November 19, 2011

Stanton A. Glantz, PhD

Logical and factual errors in Judge Leon’s injunction against the FDA’s graphic warning labels

There is a clear double standard in the way that the courts are considering “public health” justifications when identifying the limits of the First Amendment. 

Assertions of the need to “protect public health” have been widely used by authorities to shut down Occupy Wall Street camps around the country despite the fact that the occupation, symbolized by the tent, is at the center of the frankly political statement the occupiers are making.  My wife, a public health nurse, has been volunteering to help staff the first aid tent at the San Francisco Occupy encampment and has been impressed with the porta-potties and general cleanliness.  (When I went down there with her last week to deliver some supplies, I thought the same thing.)  She summed it up this way: “It’s a lot cleaner than the Tenderloin or Mid-Market, which often smell of urine,” poor areas near City Hall.

The courts’ willingness to sanction dismantling these political protests contrasts sharply with Judge Richard J. Leon’s blithe disregard for public health when he sided with Big Tobacco and issued an injunction preventing the FDA from moving forward with its mandate to require cigarette companies to place graphic warnings on their products, cigarette packages and the advertising for these products.

The courts have established a much lower standard for imposing limitations on commercial speech than political speech.  In order to justify his decision that the warning labels constitute “compelled speech” that violate the companies’ First Amendment rights, Judge Leon strives to elevate the tobacco industry’s interests to that of a political debate in which the two sides (the government and the tobacco industry) “advocate” for different sides of a “policy agenda.” Specifically, he states, “It is the residual effect of unconstitutionally compelled commercial speech designed to advocate, at a company's expense, a competing policy agenda.”

It is true, of course, that the government does have a policy agenda, as defined in the legislation that Congress enacted: protecting public health.  Accomplishing the goal of protecting public health requires providing warning labels that will affect behavior (preventing people from starting to smoke or convincing them to quit), something that Judge Leon asserts goes beyond “providing objective information” into the forbidden (political) realm of “advocacy.”

If one takes Judge Leon’s position to its logical conclusion, the only warning labels that would be constitutionally permitted would be ones that would not stimulate a behavior change (since those would not be “advocating” for anything).  (Not surprisingly, he is willing to accept continuing or tinkering with the ineffective text warning labels on the sides of the packs.)

Judge Leon conveniently ignores the other side of the debate, the thing that the tobacco companies are “advocating” for: increased smoking.    

The fact that the warning labels as issued by the FDA will certainly reduce smoking is not only the public health justification for compelling the tobacco companies to place effective warning labels on their commercial products, but is the real reason that the companies are fighting them: to the extent that these labels succeed in their goal of promoting public health, the tobacco companies will lose billions of dollars in sales.  This is the real “damages” that the companies will suffer, another important point both the companies and Judge Leon assiduously ignore.   

But Leon goes even further, dismissing the likely public health benefits of the graphic warning labels.  Leon justifies dismissing these benefits when he states, “Finally, as part of its preliminary benefits analysis, the FDA estimated that ‘the U.S. smoking rate will decrease by 0.212 percentage points" as a result of the Proposed Rule, a statistic the FDA admits is ‘in general not statistically distinguishable from zero,’" and goes on to add in a footnote “Indeed, the FDA's estimated reduction in U.S. smoking rates decreased from .212% in the Proposed Rule to .088% in the Final Rule.”

Leaving aside the fact that the FDA analysis was seriously biased downward in its estimates of both the health and economic benefits of the warning labels (something we criticized in the public comment we submitted on the proposed rule), even these small numbers do not warrant dismissing with the waive of a hand, as judge Leon does.

There are 46 million smokers in the United States and .212% of 46 million is 98,000 people.  Between one-third and one-half of smokers die an average of 10-15 years prematurely because of their smoking, so even using the low ball estimate that Judge Leon cites,  the graphic warning labels would prevent 33,000-49,000 premature deaths.  (The corresponding numbers using the FDA’s even more downward biased estimate reduces these numbers to “only” 40,000 quitters and 13,000-20,000 premature deaths avoided.)

There is also an important distinction between something being “statistically indistinguishable from zero” and actually being zero.  Any statistical estimate has some uncertainty associated with it; the actual value of the thing being estimated could be bigger or smaller than the estimate.  When something is “statistically indistinguishable” from zero, it means that you cannot be 95% confident that actual effect is not zero.  It is inconceivable that the effect of the graphic warning labels is below zero (which would mean that the warning labels would increase the number of people who smoked), so Judge Leon did not need to consider the possibility that the warning labels would harm public health.  Had Judge Leon included a fair consideration of the implications of the uncertainty associated with the FDA’s estimate, he would not only have considered how small (no effect) but also how big the effects on the number of smokers could have been, which would have included the possibility that the effects would also be larger than the FDA estimated. 

This one-sided (from a statistical as well as a legal perspective) interpretation of the evidence represents a serious bias, since, in deciding whether or not to issue an injunction, the judge is required to consider whether issuing the injunction would “substantially injure other interested parties.”  He never states how many tens of thousands of additional smokers and smoking-induced premature deaths represent the necessary threshold for representing a “substantial injury” to “other interested parties,” namely the public.

Rather than seriously engaging this issue and the balancing of costs and interests involved, Judge Leon dismisses the real damage done to the public as an “appeal to emotion.”  Judge Lion wrote: “Defendants argue that the delay resulting from a grant of injunctive relief harms the public because ‘[each day, nearly 4,000 Americans under the age of 18 experiment with cigarettes for the first time, and approximately 1 ,000 children become new daily smokers.’  Consistent with its briefing and oral argument, the Government unfortunately - and once again - trumpets its appeal to emotion instead of focusing on the discrete legal issue before the Court: whether the public will be prejudiced by a temporary delay in the Rule's implementation.”

He further justifies the delay saying, “Notwithstanding its obvious desire to limit, if not eradicate, the use of tobacco, the Government utterly fails to address the real issue at hand, and in the process gives short shrift to Congress's own instruction for a 15-month implementation period.”  It goes without saying that this delay was something that the tobacco companies themselves negotiated as part of getting the law passed.  Taking Judge Leon’s logic to its logical conclusion would lead to the argument that any delay in implementing the warning labels would be evidence of lack of urgency.  But think about the alternative:  Had the law (or FDA) demanded that the new labels be on cigarette packages the day after the rule was issued, he would have argued that the rule was unreasonable because the companies were not given a reasonable period to come into compliance.

Consistent with ignoring the real and substantial injuries that delaying the warning labels will impose on the public, Judge Leon also ignores the real “damage” that the graphical warning labels will do to the tobacco companies – billions of dollars in lost sales precisely because the graphic warning labels will work and lead to fewer smokers  -- and instead justifies issuing his injunction because of the “irreparable harm” that will be done to the tobacco companies by the expense of “forging” new printing plates.  In doing so, he (as did the FDA), ignores the fact that the printing plates used to print cigarette packages wear out every few weeks and have to be replaced anyway.  The marginal cost of putting a different image on the printing plate is trivial (additional points we made in our public comment to the FDA).

At the outset Judge Leon ignores commonsense understanding of how people communicate: A picture is worth a thousand words.  This is something that the tobacco companies (and every other advertiser) clearly  understand when they use images colors to communicate ideas and emotions to sell their products.  In many ways, all the graphical warning labels are doing is putting the warning into the same lexicon as the companies use to sell their products.  Rather than recognize this reality, first footnote, he refuses to even refer to the required pictorial labels as “warning labels” on the grounds doing so is “self-serving” because they are “more about shocking and repelling than warning.”

Stanley Fish in the New York Times explains why Judge Leon is wrong:

But is the producing of an effect, even of an effect that is visceral, unrelated to the communication of information? Maybe yes if we’re talking about a horror movie where the eliciting of shock, disgust and fear is the entire point. That’s what people go to horror movies for — to experience an emotional rollercoaster that is unattached to any cognitive message.

In the case of the tobacco warnings, however, the emotions intentionally produced by the graphic images bring a cognitive message home. It is in fact a horror-message — if you smoke, all kinds of horrible things are likely to happen to you — and it is the government’s judgment, expressed in its brief, that the print warnings we are now accustomed to have become “stale” and no longer “convey [the] relevant information in an effective way,” no longer, that is, convey the message.

Of course, the tobacco industry has lived with print warnings for a long time and is fully aware of how humdrum they have become. What alarms them is the specter (another kind of horror show) of warnings that might really convey the relevant information effectively. What alarms them is not that the proposed images distort the truth, but that they tell it. “Ultimately,” the government’s brief concludes, “plaintiff’s objection to the pictorial health warnings is not that they are false, but that they are true.”

