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Tobacco Industry Batting a Thousand With Federal Judge, While FDA Strikes Out

What are the odds?

In 2009, Congress passed landmark legislation directing the Food and Drug Administration to regulate tobacco products, aiming to cut the toll from the leading preventable cause of disease and death. Three times since, however, cigarette and e-cigarette companies have filed successful legal challenges to thwart rules intended to make their products less appealing to consumers–and less accessible to kids.

The three cases, which, among other things, have blocked graphic cigarette warning labels and delayed regulation of e-cigarettes for at least a few years, were decided in favor of industry plaintiffs by the same federal judge, Richard J. Leon of the U.S. District Court in Washington, D.C. Leon’s rulings have reflected concern about government overreach, and a tone of deep skepticism about the FDA’s legal positions “Please! This conclusion defies common sense,” he wrote, dismissing one of the agency’s arguments.

U.S. District Judge Richard J. Leon has ruled for cigarette and e-cigarette companies in three lawsuits against the Food and Drug Administration.

U.S. District Judge Richard J. Leon has ruled for cigarette and e-cigarette companies in three lawsuits against the Food and Drug Administration.

Given how cases are normally assigned, the fact that Leon was assigned all three is extraordinary—and extraordinarily good luck for the industry.

Court rules require cases to be randomly assigned among the court’s regular judges, plus several senior judges with reduced caseloads. According to court officials, there were 13 regular judges on hand when two of the complaints were filed, and 11 when the other suit was filed. The odds of the cases being randomly assigned to a single judge—1 in 13, 1 in 13, and 1 in 11—put the chance of drawing all three cases at one in 1,859. With senior judges also in the draw, the chance appears even more remote.

But court officials say it was a huge coincidence and nothing more. It would be “indefensible” for anyone to bend the rules on case assignments, said Greg Hughes, the court’s chief deputy clerk for operations.

Given the enormous odds, the situation “does stretch the bounds of credulity,” Hughes acknowledged, but records show the complaints were randomly assigned. “That’s what the system’s telling me,” he said, “and I have to put faith in the system.’’

There is a process for assigning a so-called ‘’related case’’ to a judge already handling an earlier complaint involving very similar issues. For that to happen, the lawyer filing the complaint must indicate that the case is related. Otherwise, a judge randomly assigned the complaint who thinks it is related can seek its transfer to the judge in the earlier case.

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Neither of those things happened, according to court officials and a review of the docket.

Leon joined the court in 2002 after his nomination by former President George W. Bush. He is considered something of a maverick conservative, and other times has come down hard on federal agencies. In December, 2013 he ruled that the bulk collection of phone records of U.S. citizens by the National Security Agency is probably unconstitutional. It’s unclear whether another judge would have ruled differently in the FDA cases—two of which have been held up on appeal. (An appeal of the third case is pending.)

Through a court spokesman, the judge declined to be interviewed for this story. “But I can tell you [that] all three cases were randomly assigned to Judge Leon, and none of the three was filed as a related case,” spokesman Sheldon Snook said. Officials with the FDA and Justice Department, which represented the FDA in court, declined comment. Tobacco company lawyers did not return calls or declined to be interviewed.

Cigarette packs now, and how they would have looked with warning labels ordered by the FDA in 2011. Congress had directed the FDA to create bold graphic warnings to replace the small text warnings that have not changed since the 1980s. But cigarette makers successfully challenged the FDA rule. (Note: Marlboro maker Philip Morris USA did not join the lawsuit). FDA officials say they are working on a new set of warnings. (Design and photos by David LaFontaine for FairWarning).

Tobacco control advocates, however, were deeply skeptical. Richard Daynard, a Northeastern University law professor and chairman of the Boston-based Tobacco Products Liability Project, said it seemed “very, very strange that somebody who has demonstrated a sustained hostility to the federal regulation of tobacco products keeps getting assigned to these cases. It certainly leaves one wondering what is going on.”

Matthew L. Myers, president of the Campaign for Tobacco Free Kids, remarked that while there was “no evidence that the system was manipulated,’’ the impact of the rulings has been “enormous.”

Judge Leon “has fundamentally altered FDA’s authority and ability to carry out its congressional mandate,” Myers said. “It has had a direct effect on what has happened with e-cigarettes, [and] the fact that the United States still has among the weakest warning labels in the entire world.”

“But there is no evidence of wrongdoing,” Myers said. “You can’t point to anything. I wish I could.”

