human breast milk by immunoassay. Int J Cancer, 1987; 40:328-333 Denning DW, Allen R, Wilkinson, AP, Morgan MRA. Transplacental transfer of aflatoxin in humans, Carcinogenesis, 1990; 11:1033-1035. Of particular concern are those crippled by disease of immune deficiency as benzpyrene and aflatoxin have been shown to increase HIV titers 500% and 400% respectively in vitro, which is in agreement with conventional clinical wisdom. Yao Y, Hoffer A, Chang C, Puga A.

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Dioxin activates HIV-1 gene expression by an oxidative stress pathway requiring a functional cytochrome P450 CYP1A1 enzyme. Env Health Persp, 1995; 366; Hendrickse RG, Maxwell SM. Heroin addicts, AIDS, and aflatoxins, Brit Med J. 1988; 296:1257. Immunosuppression by aflatoxin is prevented by the chemo-protective drug oltipraz, which also inhibits HIV replication. Pier AC, McLoughlin ME. Mycotoxic suppression of immunity, In: Lacey J. ed. Trichothecenes and Other Mycotoxins; John Wiley & Sons, Chichester; 1985: Pages 507-519; Prochaska HJ, Yeh Y, Baron P, Polsky B. Oltipraz, an inhibitor of human immunodeficiency virus type 1 replication. Proc Natl Acad Sci, USA. 1993; 90:3953-3957; Roebuck BD, Liu YL, Rogers AE, Groopman JD, Kensler TW, Protection against aflatoxin B1-induced hepatocarcinogenesis in F344 rats by 5-(2-pyrazinyl)-4-methyl-1, 2-dithiole-3-thione (oltipraz), predictive role for short-term molecular dosimetry. Cancer Res. 1991; 5501-5506.

D. Suppression of Knowledge of Harmful Health Effects and Emerging Diseases- AIDS

Aspergillus species can produce the mycotoxin Gliotoxin, which instantly kills CD4 cells in vivo. Low CD4 cell counts are the hallmark of AIDS. Aspergillus spores are aerosolized from tobacco combustion.

Aspergillus fumigatus (AF) is a ubiquitous mold and is the most common cause of invasive aspergillosis, an important source of morbidity and mortality in immunocompromised hosts. Using cytokine flow cytometry, we assessed the magnitude of functional CD4+ and CD8+ T-cell responses following stimulation with Aspergillus antigens. Relative to those seen with cytomegalovirus (CMV) or superantigen stimulation, responses to Aspergillus antigens were near background levels. Subsequently, we confirmed that gliotoxin, the most abundant mycotoxin produced by AF, was able to suppress functional T-cell responses following CMV or staphylococcal enterotoxin B (SEB) stimulation. Additional studies demonstrated that crude

28

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AF filtrates and purified gliotoxin inhibited antigen-presenting cell function and induced the preferential death of monocytes, leading to a marked decrease in the monocyte-lymphocyte ratio. Analysis of caspase-3 activation confirmed that gliotoxin preferentially induced apoptosis of monocytes; similar effects were observed in CD83+ monocyte-derived dendritic cells. Importantly, the physiologic effects of gliotoxin in vitro were observed below concentrations recently observed in the serum of patients with invasive aspergillosis. These studies suggest that the production of gliotoxin by AF may constitute an important immunoevasive mechanism that is mediated by direct effects on antigen-presenting cells and both direct and indirect effects on T cells. Aspergillus fumigatus suppresses the human cellular immune response via gliotoxin- mediated apoptosis of monocytes. Blood. 2005; 105(6): 2258-65 (ISSN: 0006-4971) Stanzani M; Orciuolo E; Lewis R; Kontoyiannis DP; Martins SL; St John LS; Komanduri KV. Transplant Immunology Section, Department of Blood and Marrow Transplantation, MD Anderson Cancer Center, SCRB 3.3019, Unit 900, 7455 Fannin St, Houston, TX 77030, USA.

E. The toxicology of aflatoxins as a basis for public health decisions

Aflatoxins have been extensively studied with respect to their mechanisms of toxicity. An understanding of metabolism, DNA adduct induction, mutagenicity and carcinogenicity has been paralleled by the development of biomarkers of aflatoxin exposure and biological effects (e.g. mutations) applied to human populations. The improvements in exposure assessment and their application in prospective epidemiological studies and the demonstration of a specific mutation in the TP53 gene in hepatocellular carcinomas from areas of high aflatoxin exposure have contributed significantly to the classification of aflatoxins as human carcinogens. In addition to establishing the carcinogenicity of aflatoxins in humans, understanding molecular mechanisms of action has provided the scientific rationale for prevention strategies, including primary and chemoprevention approaches. Overall, integrated, multidisciplinary research on

29

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aflatoxins has provided the platform on which to base decisions regarding acceptable exposures and priorities for interventions to reduce human risk in a public health context. From C.P. Wild and P.C. Turner , Molecular Epidemiology Unit, Epidemiology and Health Services Research, Algernon Firth Building, School of Medicine, University of Leeds, Leeds LS2 9JT, UK

F. Aflatoxins and Smoke Studies

Methods were developed to study sidestream smoke produced from machine-smoked cigarettes. These methods show aflatoxin is carried by sidestream smoke in significant amounts. Journal of Chromatography A, 1083 (2005) 127–132 Determination of aflatoxin B1 in sidestream cigarette smoke by immunoaffinity column extraction coupled with liquid chromatography/mass spectrometry. From Leslie E. Edinboro, H. Thomas Karnes, Department of Pharmaceutics, Virginia Commonwealth University, School of Pharmacy, P.O. Box 980533, 410 N 12th Street, Richmond, VA 23298-0533, USA.

G. Aflatoxin Remediation by Ammoniation

The effectiveness of ammonia treatment in reducing the chronic toxicity of aflatoxin- contaminated corn was determined. Fischer 344 rats were fed semi-purified rations containing 20% w/w corn that was either free of aflatoxin or naturally contaminated with 880 micrograms/kg total aflatoxin and was either treated with ammonia gas or was not treated. Therefore the rats that were fed the aflatoxin-contaminated diet received 176 ppb total aflatoxins. Body weight and food consumption were recorded throughout the study; hematological measurements were made after 87 weeks of feeding; and after 91 weeks the rats were killed and histopathological abnormalities were noted. Signs of chronic toxicosis in rats fed aflatoxin-contaminated corn included increased mortality, decreased hematocrit and hemoglobin levels, elevated serum alkaline phosphatase activities, and a 100% incidence of

30

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liver neoplasia. These signs did not occur in rats in the other dietary treatment groups, including those fed ammoniated, aflatoxin-contaminated corn. The results provide further evidence that the atmospheric ammoniation process effectively reduces the toxicity of aflatoxin. From Effects of long-term feeding of ammoniated, aflatoxin-contaminated corn to Fischer 344 rats, Norred WP; Morrissey RE, Toxicol Appl Pharmacol; VOL 70, ISS 1, 1983, P96-104, TOXBIB/83/303131.

H. p53 Tumor Suppressor Gene Mutated by Aflatoxin and Industry Deception

Mutations in the p53 tumour suppressor gene lead to uncontrolled cell division and are found in over 50% of all human tumours, including 60% of lung cancers. Research published in 1996 by Denissenko and colleagues demonstrated patterned in-vitro mutagenic effects on p53 of benzo[a]pyrene, a carcinogen present in tobacco smoke. We investigated the tobacco industry’s response to p53 research linking smoking to cancer. We searched online tobacco document archives, including the Legacy Tobacco Documents Library and Tobacco Documents Online, and archives maintained by tobacco companies such as Philip Morris and R J Reynolds. Documents were also obtained from the British American Tobacco Company depository in Guildford, UK. Informal correspondence was carried out with scientists, lawyers, and tobacco control experts in the USA and Europe. This research indicated that executives and scientists at the highest levels of the tobacco industry anticipated and carefully monitored p53 research. The tobacco industry’s own scientists conducted research which appeared to cast doubt on the link between smoking and p53 mutations. Researchers and a journal editor with tobacco industry ties participated in the publication of this research in a peer-reviewed journal without clear disclosure of their tobacco industry links. Tobacco industry responses to research linking smoking to carcinogenic p53 mutations mirror prior industry efforts to challenge the

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science linking smoking and lung cancer. The extent of tobacco industry involvement in p53 research and the potential conflict of interest discussed here demonstrate the need for consistent standards for the disclosure and evaluation of such potential conflicts in biomedical research. The p53 tumour suppressor gene and the tobacco industry: research, debate, and conflict of interest, Asaf Bitton MD, Mark D Neuman MD, Joaquin Barnoya MD and Stanton A Glantz Prof PhD, Center for Tobacco Control Research and Education, University of California, San Francisco, CA 94143, USA, Corresponding to: Prof Stanton A. Glantz.

III. CONCLUSION Several independent lines of evidence indicate the tobacco industry has been aware of the contamination of tobacco by aflatoxin, of the resulting adverse health effects of this contamination and of methods of making tobacco safer by aflatoxin removal. The details of programs to minimize this problem are unknown. Most likely documents exist that detail the industry response, but remain hidden. As it now stands many adverse health effects, including immunosuppressive diseases and cancers, may be tied, not to the tobacco itself, but to the more easily treatable infectious fungal spores and their mycotoxins which are found on the tobacco. This court needs to address these issues at this time in order to formulate a complete response to the Defendants’ actions.

Respectfully Submitted,

/s/

Kerry Scott Lane M.D. St. Mary’s Medical Center 901 45th Street West Palm Beach FL 33407

(561) 844-6300

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Financial Disclosure-Potential Conflict of Interest: In the course of researching this topic, the author, Kerry Scott Lane M.D. obtained patents on technologies to help solve this problem. He holds United States Patents 6,058,940, 6,637,438, 6,786,221 and others are pending. These include worldwide patent rights. Additional patents directed towards AIDS and other diseases are pending.

Duty to Confer under Local Civil Rule 7(m). The author certifies that he has conferred with counsel for the parties to this proceeding. The Joint Defendants oppose the filing of this amicus brief. The Plaintiff, in view of government policy, has no comment.

33

COURT OF APPEALS GRANTS STAY OF KESSLER JUDGEMENT

November 13, 2006 8:08 pm by Gene Borio

On Oct. 31, 2006, a 3-judge DC Court of Appeals panel granted the Defense’s motion to stay Judge Kessler’s Judgement and Order.

It’s odd, to me, that no news source pointed out that the panel included, once again, Judges Sentelle and Tatel. Judge Sentelle, once again, found for tobacco. Judge Tatel, once again, dissented from the majority.

Text follows of:

DC Court of Appeals Grant Motion to Stay

http://www.tobacco-on-trial.com/files/20061031stayappealgranted.pdf

Below that, the Docket Summary for the case.

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United States Court of Appeals

For THE DISTRICT OF COLUMBIA CIRCUIT

No. 06-5267

September Term, 2005

99cv02496

Filed On: OCTOBER 31, 2006

[1001691]

UNITED STATES COURT OF APPEALS FOR DISTRICT OF COLUMBIA CIRCUIT

United States of America, United States Department of Justice, et al.,

Appellees

V.

Philip Morris USA Inc., et al., f/k/a Philip Morris Incorporated,

Appellees

British American Tobacco (Investments) Ltd., Directly and as Successor to BRITISH-AMERICAN TOBACCO COMPANY, Ltd.,

Appellant

Consolidated with 06-5268, 06-5269, 06-5270, 06-5271, 06-5272

BEFORE; Sentelle, Randolph, and Tatel,* Circuit Judges

ORDER

Upon consideration of the emergency motion to stay the final judgment and remedial order pending appeal, the opposition thereto, and the reply, It is

ORDERED that the motion for stay be granted. Appellants have satisfied the stringent standards required for a stay pending appeal. See Washington Metropolitan Area Transit Commission v Holiday Tours, nc 559 F.2d 841, 843 (D.C. Cir. 1977); D.C Circuit Handbook of Practice and Intern Procedures 33 (2006).

Per Curiam

*Judge Tatel would deny the motion for stay.

