Low Tar/Light Cigarettes Offer No Clear Health Benefit over Regular Cigarettes

Low Tar/Light Cigarettes Offer No Clear Health Benefit over Regular Cigarettes

History of Health Claims

¶2029. In the early 1950s, on the heels of a series of studies linking smoking and disease, the Defendant cigarette manufacturers began making health claims, often using models in doctors' white coats, in their advertising:

• American Tobacco Co. made representations "that its cigarettes were less irritating to the throat than competing brands, offered one's throat protection, were easy on one's throat, and provided protection against throat irritation and coughing. . . ." Federal Trade Commission, In the Matter of American Tobacco Co., Complaint, Findings, and Order in Regard to the Alleged Violation of Sec. 5 of an Act of Congress Approved Sept. 26, 1914 (47 F.T.C. 1393), decided June 20, 1951.

• R.J. Reynolds Tobacco Co. "represented to the public . . . that the smoking of such cigarettes . . . aided digestion"; "represented that the wind and physical condition of athletes would not be impaired by the smoking of as many Camel cigarettes as desired"; and "represented that the smoking of Camel cigarettes was soothing, restful, and comforting to the nerves, and protected one against becoming 'jittery' or 'unsure' when subjected to intense nerve strain …." Federal Trade Commission, In the Matter of R.J. Reynolds Tobacco Co., Complaint, Findings, and Order in Regard to the Alleged Violation of Sec. 5 of an Act of Congress Approved Sept. 26, 1914 (46 F.T.C. 706), decided March 31, 1950.
• Liggett & Myers Tobacco Co. represented "'directly or by implication, that Chesterfield cigarettes can be smoked by an [sic] smoker without inducing any adverse affect upon the nose, throat and accessory organs of the smoker.'" FTC v. Liggett & Myers Tobacco Co., 108 F. Supp. 573 (S.D.N.Y. 1952).
• Lorillard made comparisons between the tar and nicotine yields of its cigarettes and those of its competitors. For

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example, Old Gold advertisements included statements that Old Gold was "lowest in nicotine and throat irritating tars and resins when compared with 6 other leading brands." Langenfeld WD at 42:5-10 (citing In the Matter of P. Lorillard Co., 46 F.T.C. 735 (1950)).

¶2030. As discussed in great detail in section V(E)(1)(a), infra, the FTC successfully prosecuted the Defendant cigarette manufacturers' for some of these health claims. See In the Matter of American Tobacco Co., 47 F.T.C. 1393 (F.T.C. 1951); R.J. Reynolds Tobacco Co., 46 F.T.C. 706 (1950), modified, 192 F.2d 535 (7th Cir. 1951), on remand, 48 F.T.C. 682 (1952); Federal Trade Commission v. Liggett & Myers Tobacco Co., 108 F. Supp. 573 (S.D.N.Y. 1952), affirmed on opinion below, 203 F.2d 955 (2d Cir. 1953); P. Lorillard Co. v. Federal Trade Commission, 186 F.2d 52, 56-57 (4th Cir. 1950).

¶2031. Those prosecutions led to public calls for a ban on advertisements containing such health claims. (no bates) (JD 043377) (Advertising Age (Dec. 21, 1953)) ("Cigarette advertisers were urged today by the National Better Business Bureau to adopt an eight point code to eliminate unfounded health claims in cigarette advertising.").

¶2032. Given the public's concern over tar and lung cancer, the "White Coat" ads of the 1940s and early 1950s gradually disappeared, and a wave of ads featuring claims about filtration and tar reduction became the new basis for competition. See (no bates) (JD 000636 at 5) (1981 Surgeon General's Report) ("In the 1950s, cigarette manufacturers introduced cigarette filters as 'health protection' and advertised them widely."); Harris TT, 10/18/04, 2783:15-18.

¶2033. Defendants competed through comparative filtration ads in the period following 1953. (no bates) (US 58700 at 199) (NCI Monograph 13) ("Companies initially responded to this health scare by introducing filtered products that were accompanied by advertisements with explicit health-related statements.").

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¶2034. In 1954, the FTC issued a letter to all tobacco companies announcing its intention to adopt uniform standards for cigarette advertising "to prevent the use of false or misleading claims." (no bates) (JD 000332 at 276) (False & Misleading Advertising (Filter-Tip Cigarettes), Hearings before the House Subcomm. of the Comm. on Gov't Operations, 85th Cong. (1957)) . During the ensuing negotiations with cigarette manufacturers, the FTC advised the industry to conform its advertising with FTC decisions, "including decisions finding that comparisons of tar and nicotine between brands were false and misleading." Id.

¶2035. In 1955, the FTC adopted the "Cigarette Advertising Guides," proscribing any implicit or explicit health claims in cigarette advertising. The Guides did, however, provide a limited exception to this general rule, for what the FTC believed were implicit health claims. This exception allowed comparative ads claiming that a cigarette was "low in nicotine or tars," provided it has "been established by competent scientific proof applicable at the time of dissemination that the claim is true, and if true, that such difference or differences are significant." 50202 3956-57 (JD 003616 at 2) (FTC Press Release of 9/22/55 (Cigarette Advertising Guides)); (no bates) (JD 021949) (4 Trade Reg. (CCH) ¶ 39,012 (1995)). At the same time, some members of the public health community urged the development and adoption of cigarettes with reduced tar yields. Harris TT, 10/18/04, 2782:7-13; Burns TT, 2/15/05, 13357:8-16; Townsend WD, 80:22-81:10.

¶2036. By the mid to late 1950s, the American cigarette manufacturers responded with a heated "tar derby" of competing claims about the effectiveness of various filters: "[C]igarette companies advertised that certain brands were lower in 'tar' and nicotine and, by implication, less dangerous." (no bates) (JD 001032 at 1-49, n.174) (FTC Staff Report on the Cigarette Advertising Investigation (May 1981)); see also (no bates) (JD 004344 at 8343) (Unfair or Deceptive Advertising & Labeling of Cigarettes in Relation to the Health Hazards of Smoking, 29 Fed. Reg. 8324 (June 22, 1964)).

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¶2037. Smokers responded too, switching in droves to filtered cigarettes. Krugman TT, 12/15/04, 8603:8-14; (no bates) (US 58700 Fig. 4-3, at 93).

¶2038. However, Congress and the FTC perceived that the resulting competition was confusing since different cigarette manufacturers sought to substantiate their "low tar" claims based on different "scientific" testing methods. (no bates) (JD 000332 at 276) (False & Misleading Advertising (Filter-Tip Cigarettes), Hearings Before a Subcomm. of the House Comm. on Gov't Operations, 85th Cong. (1957)) (discussing lack of standardized test method).

¶2039. Faced with the "tar derby" and perceived consumer confusion, the FTC concluded that, "[i]n the absence of uniform testing procedures, it was impossible to make claims about 'tar' and nicotine levels that could be substantiated. . . ." (no bates) (JD 001032 at 1-49, n.174) (FTC Staff Report on the Cigarette Advertising Investigation (May 1981)). Accordingly, in 1959, the FTC called a halt to the "tar derby" and "reiterated its view that tar and nicotine claims would be regarded as conveying the additional claim that lower levels of tar and nicotine reduced health risks." (no bates) (JD 000435 at 41) (J. Calfee, Cigarette Advertising, Health Information and Regulation Before 1970, Working Paper No. 134 (Dec. 1985)).

¶2040. "[T]he position taken by the FTC at this time was that the simple fact of listing tar and nicotine deliveries . . . constituted an implied health claim," because the "implication was that these cigarettes would be less hazardous or less harmful." Harris TT, 10/19/04, 2902:19-2903:3.

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¶On December 17, 1959, the FTC informed tobacco manufacturers that it henceforth would bar all health claims in advertising, including "all representations of low or reduced tar or nicotine, whether by filtration or otherwise." 1005150070 (JD 004534). The FTC further "inform[ed] the industry that in its opinion the evidence then available would support a complaint against any marketer who made any reference to tar or nicotine content, charging that such a reference was false and misleading." 670310575-588 (JD 040931 at 3).

¶2041. A month later, the FTC requested that the cigarette manufacturers agree to make no references to tar and nicotine in their advertising, and the manufacturers agreed. 1005150056-57 (JD 004535); 1005150051-52 (JD 003617).

The FTC Method

¶2042. The FTC thought the 1964 Surgeon General's Report provided "an evidentiary foundation to support a Rule requiring a positive statement [of average 'tar' and nicotine yields] in [cigarette] labeling and advertising." Letter of 4/11/66 from Paul Rand Dixon, FTC Chairman, to Sen. Warren Magnuson (670310575-588), JD 040931 (at 3).

¶2043. Within a week of the issuance of the 1964 Surgeon General's Report, the FTC proposed a Trade Regulation Rule that, among other things, would permit the advertising of tar and nicotine yields, provided that such advertising was "verified in accordance with a uniform and reliable testing procedure approved by the Federal Trade Commission." 29 Fed. Reg. 530, (no bates) (JD 040184 at 532); 29 Fed. Reg. 8324 (1964), (no bates) (JD 004344 at 8355-56).

¶2044. According to the FTC, "[c]onfusion can be obviated, and the ability of consumers to make an intelligent choice among competing brands protected, only if the measurement of cigarettesmoke ingredients accords with a uniform, fully reliable and approved testing procedure." 670310575-588 (JD 040931 at 4).

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¶2045. "[T]here was substantial support for the proposition that an accurate statement of tar and nicotine content would be in the public interest. . . ." 0002905512 (JD 004537 at 5512).

¶2046. The National Interagency Council on Smoking and Health "hope[d] that [the FTC would] take the steps necessary to make it permissible for cigarette manufacturers to list tar and nicotine content on the labels of cigarette packages." 670310575-588 (JD 040931 at 8); 1002905514 (JD 004537).

¶2047. The American Cancer Society, the American College Health Association, the Roswell Park Memorial Institute, and others expressed support for the proposed rule. 1002905512-5519 at 5514-5519 (JD-004537).

¶2048. On March 24, 1966, the FTC notified cigarette manufacturers that they would be permitted to advertise tar and nicotine yields provided they used the Cambridge Filter Method, as published by Dr. C.L. Ogg of the U.S. Department of Agriculture, to substantiate any yield claims, and so long as "no collateral representations" were made as to the "reduction or elimination of health hazards" from lower yield cigarettes. (no bates) (JD 004538); see also 680236589 (JD 004612); (no bates) (JD 001032 at 4-3).

¶2049. The FTC Cambridge Filter Method uses a machine to "smoke" the cigarette for a designated puff volume at a designated interval for a designated period of time. As the smoke is drawn into the machine, it passes over a filter known as a Cambridge pad, on which the particulate tar matter is collected. That accumulated matter is measured to calculate the tar and nicotine yields for the cigarette. The FTC Method was developed to provide consumers with a relative ranking of nicotine, tar, and carbon monoxide yields from any cigarettes that were tested. Henningfield WD, 47:11-48:2; Henningfield TT, 11/22/04, 6794:8-6796:6.

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¶2050. When the FTC gave manufacturers permission to make disclosures of tar and nicotine yields, it "recognized that the result would be that consumers would, in fact, believe that lowered delivery cigarettes were less hazardous and less harmful." Harris TT, 10/19/04, 2913:20-24.

¶2051. The FTC's change in policy to permit these claims was designed to achieve two goals: provide consumers with an incentive to smoke the lower tar/nicotine cigarettes rather than the higher tar/conventional cigarettes and give manufacturers a competitive incentive to produce cigarettes with low levels of tar and nicotine. Harris TT, 10/19/04, 2909:1-25.

¶2052. The federal government wanted to provide consumers with information that they could use to compare brands. See, e.g., FTCDOCS 0259-1751-1793 (JD 004353 at 1) ("The 'tar' and nicotine testing program was intended to provide smokers seeking to switch to lower 'tar' cigarettes with a single, standardized measurement with which to choose among the then-existing brands.").

¶2053. In addition, given the premise of a dose-response relationship -- i.e., more tar equals more disease risk -- the FTC wanted to encourage competition among the cigarette manufacturers, thereby increasing the research, development, and production of cigarettes with lower FTC-measured tar yields. See, e.g., (no bates) (JD 043418 at 17) ("Based upon the proposition that lower yield cigarettes present a lessened hazard to the American public," the FTC has acted to "prompt cigarette manufacturers to develop less hazardous cigarettes."); see also (no bates) (JD 004615 at 1) (Sen. Warren G. Magnuson, News Release, Nov. 27, 1967) ("The results of the first government tests ranking cigarette brands by tar and nicotine levels were released today. . . . Hopefully, the wide dissemination of this information and the growing awareness of its significance among the smoking public will channel competition in the cigarette industry toward the marketing of cigarettes of progressively lower tar and nicotine content.").

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¶2054. The theory was that the public would shift its consumption away from higher tar products, and toward lower tar products, just as it had done with the advent of filter-tipped cigarettes. In this way, it was anticipated that the national sales-weighted-average tar yields of cigarettes sold in the United States would decline, and the public health would benefit. (no bates) (JD 053570 at 1).

¶2055. On July 31, 1967, the FTC directed its staff to commence "formal test[ing]" of cigarettes using the Cambridge Filter Test. (no bates) (JD 002477 at 2064360211); (no bates) (JD 004348 at 1).

¶2056. On August 8, 1970, the FTC proposed a rule to mandate disclosure of tar and nicotine ratings in all cigarette advertising. (no bates) (JD 004350).

¶2057. The FTC also invited the cigarette manufacturers to submit a voluntary proposal, in lieu of the proposed rule, for such disclosures in cigarette advertising. 2023098316 (JD 040304) ("If the industry can devise a voluntary plan that is feasible and appropriate, the Commission is willing to consider it.").

¶2058. The tobacco companies complied, (no bates) (JD 040305), and the FTC solicited public comment on the industry plan. 1005045883-84 (JD 041337); (no bates) (JD 002066).

¶2059. Ultimately, the FTC agreed to allow tobacco companies make certain disclosures about tar and nicotine content in cigarette advertising instead of issuing a formal rule. On December 22, 1970, the FTC formally adopted a revised version of the cigarette manufacturers' proposal for displaying FTC tar and nicotine ratings in all advertising. The agreement was implemented by the FTC on January 13, 1971, as a substitute for its proposed trade regulation rule requiring such disclosure. 1005045883-84 (JD 041337); (no bates) (JD 003634).

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¶2060. The FTC concluded that the voluntary agreement to provide "tar and nicotine disclosure and the voluntary agreement . . . to put the Surgeon General's health warning on the side of the pack in advertisements . . . [were] highly responsible activit[ies] by" the cigarette manufacturers. Public Health Cigarette Amendments of 1971, Hearings on S. 1454 before the Consumer Subcomm. of the Senate Comm. on Commerce, 92nd Cong. (1972) (statement of Robert Pitofsky, Dir., Bureau of Consumer Protection); (no bates) (JD 042276 at 58).

The FTC Method Does Not Measure Actual Tar and Nicotine Delivery

¶2061. Within months after it notified cigarette manufacturers on March 24, 1996 of its decision to allow advertising of tar and nicotine yields so long as the Cambridge Filter Method was used, the FTC invited cigarette manufacturers to comment in detail on the precise method to be used to measure tar and nicotine yields. See, e.g., (no bates) (JD 040780); (no bates) (JD 003620).25

¶2062. Defendants "initially resisted imposition of the Cambridge testing method and claimed it would be inaccurate" because different smokers "smoke differently -- and even smoke differently at different times." Henningfield WD, 48:3-50:12. This is known as smoker variation. Early in the FTC process of developing a standard testing method, Defendants advised the Agency that, because of smoker variation, the Cambridge Filter Method would not measure the tar or nicotine that a human being would ingest from smoking any particular cigarette:

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No two human smokers smoke in the same way. No individual smoker always smokes in the same fashion. The speed at which one smokes varies both among smokers, and usually also varies with the same individual under different circumstances even within the same day. Some take long puffs (or draws); some take short puffs. That variation affects the [tar and nicotine] quantity in the smoke generated.

¶(no bates) (JD 004362 at 2). See also United States' Obj. and Answers to Joint Defs' Modified Eleventh Set of Req. for Admis. to the Pl. United States, RFA Resp. 5, 49-50, 54 (4/12/02) (The Government admits that in 1966, during the comment period for discussion of the Cambridge method, certain tobacco companies stated that the FTC method would only be an effective measurement for certain conditions of smoking behavior).

¶2063. The FTC also heard from, among others, Clyde L. Ogg, Ph.D., of USDA, who developed the method initially adopted by the FTC. He admitted that: "Since smokers vary so greatly in their smoking habits, the proposed ... method will not tell a smoker how much tar and nicotine he will get from any given cigarette. It will indicate, however, whether he will get more from one than from another cigarette if there is a significant difference between the two and if he smokes the two in the same manner." (no bates) (JD 004748 at 38).

¶2064. The FTC's press release announcing its decision clearly described the limitations of the standardized test method it was adopting. (no bates) (JE 061264 at 1-2). The FTC stated:

No test can precisely duplicate conditions of actual human smoking and, within fairly wide limits, no one method can be said to be either "right" or "wrong." The Commission considers it most important that the test results be based on a reasonable standardized method and that they be capable of being presented to the public in a manner that is readily understandable. . . . [T]he public interest requires that all test results presented to the public be based on a uniform method used by all laboratories. Use of more than one testing method would produce

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different results which would only serve to confuse or mislead the public.

The Cambridge Filter Method does not and cannot measure these many variations in human smoking habits. . . . It does not measure all of the tar and nicotine in any cigarette, but only that in the smoke drawn in the standardized machine smoking according to the prescribed method. Thus, the purpose of testing is not to determine the amount of tar and nicotine inhaled by any human smoker, but rather to determine the amount of tar and nicotine generated when a cigarette is smoked by machine in accordance with the prescribed method.

¶(no bates) (JE 061264 at 1-2).

¶2065. On that same day, the Tobacco Institute issued a press release stating that the FTC method was "unsound" and declaring that the "'tar' and nicotine results" produced by the FTC method "may be inaccurate [and] misleading" to consumers. Tobacco Institute Press Release, Tobacco Institute Says FTC Chose Unsound Test Methods: 'Tar' and Nicotine Results May Be Inaccurate, Misleading, Aug. 1, 1967, 500031952-1955 (JD 047658 at 1). Among other things, the press release pointed out that humans smoke cigarettes differently and that "per cigarette" tar and nicotine yields therefore would be "useless and misleading" to smokers who do not smoke within the FTC parameters. (no bates) (JD 047658 at 1).

¶2066. Defendants did not, however, disclose their knowledge that smokers would ultimately ingest as much if not more nicotine and tar from low-delivery cigarettes as they would from full-flavor products. Defendants knew that the phenomenon of smoker compensation, discussed in greater detail infra, would cause smokers to smoke low-delivery products more intensely and more frequently in order to obtain their desired level of nicotine. To feed their addiction, therefore, these smokers would defeat the stated purpose of the lower-delivery products. Henningfield WD, 48:3- 50:12. Nor did Defendants disclose to the FTC that "a major reason that the method could yield misleading data was that nicotine addiction would drive smokers to achieve relatively stable nicotine intakes" and that smokers' "physiological need to obtain nicotine substantially lessens the accuracy of the FTC ratings." Henningfield WD, 48-14-49:7. According to Dr. Farone, Defendants did not inform the FTC in 1966 "that smokers alter their smoking behavior to get nicotine." Nor did Defendants tell the FTC that people's "smoking behavior was driven by the need to satisfy their nicotine addiction." Farone TT, 10/12/04, 2170:5-23. .

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¶2067. There is a dose-response relationship between smoking and lung cancer. That is, the less smoke to which smokers are exposed, the lower their lung cancer risk. Benowitz TT, 11/1/04, 4521:13-16; Townsend WD, 80:9-18. The predicate for the development and marketing of lower FTC-yield cigarettes was the expectation that, as a group, smokers of lower FTC-yield cigarettes would be exposed to less smoke. Townsend WD, 80:9-18.

¶2068. Because of compensation and the need of smokers to obtain a desired dose of nicotine, they may offset the decrease in their cigarettes' FTC tar and nicotine yields, in whole or in part, by one of two means. First, smokers may engage in so-called "puff" or "within cigarette compensation." This is done by smoking individual, lower FTC-yield cigarettes more intensively by taking bigger puffs, taking more frequent puffs, smoking the cigarette closer to the butt, blocking ventilation holes placed in the filter that dilute the smoke, or other means. Second, they may simply smoke more cigarettes. Benowitz TT, 11/1/04, 4512:11-4513:1; Dixon WD, 16:13-21.

¶2069. The issue of compensation has been discussed in the scientific literature since at least the 1940s. Benowitz TT, 11/1/04, 4526:19-4527:3. The early literature on nicotine, including compensation, was summarized in a well respected compendium of articles collected by Larson, P.S. et al., in Tobacco: Experimental and Clinical Studies: A Comprehensive Account of the World

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¶Literature (Baltimore, Williams & Wilkins Co. 1961). (no bates) (JD 000500); Rowell WD, 17:4- 17. This useful research tool was cited repeatedly in the 1964 Surgeon General's Report. Rowell WD ,18:1-18. The Larson volume was funded by TIRC. McAllister WD, 102:9-22; Rowell WD , 17:18-20.

¶2070. It was a "common concern" in the early 1960s that smokers who switched to filtered cigarettes might "compensate" by smoking more cigarettes each day. Burns TT, 2/16/05, 13580:18- 13581:7; see also Samet TT, 9/29/04, 1183:5-9.

¶2071. "Compensatory smoking behavior is a manifestation of nicotine addiction," and "occurs primarily due to nicotine." Dr. Benowitz described "the consensus in the medical and scientific fields" regarding compensation: "The concept of smoking to obtain desired levels of nicotine and the concept of nicotine titration with associated compensation is widely accepted by the scientific and public health communities." Methods of smoker compensation include taking "bigger puffs," taking "more frequent puffs," "block[ing] the ventilation holes in the filter," and smoking more cigarettes. Benowitz WD, 55:11-22, 56:22-23, 57:5-9, 57:23-1; Benowitz TT, 11/2/04, 4762:23-24, 4763:14-16. Even as to ultra low tar cigarettes, where a smoker switching down may not be able to compensate fully "on a per cigarette basis[,] . . . that smoker could always smoke more cigarettes." Farone WD, 103:18-104:1; accord Farone TT, 10/12/04, 2169:18-19 (testifying that "the requirement for nicotine" drives smoker compensation).

¶2072. Because each smoker smokes to obtain his or her own particular nicotine quota, smokers end up inhaling essentially the same amount of nicotine -- and tar -- from so-called "low tar and nicotine" cigarettes as they would inhale from regular, "full flavor" cigarettes. This is referred to as "complete" compensation. Virtually all smokers, over 95%, compensate for nicotine.

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¶Benowitz WD, 59:6-17; 61:15-62:13; Benowitz TT, 11/2/04, 4769:25-4770:4; (no bates) (US 58700 at 10) (Monograph 13); accord Burns WD, 1:10-15, 12:10-11, 43:19-45:2; Burns TT, 2/15/05, 13311:9-15; Burns TT, 2/16/05, 13537:6-9.

¶2073. The amount of nicotine that smokers need to sustain their nicotine addiction does not change over time. Therefore, compensation for reduced deliveries is permanent, and occurs for as long as the smoker smokes the low tar product. Benowitz WD, 70:25-71:10; see generally DXA0310399-0650 at 0452-0476 (US 58700) (Monograph 13) (indicating no evidence to warrant conclusion that there is reduction in compensation over time).

¶2074. Because compensation is essentially complete, low tar cigarette smokers inhale essentially the same amount of tar and nicotine as they would from full flavor cigarettes, thereby eliminating any purported health benefit from low tar cigarettes. In short, "light and ultra-light cigarettes" do not, in actuality, "reduce the risks of smoking":

Considering the overall exposure data for individuals selecting their own brand, there is little reason to expect that smokers of cigarettes with low machine measured yields will have a lower risk of disease than those who smoke higher yield cigarettes.

¶Benowitz WD, 72:9-14; (no bates) (US 58700 at 60); see also Benowitz WD, 61:6-13 (explaining the conclusions of Chapter 3 of NCI Monograph 13).

¶2075. As Dr. Benowitz pointed out,

Compensation explains why smoking of light cigarettes has not been associated with a reduction of smoking-induced disease risks. One would think, looking at the FTC yield data, that toxic exposures would be substantially reduced if one switches to light cigarettes; however, because of compensation, resulting toxic exposures are similar for light and regular cigarettes.

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¶Benowitz WD, 60:23-61:14.

¶2076. Despite the fact that tar deliveries, as measured by the FTC Method, decreased by more than two-thirds between 1954 and 1994, lung cancer in smokers actually increased. (no bates) (US 58700) (Monograph 13); (no bates) (US 76212) (1997 CDC MMWR article); see also (no bates) (US 88626) (1995 Thun et al. article).

¶2077. Compensation behavior is distinct from "individual smoker variation":

Individual smoker variation refers to the fact that one smoker may smoke cigarettes -- either regular or low tar -- differently than another smoker, and that the same person may smoke the same cigarette differently on different occasions. . . . Individual smoker variability relates to the fact that cigarettes are smoked differently by different individuals. This type of variability is separate and distinct from the issue of compensation, which relates to the phenomenon of smokers smoking purportedly low-delivery cigarettes more intensely in order to achieve their particular desired level of nicotine intake.

¶Benowitz WD, 56:6-23.

¶2078. In its August 1, 1967 press release, the FTC set forth the Commission's understanding of smoker variation:

No two human smokers smoke in the same way. No individual smoker always smokes in the same fashion. The speed at which one smokes varies both among smokers, and usually also varies with the same individual under different circumstances even within the same day. Some take long puffs (or draws); some take short puffs. That variation affects the tar and nicotine quantity in the smoke generated.

Even with the same type of cigarette, individual smokers take a different number of puffs per cigarette depending upon the circumstances. When concentrating, or talking, the number of puffs is usually less. When listening, or required to listen to another person talking, the number of puffs per cigarette, as well as duration of each puff, usually increases. Smoking rates while reading a book may differ from smoking rates while viewing a television program. The number of puffs and puff duration (as well as butt length) will vary

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according to emotional state. Some smokers customarily put their cigarettes down in an ashtray where they burn between puffs; other smokers constantly hold cigarettes in their mouths; others hold them between their fingers.

¶(no bates) (JD 040254 at 2); 03573029-3030 at 3029 (US 22244).

¶2079. Significantly, the August 1, 1967 press release does not demonstrate a similar understanding of nicotine or addiction. It does not even mention nicotine and does not discuss the fact that nicotine addiction would lead smokers to obtain essentially the same amount of nicotine from so-called low tar cigarettes as they would from regular cigarettes. (no bates) (JD 040254); Farone TT, 10/12/04, 2170:5-23.

¶2080. Public service announcements of the Office on Smoking and Health from the early 1980s relating to the potential for compensation reflected a similarly incomplete and ultimately incorrect view of compensation. Rather, they "implie[d] that the individual has within [his/her] ability automatically not to compensate; that is, that the compensation is not driven by the addictive process. That was the understanding we had in the early 1980s . . . . It was only after that [] that we understood with precision and specificity how the nicotine drives that smoking change." Burns TT, 2/16/05, 13565:8-13566:4.

¶2081. Defendants suggested an analogy between the FTC tar and nicotine yields and automobile gas mileage estimates, intimating that they are both useful, albeit imperfect. As Dr. Henningfield explained, this comparison is not valid:

[W]e know through that [gas mileage] rating system that if you buy a car with a better gas mileage rating, virtually no matter how you drive it, you're going to get better mileage than a car with a worse rating. But in cigarettes, by just subtle changes in the way you smoke and things that most people don't even know about, the ventilation and the channels and the burn accelerants and all these different

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tricks, makes those two cigarettes look the same. Thus, for example, when humans smoke Marlboro cigarettes . . . Marlboro Lights can yield approximately twice as much nicotine as the Regulars are claimed to deliver by the standard FTC method. Marlboro Ultra Lights can deliver three times their advertised rating and most of the Carlton brands can deliver seven or more times their advertised rating.

¶Henningfield WD, 83:14-84:10.

¶2082. Light cigarette descriptors also "are totally different" from the information on food labels and drug labels, because "if you eat the listed serving size of [foods], you will receive the amount of [the constituents] listed on the label. . . . By contrast, . . . the advertised FTC tar and nicotine ratings for cigarettes bear very little relation to the actual dose a smoker can and, in most instances, does receive from smoking that cigarette. The inaccuracy in the FTC ratings is especially pronounced for cigarettes sold as 'light' or 'low tar' by the tobacco companies. This discrepancy is especially serious because it is in the direction of more toxins than advertised." Henningfield WD, 84:11-85:3.

