RJR v. FDA Hearing Feb. 1, 2012–FDA chooses to demur

February 2, 2012 10:55 am by Gene Borio


On Sept. 21, 2011, oral argument was held in the United States District Court in Washington on RJR, et.al.’s request for a preliminary injunction against the FDA’s Final Rule, which mandated graphic warning labels. The FDA had been given the power to change the labels by the 2009 Family Smoking Prevention and Tobacco Control Act .

On Nov. 7, 2011, US District Judge Richard J. Leon blocked implementation of the FDA’s Final Rule, saying that cigarette makers were likely to win a free speech challenge against the proposed labels. (see: ecf.dcd.uscourts.gov/cgi-…) Leon determined that the labels were not factual and required the companies to use cigarette packages as “[a] ‘mini-billboard,’ indeed, for its obvious anti-smoking agenda!” In January, Leon called for a hearing on Wed., Feb. 1, on both sides’ requests for summary judgement.


Judge Leon is large, with dark curly hair. He looks far better and less intimidating in person than in his court portrait. Today he seemed quite relaxed, and started out genially enough, very accommodating– he told all and sundry that he was aware the Appeals Court was scheduled on April 10 to hear the FDA’s challenge of his November preliminary judgement, and he promised that he would indeed do all a favor and provide his final judgement long before then.

Still, there was an undercurrent. The hearing itself was weird, like being at a family dinner where everyone is all comfy-cosy, and yet every interaction is fraught with layer upon layer of history and meaning.

Not that there was any apparent tension, especially between Judge Leon and RJR’s Noel Francisco. In fact, it was all pretty buddy-buddy up there, a real meeting of the minds, with Judge Leon kind of hemming and hawing, and oh! suddenly thinking of some legal concept, or some fact he wasn’t quite clear on, and leading Francisco on (”Say, wasn’t there . . . “) so that Francisco could pick up the slack and elucidate, while Judge Leon would nod in agreement. It was like 2 avid backers of a candidate discussing the election–pretty much an echo chamber.

But Judge Leon was cordial even with FDA lawyer Mark Stern, almost collegial, sitting way back in his judge’s chair, and in so many words asking, “C’mon, Stern, work with me here, just a little bit. I’m doing you a favor, here’s your chance to rebut the horrible things being said about your case. Give me something, anything.” And in fact, Judge Leon said several times, in essence: “Don’t you have _any_ kind of answer to the matters that were just brought up by the opposition?”

And Stern kept responding, his arms often extending from his sides, palms out, “Oh, well, you know, not really, Judge, we said it all in Nov., and in our brief here, and you’ve made it clear that you you don’t agree with us, and we don’t agree with you, so there’s just not really that much left to say now is there?” Think I’m laying it on too thick here? No, Stern literally started out by saying, “What can I tell you? This has all been briefed. I don’t have more to add.” and after 2 hours, very near the end, he said, and I kid you not: “That’s our story and we’re sticking to it.”

All in all, kind of insulting. It’s like saying, Look, Judge, you ruled, we didn’t like it, we all know how you’re going to rule here, so why don’t you just do it already, we need to have you out of the way, so we can deal with all this in the Appeals Court.

Thus, by the end it became clear that this hearing, which Judge Leon seemed to have called, so accommodatingly, in order to give the FDA a final chance to make a plea for its case, was really a big waste of time for all concerned.

Throughout the hearing, the big argument was the Constitutional Issue–the 1st Amendment.

Famed 1st Amendment legal scholar Floyd Abrams, who had argued the case for Lorillard in Sept., said FDA not only doesn’t address it; but simply states there are no 1st Amendment issues.

To use a cigarette pack’s label to inform is legitimate, he said. To use it to try to directly persuade, to force a business to ADVOCATE against its product is not, according to the plaintiffs and Judge Leon. Yet there’s some room for judgement here, and Judge Leon said several times, “I’m trying to see where the line was crossed–into advocacy.”

