United States v. Philip Morris USA Inc.: Amended Final Opinion

IN CONTRAST, THE INTERNAL PAPERS -- OF WHICH THIS INTRODUCTION IS ONE -- ARE FOR USE INSIDE THE INDUSTRY ONLY AND SHOULD BE TREATED AS CONFIDENTIAL. FOR THIS REASON, THE INTERNAL PAPERS HAVE BEEN PRODUCED IN A FORM WHICH IS INAPPROPRIATE FOR PUBLIC USE AND ARE CLEARLY

IN CONTRAST, THE INTERNAL PAPERS -- OF WHICH THIS INTRODUCTION IS ONE -- ARE FOR USE INSIDE THE INDUSTRY ONLY AND SHOULD BE TREATED AS CONFIDENTIAL. FOR THIS REASON, THE INTERNAL PAPERS HAVE BEEN PRODUCED IN A FORM WHICH IS INAPPROPRIATE FOR PUBLIC USE AND ARE CLEARLY

MARKED AS CONFIDENTIAL INFOTAB DOCUMENTS. 2501155644-5648 at 5648 (US 45901*) (emphasis in original).

  1. INFOTAB was dissolved in 1991. In 1992, the Tobacco Documentation Centre (TDC) was formed to carry forward the information collection and database functions of INFOTAB. Proctor PD, United States v. Philip Morris, 6/12/02, 16:13-18. As described infra, the international coordination of Defendants' passive smoking strategy, positions, and research was taken over in 1992 by an industry committee of lawyers and scientists called the International ETS Management Committee, or IEMC. 502601564-1567 at 1565 (US 29570).

(3) 1987: Operation Downunder 3481. In a June 8, 1987 letter, Philip Morris Companies Vice Chairman Bill Murray invited

a small group of executives to attend a conference on Hilton Head Island, South Carolina, to assess the ETS problem and formulate solutions. The conference would come to be known as "Operation Downunder." 2023551340-1343 (US 85518).

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  1. In his June 8, 1987 letter to invitees, Murray emphasized the gravity of the passive smoking problem, and his belief that the problem had to be addressed both as a company and as an industry:

It will come as no surprise to you that the public policy situation affecting our industry and our company has deteriorated in recent months. This is largely due to the recent Surgeon General's report dealing with environmental tobacco smoke and its alleged harmfulness to nonsmokers. Clearly the climate in which we are now operating requires that we, as a company and as an industry, take action to at a minimum slow down the anti-smoking forces and at best actually reverse some of their advances. . . .

Your personal participation in this vital activity is extremely important. I cannot overemphasize the importance of this activity. . . .

It is important to point out that we are not embarking on this exercise to simply exchange ideas on the ETS problem. Rather, we have been instructed to examine the problem and to arrive at solutions that can be immediately implemented.

2023551340-1343 (US 85518).

  1. Murray, who was involved in Operation Berkshire in 1977, was on the CTR Board of Directors at the time of Downunder. His letter was copied to the Chairman of Philip Morris

Companies, Hamish Maxwell. According to the Downunder agenda, the conference began on June

23, 1987, and ended on the afternoon of June 26 with the presentation of a plan to senior management. All expenses were paid by Philip Morris. 2024270524-0527 (US 75083).

  1. According to the "PROJECT DOWNUNDER CONFERENCE NOTES," John Rupp addressed the group, noting the "watershed significance" and "tremendous credibility" of the 1986

Surgeon General's report. He told the conference attendees the industry's position on passive smoking was restricted to "ETS not shown to be health hazard to non-smoker." He cautioned that:

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"We cannot say ETS is 'safe' and if we do, this is a 'dangerous' statement.'" 2021502102-2134 at

  1. The conference notes revealed that sales were declining in the United States, and "in U.S., [the] ETS issue will have [a] devastating effect on sales." Philip Morris was very concerned that the industry was "just at the beginning of [the] impact of [the] ETS issue." 2021502102-2134 at 2109-2110 (US 20346).

  2. According to the notes, Philip Morris was concerned about public perception of passive smoking and felt that "perception is everything." The task of altering public perception had to be carried out (1) "in [the] face of overwhelming adverse information and publicity" relating to the harm of passive smoking to nonsmokers; (2) in the absence of "objective science" in favor of the industry's position; and (3) despite the fact that "10 of the 13 [ETS] studies show [an] effect in the direction of harm." 2021502102-2134 at 2110-2112 (US 20346).

  3. Philip Morris also noted that ETS research was historically feared and avoided by the industry partly because of the "risk in doing research where you don't know where it will lead." 2021502102-2134 at 2112, 2115 (US 20346).

  4. The notes indicate that conference attendees agreed that the industry needed "substantial funding in ETS via CIAR" and needed to "increase [the] number of scientists up to 50 in the U.S. and also throughout world." The "effort should be organized worldwide" and the "science program has to be joint-industry based." 2021502102-2134 at 2130-2132 (US 20346); 2021502679-2683 (US 75077).

  5. On June 26, 1987, the final day of "Project Downunder," the conference attendees presented their conclusions and recommendations to R. William Murray, President and C.O.O. of

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  1. The Philip Morris group also stated its intent to bring on the other members of the tobacco industry though discussions "at the highest level":

We also need to tell the tobacco industry, regarding accommodation strategy, [sic] This is what we are doing, join us. Use TI if helpful to do so. RJR can be expected to buy on. Concept should be introduced to R.J. Reynolds and other majors at the highest level. CEO to CEO, Chairman to Chairman.

2021502671-2678 at 2676 (US 22950).

  1. One week later, Rupp took the Philip Morris ETS message out to the other members of the industry. A document, titled "Report on Industry Meeting Concerning ETS," indicates that Rupp met with representatives of Reynolds, Philip Morris, Liggett, Hill & Knowlton, and the Tobacco Institute on July 2, 1987. Rupp warned participants that the manufacturers had to act as a unified front on ETS: "Individual companies, he noted, are in a position to take advantage of their commercial resources but should make every effort to do so toward the common goal of the industry as a whole." 87697186-7193 (US 88587).

  2. On January 4, 1988, the Tobacco Institute's Executive Committee "approved the concept of Operation Downunder." On February 18, 1988, representatives of Reynolds, Lorillard,

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Liggett, American, the Tobacco Institute, and Covington & Burling were invited by the Tobacco Institute to develop a consensus recommendation for the Executive Committee. Tobacco Institute vice president Roger Mozingo wrote that:

We have long agreed with many of Downunder's basic goals. . . . Further, the aggressive industry posture evident throughout the plan is needed if we are to stem the tide of legislative and private industry initiatives to ban or severely restrict smoking, as well as deal with other important industry issues.

TIDN0002710-2719 at 2711 (US 65548); 506617595-7596 (US 20760).

  1. At a February 3, 1988 meeting of the Tobacco Institute's Communications Committee, Sam Chilcote told the Executive Committee that they were now tasked to "move forward with an expanded comprehensive effort" to deal with the ETS threat. The "two basic objectives" in implementing Downunder were "to defeat or lessen all smoking restrictions" and "to slow the decline of the social acceptability of smoking." These goals were to be achieved through, inter alia, funding the Center for Indoor Air Research, "media tours," and "more experts." TIDN0008865-8890 (US 65559).

  2. In an October 8, 1987 memorandum from Helmut Gaisch, Director of FTR's Science and Technology, to Lee Pollak, in-house counsel in New York, Gaisch advised that Operation Downunder was being implemented in Europe with other cigarette companies and Covington & Burling. Gaisch described the link between Downunder and the recruitment of scientific consultants, or "whitecoats" as they were called, who would work on behalf of the industry throughout the world:

Within the framework of the scientific part of "Downunder," we are involved in the process of enlisting the assistance of scientific experts on a world-wide basis. As there are other tobacco companies involved, e.g. RJR, John Rupp of C&B has been charged with coordinating this part of the project. . . . I have personally arranged

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meetings of John Rupp with key "whitecoats" in a number of European countries.