¶2083. Dr. Whidby, a scientist, former employee, and consultant for Philip Morris USA, agreed that: "[m]easurements of tar and nicotine yields using the FTC method do not offer smokers meaningful information on the amount of tar and nicotine they will receive from a cigarette . . . [or about] the relative amounts of tar and nicotine exposure likely to be received from smoking different brands of cigarettes." Whidby TT, 2/22/05, 13993:14-19; DXA0310399-0650 at 0423, 0452-0476 (US 58700).

¶2084. Compensation has been documented by various scientific methods. Three different kinds of studies are generally used to conduct research on compensation: (1) spontaneous brand switching studies, (2) forced brand switching studies, and (3) cross-sectional studies. Benowitz WD, 62:14-20.

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¶2085. First, spontaneous brand switching studies are longitudinal studies that follow the same group of smokers over a specific period of time. At the start, the study measures the smokers' daily smoke exposure and records the FTC-yield of the smokers' usual brand. Later, at follow-up, the same smokers are re-contacted, at which time the study observes any change in the FTC-yield of the smokers' usual cigarette and again measures the smokers' daily smoke exposure. Benowitz WD, 62:21-63:4; Benowitz TT, 11/1/04, 4513:2-4514:3, especially 4513:13-21; (no bates) (US 58700 at 45) (Monograph 13).

¶2086. Such a study permits estimation of the changes in the daily smoke exposure of those smokers who, over the course of the study, spontaneously and voluntarily switched to cigarette brands with higher or lower FTC yields, as well as any changes in the daily smoke exposure of those smokers who did not change the FTC yield of their cigarette. Benowitz WD, 63:22-64:2; Benowitz TT, 11/1/04, 4513:2-4514:3, especially 4513:13-21.

¶2087. Spontaneous brand switching studies, like randomized experiments, may be long term or short term. Dixon TT, 3/9/05, 15051:14-15052:5.

¶2088. Spontaneous brand switching studies "are more informative of smokers' exposure in the real world when switching from higher to lower yield cigarettes," because "the brand of cigarette has been selected by the smoker and not by the researchers." Benowitz WD, 63:22-64:2. "[S]pontaneous brand switching studies generally show that there is no reduction in smoke intake [including nicotine and tar intake] per cigarette. . . . The per cigarette figure [is important because it] shows what an individual can take in from a particular cigarette. Thus, it provides information on the delivery characteristics of the product." Id. at 64:8-16, 66:3-5.

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¶2089. There is only one complete, peer-reviewed long-term spontaneous brand switching study, Lynch and Benowitz 1987, "Spontaneous Cigarette Brand Switching: Consequences for Nicotine and Carbon Monoxide Exposure," J. Public Health, 78(9): 1191-1194, (no bates) (JD 063010); Benowitz TT, 11/2/04, 4753:11-4755:5. The study found:

a. per cigarette nicotine intake was about the same, comparing smokers who switched to lower FTC-yield cigarettes during the course of the study to their own baseline per cigarette nicotine intake. (no bates) (JD 063010 at 1192).

b. per cigarette nicotine intake was lower, comparing smokers who switched to lower FTC-yield cigarettes during the course of the study to a similar "control group" of full-flavor smokers who did not switch. Benowitz TT, 11/2/04, 4758:25-4760:13; (no bates) (JD 063010 at 1192).

¶2090. Only daily nicotine intake was actually measured in the study. The per cigarette nicotine values were calculated by dividing daily nicotine intake by the number of cigarettes the smokers reported they smoked per day. Benowitz TT, 11/2/04, 4758:12-18; Wecker WD, 9:9-10:3.

¶2091. Dr. Benowitz drew this conclusion from his study:

For smokers who switched to lower yield cigarettes, the analysis of cotinine concentration or carbon monoxide per cigarette showed no change despite the reduction in nominal machine measured yield. Therefore, these smokers obtained the same dose of nicotine and carbon monoxide from each cigarette even though the machine measured yield was lower.

¶Benowitz WD, 63:22-64:2. The Benowitz study demonstrated that: "For spontaneous brand switchers, there is complete compensation for each cigarette smoked. As a result, for these smokers, switching from higher to lower yield cigarettes is not likely to reduce the risk of smoking." Id. at

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¶64:14-65:6, 65:14-17. The evidence that there is no reduction per cigarette by switching to lower tar cigarettes is particularly compelling in light of Dr. Benowitz's testimony that "we do know that on average people who are smoking lower-yield cigarettes smoke the same or even slightly more than higher-yield cigarettes." Benowitz WD, 63:22-64:2; 64:14-65:6; 65:14-17; Benowitz TT, 11/2/04, 4762:23-24; 4763:14-16; see also Benowitz WD, 63:5-10 (explaining that "[c]otinine is a major breakdown product of nicotine" that "is metabolized . . . by the liver" in humans, and therefore "has become the accepted marker for looking at nicotine exposure measurement from tobacco products").

¶2092. Based on this study, Monograph 13 concluded:

For spontaneous brand switchers, there appears to be complete compensation for nicotine delivery, reflecting more intensive smoking of lower-yield cigarettes.

*** Spontaneous brand-switching studies suggest that there is no reduction in smoke intake per cigarette. . . .

¶(no bates) (US 58700 at 10 and 60); see also Dixon TT, 3/9/05, 15046:7-15047:7.

¶2093. There are also short-term spontaneous brand switching studies on compensation. Dixon TT, 3/9/05, 15051:14-15052:05; Dixon WD, 40:7-13.

¶2094. The peer-reviewed literature contains a 1999 meta-analysis of the brand switching studies that employed nicotine biomarker data. The mean estimate of the extent of compensation in that article was about 50-60%. Dixon WD, 40:14-20; see also (no bates) (JD 000547 at 1).

¶2095. Second, in experimental studies for forced brand switching, smokers are randomly assigned to smoke cigarettes with higher or lower FTC yields. The smokers' daily smoke exposure, as measured by various biologic markers, is compared to see if the smokers assigned to smoke lower

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¶FTC-yield cigarettes have a lower daily smoke exposure than smokers assigned to smoke higher FTC-yield cigarettes. Benowitz WD, 68:6-9.

¶2096. Daily smoke exposure takes into account both forms of potential compensation -- the tendency of smokers of lower FTC-yield cigarettes to smoke individual cigarettes more intensively, as well as the tendency of smokers of lower FTC-yield cigarettes to smoke more cigarettes. Benowitz TT, 11/2/04, 4739:13-4740:3; Wecker WD, 5:22-6:7.

¶2097. In these long-term randomized experiments on forced brand switching, smokers randomly assigned to smoke lower tar cigarettes were exposed to less smoke each day than the smokers randomly assigned to smoke higher tar cigarettes. The estimated compensation is about 75- 80%, suggesting substantial but incomplete compensation. Benowitz WD, 70:19-21; Benowitz TT, 11/2/04, 4751:1-7; Wecker WD, 5:10-17.

¶2098. Dr. Benowitz explained that the substantial but incomplete compensation shown in the forced switching compensation studies is likely due to the act of forcing participants to switch brands:

[S]mokers are switched only for the purpose of the research. Motivation and cigarette acceptability differ from the natural situation of brand switching. . . . The forced brand switching studies show on average about eighty percent compensation. . . . Presumably compensation is not complete because the smokers have been switched to cigarettes that were not of their own choosing.

¶Benowitz WD, 68:6-21; 70:19-24.

¶2099. Third, in cross-sectional studies, the daily nicotine intake of smokers smoking their usual, voluntarily-selected brand is measured, typically using biologic markers for exposure to cigarette smoke, such as cotinine in the blood or saliva, and compared with the FTC-yield of the smokers' cigarettes. Benowitz TT, 11/2/04, 4742:25-4743:11.

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¶2100. Cross-sectional studies also lead to the conclusion that compensation is essentially complete:

Cross-sectional studies involve sampling smokers in the general population who are smoking their own chosen brand of cigarettes . . . show that there is very little difference in tobacco smoke exposure in people smoking cigarettes with different machine-determined yields. . . . There have been many cross-sectional studies performed, and overall they demonstrate that while there are some differences in nicotine exposure when high- and low-yield cigarette brands are compared, these differences are quite small. . . . Cross-sectional studies show nearly 100 percent compensation.

¶Benowitz WD, 66:9-68:5.

¶2101. In cross-sectional studies where the participants themselves choose the tar level of their cigarettes, there is a "very shallow slope" or "very tiny slope across the range of tar and nicotine" comparing the nicotine intake of smokers of various tar levels, demonstrating that smokers who smoke cigarettes of widely varied FTC tar levels are ingesting similar amounts of nicotine. This data indicates that compensation is essentially complete. As Dr. Burns explained, the fact that lower tar smokers may show, on the whole, slightly lower levels of nicotine than higher tar smokers does not mean that the lower levels are the result of the type of cigarette, but rather that the nicotine quota of smokers able to smoke lower tar cigarettes is customarily lower:

The effect is one that one would expect to be present as a small slope, since one would expect that high yield smokers would be likely to have higher nicotine levels and that the very lowest yield cigarette smokers would be there because they don't need much nicotine. That's independent of the brand of cigarettes they smoke. That's why they chose those brands. It's not an effect of the brand that they smoke. And so you would expect to see a small slope. The fact that

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the slope is as small as it is suggests that . . . there is full compensation on a population level when people in the natural setting move from one brand to another.

¶Dr. Benowitz's 1983 study, which showed this "very shallow slope," has been "replicated [in]numerable times by other scientists," and "those studies show basically the same picture, that there's a very shallow slope between the machine yield and cotinine levels." Burns TT, 2/16/05, 13541:8-13542:14; Benowitz WD, 67:10-18 (discussing his 1983 cross-sectional study); Benowitz TT, 11/1/04, 4564:13-15; Benowitz TT, 11/2/04, 4826:13-4827:5; see also Burns TT, 2/16/05, 13547:7-11 (indicating that the Gori and Lynch compensation study "was presented and examined in [Monograph 13] by Dr. Benowitz and was part of the data that was examined in that chapter that reached the conclusion that compensation was essentially complete").26

¶2102. The cross-sectional studies as a whole suggested that compensation is not complete but substantial. Benowitz TT, 11/2/04, 4737:22-4738:9, 4738:15-18; Dixon WD, 44:23-45:18; Mulholland WD, 19:18-20:13.

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¶2103. Evaluating all the types of studies as a whole, the evidence demonstrates, at a minimum, that compensation for daily nicotine is substantial if not complete. Benowitz TT, 11/2/04, 4737:22-4738:9, 4738:15-18 (cross-sectional studies); 4751:1-7 (randomized experiments); 4757:4- 8, 4757:19-23, 4766:24-4767:3 (spontaneous brand switching, daily nicotine intake); Wecker WD, 15:19-16:5; Dixon TT, 3/9/05, 14942:5-14943:14; Mulholland WD, 57:12-22; Mulholland TT, 4/25/05, 19943:12-19945:19.

The Public Health Community Has Concluded that Low Tar Cigarettes Offer No Clear Health Benefit

¶2104. Low tar cigarettes have not reduced the risks of smoking relative to full-flavor cigarettes. Burns WD, 1:10-15; 12:10-11; 30:5-12 ("I have concluded that the changes in cigarettes that resulted in a lowering of the FTC tar and nicotine yields over the past 50 years have not resulted in a reduction in the disease risks of smoking cigarettes for the smokers who use these cigarettes."); Burns TT, 2/15/05, 13311:9-15. Dr. Jonathan Samet, a Government expert with extraordinary qualifications, is a physician and epidemiologist with extensive experience treating patients with lung cancer and COPD. He is the Chair of the Department of Epidemiology at the Johns Hopkins University Bloomberg School of Public Health and has served as author and/or editor of several Surgeon Generals' Reports over more than 25 years, contributed to several National Cancer Institute Tobacco Control Monographs, and served as an author of Chapter 4 of Monograph 13. As an expert in the science of tobacco smoking and health, including epidemiology, pulmonary medicine, and internal medicine, he concluded that the use of lower tar and lower nicotine cigarettes "has had no clear benefit on the health risks of active smoking." Samet WD, 1:3-12, 2:20-3:3, 3:7-11, 3:19-23, 10:15-12:16, 14:1-15:13, 18:12-16, 168:17-19; Samet TT, 9/29/04, 10-18. Similarly, Dr. William

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¶Farone, fact and expert witness and former Director of Applied Research at Philip Morris, concluded that, based on his training and experience, "'light' cigarettes -- because they generally permit easy compensation and employ levels of dilution that increase the mutagenicity of the tar – are not any less hazardous than their full flavor versions." Farone WD, 123:21-124:4. The Court credits the testimony of these three experts.

¶2105. The 1981 Surgeon General's Report concluded, referring to the FTC Method of measuring tar and nicotine:

[T]he smoking-machine model is limited in accurately reproducing human smoking behavior.... Smokers, however, are able to take larger, more frequent, and higher velocity puffs than the machines do. It appears that such compensatory adjustments often turn nominally lower 'tar' and nicotine cigarettes into higher 'tar' and nicotine cigarettes. . . . Even if the compensations made in smoking a single cigarette are small or nonexistent, smokers can increase their intake of 'tar' and nicotine by smoking more cigarettes.

¶(no bates) (JD 000636 at 180) (1981 Surgeon General's Report).

¶2106. The 1981 Report recognized that there are still "smokers who are unwilling or as yet unable to quit." As to them, the Report concluded that they "are well advised to switch to cigarettes yielding less 'tar' and nicotine, provided they do not increase their smoking or change their smoking in other ways." Id. at v.

¶2107. Dr. Burns, an editor of the 1981 Surgeon General's Report as well as "an author, editor or reviewer for each of the annual Reports of the U.S. Surgeon General on the Health Consequences of Smoking since 1975," concluded that, in his expert opinion,

had the information available to the tobacco industry been available to the scientists preparing the 1981 Surgeon General's Report, that Report would not have drawn the erroneous conclusion that lower tar cigarettes produced lower risk or have made the recommendation that

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smokers who could not quit were "well advised to switch to cigarettes yielding less 'tar' and nicotine."

¶Burns WD, 1:10-15, 12:10-11, 36:3-37:12, 55:17-56:13, 56:21-57:17; Burns TT, 2/15/05, 13311:9- 15; Burns TT, 2/16/05, 13666:25-13667:24 ("Had that information been available to us, we would not have then offered the recommendation to the population of the United States that it would be a good idea to shift to these products."); see also Burns WD, 56:14-20 ("The Surgeon General clearly expressed a concern [in the 1981 Report] about reduced yield smoking leading to compensatory increases in smoking behaviors; but, at that time, the public health community was not aware of the role of nicotine addiction in altering puffing behavior, the elasticity of delivery designed into cigarettes then on the market which facilitated compensation on the part of the smoker, or the observations made by the industry that showed compensation was essentially complete for some 'light' cigarettes. Had we known that, the recommendation would not have been made."); Burns WD, 38:10-13 (indicating that "some of the same concerns [relating to the lack of a health benefit to lower tar cigarettes] were expressed in the 1989 Surgeon General's Report").

¶2108. The 1981 Report

did not fully take into consideration the phenomenon of compensation, and how smokers smoke to get a certain amount of nicotine, and will even adjust their smoking behavior to get the amount of nicotine they seek or are accustomed to . . . we didn't know in 1981 the extent to which smokers would compensate after switching to a 'low tar' and low nicotine yield product.

¶Samet WD, 164:15-165:5.

¶2109. Dr. Burns provided the "three principal reasons" that "the traditional epidemiological approaches that were employed at the time of the 1981 Surgeon General's Report" yielded results erroneously suggesting that lower tar cigarettes provided less lung cancer risk:

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(1) "[T]hat people who smoked low-tar and nicotine cigarettes" were smoking them largely "based on the understanding that these cigarettes . . . offered less risk." As a result, the people who choose these cigarettes "have different health behaviors" and often "different smoking characteristics" than smokers of higher tar cigarettes, leading to different expectations of health outcomes.

(2) That "very few people in the epidemiologic studies started out smoking low tar and nicotine or even filtered cigarettes." Most smokers who smoke the high-tar cigarettes very intensely are not able to switch down to lower tar cigarettes, whereas people who do not smoke the higher tar cigarettes very intensely, "when they switched to a low-tar cigarette . . . may be successful because they didn't have much nicotine intake that they needed to satisfy, and correspondingly they didn't have much tar intake. So the process of switching to low tar and nicotine starts to separate individuals who have different intensities of smoking, different amounts of tar that they are ingesting and, therefore, will have different risks."

(3) That "a substantial fraction of people who switch from high-tar and nicotine cigarettes to low-tar and nicotine cigarettes use increased numbers of cigarettes . . . as a mechanism of compensation. . . . In order to control for intensity of smoking, the epidemiologic studies used the number of cigarettes smoked per day as a measure of intensity with the mistaken assumption that people wouldn't change the number of cigarettes they smoked per day. That leads us to underestimate the actual number of cigarettes smoked per day as a measure of exposure in low-tar and nicotine cigarette smokers," because the epidemiological analysis compares people who smoke a higher number of cigarettes per day after switching to a lower tar cigarette to people who smoked this higher number of cigarettes per day of the higher tar cigarette. "That produces an erroneous, or incorrect, perception that switching to [the lower tar] cigarette lowered your lung cancer risk as an individual."

¶Burns TT, 2/15/05, 13327:21-13331:3; 13334:6-13337:5.

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¶2110. Moreover, epidemiological studies may underestimate the risks for lower tar smokers because these smokers may have other characteristics – such as healthier lifestyles – that contribute to a reduction in risk regardless of the type of cigarette smoked:

Epidemiological studies often assume that smokers who switch to low-yield products are similar to smokers who do not. There is evidence that this may not be true. For example, switchers may smoke their cigarettes differently, they may have started smoking later as teenagers, they may attempt to quit more often. Switchers may have smoked less intensely before they switched, when compared to their high-yield, non-switching counterparts. Switchers may have smoked less at younger ages. When these aspects of smoking behavior are not accounted for, study results may be misleading. In addition, switchers are [a] generally healthier group in terms of diet, exercise, and lifestyle in comparison to smokers who do not switch to a low yield product. The cumulative effect of these group differences is that any reduction in the risks among switchers may be the result of these differences, rather than the fact that they switched to a low yield product. This was also an observation in Monograph 13.

¶Samet WD, 167:13-168:2.

¶2111. Recent studies, including the National Cancer Institute's Monograph 13 and the 2004 Surgeon General's Report, have confirmed that low tar and filtered cigarettes are no less harmful than conventional delivery and unfiltered cigarettes. The 2001 NCI Monograph 13, "Risks Associated With Smoking Cigarettes With Low Machine Measured Yields of Tar and Nicotine" ("Monograph 13") concluded:

Epidemiological and other scientific evidence, including patterns of mortality from smoking-caused diseases, does not indicate a benefit to the public health from changes in cigarette design and manufacturing over the last fifty years. . . . Widespread adoption of lower yield cigarettes in the United States has not prevented the sustained increase in lung cancer among older smokers. . . . Considering the overall exposure data for individuals selecting their own brands, there is little reason to expect that smokers of low yield

800

cigarettes will have a lower risk of disease than those who smoked higher yield cigarettes.

¶DXA0310399-0650 at 0422-0423, 0473 (US 58700).

¶2112. Dr. Samet testified that: "The evidence is clear. We have tracked the risk of lung cancer closely and not seen a fall in relative risks to smokers." Samet WD, 169:14-16.

¶2113. The 2004 Surgeon General's Report reached the definitive conclusion: "[C]igarettes with lower machine-measured yields of tar and nicotine (i.e., low-tar/nicotine cigarettes) have not produced a lower risk of smoking-related diseases." In addition, the Report concluded that "[s]moking cigarettes with lower machine-measured yields of tar and nicotine provides no clear benefit to health" and that, "[a]lthough characteristics of cigarettes have changed during the last 50 years and yields of tar and nicotine have declined substantially, as assessed by the Federal Trade Commission's test protocol, the risk of lung cancer in smokers has not declined." TLT0930001-0949 at 0042, 0340, 0911 (US 88621). See also VXA100001-0604 (US 77217) (NCI Monograph 8); MTP0032477-2481 (US 76212) (11/7/97 CDC MMWR article); VXA1611681-1689 (US 77222) (1996 Samet et al. article); VXA1601456-1742 (US 64059) (1984 Surgeon General's Report).

¶2114. Both the 2004 Surgeon General's Report and the NCI's Monograph 13 were based on evidence "derived from research on human behavior and exposures, cigarette design and yields, smoke chemistry, epidemiological [and other] population-based data on human disease risk." DXA0310399-0650 at 0422-0423 (US 58700).

¶2115. Extensive research into the relationship between research of biomarkers of nicotine in humans and FTC tar and nicotine yields demonstrates that lower tar cigarettes do not provide a reduction in harm:

801

Generally speaking, research using these biomarkers has indicated little, if any, correlation between the FTC-yield of tar or nicotine, and the levels of the biomarkers measured in smokers. . . . These results suggest that there is little difference in the levels of biomarkers comparing smokers of higher yield tar/nicotine cigarettes and lower yield tar/nicotine cigarettes, as measured by the FTC method. This implies that doses of carcinogens or other toxic materials that smokers ingest have little relationship, if any, to the FTC tar yield. This, in turn, suggests that the gradual reduction in tar yield over the past several decades has not resulted in a reduction in smokers' exposure to carcinogens, and that the FTC test method is not informative with respect to lung cancer risk or to the risk of smoking-caused diseases generally. . . . In fact, evidence with respect to smoker compensation and biomarkers shows that those smokers who switch to "Low Tar" cigarettes modify their pattern of smoking to obtain the same or similar amounts of tar and nicotine as from the "High Tar" cigarettes they used to smoke. The bottom line is that a "Low Tar" label-based brand under the FTC protocol does not mean that a smoker is actually ingesting "Lower Tar" than from any other cigarette.

¶Samet WD, 147:11-148:21; 149:23-150:4.

¶2116. The conclusions of Monograph 13 and the 2004 Surgeon General's Report -- that lower tar cigarettes do not provide a health benefit -- "represent[] the consensus view of the scientific community on this issue." Burns WD, 1:10-15; 31:6-9; 41:12-18; 58:20-61:13 (discussing Monograph 13 (US 58700); IOM Report (US 20919); WHO Sactob Report (US 86658); and 2004 Surgeon General's Report (US 88621)); Burns TT, 2/15/05, 13311:9-15; 13668:1-8; see also Benowitz WD, 72:21-24 ("Most authorities are now convinced that there is little if any benefit with respect to health risk to smoking low yield versus regular cigarettes"); (no bates) (US 86657) (Canadian Expert Panel, Putting an End to Deception: Proceedings of the International Expert Panel on Cigarette Descriptors. A report to the Canadian Minister of Health from the Ministerial Advisory Council on Tobacco Control 9) (2001) ("There is no convincing evidence of a meaningful health benefit to either individuals nor to the whole population resulting from cigarettes marketed as 'light' or mild'").

802

¶2117. In 2001, the Institute of Medicine published "Clearing the Smoke: Assessing the Science Base for Tobacco Harm Reduction," which concluded that "the public health of PREPs [potential reduced-exposure products] is unknown." The IOM report went on:

The major concern for public health is that tobacco users who might otherwise quit will use PREPs instead, or others may initiate smoking, feeling that PREPs are safe. That will lead to less harm reduction for a population (as well as less risk reduction for that individual) than would occur without the PREP, and possibly to an adverse effect on the population.

¶(US 20919).

¶2118. In 2001, the World Health Organization Scientific Advisory Committee on Tobacco Product Regulation issued a report that concluded:

1. Tar, nicotine, and CO numerical ratings based upon current FTC methods and presented on cigarette packages and in advertising . . . are misleading and should not be displayed. . . . 4. Banned terms should include light, ultralight, mild and low-tar, and may be extended to other misleading terms. The ban should include not only misleading terms and claims but also, names, trademarks, imagery and other means of conveying the impression that the product provides a health benefit.

¶TLT1010692-0699, 0695 (US 86658).

¶2119. In 2004, the World Health Organization International Agency for Research on Cancer ("IARC") released its Monograph 83, "Tobacco Smoke and Involuntary Smoking," which concluded that "changes in cigarettes since the 1950s have probably tended to reduce the risk for lung cancer associated with the smoking of particular numbers of cigarettes at particular ages." However, the

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¶IARC Monograph attributed any reduced risk largely to the shift from unfiltered to filtered cigarettes which occurred in the 1950s, not the shift from high yield to low yield cigarettes which occurred in the last few decades. Moreover, the IARC's conclusion did not apply to individuals who increased the number of cigarettes they consumed as they shifted to low yield cigarettes. 1000861953-1953 (US 35484) (Wakeham 3/24/61) ("As we know, all too often the smoker who switches to a hi-fi cigarette winds up smoking more units in order to provide himself with the delivery which he had before."). The IARC Monograph went on: "the introduction of cigarettes that can be misperceived as 'safe' may well have adversely affected smoking uptake rates, cessation rates, and consumption per smoker." TLT0970001-1455, 0180 (US 86746)

¶2120. All the major scientific bodies that have addressed this question in recent years have clearly concluded that lower tar cigarettes provide "no clear benefit" to health:

I think there's no evidence of clear benefit. . . . I think the state of the evidence has been well summarized in the reports of the Surgeon General, IARC, the Institute of Medicine, each group that's looked at the question of whether today's lower yield cigarettes are likely to produce -- are likely to produce lower risk of lung cancer, has said, you know, no clear benefit.

¶Samet TT, 11/29/04, 1168:12-16; 1169:2-18.

¶2121. Echoing the conclusions of Monograph 13 and the 2004 Surgeon General's Report, a January 2004 article in the British Medical Journal reported on a study intended "to assess the risk of lung cancer in smokers of medium tar filter cigarettes compared with smokers of low tar and very low tar cigarettes":

There was no difference in risk among men who smoked brands rated as very low tar . . . or low tar . . . compared with those who smoked medium tar brands. The same was seen for women. . . . Men and women who smoked very low tar . . . and low tar . . . brands had risks

804

of lung cancer indistinguishable from those who smoked medium tar . . . brands. . . . Our finding that there was no difference in the risk of lung cancer between people who smoked medium tar filter, low tar filter, and very low tar filter cigarettes is consistent with evidence of compensatory smoking.

¶TLT1020160-0167 at 0160, 0164, 0166 (US 88622).

¶2122. Two very large American Cancer Society's Cancer Prevention Studies ("CPS"), "conducted approximately 20 years apart," which show that lung cancer death rates have not gone down as a result of the introduction of low-tar cigarettes, provide powerful confirmatory evidence. CPS-I was conducted in the late 1950s and early 1960s, and CPS-II was conducted in the 1980s. Because of this 20 year gap, the smokers in the CPS-I study were smoking mostly high-tar, unfiltered cigarettes, and the "vast majority" of the smokers in the CPS-II study were smoking filtered cigarettes with much lower machine-measured tar and nicotine yields. CPS-I and CPS-II are "the two largest studies of smoking and disease risks;" they included "over a million men and women each," and "followed those individuals for"¹²¹² While the Court has not relied upon certain portions of Dr. Brandt's testimony, a careful review of all of Dr. Brandt's testimony, the documents he cited, and the documents which Defendants cited to rebut his testimony reveals that many of Defendants' characterizations of both the testimony and individual documents are out of context, unrepresentative, and unfair. -232- to 18 years. The results of these studies showed that, "[d]espite the substantive reduction in tar yield of the cigarettes smoked in CPS-II, lung cancer disease risks increased rather than decreased in comparison to CPS-I." Burns WD, 1:10-15, 12:10- 11, 33:18-34:6, 35:14-35:9; Burns TT, 2/15/05, 13311:9-15, 13313:9-13314:6, 13316:19-13317:15, 13322:9-10.