Given that the conveying of true information about the risks of a legal product has been held constitutional even when the government burdens a manufacturer’s delivery of its message, one would have expected the government to prevail. But is does not. Judge Richard J. Leon issued the injunction sought by the tobacco companies and gave as a reason the illegitimacy of images as conveyers of information: “[T]he government’s emphasis on the images’ ability to provoke emotion strongly suggests that the government’s actual purpose is not to inform, but rather to advocate a change in consumer behavior.” And again, “the graphic warnings cross the line from information to advocacy.”

This is wrong in both directions. Images can inform and the bare recital of information can advocate by appealing to the emotions. The line Leon wants to draw is, at best, a blurry one, as is his contrast (borrowed from the plaintiff’s brief) between images “calculated to provoke the viewer to quit” and “disseminating purely factual and uncontroversial information.” It takes only a second’s thought to undermine the contrast. Is the factual and uncontroversial assertion that “ smoking can kill you” (one of the new print warnings) without persuasive intent or effect? “Oh, I just thought I’d tell you that smoking kills and can harm your children. Nothing hortatory on my mind, just sayin’.” And just as the information that smoking kills is offered with the intention to “provoke” the informee to quit, so is the image of a cadaver on a slab offered with the intention of conveying a piece of factual and uncontroversial information — smoking kills.

Finally, in assessing the credibility of the tobacco companies’ arguments that the graphical warning labels do not provide “purely factual” information about the dangers of smoking, it would have been gratifying if he had taken judicial notice of fellow Judge Gladys Kessler’s ruling in the government’s Racketeer Influenced and Corrupt Organizations Act case against the same companies suing the FDA in this case: “Despite internal recognition of [the fact that cigarette smoking causes disease, suffering and death], defendants have publicly denied, distorted, and minimized the hazards of smoking for decades.”   Indeed, fighting these warning labels is evidence that the RICO defendants who are plaintiffs in the FDA case are continuing their efforts to publicly deny, distort, and minimize the hazards of smoking.

Even accounting for the uncertainty in the actual benefits of the graphical warning labels, there is overwhelming evidence that his injunction will “substantially injure other interested parties,” that “the “irreparable harm if the injunction is not issued” to the tobacco companies is trivial (at least in the dimension he relies on to justify his ruling), and that the injunction does not reach the legal standard that “the public interest would be furthered by the injunction.”

Hopefully the DOJ will aggressively pursue vacating this injunction and the courts will recognize that this is an example of reasonable regulation of commercial speech, not the kind of real political debate being joined by Occupy Wall Street and the aspirations they represent.



Very nice posting and very persuasive analysis.
These super pro-business judges reject the holding of the Central Hudson decision (limiting the extent to which the first amendment protects commercial speech) and think that corporations have full speech rights that individuals have. And they are trying to find ways to wield the "compelled speech" concept everywhere
they can (as though requiring product warnings is the same as requring religious objectors to recite the Pledge of Allegiance in public schools). Some of them even believe that if we use the proceeds of cigarette taxes to put up government ads telling people of the dangers of smoking, that too is unconstitutional compelled speech. There is no reasoning with these folks.
Steve Sugarman UC Berkeley Law


The story is told of an assembly at which Josef Stalin gave a speech. The Party loyal were there, and duly applauded. And applauded. And applauded. Knowing they were being watched, everyone was afraid to be the first one to stop applauding. Finally one brave soul stopped the madness, and stopped applauding. He was later purged.
Compulsory speech is as offensive as muzzled speech. Forcing cigarette manufacturers to display ugly images on cigarette packs is a step toward Stalin's dystopia. It forces them to say something they don't believe. Indeed, it forces them to disseminate misleading information. Leaving aside the doctored images that have resulted from such laws, showing horrendous results of smoking is misleading because, while some smokers develop disfiguring facial cancer, most do not. This is merely the flip side of pro-tobacco forces pointing out the exceptional 95-year-old smoker.
The distinction between commercial and noncommercial speech is bogus. That distinction exists nowhere in the Constitution. It was invented by judges hostile to certain types of speech. Their rulings are themselves the type of government speech control the Bill of Rights forbids.
I have never smoked, loathe cigarette smoke, and have no truck with tobacco companies. But free speech is indivisible. Violation of a tobacco seller's free speech rights is a violation of my free speech rights. Yours too.
John Braden,
plaintiffs' personal injury lawyer

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