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BELOW IS THE DOCKET SUMMARY:

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US Court of Appeals for the DC Circuit

Case Summary

Court of Appeals Docket #: 06-5267

Filed: 9/14/06

Nsuit: 2890 Other Statutory Actions

USA v. Philip Morris USA, et al

Appeal from: United States District Court

Lower court information:

District: 0090-1 : 99cv02496

lead: 99cv02496

Trial Judge: Gladys Kessler, US District Judge

10/12/06 OPPOSITION filed [998354-1] (5 copies) by Appellee USA in 06-5267, 06-5268, 06-5269, 06-5270, 06-5271, 06-5272 (certificate of service dated 10/12/06, by hand-delivery) to a motion for a stay pending appeal [994788-1]. [06-5267, 06-5268, 06-5269, 06-5270, 06-5271, 06-5272] (lvs) [06-5267 06-5268 06-5269 06-5270 06-5271 06-5272]

10/16/06 REPLY filed [1000573-1] (5 copies) by Appellees Philip Morris USA, Altria Grp Inc, R J Reynolds Tobacco, Brown & Williamson, Lorillard Tobacco Co, British Amer Tobacco, British Amer Tobacco, (certificate of service dated 10/16/06, by hand-delivery) to a response to the motion stay case [994788-1]. [06-5267, 06-5268, 06-5269, 06-5270, 06-5271, 06-5272] (lvs) [06-5267 06-5268 06-5269 06-5270 06-5271 06-5272]

10/23/06 CLERK’S ORDER filed [999467], on the court’s own motion, that these cases be consolidated. It is FURTHER ORDERED, on the court’s own motion, that the deadlines established in the order of October 2, 2006 in Nos. 06-5267, et al., are extended to the dates established in the order of October 23, 2006 in No. 06-5332 [999467-1] [999467-2]. [Entry Date: 10/23/06] [06-5267, 06-5268, 06-5269, 06-5270, 06-5271, 06-5272] (lvs) [06-5267 06-5268 06-5269 06-5270 06-5271 06-5272 06-5332]

10/27/06 ENTRY OF APPEARANCE filed by Attorney David Stewart Eggert for Appellant Philip Morris USA, Murray Richard Garnick for Appellant Philip Morris USA [1002259-1] . [06-5267, 06-5268, 06-5269, 06-5270, 06-5271, 06-5272, 06-5332] (smc) [06-5267 06-5268 06-5269 06-5270 06-5271 06-5272 06-5332]

10/31/06 PER CURIAM ORDER filed [1001691] granting emergency motion to stay the final judgment and remedial order pending appeal filed by Philip Morris USA, et al. [994788-1]. Before Judges Sentelle, Randolph, Tatel (Judge Tatel would deny the motion for stay). [Entry Date: 10/31/06] [06-5267, 06-5268, 06-5269, 06-5270, 06-5271, 06-5272, 06-5332] (sha)
[06-5267 06-5268 06-5269 06-5270 06-5271 06-5272 06-5332]

UNPROVEN CORRECTIVES

November 13, 2006 7:22 pm by Gene Borio

On October 30, 2006,the parties submitted their praecipes on the practicality and effectiveness of each others’ correctives, as required by Judge Kessler in her Order #1025 (Kessler Order #1025 on Correctives, Oct. 19, 2006.) She had found the parties’ previous filings had raised new issues, and some suggestions might require too “hands on” an approach from the Court, and require too much time to implement.

The whole issue, however, is moot at the moment. Judge Kessler had planned to order a final ruling on Corrective statements by Nov. 9, but that was before Halloween, when the DC Court of Appeals stayed all aspects of her Aug. 17 judgement and remedial order.

But still, the filings are instructive.

Oddly enough, all the parties felt their proposals were most practicable and effective.

The Court wanted to know:

(1) The practical impact of adopting the proposal contained in the submissions of the Government and Plaintiff-Intervenors, including that the Court consult with appropriate independent experts, to be paid by Defendants, to evaluate any proposed corrective statements, and that the Court undertake basic market testing research to evaluate the effectiveness of such statements

(2) Whether the corrective statements should indicate that they are being issued pursuant to Court order

(3) Whether the Court should approve all relevant details of such corrective statements, such as print size, colors, spacing and format, voice-over in television advertisements, etc.

DOJ felt its proposal for an independent marketing firm to develop and test the proposals would not cause the undue delay Judge Kessler had feared, and could be done by the February 2007 deadline for dissemination of the correctives. Also, considering the Defendants’ track record in forthright and honest communications–as found by this very court, and as markedly exemplified in the Defendants’ own current proposed correctives–hiring independent experts is the only viable option.

Independent market consultation and testing would also:

1. Determine the effectiveness of Lorillard’s and the Intervenors’ proposals that the correctives openly state that they are mandated by court order.

2. Relieve the court of dealing with the minutiae of format decisions in type, graphics and voice-over.

DOJ provides a very revealing chart of each company’s former statements, compared with its proposed corrective statements on each issue.

Defense’s proposed statements almost flagrantly skirt the very subterfuges that brought them low in the first place. As DOJ’s filing states,

Defendants’ submissions demonstrate, starkly, that the implementation of the corrective statements cannot be left to their discretion.

While Judge Kessler’s latest Oct. 19 order did not mention the need for “exact language,” the companies’ filings lambast DOJ for attempting to “modify the Court’s (Aug. 17) judgement” by not providing exact language, and by insisting that marketing experts should determine, after suitable testing, the exact wording and formatting of the statements–a requirement which the Joint Defense (minus Liggett) filing says would “draw out the process indefinitely.”

DEPARTMENT OF CORRECTIONS

Philip Morris’ statements, on the whole, seem most direct, but their secondhand smoke statement still cavils:

Public health officials have concluded that secondhand smoke from cigarettes causes disease

BAT has 2 very curious statements.

1. On “No Health Benefit to ‘Light’ Cigarettes:”

There is no significant health benefit from smoking “low tar,” “light,” “ultra light,” “mild,” or “natural,” cigarettes.

2. On “Nicotine Manipulation:”

BATCo manipulates the design of its cigarette brands to ensure that every cigarette of a particular brand or style will deliver the amount of nicotine (within 0.1 mg.) advertised for that brand, according to the test for nicotine in cigarette smoke adopted by the International Standards Organization.

But the Deja Vu Prize has to go to Lorillard and RJR, for taking us back 40 years in time, and giving us, yes,

“The Surgeon General has concluded . . . “(!)

RJR and Lorillard also make use of a disclaimer of mandate, ie, “This message is furnished by [Defendant] pursuant to a Court Order and is taken from the 2006 Surgeon General’s Report” (RJR) and “The following statement is made by Lorillard Tobacco Company pursuant to a Court Order in United States of America, et al. v. Philip Morris USA, Inc., et al., Civil Action No. 99-2496 (GK) (Order #1015, Aug. 17, 2006, at 4; Final Op. at 1636) (on appeal)” (Lorillard).

As the DOJ filing states,

Clearly, it is the Court’s intent that the corrective statements will not simply be a pro forma utterance of mandated words, but rather, will have the effect of actually correcting defendants’ ongoing false statements.

Defendants, however, have each proposed text that makes no progress beyond the first step forward acknowledged by the Court and that may constitute continuing affirmative statements that are fraudulent. For example:

• No defendant’s statement actually concedes that secondhand smoke causes disease in nonsmokers.

• No defendant’s statement admits that it manipulates the design of cigarettes to enhance the delivery of nicotine regardless of the machine-rated delivery levels of nicotine.

• BATCo’s proposed statements regarding nicotine manipulation completely fail to acknowledge the Court’s finding that BATCo manipulates nicotine delivery in cigarettes to create and sustain addiction. As such, the statement is affirmatively misleading.

BATCo also continues to acknowledge only “health effects” from smoking, rather than any of the actual fatal diseases caused by smoking.

• Philip Morris’s proposed statements are virtually identical to its existing website statements (which the Court clearly found to be only a “first step” toward correcting its decades of deceit); the only change in content is its statement that the nicotine in cigarettes is addictive and that “well-known” design features affect the delivery of nicotine.2

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Text follows of:

UNITED STATES’ PRAECIPE RESPONDING TO ORDER #1025

http://www.tobacco-on-trial.com/files/20061030dojprae1025.pdf

Exhibit A: Comparison of Defendants’ Current Public Statements With Their Proposed “Corrective” Statement

http://www.tobacco-on-trial.com/files/20061030dojcorrcompare.pdf

CERTAIN DEFENDANTS’ MEMORANDUM IN RESPONSE TO THE COURT’S OCTOBER 19, 2006 ORDER

http://www.tobacco-on-trial.com/files/20061030jdresponse.pdf

PLAINTIFF-INTERVENORS’ SUBMISSION PURSUANT THE COURT’S ORDER #1025

http://www.tobacco-on-trial.com/files/20061030venorsresponse.pdf

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http://www.tobacco-on-trial.com/files/20061030dojprae1025.pdf

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UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

_________________________________________

UNITED STATES OF AMERICA,

Plaintiff,

and

TOBACCO-FREE KIDS ACTION FUND, et al.,

Plaintiff-Intervenors,

v.

PHILIP MORRIS USA INC.,

f/k/a PHILIP MORRIS INC., et al.,

Defendants.

Civil Action No. 99-CV-02496 (GK)

Next scheduled appearance: None Scheduled

__________________________________________)

UNITED STATES’ PRAECIPE RESPONDING TO ORDER #1025

The Court has directed the parties to address certain questions pertinent to its October 16, 2006 Proposal for Corrective Statements. Order #1025. Through this filing, the United States responds to the specific questions posed by the Court, as follows:

(1) The practical impact of adopting the proposal contained in the submissions of the Government and Plaintiff-Intervenors, including that the Court consult with appropriate independent experts, to be paid by Defendants, to evaluate any proposed corrective statements, and that the Court undertake basic market testing research to evaluate the effectiveness of such statements

The United States’ proposal is practical. Consulting with an independent advertising and market research firm will serve to minimize the need for the Court to deal with the detailed design and development aspects of the statements in the first instance. The marketing firm will design and test the statements for effectiveness based on the proposals already submitted and any further guidance provided by this Court. Only after completion of market testing and a review of

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2

the results will the Court make its final determination about the statements to be disseminated.

As the Department of Justice is the “enforcing agent for [the Court’s final] decree,” Final Op. at 1644, it is its considered recommendation that its proposal be adopted to ensure meaningful enforcement of the corrective statement remedy.

In fact, if independent experts are not consulted, the Court will either have to make these precise design determinations – aspects of message communication that can have a major impact, according to the evidence elicited in this case, see, e.g., Krugman WD at 187-197 (testimony regarding ineffectiveness of cigarette warnings) – or else leave all such decisions to the discretion of defendants. The latter option is clearly inappropriate given this Court’s findings with respect to defendants’ lengthy record of manipulation and deception through its communication with the public.

To the extent there is a concern about an unwarranted delay associated with this process, there is no indication that significant, or perhaps any, delay will be incurred. If the Court adopts the United States’ proposal, a marketing firm could be retained immediately to develop and test the statements, based upon the proposals already submitted, as directed by the Court. Because the majority of the corrective statements are not currently scheduled to begin to be disseminated until February 2007, there should not be delay1. Defendants can arrange for the purchase of media time/space and engage in other logistical planning while the statements are being tested by the market research firm.

With respect to the onserts, Philip Morris has argued that it will be unable to meet the

—–

1 According to the Court’s Final Order, some of the defendants are scheduled to publish the corrective statements in full page newspaper advertisements beginning in December 2006. To the extent the statements are not finalized by that time, the United States recommends that the commencement of dissemination via newspaper ads be moved to February 2007 – the date dissemination begins with respect to the other media.

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3

Court’s timeline if it does not receive the final language by November 9, 2006. See Philip Morris USA’s Proposed Corrective Statements as Compelled by the Final Judgment and Remedial Order, at 9. There are at least two options to address this concern that will cause little, if any, delay in the overall process. First, the Court could order defendants to include the corrective statement in which the Court has the most confidence absent market testing in their February 2007 onsert installment. That could certainly be accomplished by November 9. In the meantime, evaluative market testing can be done on that corrective statement, as well as the other statements. Thereafter, beginning with the June 2007 onsert installment, the Court can order defendants to publish independently developed, market tested corrective statements.

A second option is to order all the proposed statements to undergo initial market testing, with at least one statement to be fully evaluated and completed by mid-December. The Court could then commence dissemination of the corrective statements in all media excluding onserts in February 2007, pushing back the commencement date for the onserts to March 2007. Although this would create a month delay in dissemination of the statements on onserts, it may well provide the level of comfort in the effectiveness of the remedy that warrants such a relatively minimal delay. Given the significance of this remedy, the possibility of a short delay is justified to achieve the purpose of the statements.

