Defendants Made False and Misleading Public Statements Denying that ETS Is Hazardous to Nonsmokers

¶3793. Despite the positions of the public health authorities and despite their own internal recognition of the link between ETS and disease in nonsmokers, Defendants made numerous public statements denying the linkage.

¶3794. In 1979, Defendant Tobacco Institute issued a brochure to the public called "Fact or Fancy?" that denied any adverse health effects caused by cigarettes. With respect to passive smoking, the brochure denied that: "Women who smoke harm their babies before and after birth." Moreover the brochure claimed: "It is difficult to understand why parental smoking is blamed for a child's coughs or wheezes, in view of these conflicts in research findings." TIMN0133740-3798 at 3741, 3754 (US 21280).

¶3795. In 1980, the Tobacco Institute published a brochure titled "A Two-Way Street" which stated: "First of all, it is important to understand that there is no convincing evidence that tobacco smoke causes disease in nonsmokers." 2024299572-9575 at 9573 (US 20401).

¶3796. In response to the three 1981 studies showing an increased risk of lung cancer among spouses married to smokers and the Surgeon General's warning of a "possible serious public health problem," Defendant Tobacco Institute ran a series of advertisements called "Answers to the most asked questions about cigarettes." "Question 5" was "Does Cigarette Smoke Endanger Nonsmokers?" The Tobacco Institute's "answer" in the advertisement distorted the scientific evidence and the Surgeon General's conclusions:

¶Here's what two major opponents of smoking said on the subject:

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The Surgeon General. Clearly and simply put, he has not concluded from the scientific literature reviews that cigarette smoking causes disease in nonsmokers.

The American Cancer Society. A report covering 17 years and some 200,000 people indicated that 'second-hand' smoke has an insignificant effect on lung-cancer rates in nonsmokers. Fact from a report published by the Statistical Director of the Society in June, 1981.

A recent Japanese study made claims about lung cancer rates among nonsmokers. This got wide press coverage. But the validity of the study was seriously questioned by a variety of experts around the world.

¶TIMN0121194-1205 at 1196 (US 85358); see also 93852854-2869 at 2854 (US 88574).

¶3797. The ad campaign attacking the 1982 Surgeon General's Report was substantial:

The campaign . . . [was] targeted to reach eight out of 10 Americans 25 years or older. It is appearing in publications including Newsweek, People, Sports Illustrated, Time, TV Guide, U.S. News & World Report. . . .

¶TIMN0121194-1205 at 1196 (US 85358). Previous ads had already generated 10,000 requests for the Tobacco Institute's booklet. A series of nine ads were planned to run throughout 1982. Id., see also 93852922-2933 at 2931 (US 21118); TI04591849-1855 at 1853 (US 22028); TINY0006369- 6379 at 6376 (US 87667).

¶3798. In October 1983, the Tobacco Institute ran another advertisement in the series called "Answers to the most asked questions about cigarettes," posing the question "What happens to cigarette smoke in the air?" The ad ran in the Wall Street Journal and other news media. Among other things, the ad stated,

Even the U.S. Surgeon General, an outspoken critic of smoking, said in 1982 that the available evidence is not sufficient to conclude that other people's smoke causes disease in nonsmokers. The fact is, no

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claim of adverse health effect of cigarette smoke on a healthy nonsmoker has yet been proved.

¶TLT0601093-1095 at 1094 (US 65131); TLT0601100-1104 at 1101-1102 (US 65133).

¶3799. In 1984, Defendant Reynolds ran an advertisement titled, "Can we have an open debate about smoking?" Among other things, the advertisement stated, "Studies which conclude that smoking causes disease have regularly ignored significant evidence to the contrary. These scientific findings come from research completely independent of the tobacco industry. We at R. J. Reynolds think you will find such evidence very interesting. We think reasonable people who analyze it may come to see this issue as not a closed case, but as an open controversy." Reynolds included the adverse health effects of secondhand smoke in its campaign:

We will also explore other important issues including relations between smokers and non-smokers, smoking among our youth, and "passive smoking." Some of the things we say may surprise you. Even the fact that we say them may prove controversial. But we won't shy away from the controversy because, quite frankly, that's our whole point. We don't say there are no questions about smoking. Just the opposite. We say there are lots of questions -- but, as yet, no simple answers.

¶513943434-3434 (US 50268).

