FDA Appeal: “We’re in New Territory Here”

April 10, 2012 4:49 pm by Gene Borio

A surprisingly small crowd showed up at the DC courthouse to hear the government’s Appeal of U.S. District Judge Richard Leon’s Feb. 29 ruling striking down the FDA’s 9 proposed warning labels developed in accord with 2009’s Tobacco Control Act.

Campaign for Tobacco-Free Kids’ Matt Myers was there, as well as USA v. Philip Morris lawyer Daniel Crane-Hirsh as a spectator(!), and various interests from American Lung to Lorillard. Roughly 80 people in a courtroom about the same size, gallery-wise, as Judge Kessler’s Courtroom #19, though the lawyers’ space beyond the bar was smaller. Large portraits of previous DC Circuit Judges hung on the dark, wood-paneled walls–including current Supreme Court Justice Ruth Bader Ginsburg and famed Supreme Court nominee Robert Bork.

The bench was wide, accommodating the three judges of today’s appellate panel. Some of their questions may have seemed shockingly dumb, as if they’d hardly looked over the case at all, and sometimes the lawyers’ answers seemed off-point, but I think all the jockeying was because, as Judge A. Raymond Randolph said, “We’re in new territory here”.

That’s because, as the Court established, there is no case law that says the government may not compel companies to speak in the public interest. Government can make manufacturers label their poisonous products with a prominent skull and crossbones. It can mandate that pharmaceuticals display the risks of their products. Congress first established warning labels on cigarette packs almost 50 years ago.

“And there’s no 1st Amendment case law on this??” Judge Randolph asked.

“Not that I know of,” replied the DOJ’s Mark Stern.

The Government may compel speech, OK, but the question then is: how much? How far can the government go, to what purpose, and for what reason? So our lawyers and judges today were desperately trying to find that “fuzzy at the border” line between providing information and advocacy. As Judge Leon wrote in his ruling, “[T]he line between the constitutionally permissible dissemination of factual information and the impermissible expropriation of a company’s advertising space for government advocacy can be frustratingly blurry.” Judge Leon found the line clear, but this panel wondered on what bases do you determine where the line is? As Judge Janice Rogers Brown said, can you test for the line between warning and campaigning? “Quit Now,” or “Don’t Smoke,” she felt, is not a warning, but advocacy.


Mr. Stern argued that the enormity of the health risks and the public’s proven ignorance of the true nature and magnitude of those risks justified the increased taking of pack space, and a rigorous investigation by the FDA determined the content and tone of the graphics.

Size, color and image as a package with words is, after all, how you get a message across; and the full impact of that message is characterized by what Mr. Stern described as “saliency”–how one perceives a combined message of text and graphics, and how it impacts a person who sees that message daily, over years. The total impact is a combination of cognition and emotion which is predictive of how a person reacts into the future, how a person processes that information daily, year after year. (No mention was made of the small, easily ignored black and white text warnings of the last 5 decades; not this session.) It’s how you get across a warning that sinks in, and sticks. (As Judge Brown said, “Tobacco companies have already proved that size and colors and graphics work, in their own advertising.”)


The nature of the proceeding was also questioned. Judge Randolph seemed disturbed that the District Court (Judge Leon) approached the matter as if it were a trial. (”Summary Judgment?? This is a Judicial Review of an agency action, NOT A TRIAL,” he said. “)

Mr. Stern said that, as a judicial review that gives the appropriate deference to Congress, the analysis should begin with the record examined by the FDA as well as the deliberations of Congress and the testimony before it. As Mr. Stern emphasized, saying twice during his time at the podium, “All this didn’t just pop up out of the blue.” The FDA studied many aspects of the labels before deciding on the 9 chosen (though the Defense in its turn challenged the evidence, on the basis of its precis of 2 of the studies).

Judge Randolph may have disliked the District Court’s “trial,” but he seemed most displeased with Mr. Stern’s position. Whenever Judge Randolph–older, grey-haired and slight–asked a question he resembled a thoroughly disgusted Mr. Rogers finding himself in a not-so-nice neighborhood & having to endure a plethora of near gag-worthy smells. He questioned whether cars should have “SPEED KILLS” on every door–not a good thing, as he even finds just those yellow tags every time you pull down the visor “very annoying.”


Mr. Stern said there was lots of evidence for the FDA’s proposed labels, including studies from Australia, Canada and the UK. The US, he said, was the only country without graphic labels.