(2) Whether the corrective statements should indicate that they are being issued pursuant to Court order

R.J. Reynolds and Brown & Williamson jointly maintain that each of the corrective statements should include a declaration to the effect that “this message is furnished by [defendant] pursuant to a Court Order.” See Certain Joint Defendants’ Submission of Proposed Corrective Statements Pursuant to Order #1015 (RJR and B&W Proposal). Lorillard maintains

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4

that each of the corrective statements include the clarification that “The following statement is made by Lorillard Tobacco Company pursuant to a court Order in United States of America, et al. v. Philip Morris USA, Inc., et al., Civil Action No. 99-2496 (GK) (Order #1015, Aug. 17, 2006, at 4; Final Op. at 1636) (on appeal).” See Lorillard Tobacco Company’s Proposed Corrective Statements Required by Order #1015. The Intervenors in this action also recommend that the messages contain a clear statement to the effect that “a Federal District Court is requiring us to make this statement.” See Plaintiff-Intervenors’ Proposed Corrective Statements and Supporting Memorandum.

The United States does not know whether the purpose of the remedy will be served by inclusion of such declarations in the corrective statements. Without market testing, it is difficult to know the impact or effectiveness of that communication. This example makes clear the need to market test the statements to gauge their impact on the consuming public. An independent marketing firm should test the messages with and without the declaration, determining which form of the communication serves to best correct the existing misperceptions.

(3) Whether the Court should approve all relevant details of such corrective statements, such as print size, colors, spacing and format, voice-over in television advertisements, etc.

The Court should adopt an integrated proposal for corrective statements that addresses both content and format. As the Court is well aware, defendants have an incentive to comply with the letter of the Court’s order while creating and disseminating communications that avoid their intended effects. While defendants’ October 16 submissions addressed only the text and not the format or other details of how the corrective statements will be communicated to the public, each defendant attempted, in different ways, to limit or nullify the effectiveness of the

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5

statements. Defendants’ submissions demonstrate, starkly, that the implementation of the corrective statements cannot be left to their discretion. As described above, the Court can achieve this result without involving itself in decisions about minutiae by retaining independent consultants with expertise in developing effective multimedia communications. In ordering the corrective statements, the Court found that “[t]he trial record amply demonstrates that Defendants have made false, deceptive, and misleading public statements about cigarettes and smoking from at least January 1954 . . . . [and] that certain Defendants’ public statements communicating their positions on smoking and health issues continue to omit material information or present information in a misleading fashion” even today. Final Op. at 1632. The Court expressly found that while “certain language in some of Defendants’ most recent positions on smoking and health issues . . . represent a step forward[,]” id. at 1633, those recent changes were not sufficient to prevent and restrain future fraudulent statements, much less correct their “decades of denial and distortion.” Id. Moreover, the Court found that “[e]vidence in the record also amply demonstrates that certain of Defendants’ public statements communicating their positions on smoking and health issues continue to omit material information or present information in a misleading and incomplete fashion.” Id. at 1632. Clearly, it is the Court’s intent that the corrective statements will not simply be a pro forma utterance of mandated words, but rather, will have the effect of actually correcting defendants’ ongoing false statements.

Defendants, however, have each proposed text that makes no progress beyond the first step forward acknowledged by the Court and that may constitute continuing affirmative statements that are fraudulent. For example:

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6

• No defendant’s statement actually concedes that secondhand smoke causes disease in nonsmokers.

• No defendant’s statement admits that it manipulates the design of cigarettes to enhance the delivery of nicotine regardless of the machine-rated delivery levels of nicotine.

• BATCo’s proposed statements regarding nicotine manipulation completely fail to acknowledge the Court’s finding that BATCo manipulates nicotine delivery in cigarettes to create and sustain addiction. As such, the statement is affirmatively misleading.

BATCo also continues to acknowledge only “health effects” from smoking, rather than any of the actual fatal diseases caused by smoking.

• Philip Morris’s proposed statements are virtually identical to its existing website statements (which the Court clearly found to be only a “first step” toward correcting its decades of deceit); the only change in content is its statement that the nicotine in cigarettes is addictive and that “well-known” design features affect the delivery of nicotine.2

• Lorillard’s and Reynolds American’s statements do not concede that smoking and secondhand smoke causes disease and are couched in language that cannot effectively communicate the intended message in any media; the statements are long, cluttered, and technical.

A more complete comparison between each defendant’s existing statements and its proposed “corrective” statements is set forth in a chart, attached hereto as Exhibit A. This comparison amply demonstrates defendants’ intention to limit the effect of the corrective

—–

2 Philip Morris has presented no evidence that any design features are “well known” to consumers.

**———————————————————

7

statements. Consequently, the Court should foreclose defendants’ ability to influence in any way the format or content of the statements.

Defendants complain that the United States is seeking remedial relief beyond that which they had an opportunity to litigate, pursuant to United States v. Microsoft. This is not true. The remedy that Defendants make corrective statements to help dispel the misperceptions created by their fifty plus years of deceiving the American public has long been a part of the United States’ case. The genesis of the United States’ request for corrective statements dates back to its complaint. The Amended Complaint expressly requests an injunctive order that, “each defendant fund, but have no part of or influence over the control of or decision making relating to, a legitimate and sustained corrective public education campaign, administered and controlled by an independent third party, relating to the public health issues of cigarette smoking and nicotine addiction.” and that “each defendant make corrective statements regarding the health risks of cigarette smoking and the addictive properties of nicotine in future advertising, marketing, and promotion of their tobacco products.” See Amended Cplt. § VII.B.2.f. and h. The United States disclosed in discovery this same remedy. See United States’ Responses to Joint Defendants’ Fourth Set of Continuing Interrogatories to Plaintiff, (Dec. 14, 2001) at 43 (same); United States’ Supplemental Responses to Joint Defendants’ Fourth Set of Continuing Interrogatories to Plaintiff, (Mar. 29, 2004) (same); U.S. Proposed Conclusions of Law, (July 2004) at 76-79 (corrective statements necessary to eviscerate ongoing fraud).

The United States developed testimony at trial on this issue as well. Eriksen WD (remedies) at 11 (recommendation that the Court order corrective communications devised by an independent third party). Defendants had a full and fair opportunity to take discovery on and

**———————————————————

8

litigate this issue during the remedies phase of the trial. Defendants cross-examined Dr. Eriksen at trial and were in no way limited on the scope of their cross-examination. See Trial Tr. 21102- 21122. Defendants’ tactical decision not to examine Dr. Eriksen about his opinion that an independent third party should develop the corrective statements cannot now be exploited to minimize the effectiveness of the ordered remedies.

The United States submitted its proposed remedial order at the conclusion of trial. The proposed order states that, “[t]he IO shall have authority to retain appropriate consultants to assist in the development, design, coordination, and execution of the affirmative communications as ordered herein, in order to ensure scientific accuracy, and to ensure maximum exposure and comprehension by smokers and the general public.” See United States’ Notice of Filing Proposed Final Judgment and Order Pursuant to Order #964-A at § IV.E.3. Although the Court rejected the proposal to order monitors, this decision does not limit the Court’s own ability to control a remedial scheme that it did impose.

The salient point, however, is that an effort to make the remedial action effective and meaningful is not a request for a new or different remedy – it is nothing more than the implementation of a long requested, court-ordered remedy. To be sure, statements disseminated to the public with an intended purpose of correcting misperceptions – and certainly those disseminated by an industry found to have engaged in a long running and overarching campaign to deceive the public on these very issues, through a similar process, and in the same media in which the statements are to be disseminated – ought be independently tested to achieve a level of confidence that the statements will meet their intended purpose.

Dated: October 30, 2006

Washington, DC

**———————————————————

9

Respectfully submitted,

PETER D. KEISLER

Assistant Attorney General

STUART SCHIFFER

Deputy Assistant Attorney General

/s/

LINDA M. McMAHON

DC Bar No. 446130

/s/

MICHELLE GLUCK

United States Department of Justice

Post Office Box 14524

Ben Franklin Station

Washington, DC 20044

Attorneys for Plaintiff

United States of America

**———————————————————

http://www.tobacco-on-trial.com/files/20061030dojcorrcompare.pdf

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Exhibit A

Comparison of Defendants’ Current Public Statements With Their Proposed “Corrective” Statements

PMUSA’s Current Website Statements

PMUSA’s Proposed “Corrective” Statements

Health Effects of Smoking

Philip Morris USA (PM USA) agrees with the overwhelming medical and scientific consensus that cigarette smoking causes lung cancer, heart disease, emphysema and other serious diseases in smokers. Smokers are far more likely to develop serious diseases, like lung cancer, than non-smokers. There is no safe cigarette.

Health Effects of Smoking

Cigarette smoking causes lung cancer, heart disease, emphysema, and other serious diseases in smokers. Smokers are far more likely to develop serious diseases, like lung cancer, than non-smokers. Smoking by pregnant women increases the risks for fetal injury, premature birth, and low birth weight. There is no safe cigarette.

Addictiveness of Smoking

Philip Morris USA agrees with the overwhelming medical and scientific consensus that cigarette smoking is addictive. It can be very difficult to quit smoking, but this should not deter smokers who want to quit from trying to do so.

Addictiveness of Smoking

Cigarette smoking is addictive. The nicotine in cigarette smoke is addictive. It can be difficult to quit smoking, but this should not deter smokers who want to quit from trying to do so.

No Health Benefit to “Light” Cigarettes

A smoker should not assume that brand descriptors such as “light” or “ultra light” indicate with precision either the actual amount of tar and nicotine inhaled from any particular cigarette, or the relative amount as compared to competing cigarette brands. Some researchers report that smokers of “light” cigarettes inhale as much tar and nicotine as from full-flavor brands. The amount of tar and nicotine inhaled will be higher if, for example, a smoker blocks ventilation holes, inhales more deeply, takes more puffs or smokes more cigarettes.

PM USA does not imply in our marketing, and smokers should not assume, that lower-yielding brands are safe or safer than full-flavor brands. There is no safe cigarette. “Medium,” “mild,” “light” and “ultra light” cigarettes are no exception. Health warnings are required on all of our brands, irrespective of their tar and nicotine yields. . . . . It is important to remember that, as of today, there is no cigarette on the market which the public health community endorses as offering “reduced risk.” It continues to be the case that, if smokers are concerned about the risks of smoking, quitting is by far their best alternative for reducing those risks

No Health Benefit to “Light” Cigarettes

There is no safe cigarette. “Low tar,” “light,” “ultra light,” “medium,” and “mild” brands are no exception. You should not assume that these brands are safe or safer than full flavor brands or that smoking these brands will help you quit. If you are concerned about the health risks of smoking, you should quit

PMUSA’s Current Website Statements

PMUSA’s Proposed “Corrective” Statements

Dangers of Exposure to Secondhand Smoke:

Public health officials have concluded that secondhand smoke from cigarettes causes disease, including lung cancer and heart disease, in non-smoking adults, as well as causes conditions in children such as asthma, respiratory infections, cough, wheeze, otitis media (middle ear infection) and Sudden Infant Death Syndrome. In addition, public health officials have concluded that secondhand smoke can exacerbate adult asthma and cause eye, throat and nasal irritation

Dangers of Exposure to Secondhand Smoke:

Public health officials have concluded that secondhand smoke from cigarettes causes disease, including lung cancer and heart disease, in non-smoking adults, as well as causes conditions in children such as asthma, respiratory infections, cough, wheeze, otitis media (middle ear infection) and Sudden Infant Death Syndrome.

Nicotine Manipulation:

[S]ome have alleged that we use specific ingredients to affect nicotine delivery to smokers. That is simply not true.

Nicotine Manipulation:

Cigarettes deliver tar and nicotine. Well known design features affect the delivery of tar and nicotine. The amount of tar and nicotine you inhale will vary, depending upon how you smoke. Generally speaking, the more intensely you smoke a cigarette, the more tar and nicotine you will inhale.

BATCo’s Current Website Statements

BATCo’s Proposed “Corrective” Statements

Health Effects of Smoking

Smoking is a cause of various serious and fatal diseases, including lung cancer, emphysema, chronic bronchitis and heart diseases.

Studies

The health risks of smoking are derived from epidemiology.

Epidemiology is a statistically based science, dealing with risks among large groups of people, rather than with individuals. Through questionnaires and observations of people, epidemiological studies can identify the incidence of disease in a given group, such as smokers, and compare it with the incidence in another group, such as non-smokers.

Over many years, epidemiological studies have consistently reported a much higher incidence of certain diseases among smokers compared with non-smokers. The studies also report that the risks are reduced after quitting and that quitting earlier has by far the best effect on reducing risks.

Traditionally, epidemiology has been used to identify associations that point to possible causes of a disease, providing direction for thorough laboratory investigations. With smoking, the many laboratory investigations over the years have proved more problematic, and science has not to date been able to identify biological mechanisms which can explain with certainty the statistical findings linking smoking and certain diseases, nor has science been able to clarify the role of particular smoke constituents in these disease processes.

This means that science is still to determine which smokers will get a smoking related disease and which will not. Nor can science tell whether any individual became ill solely because they smoked. This is, in part, because all the diseases that have been associated with

Health Effects of Smoking

There are adverse health effects from cigarette smoking. For a list of health effects from smoking and a discussion of the relevant science, see the 2004 Report of the Surgeon General “The Health Consequences of Smoking.”

BATCo’s Current Website Statements

BATCo’s Proposed “Corrective” Statements

Addictiveness of Smoking

Smoking can be hard to quit. However, we believe it is important that smokers who decide to quit realise they can, provided they have the motivation to quit and the belief that they can. Many smokers are said to be dependent on cigarettes because they know the real risks of disease involved but still smoke frequently and find it very difficult to quit.

It has been known for centuries that smoking is difficult to quit. Under international definitions for determining whether people are dependent on smoking, including those from the World Health Organisation, many smokers would be classified as being dependent.

However, millions of smokers have quit without any medical help, and millions have modified how often, where and when they smoke in the light of differing social norms. In some countries, such as the UK, there are now as many ex-smokers as smokers.

While smoking is commonly understood to be addictive, we believe it is important that smokers who decide to quit realise they can, provided they have the motivation to quit and the belief that they can. We believe that if you want to quit, you should.

Various ways have been suggested to help people quit, including using ‘nicotine replacement therapy’ (patches and gums). While all these forms of assistance may be beneficial, the most important factors in successfully quitting are having the motivation to quit and the selfbelief that you can do so.

Addictiveness of Smoking

Cigarette smoking and nicotine are addictive.

BATCo’s Current Website Statements

BATCo’s Proposed “Corrective” Statements

No Health Benefit to “Light” Cigarettes

Lower tar products

After much work on specific smoke constituents, it was found that a practical and simpler way to reduce deliveries of individual smoke constituents would be to reduce smoke yields overall, as measured by a standardised machine method. The work, therefore, focused on using filters, ventilation and other design features to reduce tar. In lower tar products, there has been an overall reduction in the levels of most of the constituents of concern to governments and health bodies as measured by standardised machine test methods. However, many public health bodies no longer support the theory that lowering cigarette tar deliveries somewhat lowers the risks of smoking. Recent reports by the World Health Organisation and the US National Cancer Institute conclude that smoking lower tar delivery cigarettes does not reduce the risks of smoking. While the hypothesis that reducing exposure should reduce risks remains, questions are currently being asked as to whether low tar yielding cigarettes, as measured on machines, actually result in reduced exposure when in the hands of smokers.

No Health Benefit to “Light” Cigarettes

There is no significant health benefit from smoking “low tar,” “light,” “ultra light,” “mild,” or “natural,” cigarettes.

BATCo’s Current Website Statements

BATCo’s Proposed “Corrective” Statements

Dangers of Exposure to Secondhand Smoke:

The World Health Organisation and various other public health bodies have reported that exposure to environmental tobacco smoke (ETS), sometimes called ‘passive smoking’, is a cause of various diseases. The risks they report are far lower than those associated with active smoking, but are said to be large enough to make public smoking an important public health issue.

Our view of the science is that ETS exposure is associated with various short term health impacts, such as exacerbating symptoms in asthmatics and respiratory illnesses in children. The science on ETS and chronic diseases, such as lung cancer and heart disease, is in our view not definitive and at most suggests that if there is a risk from ETS exposure, it is too small to measure with any certainty.

So while we understand and support measures to reduce involuntary exposure to ETS, we do not believe that blanket bans on public and workplace smoking are fair or necessary, as there are more practical solutions based on air quality standards.

Dangers of Exposure to Secondhand Smoke:

There are adverse health effects from exposure to second hand smoke (also known as environmental tobacco smoke or ETS). For a list of health effects and a discussion of the relevant science, see the 2006 Report of the Surgeon General “The Health Consequences of Involuntary Exposure to Tobacco Smoke.”

Nicotine Manipulation:

N/A

Nicotine Manipulation:

BATCo manipulates the design of its cigarette brands to ensure that every cigarette of a particular brand or style will deliver the amount of nicotine (within 0.1 mg.) advertised for that brand, according to the test for nicotine in cigarette smoke adopted by the International Standards Organization.

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RJR/B&W’s Most Recent Website Statements1

Reynolds American’s Proposed “Corrective” Statements

Health Effects of Smoking

RJR: Smoking “causes disease in some individuals” but only “in combination with other factors.”

B&W: “Smoking cigarettes is a cause of lung cancer, emphysema, heart disease and other diseases.”

Health Effects of Smoking

The Surgeon General has concluded that cigarette smoking causes the following diseases and adverse health effects:

Bladder cancer, cervical cancer, cancers of the esophagus, renal cell and renal pelvis cancers, cancer of the larynx, acute myeloid leukemia, lung cancer, cancers of the oral cavity and pharynx, pancreatic cancer, gastric cancers, abdominal aortic aneurysm, atherosclerosis, stroke, coronary heart disease, chronic obstructive pulmonary diseases such as emphysema and chronic bronchitis, pneumonia, respiratory effects in utero, respiratory effects in children, adolescents, and adults, respiratory symptoms among adults including coughing, phlegm, wheezing, and dyspnea, poor asthma control, fetal death and stillbirths, reduced fertility in women, fetal growth restrictions and low birth weight, premature rupture of the membranes, placenta previa, placental abruption, preterm delivery and shortened gestation, cataracts, diminished health status/morbidity, hip fractures, low bone density in postmenopausal women, and peptic ulcer disease.

This message is furnished by [Defendant] pursuant to a Court Order and is taken from the 2004 Surgeon General’s Report.

You should rely upon your medical provider and the Surgeon General in making decisions regarding smoking.

RJR/B&W’s Most Recent Website Statements1

Reynolds American’s Proposed “Corrective” Statements

Addictiveness of Smoking

RJR: “Many people believe that smoking is addictive and as that term is commonly used today, it is. Many smokers find it difficult to quit and some find it extremely difficult. . . . [H]owever, we disagree with characterizing smoking as being addictive in the same sense as heroin, cocaine or similar substances.”

B&W: B&W “agrees that, by current definitions of the term ‘addiction,’ including that of the Surgeon General in 1988, cigarette smoking is addictive” but that:

“Although smoking can be very difficult to quit, we do not believe that the term “addiction” should be used to imply that there is anything in cigarette smoke that prevents smokers from reaching and implementing a decision to quit. Smoking may indeed be difficult to quit, but people can quit and do so in large numbers. The scientific literature demonstrates that smokers who believe they can quit, and who believe that the benefits of quitting outweigh the enjoyment of continuing to smoke, can do so.”

Addictiveness of Smoking

The Surgeon General has concluded:

Cigarettes and other forms of tobacco are addicting. Nicotine is the drug in tobacco that causes addiction.

This message is furnished by [Defendant] pursuant to a Court Order and is taken from the 1988 Surgeon General’s Report.

You should rely upon your medical provider and the Surgeon General in making decisions regarding smoking.

RJR/B&W’s Most Recent Website Statements1

Reynolds American’s Proposed “Corrective” Statements

No Health Benefit to “Light” Cigarettes

RJR: “Our company, like other cigarette manufacturers, uses brand descriptors such as ‘full flavor,’ ‘lights’ and ‘ultra lights’ to differentiate cigarette brand-styles in terms of such characteristics as strength of taste, and reported ‘tar’ and nicotine yield. These terms do not, and are not meant to, imply that any cigarette brand-style or any category of cigarettes is safer than any other.”

B&W: “Cigarette brands in the U.S. are usually identified on packs, cartons and advertising as belonging to the following categories: ‘Ultra Lights’ or ‘Ultra Low Tar’, ‘Lights’ or ‘Low Tar’, and ‘Full Flavor” . . . .

Recent published studies suggest that the majority of smokers use descriptors to guide their product selection based on taste. . . . It is not Brown & Williamson’s intention to suggest that any individual brand, regardless of the category descriptor terminology used, or tar yield, is safer than any other. . . . We do not believe that people who are concerned about the health risks of smoking should view lower tar products as an alternative to quitting.”

No Health Benefit to “Light” Cigarettes

The Surgeon General has concluded:

Smoking cigarettes with lower machine-measured yields of tar and nicotine (including those that have been labeled “low tar,” “light,” “ultra light, “mild” and “natural”) provides no clear benefit to health in comparison to smoking cigarettes with higher machine measured yields of tar and nicotine.

This message is furnished by [Defendant] pursuant to a Court Order and is derived from the 2004 Surgeon General’s Report.

You should rely upon your medical provider and the Surgeon General in making decisions regarding smoking.

RJR/B&W’s Most Recent Website Statements1

Reynolds American’s Proposed “Corrective” Statements

Dangers of Exposure to Secondhand Smoke:

RJR: Reynolds’ website stated “that there are still legitimate scientific questions concerning the reported risks of secondhand smoke” and that “considering all of the evidence, in our opinion, it seems unlikely that secondhand smoke presents any significant harm to otherwise health nonsmoking adults at the very low concentrations commonly encountered in their homes, offices and other places where smoking is allowed. We recognize that exposure to high concentrations of secondhand smoke may cause temporary irritation, such as teary eyes, and even coughs and wheezing in some adults. In addition, there is evidence that secondhand smoke, like other airborne irritants, or allergens such as pollen and dust may trigger attacks in asthmatics.” B&W: “In our opinion and in the opinion of others, . . . there are legitimate scientific questions concerning the extent of the chronic health risks of ETS.”

Dangers of Exposure to Secondhand Smoke:

The Surgeon General has concluded:

Exposure to environmental tobacco smoke has been proven to cause premature death and disease in children and in adults who do not smoke. Children exposed to secondhand smoke are at an increased risk for sudden infant death syndrome (SIDS), acute respiratory infections, ear problems, and more severe asthma. Smoking by parents causes respiratory symptoms and slows lung growth in their children. Exposure of adults to secondhand smoke has immediate adverse effects on the cardiovascular system and causes coronary heart disease and lung cancer. The scientific evidence indicates that there is no risk-free level of exposure to secondhand smoke.

This message is furnished by [Defendant] pursuant to a Court Order and is taken from the 2006 Surgeon General’s Report.

You should rely upon your medical provider and the Surgeon General in making decisions regarding smoking.

Nicotine Manipulation:

RJR “do[es] not add nicotine or any nicotinic compounds to any of our cigarettes, nor do we do anything to enhance the effects of nicotine on the smoker.”

B&W: “Brown & Williamson does not in any way control the level or nature of nicotine in cigarettes to induce people to start smoking or to prevent people from quitting.”

Nicotine Manipulation:

A United States District Court has found that:

“Cigarettes are specifically designed to deliver a range of nicotine doses so that a smoker can obtain her optimal dose from virtually any cigarette on the market, regardless of that cigarette’s nicotine delivery level as measured by the FTC method.”

“Cigarette manufacturers controlled the amount and form of nicotine delivery in commercial products by controlling the physical and chemical make-up of the tobacco blend and filler.”

This message is furnished pursuant to a Court Order by [Defendant].

You should rely upon your medical provider and the Surgeon General in making decisions regarding smoking.

Lorillard’s Recent Public Statements2

Lorillard’s Proposed “Corrective” Statements

Health Effects of Smoking

Cigarette smoking is a risk factor for disease.

Health Effects of Smoking

The Surgeon General has concluded that the evidence is sufficient to infer a causal relationship between cigarette smoking and the following: Bladder cancer, cervical cancer, cancers of the esophagus, renal cell and renal pelvis cancers, cancer of the larynx, acute myeloid leukemia, lung cancer, cancers of the oral cavity and pharynx, pancreatic cancer, gastric cancers, abdominal aortic aneurysm, subclinical atherosclerosis, stroke, coronary heart disease, chronic obstructive pulmonary disease morbidity and mortality, acute respiratory illnesses, including pneumonia, in persons without underlying smoking-related chronic obstructive lung disease, impaired lung growth during childhood and adolescence, early onset of lung function decline during late adolescence and early adulthood, respiratory symptoms in children and adolescents, including, coughing, phlegm, wheezing, and dyspnea, asthma-related symptoms (i.e., wheezing) in childhood and adolescence, premature onset of and an accelerated age-related decline in lung function in adults, all major respiratory symptoms among adults including coughing, phlegm, wheezing, and dyspnea, poor asthma control, nuclear cataract, diminished health status that may manifest as increased absenteeism from work and increased use of medical care services, increased risks for adverse surgical outcomes related to wound healing and respiratory complications, hip fractures, low bone density in postmenopausal women, peptic ulcer disease in persons who are Helicobacter pylori positive, and periodontitis.

The Surgeon General has also concluded that the evidence is sufficient to infer a causal relationship between maternal smoking during pregnancy and the following:

Fetal growth restrictions and low birth weight, premature rupture of the membranes, placenta previa, placental abruption, and preterm delivery and shortened gestation.