¶3800. Subsequently in 1984, Reynolds ran an advertisement titled "Smoking and Health: Some facts you've never heard about." The advertisement directly attacked the conclusions of the Hirayama study:

You also hear a lot today about "passive smoking" -- breathing other people's cigarette smoke. One study from Japan, which recently received tremendous publicity, claimed to have shown that wives of smokers ran a greater risk of lung cancer than wives of non-smokers. But this study contained such serious flaws that it was quickly and strongly criticized by several independent scientists -- including the statistician who designed the test used in the study.

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¶506100136-0136 (US 50882).

¶3801. From January 1984 to April 1986, Reynolds ran a series of advertisements in newspapers across the country. One was titled "Smoking in Public: Let's separate fact from fiction"; another was titled "Secondhand smoke: Let's clear the air"; and a third ran under the headline "Secondhand smoke: The Myth and the Reality." The three Reynolds advertisements asserted: "In fact, there is little evidence -- and certainly nothing which proves scientifically -- that cigarette smoke causes disease in nonsmokers." 506290558-0792 at 0608, 0611, 0612 (US 29799).

¶3802. In December 1986, the Tobacco Institute published a brochure, titled "Tobacco Smoke and the Nonsmoker: Scientific Integrity at the Crossroads." The Tobacco Institute claimed in its brochure that "a detailed review of the scientific literature on ETS" led to the conclusion that: "The evidence does not support conclusions that ETS represents a health hazard to nonsmokers." TIMN 284404-4413 at 4405 (US 77088).

¶3803. Defendants continued their drumbeat of public statements denying that cigarettes and tobacco smoke are a hazard to nonsmokers. The statements often borrowed from what the industry had said with respect to active smoking. For example, the Tobacco Institute published a booklet in 1987, titled "Smoking Restrictions: The Hidden Threat to Public Health." In this booklet, the authors asserted with respect to the health effects of passive smoke that:

A detailed review of the scientific literature on environmental tobacco smoke yields two basic conclusions:

First, environmental tobacco smoke has not been shown scientifically to pose a health hazard in nonsmokers.

Second, as a National Academy of Sciences panel noted recently, more and better research needs to be done.

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¶520911538-1542 at 1539, 1540-1541 (US 85593).

¶3804. A 1987 series of Philip Morris advertisements had pictures of smokers "talking" to the reader. The smokers in the ads asserted: "Please don't tell me my cigarette smoke is harmful to you. There's just no convincing proof that it is"; and "I know there's no proof my smoke can hurt you." 2500146093-6096 (US 20554).

¶3805. The Tobacco Institute published a brochure in 1988, titled "Environmental Tobacco Smoke and Health: THE CONSENSUS." This brochure referred to the 1986 reviews on passive smoking, then declared: "SCIENTIFIC CONSENSUS: No scientific case against environmental tobacco smoke." 507828094-8102 at 8096 (US 51276).

¶3806. An April 1990 INFOTAB publication, titled "Children & Smoking-The Balanced View," stated: "Exposure to ETS has not been scientifically proven to adversely affect the health of children." 2501342105-2110 at 2109 (US 20565).

¶3807. In November 1989, EPA had requested comments on a draft document titled "Environmental Tobacco Smoke: A Compendium of Technical Information," a companion document to the upcoming ETS Risk Assessment. TI11951245-1685 at 1251 (US 85699). In its February 1990 comments to EPA, the Tobacco Institute relied heavily on the conclusions of the McGill symposium, an industry funded and managed conference discussed Section V(G)(6)(a)((7))((e)), supra, but did not disclose the connection:

In addition, we would like to point out that in November of this past year, a symposium on ETS involving some 80 scientists from 20 countries was held at McGill University in Montreal. The proceedings of the symposium reflect a thorough, up-to-date discussion of the relevant literature. We believe that the results of this conference -- which concluded, overall, that ETS has not been shown to present a health hazard to nonsmokers -- should be carefully considered in

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further development of the EPA Compendium. Accordingly, we are transmitting copies of the McGill proceedings for use by EPA and its consulting authors.

¶TI11951245-1685 at 1254 (US 85699).

¶3808. In support of its arguments opposing the compendium's conclusions, the Tobacco Institute also cited published papers by industry consultants Sterling, Kessler, Fleiss, Layard, Reasor, HBI, Robertson, Hood, Tollison, Wagner, Ecobichon, Wu, Gori, Turner, Holcomb, Weinberg Consulting Group, Viren, Lee, Koo, Kabat, Wynder, Eatough, Witorsch and Haley. The Tobacco Institute did not disclose that it and the cigarette manufacturers funded and managed these consultants. TI11951245-1685 (US 85699).

