Thursday, September 13, 2012

Campaign for Tobacco-Free Kids' Argument that Sixth Circuit Validated Graphic Warning Labels is Not Entirely Correct; Supreme Court Will Never Affirm Sixth Circuit's Reasoning on the Actual Proposed Warning Labels

Last month, I reported on the U.S. Court of Appeals for the District of Columbia upholding a district court decision that invalidated the graphic cigarette warning labels proposed by the Food and Drug Administration (FDA).

The Campaign for Tobacco-Free Kids has argued that the D.C. Circuit's ruling is "wrong on the law" and "wrong on the science" and urged the FDA to appeal to the Supreme Court.

The Campaign wrote: "The Justice Department should quickly appeal today's ruling by the U.S. Court of Appeals for the D.C. Circuit that struck down the large, graphic cigarette warnings required by the landmark 2009 law giving the FDA authority over tobacco products. Today's ruling is wrong on the science and law, and it is by no means the final word on the new cigarette warnings. The only other appellate court to consider the issue, the U.S. Court of Appeals for the Sixth Circuit, upheld the graphic warnings requirement in March. ... The Sixth Circuit found that the law's requirements for graphic warnings "are reasonably related to the government's interest in preventing consumer deception and are therefore constitutional." That court found that the warnings "do not impose any restriction on Plaintiff's dissemination of speech, nor do they touch on Plaintiffs' core speech. Instead, the labels serve as disclaimers to the public regarding the incontestable health consequences of using tobacco."

There seems to be a widely-held perception that the D.C. and Sixth Circuit court rulings are in direct contradiction. Because of this, many anti-smoking groups have played down the significance of the D.C. Court's ruling, asserting that the Sixth Circuit upheld the graphic warning labels and that there is therefore a good chance that the Supreme Court will side with the Sixth Circuit's opinion.

The Rest of the Story

Not so fast.

While there clearly is a discrepancy in the two Circuit Court rulings, making it very likely that the Supreme Court would take the case if the FDA appeals, it is not as simple as arguing that the Sixth Circuit approved the graphic warning labels proposed by the FDA.

Importantly, the Sixth Circuit was ruling on the general principle of the use of graphic warning labels on cigarette packages, rather than on the specific warning labels proposed by the FDA. The Court ruled that warning labels, even those that incorporate pictures to enhance the understandability of the warning, are factual and non-controversial disclosures that are subject to only light scrutiny under Zauderer. There must only be a rational basis for the requirement, which there clearly is with regard to warning people about the hazards associated with cigarette use.

However, the Court did not rule on the specific warning labels proposed by the FDA and perhaps did not even see the labels that FDA proposed, which are not mentioned in the decision. Instead, the decision relates to textual warnings that are accompanied by pictures used to illustrate the warnings, such as one might encounter in a medical textbook.

The Court writes: "Without any specific graphic images to challenge, Plaintiffs’ argument is and must necessarily be that the graphic warning requirement on its face violates the First Amendment." Thus, the Court is making it clear that it is only evaluating the general concept of requiring a graphic component to a warning label, not the specific warning labels proposed by the FDA.

Furthermore, the district court made it clear that it, too, was ruling just on the general concept of requiring pictures to accompany a warning: "In finding that the new warnings were permissible under the First Amendment, the court stated that it “does not believe that the addition of a graphic image will alter the substance of [the new warnings], at least as a general rule. Accordingly, . . . the Court finds that the warning requirement is [constitutional]."

Moreover, the Court writes: "Supreme Court precedent dictates that we review Plaintiffs’ challenge to
the Act’s warnings as a facial one." Again, the Sixth Circuit makes it exquisitely clear that it is ruling only on the idea of requiring pictures as part of a warning, not on the specific graphic warning labels designed by the FDA.

The actual meaning - and limited scope - of the Sixth Circuit decision is made explicit by the Court's own language: "Because Plaintiffs bring a facial challenge to the warning requirements, our concern is not the specific images the FDA chose—those are under review elsewhere—but rather whether
Plaintiffs can show that “ no set of circumstances exists under which [the statute] would be valid, or that the statute lacks any plainly legitimate sweep.”"

Obviously, this is a very broad criterion, and it is almost certainly possible to demonstrate at least one example of a pictorial warning label that would convey factual and non-controversial information. In fact, the Sixth Circuit court is able to imagine such a situation: the use of pictures such as in a medical textbook.

Here is what the Sixth Circuit is imaging in upholding the graphic warning label requirement: "Students in biology, human-anatomy, and medical-school courses look at pictures or drawings in textbooks of both healthy and damaged cells, tissues, organs, organ systems, and humans because those pictures convey factual information about medical conditions and biological systems."

What the Sixth Circuit has in mind is a textual warning accompanied by a simple demonstrative picture: "a picture or drawing of a nonsmoker’s and smoker’s lungs displayed side by side; a picture of a doctor looking at an x-ray of either a smoker’s cancerous lungs orsome other part of the body presenting a smoking-related condition; a picture or drawing of the internal anatomy of a person suffering from a smoking-related medical condition; a picture or drawing of a person suffering from a smoking-related medical condition; and any number of pictures consisting of text and simple graphic images."

The actual graphic warning labels proposed by FDA go far beyond these simple descriptive pictures. Moreover, they include a 1-800 telephone number designed to refer smokers for medical treatment, something that was clearly not an example conjectured by the Sixth Circuit.

The FDA is not going to win any argument that its actual proposed graphic warning labels, accompanied by the 1-800-QUIT-NOW placard, are merely pieces of factual information. The FDA itself admits that the warnings are intended to convince smokers to quit, and the inclusion of the 1-800 referral number cinches this fact.

In other words, the Supreme Court will never apply the Zauderer standard to the actual warning labels proposed by the FDA, rendering the Sixth Circuit's decision almost moot with respect to the Supreme Court's review.

The rest of the story is that the Sixth Court's opinion was merely a facial review of the general idea of requiring a simple picture as part of a textual warning, not an evaluation of the actual graphic warning labels proposed by the FDA. The simple, pictorial, graphic warning labels envisioned by the Sixth Circuit appeals court are far removed from the emotion-invoking, medical referral-providing warnings promulgated by the FDA. The U.S. Supreme Court will never apply the Zauderer standard to these graphic warning labels. While the Sixth Circuit decision does make it more likely that the Supreme Court will take the case, it does not in any way provide legal reasoning that can play a role in the Supreme Court's consideration of the issue at hand. It is the Campaign for Tobacco-Free Kids, then, that I believe is "wrong on the science" and "wrong on the law."

No comments: