Last month, while grappling with an aphrodisiac false-advertising case, we joked that we felt like having a cigarette after reading the court's opinion. Today we get our cigarette. Or, rather, our e-cigarette. Today's post is about a tobacco, not a drug or device case. We aren't squeamish about that, not one bit. Before we worked on drug or device cases, we spent several years litigating tobacco cases. It was good practice. After dealing with tobacco cases, no internal documents worry us all that much. Tobacco litigation is the ultimate challenge for a defense lawyer. Judges and juries treat tobacco differently – and by differently, we mean worse. Much worse. It was a point of faith among the defense hacks that many judges found occasions to reach down to some lower shelf and retrieve a Tobacco Rules of Evidence, which permitted judges to stiff the defendant in a myriad of ways. This crazy, result-oriented one-sidedness was not confined to the judicial branch. Remember how Florida passed an ex post facto law removing many tobacco affirmative defenses?
Moreover, tobacco litigation was good practice on the issue of preemption. Most tobacco cases were and are about an alleged failure to warn. But federally mandated warnings have been on cigarette packs for over 50 years. One of the key express preemption decisions, Cipollone v. Liggett Group, Inc., 505 U.S. 504 (1992), is about the effect of those warnings. That case is as important as air and as clear as mud. Lawyers and judges are still trying to figure out exactly what it held. Does the express preemption provision for cigarette warnings blow a hole through all failure to warn theories? Is there a distinction between failing to warn and affirmative deceit? To the extent they have to try to figure out the scope of preemption, judges usually hate it. Preemption is so powerful, so completely dispositive of plaintiff claims, that some judges regard it with the same degree of affection they harbor for the bubonic plague or the last season of Dexter. During one sidebar in a tobacco case, the judge sputtered that preemption "boggled his mind and boiled his blood." No wonder, then, that his rulings on preemption were a tad sketchy.
The preemption ruling in In re Fontem, U.S., Inc. Consumer Class Action Litigation, 2016 WL 6520142 (C.D. Cal. Nov. 1, 2016), isn't too bad, but neither is it completely free of sketchiness. The plaintiffs brought an action against e-cigarettes asserting every theory under the sun. The defendants argued that the claims were preempted by an FDA final rule deeming e-cigarettes to be tobacco products falling under Tobacco Control Act ("TCA") restrictions on how products can be sold and what warnings need to be on products and advertisements. In issuing the its final rule on the subject, the FDA declined to be explicit about what it would and would not preempt (despite urging by interest groups on both sides) but did say that "No state or local laws in effect at the close of he public comment period were identified that FDA determined would be preempted by this final rule". Nevertheless, there is an express preemption provision governing tobacco products and it can be found in 21 USC section 387p(a)(2)(A): "No state or political subdivision if 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 subchapter relating to tobacco product standards, premarket review, adulteration, misbranding, labeling, registration, good manufacturing standards, or modified risk products." If you think that sounds a lot like the express preemption language for PMA devices, you aren't wrong.
The Fontem court holds that parts of the plaintiffs' failure to warn claims are preempted and parts aren't. In getting to that result, the court discusses the medical device preemption case of Lohr, but not Riegel. It was actually the plaintiffs who raised Lohr. They argued that Lohr drew a distinction between federal preemption of only "generic and limited" warnings vs. no preemption of "more specific state law claims." The court did not buy the plaintiffs' argument. Whatever the device regulations might have said about device-specific as opposed to more general regulations, no such distinction resided within the TCA's preemption provision. The plaintiffs then tried a different tack. They suggested that the TCA set only a floor for regulation, not a ceiling. (Where have we heard that before?) But the court pointed to that preemption language forbidding any requirement "in addition to" the federal rules. Nice try. The preemption language actually has preemptive effect, and any claim that e-cigarettes should have additional warnings on their labels is a goner.
But here comes the part where the defendants got burned. While the court dismissed most of the plaintiffs' failure to warn claims, it let a few survive, and it did so for reasons that strike us as quintessentially Californian – which captures a couple of thoughts, among them that the reasoning is flakey. One of the claims was premised on the warning requirement in California Proposition 65. (Perhaps you once entered an office building in California and encountered the following silly sign: "WARNING: This product contains chemicals known to the State of California to cause cancer and birth defects or other reproductive harm." What to do after seeing this sign? Call off the meeting? It is well-intentioned and useless. See what we mean about quintessentially Californian?) Prop 65 warnings can come in the form of a label, point of sale communications, public advertising, or "any other system that provides clear and reasonable warnings." The Fontem court ends up ruling that the plaintiffs' Prop 65 warning claims are preempted only to the extent they reach e-cigarette labeling, but not to the extent they reach other warnings media such as advertising or point of sale communications. But the only way to arrive at that result is to employ a more restrictive definition of "labeling" than is applicable to drug and device cases. Under the SCOTUS case of Kordel v. United States, 335 U.S. 345 (1948), "labeling" of drugs and devices is a broad term, encompassing all sorts of things that might accompany the product. It is certainly not restricted to the label itself. Instead of following Kordel, the Fontem court follows Chemical Specialties Manufacturers Ass'n v. Allenby, 958 F.2d 941 (9th Cir. 1992), which went with a narrower definition of labeling. Of course, Allenby did not address FDA regulations, which is what are now relevant to e-cigarettes. Instead, Allenby interpreted the Federal Insecticide, Fungicide, and Rodenticide Act ("FIFRA"), 7 U.S.C. §§ 136-136y (1988), and the Federal Hazardous Substances Act ("FHSA"), 15 U.S.C. §§ 1261-1277. That is one mistake. Next, we get this howler from the court: "[T]his court is obliged to follow Ninth Circuit precedent, including precedent that purports to discern when a Supreme Court precedent applies, or not." The idea of the Ninth Circuit being able to call off SCOTUS precedent is enough to make us smile. But resorting to that rather bizarre concept is especially misplaced when the Ninth Circuit case in question was talking about something different from the SCOTUS case. In other words, the Fontem court really did not need to go there (and by "there," we mean crazytown.).
There is one other unfortunate moment in Fontem. In the court's discussion of Lohr, it refers to an "assumption" against preemption of state police powers. Is an assumption any different from a presumption? It doesn't feel like it. No matter. But as we discussed last August, in Puerto Rico v. Franklin-California Tax-Free Trust, 136 S. Ct. 1938 (2016), SCOTUS seems to have interred the presumption against preemption in express preemption cases. That much abused presumption, or assumption, should remain in the ash heap of history.
This article is presented for informational purposes only and is not intended to constitute legal advice.