¶3809. On June 25, 1990, the day the EPA released its draft Risk Assessment, the Tobacco Institute issued a press release which stated, under the headline "DRAFT RISK ASSESSMENT DESCRIBED AS SPECULATION; Underlying scientific foundation inadequate," that the conclusion that "ETS has been shown to be a cause of disease" was "contrary to fact." The Tobacco Institute then cited the McGill symposium findings, with no disclosure or attribution, as independent authority in support of its view:

This very issue was recently addressed by a prestigious panel of scientists at an international symposium on ETS held at McGill University in Montreal, Canada. As the opening presenter to the risk assessment panel at the symposium emphasized:

"The first order of business . . . is for proper studies to be carried out with respect to a possible causal link between ETS and particular diseases. If studies justifying a causal inference were to become available, we could then employ the remaining steps in the risk assessment technique."

¶87697659-7664 at 7659, 7660 (US 85586); Dawson WD, 135:18-137:3.

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¶3810. The Tobacco Institute also critiqued the EPA Draft Policy Guidelines, which related to smoking in the workplace. A Tobacco Institute Public Affairs Progress Report stated:

We continued coordinating the industry's submissions on both draft documents with two member companies who plan to submit independent comments. . . .

Editorials by scientific consultants criticizing the EPA ETS risk assessment in light of the findings of the McGill ETS symposium were published in the Detroit News, the Las Vegas sun and the Chicago Sun-Times. . . .

¶TI09911997-2033 at 2005 (US 22367).

¶3811. Industry consultants prepared letters to the editor for publication in major newspapers attacking the draft Risk Assessment with the results of the McGill symposium. As stated in the Progress Report quoted above, a number of these editorials/ letters were published. TI09911997- 2033 at 2021 (US 22367). By omitting industry attribution, the letters appeared to have been written by individuals with no industry connection. 1990 letters by Tobacco Institute consultant Jack Peterson in the Chicago Sun-Times, Las Vegas Sun and the Salt Lake Tribune, and by Tobacco Institute consultant David Weeks in the Richmond-Times Dispatch. Dawson WD, 133:13-135:13; TI12201464-1465 (US 86722) (Peterson letter titled "Passive smoking danger? Don't believe what you read"); TIMN343061-3061 (US 85582) (Weeks editorial titled "The Facts About ETS"); TIDN0019217-9268 at 9228-9229 and 9232-9233 (US 85597).

¶3812. As described below, the Tobacco Institute and other Defendants filed lengthy comments with the EPA on October 1, 1990, disputing the conclusions of and evidence cited in the Risk Assessment and policy guide. In these submissions, Defendants relied on the industry's ETS initiatives.

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¶3813. On October 1, 1990, the Tobacco Institute made its submission to the EPA. 87653565-6820 at 3941- 3998 (US 88596). The comments emphasize the findings of the papers presented at the McGill symposium, as well as industry-funded papers by industry consultants Lee, Balter, Gori, LeVois, Mantel, Bacon-Shone, Lunau, G.L. Reynolds, Viren, Fleiss, Gross, Wynder, Kabat, Reasor, Ecobichon, Wu, Gross, Kilpatrick, Todhunter, Perry, Kirk, Layard, Koo, Bieva and Witorsch, as well as the 1987 Tokyo conference and the 1988 "Perry" conference (organized by industry ETS consultant Roger Perry). 87653565-6820 at 3958, 3963-3967, 3969, 3972-3976 (US 88596).

¶3814. On October 1, 1990, R.J. Reynolds also made a submission to the EPA, which relied on many of the same industry consultant papers and industry-managed conferences, including: Koo, Witorsch, Kabat, Lee, Mantel, Kornegay, Kastenbaum, MacDonald, Layard, Viren, Kilpatrick, Butler, Rylander, the American Health Foundation (AHF), Adlkofer, Gori, Haley, Viren, Bieva, Sterling, Yano, Eatough, Proctor, Carson/Erikson. 87654420-4485 (US 92098).

¶3815. Oldaker and Paul Nelson were among a number of Reynolds scientists who wrote separate comments on the draft EPA Risk Assessment for the company. They similarly cited the industry's symposia and consultants in support of their opposition. Oldaker, the writer of the 1988 Carson/Erickson paper, repeatedly cited the paper as one of the authorities in support of his comments. 87653565-6820 at 4515-4531, 4604-4612, 4613-4618, 4619-4645 (US 88596).