2501000364-0365 at 0365 (US 45866).

  1. On February 17, 1988, Philip Morris and Covington & Burling presented the

Downunder recommendations in London to BATCo and other European cigarette manufacturers to bring them on board. BATCo Scientific Director Sharon Boyse (Blackie) recorded the following from the London meeting:

Philip Morris presented to the UK industry their global strategy on environmental tobacco smoke. In every major international area (USA, Europe, Australia, Far East, South America, Central America & Spain) they are proposing, in key countries, to set up a team of scientists organised by one national coordinating scientist and American lawyers, to review scientific literature and carry out work on ETS to keep the controversy alive. . . .

Because of the heavy financial burden, Philip Morris are [sic] inviting other companies to join them in these activities to whatever extent individual companies deem appropriate. . . .

Dr. Gaisch said that their strategy on ETS had been established in the USA at a meeting between Philip Morris and Covington & Burling, the lawyers acting for the Tobacco Institute in the USA. At a later date R.J. Reynolds were also brought in to support some of their US activities, one of these being the Centre for Indoor Air Research."

321140944-0949 (US 20586).

  1. Operation Downunder became part of Defendants' coordinated, global efforts.

(4) 1988-1999: The Center for Indoor Air Research (CIAR)

  1. In 1986, "[m]embers of the [ETSAG] group began to express the opinion that a more efficient mechanism to search out and supervise such [ETS] research needed to be considered."
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  1. At a May 26, 1987 ETSAG meeting, members decided that a new ETS research coordinating organization for the Defendants should be called the Center for Indoor Air Research ("CIAR") "in order to dissociate it and avoid confusion with the Tobacco Institute." 506300804- 0815 (US 20756); 511252621-2626 at 2621 (US 51554); 620002505-2506 (US 53330).

  2. CIAR was also an important component of the industry's ETS program established at "Operation Downunder" in June 1987. 2021502102-2134 at 2130-2132 (US 20346); 2021502679-2683 at 2681 (US 75077); 508221912-1914 at 1912-1913 (US 24738).

  3. ETSAG proposed "the formal organization of a research organization to deal with issues relating to indoor air quality," which became CIAR. The proposal for CIAR, presented to the Tobacco Institute Executive Committee on December 10, 1987, called for the creation of an organization "with its own staff and an increased research budget" for the ongoing ETSAG projects. At the end of the Executive Committee meeting, "it was agreed that Dr. Osdene and his group would proceed with the hiring of an Executive Director and the preparatory corporate and other steps for the establishment of the CIAR." TIMN0014390-4393 (US 62782).

  4. Pursuant to the Tobacco Institute Executive Committee agreement, CIAR was officially incorporated in January 1988 to take over the research responsibilities of the ETSAG. The charter members of CIAR were Philip Morris, Lorillard, and Reynolds, who constituted the Board of Directors. 87824558-4562 (US 23564).

  5. Brown & Williamson joined CIAR as a voting board member in 1995. Eisenberg WD, 25:14-15. While Liggett was never officially a member of CIAR, it attended at least one of its meetings and participated in ETS seminars and meetings organized by Covington & Burling. Dietz PD, United States v. Philip Morris, 7/1/02, 132:1-138:17; 2023053733 (US 86513). BATCo, while not a formal member of CIAR, provided funding for several CIAR "sponsored" projects. See, e.g., discussion of Malmfors/SAS Study, Hazleton Project, and Latin American Project, infra.

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  1. CIAR stepped into the shoes of the ETSAG with respect to industry ETS projects existing in 1988. Compare 2021001205-1205 (US 25534) (12/7/87 ETSAG meeting agenda) with 2021000945 (US 25532) (3/10/88 CIAR Board of Directors meeting agenda); compare 2021004058-4064 (US 20339) (1986 list of ETSAG-managed projects) with 2021006060-6065 (US 89161) (minutes of 10/25/88 CIAR meeting). All of the ETSAG-managed projects existing in 1987 were managed through CIAR from 1988 forward. These projects included the Malmfors/SAS airline study, the ORNL air sampler project, an aircraft study by Delbert Eatough, the ETS/asthma project at Tulane, and several critiques of epidemiology by industry ETS consultants. 2021006060-6065 (US 89161); see also 2023054167-4167 (US 75232) (CIAR board member Bob Pages wrote: "CIAR evolved out of an ad hoc ETS advisory group to the Tobacco Institute . . . ."); 86003256-3257 (US 23510) (In requesting Committee of Counsel approval for an ETSAG project, Hoel refers to CIAR as a "new funding mechanism for ETS projects.").

  2. Defendants first offered the job of CIAR Executive Director to outsider Irwin H. Billick. When Dr. Billick questioned the independence, objectivity, and credibility of the organization because all research funding decisions would be made by the Board of Directors, the offer was withdrawn. 2023555370-5370 (US 22842); 2023553133-3137 (US 22991); 2023555364-5365 (US 22844); 2023553132-3132 (US 22845).

  3. Reynolds scientist and ETSAG member Guy Oldaker served as "interim director" in 1987 and throughout much of 1988 until another executive director candidate could be located. TI00682069-2070 at 2069 (US 62088); 508220128 (US 92022). Moreover, until CIAR was established in its own office, it was administered as part of the Tobacco Institute. 2023554658-4660

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  1. On August 1, 1988, the Board of Directors selected Max Eisenberg, formerly Maryland's Assistant Secretary for Environmental Science and Health, to be CIAR's first and only executive director. At the time of Eisenberg's hiring, CIAR's Board of Directors was composed of Tom Osdene and Bob Pages from Philip Morris, Charles Green and Gary Burger from Reynolds, and Alexander Spears and Vello Norman from Lorillard. Eisenberg WD, 1:15-22; 3:10-13.

  2. CIAR had three membership categories -- charter members, regular members, and associate members. According to the CIAR Bylaws, only a "corporation engaged in the business of manufacturing and marketing of cigarettes that produced two billion or more tax-paid cigarettes during calendar year 1987" was eligible to become a charter member of CIAR. The CIAR Certificate of Incorporation stipulated that only the directors of charter members were entitled to select Board members and vote on what research would be funded. During the entire existence of CIAR (1988- 1999) only cigarette company executives/scientists sat on the Board of Directors. 86205444-5452 at 5444 (US 21827); 87824558-4562 at 4560 (US 23564); Eisenberg WD, 3:20-4:10.

  3. John Rupp of Covington & Burling was appointed general counsel to CIAR, and attorneys Mary Ward and Don Hoel regularly attended Board meetings just as they had earlier attended ETSAG meetings before. Eisenberg WD, 26:3-6.

  4. Philip Morris, Reynolds, Lorillard, BATCo and (after 1995) Brown & Williamson, paid over $4 million annually to fund ETS projects through CIAR. Funding was determined by market share. 2050764508-4508 (US 20492); 2021006060-6065 at 6060 (US 89161); Ward TT, 11/3/04, 4968:4-19; 2041653307-3385 at 3382-3385 (US 38214).

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  1. CIAR also had "regular" or "associate" members, who were not cigarette manufacturer charter members. However, they provided less than one-half of one percent of the operating costs for CIAR projects. For example, in 1996, the non-cigarette manufacturers (associate members) contributed $36,000, or .47%, of CIAR's $7.7 million in funding. 566943537-3528 (US 92018); Eisenberg TT, 11/8/05, 5444:22-5446:11.

  2. Moreover, all "regular" and "associate" members were connected to the tobacco industry, and most were suggested to Eisenberg by members of the CIAR Board of Directors. Using the 1988 and 1996-97 Request for Applications (RFA) as examples, associate members Consolidated Safety Services, ENV Services, and Meckler Engineers Group were all consultants to the Tobacco Institute; Universal Corporation, DIMON International, and Standard Commercial Corporation are the three largest tobacco leaf merchants in the world; Hoechst Celanese is a maker of cigarette filters; Mead Paper, Mundet International, and Ecusta are all paper suppliers to the tobacco industry; and Quest International Flavors is a flavorant supplier to the industry. 321141105-1144 (US 20588), 2061691882-1913 (US 24012); Eisenberg TT, 11/8/04, 5428:16-5431:10; 5443:7-21; 5453:2-5456:5.