Legal experts had to agree. “The odds are long,” said Andrew Bradt, an assistant professor and expert on litigation procedure at the UC Berkeley School of Law, “but I would have no basis for saying there’s any shenanigans going on.’’

Nothing happened that “is malicious or evil or affecting outcome.”–Alan B. Morrison, George Washington University law professor

Alan B. Morrison, a George Washington University law professor with extensive litigation experience in the D.C. District Court, concurred the odds were “quite astounding.” But given that two of the rulings were affirmed on appeal, he said he did not think anything happened that “is evil or malicious or affecting outcome.”

Leon’s rulings nonetheless have stymied federal oversight in these areas:

E-cigarettes. In 2009, the FDA tried to halt a shipment of e-cigarettes into the U.S., on grounds that the products — which produce nicotine vapor without burning tobacco — were unapproved drug delivery devices. E-cigarette marketers sued the agency. In January, 2010, Leon issued an injunction, saying the FDA lacked authority to regulate e-cigarettes as drug delivery devices because marketers of the products weren’t making therapeutic claims. The ruling was affirmed on appeal.

Almost five years later, e-cigarettes are still exempt from FDA oversight. Although e-cigarette vapor appears to be less harmful than tobacco smoke, the nicotine is highly addictive. Health officials fear kids who get hooked using the devices may well graduate to smoking. Indeed, according to a recent study by the Centers for Disease Control and Prevention, more than a quarter of a million middle and high school students who had never smoked said they had used e-cigarettes in 2013. And because they are unregulated, e-cigarettes aren’t bound by federal age limits, bans on kid-friendly flavorings, or restrictions on advertising.

In April, the FDA, issued a proposed rule that would give it authority to regulate e-cigarettes as tobacco products (as opposed to drug delivery devices). The rule will become final next year at the earliest.

It seems “very, very strange that somebody who has demonstrated a sustained hostility to the federal regulation of tobacco products keeps getting assigned to these cases. It certainly leaves one wondering what is going on.”  Richard Daynard, Northeastern University law professor and chairman of the Tobacco Products Liability Project

It seems “very, very strange that somebody who has demonstrated a sustained hostility to the federal regulation of tobacco products keeps getting assigned to these cases. It certainly leaves one wondering what is going on.” —Richard Daynard, Northeastern University law professor and chairman of the Tobacco Products Liability Project

Graphic Warning Labels. The 2009 tobacco control law directed the FDA to create bold pictorial warnings for cigarette packs to replace the small text warnings that have been unchanged since the 1980s. Seventy four countries and territories around the world require such graphic warnings, according to survey data from the Canadian Cancer Society, but the U.S., with the world’s biggest tobacco control program, still doesn’t have them.

In June, 2011, the FDA ordered the use of nine rotating warnings to cover 50 percent of cigarette packs with such images as diseased lungs and a cadaver lying on an autopsy table.

Five tobacco companies, including R.J. Reynolds Tobacco and Lorillard Tobacco — the 2nd and 3rd biggest cigarette makers —  filed a lawsuit claiming the mandate violated their First Amendment rights. Leon agreed, ruling that the labels were “more about shocking and repelling than warning,” and amounted to an “impermissible expropriation of a company’s advertising space for Government advocacy.” A federal appeals court upheld the decision in August, 2012.

The FDA has gone back to the drawing board, conducting research to develop new warnings that will pass legal muster. But officials aren’t saying when new labels will be proposed.

Menthol Cigarettes. The tobacco control law directed the FDA to create an expert panel—the Tobacco Products Scientific Advisory Committee — to study whether menthol cigarettes pose more of a risk to public health than regular brands. In a report to the FDA in July, 2011, the panel found that menthol, by anesthetizing the throat against the harshness of tobacco smoke, likely makes it easier for teens and young adults to take up smoking. As a result, the report said, menthol cigarettes have an adverse impact on public health.

Lorillard and R.J. Reynolds sued to invalidate the report, complaining that several panel members had conflicts of interest because they had been consultants to pharmaceutical companies developing stop-smoking aids, and served as witnesses in anti-tobacco lawsuits.

This July, Leon ruled for the industry, finding that panel members Neal Benowitz and Jack Henningfield, both renown addiction experts, and Dr. Jonathan Samet, an editor on several Surgeon General reports, had conflicts that “fatally tainted” the panel and the menthol report. He ordered the FDA to reorganize the committee, and forbade the agency from considering the findings of the menthol report. The FDA has filed a notice of appeal.

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Myron Levin - FairWarning

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Myron Levin is editor of FairWarning.