¶3816. Philip Morris submitted comments to the EPA dated September 28, 1990. Like those of the Tobacco Institute and R.J. Reynolds, the Philip Morris submission cited to: Adlkofer, Haley, Robertson, Sterling, Kirk, Perry, Carson & Erikson, Proctor, Eatough, Jenkins, Kilpatrick, Viren, Koo, Lee, Ueberla, Mantel, Wynder, Kabat, First, Guerin, Schwartz, Balter, Aviado, Lunau,

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¶Rylander, Fustinoni, Kasuga, Katzenstein and Faccini, as well as several industry "symposia" and conferences. 2070140494-0630 at 0537-0553, 0595-0600, 0604-0608, 0611-0615 (US 88604).

¶3817. Defendants also paid a number of their consultants to submit free-standing comments to EPA in opposition to the draft Risk Assessment. The following scientists submitted separate comments to the EPA, but did not disclose their affiliation with the tobacco industry: Adlkofer; Aviado; Bridges; Bucci; Butler; Furst; Rutsch; Rylander; Schneider; Skrabanek; Springall; Sterling (individually and with Weinkam and Rosenbaum); Sullivan; Tweedie; and Ueberla. 2026127293- 7298 (Adlkofer); 2026128531-8559 (Aviado); 2026129063-9064 (Bridges); 2026127908-7912 (Bucci); 2026135132-5136 (Butler); 2026128569-8575 (Furst); 2026128171-8176 (Rutsch); 2026127783-7790 (Rylander); 2026127753-7760 (Schneider); 2023475720-5728 (Skrabanek); 2023128950-8981 (Springall); 2026127212-7236 (Sterling and Collett)); 2026128426-8477 (Sterling, Weinkam, Rosenbaum); 2026134124-4134 (Sullivan); 2026127923-8001(Tweedie); 2026127065-7102 (Ueberla) (US 92064); 2026127628-7636 (US 85564) (Crepat); 2081369202-9220 at 9205-9206 (US 27796) (list of PM consultants); Parrish TT, 1/26/05, 11147:12- 11148:22, 11160:22-11167:9.

¶3818. Under cover letter dated September 28, 1990, industry consultant and McGill symposium co-host Donald Ecobichon separately submitted the proceedings of the symposium directly to the EPA, urging that EPA consider the conclusions of the participants; Ecobichon did not disclose any tie to the industry. 2026134978-4978 (US 87395).

¶3819. In December 1990, EPA's Scientific Advisory Board held a public meeting to discuss the Draft Risk Assessment and the draft policy guide. 2040226083-6212 (JD 002884). That morning, the Tobacco Institute issued a press release claiming that there were major flaws in the draft EPA Risk Assessment and Policy Guide. Critical comments by Tobacco Institute consultants Lee, LeVois, and Fleiss are quoted in the release. However, neither their affiliation with the Tobacco Institute nor the fact they were paid industry consultants was disclosed.

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¶3820. The Tobacco Institute created and fostered the impression that a large number of scientists existed who, independent of the tobacco industry, opposed the EPA's proposed Risk Assessment. The press release was accompanied by 69 pages of background materials, including "an annotated list of scientific comments critical of the documents." The Tobacco Institute claimed that "dozens of scientists have challenged fundamental and technical aspects of the draft documents." 87697701-87697772 (US 85587). Of the 59 scientists included on the list, "most of if not all of the scientists commenting would have been retained by the industry." Dawson WD, 142:19-22, 143:9- 19; Dawson TT, 1/12/05, 10008:5-10011-9.

¶3821. Under cover letter dated October 15, 1990, Covington & Burling forwarded Lorillard a compilation of comments that were "filed by and on behalf of the tobacco industry" with respect to the draft ETS risk assessment and policy guide. The compilation contains submissions from various third party entities with varying document dates. For example, on October 1, 1990, the tobacco-industry funded Washington Legal Foundation filed comments on behalf of itself and twelve congressmen from tobacco-growing states who opposed the EPA action. WLF also issued a news release to publicize their comments. Nowhere in the submission to EPA or in the press release did WLF acknowledge its industry funding. 87653565-6820 at 3567-3583 (US 88596).

¶3822. Defendants' critique of the EPA continued after the final EPA Risk Assessment was published in 1992. In 1993, John Luik was hired by CECCM to write a paper titled "Pandora's Box: The Dangers of Politically Corrupted Science for Democratic Public Policy;" which attacked the

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¶Risk Assessment. Blackie WD, 132:19-133:10. Shook, Hardy & Bacon helped craft Luik's response to peer review criticisms after he submitted "Pandora's Box" to a journal for publication. 2024215189-5190 (US 37097); 2025495375-5376 (US 89050). In spite of this, and although Luik received funding from Reynolds, Philip Morris, and BATCo, neither the funding nor the industry support was acknowledged or disclosed in the paper, which was ultimately published in a Boston University alumni journal called Bostonia. 2025495237-5249 (US 89052).35

¶3823. In 1999, B&W funded a book by Luik and fellow industry consultant Gio Gori through a third party, the Fraser Institute. Blackie WD, 143:6-12. The book, titled Passive Smoke: The EPA's Betrayal of Science and Policy, alleged scientific misconduct on the part of the EPA in conducting its Risk Assessment. JDX2781834-1954 (JD 067661). The authors did not acknowledge tobacco industry funding. Blackie WD, 143:10-17.