  3. Tobacco Institute executives attended a number of CIAR Board of Directors meetings after Eisenberg established an office in Linthicum, Maryland. In April 1989, Eisenberg, Spears, and Rupp gave a presentation and status update to a meeting of the Tobacco Institute Executive Committee. Eisenberg WD, 6:8-10; TIMN0014955-4960 (US 62784); 2023053733 (US 86513).

  4. On January 19, 1993, Liggett Scientific Issues Manager Dennis Dietz attended a CIAR meeting in London, along with executives from Philip Morris, Lorillard, Reynolds, BATCo, B&W, and several international manufacturers. 2023053733 (US 86513).

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  1. In 1989, Eisenberg recruited outside scientists to serve on CIAR's Scientific Advisory Board ("SAB"), including Dr. Jared Cohon (Johns Hopkins), Dr. James Crapo (Duke), Dr. Gareth Green (Johns Hopkins), Dr. Irving Kessler (Univ. of Maryland), Dr. Morton Lippmann (NYU), Dr. Demetrios Moschandreas (ITT Research Institute), and Dr. Alfred Wolf (Brookhaven National Laboratory). Eisenberg TT, 11/09/04, 5665:16-5666:14; US 20588 (at 321141106).

  2. CIAR's SAB research agenda stated an interest in (1) "[e]nvironmental tobacco smoke (ETS), including respirable particulate and vapor-phase components;" (2) "[c]hemical contaminants from all sources, organic and inorganic;" and (3) "[b]iological agents, including aeroallergans and aeropathogens." (US 20588) (at 321141115).

  3. Despite the establishment of a functioning Scientific Advisory Board, only the CIAR Board of Directors had authority to approve the funding of any CIAR project. Eisenberg WD, 3:20- 23, 15:21-16:6.

  4. Research proposals submitted in response to CIAR's annual requests for applications were reviewed initially by peer reviewers, then by the scientists on CIAR's SAB, then by the Executive Director, and then by the member company scientists who served on CIAR's board of directors and made the final funding decisions. 11/09/04 Tr. (a.m.) at 5495:1-25 (Eisenberg).

  5. In order to reach out to prospective researchers, CIAR issued its "Request for Applications" (RFA). CIAR RFAs were published from 1989 to 1998. The introduction in the 1988 RFA described CIAR as "an independent, non-profit corporation" whose purpose was "to sponsor scientific and technical research" on indoor air issues. 321141105-1144 (US 20588) (1989-1990 RFA); TI01900054-0094 (US 77530) (1991 RFA); 2023523979-4010 (JD 080303) (1992-1993

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RFA); 2025471735-1762 (JD 024508) (1994 RFA); 2057790373-0404 (US 23995) (1995 RFA); 2061691882-1913 (US 24012) (1996-1997 RFA); 86616778-6810 (JD 042662) (1998 RFA).

  1. The names of the Charter Members was printed only on one page in an appendix in each of RFAs, on the same page with the names of the "regular" and "associate" members. See, e.g., 321141105-1144 at 1142 (US 20588) and 2061691882-1913 at 1898 (US 24012).
  1. CIAR RFAs did not disclose that: • CIAR was almost exclusively funded by major cigarette manufacturers, and that the remainder of the funding (<½ %) was supplied by other companies affiliated with the manufacture of cigarettes; • CIAR received significant funding from international cigarette manufacturers, including BATCo, Rothmans, and Imperial Tobacco (see discussion of Malmfors and Hazleton projects, below). • Although CIAR had a Scientific Advisory Board in place as of early 1989 to review proposals for scientific merit, CIAR funded and managed a large number of projects that never went through the SAB process (see discussion of Applied Projects, below). 3521. CIAR also published a quarterly newsletter called "CIAR Currents" from 1991 to
  1. Eisenberg TT, 11/9/04, 5486:15-5487:2. In total, CIAR published 19 editions of "CIAR Currents," none of which disclosed that CIAR was controlled and funded by the tobacco industry. 88803301-3304, 2023055036-5039, 88803309-3312, 2028462984-2987, 2023521998-2001, 87251727-1730, 2028462980-2983, 89273328-3331, 89273324-3327, 89273320-3323, 89273316- 3319, 89273312-3315, 89273308-3311, 515952380-2383, 517577679-7682, 2063650763-0767, 517557109-7112, 517557145-7148, 2063835149-5152 (US 92019).
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  1. The CIAR newsletters, like the RFAs, did disclose the names and university affiliations of Scientific Advisory Board members. The newsletter did announce new additions/replacements to its SAB, but never disclosed the departure or arrival of new members of the cigarette manufacturer Board of Directors. (US 92019); Eisenberg TT, 11/9/04, 5499:18-22, 5501:5-11.

  2. From 1988 until its dissolution as required by the MSA in 1999, CIAR funded over 150 projects at over 75 institutions that resulted in roughly 250 peer-reviewed publications. (JD 002923 at 8360029); (JD 054352). Total research funding provided through CIAR was in excess of $60,000,000. See US 25643

(a) CIAR Applied Projects 3524. In addition to SAB projects, CIAR funded a class of studies called "Applied Projects,"

similar to CTR Special Projects, which were approved and directed by the Board of Directors with no review or recommendation by the Scientific Advisory Board. As described below, CIAR Applied Projects were used by Defendants to generate data and conclusions to support the industry's position on passive smoking.

  1. CIAR Board member and Lorillard scientist Vello Norman wrote in his minutes of the February 2, 1989 Board of Directors meeting:

CIAR funds two kinds of studies: a. Research -- involvement by SAB, peer review, etc. b. Special Studies -- would normally be initiated by the Board, not subject to peer review (airlines, indoor air surveys, reviews, etc.)

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87823747-3750 (US 85695). Board member Tom Osdene took notes from the same meeting, recording that "Special Studies" were distinct from CIAR "research," were not peer reviewed, would be initiated by the Board, and were also called "Applied Projects." 2021005961-5969 (US 25580).

  1. Fellow Board member and Philip Morris scientist Bob Pages wrote in a September 14, 1990 memorandum that CIAR was a "vehicle to sponsor/conduct special projects (Applied Studies)." 2023530026-0029 (US 23003).

  2. In a May 14, 1992 memorandum to Jim Charles, Pages distinguished "Applied Studies" from CIAR's ordinary research in these terms:

The SAB recommends proposals for funding after they have been peer reviewed. Proposals can only be funded subsequent to approval by the Board. A second class of research projects -- Applied Studies -- are also funded if approved by the Board; such projects are not normally reviewed or recommended by the SAB.

2023054167-4167 (US 75232).

  1. Funding for Applied Projects was often billed by CIAR as "Special Assessments" in addition to the yearly market share-based payments of the companies to CIAR. (US 92032).

