Judge Kessler’s Tobacco Ruling is Anti-Science


Author: John Dunn, MD
Article Published: 22/10/2008


Federal Judge Gladys Kessler blatantly ignored the rules of toxicology and epidemiology published in the Federal Judicial Center’s Reference Manual on Scientific Evidence (2nd Edition) in her decision in United States of America and Intervenors v. Phillip Morris USA Inc., et.al. United States District Court Civil Action No. 99-CV-02496 (GK) August 17, 2006. (449 F Supp 2nd 1, Dist. Ct.WashingtonDC, 2006).

Judge Kessler is a graduate of Cornell, then Harvard, who went to work as a labor and public interest lawyer and legislative aid for Democrat politicians in Congress and the Senate. President Clinton successfully nominated her to the federal bench in 1994. Her reputation is that of an activist leftist, for example, she ordered the Washington police department to reveal inside research on the communists in the anti-Iraq war movement, finding in favor of terrorists under indictment, who sought to open Washington DC police department investigative files and reports on communists in the anti war movement.  
 
Judge Kessler’s decision in the 6 year long Racketeering case brought by the Federal Department of Justice against the tobacco industry tobacco case is an example of the grand overreach and tyrannical approach that characterizes activist judges when they have an American industry in their gun sights and a quasi-religious grudge.   The Department of Justice lawyers invoked the provisions of the Racketeering statute on the theory that tobacco arguments that were contrary to government positions on tobacco use and health effects were criminal.
 
Judge Kessler ignored the insightful opinion of Judge William Osteen in 1998 that nullified the EPA’s research on second hand smoke as scientific misconduct.
 
Flue-cured Tobacco Cooperative, Phillip Morris Inc. v. United States Environmental Protection Agency  4 F.Supp.2d 435 (M.D.N.C.. 1998).
 
 
In the opinion, Osteen vacated Chapters 1-6 and the Appendices to EPA's Respiratory Health Effects of Passive Smoking (second hand smoke): Lung Cancer and other Disorders, EPA/600/6-90/006F (December 1992).
 
Judge Kessler in contravention of the Osteen opinion, ruled:
  • The tobacco companies were guilty of racketeering under the criminal code for asserting that secondhand smoke and low tar and nicotine cigarettes have less toxic effects on human health.
  • She prohibited the tobacco industry from promoting or publicizing any research on evidence of ways to mitigate the effects of cigarette smoking, such as smoking less or smoking lighter cigarettes. .
  • She prohibited any further research or activity related to the position of the tobacco companies that secondhand smoke was not a toxin causing death or disease.
  • She ordered the tobacco companies to publicize her orders widely in newspapers and on the web at their expense, essentially becoming yielding to her her publicity agents on all matters related to secondhand smoke and any cigarette smoking information that would encourage people to smoke lighter cigarettes and smoke less.
  • She prohibited, under threat of criminal conviction, any activity furthering the research of the any organizations associated with the tobacco defendants that would assert any health related benefits from lighter cigarettes or any assertions by the defendants that secondhand smoke was not toxic and had no proven adverse health effects.
  • She ordered the tobacco defendants to pay the government’s extraordinary legal fees, stretching for more than 5 years and tallying in the tens of millions of dollars.
  • She did not award the government’s RICO damage claim which was for a punitive amount in billions of dollars.
  • She prohibited any publicity or activity that would influence “a reasonable consumer or potential consumer would attach importance to in determining whether to purchase or smoke cigarettes; or (c) the Defendant, Covered Person or Entity making the representation knows or has reason to know that its recipient regards or is likely to regard as important in determining whether to purchase cigarettes or to smoke cigarettes, even if a reasonable person would not so regard it.” 
  • She prohibited all defendants and their associated research and publicity firms “from conveying any express or implied health message or health descriptor for any cigarette brand either in the brand name or on any packaging, advertising or other promotional, informational or other material.”
  • She forbade health descriptors such as ‘low tar,’ ‘light,’ ‘ultra light,’ ‘mild,’ ‘natural,’ for any tobacco adds or any use of those words “that could be expected to result in a consumer believing that smoking the cigarette brand using that descriptor may result in a lower risk of disease or be less.”
  • Defendants are also prohibited from representing directly, indirectly, or by implication. . . that low-tar, light, ultra light, mild, natural, or low-nicotine cigarettes may result in a lower risk of disease or are less hazardous to health than other brands of cigarettes.”
Judge Kessler refused to allow the defendant tobacco companies at trial to show the clear-cut evidence that secondhand smoke even in the worst of circumstances is the equivalent of one cigarette a day and that no research has ever shown a health effect from such a low exposure. Even worse, in making her sweeping decision, Judge Kessler has decided to criminalize research that she disagrees with and advocacy by or for people of whom she disapproves.
 
The Court received arguments and pleadings in the case filed by the United States that branded as a criminal conspiracy the writings of columnists, researchers, and scientists who disagreed with the claims of anti-smoking activists. Epidemiologists whose research was published in peer reviewed journals and who found results that conflicted with the EPA position were implicated as conspirators by the Kafkaesque opinion of Judge Kessler.
 
Although these writers and researchers who disagreed with the EPA were accused of complicity in the charges of Racketeering by the Department of Justice (DOJ). These researchers and policy opinion writers were not named defendants, just condemned by the government for dissent from the EPA “consensus” on second hand smoke that was previously found to be based on junks science by Federal Judge Osteen. 
 
One might ask if Judge Kessler includes Judge Osteen as complicit, since his opinion supports the position of the researchers that second hand smoke science by the EPA is the product, as Judge Osteen concluded that the EPA was guilty of misconduct in the following examples of administrative and scientific perfidy:
 
The studies EPA selected did not include a significant number of studies and data which demonstrated no association between ETS and cancer. EPA did not explain its criteria for study selection, thus leaving itself open to allegations of "cherry picking."
 
