Friday, October 14, 2005

The Campaign for Tobacco-Free Kids' FDA Policy: Immunity for the Tobacco Industry

A little-noticed (among tobacco control advocates) article in the Florida Coastal Law Review warns that the proposed FDA tobacco legislation may be a death-knell for all tobacco litigation in this country by virtue of its preemption of common law claims based on a wide range of potential actions (see: Reeder HC. The 'law of tobacco' is a major contributing factor that hampers effective resolution to the country's tobacco problem. Florida Coastal Law Review 2004 (Fall); 6(1):17-175).

Writing in the Fall 2004 issue of the journal, Cleveland-based public interest law attorney Harold C. Reeder writes that: "What is clear is that FDA regulation would bring with it a new basis for preemption based on the FDCA [Food, Drug, and Cosmetics Act] and not just the FCLAA [Federal Cigarette Labeling and Advertising Act]. Although FDA regulation may be desirable, the preemption problem must not be compounded."

Reeder points out that there are "numerous cases dealing with preemption as it relates to the FDCA. See, e.g., Mitchell v. Collagen, 67 F.3d 1268 (7th Cir. 1995) (relying on Cipollone finding that the preemption provision of the Medical Device Amendments...to the FDCA was broad enough to encompass common-law causes of action within its preemptive scope)."

The Rest of the Story

After reviewing Reeder's article, the proposed FDA legislation, and the relevant cases that he cites, I have concluded that the proposed legislation would indeed grant the tobacco companies immunity from liability based on many of the major causes of action that have been brought to bear against the companies so far, and many which might be brought to bear in the future.

Here is the problem:

First, the proposed legislation states: "no State or political subdivision of a State may establish or continue in effect with respect to a tobacco product any requirement which is different from, or in addition to, any requirement under the provisions of this chapter relating to tobacco product standards, premarket approval, adulteration, misbranding, labeling, registration, good manufacturing standards, or modified risk tobacco products."

Second, the courts have established that this type of preemption of state and local regulation applies not only to legislation (i.e., laws passed by the state) but that it is broad enough to also preempt litigation (i.e., common law claims brought by citizens against the companies).

For example, in Mitchell v. Collagen, the 7th Circuit Court of Appeals ruled that an almost identical clause in the FDCA did preclude common law causes of action: "Our first task is to determine whether the phrase 'any requirement' encompasses state common law causes of action. Collagen submits that the Supreme Court's decision in Cipollone v. Liggett Group, Inc., 505 U.S. 504 , 112 S. Ct. 2608 (1992), makes clear that Congress' preemption of state 'requirements' encompasses common law causes of action. ... A majority of the Justices agreed that the phrase 'no requirement or prohibition' sweeps broadly and suggests no distinction between positive enactments and common law; to the contrary, those words easily encompass obligations that take the form of common law rules." ... Cipollone suggests that 21 U.S.C. sec. 360k(a)'s preemption of state 'requirements different from, or in addition to,' those of the MDA is broad enough to include state common law causes of action."

In Cipollone itself, the Supreme Court ruled that FCLAA (which has language which is, again, almost identical to that in the proposed FDA legislation) did indeed preempt common law causes of action based on failure to warn theories and on fraudulent misrepresentation claims:

"Insofar as claims under either of petitioner's failure-to-warn theories - i.e., that respondents were negligent in the manner that they tested, researched, sold, promoted, and advertised their cigarettes, and that they failed to provide adequate warnings of smoking's consequences - require a showing that respondents' post-1969 advertising or promotions should have included additional, or more clearly stated, warnings, those claims rely on a state-law 'requirement or prohibition ... with respect to ... advertising or promotion' within 5(b)'s meaning and are preempted."

"Because 5(b) preempts 'prohibition[s]' as well as 'requirement[s],' it supersedes petitioner's first fraudulent misrepresentation theory, which is predicated on a state-law prohibition against advertising and promotional statements tending to minimize smoking's health hazards, and which alleges that respondents' advertising neutralized the effect of the federally mandated warning labels."

While there were several common law causes of action that were not precluded by the Supreme Court in Cipollone, the reason for these exclusions was that the Court was being guided by the specific language of FCLAA, which stated that: "No requirement or prohibition based on smoking and health shall be imposed under State law with respect to the advertising or promotion of any cigarettes the packages of which are [lawfully] labeled."

Thus, any requirement not based on health concerns or not dealing with the advertising and labeling of cigarettes on packages could be viewed as not being explicitly preempted by FCLAA.

In the case of the proposed FDA legislation, however, the express preemption laid out in statute is quite broad and includes all the major areas that would be necessary to rely upon to bring any meaningful claims against the tobacco companies: "tobacco product standards, premarket approval, adulteration, misbranding, labeling, registration, good manufacturing standards, or modified risk tobacco products."

Since the tobacco product standards relate to the toxicity and safety of the components within cigarettes, it is very unlikely that any claims regarding tobacco companies' failure to make their products safer would be allowable. Thus, a whole range of lawsuits based on claims that cigarette companies could have, but did not, produce safer cigarettes would be precluded.

In addition, since the tobacco product standards are so broad and encompass ingredients, additives, and smoke components, there are few areas left to make any claim of health damage based on the toxic effects of any tobacco constituent.

Moreover, since modified risk tobacco products are included in the preemption, there would be no possible claims that could be brought against tobacco companies for misleading health claims related to such products. All of their public statements, advertising, etc. concerning these products would be regulated by FDA; thus, there would literally be no possible cause of action related to damages caused by these products or any deceptive advertising or marketing practices.

This is, I think, one reason why Philip Morris wants this legislation so badly.
It would give the company immunity and allow it to develop and market its reduced exposure products without risk of liability. Under the status quo, Philip Morris cannot do that. The risk of litigation is simply too high.

The rest of the story reveals that the debate over the proposed FDA legislation is 1997 all over again.

The debate is truly about whether to try to achieve some public health gains at the expense of giving the tobacco companies immunity. Once again, the Campaign for Tobacco-Free Kids is out in front, apparently willing to concede the legal rights of American citizens in order to achieve what it thinks will be public health gains.

There's just one major difference: in 1997, there truly were some public health gains that might have been achieved from the global tobacco settlement. But in 2005, there are, I believe, very few clear public health gains to be realized. In my opinion, there is no solid evidence that there would be any substantial public health gains from the proposed legislation at all.

I guess there's one other major difference as well: in 1997, the Campaign for Tobacco-Free Kids was joined only by the American Cancer Society and American Heart Association as the groups willing to trade away tobacco industry immunity for some public health gains and most other major public health groups were against the idea. In 2005, the Campaign has been successful in convincing a large number of public health groups to go along with this idea.

So we have a situation where in my opinion, many public health groups are actually supporting a policy that is going to trade in the legal rights of American citizens (in the form of immunity for the tobacco companies) for alleged public health gains for which there is no evidence.

I can only hope that the public health groups that have joined forces with the Campaign for Tobacco-Free Kids will realize their huge mistake before it is too late.

1 comment:

Dr. Steve Hansen said...

What does Dick Daynard say about this?