Francisco claimed that the 2009 Institute of Medicine report “Ending the Tobacco Problem: A Blueprint for the Nation” formed the “chief evidentiary basis” for the Family Smoking Prevention and Tobacco Control Act. And the IOM report “says right out: ‘The primary object is to discourage’ smoking.” Francisco said the warning labels are basically anti-tobacco advertising, and their purpose is not to inform, but to scare.

Francisco questioned if there were not less restrictive means to achieve the Government’s goal, means that were obvious and obtainable. Why, the FDA could use its own new $600 million campaign. “Do they have to use OUR voice?” he asked.

He critiqued the warning label requirements for not being “narrowly tailored” to the task. Did the government take the least disruptive path? The labels could be 30% instead of 50%, say, or could be at the bottom of the pack instead of the top, or could be on the back instead of the front. He claimed even the WHO requirements were less onerous than the FDA’s.

But Stern did rebut here, saying that all these “fine tunings” were not the Court’s province, but Congress’, which passed the Act. It wasn’t the Court’s province to dictate how. He said there was virtually no impact on Constitutional speech, the provisions of the Act were tailored to have minimal impact, and the public was not in fact getting less commercial information.

But these were not fine tunings for Francisco, Leon and Floyd Abrams–they struck to the heart of the 1st Amendment and the “narrowly tailored” issue, and many times the Courts have overturned misguided legislation. Francisco said there was no evidence that these measures had been adjudged the least restrictive possible. Judge Leon asked where he he could go to see these deliberations. In fact, Judge Leon expressed some amazement that there was no evidence Congress had even considered the Constitutional Issue at all before passing the Act.

Francisco cited studies, claiming that there was no evidence that warnings reduce smoking, or that graphics increase knowledge of smoking’s harms. Consumers already know, he said. He said he recalled some 117-year-old French woman who had smoked all her life. A tobacco company could feature someone like her, saying “117 and still smoking!” and that would be no less purely factual as a person smoking out of a tracheotomy. Judge Leon wondered how often that did indeed happen.

Francisco had just summarized the plaintiffs’ objections:
–The warning labels are advocacy. They could as well make us say “Vote For . . .”
–They are a massive disruption
–They are meant to shock and disgust
–Their purpose is to rebrand the product with not our message, but the Government’s.
–Their purpose is not to promote informed choice, but to discourage smoking

The totality of these factors, Francisco said, prove that the warning label requirements are plainly unconstitutional.

Then Floyd Abrams took the podium for a final time to draw the distinction between the current text warnings and the proposed graphics. “‘Smoking is Addictive’–That’s perfectly factual, non-controversial. A hole in the chest is not.”

When asked to respond to Abrams and Francisco, he said (approximately),

Stern: I’m happy to answer. There’s nothing new to rebut.

Judge Leon: You don’t ant to address what was just said?

Stern: Well, we’re going around in circles. We seem like ships passing in the night, and at a considerable distance.

All in all, things had been pretty genial there for the 2 hours of the hearing, but it seemed to take a harsh and almost nasty turn at the end.

Now, perhaps, Stern was getting a bit too pushy, worrying about the timing of the appeal.

Stern: We would like your ruling, so Court of Appeal can rule.

Judge Leon: you’ll get your 2nd opinion; you’ve had your 2nd hearing here. The Court of Appeal picked April. They don’t have enough cases. If they want May, that’s up to them. I’m accommodating you and them.

But suddenly Leon got a bit loud, saying, “I’ll let the Appeals Court make their own schedule, they have plenty of time on their calendar. They don’t have a lot of activity lately, you know that don’t you?”

Stern didn’t know that.

“Well they don’t. There are a lot fewer appeals coming in. And they only work 9 months out of the year. In THIS court, we work 12 months. TWELVE. Case is recessed.”

And suddenly it seemed clear that some fragile treaty had been broken here at the family dinner, and Big Daddy peremptorily got up from the table–er, bench–and swept out, too dignified to actually storm. This was sharply different from Judge Leon’s easy-going demeanor throughout the hearing.

Maybe FDA just didn’t care, and saw Leon’s hearing as a ploy of some sort, a sucker play they refused to take part in. Leon’s upcoming ruling, and the April 10 Appeals Court hearing, promise to make a lot of waves.

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