Using its normal methodology and its selected studies, EPA did not demonstrate a statistically significant association between ETS and lung cancer. This should have caused EPA to reevaluate the inference options EPA did not find a statistically significant association. EPA then claimed the bioplausibility theory, renominated the a priori hypothesis, justified a more lenient methodology. With a new methodology, EPA demonstrated from the selected studies a very low relative risk for lung cancer based on ETS exposure. Based on its original theory and the weak evidence of association, EPA concluded the evidence showed a causal relationship between cancer and ETS. The administrative record contains glaring deficiencies. P 87, 88.
 
In conducting the ETS Risk assessment, disregarded information and made findings on selective information; did not disseminate significant epidemiologic information; deviated from its Risk Assessment Guidelines; failed to disclose important findings and reasoning; and left significant questions without answers.
 
EPA's conduct left substantial holes in the administrative record. While so doing, produced limited evidence, then claimed the weight of the Agency's research evidence demonstrated ETS causes cancer. Gathering all relevant information, researching, and disseminating findings were subordinate to EPA's demonstrating ETS a Group A carcinogen. EPA's conduct transgressed the general meaning of the Radon Research Act's operative language. p.  89,90.
 
Judge Osteen is on the record, and researchers and writers who agree with his conclusions were never given an opportunity in Judge Kessler’s Court to defend themselves or to show Judge Kessler why Judge Osteen so strongly condemned the EPA’s positions. Instead a narrowly focused Judge Kessler took in everything that Jon Samet said and closed the book, but also warned anyone who might disagree with her opinions and rulings. She also by her language in the opinion accused anyone who disagreed with her high opinion of Dr. Jon Samet, or the EPA, of complicity in an illegal enterprise and prohibited any further writing or research in support of a position contrary to her ruling supporting the EPA.   Judge Kessler’s reach is breathtaking, but she apparently will not tolerant dissent or disagreement on second hand smoke, now that she has consumed the EPA/Jon Samet Koolaid.
 
Few scientists would be able to endure the kind of intimidation that comes from this case, which cost the DOJ tens of millions and has produced such a far reaching ruling on tobacco related issues and research. The charges and claims by the DOJ and Judge Kessler’s ruling  in this case mean that even peer reviewed research is condemned if it does not comply with the Judges or the EPA’s position on second hand smoke. Judge Kessler essentially says any dissent is violative of her orders and condemns any dissenters as complicit in tobacco company’s illegal activity.
 
Judge Kessler has, in effect, prohibited scientific inquiry if it agrees with Judge Osteen and disagrees with the EPA, Jon Samet’s testimony, and the ruling of Judge Kessler.
 
The cloud of the Kessler decision hangs over all tobacco company activities and certainly creates a new standard for protected commercial speech and scientific inquiry if allowed to stand by the DC Circuit. Judge Kessler prohibits claims on light cigarettes, and it appears that her long arm might reach to any claims on the benefits of chewing tobacco or using snuff as an alternative to smoking cigarettes. She did not elucidate her plans to control dissenting opinions or research.
 
Judge Kessler’s opinion was rendered with all the specifics in August of 2006 and now is still on appeal to the District of Columbia Circuit Court. The political correctness environment in the country makes it unlikely the appellate court will reverse or vacate her decision. A stay on the orders was granted in October of 2006 by the DC Circuit, but as late as March of 2007 Judge Kessler refused a defendant’s request to use the words light and low tar in adds outside the United States.
 
Free speech and inquiry are threatened by Judge Kessler, who, speaking from the left side of the political spectrum, would excuse her fascist tactics as justified to eliminate tobacco—which she seems to have forgotten is still a legal substance. 

There are significant implications for journal publishers of opinions or research that depart from the “consensus” created by bench tyrants or at the EPA and by those who agree with the EPA position in academia, and general or academic media circles.   However the epidemiological and toxicological implications are more far reaching, since the EPA is always involved in weak relative risk observational studies that result in aggressive regulatory posturing and then push back from the scientific skeptics who know the rules that were cited by Judge Osteen..
 
The political climate has already been inalterably changed by the conduct of the EPA and the recent irresponsible junk science from many sources, including Surgeon General Carmona’s monograph on second hand smoke, titled The Health Consequences of Involuntary Exposure to Tobacco Smoke: A Report of the Surgeon General published June 27, 2006, which was Edited by Samet and included the same junk science condemned by Osteen, while at the same time the report refused to even reference or comment on studies by the World Health Organization (WHO) and another large study in California published in the British Medical Journal that showed no second hand smoke health effect.

 
The WHO study is Boffetta, Agudo, Ahrens et al. “Multicenter case-control study of exposure to environmental tobacco smoke and lung cancer in Europe" Journal of the National Cancer Institute, Vol. 90, No. 19, October 7, 1998
 
The British Medical Journal article is Enstrom and Kabat "Environmental tobacco smoke and tobacco related mortality in a prospective study of Californians", 1960-98 BMJ .com 2003;326:1057 MAY 2003 bmj.com
 
The Study in Inhalation Toxicology is from the same cohort in California -- Enstrom and Kabat "Environmental Tobacco Smoke and Coronary Heart Disease Mortality in the United States — A Meta-Analysis and Critique". Inhalation Toxicology, 18:199–210, 2006
 
 
 
John Dale Dunn MD JD
Science and Policy Board American Council on Science and Health
Policy Advisor Heartland Institute, Chicago, IL
EmergencyMedicineCivilianFacultyCarlRDarnallArmyMedicalCenter
Fort Hood, Texas.




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