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¶3824. Defendants knew that a one-tailed 95% confidence interval was used by EPA. See Section V(G)(2)(a)(¶¶3341-3344) for a detailed explanation of this issue. In a November 22, 1993 memorandum to industry consultant John Luik, with copies to BATCo's Chris Proctor and Philip Morris's Matt Winokus, Rothmans scientist David Rowland summarized the facts and the source of the confusion over whether the EPA had applied a 90% or 95% confidence interval. Luik was in the process at that time of finding a journal to publish his "Pandora's Box" paper, discussed above. Rowland described a meeting with counsel at Shook, Hardy & Bacon:

[SHB attorney] Bernie O'Neill and I went through the EPA document. The key to the whole thing is a short paragraph on page 5-2. . . .

So the EPA used a one-tailed test of significance at p=0.05 (i.e., the 95% confidence level). To effect this, they performed a two-tailed test with 90% confidence intervals, which is equivalent. Hence the source of confusion perpetuated by Stanton Glantz and other commentators.

Since getting back to the office this morning, I see that Kim Davis of Lovell, White and Durrant has come to a similar conclusion after considering pages 5-34/35 and speaking to his contacts in the US.

Thus, the 90% argument is out: what has to be attacked is the EPA's assumption that they were justified in using the one-tailed test.

¶2025495375-5376 at 5375 (US 89051).

¶3825. Rowland had undertaken his investigation of the 90% confidence interval allegation after Luik was told by a journal reviewer that "Luik's claim that EPA used BOTH a 90% confidence interval and a one-tailed test is 'manifestly false.'" 2024215189-5190 at 5189 (US 37097). Notwithstanding Rowland's confirmation to Luik that EPA used a 95% confidence interval and a one-tailed test, Luik's article was not corrected. 2024595237-5249 at 4239, 5243 (US 89052).

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¶3826. Indeed, under questioning by the Court, Defendants' expert Dr. Bradley admitted to understanding the EPA's rationale for a one-tailed test, noting that the EPA

had stated that they [EPA] felt like you could not have reduced risk with exposure to ETS, so therefore, that was not a possibility that the relative risk could be less than 1, it could only be greater than 1, and consequently, they wanted to look only at the increase. . . .

¶Bradley TT, 3/14/05, 15456:23-15457:3.

¶3827. At the RJR Nabisco Holdings Company annual shareholders' meeting held on April 17, 1996, in Winston-Salem, corporate executives of the holding company, RJR Nabisco, and RJR Tobacco presented an overview of their companies' performance and answered questions from shareholders. One shareholder asked the companies' position on passive smoking and children, that is, whether the company believed that people should smoke around children. The answer from management did not acknowledge any health risk to children. Instead, the following ensued between the shareholder and the chairman of RJR Nabisco:

THE CHAIRMAN: I will not restrict anybody's right to smoke. If the children don't like to be in a smoky room, and I wouldn't like to be, they'll leave. I don't know if you've got any grandchildren; I do. And if there is smoke around that's uncomfortable, they'll leave.

¶MS. DONLEY: An infant cannot leave a room.

THE CHAIRMAN: Well -- Okay. At some point they begin to crawl, okay. And then they begin to walk, and so on. I guess that's enough said. Thank you very much.

¶520800648-0821 at 0708-0709 (US 92100).

¶3828. On October 2, 1997, Philip Morris Companies sent a letter to Congress in response to a request from senators asking for Philip Morris's position on smoking and health issues. In this letter, often referred to as the "Hatch Statement," the company stated that "the evidence with respect to ETS is not persuasive." 2085633197-3198 at 3198 (US 45754). Philip Morris Companies Chairman Geoffrey Bible repeated this statement during his testimony before the House Commerce Committee on January 28, 1998. 86592673-86592675 at 3344 (US 21820). Lorillard's letter to Congress, dated October 1, 1997, similarly asserted, "We do not agree that exposure to environmental tobacco smoke has been shown to be a cause of disease in nonsmokers. 86592673-2675 at 2675 (US 56175).

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