The Surgeon General has also concluded that the evidence is sufficient to infer a causal relationship between maternal smoking during and after pregnancy and sudden infant death syndrome.

These conclusions are contained in the 2004 Surgeon General’s Report. Lorillard encourages consumers to rely upon the conclusions of the Surgeon General in making decisions about smoking.

Lorillard’s Recent Public Statements2

Lorillard’s Proposed “Corrective” Statements

Addictiveness of Smoking

Lorillard’s website stated that “Cigarette smoking can also be addictive”; Lorillard also publicly stated that smoking is addictive in the same sense as any pleasurable activity that can be difficult to stop.

Addictiveness of Smoking

The following statement is made by Lorillard Tobacco Company pursuant to a Court Order in United States of America, et al. v. Philip Morris USA, Inc., et al., Civil Action No. 99-2496 (GK) (Order #1015, Aug. 17, 2006, at 4; Final Op. at 1636) (on appeal).

The Surgeon General has concluded:

Cigarettes and other forms of tobacco are addicting. Nicotine is the drug in tobacco that causes addiction.

These conclusions are contained in the 1988 Surgeon General’s Report. Lorillard encourages consumers to rely upon the conclusions of the Surgeon General in making decisions about smoking.

Lorillard’s Recent Public Statements2

Lorillard’s Proposed “Corrective” Statements

Dangers of Exposure to Secondhand Smoke:

Lorillard has never admitted that secondhand smoke causes disease in any form. Lorillard’s website directed readers to public health authority statements on secondhand smoke.

Dangers of Exposure to Secondhand Smoke:

The following statement is made by Lorillard Tobacco Company pursuant to a Court Order in United States of America, et al. v. Philip Morris USA, Inc., et al., Civil Action No. 99-2496 (GK) (Order #1015, Aug. 17, 2006, at 4; Final Op. at 1636) (on appeal).

The Surgeon General has concluded:

The evidence is sufficient to infer a causal relationship between exposure to secondhand smoke and sudden infant death syndrome; and a lower level of lung function during childhood.

The evidence is sufficient to infer a causal relationship between maternal exposure to secondhand smoke during pregnancy and a small reduction in birth weight; and persistent adverse effects on lung function across childhood. The evidence is sufficient to infer a causal relationship between secondhand smoke exposure from parental smoking and lower respiratory illnesses in infants and children; middle ear disease in children, including acute and recurrent otitis media and chronic middle ear effusion; cough, phlegm, wheeze, breathlessness and ever having asthma among children of school age; and the onset of wheeze illnesses in early childhood.

The evidence is sufficient to infer a causal relationship between exposure to secondhand smoke and lung cancer among lifetime nonsmokers; increased risks of coronary heart disease morbidity and mortality among both men and women; odor annoyance; nasal irritation; atherosclerosis in animal models; endothelial cell dysfunctions; a prothrombotic effect; and tumors in laboratory animals.

These conclusions are contained in the 2006 Surgeon General’s Report. Lorillard encourages consumers to rely upon the conclusions of the Surgeon General in making decisions about smoking.

Lorillard’s Recent Public Statements2

Lorillard’s Proposed “Corrective” Statements

1. Reynolds American has taken down its website statements on smoking and health. The above are recent public statements by those companies on these topics.

2. Lorillard has taken down its corporate website. The above are recent public statements by the company on these topics.

No Health Benefit to “Light” Cigarettes

N/A

No Health Benefit to “Light” Cigarettes

The following statement is made by Lorillard Tobacco Company pursuant to a Court Order in United States of America, et al. v. Philip Morris USA, Inc., et al., Civil Action No. 99-2496 (GK) (Order #1015, Aug. 17, 2006, at 4; Final Op. at 1636-37) (on appeal).

The Surgeon General has concluded:

Smoking cigarettes with lower machine-measured yields of tar and nicotine (including those that have been labeled “low tar,” “light,” “ultra light, “mild” and “natural”) provides no clear benefit to health in comparison to smoking cigarettes with higher machine-measured yields of tar and nicotine.

This conclusion is contained in the 2004 Surgeon General’s Report. Lorillard encourages consumers to rely upon the conclusions of the Surgeon General in making decisions about smoking.

Nicotine Manipulation:

Lorillard’s public statements have stated that “nicotine follows tar levels” and that the company “does not take any steps to assure a minimum level of nicotine in our products.”

Nicotine Manipulation:

The following statement is made by Lorillard Tobacco Company pursuant to a Court Order in United States of America, et al. v. Philip Morris USA, Inc., et al., Civil Action No. 99-2496 (GK) (Order #1015, Aug. 17, 2006, at 4; Final Op. at 1636) (on appeal).

Cigarette manufacturers “controlled the amount and form of nicotine delivery in their commercial products by controlling the physical and chemical make-up of the tobacco blend and filter.”

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http://www.tobacco-on-trial.com/files/20061030jdresponse.pdf

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UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA UNITED STATES OF AMERICA,

Plaintiff,

And

TOBACCO-FREE KIDS ACTION FUND,

et al.,

Plaintiff-Intervenors,

v.

PHILIP MORRIS USA INC. (f/k/a

PHILIP MORRIS INCORPORATED),

et al.,

Defendants.

Next Scheduled Court Appearance: None

Civil Action No. 99-CV-2496 (GK)

CERTAIN DEFENDANTS’ MEMORANDUM IN RESPONSE TO THE COURT’S OCTOBER 19, 2006 ORDER

This Court’s August 17, 2006 Final Judgment and Remedial Order (“Order”) instructed each party to “submit a proposal for the exact wording of . . . corrective statements” within 60 days of the date of the Order. Order ¶ II.B.5 (emphasis added). Instead of complying with the Court’s Order, the government and Intervenors submitted memoranda requesting the Court to appoint a third party to develop text for the corrective statements — as well as formatting and presentation — that in their view would be appropriate and effective for particular mediums, and then to test market those statements before they were publicly disseminated. Faced with these submissions, which would lengthen the process significantly, the Court, in an order of October 19, 2006, instructed the parties to submit supplemental memoranda addressing the following issues:

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2

• The practical impact of adopting the proposals contained in the submissions of the government and plaintiff-intervenors, including that the Court consult with appropriate independent experts, to be paid by defendants, to evaluate any proposed corrective statements, and that the Court undertake basic market testing research to evaluate the effectiveness of such statements;

• Whether the corrective statements should indicate that they are being issued pursuant to Court Order; and

• Whether the Court should approve all relevant details of such corrective statements, such as print size, colors, spacing and format, voice-over in television advertisements, etc.

This memorandum responds to the Court’s request. As explained below, the government’s and Intervenors’ proposals ignore the Order. Both of their proposals are untimely and unsupported attempts to modify the Court’s judgment. Further, the proposals infringe defendants’ substantive legal rights as described in United States v. Microsoft Corp., 253 F.3d 34 (D.C. Cir. 2001), and would improperly delegate the Court’s authority to non-judicial personnel to the extent the proposed third party would choose both the content of the statements and the criteria to assess whether the chosen statements are “effective.” And beyond these substantive infirmities, the proposals are also highly impractical. Both proposals would draw out the process indefinitely, contrary to what the Court ordered. Accordingly, for these reasons and those set forth below, the Court should disregard the government’s and Intervenors’ submissions and base the corrective statements it issues on defendants’ submissions, which (1) fully comply with the Court’s mandate, (2) would permit the Court’s Order to be implemented without necessarily extending the deadlines in the Court’s mandate; and 3) would avoid unnecessarily tangling the Court in a time-consuming, fact-intensive process.

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3

I. The Court Should Reject the Proposals Contained in the Submissions of the Government and Intervernors, Including The Proposal that the Court Consult with Independent Experts and Undertake Market Testing and Research.

As an initial matter, the Court should not consider the government’s and Intervenors’ submissions. The lengthy trial of this case is over. The Court entered a Final Judgment and Remedial Order that clearly directed the parties to “submit a proposal for the exact wording of . . . corrective statements.” Order II.B.5 (emphasis added). Defendants complied with the Court’s Order; the government and Intervenors did not. For that reason alone, their submissions should be disregarded.

Moreover, these submissions and the process they contemplate are flawed for a variety of reasons. First, the government’s and Intervenors’ submissions are in fact veiled attempts to seek reconsideration of this Court’s Order and an opportunity to supplement the record. Both requests are untimely and improper. During trial, the government specifically requested that corrective statements be approved by an Independent Monitor with the authority to retain consultants to “assist in the development, design, coordination and execution of the affirmative communications as ordered herein.” Proposed Remedies Order at 17. The Court correctly declined to impose the government’s proposal, ruling that it lacks “power . . . to delegat[e] substantial judicial powers to non-judicial personnel in violation of Article III of the Constitution.” Op. at 1650-51. The government’s and Intervenors’ new proposal is a mere reformulation of the government’s prior request and an improper attempt to “relitigate old matters.” See Lightfoot v. D.C., 355 F. Supp.2d 414, 421 (D.D.C. 2005).

Where, as here, the ten-day deadline for filing a Rule 59(e) motion to amend or modify a judgment has expired, the Court possesses jurisdiction to modify its order only if plaintiffs can demonstrate entitlement to relief under Rule 60(b) of the Federal Rules of Civil Procedure. See Lightfoot, 355 F. Supp.2d at 420 (“The general rule is that a motion for reconsideration is treated

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4

as a ‘[Fed.R.Civ.P.] 59(e) motion if filed within 10 days of entry of the challenged order and as a Rule 60(b) motion if filed thereafter.’”) (quoting United States v. Pollard, 290 F. Supp.2d 153, 156 (D.D.C. 2003. To be sure, the Court also possesses inherent authority to modify an injunction where such modification is necessary to effectuate the purposes of the original order. See 1250 24th Street Assocs. Ltd. P’ship v. Brown, 684 F. Supp. 326, 328-329 (D.D.C. 1988). As a practical matter, however, this standard is encompassed by Rule 60 standards. See Pigford v. Johanns, 416 F.3d 12, 16 (D.C. Cir. 2005); Wright and Miller, 11A Fed. Prac. & Proc. Civ.2d § 2961 (Rule 60 “is little more than a codification of the universally recognized principle that a court has continuing power to modify or vacate a final decree.”). The government and Intervenors fail to demonstrate the applicability of any of the Rule 60(b) provisions and, thus cannot justify modification of the Court’s Order.

Furthermore, even if the government and Intervenors had not made this precise proposal before, the proposal would be an impermissible attempt to raise issues that could have been presented during the nine month trial, in the 2,500 pages of proposed findings of fact, or in the hundreds of pages of post-trial briefing. Presumably, the government and Intervenors now believe that the record they created cannot justify a corrective statements remedy without more evidence. But the government and Intervenors should not be allowed to convert the Court’s Order requiring the “exact wording” of the corrective statements into an additional opportunity to advance the arguments and theories they neglected to make before. This is an improper basis for modification and should be rejected. See Lightfoot, 355 F. Supp.2d at 421 (motions to reconsider should not be used to “present evidence that could have been raised prior to the entry of judgment.” )

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5

Additionally, the government’s and Intervenors’ proposals would violate defendants’ rights under the Due Process Clause and conflict with the holding in United States v. Microsoft Corp., 253 F.3d 34 (D.C. Cir. 2001). In Microsoft, after the evidentiary phase of the trial was concluded, the plaintiffs, including the United States and various states, submitted a proposed remedy for inclusion in the final judgment that had not been previously proposed. Microsoft, 253 F.3d at 98. Over Microsoft’s objection, the court entered final judgment without further evidentiary proceedings “because it doubted that an evidentiary hearing would ‘give any significantly greater assurance that it will be able to identify what might be generally regarded as an optimum remedy.’” Id. at 99. The court then entered a remedies order that was nearly identical to the plaintiffs’ proposal. See id. On appeal, the D.C. Circuit reversed, holding that “[i]t is a cardinal principle of our system of justice that factual disputes must be heard in open court and resolved through trial-like proceedings.” Id. at 101. The Court, noting that “the parties disputed a number of facts during the remedies phase,” id. at 101, held that it was error for the trial court not to hold an evidentiary hearing. Here, the government is seeking to introduce new evidence through third-party “experts” more than a year after the close of trial and over two months after the Court issued its Order. To consider the government’s new evidence would constitute a fundamental violation of Microsoft.1

Finally, practical considerations independently militate against adopting the government’s and Intervenors’ proposals. The time consuming procedures the government and Intervenors recommend will result in substantial delays and render it impossible to meet the Court’s time-table. The process the Government envisions — of retaining a third party, having

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1 Indeed, the government’s proposal, if adopted, would be akin to permitting it to designate experts post trial without providing reports or permitting them to be deposed.