¶2123. Despite the dramatic shift to filtered and "light" cigarettes in the last 50 years, the effect the public health community was expecting to see from a change in the type of cigarettes smoked in the U.S never materialized. To the contrary, health risks increased significantly. With reference to the CPS-I and CPS-II studies, Dr. Burns explained:

805

For males, when you look at the risk of smoking, you see that it just about doubled between CPS-I and CPS-II. . . . For females, it went up almost fourfold. . . . [E]ven after adjustment for differences in number of cigarettes smoked and the duration of smoking, the rates increased for males and increased for females between these two studies that were conducted over a period of time when there was approximately a 50 to 60 percent decline in the tar value of the cigarettes being smoked and a dramatic increase in the number of smokers who were smoking filtered cigarettes. So, instead of seeing a reduction in the risk of smoking with the introduction of these products, we have seen the risk of smoking actually increase over that interval. . . . we had watched and waited for the decline in lung cancer to occur. It did not.

¶Burns TT, 2/15/05, 13322:22-13323:22, 13325:6-13326:22; (no bates) (U.S. 17802) (depicting the "sales-weighted tar and nicotine values for U.S. cigarettes" over time); (no bates) (U.S. 17803) (depicting data from the CPS-I study); (no bates) U.S. 17804 (comparison of lung cancer risk for nonsmokers and smokers based on CPS-I and CPS-II data); (no bates) (U.S. 17806) (graph showing that risk of lung cancer from smoking has not declined, notwithstanding the drastic shift to filtered cigarettes and those with lower machine-measured tar and nicotine deliveries).

¶2124. As Dr. Samet explained, "[i]f there were substantial benefits of the change in tar yield over the 20 years between [CPS-I in the 1960s and CPS-II in the 1980s], we would expect lower relative risks; instead they increased." Dr. Samet also explained that the British Physician's study, which was conducted over two 20-year periods, also "shows that the relative risk values [for lung cancer] have gone up comparing the first 20 years (1951-1971) to the second 20 years (1972-1991)." Samet WD, 154:21-156:4, 156:5-12, 157:20-158:15; VXA1601833-1843 (US 64058) (published article on British Physician's Study, cited in Samet Written Direct).

¶2125. Even if it were true that lower tar cigarettes result in some minor incremental reduction in tar, they do not provide any meaningful health benefit relative to higher tar cigarettes

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¶"from the perspective of human exposure . . . or meaningful exposure." Henningfield TT, 11/3/04, 7295:2-7298:2. As Dr. Henningfield explained:

It would be a little bit like low fat cheese has 100 grams, lets say, of X, and then there is another type that gave you 98 grams, and you could say, yes, that's lower, and the next lower one is 97 grams, but that's a meaningless difference, even though it's accurate and reliable by a machine test and you can say it does go down, it's a meaningless difference. . . . In this case, what Benowitz['s] study, and then many other studies showed, is that if you looked at actual intake of people, there was virtually no difference at all in intake. And it wasn't just that the ranking was off a little bit, it was that, for example, the Marlboro Light, according to the Massachusetts data can get – give you about three times as much nicotine as it was rated, and more than twice as much as the Marlboro regular, so it's off by several orders of magnitude, but most importantly, it is just -- if [a] consumer says, okay, I want to get lower tar and nicotine and they pick a light versus a regular, they're not getting biologically meaningful lower tar and nicotine. . . . There is no meaningful difference in exposure to people. . . . what U.K. realizes now, what U.S. realizes, the World Health Organization realizes is that it is still a meaningless difference. And that's why . . . the resistance to even using the . . . label "light" cigarettes.

¶Id.; see also Henningfield TT, 12/1/04, 7535:12-7536:23 (explaining that the "light cigarette debacle" centers around the fact that the historical reduction in machine-measured tar "was biologically meaningless," citing NCI Monograph 13).

¶2126. Dr. Samet echoed these conclusions, stating that "while some earlier studies suggested a modest benefit in terms of lung cancer risk, late, more recent evidence suggests otherwise, namely that there is no benefit." He pointed out that, even excluding the more recent evidence and postulating some reduction in risk, the "overall risk [of smoking these cigarettes] is so high that even a small reduction is of no public health or medical significance." Samet WD, 170:11-23.

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¶2127. Notwithstanding the widespread acceptance and independent validation in the scientific community of Monograph 13 and its conclusions, Defendants tried to challenge its conclusions and methodology, including the selection of its contributors. Defendants criticized the authors of Monograph 13 for not acknowledging the few scientists who expressed skepticism about its results. In addition, Defendants challenged NCI's selection of contributors to the Monograph, namely, that the scientists chosen were biased in favor of concluding that low tar cigarettes yield no clear benefit. However, as Dr. Burns noted, many of the contributors to Monograph 13 "represent some of the more distinguished scientists and experts on this issue in the country" and:

[T]he consensus statement of the organization, that is the NCI. . . . prevents individual opinion from being presented as the consensus of scientific thought. . . . The way that you know that [collective biases are not influencing the final document] is by taking it through a series of reviews by the governmental organization. . . . The organization that then produces the volume and puts its seal of consensus approval on it, that is the National Cancer Institute, that undergoes a series of reviews that it takes to ensure that the data contained in the volume are scientifically accurate and represent the consensus of scientific thought.

¶Burns TT, 2/15/05, 13383:1-13389:4.

¶2128. Defendants' scientists were not involved with the production of Monograph 13 because:

At the time which this was undertaken, the tobacco industry's position was still that . . . there were no disease risks that were causally associated with cigarette smoking. . . . For that reason, the tobacco industry has not been included in the Surgeon General's Report process and various other processes because they weren't part of the consensus of scientific thought at that point in time. They were perceived as adopting positions that had so little scientific credibility that they could not be meaningfully utilized in the formation of a consensus.

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¶Burns TT, 2/15/05, 13389:11-13391:21 (explaining also that Monograph 7, in which RJR scientists participated, "was not a consensus document, it was simply the results of the proceedings of a meeting. Those proceedings come out under the author's name, are understood to be the individual opinions of the authors. That was not what was being requested with Monograph 13").

¶2129. The Court finds that the testimony of Dr. Burns is totally credible and persuasive on each of the issues which he discussed, including low tar cigarettes and their relative health effects. Dr. Burns, qualified by the Court without objection as an expert in "[t]he science of tobacco and health, including disease causation," is a medical doctor and professor of family and preventive medicine with 30 years' experience studying the health consequences of smoking. Dr. Burns has extensive experience, including as a teacher, in various medical areas, including smoking and health, and has studied epidemiology, addiction, nicotine, cigarette design and ETS in the context of smoking and health. He has over 200 publications, most of which are peer-reviewed, in the area of smoking and health, including chapters in two of the leading medical textbooks. Furthermore, Dr. Burns has studied and taught extensively in the area of lung diseases, including lung cancer, and has personally participated in the treatment of thousands of patients with lung disease. In addition, he has served as "an author, editor or reviewer for each of the annual Reports of the U.S. Surgeon General on the Health Consequences of Smoking since 1975," and has served as contributing author and Senior Scientific Editor for several of the National Cancer Institute Tobacco Control Monographs. Dr. Burns has also received numerous award and honors for his work in the area of smoking and health, including the Surgeon General's Medallion. Finally, Dr. Burns's demeanor during his testimony, which spanned nearly two full days and consisted mostly of cross-examination, further demonstrated his credibility. He fully answered the questions posed to him by well-prepared counsel, he was totally versed in the complex scientific areas about which he was questioned, he was neither evasive nor combative, and demonstrated an enormous familiarity with the science of smoking and lung cancer, the history of the issue in this country as scientists learned more and more about the subject, and the manner in which preparation of the Surgeon General's Reports represented the most up-to-date scientific consensus on the topic being studied. Burns WD, 1:3-5; 1:10-15; 12:10-11; (no bates) (US 78526).

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¶2130. For the reasons set forth at length in previous Sections, the Court also finds that the testimony of Drs. Samet, Henningfield, Benowitz, and Farone is also highly credible and persuasive.

¶2131. To rebut the compelling testimony of Drs. Burns, Samet, Henningfield, Benowitz, and Farone, Defendants called a statistician, William Wecker, who, by his own admission, has "never been qualified by a Court as an expert in the subject of smoking and health."27 Wecker TT,

¶Dr. Jerry Whidby and Dr. Joseph Mulholland also offered testimony criticizing Monograph 13. Their testimony was neither reliable nor persuasive. Called to testify by the United States as an adverse witness, Dr. Whidby admitted that he was a paid consultant for Philip Morris and would earn $2,800 per day (total amount $14,000 for five days) for preparing and delivering his fact testimony; and that his agreement with Philip Morris obligates him to testify on its behalf in litigation, and does not leave him the option of not testifying.

¶Dr. Whidby was repeatedly impeached with prior inconsistent statements during his live examination. In some instances, portions of Dr. Whidby's Corrected Written Direct Testimony were in conflict with each other. Whidby WD, 2:5-3:15 (addressing consultancy agreement); Whidby TT, 2/22/05, 13942:23-13943:17 (same); Whidby TT, 2/22/05, 13945:23-13947:5 (impeached with prior inconsistent testimony relating to whether increased ventilation has an impact on biological activity); Whidby TT, 2/22/05, 13947:6-13948:10 (impeached with prior inconsistent testimony relating to whether witness had any empirical evidence that Marlboro Reds sold today are any less harmful than those sold in 1960); Whidby TT, 2/22/05, 13948:8-13949:18 (impeached with prior inconsistent testimony on whether witness had any evidence that Philip Morris's general reduction and selective reduction techniques have led to one less case of lung cancer in the United States); Whidby TT, 2/22/05, 13952:23-13954:3 (impeached with prior inconsistent testimony on whether witness had any empirical evidence that Philip Morris's general and selective reduction techniques have in fact made its cigarettes less harmful).

¶(continued...)