“And the only country with a 1st Amendment,” snapped Judge Brown, who said the warnings must be consistent with Zauderer. Otherwise, “the government can put anything they want on a disfavored product.”

Disfavored?? It was a shock to hear this term coming from a Judge in a court. This is a hoary tobacco industry shibboleth, pulled out whenever the industry or its advocates want to paint the government as capricious and arbitrary, as if there is no serious reason behind efforts at tobacco control. It’s not that it kills 450,000 a year; it’s that the government just doesn’t like it.

And it was here that Mr. Stern, who had stammered and stumbled a bit in the beginning, like a jittery boxer who has to get solidly hit before his true talent starts to flow, rose to the occasion.

Respectfully but firmly, he said, “I must take exception to the word ‘disfavored.’ That connotes something different than a dire health risk.” Stern and Brown went back and forth a bit, politely, and finally Judge Brown said, “OK, I will not use ‘disfavored.’” But when does it stop? . . . Can you say, ‘If You Use This Product, You’re a MORON?’”

No, said Mr. Stern, because that’s not true, not accurate.


In context, he said, we’re talking about an addictive product, whose major new market are people using it illegally, and 40% of smokers wish they weren’t smoking. In that context, if the warnings are accurate–are they too burdensome?

Judge Randolph said there are lots of risks with lots of products–chainsaws, ladders. And people don’t know everything. But in this case, he said, “99% know about lung cancer, 98% know about emphysema . . . ”

And again, Mr. Stern reacted, unleashing his big punch: “No. They don’t,” he corrected. “They don’t know about emphysema. Or other cancers. . . . Tobacco says, ‘everybody knows,’ but beyond lung cancer, it’s been proven that people know very little.”

Judge Randolph asked about limits: could the Government take over, say, 100% of the package?

And Mr. Stern simply pointed out, “That’s not what Congress did.”


For the plaintiffs, Jones Day’s Noel Francisco compared the FDA’s proposal to a scene in a restaurant where someone is eating a bacon cheeseburger, and another patron says, “That’s bad for you.” OK, but then the patron does the same thing, day after day, shouting, hectoring, “That’s BAD for you.” That’s what the graphics do, he said. He said the Supreme Court had determined such speech had to be purely “factual and non-controversial.”

“Non-controversial??” asked Judge Randolph. “How do you make that a legal test? . . . You can bring a lawsuit, and then it becomes controversial.”


Mr. Francisco was asked if the Defendants objected to the text.

Not the substance, he said. But, for example, in the “Stoma” graphic depicting a man smoking out of his stoma, the text reads, “Smoking is Addictive.” The graphic tells nothing about addiction, and the government’s own studies show that warning label graphics actually undermined recall of the text.

Judge Judith W. Rogers, who had been quiet during Mr. Stern’s presentation, asked, “So if there’s no effect, why do you object?”

Mr. Francisco said the graphics and the “Quit Now” text could be compared to a bottle of rat poison. Skull and Crossbones, fine. But the government can’t compel the manufacturer to also post a prominent message to “Call PETA.”

He said the FDA labels are not about informed choice, but their purpose is effective anti-smoking advertising.

Judge Randoph opined that there is “substantial” evidence to support the FDA’s findings.

Mr. Francisco said the record is irrelevant; compelled speech is the issue. But even so, there was no legislative finding about warnings by Congress, and the FDA has the burden of proof–and their own studies have found there is no impact on either behavior or knowledge of risk.


Mr. Stern was granted time for rebuttal. He started out by saying Mr. Francisco’s representation of the studies is plain wrong. And the proposed labels were tested for saliency, especially the prominence of the message in context.

For example, the Stoma label Mr. Francisco had found so contradictory. While stoma-smoking is rare, the point is: people with cancer often continue to smoke self-destructively. “This is real addiction,” Mr. Stern said. “Does it accurately depict the message that tobacco is addicting? Yes.”

Judge Randolph said the Government can use billboards, TV, etc. to get that message out. The question is, can it use commercial products to advertise its message?

Yes, said Mr. Stern, the Government can do that.


George H.W. Bush appointee Judge Randolph, for all his apparent disgust at the DOJ’s position, did ask some very tough questions of the Defense. He may come down on the side of deferring to Congress.

Clinton appointee Judge Rogers seemed fully behind the DOJ’s position.

George W. Bush appointee Judge Brown, like Judge Randolph, is hard to read. But based on her “disfavored” comment, she may be spending too much time reading the wrong kinds of webblogs.

Whatever, no one doubts this one is headed for the Supreme Court.

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