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6

that third party develop proposed statements itself, develop designs, and then test market those statements and designs — would take months at a minimum. Implementation of the final statements will require an additional several months to implement. See Declaration of David Beran at ¶¶ 5-6 (submitted with PM USA’s Corrective Statements). In addition, the government’s proposal will require an extraordinary level of Court involvement and supervision as well as delay.

II. Whether to Include Attribution Depends on the Content of the Statement, and the Court should Permit Defendants to Make this Determination on a Statement by Statement Basis.

As defendants’ proposed corrective statements submissions reflect, defendants hold differing views about whether the statements should be attributed to the Court’s Order. Defendants have articulated their respective views on the propriety of attribution to the Court’s Order in their prior submissions. See Philip Morris USA’s Proposed Corrective Statements As Compelled By The Final Judgment and Remedial Order at 3-7; Certain Joint Defendants’ Submission of Proposed Corrective Statements Pursuant to Order # 1015 at 3-7; Submission of British American Tobacco (Investments) Limited (“BATCo”) Pursuant to Order # 1015,§ II.B.¶5 at 2; Lorillard Tobacco Company’s Proposed Corrective Statements Required By Order # 1015 at 2-5.

Defendants, however, agree that they have a clear constitutional right to disassociate themselves from compelled speech and that this right requires that they have the option to indicate that objectionable statements are made pursuant to the Court’s Order. See United States v. Nat’l Soc. of Professional Engineers, 555 F.2d 978, 984 (D.C. Cir. 1977) (where court strikes professional society’s rule that competitive bidding was unethical, and requires the society to state that the rule has been judicially invalidated on antitrust grounds, it was improper for a district court to require the society to state that “in its view” competitive bidding was ethical);

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7

Planned Parenthood Minnesota v. Rounds, 375 F. Supp.2d 881, 886-87 (D.S.D. 2005) (striking down legislation requiring compelled speech where no opportunity for speaker to disassociate him or herself from content of speech); see also Prune Yard Shopping Center v. Robins, 447 U.S. 74 (1980) (upholding law requiring shopping mall owner to permit petitioning on its property because no risk existed that the speech would be attributed to property owner). Accordingly, defendants should have the option of including a statement of attribution in any statement ultimately approved by the Court.

Defendants object to the inclusion of an introductory phrase suggesting that the content of the statements conflicts with defendants’ prior positions, such as the introductory phrases proposed by the government (“Despite our prior denials”) and Intervenors (“For decades, we deliberately misled the American Public about the health effects of smoking”). In the first place, the purpose of the statements, in the Court’s view, is to provide information to consumers, not to unfairly prejudice consumers against these defendants. Yet that is the only conceivable justification for these introductory clauses. In any event, the government and Intervenors in their submissions provided no supporting materials, let alone citations to this Court’s findings, for their claims, often erroneous, that defendants denied each of the “concepts” it submitted, or that such statements are required to prevent or restrain future RICO wrong-doing. See, e.g., Op at 1635.

III. The Court Should Not Approve All Relevant Details of the Corrective Statements.

The Court’s Order is unambiguous in what it required the parties to submit — it required the submission of the “exact wording” of proposals. Nonetheless, the government and Intervenors ask the Court to go beyond approving the wording of the corrective statements and involve itself in every aspect of the development and dissemination of the corrective statements. Under the government’s and Intervenors’ view, the Court should dictate everything from the

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8

print size, to color, spacing and format — a result the Court’s Order clearly does not contemplate. Like the government’s and Intervenors’ other requests, this too would involve an exceptional level of court involvement and the expenditure of significant judicial resources. This approach was not ordered and was not contemplated by the Court’s Order, and the Court should not become entangled in micromanaging the vast number of details that will arise in publishing these statements.2 The government and Intervenors again fail to justify modifying the Court’s Order in the manner proposed.

Additionally, defendants are concerned that such specification will adversely impact implementation, timing, or efficiency. For example, if the Court specifies a type size that is too large or too small for the multitude of different sized header displays, the parties’ ability to rapidly implement the Order will be severely disrupted by the need to make submissions on such details. And while the Intervenors seek to have a third party develop its statements into proper and effective corrective statements, the “statements” they submit — if considered that — fall far short of that mark. They are extremely lengthy, which makes it unlikely that they will be read, let alone understood, in the context in which the Court has ordered them to be made. They contain graphic images that are neither part of the record nor contemplated by this Court’s request for “exact wording,” and which the government did not request at trial. The defendants intend to implement the required statements in a simple and direct manner. Thus, they request that the Court approve the wording of the corrective statements as contemplated in the Order, and not extend the reach of the Order to the level of detail demanded by the Government Intervenors.

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2 In no event should a third party be given blanket authority to develop the print size, color, spacing and format of the statements.

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CONCLUSION

For the foregoing reasons, defendants respectfully request that the Court reject the government and Intervenors’ proposals in their entirety and instead base the corrective statements on defendants’ respective proposals.

DATED: October 30, 2006

Respectfully submitted,

/s/ Matthew A. Campbell for _______________

Timothy M. Broas (D.C. Bar No. 391145)

WINSTON & STRAWN LLP

1700 K Street, N.W.

Washington, D.C. 20006-3817

Telephone: (202) 282-5000

Fax: (202) 282-5100

Dan K. Webb

Thomas J. Frederick

WINSTON & STRAWN LLP

35 West Wacker Drive

Chicago, Illinois 60601-9703

Telephone: (312) 558-5600

Fax: (312) 558-5700

Theodore V. Wells, Jr. (D.C. Bar No. 468934)

James L. Brochin (D.C. Bar No. 455456)

PAUL, WEISS, RIFKIND, WHARTON &

GARRISON LLP

1285 Avenue of the Americas

New York, New York 10019-6064

Telephone: (212) 373-3000

Fax: (212) 757-3990

Attorneys for Defendants

Altria Group Inc. and Philip Morris USA Inc.

/s/ Matthew A. Campbell for _______________

Robert F. McDermott (D.C. Bar No. 261164)

Peter J. Biersteker (D.C. Bar No. 358108)

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JONES DAY

51 Louisiana Avenue, N.W.

Washington, D.C. 20001-2113

Telephone: (202) 879-3939

Fax: (202) 626-1700

Paul G. Crist

JONES DAY

North Point

901 Lakeside Avenue

Cleveland, Ohio 44114-1190

Telephone: (216) 586-3939

Fax: (216) 579-0212

Attorneys for Defendant

R.J. Reynolds Tobacco Company

/s/ Matthew A. Campbell for _______________

David E. Mendelson (D.C. Bar No. 471863)

KIRKLAND & ELLIS LLP

655 15th Street, N.W., Suite 1200

Washington, D.C. 20005

Telephone: (202) 879-5000

Fax: (202) 879-5200

David M. Bernick

Stephen R. Patton

Renee D. Honigberg

KIRKLAND & ELLIS LLP

200 East Randolph Drive, Suite 5900

Chicago, Illinois 60601

Telephone: (312) 861-2000

Fax: (312) 861-2200

Attorneys for Defendant

Brown & Williamson Tobacco Holdings, Inc.

/s/ Matthew A. Campbell for _______________

Michael B. Minton

THOMPSON COBURN LLP

One US Bank Plaza, Suite 3500

St. Louis, Missouri 63101-1693

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Telephone: (314) 552-6000

Fax: (202) 552-7597

Kamran Q. Khan

SHOOK, HARDY & BACON LLP

2555 Grand Blvd.

Kansas City, Missouri 64108-2613

Telephone: (816) 474-6550

Fax: (816) 421-2708

Attorneys for Defendant

Lorillard Tobacco Company

/s/ Matthew A. Campbell for _______________

Bruce G. Sheffler

David L. Wallace

CHADBOURNE & PARKE LLP

30 Rockefeller Plaza, 34th Floor

New York, New York 10112-0219

Telephone: (212) 408-5100

Attorneys for Defendant

British American Tobacco (Investments)

Limited (f/k/a British-American Tobacco

Company Limited)

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http://www.tobacco-on-trial.com/files/20061030venorsresponse.pdf

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UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

____________________________________

UNITED STATES OF AMERICA,

Plaintiff,

and

TOBACCO-FREE KIDS ACTION FUND,

et al.

Plaintiff-Intervenors

v.

PHILIP MORRIS USA, INC., et al.,

Defendants.

Civil Action No. 99-CV-2496 (GK)

____________________________________

PLAINTIFF-INTERVENORS’ SUBMISSION PURSUANT THE COURT’S ORDER #1025

Introduction

Pursuant to the Court’s Final Judgment and Remedial Order (Order # 1015), on October 16, 2006 the Public Health Intervenors (Tobacco-Free Kids Action Fund, American Cancer Society, American Heart Association, American Lung Association, Americans for Nonsmokers’ Rights, and National African American Tobacco Prevention Network) submitted proposed corrective statements on the five issues identified by the Court. In that submission, the Public Health Intervenors also recommended that, in order to insure that the Court-Ordered corrective statements serve their intended purpose, the Court should not only determine the precise wording of the corrective statements, but should rely on an independent communications/advertising firm to determine the specific criteria governing the execution of each of the statements (e.g., the print sizes and colors,

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voices, use of graphics). As is standard in the industry, this firm would oversee basic market testing before making final recommendations to the Court.

In response to this and the United States’ submissions, the Court has ordered the parties to address several issues. First, the Court has asked about the practical impact of taking these additional steps in connection with the corrective statements requirement. Second, the Court has inquired whether the statements should indicate that they are being issued pursuant to Court Order. Finally, the Court has asked whether it is appropriate for the Court to approve the details of the corrective statements, in addition to the specific wording of the statements. Order # 1025.

As explained below, the Public Health Intervenors believe it is entirely appropriate – indeed essential – for the corrective statements to indicate that they are issued by Court Order, as well as for the Court to approve the details of these statements. As regards the practical impact of determining these details, the Public-Health Intervenors recommend that the Court either permit the United States to oversee this task, as they have suggested, or alternatively, appoint a Rule 53 Special Master to do so. See Fed. R. Civ. P. 53. Either way, if adopting these steps for some media – such as the onserts – requires a relatively brief delay in the Court’s deadlines, the Public Health Intervenors believe that the enormous benefits that would accrue from insuring truly effective corrective statements far outweighs any risks posed by such a minor delay. In any event, as also explained below, all the steps being recommended can be completed in approximately six to eight weeks, which would not significantly delay the date by which the public will finally be hearing the truth about the adverse health impacts of smoking, addictiveness, nicotine manipulation, “light” cigarettes, and secondhand smoke.

2

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Discussion

1. The Practical Impact Of Plaintiffs’ Proposals

Both the United States and the Public Health Intervenors have recommended that, before the corrective statements are finalized, the Court should utilize an independent communications firm to develop the most effective design characteristics for each of the media. The Court has asked the parties to explain the practical impact of such an approach.

The first question the Court must address is who will oversee the appointment of these experts and their work. As a threshold matter, the Public Health Intervenors have no objection to the United States’ suggestion that they be authorized to be the managers of this project. See U.S. Notice of Compliance With Order # 1015, at 1. Under that approach, the Court would permit the United States to retain appropriate third party professionals to design and test the corrective statements based on the language selected by the Court and submit final products for the Court’s approval.

Alternatively, the Public Health Intervenors suggest that this might be an appropriate role for a Special Master, who, under Rule 53, may be appointed to “address pretrial and postrial matters that cannot be addressed effectively and timely by an available district judge . . . .” Fed. R. Civ. P. 53(a)(1)(C) (emphasis added); e.g., In re Holocaust Victim Asset Litigation, 282 F.3d 103, 104-07 (2d Cir. 2002) (discussing appointment of Special Master to implement a court-approved settlement). Earlier in this litigation, the Court appointed Judge Richard A. Levie (Ret.) as a Special Master. See Dec. 22, 2000 Order (making appointment); Order # 909 (terminating appointment). In light of the more than 170 reports Judge Levie issued in that role, and his consequent

3

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familiarity with these proceedings, if he is available Judge Levie would certainly be an appropriate Special Master for this specific post-trial matter. See Cobell v. Norton, 334 F.3d 1128, 1142 (D.C. Cir. 2003) (noting “the practice of a federal district court appointing a special master pursuant to Rule 53 to supervise implementation of a court order . . . .”) (emphasis added); Woodson v. Green, 191 F. Supp. 2d 1231, 1233 (D. Kan. 2002) (Special Master appointed to monitor defendants’ compliance with consent judgment); Johnson v. Bd. of Ed. Of Champaign Unit School Dist., 188 F. Supp. 2d 944, 985 (C.D. Ill. 2002) (same); Rosen v. Tennessee Commr. of Fin. and Admin, 204 F. Supp. 2d 1061, 1095 (M.D. Tenn. 2001) (same). .1

Under either scenario, the Public Health Intervenors would recommend that the Court direct the United States (or the Special Master) to hire an independent communications/advertising firm that would take the specific language approved by the Court for each corrective statement and determine the relevant details governing the execution of each of the statements (e.g. the print sizes and colors, voices, use of graphics), after which the firm would make final recommendations for the Court’s approval.2 The Court would then issue a final Order approving the final artwork to be used by Defendants in each the five media.