8 comments to “Tobacco Industry Batting a Thousand With Federal Judge, While FDA Strikes Out”

  1. john kelly

    ^ What Bill Godshall said. Nothing further required.

  2. Bill Godshall

    If anyone is to be blamed for Richard Leon’s three decisions (all of which I strongly supported), its Obama’s FDA (and other DHHS) appointees, their staff and their intolerant anti tobacco/nicotine extremist allies at CTFK, ACS, AHA, ALA, UCSF, AAP, Legacy, etc.

    When I convinced Senator Mike Enzi to amend the FSPTCA to require color graphic warnings on cigarettes during the HELP Committee markup session in 2007, Big Pharma funded CTFK, ACS, AHA, ALA denounced Enzi, urged Kennedy and other Democrats to reject them, and falsely claimed Enzi’s amendment (and other public health amendments offered by Enzi) were “trojan horses” and “poison pills” to protect Big Tobacco. Of course that was because Matt Myers negotiated and agreed to the FSPTCA legislative deal with Philip Morris lawyers and GSK funded Mitch Zeller in 2003/04 that only required ineffective print warnings for cigarette packs.

    But after the FSPTCA was enacted in 2009, the FDA (after being lobbied by those same groups, Stan Glantz and other extremists) approved a regulation for color graphic warnings that was clearly unconstitutional (because they included a phone number that hawked ineffective FDA approved smoking cessation drugs as the only effective way to quit smoking, because some of the disgusting photos were unrelated to the accompanied text warning, and because the warnings were clearly intended to scare viewers instead of provide useful or helpful information).

    I and others submitted comments to the FDA’s docket informing them of these very concerns, but the FDA ignored our concerns. And when FDA announced the final regulation, the FDA, CTFK, ACS, AHA, ALA congratulated themselves for the color graphic warnings that Judge Leon subsequently ruled unconstitutional (citing the very same reasons we had previously informed FDA about our concerns).

    But instead of promulgating new constitutional cigarette warnings (which could actually reduce smoking), Obama’s FDA CTP (and CDC, US SG and other DHHS agencies) have spent much of their energy lying about, demonizing and trying to ban electronic cigarettes.

    As one who collaborated with the two e-cigarette companies (SE and NJOY) in suing the FDA (and who filed an amicus brief with the DC Court of Appeals opposing FDA’s unlawful e-cigarette ban that resulted in nearly 1,000 seizures of e-cigarette shipments at US ports by Customs agents), I pleaded with Obama appointed FDA Deputy Commissioner Josh Sharfstein (who previously worked for Waxman to lobby the FSPTCA through Congress) to not ban e-cigarettes, and even sent him a petition signed by 7,000 vapers who had quit smoking by switching to e-cigs.

    In April 2009, Obama’s FDA revealed its unscientific, unethical and inhumane policy to deceive Americans about e-cigs and defend the FDA’s e-cig ban: “We don’t want the public to perceive them as a safer alternative to cigarettes.”
    http://www.webmd.com/smoking-cessation/features/ecigarettes-under-fire

    In July 2009, Obama appointee (and former Waxman staffer) FDA Deputy Cmsnr Josh Sharfstein held a press conference along with CDC OSH Director Matt McKenna and Big Pharma funded AAP’s Jonathan Winickoff (to defend the agency’s unlawful e-cig ban from lawsuits by SE and NJOY after their products were seized) where FDA’s e-cigarette lab findings were grossly misrepresented to scare the public to believe e-cigarettes are carcinogenic and toxic, where e-cigarette companies were falsely accused of target marketing to youth, and where it was alleged (without any evidence) that e-cigs are addicting children, can be gateways to cigarettes, can renormalize smoking, and don’t help smokers quit.
    http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm173175.htm
    http://www.fda.gov/downloads/NewsEvents/Newsroom/MediaTranscripts/UCM173405.pdf

    Sound familiar? Since then, Obama’s DHHS has not only repeated those same false claims many times, but they’ve made even more fear mongering claims about them (e.g. falsely claiming e-cigs are poisoning children).

    Thankfully for the rule of law, public health, civil liberties, market competition and common sense, all 12 federal appeals court judges upheld Judge Richard Leon’s ruling striking down FDA’s e-cig ban as unlawful.
    https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2009cv0771-54
    https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2009cv0771-55

    Unfortunately for public health, the FDA’s recently proposed Deeming Regulation for e-cigarettes would protect cigarettes by banning >99.9% of e-cigarettes (including all of the most effective e-cigs for smoking cessation) and by giving the entire e-cig industry to Big Tobacco companies.

