July 21, 2014

Stanton A. Glantz, PhD

Judge Leon strikes again: His ruling on FDA’s Tobacco Advisory Committee is misguided and must be appealed

Judge Richard Leon, who has consistently ruled against the FDA on everything related to tobacco, is at it again, ruling that the FDA Tobacco Products Scientific Advisory Committee is flawed.  (Why does every tobacco case on the FDA end up in front of the same hostile judge?)
 
The opinion basically concludes that because the challenged members acted as consultants to companies selling cessation products (or in the case of Henningfield an ownership interest in a cessation product), they would have a conflict because banning Menthol might generate consulting fees.  The judge also concludes that the challenged members would have a conflict because they would want to protect their past expert testimony on tobacco (and in one case menthol) issues and would want plaintiff lawyers to hire them in the future. 
 
This is truly amazing to disqualify scientists for something they might do in the future.  Perhaps Judge Leon has a time machine to observe the future.
 
You can read Judge Leon's ruling at https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2011cv0440-82
 
TFK put out the following statement, which I completely agree with:
 
Court Ruling on FDA’s Tobacco Advisory Committee Is Misguided and Must Be Appealed
 
FDA Should Move Forward in Banning Menthol Cigarettes Based on Conclusions of Its Own Independent Review
 
Statement of Matthew L. Myers
President, Campaign for Tobacco-Free Kids
 
WASHINGTON, DC – The Justice Department should immediately appeal today’s misguided ruling by a federal judge that concluded three members of the FDA’s Tobacco Products Scientific Advisory Committee (TPSAC) had conflicts of interest – or just the appearance of conflicts of interest – and barred the FDA from using a March 2011 report on menthol cigarettes issued by the committee.
 
This ruling by U.S. District Court Judge Richard Leon would not only deprive the tobacco advisory committee of the best scientific minds available, but could also impact the FDA’s broader ability to carry out its mission and protect public health.  The three scientists named in the lawsuit are individuals of unquestioned integrity, and the tobacco advisory committee has operated in a transparent, open manner consistent with all U.S. laws.
 
Even as this ruling is appealed, the FDA can and should move forward to ban the sale of menthol cigarettes based on the conclusions of its own, independent scientific review of the public health impact of menthol cigarettes.  The FDA’s report, issued in July 2013, concluded that menthol cigarettes pose a greater public health risk than regular cigarettes because they lead to increased youth initiation.  The FDA does not need TPSAC’s report to take action on menthol, but it is important to note that TPSAC’s report was prepared with great integrity and is a sound scientific document.
 
The FDA’s advisory committee was constituted and acted in accordance with the 2009 law that granted the FDA authority over tobacco products, as well as other relevant federal laws.  Judge Leon’s ruling is clearly inconsistent with these laws and would deprive the FDA of critical advice from the nation’s foremost experts in reducing tobacco use.  In fact, that is precisely the goal of the Lorillard and R.J. Reynolds tobacco companies, which filed this lawsuit.  The companies, which stand to gain the most from selling more menthol cigarettes, are once again putting their profits ahead of lives and health.
 
Today’s decision should not slow FDA’s progress in addressing the problem of menthol cigarettes. FDA’s own independent review found that menthol cigarettes lead to 1) increased smoking initiation among youth and young adults; 2) greater addiction; and 3) decreased success in quitting smoking. “These findings, combined with the evidence indicating that menthol’s cooling and anesthetic properties can reduce the harshness of cigarette smoke and the evidence indicating that menthol cigarettes are marketed as a smoother alternative to nonmenthol cigarettes, make it likely that menthol cigarettes pose a public health risk above that seen with nonmenthol cigarettes,” the FDA’s report concluded
 
The FDA has an obligation to act on this scientific evidence and ban menthol cigarettes in the U.S.  The FDA’s own report provides more than adequate scientific evidence for the FDA to take immediate action.
 
Vince Willmore
Vice President, Communications
Campaign for Tobacco-Free Kids
1400 I Street NW, Suite 1200
Washington, DC 20005
PH: 202-296-5469
FX: 202-296-5427
http://www.tobaccofreekids.org
http://global.tobaccofreekids.org
 
 

Comments

Comment: 

In his ruling, Judge Leon said that the fact that Neal Benowitz was "designated" to testify in 585 cases (on page 16 of the ruling) makes it sound like Neal spends his whole life making money testifying for plaintiffs against the tobacco companies, which creates a huge bias.  Leaving aside the fact that providing expert testimony on nicotine addiction is a good and responsible thing to do, the fact is that Neal has not agreed to testify in a single pending case. 
 
(I saw Neal yesterday and asked him.)
 
While I suppose that lawyers might have listed Neal as a potential witness (without talking to him), Judge Leon should know that being listed and actually testifying are two different things.
 
Moreover, Judge Leon ignores the fact that providing scientifically accurate testimony is a responsible contribution to public health.
 
Making such a big deal over this point is just the latest example of Judge Leon's bias against the FDA on tobacco issues.
 
The most amazing thing is that all these FDA tobacco cases are going to the same judge who has <em;his</em; biases written all over his opinions.&nbsp;
&nbsp;
I thought that cases were supposed to be randomly assigned to judges.&nbsp; The DC District Court has http://www.dcd.uscourts.gov/dcd/judges" target="_blank";14 active judges (the chief judge plus 13 district judges).&nbsp; The probability of having all three FDA cases (ecigs, warning labels, and menthol) assigned at random to the same judge is (1/14)^3 = 0.00036 or 1 chance in 2744.
&nbsp;
Someone with the authority to look into why this is happening needs to do so, so we don't have one heavily biased judge having a veto power over implementation of the Family Smoking Prevention and Tobacco Control Act.

Comment: 

Stan –
I think this is the federal rule that allows the industry to designate all the tobacco regulatory cases as related cases.&nbsp;
http://www.law.cornell.edu/uscode/html/uscode28a/usc_sec_28a_06000040---...
But as of 2013, there is a new rule to “require any party that seeks to mark a lawsuit as “related” to another case before a judge to file a statement ‘stating clearly and succinctly the basis for the contention.’”&nbsp; (see NYT piece - http://www.nytimes.com/2013/12/24/nyregion/federal-court-alters-rules-on...).
It might be interesting to see if there is really a sufficient relation between allegations of bias on an advisory committee and, for example, First Amendment concerns over proposed graphic warnings, to justify the risk of running every significant case involving the regulation of the tobacco industry through one judge. &nbsp;Perhaps there is an argument that this is an abuse or misapplication of the related case rule.
Mark Gottlieb, Executive Director
Public Health Advocacy Institute
Northeastern University School of Law
360 Huntington Avenue / 117 Cushing&nbsp;Hall
Boston MA 02115
mailto:[email protected]";mark@phaionline.org
http://www.phaionline.org";www.phaionline.org

Comment: 

I couldn't agree more, Stan. Judge Leon's consistent anti-science, anti-public health record regarding FDA and the regulation of tobacco needs to be widely and loudly condemned. It would be useful to understand the origins of his bias.
&nbsp;
-- Ken Warner

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