  2. CIAR Applied Projects was used by Defendants to fund studies that were previously approved by the TI-ETSAG, or Hoel Committee, and underway at the time of CIAR's formation in early 1988. These studies included:

  1. James Enstrom ($525,000); this study examined the association between spousal smoking and lung cancer using CPS 1 data. 2. Torbjorn Malmfors ($638,806); a study of air cabin air quality aboard SAS aircraft.
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  1. Roger Jenkins/ORNL ($920,794); three projects measuring ETS and passive exposure to tobacco smoke in Knoxville; in a restaurant/bar; and in a corporate facility.
  1. Roger Jenkins/Michael Guerin/ORNL ($1.7 million); an ETS exposure study of subjects in 16 cities across the country. (Guerin was a member of the CIAR SAB.)
  1. Marvin Kastenbaum ($170,935); a statistical project to develop certain tables to evaluate indoor air components. (Kastenbaum was a statistician employed by the Tobacco Institute.)
  1. Keith Phillips/Hazleton Labs (later called Covance Labs) ($8.0 million); a number of exposure/measurement studies conducted in foreign cities.
  1. ETS "Treatises" (funding amount unknown); textbooks on ETS and related indoor air topics (See BR2000545-0785 (JD 065024); (no bates) (JD 044893); (no bates) (JD 080699); (no bates) (JD 080700)).
  1. Samuel Lehrer ($2.45 million); at least three projects assessing ETS and asthma in children and adults, and a project to assess asthmatic responses to perfumes.
  1. Alan Hedge ($979,092); this study examined "the extent to which ETS is related to the perception of comfort and health of office workers in office buildings," as well as ventilation conditions.
  1. Genevieve Matanowski ($2.3 million); one project ($1.6 million) was a confounders study designed to attack documented associations between ETS and lung cancer; the second project ($679,000) investigated lung cancer in nonsmokers in South America. (Matanowski was a member of the CIAR SAB.)
  1. Ragnar Rylander ($333,031); a study using a questionnaire to determine lifestyle differences (confounders) between groups in Sweden and Switzerland.
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  1. Thomas Platts-Mills ($590,642); a project evaluating ventilation, wheezing, and allergens.
  1. Milt Meckler ($127,318); a project to assess the impact of a ventilation/filtration system on indoor air. (Meckler was a paid Tobacco Institute consultant.)
  1. Demetrios Moschandreas/IITRI ($525,312); three projects assessing perceptions/reactions of persons to ETS in the air. (Moschandreas was a member of the CIAR SAB.)
  1. Antonio Miguel ($72,760); a project to test for gas and particle phase substances in indoor air in Brazil.
  1. Gray Robertson/HBI ($138,000); testing of air samples in office buildings.
  1. Robert Tardiff ($466,297); a project, using the Jenkins/ORNL data, "to produce distributions of exposure to ETS."
  1. Giovanni Viegi ($1.28 million); research into ETS confounders, assessing risk factors for cardiovascular and respiratory disease in Italy.

2505442777-2960 (US 25643*); 83205526-5581 (US 92033) (Applied Projects are indicated with the notation "Other"). Defendants spent over $21.5 million in, or one-third of its total funding, on

CIAR "Applied Projects." 2505442777-2960 (US 25643*); 83205526-5581 (US 92033).

  1. John Rupp summarized the work of CIAR in 1993 by stating that "a number of CIARfunded projects have contributed significantly to the industry's ongoing efforts to oppose unwarranted smoking restrictions." Rupp then ticked off the Applied Projects that had proven valuable for Defendants, including the HBI project, the Malmfors/SAS study, his "Asia Project" by

Sarah Liao, the Hazleton Project, and the Jenkins/ORNL projects. Rupp continued, "What we have learned over the past five years, the period of CIAR's existence, is that CIAR can make -- indeed, already has made -- an important contribution to the industry's efforts to fight unwarranted smoking restrictions." 87602277-2281 at 2278-2279 (US 23516).

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  1. Applied Projects eventually assumed a more prominent role in CIAR operations than the SAB-reviewed studies as the industry's "needs" for certain types of studies grew. CIAR Board member Bob Pages wrote the following in an August 19, 1992 Philip Morris e-mail to Steve Parrish with respect to the future CIAR budget:

As I mentioned at our July 1st ETS science meeting, the CIAR board has come up with a plan to refocus CIAR efforts so that we get more research results which will be useful and responsive to our needs: maintain the SAB-related research budget at a (reduced) constant, self-sustaining level; and fund more applied projects which are better targeted to meet our needs.

2023132080-2081 at 2080 (US 92031).

  1. CIAR's primary value was to generate data for defensive use in litigation. CIAR Board of Directors chairman Tom Osdene of PM wrote Sam Chilcote of the Tobacco Institute five years earlier in an April 25, 1988 letter that "the purpose of CIAR" was "to provide ammunition" for the industry on the ETS "battlefield." 2021012384-2388 at 2384 (US 20340). Rupp wrote in a March 1993 letter to Imperial Tobacco: "In sum, while one might wish it otherwise, the value of CIAR depends on the industry's playing an active role (1) in identifying research projects likely to be of value and (2) working to make sure that the findings of funded research are brought to the attention of decision makers in an appropriate and timely manner." 2023053717-3720 at 3719 (US
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  1. An August 17, 1988 memorandum, written by former Covington & Burling advisor and current BATCo scientific head Chris Proctor, discussed CIAR and the advantages of membership to BATCo and Brown & Williamson. Proctor wrote:

Meetings of the board are held every five weeks in Washington and, in addition to the board members, John Rupp (Covington and Burling), Don Hoel (Shook, Hardy and Bacon), Mary Ward (R.J. Reynolds) and a TI representative attend to observe. Rupp and Hoel comment on product liability aspects. In terms of scientific acceptability, CIAR provides a further buffer between the Company and the third party, yet allows strong control of projects without major in house effort.

400974598-4600 at 4598, 4600 (US 47526).

  1. CIAR also served as a buffer between Defendants and the projects they funded. In an internal PM e-mail April 15,1991 to 1995. This program studied the correlation between lifestyle and environmental exposures and major chronic illnesses, and the role of diet in cancers of the lung, oral cavity and bladder. 2046988683-8683 (US 85673); 2021630974-0975 (US 87371); 2046988682-8682 (US 85674). -1358- from Bob Pages to Steve Parrish, Pages recommended against using CIAR to fund what would become the Japanese Spousal Study, but added: "although there

MAY be (I'm not convinced yet) a reason to say it was sponsored by CIAR so as to "hide" industry involvement (as was done in Rupp's 'Asia project')." 2023544456 (US 22816) (emphasis in original).

  1. BATCo Scientific Director Sharon Boyse (Blackie) made a similar comment when she observed in a June 19,1991 to 1995. This program studied the correlation between lifestyle and environmental exposures and major chronic illnesses, and the role of diet in cancers of the lung, oral cavity and bladder. 2046988683-8683 (US 85673); 2021630974-0975 (US 87371); 2046988682-8682 (US 85674). -1358- memorandum that

the Japanese study could be channeled through an 'independent' organization such as CIAR. No matter how good the science, independence is always preferable, and in fact BAT made the decision to discontinue part of its research on ETS for this very reason.

  1. In a March 12,1991 to 1995. This program studied the correlation between lifestyle and environmental exposures and major chronic illnesses, and the role of diet in cancers of the lung, oral cavity and bladder. 2046988683-8683 (US 85673); 2021630974-0975 (US 87371); 2046988682-8682 (US 85674). -1358- letter to Boyse, Rupp commented:
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In fact, I am not aware of an instance in which our opponents have been able to dismiss the results of CIAR-funded projects by attacking the funding source. That is, it seems to me, a very real and important achievement.

87602277-2281 at 2278 (US 23516).

  1. Tobacco industry attorneys had a significant role in the funding and approval of CIAR projects. In a June 28, 1988 memorandum to Philip Morris Assistant General Counsel Todd Sollis detailing Shook, Hardy & Bacon's ETS initiatives, Don Hoel wrote:

SHB is instrumental in developing scientific research in the area of ETS. In the United States, much of this development is now undertaken through the Center for Indoor Air Research (CIAR). PM is a member of CIAR and currently chairs its Board of Directors. Within that organization, SHB represents the interests of PM in evaluating research proposals and in determining which existing projects should be continued. The firm also monitors ETS Advisory Group projects, which are now being "folded" into CIAR.

2015007199-7207 at 7205 (US 20311).

  1. At least one of the industry attorneys (Hoel, Rupp, or Ward) attended every CIAR Board meeting where project proposals were discussed and approved. See, e.g., 2021006342-6347 (US 25581); 2023531016-1018 (US 23674); TIBU34458-4469 (US 65527); TI01900211-0214 (US 21241); 87823743-3746 (US 90011); 87802318-2319 (US 23535); 87823747-3750 (US 85695); 2353587697352-7354 (US 56308); 400974598-4600 (US 47526).