As regards the selection of language, for all the reasons detailed in the Public Health Intervenors earlier Memorandum, the Court should choose the specific language

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1 Although, in response to requests for Court Monitors to oversee certain proposed corporate structural changes, the Court determined that it would be inappropriate to delegate such broad powers, see Opinion at 1648-52, the limited role that a Special Master would be playing here – i.e., overseeing implementation of the Court’s corrective statements requirement – raises none of those concerns. Id. at 1652 (“it is permissible for the court to appoint an individual to oversee and monitor implementation of a decree”).

2 As the Public Health Intervenors have explained, it is imperative that the firm hired for this project not have tobacco companies as current or recent clients. See Plaintiff-Intervenors’ Corrective Statements Memorandum (“PHI Mem.”) at 43.

4

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the Public Health Intervenors have proposed for each statement, including all three elements outlined – (a) the headline admission of Defendants’ prior deliberate misstatements; (b) the language indicating that the statement is being issued pursuant to a Court Order (see Part 2, infra); and (c) a listing of the most important accurate facts concerning each topic, presented in a succinct and simple manner. Of the proposed corrective statements submitted to the Court, the Public Health Intervenors believe – based on extensive experience in this kind of communication effort – that their proposed language will be the most effective at correcting the public’s and smokers’ misunderstandings on these topics.

The two other questions raised by this approach are the time and cost involved. To answer those questions, the Public Health Intervenors have consulted with two communications firms with whom they have worked in the past, and who have extensive experience in tobacco-education related advertising campaigns. Those firms have estimated that, once given the assignment, a firm could develop the final statements in six to eight weeks, two to three weeks of which would involve the market testing element. At the conclusion of the process the firm would produce, for the Court’s consideration and approval, the final artwork for each corrective statement in each medium, which the companies would use for placement.3

While this approach would not permit completion of the onserts by the November 9, 2006 date requested by Philip Morris, it would delay the completion date by only up to two months. While this would require the deadlines for the onserts to be extended, the

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3 For the newspapers, onserts, countertop displays, and websites, the final product would be camera ready documents that would just need to be appropriately sized for the specific media (e.g, to accommodate the size of the specific newspaper). For the television advertisements, the final product could be final film that would just need to be put into the appropriate format.

5

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Public Health Intervenors urge that the benefits in terms of insuring effective onserts – which will be directed primarily at smokers themselves (who buy the cigarette packs on which the onserts will appear) – far outweigh the downsides of such a brief delay. Thus, while the Public Health Intervenors agree that it is critical for the corrective statements to be issued as soon as possible, that urgency does not counsel against the additional steps recommended here.4

No similar concerns have been raised regarding the other media, and thus it appears that, even taking these steps, the deadlines for the other media may remain on or near the present timetable. These steps could certainly be completed in time to meet the February 2007 deadlines for the countertop displays and television advertisements. As for the newspaper advertisements, the first of which is due December 3, 2006, these steps might require moving the current schedule back for up to two periods. See Final Order at II.B.7.c (requiring advertisements to be run once every four weeks). Again, in the view of the Public Health Intervenors, such a brief delay would be well worth the benefits in terms of insuring that the corrective statements are as effective as possible.

Finally, in terms of cost, according to the several firms with whom the Public Health Intervenors have consulted, these steps (including the market testing) would cost at most, approximately $675,000, and potentially much less in light of the various fees

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4 Alternatively, in order to shorten the delay, the Court could forego the market testing, which would save two to three weeks. While basic market testing – which the Public Health Intervenors have assumed would involve 8-12 focus groups of 10-12 individuals, as well as an online survey of approximately 2,000 – would help to provide a final check on the corrective statements (see, e.g., Designing and Implementing an Effective Tobacco Counter-Marketing Campaign, Chapter 3 (”Gaining and Using Target Audience Insights”), Centers for Disease Control and Prevention, U.S. Department of Health and Human Services Office on Smoking and Health (October 2003) (Accessed at http://www. cdc.gov/tobacco/mcrc /countermarketing /pdf/Tobacco_CM_Manual.pdf); see also Making Health Communications Programs Work, Stage 2: Developing and Pretesting, National Cancer Institute, U.S. Department of Health and Human Services, at 83 (Accessed at www.cancer.gov/pinkbook)), in the Public Health Intervenors’ view the Court could direct that the outside firm forego this step if the Court adopted the Public Health Intervenors’ proposed language.

6

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charged by different agencies that do this kind of work.5 Even assuming the higher cost estimate here, when divided among the six Defendants this would require an expenditure of at most less than $115,000 each. Certainly, when compared to the Defendants’ exponentially larger advertising budgets, this is a paltry sum indeed. See, e.g., Op. at 997-99 (discussing billions of dollars spent on tobacco advertising).6

Moreover, if the Court were to simply dictate the language of the corrective statements, and then permit the Defendants to take these next steps on their own, they are likely to incur commensurate costs in any event, by either hiring their own communications firm, or paying staff to perform the work internally. Indeed, should Defendants each choose to take these steps independently, rather than pooling their efforts, it may be even more expensive than the approach Plaintiffs are proposing.

At the same time, Plaintiffs’ approach will also be more effective, for at least two reasons. First, as noted, if Defendants are permitted to control the relevant details of these statements, those details are likely to undermine their effectiveness. See PHI Mem. at 39-40 and Exhibit B (providing an example of an ineffective newspaper advertisement). Second, while, if permitted, Defendants are likely to create six very different designs, by having one independent firm design all of the corrective statements the Court will insure that consumers see the statements in one consistent design. In addition to the economic efficiencies of this approach, such statements will clearly be

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5 This estimate does not include the cost of purchasing any of the media – i.e., buying space in newspapers – which the Defendants will have to incur regardless of whether the Court adopts these proposals.

6 In this regard, it bears noting that a recent Center for Disease Control study concluded that, while smoking rates had been declining for eight straight years, that decline stalled in 2005, and suggested that “influencing factors may include” the fact that “tobacco-industry advertising and promotional expenditures . . . more than doubled from $6.7 billion in 1998 to $15.1 billion in 2003.” See Tobacco Use Among Adults — United States, 2005, 55 MMWR Weekly 1145, 1146 (2005) (available at www.cdc.gov/mmwr/ preview/mmwrhtml/mm5542a1.htm).

7

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more effective from a communications standpoint. In short, relying on a single independent firm to create one set of statements for each of the Defendants to use (with the only difference being the company name) will insure the use of an effective design that is communicated consistently to the public.

In sum, while it would cause some delay in the Court’s present deadlines, the steps the United States and the Public Health Intervenors are recommending are critical to insuring that these corrective statements are as effective as possible in counter-acting Defendants’ decades-long, multi-billion dollar effort to misinform the public about each of the issues the corrective statements will address.

2. Whether The Statement Should Indicate They Are Issued Pursuant to Court Order.

As for the Court’s second question, as the Public Health Intervenors have explained, it is critical that the corrective statements state that they are being provided pursuant to Court Order. See PHI Mem. at 26-27. This language is necessary both to insure the believability of the message, and to distinguish this advertising from Defendants’ independent advertising, which the public should continue to view with skepticism. Id.

Several Defendants have also specifically suggested this language. See Lorillard Tobacco Company’s Proposed Corrective Statements (“Lorillard Mem.”) at 2-3 (“The following statement is made by Lorillard Tobacco Company pursuant to a Court Order . . . ); Certain Joint Defendants’ Submission of Proposed Corrective Statements at 3-7 (“This message is furnished by [Defendants] pursuant to a Court Order . . .). While the Public Health Intervenors do not agree with Defendants’ argument that “[t]he first amendment requires that such attribution be included in any statement ordered by the

8

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Court,” Lorillard Mem. at 3 (emphasis added), there is no disagreement on the result, and thus the corrective statements should indicate that they are being issued pursuant to Court Order.

3. Whether The Court Should Approve All Relevant Details Of The Corrective Statements.

As the original submissions of the United States and the Public Health Intervenors demonstrated, it is both necessary and appropriate for the Court to approve all the details of the corrective statements before directing Defendants to issue them in the five media. See PHI Mem. at 18-44. The proposed corrective statements the Defendants have submitted to the Court only further reinforce those points.

In particular, even a cursory review of those proposals reveals that, far from correcting the decades of misinformation the Defendants have disseminated about their products, their proposals would either have no effect at all, or worse, would sow additional confusion about tobacco and its negative effects. For example, Lorillard recommends that the Court-Ordered corrective statement on the adverse health effects of smoking list more than thirty diseases and conditions, including “increased absenteeism from work and increased use of medical care services.” Lor. Mem. at 3. Certainly, this statement would not be an effective corrective communication.

Similarly, British American Tobacco (“BATCo”) recommends that the statement on nicotine manipulation state that:

BATCo manipulates the design of its cigarette brands to ensure that every cigarette of a particular brand or style will deliver the amount of nicotine (within 0.1 mg.) advertised for that brand, according to the test for nicotine in cigarette smoke adopted by the International Standards Organization.

9

**———————————————————

If anything, this statement will convey that BATCo’s manipulation of nicotine is entirely lawful and legitimate, rather than correcting the company’s prior misstatements concerning nicotine manipulation.

In light of the ineffectiveness of Defendants’ proposed language, it is evident that if the Court were to permit Defendants to control the other relevant details of the corrective statements, those other elements will also be designed to minimize, rather than maximize, the effectiveness of the message the corrective statements are meant to convey. Accordingly, Defendants’ proposed language further demonstrates that it is critical for the Court to approve all the relevant details of the corrective statements and thereby to prevent the Defendants from undermining their effectiveness.

It is also entirely appropriate for the Court to do so. As the Public Health Intervenors have noted, these are the kind of elements that the Federal Trade Commission dictated in a corrective statement approved by the D.C. Circuit. PHI Mem. at 37-39, citing Warner-Lambert Co. v. FTC, 562 F.2d 749, 763 (D.C. Cir. 1977) (dictating, e.g., the details of television advertisements). Moreover, in light of this Court’s overwhelming findings regarding Defendants’ myriad legal violations and decades-long efforts to misinform the public about the topics of the corrective statements, the Court should not only dictate the language of those statements, but should take these additional steps to insure that the final corrective statements are as effective as possible in achieving their intended purpose.

10

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CONCLUSION

For the foregoing reasons, the Public Health Intervenors urge the Court to not only identify the specific language of the corrective statements, but to take appropriate steps to insure that the relevant details of these corrective statement enhance, rather than detract from, their effectiveness.

Respectfully submitted,

/s/____________

Howard M. Crystal

(D.C. Bar No. 446189)

Katherine A. Meyer

(D.C. Bar No. 244301)

MEYER GLITZENSTEIN & CRYSTAL

1601 Connecticut Avenue, Suite 700

Washington, DC 20009

202-588-5206

October 30, 2006

A HALLOWEEN CAROL

November 1, 2006 11:56 am by Gene Borio

After the Supreme Court hearing in Philip Morris v. Williams, I stopped by the old campus, the Prettyman courthouse, to see some of the old gang. Ah, but the press room was almost empty today, everyone off covering new momentous events.

Well, I thought, I’ll take a jaunt up to Courtroom #19, maybe catch just a bit of that old Kessler jurisprudence magic. I’ve been thinking a lot about that lateley, but not in regards to the tobacco trial. No, strangely enough, though I hadn’t even taken any notes on it, I’ve been haunted lately by an event that took place early one winter morning in 2005, an “emergency” hearing which had preempted the usual tobacco proceedings.

As I recall without notes, a very young woman, early 20s, black, a bit overweight, was in danger of losing her child if she didn’t faithfully adhere to a drug treatment program. She’d apparently had been having a terrible time with crack or meth or heroin, and though many people and agencies had tried to work with her, she had once again violated the terms of the latest agreement. The lawyers and Judge Kessler painstakingly worked out the details to give her this one last chance. After the legal technicalities were completed, Judge Kessler said she now needed to speak with the woman herself.

