Opinion ID: 2572676
Heading Depth: 1
Heading Rank: 4

Heading: can the fda prohibit defendants from using a truthful warning?

Text: Plaintiff contends that his proposed warning advising pregnant women that defendants' products contain nicotine which can harm your baby  or words to that effect  is truthful. He argues that the enforcement authority of the FDA is limited to prohibiting adulterated or misbranded products (21 U.S.C. § 331(a)), and that a truthful warning cannot render a product misbranded. He points out that not only California, but also the United States Surgeon General and the Environmental Protection Agency (EPA) list nicotine as a chemical harmful to the fetus. (See Reducing Tobacco Use, A Report of the Surgeon General (2000) at p. 118; 40 C.F.R. § 372.65 (2003) [EPA determination].) Defendants dispute the point, arguing that the evidence is insufficient to show that nicotine can harm the fetus. The FDA's August 17, 2001, letter sets out its views on the effect of nicotine on the fetus. Because of the FDA's scientific expertise and long administrative experience, these views are entitled to judicial deference. ( Serono Laboratories, Inc. v. Shalala (D.C.Cir.1998) 158 F.3d 1313, 1320; see Geier, supra, 529 U.S. at p. 883, 120 S.Ct. 1913.) But a close reading of that letter shows that the FDA is aware that nicotine may endanger the fetus. The August 17 letter states: Although some of the pharmacologic effects of NRT products on the mother and unborn child are known, the full range of compliance or risks to the unborn child are not fully known.... NRT drug products have not been tested in pregnant women ... Extrapolating from the animal data on nicotine exposure and considering the smoking data in humans, the agency believes that chronic nicotine exposure may represent some risk in humans for embryo-fetal lethality, but likely presents little risk for teratogenic or adverse development effects.... While smoking has clearly been associated with fetal harm, the contribution of nicotine has not been clearly delineated. There are numerous other constitutants of cigarette smoke that may be major contributing factors to the harm caused by smoking. There continue to be unanswered questions involving the clinical pharmacology and toxicology of NRT use during pregnancy in humans and additional research should be conducted to answer those questions. (Aug. 17, 2001, letter, p. 4.) The FDA's August 17 letter recognized that its approved warning to doctors for prescription products containing nicotine states: It is presumed that [the product] can cause fetal harm when administered to pregnant women. (Aug. 17 letter at p. 3.) But the FDA explains: This labeling was intended to provide doctors with information to help them make treatment recommendations to their patients. The complexity of the data regarding exposure to nicotine during pregnancy and the relative risks of smoking versus use of NRT products are not easily translated into consumer friendly language on an OTC package. (Aug. 17 letter at pp. 3-4.) The August 17 letter rejected the proposal that defendants' products use the can harm your baby warning approved for Habitrol. It said that this warning overstates what is known about nicotine and its effect on the unborn child. The words `can harm' may suggest to consumers that harm will occur in most, if not all, pregnant women who use NRT products.... The `Harm your baby' warning may lead some consumers simply to continue smoking after failed attempts at abstinence because they will be resigned to the belief that use of NRT drug products are just as harmful as smoking. (Aug. 17 letter at p. 5.) Contrary to defendants' contention, the FDA's August 17, 2001, letter and its summary of the evidence do not show that the FDA considers the evidence insufficient to show that nicotine can harm the fetus. The letter notes both that the effect of nicotine on the fetus is not fully understood, and that it has not been shown that defendants' products are harmful. But it does not dispute that the nicotine in defendants' products is a potential hazard to the fetus, even though the risks to the unborn child are not fully known. (Aug. 17 letter at p. 8, italics added.) The FDA's objection to labels warning that nicotine can harm the baby is not that they are false, but that consumers may give too much weight to the warnings and decide to continue smoking instead of using an NRT product to stop smoking. But even though it is probably true that the nicotine in defendants' products can cause reproductive harm, the FDA has authority to prohibit truthful statements on a product label if they are misleading (21 U.S.C. § 321(n), § 352(a); see United States v. Watkins (9th Cir.2002) 278 F.3d 961, 967), or if they are not stated in such manner and form, as are necessary for the protection of users. (21 U.S.C. § 352(f).) There are numerous examples involving product descriptions. For example, in United States v. Ninety-Five Barrels of Vinegar (1924) 265 U.S. 438, 44 S.Ct. 529, 68 L.Ed. 1094, the label on the vinegar said it was made from apples. It was, but it was made from dehydrated apples and was different from vinegar made from fresh apples. The United States Supreme Court found the vinegar to be misbranded, observing that deception may result from the use of statements not technically false or which may be literally true. ( Id. at p. 444, 44 S.Ct. 529.) In United States v. An Article of Food, Etc. (E.D.N.Y.1974) 377 F.Supp. 746, the district court found the label of Manischewitz's Diet-Thin matzos misleading because they contained the same number of calories as Manischewitz's plain matzos. The opinion observed: Even a technically accurate description of a food or drug's content may violate 21 U.S.C. § 343 if the description is misleading in other respects. ( Id. at p. 749.) In United States v. An Article of Food (8th Cir.1973) 482 F.2d 581, the government did not challenge the factual accuracy of the Nuclomin label; rather it claims the label is misleading to the public because some of the ingredients are either not needed in human nutrition or are included in such insignificant amounts as to be valueless. ( Id. at p. 582.) The federal appellate court held that even though the Nuclomin label was technically accurate, it was misleading, and the product was subject to seizure. ( Id. at p. 584.) A truthful warning can be misleading or fail to communicate the facts necessary for the protection of users. This court discussed that concern in Carlin v. Superior Court (1996) 13 Cal.4th 1104, 56 Cal.Rptr.2d 162, 920 P.2d 1347, a product liability action in which the plaintiff claimed that the FDA-approved warning for Halcion, a prescription drug, was inadequate because it failed to warn of certain dangers. Quoting Finn v. G.D. Searle & Co. (1984) 35 Cal.3d 691, 701, 200 Cal.Rptr. 870, 677 P.2d 1147, Justice Mosk's majority opinion noted: [E]xperience suggest[s] that if every report of a possible risk, no matter how speculative, conjectural, or tentative, imposed an affirmative duty to give some warning, a manufacturer would be required to inundate physicians indiscriminately with notice of any and every hint of danger, thereby inevitably diluting the force of any specific warning given. ( Carlin v. Superior Court, supra, at p. 1115, 56 Cal.Rptr.2d 162, 920 P.2d 1347; see Walsh & Klein, The Conflicting Objectives of Federal and State Tort Law Drug Regulation (1986) 41 Food Drug Cosm. L.J. 171, 182.) The concurring and dissenting opinion expanded on this problem. It noted that even if scientific evidence supports the existence of a risk, a warning is not necessarily appropriate: The problems of overwarning are exacerbated if warnings must be given even as to very remote risks.... ( Carlin v. Superior Court, supra, 13 Cal.4th at p. 1126, 56 Cal.Rptr.2d 162, 920 P.2d 1347 (conc. & dis. opn. of Kennard, J.).) Against the benefits that may be gained by a warning must be balanced the dangers of overwarning and of less meaningful warnings crowding out necessary warnings, the problems of remote risks, and the seriousness of the possible harm to the consumer. ( Id. at p. 1133, 56 Cal.Rptr.2d 162, 920 P.2d 1347.) The New Jersey Supreme Court in R.F. v. Abbott Laboratories (2000) 162 N.J. 596, 745 A.2d 1174, in holding that an FDA regulation preempted state law on the duty to warn, reasoned that the FDA could prohibit a truthful warning. The FDA label for donated blood specified a test to determine whether the blood was contaminated with HIV, and established a cutoff point requiring rejection of blood scoring above a certain value. The plaintiff suggested that the FDA label should also require retesting of marginal samples that fell within 10 percent of the cutoff point. The FDA rejected this suggestion, and plaintiff unfortunately was infected with donated blood that fell within this 10 percent range. The court rejected plaintiff's challenge to the FDA regulation, relying on FDA findings that (1) there was no scientific evidence that borderline samples were more likely to be false-negative than samples falling well below the borderline, so retesting of borderline samples would not find many cases of contamination; and (2) blood banks would be likely to throw out donations falling in the borderline range instead of incurring the expense of retesting, a consequence that would imperil the nation's blood supply. (See id. at p. 1180.) The New Jersey Supreme Court emphasized that deciding upon a warning may involve balancing of competing interests. ( R.F. v. Abbott Laboratories, supra, 745 A.2d at p. 1180.) The FDA's active involvement at every step of the test's development, approval, and use in the field, reflected the risk-utility analysis undertaken by the FDA to address significant public policy considerations. [¶] [T]he FDA's mandate directing Abbot not to provide for retesting of samples near the cutoff ... remained in force as part of a conscious ongoing risk-benefit analysis by the FDA in managing a public health crisis. ( Id. at p. 1192.) Plaintiff here disputes the proposition that the FDA can undertake a risk-utility analysis in formulating an appropriate label. He relies on the United States Supreme Court decisions in Food and Drug Admin. v. Brown & Williamson Tobacco Corp. (2000) 529 U.S. 120, 120 S.Ct. 1291, 146 L.Ed.2d 121 ( Brown & Williamson ) and Thompson v. Western States Medical Center (2002) 535 U.S. 357, 122 S.Ct. 1497, 152 L.Ed.2d 563 ( Western States Medical Center ). Brown & Williamson concerned whether the FDA could classify tobacco as a drug and regulate it accordingly. The majority held that Congress had precluded FDA regulation. One basis for this conclusion was that if the FDA followed its own reasoning and analysis, it would have to conclude that tobacco was unsafe and ban its distribution  an action that would frustrate congressional acts regulating the growing and marketing of tobacco. ( Brown & Williamson, supra, 529 U.S. at p. 142, 120 S.Ct. 1291.) In response to that argument, the FDA contended that even though tobacco was unsafe and had no therapeutic purpose, the FDA could balance other considerations, such as the risk of creating a black market for cigarettes, and impose something less than an outright ban. The high court disagreed: Section 352(j) focuses on the dangers to the consumer from use of the product, not those stemming from the agency's remedial measures.... [¶] The FDA, consistent with the FDCA, may clearly regulate many `dangerous' products without banning them. Indeed, virtually every drug or device poses dangers under certain conditions. What the FDA may not do is conclude that a drug or device cannot be used safely for any therapeutic purpose and yet, at the same time, allow that product to remain on the market. ( Brown & Williamson, supra, 529 U.S. at pp. 141-142, 120 S.Ct. 1291.) Thereafter, in Western States Medical Center, supra, 535 U.S. 357, 122 S.Ct. 1497, the United States Supreme Court held that a provision of the Modernization Act prohibiting the advertising of compounded drugs violated the First Amendment to the federal Constitution. The FDA sought to justify the challenged provision on the ground that it was necessary to prevent unnecessary prescription of compounded drugs. The court described this argument as paternalistic ( id. at p. 375, 122 S.Ct. 1497), and said the FDA's concern amounts to a fear that people would make bad decisions if given truthful information about compounded drugs. ( Id. at p. 374, 122 S.Ct. 1497.) The high court went on to say: We have previously rejected the notion that the Government has an interest in preventing the dissemination of truthful commercial information in order to prevent members of the public from making bad decisions with the information. ( Id. at p. 374, 122 S.Ct. 1497, citing Virginia State Bd. of Pharmacy v. Virginia Citizens Consumer Council, Inc. (1976) 425 U.S. 748, 769, 96 S.Ct. 1817, 48 L.Ed.2d 346 [state statute barring advertising of prescription drug prices violates First Amendment].) Both cases cited by plaintiff raise issues distinct from those here. This case does not involve the marketing of an unsafe product as in Brown & Williamson, supra, 529 U.S. 120, 120 S.Ct. 1291, and unlike Western States Medical Center, supra, 535 U.S. 357, 122 S.Ct. 1497, it presents no constitutional issues. There is no question but that the FDA has jurisdiction to regulate the labeling of defendants' products, and that its rulings are valid and preemptive as to products sold in every state, subject only to the savings clause in 21 United States Code section 379r(d) (2). The United States Supreme Court described the reasoning underlying the FDA arguments in Brown & Williamson, supra, 529 U.S. 120, 120 S.Ct. 1291, and Western States Medical Center, supra, 535 U.S. 357, 122 S.Ct. 1497, as paternalistic. The same can be said of the FDA's reasoning here. But we do not know of any statute or constitutional provision that precludes the FDA from taking this approach to regulation of nonprescription drugs. In formulating the label for a product to be marketed  as distinguished from a decision whether or not to permit the product to be marketed the  FDA must take into account the effect of proposed labels on the consumer. Whether a label is potentially misleading or incomprehensible is essentially a judgment of how the consumer will respond to the language of the label. As we have noted, a truthful warning of an uncertain or remote danger may mislead the consumer into misjudging the dangers stemming from use of the product, and consequently making a medically unwise decision. The authority of the FDA, we conclude, extends to barring warnings that are misleading in this fashion. Although there is reason to believe that nicotine can cause reproductive harm, plaintiff has offered no qualitative assessment of this risk. The mere existence of the risk, however, is not necessarily enough to justify a warning; the risk of harm may be so remote that it is outweighed by the greater risk that a warning will scare consumers into foregoing use of a product that in most cases will be to their benefit. The FDA has so determined in this case, and we find no basis to question the FDA's expert determination. The United States Attorney General, as amicus curiae for defendants, goes further and argues that every FDA labeling decision involves balancing all relevant considerations relating to the precise wording of the label, and that consequently any nonidentical state warning would constitute misbranding. That argument would nullify the savings clause in the Modernization Act, which plainly permits Proposition 65 warnings that differ from the FDA warnings. As defendants point out, this is an unusual case; in most cases FDA warnings and Proposition 65 warnings would serve the same purpose  informing the consumer of the risks involved in use of the product  and differences in wording would not call for federal preemption. Here, however, the FDA warning serves a nuanced goal  to inform pregnant women of the risks of NRT products, but in a way that will not lead some women, overly concerned about those risks, to continue smoking. This creates a conflict with the state's more single-minded goal of informing the consumer of the risks. That policy conflict justifies federal preemption here.