  2. In sum, it is clear that although CIAR was publicly billed as an independent scientific entity organized to support research projects addressing indoor-air issues, its funding was controlled by the tobacco industry, and projects were sought for the purpose of establishing industry-favorable science and potential expert witnesses.

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(b) Defendants Cultivated CIAR's Apparent Independence 3540. Defendants selected and funded Applied Projects, those not reviewed by CIAR's

SAB, in order to counter the impact of studies linking ETS and disease and to generate data favorable to the industry's public ETS position. Several CIAR-sponsored Applied Projects are described below to illustrate how CIAR served the industry's goal of concealing tobacco industry funding and control.

  1. The Rylander Confounders Study. From 1994-1996, CIAR sponsored a project by long-time industry consultant Ragnar Rylander, resulting in a 1999 published paper, titled "Dietary Habits for Non-Smoking Females Living With Smokers or Non-smokers." The paper highlighted differences between groups, differences which suggested that confounders (risk factors other than ETS) explained the association between ETS and disease. 2067224066-4069 (US 85733).

  2. Philip Morris funded the project alone. 2028381480-1480 (US 26873); 2028381481-1490 (US 26874), and paid for Rylander's project via a "special assessment" from CIAR. 2050764511 (US 92032); Eisenberg WD, 43:16-19. Though the Rylander study was a Philip Morris project, the published paper stated only that the study was "supported by CIAR." 2067224066-4069 (US 85733).

  3. "Rupp's Asia Project." In 1991, industry ETS consultants Sarah Liao and John Bacon-Shone published a paper, titled "Factors Influencing Indoor Air Quality in Hong Kong: Measurements in Offices and Shops." The paper concluded that indoor air quality in Asian cities was largely influenced by outdoor air pollutants, and that ETS played only a very minor role in indoor air quality. The paper fails to disclose the source of funding. TLT0500039-0047 (US 65087).

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  1. The Hong Kong project protocols were designed by BATCo's Chris Proctor and Reynolds's Guy Oldaker for industry ETS consultant Liao to use. 2500048508-8515 at 8509-8510 (US 20549); 300541891-1894 (US 85550). A project proposal from Liao to CIAR was dated March 6, 1990; the introduction in the proposal stated: "The project shall be sponsored by Centre for Indoor Air Research (CIAR) of U.S.A." 2023530411-0428 at 0412 (US 23672). See also 2023530327-0330 at 0329 (US 90023).

  2. The Hong Kong project went forward sponsored by CIAR. Proctor presented a progress report on the project at the February 6,1991 to 1995. This program studied the correlation between lifestyle and environmental exposures and major chronic illnesses, and the role of diet in cancers of the lung, oral cavity and bladder. 2046988683-8683 (US 85673); 2021630974-0975 (US 87371); 2046988682-8682 (US 85674). -1358- CIAR Board of Directors meeting. 87802318-2319 at 2318 (US 23535). Proctor sent Eisenberg and the Philip Morris and Reynolds directors a draft of the Hong Kong paper under a cover letter dated March 1, 1991. 2023546632 (US 90026). CIAR Board member Bob Pages wrote Steve Parrish on April 15,1991 to 1995. This program studied the correlation between lifestyle and environmental exposures and major chronic illnesses, and the role of diet in cancers of the lung, oral cavity and bladder. 2046988683-8683 (US 85673); 2021630974-0975 (US 87371); 2046988682-8682 (US 85674). -1358- that CIAR was used to sponsor the study "so as to 'hide' industry involvement." 2023544456 (US 22816). Rupp himself told Sharon Boyse (Blackie) in a letter dated March 12, 1993 that the Liao/Hong Kong study was one of many CIAR sponsored projects that had proven valuable to the industry. 87602277-2281 at 2278 (US 23516).

  3. The value of the study was in its perceived independence from the tobacco industry. In a February 14, 1990 memo to Defendants, Rupp stated, "Because the Hong Kong study will be conducted and reported by independent scientists, we expect that the results (however inappropriately) will carry more weight with a variety of target audiences than have the results of previous studies conducted and reported by industry scientists." 2500048976-8998 at 8989 (US 23007). Proctor distributed the published paper to sponsors from BATCo, Philip Morris, and Reynolds, thanking them for their "commitment to the study." 300541761 (US 23597). The

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Tobacco Institute cited the paper as seemingly independent authority in support of its March 20, 1992 comments to OSHA denying the need for workplace smoking restrictions. TLT1022319-2405 at 2367 (US 87404).

  1. In a January 29, 1999 article in the South China Morning Post, Liao admitted that she received approximately $1 million from CIAR to carry out the Hong Kong study with Bacon-Shone. Liao stated that she was not aware that the source of the CIAR funding was the tobacco industry. 2072522793-2795 at 2793 (US 24607).32

  2. The Hazleton/Covance Project. At a cost of over $8 million, CIAR sponsored a number of exposure projects carried out by Hazleton Laboratories, which later became Covance Laboratories. The purpose of the Hazleton studies was to portray ETS as only a minor indoor air pollutant in the context of overall air quality and to generate bias data to undermine epidemiological studies showing an association between spousal smoking and lung cancer in nonsmokers. The Hazleton Project resulted in the publication of more than 11 studies. 2505442777- 2960 at 2880- 2885 (US 25643*); 2501003237-3242 at 3238-3239 (US 22320).

  3. Defendants, through the IEMC, discussed in detail in Section V(G)(6)(a)((5)), infra, agreed to fund Hazleton as part of the industry's broad "Response to the IARC ETS Study." 2505443991-4000 at 3996 (US 22202); 2028363615-3616 (US 37366).

  4. According to the Rothman's scientist Barry Frost's January 1993 presentation to the IEMC, the contributors to the first of the Hazleton studies were Rothmans, Philip Morris, Reynolds, Imperial Tobacco, BATCo, Japan Tobacco, the German Verband (VdC), French manufacturer Seita,

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Spanish manufacturer Tabacalera, and the Swedish tobacco organization Reserca. 2021520163-0180

  1. The Hazleton Project resulted in numerous publications, some of which appeared in the tobacco industry's journal Indoor and Built Environment. 2505442777-2960 at 2883-2885 (US 25643*).

  2. The Latin American Project. In 1995, Antonio Miguel published a paper, titled "Characterization of Indoor Air Quality in the Cities of Sao Paolo and Rio de Janiero, Brazil," in the journal Environmental Science & Technology. The paper concluded that ETS was only a minor part of indoor air particulate matter in the restaurants and offices tested. The paper included an acknowledgment at the end stating that the study was funded in part by CIAR. 89273967-3974 (US 92023).

  3. The Miguel paper was part of the Latin American Project funded directly by the CIAR Board of Directors as an Applied Project. Under cover letter dated September 30, 1992, Covington & Burling analyst Chris Proctor forwarded two project proposals, the first by Miguel the second by Maria Calfaro, directly to Eisenberg and the CIAR Board of Directors for funding. The purpose of the projects was to gather data on indoor air in restaurants and offices in Brazil, Costa Rica, and other Latin American countries. The cost of the projects as proposed was $72,760 and $76,820, respectively. 2023591432-1459 (US 26794).

  4. Proctor wrote in his letter that funding the projects through CIAR would have "no direct implications for CIAR's budget." This was because, according to notes written by CIAR Board member Bob Pages on Proctor's cover letter, the projects were not funded by CIAR, but directly by Philip Morris (40%) and BATCo (60%). Moreover, Proctor's expenses in managing the projects were to come out of the "ongoing consultant program," and John Rupp would "pick up out of pocket CIAR expenses." Thus, CIAR was used for sponsorship only, to avoid having to name Philip Morris and BATCo as sponsors in the published paper. 2023591432-1459 (US 26794).