The young woman pulled herself off the edge of the jury box she’d been leaning on, and came to the center. Judge Kessler then gave her just about the most astounding, heartfelt speech I’ve ever heard, emphasizing how important this was for her life, and that she must take advantage of this last-chance deal, or she could go back to prison, and worse, she could lose her child. Judge Kessler was just so direct, so personal, so concerned yet so honest and tough, so, so — so human. (When I mentioned the incident to Sharon Eubanks during our interview last summer, she burst out, “Oh, yes! I remember that!” She too had been tremendously impressed and moved.)

Well, I couldn’t see the young woman’s face as Judge Kessler talked to her, but something about her body language told me that even Judge Kessler, with all her considerable linguistic and humanist powers, may not be getting through. And indeed, I don’t believe she saw what really happened after her speech. As the young woman turned and began walking toward the door, stonily impassive, she casually resumed chewing the gum that had been lodged somewhere in her mouth all this time. It was a heartbreaking moment, and I feared Judge Kessler was destined to have an even sadder day in court with the young woman sometime very soon.

So today I got off the elevator at the 6th floor, thinking maybe I’d see some case in Judge Kessler’s court, something undoubtedly more pedestrian than USA v. Philip Morris, and certainly nothing as dramatic as the young woman’s; but something. As I turned from the elevator foyer and looked down the broad hallway, I got a shock–what had been a solid wall at the end of the hallway, just beyond Courtroom #19, was now an open archway into a bright, gleaming new space. Of course! That huge new building they had been working on during the trial was open now, and in fact was an annex to the old Prettyman courthouse.

The new hole in the wall was a bit weird, but what was even weirder was Courtroom #19 itself. If broken-off boards had been nailed askew across the doors it could not have looked more abandoned. Once, a plaque with Judge Kessler’s name had been outside; now the rectangular space was empty, raw; the entire mounting plate had been ripped out of the wall, as if no one would ever preside here again. No docket sheet hung from the corkboard underneath; only a leftover, now-useless push-pin. The doors were locked, but if you looked through the small window, you could see the inside seemed intact; but everything was so very dark it was impossible to see beyond the visitors’ gallery. What was clear is that it hadn’t been in use for some time. #19 was a derelict courtroom.

Well, that ended that plan. So I stepped, white-rabbit-like, through the doorway in the wall and into the wide-open, sparkling new building, enjoying its architectural wonders till I found the exit.

As I was going to the Metro, who should be coming the other way but Judge Kessler! She looked quite nice, as if she had had a makeover bringing her not just into sync with the slick new annex, but fully into the 21st Century. Her hair was still blonde, but the mini-bouffant had given way to a kind of lightly haphazard, longish bob in a layered modern style; her clothes seemed far too nice to wear under those dingy Judge’s robes, combining color and style in a way that was quietly exquisite (perhaps she had an event tonight). And wait, am I misremembering here? Were her nails, once always traditional shades of red, now, daringly, powder blue?? And I hadn’t noticed before, never having seen her up close in full daylight, that her skin has a smooth, delicate, almost translucent quality. OK, 67, maybe 68, and looking, frankly, pretty hot.

I told her I’d been to the Supreme Court for the Williams case. She asked about it and I gave a quick rundown, hoping my legalese would pass muster. She talked about how painfully slow and bureaucratic the wheels of justice were these days. Her judgement in USA v. Philip Morris itself, she said, was 2 years from being final. She mentioned how much it had taken for her to write those 1700+ pages. Though our chance meeting was an hour or so before the DC Court of Appeals’ decision to stay her landmark ruling came down, perhaps she already knew of this terrible blow through some courtroom grapevine.

When I mentioned the empty shell that had been Courtroom 19, she said oh, no, she’d been in the new annex for a long time now. The old place was apparently an ancient reminiscence, dutifully dredged up, but the freshness of its memories had wilted, buried under new trials, new troubles, new dilemnas in the human parade that, never-endingly, passes daily through her bright new courtroom.

I got a sense, for the first time from this Happy Warrior, that there must be times, when you’re fighting on this level, this constantly, this intensely, and when there’s only so much even you can humanly, Sysipheanly do–from bringing multinationals to account, to helping a young woman in desperate trouble, to the myriad intractables she must face down every day–there must be times when–no matter how spruced-up and streamlined the externals–you do get weary.

But when I think about how she could so expertly disentangle and encapsulate prickly legal issues, and when I compare what I would hear from her with what I heard from the Supreme Court Justices as they fumbled about for a satisfactory jury instruction, I rued again that she is not on that Court. Her strength, clarity and force of vision would be an incredible asset, and even an inspiration to the entire Court, imho.

—————

Ah well, so that was my run-in with Judge Kessler.

And also, this Halloween, with the Ghosts of Courtrooms Past, Courtrooms Present, and Decisions Yet to Come.

God Bless us, every one.

SUPREME COURT WILLIAMS HEARING: A BOG BETTER HANDLED BY A BLOG

October 31, 2006 12:10 pm by Gene Borio

Granted, I’m not a lawyer, and frankly I get thoroughly lost in a lot of these legal joustings, but I thought I’d prepped pretty well to hear the arguments this morning. Yet, 45 minutes in, I remember thinking, “Why are we spending all this time on Philip Morris’ proposed jury instruction, long after the Justices seemed to agree it was inadequate anyway, and even as they tinker away at it, trying to determine just the right language, the exact phraseology that would communicate, in a way ordinary jury members could understand, that the jury could consider, in its determination of reprehensibility, the potential harm Philip Morris’ conduct might cause to others, but THEY COULD NOT PUNISH PHILIP MORRIS FOR THAT HARM (ie, the award is to punish only the reprehensible conduct itself, not the harm it may have caused to others.)

Clear? If you were on a jury, how would you reconcile the difference?

Justice Breyer described the issue as a “kind of bog:”

[W]hat’s worrying me about this is I see as we try to determine what this instruction said, whether it was good enough, whether the instructions without it are good enough, that we’re going to be in a kind of bog of mixtures of constitutional law, unclear Oregon state law, not certain exactly what was meant by whom in the context of the trial, et cetera.]

Remember, the court was to consider:

QUESTIONS PRESENTED

1. Whether due process allows a state to impose punitive damages based on the actual and potential effects of the defendant’s wrongful conduct throughout the state?

2. Whether the ratio between compensatory and punitive damages comprises the conclusive and overriding guidepost as to the reasonableness of a punitive damages verdict?

Of all the deep, serious issues in this case, I never expected this relatively small and hypothetical aspect to occupy the bulk of the hour-and-ten-minute session.

And when, just outside the courtroom, I asked Williams attorney Robert Peck about it, he said he thought Frey had “shot himself in the foot on that one.”

And indeed, the huddle of supreme court reporters in the press room was in agreement, criticizing Frey severely for opening with the complaint that Philip Morris was denied its proposed jury instructions. One distinguished gentleman, seemingly the most experienced and legal-minded of the group, counted 5, maybe 6 Justices whom he felt would remand for reconsideration, asking the Oregon Supreme Court, “What exactly did you mean?” in regards to whether Philip Morris was punished for harm to other Oregonians or for conduct that had the potential for great harm.

One reporter said, “I was all hyped for this case, ready to write on all the big issues, but now–I don’t even know if I’ll file.”

“Look for it tomorrow on MSNBC,” another suggested.

The senior reporter referred to all the ins and outs of the case, all the rulings, the technical shadings, the intricate parsings, and said, “This is one of those cases that’s better handled by a blog.”

The transcript is here:

http://www.supremecourtus.gov/oral_arguments/argument_transcripts/05-1256.pdf

DEFENSE ACCEPTS DOJ’s BILL OF COSTS–WITH INTEREST IF AND WHEN APPEALS ARE EXHAUSTED

October 23, 2006 9:59 pm by Gene Borio

“[T]he parties have agreed (a) that the amount submitted by the Government in its Bill of Costs $1,930,981.97, shall constitute the appropriate taxable costs and (b) that Defendants shall be liable for that amount, plus interest from this date, upon final resolution of all appeals in this matter, if the Government remains the prevailing party.”

**———————————————————

Text follows of:

Defendants Praecipe on Bill of Costs, October 23, 2006

**———————————————————

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

UNITED STATES OF AMERICA,

Plaintiff,

And

TOBACCO-FREE KIDS ACTION FUND,

et al.,

Plaintiff-Intervenors,

v.

PHILIP MORRIS USA INC. (f/k/a

PHILIP MORRIS INCORPORATED),

et al.,

Defendants.

Civil Action No. 99-CV-2496 (GK)

Next Scheduled Court Appearance: None

**———————————————————

JOINT PRAECIPE REGARDING BILL OF COSTS

The parties jointly submit this praecipe regarding the Bill of Costs.

1. In Order No. 1015, this Court ordered that “Defendants shall pay the appropriate costs of the prevailing party, which is the Government. The Government shall serve and file a bill of costs in accordance with LCvR 54 within 30 days from this date.”

2. The Government filed its Bill of Costs on October 2, 2006.

3. To expedite and facilitate resolution of the issues concerning the Bill of Costs, the parties have agreed (a) that the amount submitted by the Government in its Bill of Costs $1,930,981.97, shall constitute the appropriate taxable costs and (b) that Defendants shall be liable for that amount, plus interest from this date, upon final resolution of all appeals in this matter, if the Government remains the prevailing party.

**———————————————————

2

DATED: October 23, 2006 Respectfully submitted,

Peter D. Keisler

Assistant Attorney General

/s/ Matthew A. Campbell for

Stuart Schiffer

Deputy Assistant Attorney General

/s/ Matthew A. Campbell for

UNITED STATES DEPARTMENT OF

JUSTICE

Post Office Box 14524

Ben Franklin Station

Washington, DC 20044-4524

Telephone: (202) 616-4185

Attorneys for Plaintiff

United States of America

/s/ Matthew A. Campbell for

Timothy M. Broas (D.C. Bar No. 391145)

WINSTON & STRAWN LLP

1700 K Street, N.W.

Washington, D.C. 20006-3817

Telephone: (202) 282-5000

Fax: (202) 282-5100

Dan K. Webb

Thomas J. Frederick

WINSTON & STRAWN LLP

35 West Wacker Drive

Chicago, Illinois 60601-9703

Telephone: (312) 558-5600

Fax: (312) 558-5700

Theodore V. Wells, Jr. (D.C. Bar No.

468934)

James L. Brochin (D.C. Bar No. 455456)

PAUL, WEISS, RIFKIND, WHARTON &

GARRISON LLP

1285 Avenue of the Americas

New York, New York 10019-6064

Telephone: (212) 373-3000

Fax: (212) 757-3990

Attorneys for Defendants

Altria Group Inc. and Philip Morris USA Inc.

/s/ Matthew A. Campbell for

Robert F. McDermott (D.C. Bar No. 261164)

Peter J. Biersteker (D.C. Bar No. 358108)

JONES DAY

51 Louisiana Avenue, N. W.

Washington, D.C. 20001-2113

Telephone: (202) 879-3939

Fax: (202) 626-1700

**———————————————————

3

Paul G. Crist

JONES DAY

North Point

901 Lakeside Avenue

Cleveland, Ohio 44114-1190

Telephone: (216) 586-3939

Fax: (216) 579-0212

Attorneys for Defendant

R. J. Reynolds Tobacco Company

/s/ Matthew A. Campbell for

David E. Mendelson (D.C. Bar No. 471863)

KIRKLAND & ELLIS LLP

655 15th Street, N.W., Suite 1200

Washington, D.C. 200005

Telephone: (202) 879-5000

Fax: (202) 879-5200

David M. Bernick

Stephen R. Patton

Renee D. Smith

KIRKLAND & ELLIS LLP

200 East Randolph Drive, Suite 5900

Chicago, Illinois 60601

Telephone: (312) 861-2000

Fax: (312) 861-2200

Attorneys for Defendant

Brown & Williamson Tobacco Holdings, Inc.

/s/ Matthew A. Campbell for

Michael B. Minton

THOMPSON COBURN LLP

One US Bank Plaza, Suite 3500

St. Louis, Missouri 63101-1693

Telephone: (314) 552-6000

Fax: (314) 552-7597

Gene E. Voigts

SHOOK, HARDY & BACON LLP

2555 Grand Blvd.

**———————————————————

4

Kansas City, Missouri 64108-2613

Telephone: (816) 474-6550

Fax: (816) 421-2708

Attorneys for Defendant

Lorillard Tobacco Company

/s/ Matthew A. Campbell for

Bruce G. Sheffler

David L. Wallace

CHADBOURNE & PARKE LLP

30 Rockefeller Plaza, 34th Floor

New York, New York 10112-0219

Telephone: (212) 408-5100

Attorneys for Defendant

British American Tobacco (Investments)

Limited (f/k/a British-American Tobacco

Company Limited)