    That’s why Altria, Reynolds, Lorillard and the National Association of Convenience stores not only endorsed FDA’s proposed deeming regulation, but why their CEO just urged FDA to imposed the deeming regulation even more swiftly.
    http://www.bloomberg.com/news/2014-10-02/tobacco-ceos-urge-fda-to-adopt-e-cig-rules-quickly.html

    Nothing like FDA proposing (and CTFK, ACS, AHA, ALA, AAP, Legacy, ASTHO, NACCHO etc lobbying for) a crony capitalism regulation to enrich Big Tobacco and threaten the lives of all vapers, smokers and secondhand smokers under the deceitful guise of “protecting children and public health”.

    BTW Smokefree Pennsylvania’s 110 page comment urging FDA to kill its proposed cigarette industry protecting Deeming Regulation, citing nearly every published study on e-cigs and exposing dozens of DHHS lies about e-cigs is at: http://www.regulations.gov/#!documentDetail;D=FDA-2014-N-0189-80846

    Finally, on the issue of FDA TPSAC’s deeply flawed and biased report denouncing menthol cigarettes, I and many others repeatedly pointed out that virtually all (if not all) of the original TPSAC appointees had extensive and irreconcilable conflicts of interest.
    But of course, the FDA falsely claimed (at every TPSAC meeting) that none of the TPSAC members had conflicts of interest. In fact, it appears that having a conflict of interest is still a prerequisite for being appointed to TPSAC.

    Many members of TPSAC member have received Big Pharma funding to demonize and lobby to ban or excessively restrict tobacco products, some were paid as expert witnesses at trials against tobacco companies, some lobbied to ban smokeless tobacco and/or other tobacco products, and nearly all have publicly advocated and urged Congress to enact the TPSAC.

    Not one tobacco harm reduction advocate has been appointed to TPSAC (nor hired by Obama’s DHHS), and none of the TPSAC members have opposed anything FDA has proposed. In sum, TPSAC is nothing more than a FDA cheerleading and rubber stamp committee.

    In response to TPSAC’s proposed menthol report that was little more than cherry picked junk science, I and many others submitted comments to the docket citing lots of scientific evidence finding that menthol cigarettes are just as addictive, deadly and hard to quit as nonmenthol cigarettes. I and other public health advocates also pointed out that TPSAC report failed to consider the enormous black market a menthol ban would create (which is required by the FSPTCA). We also pointed out that the loss of menthol cigarette tax revenue and MSA payments would sharply reduce funding for SCHIP and for many tobacco education, smoking cessation and other public health programs.
    But none of those facts changed TPSAC’s predetermined conclusion that menthol cigarettes should be banned.

    So nobody should have been surprised when Richard Leon negated the TPSAC’s menthol report because 3 members of TPSAC had conflicts of interest.

    Those responsible for Judge Leon’s three rulings against the FDA were Obama appointees and their staff at FDA and other DHHS agencies, CTFK, ACS, AHA, ALA, AAP, Legacy, Stan Glantz, TPSAC, etc.

    But of course, its more convenient to blame Judge Leon.

    Bill Godshall
    Executive Director
    Smokefree Pennsylvania
    1926 Monongahela Avenue
    Pittsburgh, PA 15218
    412-351-5880
    email hidden; JavaScript is required

  3. Audrey Silk

    Going to the anti-smokers for their opinion on manipulation — even if they concede evidence is lacking — is like going to the fox to ask if the hens could have eaten other animals.

  4. Daniel

    As I have already mentioned on MotherJones where this story has also been posted, the calculations are not correct. What Myron is calculating is the probability of getting any one specific judge all three times, but we don’t care which judge we get as long as it’s the same one each time. Therefore your first choice is only restricted to the point that it ensures that you have selected one of the 11 judges that are still on the list for the final case.

    This means that the actual probability of getting the same judge all three times is roughly 11/13 * (1/13)^2 = 1/200, not 1,859

  5. Mar Burrow

    Yes, it’s almost as coincidental as when the gov’t gets all of its tobacco litigation in front of the Honorable Gladys Kessler…

  6. louis v. lombardo

    Bravo!

    Thanks to Myron Levin and FairWarning for this excellent reporting.

    Indeed!

    What are the odds?

    This judge was appointed by George W, Bush.

    Another bit of evidence that government policy (whether Legislative, Executive, or Judicial) is heavily politically influenced.

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