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  1. A November 23, 1992 update from Rupp reported that the funding of the Calfaro study, although "conducted under the auspices of CIAR" would be split among Philip Morris and BAT Group companies in Guatemala, Panama, El Salvador, Nicaragua, Honduras, and Costa Rica. 300543217-3227 at 3218-3219 (US 28139). An October 2, 1992 letter from Covington & Burling attorney Patrick Davies to Souza Cruz, the Brazilian affiliate of BATCo, advised that Rupp had asked him to respond to "questions to Sharon [Boyse] about billing for the Brazilian field study" and that Covington & Burling had set up a checking account in Sao Paolo to receive payments from BAT companies and disburse payments to the researchers. Davies also wrote that Proctor would be returning to Brazil "to oversee the field study." 300543295 (US 92025); see also 300543259-3260 at 3259 (US 28145) (11/29/92 letter from Davies acknowledging CIAR sponsorship of Central American study.)

  2. A Philip Morris record of an August 14, 1992 ETS meeting confirms that CIAR was chosen as a cover for the two projects in order to avoid disclosure of cigarette company involvement:

MW [Philip Morris's Matt Winokur] or J. Rupp to meet with A. Gonzalez/C. Rodriguez concerning how best to handle disclosure issue concerning Brazil and Central America projects (CIAR was suggested as the best way to handle the projects).

2051810375-0377 at 0376 (US 92066).

  1. In 1995, CIAR billed Philip Morris a "special assessment" of $1 million for "Latin America/Asia exposure studies." 2050764531 (US 92032).
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  1. The 16 Cities Study. One of the more expensive studies funded through CIAR as another Applied Project was the ORNL project published as the 1996 paper "Exposure to Environmental Tobacco Smoke In Sixteen Cities In The United States Determined By Personal Breathing Zone Air Sampling." (JD 044272); Ogden WD, 6:1-11; Ogden TT, 3/17/05, 15948:15- 15949:8.

  2. Defendants undertook the 16 Cities Study in response to a workplace indoor air rule proposed by OSHA in September 1991. 2023859480-9486 (JD 080318). According to an October 8, 1992 Philip Morris e-mail from CIAR Board member Bob Pages to Steve Parrish, Reynolds CEO Jim Johnston conditioned his company's continued funding of CIAR on the initiation of projects that would help the industry oppose the OSHA rule: "CIAR must use all of its resources in support of projects/activities that will help us with OSHA." In the same e-mail, Pages stated that fellow CIAR Board member and Reynolds scientist Charles Green told him that "the prevailing attitude around Winston-Salem is that 'if we lose with OSHA, it's all over.'" 2028472657A-2028472658 (US 75169); Ogden TT, 3/17/05, 15947:6-9.

  3. The 16-Cities Study was planned in early 1993 with Reynolds, ORNL, and Reynolds' long-time marketing research firm, Bellomy Research. 508692972-2972 (US 92102). Bellomy was responsible for proposing the cities in the study, locating marketing research firms in those cities, and overseeing the entire process of obtaining the questionnaire data from participants. Ogden TT, 3/17/05, 15951:23-15953:6; Ward TT, 11/3/04, 4990:6-4991:24. Bellomy and Reynolds created the questionnaire given to participants. Ogden TT, 3/17/05, 15955:4-14. CIAR funding was split between ORNL and Reynolds, who received over $500,000 from CIAR to assist ORNL with data interpretation. 522057702-7708 at 7702 (US 93165); Ogden TT, 3/17/05, 15967:23-15968:5.

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  1. As requested by the CIAR Board of Directors, all of the laboratory testing of body fluids and air samples for metabolites of nicotine was carried out at the Reynolds laboratories in Winston-Salem. Ward TT, 11/3/04, 4987:17-24; (JD 044272 at 483) ("ETS and saliva samples were shipped to the RJR/RD analytical laboratories. . . ."); 522057702-7708 at 7702 (US 93165). Ward TT, 11/3/04, 4987:25-4989:17.

  2. Reynolds scientist Mike Ogden (1) "designed and executed" the 16 Cities Study; (2) was responsible for completing all the analysis of the body fluid samples in the study; (3) authored 17 Reynolds Research & Development Memoranda (R&DMs) on the project; and (4) could have been listed as an author on the published paper. 510781780-1782 at 1780 (US 30001); 522057702- 7708 (US 93165); 519274420-4426 at 4422 (US 30351); Ogden TT, 3/17/05, 15967:10-22.

  3. The lead researchers at ORNL were Roger Jenkins and Michael Guerin. Jenkins had been a recipient of major tobacco industry funding in the 1980s through the ETSAG. 2021004058-4064 (US 20339); 507734379-4380 (US 29905). Guerin served Defendants as a member of the CIAR SAB at the time the 16-Cities Study was carried out. 2025471735-1762 at 1736 (JD 024508); 2057790373-0404 at 0375 (US 23995).

  4. The results of the 16-Cities Study were favorable to the industry: the study concluded that exposure to ETS in the workplace was only a fraction of what was estimated by OSHA in the proposed rule. (no bates at II-48-II-70) (JD 023787) ("The ORNL Study is the best evidence in the record concerning workplace exposure to ETS.").

(c) The Demise of CIAR 3565. The MSA, signed by the parties in November 1998, required that Defendants shut

down and disband CIAR within 45 days of "Final Approval." Although the MSA was signed by the parties in November 1998, "Final Approval" by the settling States did not take place until approximately one year later. (no bates at 32-33) (JD 045158).

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  1. The CIAR Board of Directors voted to dissolve CIAR on October 7, 1999, and Eisenberg formally dissolved the organization on December 6, 1999. 86205205-5206 (US 21091).

  2. Between the MSA signing in November 1998 and CIAR dissolution in December 1999, Defendants continued to fund millions of dollars of new and continuing research. In February 1999 alone the CIAR Board of Directors voted to fund over $3.5 million in new research. 2063908736-8736 (US 20514); 83205163-83205165 (US 23493).

  3. As one example of CIAR's continued activities, in 2000, the second edition of the CIAR text by ETS consultant Roger Jenkins was published, with Max Eisenberg listed as editor. The publication, titled "The Chemistry of Environmental Tobacco Smoke: Composition and Measurement," continues to dispute the known health effects of passive smoking and trivializing its role as an indoor air pollutant. According to Jenkins's introduction to his book: (1) "The degree to which ETS exposure represents a health hazard remains a point of contention"; and (2) "The contribution of ETS to the concentration of indoor air contaminants in commonly encountered environments is much less than is implied by the extreme values included in many tabulations of ranges observed." BR2000545-0785 at 0553 (JD 065024).

(5) Post-1991: IEMC 3569. In March 1991, after INFOTAB was dissolved, executives and lawyers representing

several Defendants and other cigarette manufacturers formed the International ETS Management Committee (IEMC) to (1) fund and manage research on ETS and (2) coordinate the industry's strategy and position on passive smoking.

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  1. A May 1991 Philip Morris document stated that the IEMC was established to insure that:
  1. Common position statements and policies are developed and adopted worldwide; 2. Major potential threats of smoking restrictions and bans are identified; 3. Strategies are developed to deal with them; 4. The necessary resources are made available to the staff in the markets and regions; and, 5. Finally, that optimal coordination and cooperation across the companies is promoted to ensure the best application of those resources.

2500061112-1113 (US 22821).

  1. The executives and lawyers of the IEMC represented BATCo, Reynolds, Philip Morris, American Brands/Gallahers, Imperial Tobacco, Reemstma, and Rothmans was intended to work with a larger European industry organization called the Confederation of European Community Cigarette Manufacturers, or CECCM. 2500061112-1113 (US 22821); 507782317-2318 (US 20788).

  2. According to a 1991 memorandum by BATCo's IEMC representative Sharon Boyse (Blackie), the IEMC was established "following the AFCO judgment in Australia" when "a group of international industry lawyers met in London to consider the implications for the industry." This group became the IEMC. 300522762-2767 at 2763 (US 22223).

  3. The AFCO case referred to by Sharon Boye (Blackie) arose from a July 1986 advertisement by the Tobacco Institute of Australia, published in Australian newspapers:

Lately, however, many non-smokers have been led to believe that cigarette smoke in the air can actually cause disease.

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There is little evidence, and nothing which proves scientifically that cigarette smoke causes disease in nonsmokers.

AFCO v. Tobacco Institute (Aust) (1991)27 (...continued) Defendants offered the testimony of Joseph Mulholland as a fact witness, not as an expert. He is a long-time staff economist with the FTC Bureau of Economics, who personally does not agree with the conclusion of Monograph 13 that the introduction of low tar cigarettes has not materially reduced health risks from smoking, even though the FTC has never taken an official position on this issue. Mulholland WD, 12:12-15, 14:3-6, 15:15-23, 16:3-11 (Monograph 13 has not changed the FTC's position, as the FTC has not taken an official position on the issue); Mulholland TT, 4/25/05, 19854:16-19855:3. While recognizing that Dr. Mulholland has acquired extensive knowledge, in his capacity as an FTC staff economist, concerning cigarette-related matters, as the Court observed at the trial, his "testimony is not that overwhelmingly relevant." Mulholland TT, 4/25/05, 19938:16- 19939:1. -780- FCR 149.

  1. The Australian Federation of Consumer Organizations (AFCO) brought suit against the Tobacco Institute, alleging that the advertisement was deceptive under the Australian Trade Practices Act. AFCO v. Tobacco Institute (Aust) (1991)27 (...continued) Defendants offered the testimony of Joseph Mulholland as a fact witness, not as an expert. He is a long-time staff economist with the FTC Bureau of Economics, who personally does not agree with the conclusion of Monograph 13 that the introduction of low tar cigarettes has not materially reduced health risks from smoking, even though the FTC has never taken an official position on this issue. Mulholland WD, 12:12-15, 14:3-6, 15:15-23, 16:3-11 (Monograph 13 has not changed the FTC's position, as the FTC has not taken an official position on the issue); Mulholland TT, 4/25/05, 19854:16-19855:3. While recognizing that Dr. Mulholland has acquired extensive knowledge, in his capacity as an FTC staff economist, concerning cigarette-related matters, as the Court observed at the trial, his "testimony is not that overwhelmingly relevant." Mulholland TT, 4/25/05, 19938:16- 19939:1. -780- FCR 149.

  2. Finding in favor of AFCO, the trial court held that the Tobacco Institute's advertisement was misleading and deceptive with respect to the scientific evidence that passive smoking caused lung cancer, respiratory diseases in children, asthma attacks, and middle ear disease. With respect to lung cancer, the Australian court held:

In relation to the disease of cancer, the statement was erroneous and was misleading and deceptive both in 1986 and to date because: (a) far from there being little evidence that cigarette smoke caused disease in nonsmokers, there was much evidence to that effect, irrespective of whether the primary articles alone were regarded as evidence for the purposes of the advertisement, or regard was also had to the major reviews; and (b) a review of the totality of the available data leads to the conclusion that there was scientific proof in the sense that there was compelling scientific evidence that cigarette smoke caused lung cancer in nonsmokers.

AFCO v. Tobacco Institute (Aust) (1991)27 (...continued) Defendants offered the testimony of Joseph Mulholland as a fact witness, not as an expert. He is a long-time staff economist with the FTC Bureau of Economics, who personally does not agree with the conclusion of Monograph 13 that the introduction of low tar cigarettes has not materially reduced health risks from smoking, even though the FTC has never taken an official position on this issue. Mulholland WD, 12:12-15, 14:3-6, 15:15-23, 16:3-11 (Monograph 13 has not changed the FTC's position, as the FTC has not taken an official position on the issue); Mulholland TT, 4/25/05, 19854:16-19855:3. While recognizing that Dr. Mulholland has acquired extensive knowledge, in his capacity as an FTC staff economist, concerning cigarette-related matters, as the Court observed at the trial, his "testimony is not that overwhelmingly relevant." Mulholland TT, 4/25/05, 19938:16- 19939:1. -780- FCR 149; upheld on appeal Tobacco Institute (Aust) v. AFCO (1992) 38 FCR 1; Tobacco Institute (Aust) v. AFCO (1993) 41 FCR 89.

  1. The industry realized after AFCO that it could be liable for statements that cigarette manufacturers or their trade associations (such as the Tobacco Institute) made denying the adverse health effects of ETS. In a memo on "Industry ETS Consultancy Programs," Dr. Sharon Boyse (Blackie) wrote:
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One conclusion that was very clear from the industry lawyers was that we had to further develop our resources of independent spokespersons who were not directly associated with the tobacco industry, in order to minimize situations in which we respond as an industry and so potentially lay ourselves open to legal claims.

300522762-2767 at 2763 (US 22223).

  1. One major role of the IEMC was to formulate a common position for the industry on ETS. To that end, Covington & Burling prepared a position paper, the "ETS White Paper," for the IEMC and CECCM, which concluded that (1) knowledge of the chemical composition of mainstream and sidestream smoke is not relevant to the composition of ETS; (2) knowledge of the health effects of active smoking is equally irrelevant; (3) ETS is only a very minor source of indoor air contaminants, and can be addressed via ventilation; and (4) the "pertinent evidence" did not support any claim that exposure to ETS was a cause of any disease or any adverse health effects in children or adults. 2023581802-1841 at 1808-1812, 1827, 1831, 1838 (US 88467).

  2. According to 1992 company memoranda from Philip Morris's Matt Winokur and BATCo's Sharon Boyse (Blackie) to their respective company executives worldwide, including Steve Parrish, general counsel of Philip Morris, the Covington & Burling position paper had been "approved and adopted for use by all the IEMC member companies" for public use. 2023581801-1801 (US 20392); 300528914-8914 (US 46573).

  3. The 1992 "ETS White Paper" was also forwarded to CECCM, the Tobacco Document Center (TDC) and all company representatives. 300543969-3970 (US 88468); 300543940-3942 (US 88469). Covington & Burling revised the "white paper" in 1993 and distributed it to IEMC and CECCM members for comments and approval. 500874371-4371 (US 88470); 300544202-4208 at 4206 (US 88471); 2025495368-5373 at 5370 (US 37270).

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  1. CECCM worked with the IEMC and approved the IEMC position papers for use by all of its cigarette manufacturer members both with the media and with government officials. 300545701-5705 (US 88464); 300543440-3445 at 3443 (US 88465); 2504088209-8210 at 8209 (US 20571). In the words of the Rothmans representative to the IEMC: "It was eventually resolved: IEMC will develop the messages (globally); CECCM will deliver these message (in Europe)." (emphasis in original) 900006204 (US 88482); 900006205-6209 (US 88483). An "ETS Communications Manual" was compiled and distributed to all IEMC and CECCM members. 900006078-6080 (US 88485); 2072418746-8749 at 8746 (US 89141).

  2. In the 1990s, IARC undertook a large study in multiple cities to assess the health effects of passive smoking. Defendants also used the IEMC as a platform to monitor, influence, and criticize the IARC study. Boyse wrote the following in a December 1, 1993 memorandum to BATCo executives:

IARC is to publish, in 1994 or 1995, the largest epidemiological study of ETS ever carried out, covering eleven Centres in Europe, North America, and Asia. We believe it likely that on the basis of this study, IARC will classify ETS as carcinogenic, which would lead to a situation not dissimilar to that with the EPA in the USA . . . . Through the International ETS Management Committee (BAT, PM, RJR, Rothmans, Imperial UK and Reemtsma) we are developing a strategy, both scientific and media-related, to cope with this study.

500844318-4319 (US 48464).