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¶3/15/05, 15650:5-7. Because he is a statistician, and neither an epidemiologist nor a medical doctor, Dr. Wecker is "not able to offer opinions as to causation" relating to the relative health effects of low tar cigarettes. Wecker TT, 3/15/05, 15666:6-15667:2, 15670:20-15671:8. Moreover, Dr. Wecker's statistical analyses are unconvincing because they are flawed in several ways.

¶2132. First, Dr. Wecker's core opinion -- that smokers who switch to lower delivery cigarettes do not increase the number of cigarettes per day that they smoke -- is flatly contradicted by Defendants' voluminous research reports and other documents, spanning decades, which demonstrate that smokers who switch to lower deliveries do smoke more cigarettes per day. 1000861953-1953 (US 35484) (1961 PM); 2022244449-4450 at 4449-4450 (US 36855) (1970 PM); 1000350158-0188 at 0161-0162 (US 20176) (1971 PM); 1003285403-5416 at 5403 (US 20159) (1972 PM); 1003285403-5416 at 5403 (US 20159) (same); 1003293476-3493 at 3480 (US 85073) (1974 PM); 2040066740-6766 at 6750-6751, 6754-6755 (US 20435) (1979 PM); 2071376833-6834 at 6833 (US 27273) (1992 PM); 501525355-5366 at 5360-5361 (US 29531) (1974-1976 RJR); 679009843-9867 at 9843 (US 85055) (1977 B&W); 775036039-6067 at 6050 (US 21053) (same);

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¶536000000-0090 at 0050 (US 22338) (1984 B&W); 760008596-8803 at 8760 (US 54588) (Confidential) (1998 BAT); 00044522-4523 at 4522 (US 22012) (1976 Lorillard).

¶2133. Second, Dr. Wecker testified that, in forming his opinion on this issue: "I don't reach my opinion by weighing all the evidence, but mainly on my own statistical work replicating and correcting figure 4-5" of NCI Monograph 13. Wecker TT, 3/15/05, 15656:22-15657:14. Figure 4-5 illustrates one of the new statistical analyses of CPS-I data that were performed as part of the production of NCI Monograph 13 relating to change in number of cigarettes smoked per day by smokers switching down to obtain lower tar yield. However, the Conclusions of Chapter 4 of Monograph 13 did not rely on the new analyses. Burns WD, 30:13-18, 58:4-19; Burns TT, 2/16/05, 13498:1-9; DXA0310399-0650 at 0509-0510 (US 58700).

¶2134. Dr. Burns explained that the issue of "increases in number of cigarettes per day smoked by those who switch to lower tar brands of cigarettes" is "not the only [reason and], for that matter, it's not the princip[al] one" for Monograph 13's conclusion that lower tar cigarettes provide no reduction in harm relative to higher tar cigarettes.

¶2135. The first sentence in the Monograph under the heading for these new analyses of CPS-I data clearly states that the new analyses of cigarettes per day were inconclusive and, as such, were not the basis for Monograph 13's conclusions:

A reexamination of the CPS-I data set was inconclusive as to whether compensatory changes in the number of cigarettes smoked per day when smokers switched to a lower nicotine cigarette introduce a bias sufficient to explain the observed increased lung cancer risk among smokers of high yield cigarettes.

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¶DXA0310399-0650 at 0509 (US 58700); Wecker TT, 3/15/05, 15683:5-15687:14. Consequently, Dr. Wecker's testimony, which relied on his critique of the new CPS-I analyses, was basically irrelevant since Monograph 13 did not rely on that data in reaching its conclusion.

¶2136. Third, Dr. Wecker's analysis failed to refute, or even consider, the conclusions reached by several other prominent scientific bodies -- including the 2004 Surgeon General's Report, the 2002 publication of the Scientific Advisory Committee on Tobacco Regulation to the World Health Organization, and the 2001 report to the Canadian Minister of Health from the Ministerial Advisory Counsel on Tobacco Control in Canada -- which all reached the same conclusion as did the NCI in Monograph 13, namely that lower tar cigarettes provide no significant reduction in lung cancer or other health benefit -- in direct contrast to Dr. Wecker's conclusions. Wecker TT, 3/15/05, 15661:11-15664:23. Since Dr. Wecker was only a statistician and not qualified to address the subject of smoking and health, he could not have addressed the substance of NCI's scientific conclusions in Monograph 13.

¶2137. Fourth, Dr. Wecker made several changes to the analyses in Monograph 13 that reflected his lack of understanding of the relevant subject matter. For instance, he included women in his analysis of Figure 4-5 and was unaware that the contributors to Monograph 13 excluded women because the later increase in smoking prevalence among women resulted in the lack of a valid baseline dose-response relationship. Wecker TT, 3/15/05, 15691:18-15695:11; Burns TT, 2/15/05, 13323:23-13325:4 (explaining the temporal differences in the rise of prevalence of male and female smoking, which led to exclusion of women in graph); 13342:8-20 (explaining the gender differences in prevalence in the United States and France).

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¶2138. Fifth, Dr. Wecker acknowledged that many of his reanalyses of Figure 4-5 showed no statistically significant difference in risk for smokers at the various tar levels, which is entirely consistent with the conclusion of the authors of Monograph 13, quoted above, that the results on this issue were "inconclusive." Burns TT, 2/16/05, 13526:4-6; Wecker TT, 3/15/05, 15687:15-15691:17.

¶2139. Sixth, Dr. Burns explained that studies done by Garfinkel et al. reported in the 1980 Banbury Product Liability and Health Risks report, which Dr. Wecker claimed were "consistent with [his] conclusions," were not "consistent with Dr. Wecker's findings . . . because it's a different analysis." Dr. Burns also noted: "We cited both of the [Garfinkel] studies that examined cigarettes per day in Monograph 13. We looked at them carefully." Burns TT, 2/16/05, 13517:11-13518:23; Wecker WD, 31:10-14.

¶2140. Dr. Samet explained that comparing Dr. Garfinkel's calculations, published more than 20 years ago, to those performed for Monograph 13, is a case of comparing apples to oranges, as the analyses sought to answer markedly different questions:

They're very different. . . . Dr. Garfinkel said: If people changed their brand, did they smoke more, the same or less? Just those three bins [categories], if you will. What [the Monograph 13] analysis says is: Let's look at whether there's a relationship between the reported numbers of cigarettes smoked on the first brand and on the second brand and the difference in nicotine yield on the first brand and the second brand. So [the Monograph 13 analysis] is a more quantitative analysis and Dr. Garfinkel's was more sort of: Did people change from smoking more than they used to [or] to less than they used to?

¶Samet TT, 9/29/04, 1185:11-1186:19; 1191:12-16; 1193:8-1195:11.

¶2141. Dr. Wecker maintained that examining lower tar and higher tar smokers' lung cancer rates, without controlling for cigarettes per day, provides "other empirical support" for his claim that epidemiological studies of the relative health effects of low tar cigarettes are not biased by controlling for cigarettes per day. Wecker WD, 49:5-11. However, Dr. Burns explained that neglecting to control for cigarettes per day fails to resolve "the core issue" necessary to have a reliable analysis, because it "introduce[s] other biases that are equally important":

814

The core issue is having comparable groups, that is, having groups [where] you can adjust for those characteristics other than the type of cigarettes that they smoke. If you include numbers of cigarettes for controlling, you over control. If you don't, then you're left with the two populations likely to have differences in intensity of smoking and no method by which you can control for that difference. Then you can't tell whether the difference you're seeing is due to a difference in intensity of smoking, i.e. completely independent of the type of cigarette or is a characteristic of the cigarette that you've chosen to smoke.

¶Burns TT, 2/16/05, 13661:14-13662:6; see also Burns TT, 2/16/05, 13484:18-13485:10; 13486:8-21 ("If you don't control for cigarettes per day, you have two different groups of individuals who have different intensities of smoking and, therefore, you can't compare their exposures without looking at intensity.").

¶2142. Finally, Dr. Wecker's analysis of actual versus predicted death rates was not done in the manner utilized in Monograph 13. He admitted on cross-examination that there were several discrepancies between his analysis and that described in Monograph 13. The discrepancies included the fact that Dr. Wecker used mortality data, taken from the National Health Interview Survey, from 1993 to 2000, that was not contained in the calculations in Monograph 13. Again, Dr. Wecker was unaware of a critical fact, namely that the contributors to Monograph 13 specifically excluded data after 1992 because the National Health Interview Survey "changed the definition of smoker in 1992," making the post-1992 data inconsistent with the pre-1992 data. Wecker WD, 51:3-21; Wecker TT, 3/15/05, 15698:14-15701:18.

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¶2143. Dr. Wecker also acknowledged that, while Monograph 13 discussed a chart examining lung cancer death rates at ages under 50, he attempted to create the chart described in the Monograph but only included people aged 40-50, excluding death rates for all ages under 40. Wecker TT, 3/15/05,15702:5-15706:2.

¶2144. Dr. Burns testified, upon review of a chart based on Dr. Wecker's calculations of actual versus predicted death rates, purportedly based on Monograph 13: "The data presented in this graph have essentially no meaning whatsoever. This is not the analysis that Sir Richard Doll was suggesting be done and it is not an analysis that has any valid, scientific or technical meaning." Burns TT, 2/16/05, 13666:20-23; see also Burns TT, 2/16/05, 13664:10-24 (testifying that, to his knowledge, the chart has never "appeared in published peer reviewed literature").

¶2145. In sum, there is an overwhelming consensus in the public health and scientific community, both here and abroad, that low tar cigarettes offer no clear health benefit to smokers, have not reduced the risk of lung cancer and heart disease for smokers using them, and have not produced any decrease in the incidence of lung cancer. Moreover, because of the misleading nature of the advertising for low tar cigarettes, smokers who might have quit have refrained from doing so in the belief that such cigarettes reduced their health risks.

816