  1. A September 2, 1993 Philip Morris memorandum discussing the IARC study warned that:

The results are anticipated to have significant credibility both because this study consists of original research and because IARC itself has a solid reputation. Preliminary indications suggest that the study may

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find a very weak, but positive link between ETS exposure and lung cancer in non-smokers.

2501117793-7797 at 7793 (US 27932).

  1. According to several Philip Morris documents, industry objectives in 1993 included: (1) "delay[ing] the progress and/or release of the study"; (2) taking steps to "neutralise the possible negative results of the study"; and (3) making efforts "to get the study shelved altogether." 2501117793-7797 at 7794 (US 27932); 2501348679-8683 (US 88474). The industry even asked: "Can we kill the credibility of the research up front, before publication?" 2500156109-6110 at 6109 (US 88473); 2025493279-3283 (US 88111).

  2. An updated 1993 plan was presented by Philip Morris's David Greenberg to Philip Morris Companies President and COO Bill Murray in September 1993. Objectives continued to include delaying the progress and release of the IARC study, as well as neutralising its results. Greenberg proposed setting up a Philip Morris IARC team, composed of Philip Morris employees and attorneys from Shook, Hardy & Bacon and Covington & Burling, to insure that the strategies were "implemented globally." 2021184116-4116 (US 26730); 2021184117-4121 at 4118-4119 (US 36718).

  3. Philip Morris's IARC planning involved executives and scientists from Philip Morris and Philip Morris Europe (FTR), in conjunction with the outside lawyers. Philip Morris (FTR) Scientific Director Helmut Reif took the lead in organizing and coordinating all of the inter-industry scientific efforts, which included preemptive assessment of the questionnaire to expose weaknesses; organizing with the law firms a team to identify and mobilize consultants, and offering IARC industry funded study results and protocols through Max Eisenberg at CIAR. Philip Morris's Matt

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Winokur wrote to Philip Morris's general counsel Steve Parrish in a January 24, 1994 e-mail: "I agree that S & T (Richmond and Neuchatel) must be involved with all phases -- scientific, political and communications -- that come together when developing the industry's response to the IARC study. And already this is happening." 2029174855-4855 (US 88475); 2024104538-4538 (US 88476).

  1. From 1994 forward, a plan to counter IARC was carried out through a task force of the IEMC representatives. CECCM had its own "IARC Working Group" whose membership included many members of the IEMC "subgroup." The subgroup met to formulate the industry's comments and responses (called "ETS messages") to the IARC study both before and after publication; these "messages" were then be forwarded to CECCM and IEMC member companies to ensure unified positions. 900006185-6185 (US 88480); 2028361781-1781 (US 88478); 2078742949-2949 (US 27722).

  2. In a January 17, 1994 memorandum to David Greenberg, Matt Winokur summarized how the "IARC task force" had been set up "to coordinate plans and resources among the companies and in conjunction with National Manufacturers Associations." These plans included IARC "intelligence gathering" and the development of a "global communications . . . to address the impact of the study." 2025493459-3460 at 3459 (US 26843).

  3. A 1995 Reynolds Powerpoint presentation, titled "ETS: a global offensive and defensive strategy," called IARC a "manageable threat" that could be "globalized" and countered by CIAR and other industry passive smoking initiatives. 502558482-8497 at 8483, 8488, 8489, 8492

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  1. The industry's coordinated "IARC Release Plan," as written in 1996, involved many players. The plan was presented to IEMC and CECCM, for their approval. Rupp was in charge of writing various white papers that would be included in the National Manufacturer's Association manual. Shook, Hardy & Bacon provided legal clearance. Peter Lee reviewed IARC's ETS position and past practices to allow corporate affairs to identify weaknesses in the IARC methodology. There was a "Response Coordination Team" of executives from the member companies, including David Greenberg and Ruth Dempsey of Philip Morris, Chris Proctor of BATCo, and Steven Sears of Reynolds. More than a dozen other company executives and scientists served in other roles for the "Coordination Team." 2048381563-1574 (US 88131).

  2. The "IARC Industry Release Plan" was coordinated through CECCM. The minutes of the January 28, 1997 CECCM corporate member meeting recorded that Philip Morris gave a status update on the IARC study, and the members agreed that CECCM would update the manufacturer associations (NMAs) at the next meeting in February 1997. The "IARC Industry Release Plan" involved the cigarette manufacturer members, the NMAs, and public relations firm Burson Marsteller. 2072417681-7682 (US 89132).

  3. One strategy which was adopted to counter the anticipated IARC study was to create and convince scientific groups to adopt industry-favorable epidemiology standards, dubbed "Good Epidemiology Practices" or GEPs. 2501347174-7176 at 7175 (US 45951); 2029260524-0539 (US 26895); 2025493020-3030 (US 88108); 2028381627-1627 (US 26885). Through the use of its "GEPs," Philip Morris created and pushed a standard under which relative risks of less than two would be ignored, and would automatically bar a finding of causation. Parrish WD, 86:1-88:9.

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  1. Defendants were unable to convince any organization to adopt their version of "good" epidemiological practices. In an April 3, 1998 Philip Morris e-mail from Ted Sanders to Cathy Ellis in Richmond, Sanders summarized the 1994 GEP initiative as follows:

Approximately three years ago, the concept of GEPs was discussed in considerable detail in PM. Corporate Affairs thought it was a wonderful idea, because at first they. . . felt that part of a code for Good Epidemiological Practices would state that any relative risk of less than 2 would be ignored. This is of course not the case. No epidemiological organization would agree to this, and even Corporate Affairs realizes this now. A number of initiatives were attempted, but the one initiative which continues in Europe is currently under the auspices of John Rupp.

2060566164-6165 (US 20505).

  1. In early 1998, IARC published a summary update of its ongoing Multi-Center ETS study in its Biennial Report. 2063594009-4009 (US 39763). In this Report, the researchers reported a relative risk of lung cancer() of 1.16 for spousal exposure (CI = 0.93-1.44) and 1.17 for workplace exposure (CI = 0.94-1.45). In other words, non-smoking spouses exposed to smoking spouses faced a 16% greater risk of lung cancer, and non-smoking employees exposed to smoking fellow employees faced a 17% greater risk of lung cancer. Researchers also reported that "several quantitative indicators of ETS showed a dose-response relationship with lung cancer risk." 770007956-8214 at 8018, 8177-8178 US 88132; (no bates at 9) (JD 023241).

  2. Despite the findings in the IARC study of raised relative risks and a dose-response relationship, Defendants attacked the statistical significance with their GEPs below two. A March 8, 1998 BATCo press release stated:

Europe's Largest Ever Passive Smoking Study Has Failed to Establish a Meaningful Risk of Lung Cancer to Non-Smokers

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The ten year study, which was commissioned by the World Health Organisation and involved twelve centres in seven countries, has cast further doubt on the status of passive smoking as a cause of disease.

Dr. Chris Proctor, Head of Science for British American Tobacco said: "New scientific research from the World Health Organisation has shown the risk of lung cancer from environmental tobacco smoke to be either non-existent or too small to be measured at a meaningful level. . . . If this study cannot find any statistically valid risk, you have to ask whether there can be any risk at all."

2063594018-4018 (US 39764).

  1. A March 9, 1998 B&W press release stated:

MAJOR ENVIRONMENTAL TOBACCO SMOKE STUDY FINDS NO RISK

New research from one of the world's premier health organizations is out on environmental tobacco smoke.

In the largest study of its kind ever performed in Europe, research by the World Health Organization's International Agency for Research on Cancer (IARC) has found no meaningful increase in lung cancer risk to non-smokers exposed to environmental tobacco smoke.

"This is good news for smokers and non-smokers," said Sharon Boyse, director of scientific communication at Brown & Williamson Tobacco Corporation. We welcome this new study which confirms what we and many other scientists have long believed, that while smoke in the air may annoy some non-smokers, the science overall does not show that being around a smoker is a lung cancer risk," she said.

DXA0680223-0233 at 0233 (US 79025).

  1. In response, a March 1998 WHO press release stated: