The Alcoholic Beverages Labeling Act of 1988. A preemptive shield against fetal alcohol syndrome claims?

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The alcoholic beverages labeling act of 1988 Eileen N. Wagner Ed.D., J.D.

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Clute & Associates , 1301 N. Hamilton Street, Suite 109, Richmond, Virginia, 23230–3945 Published online: 23 Jul 2009.

To cite this article: Eileen N. Wagner Ed.D., J.D. (1991) The alcoholic beverages labeling act of 1988, Journal of Legal Medicine, 12:2, 167-200, DOI: 10.1080/01947649109510850 To link to this article: http://dx.doi.org/10.1080/01947649109510850

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The Journal of Legal Medicine, 12:167-200 Copyright © 1991 by Hemisphere Publishing Corporation

THE ALCOHOLIC BEVERAGES LABELING ACT OF 1988 Downloaded by [Monash University Library] at 11:29 01 February 2015

A PREEMPTIVE SHIELD AGAINST FETAL ALCOHOL SYNDROME CLAIMS? Eileen N. Wagner, Ed.D., J.D.*

INTRODUCTION The Alcoholic Beverages Labeling Act of 1988 requires that a warning label must appear on every domestically produced and distributed container of alcoholic beverage.1 For 10 years, the Alcoholic Beverages Industry (Industry) fought vigorously any notion that it had a duty to warn against the dangers of abuse to the consumer. But mounting evidence of the indirect effects on innocent babies finally toppled the Industry's defensive stance. Fetal Alcohol Syndrome (FAS) is one danger of alcoholic consumption by pregnant women that could not be written off as too obvious to require warning.2

* Editor, Lex Claudia, the journal of the Virginia Women Attorneys Association, and member of the 1991 Authors Committee, West's Education Law Reporter. Address correspondence to Ms. Wagner at Clute & Associates, 1301 N. Hamilton Street, Suite 109, Richmond, Virginia 23230-3945. 1 "Government Warning: [1] According to the Surgeon General, women should not drink alcoholic beverages during pregnancy because of a risk of birth defects . . . ." 27 U.S.C. § 215 (1988). See also 27 C.F.R. § 16.21 (Feb. 14, 1990). 2 In 1975, Kenneth L. Jones and David W. Smith described Fetal Alcohol Syndrome in Teratology: Growth and Performance * Prenatal onset growth deficiency more pronounced in length and in weight * Concomitant microcephaly (small head circumference) even when corrected for small body weight and length * Postnatal growth deficiency in weight and length, usually below 3rd percentile * Delay of intellectual development and/or mental deficiency (mean IQ from Seattle study - 64, Range 16-92) * Fine motor dysfunction (poor coordination) Head and Face * Microcephaly * Short palpebral fissures (narrow eye slits)

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The Industry's acquiescence in 1988 to the legislative imposition of a duty to warn was triggered, in part, by the Tobacco Industry's unexpected benefit from a preemptive shield supplied by warning label legislation imposed upon it 25 years ago. Commentators pointed to parallels between the tort liability of the Tobacco and the Alcoholic Beverages Industries. They suggested the Alcoholic Beverages Industry might gain the same protection if the Industry allowed federal law to require a warning label on every container.3 Now that Congress has enacted warning label legislation, the question becomes whether the federally imposed warning actually will protect the Industry from tort claims stemming from Fetal Alcohol Syndrome and its lesser manifestation, Fetal Alcohol Effects (FAE). This article describes the emergence from a 10-year scientific debate of FAS/FAE as a major danger of alcohol consumption. Against the background of this discussion, the Industry's duty to warn about FAS/ FAE is traced. The results of tobacco products liability litigation are then evaluated with an examination of the logical extensions of the Alcoholic Beverages Labeling Act for future tort liability to the Industry. Finally, this article suggests five courses of action that the Industry should undertake in an effort to reduce the potential of substantial damage likely to result from successful products liability litigation in which FAS/FAE has occurred.

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* Midfacial (maxillary) hypoplasis (underdevelopment of midfacial region) * Flattened, elongated philtrum (middle of upper lip) associated with thin, narrow vermilon lip borders (highly specific to FAS) * Minor ear anomalies including low set ears Limbs * Abnormal creases in the palm of the hand * Minor joint anomalies —syndactyly (fingers or toes joined together) —clinodactyly (abnormal bending of fingers or toes) —camptodactyly (one or more fingers constantly flexed at one or more phalangeal joints) Heart * Ventricular and atrial sepal defects (valve defects) Brain * Absence of corpus callosum * Hydrocephalus (excess fluid in cranium) * Brain cell migratory abnormalities Other * Minor genital anomalies * Hemangiomas in infancy (benign tumors made up of blood vessels) Alcohol Labeling and Fetal Alcohol Syndrome, 1978: Hearing before the Subcommittee on Alcoholism and Drug Abuse of the Committee on Human Resources, 95th Cong., 2nd Sess. 12 (1978) (citing K. Jones & D. Smith, The Fetal Alcohol Syndrome, 12(1) TERATOLOGY 1 (1975)). Olin, This Dud's for You, 134 CONG. REC. S8822 (daily ed. June 29, 1988).

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I. FETAL ALCOHOL SYNDROME/FETAL ALCOHOL EFFECT EMERGE AS MAJOR BIRTH DEFECTS Although medical authorities have long suspected that alcohol consumption by pregnant women might harm their unborn children,4 not until the 1970s did researchers begin to single out alcohol consumption as a major source of birth defects. How harmful alcohol consumption might actually be to a developing fetus was debated for 10 years. Finally, the scientific verdict implicated all alcohol consumption with the possibility that birth defects might develop; the verdict cleared the way for warning label legislation. A. Birth Defects Research Singles Out Alcohol Consumption In 1974, American researchers Kenneth Jones and David Smith documented in Lancet the relationship of high alcohol intake with a collection of birth defects called FAS.5 The results confirmed studies reported in France in 1968.6 Further research showed that continuous consumption throughout pregnancy was not required to produce FAS.7 By the time the Senate Subcommittee on Alcoholism and Drug Abuse held hearings on the FAS problem in 1978, the National Institute of Alcohol Abuse and Alcoholism (NIAAA) had issued a warning to pregnant women to limit intake to one ounce of absolute alcohol per day.8 Beer drinkers seemed to be particularly at risk, a conclusion rein-

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"The set of physical and mental deficiencies that doctors call Fetal Alcohol Syndrome has been a recognized pitfall of pregnancy since Old Testament times, when Samson's mother was warned by an angel to avoid wine while carrying her unborn child." Leerhsen & Schaefer, Pregnancy & Alcohol - Problems, NEWSWEEK, July 31, 1989, at 57. "[A]s early as 322 B.C., Aristotle in his Problemata noted that foolish, drunken, or hare-brained women for the most part bring forth children like unto themselves, difficult and listless." M. DORRIS, THE BROKEN CORD 144 (1989). 5 See Jones, Smith, Ulleland, & Streissguth, Pattern of Malformation in Offspring of Chronic Alcoholic Mothers, 1 LANCET 1267 (1973); National Institute of Alcohol Abuse & Alcoholism, Critical Review of the Fetal Alcohol Syndrome, in 1978 Hearings, supra note 2, at 26. 6 See Lemoine, Harousseau, Borteryu, & Menuet, Les Enfants de Parents Alcooliques: Anomalies Observees, 25 ARCHIVES FRANCAISE DE PEDIATRIE 830 (1968); 1978 Hearings, supra note 2, at 25. 7 1978 Hearings, supra note 2, at 27-29. 8 Id. at 35. The National Institute of Alcohol Abuse and Alcoholism issued the following warning in June of 1977: Given the total evidence available at this time, pregnant women should be particularly conscious of the extent of their drinking. While safe levels of drinking are unknown, it appears that a risk is established with ingestion above 3 ounces of absolute alcohol or 6 drinks per day. Between 1 ounce and 3 ounces, there is still uncertainty but caution is advised. Therefore, pregnant women and those likely to become pregnant should discuss their drinking habits and the potential dangers with their physicians. 1978 Hearings, supra note 2, at 8.

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forced by studies published in 1982.9 Evidence showed that an intake as low as 1.2 ounces of absolute alcohol could produce a FAS baby.10 Women prone to occasional "binge" drinking, especially at critical stages in fetal development,11 also were in the high risk group.12 Extensive animal studies, moreover, backed up the conclusion based on observations of humans.13 By 1981, the influx of information that even low levels of alcohol consumption might trigger FAS prompted the Surgeon General of the United States to warn all pregnant women to abstain completely.14 B. Industry Questions Methodology and Conclusions In 1978, the Alcoholic Beverages Industry raised a significant number of questions about the methodology of studies linking FAS to various levels of alcohol consumption as well as questions about the reliability of resulting conclusions.15 Through the Distilled Spirits Council of the United States (DISCUS), the Industry summarized its objections to the scientific research. DISCUS found fault that: (1) "No threshold dose" was ever established, therefore, making all conclusions concerning "risk" hypothetical;16 (2) Studied populations were "not representative of the entire female child-bearing population";17 (3) "Detailed patient histories and precise drinking levels" of study subjects were missing;18 (4) No explanation was offered for why the offspring of some alcoholic women do not develop FAS;19

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See Bottoms, Judge, Kuhnert, & Sokol, Thiocyanate and Drinking During Pregnancy, 6 ALCOHOLISM 391 (1982) (beer contains thiocyanate, a known intrauterine growth depressant). See also 134 CONG. REC. S5846 (daily ed. May 13, 1988). 1978 Hearings, supra note 2, at 43 (statement of Kenneth R. Warren, NIAAA). "The most critical period is within the first 85 days. High alcohol concentration during this period, resulting from intermittent binges or daily heavy drinking, can produce [brain lesions]." Id. at 27 (citing Clarren, Alvord, Sumi, & Streissguth, Brain Malformations in Human Offspring Exposed to Alcohol in Utero, in ALCOHOLISM: CLINICAL & EXPERIMENTAL RESEARCH (1977)).

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Id. at 43 (citing Hanson & Smith, Effects of Moderate Alcohol Consumption During Pregnancy on Fetal Growth & Morphogenesis (Society of Research in Child Development, New Orleans 1977)). 13 Id. at 45-61 (50 studies cited). 14 134 CONG. REC. S5499 (daily ed. May 15, 1988). 15 1978 Hearings, supra note 2, at 255-66 (statement of the Distilled Spirits Council of the United States, Inc. [DISCUS]). 16 Id. at 262. 17 Id. 18 Id. (citing El-Guebaly & Offord, The Offspring of Alcoholics: A Critical Review, 134 AM. J. PSYCHIATRY 358 (1977)). 19

Id. (citing Warren, Critical Review of the Fetal Alcohol Syndrome 2 (National Institute of Alcohol Abuse and Alcoholism 1976)).



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(5) No multiple regression analysis addressed the "relative impact of all factors that may influence abnormal development";20 (6) The complexity of "normal fetal growth and development" was not taken into account when calculating the "largely undefined dimension" of alcohol's role in birth defects;21 (7) Consistent discrimination between FAS symptoms and "signs of distinctly different defects" were not established according to "accepted scientific procedures";22 (8) Observations of newboras may not have been reliable;23 (9) Information about drinking habits collected long after the period in question was of "challengeable reliability";24 and, (10) "Extrapolating findings from laboratory animal studies to humans," especially where the animal species metabolized alcohol more quickly than humans, requires "extreme care."25 C. Scientific Consensus Necessitates Warning Legislation By 1988, when the United States Senate conducted a second set of hearings on Fetal Alcohol Syndrome, the weight of the scientific evidence linking alcohol consumption during pregnancy to symptoms of FAS in newboras was so great that the Industry apparently deemed it futile to question either the methodologies or the conclusions of clinical studies as it had 10 years earlier.26 The Director of NIAAA stated without contradiction that "alcohol is a teratogen1271 . . . a substance capable of producing birth defects."28 The estimated occurrence of FAS, in its fully apparent form, is one to three cases per 1000 live births, thus ranking FAS as the third most prevalent birth defect and the leading cause of mental retardation.29 "At least 5000 babies each year suffer the effects of FAS," reported Senator Strom Thurmond, "[a]s many as 50,000 babies a year suffer the milder form . . . known as [FAE]."30 In terms of dollars, FAS means "$15 million a year to 20 21 22 23 24 25 26

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Id. (citing Warren, supra note 19, at 1, 6, 7 , & 10-12). Id. at 2 6 3 . Id. Id. Id. (citing Warren, supra note 19, at 14-15, 22). Id. See generally Alcohol Warning Labels: Hearings before the Subcommittee on the Consumer of the Committee on Commerce, Science, and Transportation, 100 Cong., 2nd Sess. (1988). "[T]ertatogen (a word deriving from Greek roots 'terrato-' and '-genes,' literally, 'to make monsters') [is] the scientific expression for a chemical agent that in certain doses can cause birth defects." M . DORRIS, supra note 4 , at 146. 1988 Hearings, supra note 26, at 24 (statement of Enoch Gordis, Director of NIAAA). Id. 134 C O N G . R E C . S5549 (daily ed. May 12, 1988) (statement of Senator Strom Thurmond).

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treat FAS babies . . . $670 million to treat. . . 70,000 FAS children under 18 [and] $760 million to treat the 160,000 FAS adults."31


D. Legislative and Regulatory Background Senator Thurmond originally envisioned a rotating system of four different warning statements that would appear with equal frequency on any one brand of alcoholic beverage.32 The Alcoholic Beverages Labeling Act, which was passed in 1988, did not contain the rotating warning forms Senator Thurmond had advocated.33 Not only the mechanism for delivering the warnings was changed from Thurmond's original proposal but the language of the Act was substantially different; the transformed legislation mirrored the Cigarette Packaging and Labeling Act,34 a result directly reflecting the outcome of tobacco products liability litigation.35 Ultimately, under the 1988 legislation, the Bureau of Alcohol, Tobacco and Firearms (BATF) took jurisdiction over the labeling of alcoholic beverages. In 1978, the Food and Drug Administration (FDA) was in favor of labeling.36 The FDA, however, only had authority to issue ingredient labels under section 403(1) of the Food, Drug and Cosmetics Act of 1938.37 Because the Federal Alcohol Administration had become part of the Bureau of Alcohol, Tobacco and Firearms under the Department of

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134 CONG. R E C . S5841-42 (daily ed. May 13, 1988). See Alcohol, Drug Abuse and Mental Health Amendments of 1986, S. Rep. No. 3 3 3 , 99th Cong., 2nd Sess. 13-14 (1988) [hereinafter 1986 Senate Report]. The four warning labels were to include the following: (1) "Warning: The Surgeon General has determined that consumption of this product, which contains alcohol, during pregnancy may cause birth defects;" (2) "Warning: Drinking this product, which contains alcohol, can impair your ability to drive a car or operate heavy machinery;" (3) "Warning: This product contains alcohol and is particularly hazardous in combination with some d r u g s ; " and, (4) "Warning: The consumption of this product, which contains alcohol, can increase the risk of developing hypertension, liver disease and cancer." Id. at 14.

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See 134 CONG. R E C . S5549 (daily ed. May 12, 1988); Britt, Alcohol Manufacturer's Duty to Warn, 38 FICC Q. 247, 259-60 (1988). See also Alcohol, Drug Abuse and Mental Health Amendments of 1986, supra note 32, at 7.

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15 U . S . C . § 1331 (1990). In Cipollone v. Liggett Group, Inc., 789 F.2d 181 (3rd Cir. 1986), cert. denied, 479 U . S . 1043 (1987), the court ruled that state tort actions for failure to warn were preempted by the federal Cigarette Packaging and Labeling Act, effectively foreclosing such causes of action. See infra notes 50-56. The New Jersey Supreme Court, however, ruled in Dewey v. R. J. Reynolds Tobacco, 121 N.J. 69, 577 A.2d 1239 (1990), that state tort claims were not preempted by federal warning legislation. One of the defendants in the New Jersey suit, Brown & Williamson Tobacco Corp., announced that the decision would not be appealed to the United States Supreme Court until after the Dewey case is concluded at the trial stage. Zagor, Tobacco Group Decides Against Cigarette Appeal, Financial Times, Dec. 2 8 , 1990, at 3 . See infra notes 136-50 and accompanying text. The dramatic similarities and the subtle differences between the Alcoholic Beverages Labeling Act and the Cigarette Packaging and Labeling Act are outlined in Part HI.

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See 1978 Hearings, supra note 2 , at 85-96 (statement of Donald Kennedy, Commissioner, Food & Drug Admin.). See 1978 Hearings, supra note 2 , at 86-88.



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Treasury in 1972, "BATF [apparently was] the 'primary agency responsible for promulgation and enforcements of labeling regulations,'" although it was not until 1974 that a Memorandum of Understanding between FDA and BATF was issued to set the record straight.38 Despite worries by proponents of alcoholic beverages labeling that BATF was "ill-suited to lobby for health regulation [since the agency's] role is tax collection,"39 judicial recognition of BATF's exclusive jurisdiction was settled in Brown-Forman Distillers v. Mathews.m Under the rule-making authority of BATF, the Industry was given a full year to develop rules and to comply with the 1988 legislation.41 The recognition of FAS/FAE as a major source of birth defects emerged from the decade-long period of vigorous scientific debate. Once the relationship between alcohol consumption during pregnancy and the occurrence of the telltale collection of birth defects was established, only legislation could overcome the long-standing position of the Industry that there was no duty to warn. The ultimate language of the Alcoholic Beverages Labeling Act, however, directly reflects the conflict between a com38

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See Kaizer, I'd Like to Read the Label, But It Isn't There, 33 M E D . TRIAL TECHNIQUE Q. 4 7 , 51 (1986) (quoting Cooper, The FDA, The BATF and Liquor Labeling, 34 FDA L.J. 370, 378 & 381 (1979)). Olin, supra note 3 , at S8822. 435 F. Supp. 5 (W.D. Ky. 1976). In 1989, BATF published the following rules to govern to the labeling of alcoholic beverages: § 16.20 General On and after November 18, 1989, no person shall bottle for sale or distribution in the United States any alcoholic beverage unless the container of such beverage bears the health warning statement required by § 16.21. § 16.21 Mandatory label information (not mandatory before November 18, 1989). There shall be stated on the brand label or separate front label, or on a back or side label, separate and apart from all other information, the following statement: Government warning: [1] According to the Surgeon General, women should not drink alcoholic beverages during pregnancy because of a risk of birth defects. [2] Consumption of alcoholic beverages impairs your ability to drive a car or operate machinery, and may cause health problems. § 16.22 General requirements (a) Legibility. All labels shall be so designed that the statement required by § 16.21 is readily legible under ordinary conditions, and such statement shall be on a contrasting background. (b) Size of type. [1] Containers of more than 237 milliters (8 fl. oz.). The mandatory statement required by § 16.21 shall be in script, type, or printing not smaller than 2 millimeters. [2] Containers of 237 milliters (8 fl. oz.) or less. The mandatory statement required by § 16.21 shall be in script, type, or printing not smaller than 1 millimeter. (c) Labels firmly affixed. All labels bearing the statement required by § 16.21 shall be affixed to containers of alcoholic beverages in such manner than they cannot be removed without thorough application of water or other solvents. Implementation of the Alcoholic Beverage Labeling Act of 1988, 54 Fed. Reg. 7162 (1989) (temporary rules). See 55 Fed. Reg. 5414-01 (1990) (final rules codified at 27 C.F.R. §§ 16.20-21 (1990)).

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pelling need to prevent birth defects and the traditional judicial interpretations of the duty to warn at common law.


II. EVOLUTION OF THE DUTY TO WARN At common law, whether under a negligence theory of liability or under strict liability,42 a manufacturer may have a duty to warn about the dangers of its product. Under either theory, the product must be "unreasonably dangerous." If the dangerousness of the product is hidden, the failure to warn becomes a defect in the product. Negligence theory requires that the plaintiff prove the defect resulted from the manufacturer's fault, which must be pinpointed to a specific source. Strict liability, on the other hand, merely requires proof that the defect was present when the product left the manufacturer's control; there is no need to ascribe fault to any particular source. The application of the more liberal theory of strict liability, however, is limited to commercial sellers of products.43 A. State Tort Law Plaintiffs who have been harmed by alcohol consumption face several obstacles at common law. First, the harmful property of alcohol must be established as unreasonably dangerous. Second, it must be proven that the dangerousness is hidden. If a plaintiff can clear the first two obstacles in negligence theory, then the obstacle of being able to pinpoint the source of fault is too high. Not surprisingly, causes of action for failure to warn of the latent dangers of alcohol have met with no success under negligence theory. Under strict liability, however, the third obstacle is removed; liability for the product's safety is presumed by the fact that the defect was present 42

All except four states have adopted § 402A of the Restatement (Second) of Torts, which defines the standard known as strict liability accounting for this article's exclusive emphasis on strict liability. Delaware, Massachusetts, North Carolina, and Virginia have not yet adopted strict liability. In those states, duty to warn still must be established under the particular standards of duty-breach within a negligence standard of liability set out in the case law of each jurisdiction.

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The limitations on the application of Restatement (Second) of Torts § 402A (1965) are clearly set out in the text: (1) One who sells any product in a defective condition unreasonably dangerous to the user or consumer or to his property is subject to liability for physical harm thereby caused to the ultimate user or consumer, or to his property, if (a) the seller is engaged in the business of selling such product, and (b) it is expected to and does reach the user or consumer without substantial change in the condition in which it is sold. (2) The rule stated in subsection (1) applies although (a) the seller has exercised all possible care in the preparation and sale of his product, and (b) the user or consumer has not bought the product from or entered into any contractual relation with the seller.



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when it left the manufacturer's control. Nevertheless, plaintiffs asserting harm from alcohol consumption have not fared any better under the more liberal strict liability theory. In fact, the comments accompanying the Restatement (Second) of Torts strict liability section seemed to exclude alcoholic beverages from any duty to warn by giving "good whiskey" and "alcoholic beverages" as specific examples of where the duty to warn does not apply.44 In cases where long-term consumption or over-consumption of alcoholic beverages was involved, the courts have refused repeatedly, as a matter of law, to find a common-law duty to warn about alcohol's dangers.45 1. Protective Wall of Summary Judgment Penetrated In late 1987, the Third Circuit Court of Appeals pierced the defensive wall of the strict liability provision in Restatement (Second) of Torts section 402A, comments i and j , that "good whiskey is not unreasonably dangerous merely because it will make some people drunk."46 This was the first 44

Comment i of section 402A reads: Many products cannot possibly be made entirely safe for all consumption, a food or drug necessarily involves some risk of harm, if only from over-consumption. The article sold must be dangerous to an extent beyond that which would be contemplated by the ordinary consumer who purchases it, with the ordinary knowledge common to the community as to its characteristics. Good whiskey is not unreasonably dangerous merely because it will make some people drunk, and is especially dangerous to alcoholics; but bad whiskey containing a dangerous amount of fusel [sic] oil, is unreasonably dangerous. RESTATEMENT (SECOND) O F TORTS § 402A, comment i (1965) (emphasis added). Comment j of section 402A states: In order to prevent the product from being unreasonably dangerous, the seller is required to give directions or warning, on the container. . . . But a seller is not required to warn with respect to products or ingredients which are only dangerous, or potentially so, when consumed in excessive quantities over a long period of time, when the danger, or potentiality of danger, is generally known and recognized. Again the dangers of alcoholic beverages are an example.

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Id. (emphasis added). See Rohe v. Anheuser-Busch, I n c . , 732 F.2d 155 (6th Cir. 1984) ("ordinary consumer understands that drinking excessive amounts of beer may impair motor skills"); Garrison v. Heublein, Inc., 673 F.2d 1989 (7th Cir. 1982) (defendant's motion to dismiss on suit for damages from a 20-year vodka habit properly granted); Abernathy v. Schenley Industries, Inc., 566 F.2d 242 (4th Cir. 1977) (complaint involving death from alcohol poisoning properly dismissed on summary judgment), cert, denied, 436 U . S . 927 (1978); Malek v. Miller Brewing C o . , 749 S.W.2d 521 (Tex. A p p . 1988) (brewer cannot be held liable for injuries resulting from driving while intoxicated); Morris v. Adolph C o o r s , 735 S.W.2d 578 (Tex. A p p . 1987) (the court held that dangers of driving while intoxicated are ordinary common knowledge); Maguire v. Pabst Brewing C o . , 387 N.W.2d 565 (Iowa 1986) (brewer could not be held liable for injuries stemming from traffic accident caused by drunk driving); Desatnik v. Lem Motlow Prop. I n c . , N o . 84 C . A . 104 (Ohio A p p . Ct. 1986) (1986 W L 760) (court held § 402A comments did not impose duty to warn where death resulted from alcohol poisoning); Pemberton v. American Distilled Spirits C o . , 664 S.W.2d 690 (Tenn. 1984) (defendants' motion to dismiss properly granted on complaint involving alcohol poisoning death). RESTATEMENT (SECOND) OF TORTS § 402A, comment i (1965).


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instance of a court being willing to scrutinize closely the exact language of the comments in section 402A and to question whether the drafters of the comments could have envisioned the specific fact situation that was before the court. Instead of automatically affirming dismissal, an appellate result that had been the legacy of complaints about the dangerous properties of alcohol, the court, in Hon v. Stroh,41 found that a genuine issue of material fact existed on the question of whether the dangerous propensities of alcohol were apparent. William Hon died of pancreatitis at age 26 after drinking two to three cans of light beer four nights a week over six years. Expert evidence was presented in support of the assertion that the public does not perceive that such alcohol consumption is likely to cause disease, especially of the pancreas.48 Rather, the public generally understands that "excessive and prolonged use of alcoholic beverages [is] likely to result in disease, particularly of the liver."49 The court found it a jury question whether the deceased's alcohol consumption was within the range that "the ordinary consumer would contemplate" as dangerous.50 Up to the time of the Hon decision, the issue of the obviousness of alcohol's dangers never had been submitted to the trier of fact; the wall between questions of law and questions of fact concerning the Industry's duty to warn had been effectively penetrated. Following the decision in Hon, a Texas appeals court decision in the case of Brune v. Brown Forman Corp. ,51 poked additional holes in the section 402A comments' exclusion of alcoholic beverages from the duty to warn. Marie Brinkwater died at age 18 from acute alcohol poisoning after drinking a bottle of tequila at a college party. Against background facts of inexperienced college students "drinking straight shots of tequila," the court ruled that a summary judgment was granted in error and gave comment h of section 402A a more liberal reading.52 In ruling on the issue of what dangers of alcohol are common knowledge, the court limited the

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835 F.2d 510 (3rd Cir. 1987). Id. at 511. 49 Id. 50 Id. at 512. 51 758 S.W.2d 827 (Tex. App. 1988). 52 The Brune court found an underlying rationale for the possible exception created by the unexpected fatal result and the inexperience of the deceased in Restatement (Second) of Torts section 402A, comment h: A product is not in a defective condition when it is safe for normal handling and consumption. If the injury results from . . . abnormal consumption, as where a child eats too much candy and is made ill, the seller is not liable. Where, however, he has reason to anticipate that danger may result from a particular use, as where a drug is sold which is safe only in limited doses, he may be required to give adequate warning of the danger (See comment j), and a product sold without such warning is in a defective condition. 48



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comments that mentioned alcohol, stating that "comment i [which asserts 'good whiskey' is not unreasonably dangerous] only speaks of those characteristics that result from general intoxication and dangers peculiar to alcoholics."53 The Brune court held that section 402A comments "do not preclude liability where death results from acute alcohol intoxication. Likewise, there is no basis for concluding that alcohol should be treated any differently than any other drug or poison on the market."54 Stating its conclusion that "a genuine issue of material fact exists concerning whether tequila is safe for its intended purpose without a warning," the court reversed the summary judgment in favor of the defendant and remanded the case to district court for "proceedings consistent with [its] opinion."55 For the second time, a defendant alcoholic beverages manufacturer was evicted from the safe harbor of summary judgment and forced to face the trier of fact. The language of the Brune decision concerning what may automatically be considered a matter of law and thus an automatic cue for summary judgment was particularly strong: [W]e are not prepared to hold, as a matter of law, that the general public is aware that consumption of an excessive amount of alcohol can result in death. We realize that there is no clear line between what is and is not common knowledge, but where facts, as shown by appellant's summary judgment proof, show how easily disputed the knowledge of the fatal propensities of alcohol may be, we will not recognize it as common knowledge as a matter of law.56

2. Common Knowledge Defense Although the section 402A comments could no longer be relied upon, as a matter of law, to obtain summary judgment, the common knowledge defense still afforded the Industry an effective secondary defense against liability for failure to warn. A duty to warn is automatically cancelled by common knowledge of the danger.57 "Common knowledge encompasses

Brune, 758 S.W.2d at 829 (quoting RESTATEMENT (SECOND) OF TORTS § 402A, comment h (1965)). The Brune court then analyzed the comment as follows: A close look at comment h, reveals that in a situation where the manufacturer can anticipate a danger from a particular use, such as death resulting from acute alcohol poisoning, he may be required to give an adequate warning of that danger. Nowhere does comment h state that there is no duty to warn under [these] circumstances. 53 54 55 56 57

Id. Id. Id. Id. at 8 3 1 . Id. M . MADDEN, PRODUCTS LIABILITY § 10.5, at 387 (2d ed. 1988). See also Menard v. Newhall, 135 Vt. 5 3 , 373 A.2d 505 (1977) ( " A BB gun which is neither defectively designed nor manufactured is not dangerous beyond that which would be contemplated by the ordinary consumer").


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those facts which are so patently obvious and so well known to the community generally, that there is no question or dispute concerning their existence."58 The danger inherent in consumption of large quantities of alcohol had been ruled repeatedly to be common knowledge as a matter of law, thus allowing summary judgment for defendant alcoholic beverage manufacturers in cases where intoxication had contributed to chronic alcoholism or to injuries, as in accidents resulting from drunken driving. But the Hon and Brune courts broke ranks, ruling that, under particular factual circumstances where alcohol more directly caused fatalities, the issue of common knowledge constituted a genuine issue of material fact. The question of liability was thus to be decided by individual juries with unpredictable results, hardly a source of comfort for the Industry. 3. Implications of Pierced Defenses for FAS Given that long-term moderate beer consumption is a danger not readily recognized and given that it is a question of material fact whether the lethality of chugging a bottle of tequila is common knowledge, then a full-blown case of FAS might well penetrate the alcoholic beverages industry's at-law defenses. In Thorp v. James A. Beam Distilling Co. ,59 the plaintiffs succeeded in overcoming those obstacles of proof, which traditionally blocked access to the trier of fact as a matter of law. The issue of whether it was common knowledge that alcohol consumption during pregnancy could result in birth defects went to the jury. In Thorp, the mother was a chronic alcoholic who daily consumed half of a fifth of whiskey during her pregnancy and there was evidence she had warnings from other sources.60 The jury found for the defendant-distiller on the issue of whether the plaintiff knew her alcohol consumption was dangerous to her baby and on the issue of whether a warning label would have made any difference to a chronic alcoholic.61 The Wall Street Journal reported that "the jury's conclusion [was] that

58 59

60

61

Brune, 758 S.W.2d at 830. No. C87-1527 (11th Cir. May 17, 1989) (unpublished order). The author wishes to thank Barry Epstein and Marc S. Klein of Sills, Cummis, Zuckerman, Radin, Tischman, Epstein, & Gross, of Newark, New Jersey, who permitted her to read the plaintiffs trial brief for Thorp v. James A. Beam Distilling Co. Miller, Liquor Executives Expect More Cases Over Birth Defects, Wall St. J., May 19, 1989, at B 3 , col. 5. According to a UPI Wire Service report following the Thorp verdict: Jury forewoman Lynn Arthur reiterated the question that attracted much of the panel's attention in the light of the mother's acknowledged chronic alcohol abuse: "Would the warning really have made any difference?"


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dangers of drinking during pregnancy were common knowledge in the community at this time."62 Thorp illustrated to the Industry that without the more stable defense of summary judgment as a matter of law, the secondary defense of common knowledge still could be counted upon, at least in fact situations where a pregnant woman consumed large quantities of alcohol and where she clearly had warnings from other sources. Had the mother instead been a social or binge drinker of beer,63 the jury might not have so easily applied the common knowledge defense.64 B. Federal Statute Senator Strom Thurmond recognized the need for a federal statute to provide adequate warnings of the dangers of alcohol consumption in 1978. The Senate Hearings conducted that year did much to publicize the relationship between maternal alcohol consumption and the development of birth defects even though the attempt to pass legislation was unsuccessful. 1. Legislative Initiatives After the 1978 Hearings During the Carter Administration, just as the labeling initiative was picking up momentum, a conclusion of "premature" in a 1980 report to the President effectively put the brakes on the labeling of alcoholic beverages.65 The Reagan Administration did not show the same interest as its

"Everybody knew that a label would not have done any good," said juror Staci Gilbreth. . . .

62 63

65

"We felt she had actual knowledge about the dangers," Gilbreth said. " S h e had been told by her doctor and heard it in her alcohol treatment sessions." Finn, Distiller Not Liable for Child's Birth Defects, Proprietary to United Press Int'l, May 18, 1989. Miller, supra note 60, at B3, col. 5. Beer does not usually list alcohol as an ingredient on the label nor is there an indication of the amount of alcohol in the product. This is thought to be the reason why many people believe erroneously that a can of beer contains less alcohol than a straight shot of whiskey. See 19S8 Hearings, supra note 26, at 37 (statement of William J. McCord, Director of South Carolina Commission on Alcohol and Drug Abuse). An earlier attempt to label alcohol, a withdrawn amendment to S. 2595, "mandate[d] the disclosure of alcohol content of malt beverages on labels of such beverages and [will] permit advertising of such beverages to include alcohol content." 1986 Senate Report, supra note 32, at 12. "[Alcoholic] plaintiffs are unlikely to elicit much sympathy from jurors, and a number of experts have suggested that the claims in the Seattle case [Thorp v. James A. Beam] would have been better received had M s . Thorp not been a habitually intoxicated mother whose children had once been taken away because of conditions in the home." Miller, supra note 60, at B 3 . "[T]he National Center for Health Statistics revealed that 43 percent of respondents under age 45 had never even heard of Fetal Alcohol Syndrome." 134 CONG. R E C . S8822 (daily ed. June 2 9 , 1988). See generally Report to the President and the Congress on Health Hazards Associated with Alcohol and Methods to Inform the General Public of These Hazards: U.S. Department of the Treasury and U.S. Department of Health and Human Services, 96th Cong., 2nd Sess. (1980).


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predecessor administration in the initiative to place labels on alcoholic beverages.66 In 1986, Senators Strom Thurmond, Edward Kennedy, and Orrin Hatch sponsored an amendment to a funding bill requiring rotating warning labels for liquor containers.67 The amendment did not reach the Senate floor.68 In March of 1988, Senator Thurmond tried again by attaching his amendment to a polygraph bill but the bill was never called for a vote.69 By May of 1988, Senator Thurmond voiced his impatience with the inaction of the Industry saying he had agreed to withdraw the amendment because the Industry might "voluntarily place health warning labels on their products."70 After months passed with no proposal on the negotiating table, Senator Thurmond revived his amendment as the Alcoholic Beverage Labeling Act.71 2. Industry's New Defensive Strategy in 1988 Hearings on Senator Thurmond's bill were conducted in August of 1988, during which representatives of the Alcoholic Beverages Industry argued warning labels were unnecessary. Anheuser-Busch rebutted the labeling proponents' argument that the public needed information about alcohol's dangers by stating that the public was well informed of "negative repercussions of alcohol abuse."72 The National Beer Wholesalers' Association and The Beer Institute joined Anheuser-Busch's insistence that warning labels themselves would be ineffective, because those persons who most need to heed the warning most likely would ignore the warning.73 Representatives of the Industry argued that warning labels may be misleading because the "beneficial health effects" of "moderate use of alcoholic beverages" would be contradicted.74 Industry representatives also cautioned that the public suffers from being " 'over-warned' by the government."75 Noticeably absent, however, was the vigorous attack on the scientific methodology and resulting scientific conclusions concerning the relationship between maternal alcohol consumption and the occurrence of FAS at 66 67 68 69

70 71 72 73 74

75

See Britt, supra note 3 3 , at 258. See generally 1986 Senate Report, supra note 32. See Rubin, Bad News About Booze, 60 Bus. & S o c . REV. 4, 5-6 (1987). Alcohol Beverage Labeling: Report of the Senate Committee on Commerce, Science and Transportation, S. REP. N O . 596, 100th Cong., 2nd Sess., at 3 (1988). 134 CONG. R E C . S5499 (daily ed. May 12, 1988). S. 2047, 100th Cong., 2nd Sess. (1988). See supra note 1. 1988 Hearings, supra note 2 6 , at 162. Id. at 156, 162-63, & 167. Id. at 156 (statement of Ronald R. Rumbaugh, President of the National Beer Wholesalers' Association). Id. at 167 (statement of a representative of the Beer Institute).


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birth voiced by the Industry through DISCUS in the Senate Hearings in 1978.76


3. 1988 Legislation Opening with a preamble stating the twofold purposes of the warning legislation as providing that "a nationally uniform, nonconfusing warning notice on each container," and that "commerce and the national economy may be protected" by such uniform requirements, the Alcoholic Beverages Labeling Act was passed on November 18, 1988.77 A conspicuously placed two-part warning label would be required on every container of domestically produced alcoholic beverages beginning one year after the Act's passage.78 The first part of the warning label would be directed to the pregnant consumer: "Government warning: [1] According to the Surgeon General, women should not drink alcoholic beverages during pregnancy because of the risk of birth defects."79 Rules were promulgated on February 16, 1989.80 The requirement of warning labels became effective on November 18, 1989.81 Proponents of warning labels for alcoholic beverages at last had achieved their goal. Considering the long history of the Industry's resistance to assuming a duty to warn, either at common law or by statute, advocates for warning labels were surprisingly quiet about their triumph. The Alcoholic Beverages Labeling Act itself did not even have the customary Senate Report to accompany its appearance for a vote.82 Little notice was taken of the fact that the language of the bill reported for the vote was substantially different from the language of the bill proposed during the 1988 Hearings.83 Following the complaints of Senators Thurmond and Gore that the size of the warning's lettering mandated by BATF's announced rules was too small, new rules were issued in February of 1990 requiring the warning to "appear in all-capital letters and stand out in a darker type, known as bold face."84

76 77 78 79 80 81 82

See generally 1988 Hearings, supra note 2 6 . See infra notes 112-13 and accompanying text. See supra note 1. F o r full text of the warning see supra note 4 1 . See 5 4 Fed. Reg. 7162 (1989). See 27 C.F.R. §§ 16.20-22 (1989). " N o Senate or House Report was submitted with this [P.L. 100-690] legislation." 1988 U . S . C O D E C O N G . & A D M I N . N E W S (102 Stat.) 5937.

83

84

Compare 2 7 U . S . C . §§ 213-19 (1990) with 1988 Hearings, er's written inquiries to the Beer Institute were unanswered Thurmond's office. Kelly, Alcohol Health Warnings: Less Filling?, Washington complete report on the final rule-making process by BATF see 55 Fed. Reg. 5414-01 (1990).

supra note 2 6 , at 7-11. This researchas were telephone inquiries to Senator Post, F e b . 1 3 , 1990, at A19. F o r the for alcoholic beverage warning labels,

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i n . THE IMPACT OF THE TOBACCO CASES Why did the Industry acquiesce to the statutory imposition of the duty to warn by the Alcoholic Beverages Labeling Act when it resisted so fiercely the common-law imposition as well as the voluntary assumption of that same duty? The answer comes from an examination of the tobacco liability cases.85


A. Barriers to Tobacco Torts Of the hundreds of tort claims made against the cigarette manufacturers, not one was successful until Dewey v. R. J. Reynolds Tobacco Co.,*6 which in August of 1990 broke ranks with the "consensus . . . among federal courts."87 In Dewey, the New Jersey Supreme Court concluded that regulation of the Tobacco Industry through state tort liability did not sufficiently conflict with the Cigarette Packaging and Labeling Act to bring causes of action in tort into the realm of federal preemption.88 While Dewey stands for the proposition that federal warning label statutes do not necessarily preempt state tort causes of action, the more broadly held view of the law throughout the country is reflected in Cippolone v. Liggett Group, Inc.*9 In Cippolone, the federal court had found that the requirement of a warning label by federal law preempted any state tort claim.90 Rose Cippolone smoked cigarettes for 42 years; she developed terminal lung cancer. Her cause of action claimed that the "defendants' cigarettes were unsafe and defective . . . and the defendants were subject to liability for their failure to warn of the hazards of cigarette smoking."91 The court held that pursuant to the 1966 federal legislation, which mandated warning labels on cigarette packaging, Congress had impliedly intended the federal government to "occupy the field" concerning cigarette warnings, thus preempting all state regulation.92 Because federal law does not include tort liability in private rights of action, when plaintiffs injured by cigarettes are cut off from using state tort law, they are effectively blocked from any remedy. An industry, therefore, 85

86 87

88 89 90 91 92

See Cipollone v. Ligget Group, Inc., 789 F.2d 181 (3rd Cir. 1986), cert. denied, 479 U . S . 1043 (1987). See also Pennington v. Vistron Corp., 876 F.2d 414 (5th Cir. 1989); Roysden v. R. J. Reynolds Co., 849 F.2d 230 (6th Cir. 1988); Palmer v. Liggett Group, Inc., 825 F.2d 620 (1st Cir. 1987); Stephan v . American Brands, Inc., 825 F.2d 312 (11th Cir. 1987); Kotler v. American Tobacco Co., 685 F. Supp. 15 (D. Mass. 1988). 121 N . J . 69, 577 A.2d 1239 (1990). Id. at 1246. The Dewey court rejected the principle of " c o m i t y " among courts and concluded that the New Jersey Supreme Court was not bound by "lower-federal-court-cases." Id. at 1244. Id. at 1247. 789 F.2d 181 (3rd Cir. 1986), cert. denied, 479 U . S . 1043 (1987). Id. at 187-88. Id. at 184. Id. at 187.



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which can establish Congress's intention to have federal law exclusively govern an enterprise, will be able to rely on complete insulation from causes of action under state law. Had the Alcoholic Beverages Industry voluntarily assumed a duty to warn, as Senator Thurmond urged, it would have remained liable to actions under state tort law. Under state tort law, the Industry would have been forced to cope with varying standards for effective warning from state to state. If a duty to warn has been imposed, however, by the federal government and Congress has either expressly or impliedly shown its intent for the federal regulation to occupy the field, the Industry could hope to escape all state tort liability. State tort liability had been closing in on the Industry since Hon, Brune, and Thorp. All the Industry needed was a labeling law close enough to the one that stood between the Tobacco Industry and state tort liability to activate the preemptive shield. If the federal statute contained the elements that the Cippolone court found to be the right combination from which implied preemption could be extrapolated, then the protection against state tort liability afforded by the principle of federal preemption was assured. Moreover, the United States Supreme Court had denied certiorari to Cippolone's appeal, thus signaling the relative finality of the finding that federal warning label legislation implied preemption.93 B. Preemption Mechanism The preemptive power of federal law over state law is rooted in Article VI of the United States Constitution.94 The Supremacy Clause has long-standing recognition95 and under it, preemption may be found in any one of five ways. "Congress may preempt state law by express state93

Because the New Jersey Supreme Court decision was in favor of the plaintiff and in direct contradiction to Cippolone, for which the United States Supreme Court had denied certiorari, most commentators expected the Tobacco Industry to immediately appeal the outcome of Dewey v. R. J. Reynolds, 121 N . J . 6 9 , 577 A.2d 1239 (1990), to the United States Supreme Court. See Deveny & Freedman, Warnings Don't Preempt Claims, Wall St. J., July 27, 1990, at B l , col. 3 ; Hevesi, Warning Labels Don't Protect Cigarette Makers, N.Y. Times, July 2 7 , 1990, at A l . Surprisingly, the defendants in Dewey do not seem eager to take the question of whether the federal cigarette labeling statute impliedly preempts state tort law to the Supreme Court. One defendant, Brown & Williamson Tobacco Corporation, announced that it would wait on the outcome of the trial on the merits, confident of winning at that level. See Zagor, supra note 35, at 3 .

94

The Supremacy Clause states: This Constitution, and the Laws of the United States which shall be made in Pursuance thereof; and all Treaties made, or which shall be made, under the Authority of the United States, shall be the supreme Law of the Land; and the Judges in every State shall be bound thereby, any Thing in the Constitution or Laws of any State to the Contrary notwithstanding. U . S . C O N S T . art. VI,

95

§ 2.

Gibbons v. Ogden, 9 Wheat. 1 (1824). The Supreme Court declared the federal government's preemptive power: "[W]hen Congress and the States have power to legislate over the subject, the power of Congress, when exercised, controls and extinguishes the State power." Id. at 19.


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ment."96 When Congress offers no express statement, a court may find implied intent by determining that Congress intended "to occupy the field" because the legislation was "so pervasive that no room was left for states to supplement it."97 "Where Congress has not wholly superseded state regulation in a specific area, state law is preempted 'to the extent that it actually conflicts with federal law.' " 98 In addition, when a "conflict arises where 'compliance with both federal and state regulations is a physical impossibility,' " preemption may be found.99 Finally, preemption may be found "where state law 'stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.' "10° For application to the tobacco cases, the opinion in Palmer v. Liggett Group, Inc.m states the rationale of preemption102 most eloquently and demonstrates how the terms of the Federal Cigarette Labeling and Advertising Act103 work to provide a preemptive effect. Joseph Palmer, who smoked three to four packs of cigarettes a day, died of lung cancer at age 49. In an interlocutory appeal of the granting of the defendants' motion to dismiss, the Palmer court carefully revisited the rationale of preemption, the sole issue before it. To begin its analysis, the Palmer court reasoned that just as Congress may expressly state its intention to preempt state law, Congress also may expressly state its intention to refrain from preempting state law. A statement clarifying Congress's intention not to preempt is called a "savings clause." The Palmer court began its analysis of the Cigarette Packaging and Labeling Act by pointing to the "omission by Congress of a savings clause."104 The court assessed high priority to this absence because it gave the court permission to look for preemptive effect.105 In the absence of a savings clause, the Palmer court next found the phrase "[n]o requirement shall be imposed by state law" to be an indicator of preemptive intent.106 Once the possibility of preemption was established, the Palmer court turned to the dual purposes set out in the Cigarette Labeling Act's 96

Cippolone, 789 F.2d at 185 (citing Jones v. Rath Packing C o . , 4 3 0 U . S . 5 1 9 , 525 (1977)). Id. (citing Fidelity Fed. Savings & Loan Ass'n v. De le Cuesta, 458 U . S . 141 (1982)). 98 Id. (citing Pacific Gas & Elec. C o . v. Energy Resources Conservation & Development Comm'n, 461 U . S . 190, 204 (1982)). 99 Id. (citing Florida Lime & Avocado Growers, Inc. v. Paul, 373 U . S . 132, 142-43 (1963)). 100 Id. (citing Hines v. Davidowitz, 312 U.S. 52, 67 (1941)). 101 825 F.2d 620 (1st Cir. 1987). 102 " [ T ] h e gist of preemption is whether Congress (expressly) did or (impliedly) meant to displace state law o r state l a w concepts in enacting the federal l a w . " Id. at 6 2 5 . 103 15 U.S.C. § 1331 (1990). 104 Palmer, 825 F.2d at 623 (emphasis in original). 105 Id. 106 Id. 97



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preamble.107 The court reasoned that the first purpose, educating the public, had to be balanced with the second purpose, protecting the Tobacco Industry from diverse, nonuniform labeling requirements.108 Congress had mandated the precise wording of the warning, thus bolstering the argument that the federal government intended to occupy the field and that the federal government was entitled to exclusive control of all matters relating to the regulation of that warning under the Supremacy Clause of the Constitution. The Palmer court stated: "[To] permit the interposition of state common law actions into a well-defined area of federal regulation would abrogate utterly the established scheme of health protection as tempered by trade protection."109 Once a court has discovered evidence that it is free to look for implied preemption, an evaluation of the extent to which regulation is meant to exclude any competition from the states determines whether state law will be preempted. In the analytical scheme outlined by the Palmer court to find implied preemption for the Tobacco Industry, the Alcoholic Beverages Labeling Act fits into each crucial slot. Significantly, the Alcoholic Beverages Labeling Act lacks a "savings clause,"110 the first indication that a court may be free to look for implied preemption. Like the Cigarette Act's statement excluding additional regulation by the states, a second indicator that judicial search for preemption may move forward, the Alcoholic Beverages Labeling Act has a similar provision1" and the caveat is re-

107

T h e preamble of the Cigarette Packaging and Labeling Act outlines the crucial dual purposes upon which preemption reasoning is based: It is the policy of the Congress, and the purpose of this chapter, to deal with cigarette labeling and advertising with respect to any relationship between smoking and health, whereby— (1) the public may be adequately informed that cigarette smoking may be hazardous to health by inclusion of a warning to that effect on each package of cigarettes; and (2) commerce and the national economy may be (a) protected to the maximum extent consistent with this declared policy and (b) not impeded by diverse, nonuniform, and confusing cigarette labeling and advertising regulations with respect to any relationship between smoking and health. 15 U . S . C . § 1331 (1990). In 1984 the section w a s amended to read: "(1) the public may be adequately informed about any adverse health effects of cigarette smoking by inclusion of warning notices on each package of cigarettes and in each advertisement of cigarettes . . . ." 15 U . S . C . § 1331(1) (Supp. II 1984). 108 Palmer, 825 F.2d at 623. 109 Id. at 626. 110 A savings clause appeared in the original draft of the legislation. See 1988 Hearings, supra note 26, at 11. 111 Although not an express statement of Congressional intent to preempt state law, the following exclusion of additional state requirements may be evidence of implied preemption. N o statement relating to alcoholic beverages and health, other than the statement required by section 204 of this title [27 U . S . C . § 215], shall be required under State law to be placed on any container of an alcoholic beverage, or on any box, carton, or other package, irrespective of the material from which made, that contains such a container. 27 U . S . C . § 216 (1988).


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peated in the regulations."2 Most importantly, for the actual test of whether Congress intended the federal government to "occupy the field," the similarities between the "purpose and policy" section of the Cigarette Labeling and Advertising Act and the Alcoholic Beverages Act" 3 are striking. The preamble of the Alcoholic Beverages Act was clearly designed to be interpreted by the same analytical scheme used by the Palmer court. Lining up the essential elements that allowed the court to rule in favor of implied preemption in the case of the Cigarette Packaging and Labeling Act against key provisions of the Alcoholic Beverages Labeling Act suggests an inescapable conclusion. That conclusion is the Alcoholic Beverages Labeling Act was deliberately drafted to take advantage of the protection against state tort liability that the Cigarette Industry still enjoyed without contradiction in 1988." 4 C. Exceptions to the Preemption Principle Frustrated tobacco plaintiffs have tried to poke a number of holes into the implied preemption provided to the tobacco manufacturers. Because states are sovereign entities under the Constitution, the federal courts have traditionally been reluctant to intrude on the jurisdiction of the states in matters such as health and safety. Indeed, the presumption concerning 112

113

114

The regulations governing the warning label requirements repeat the concept that federal law is to be exclusively applied: No statement relating to alcoholic beverages and health, other than the statement required by § 16.21, shall be required under State law to be placed on any container of an alcoholic beverage, or on any box, carton, or other package, irrespective of the material from which made, that contains such a container. Implementation of the Alcoholic Beverages Labeling Act of 1988, 54 Fed. Reg. 7164 (1989) (temporary rules). For permanent rules, see 55 Fed. Reg. 5414-01 (1990). Portions of the preamble to the Alcoholic Beverages Labeling Act appear to mirror the Cigarette Packaging and Labeling Act: (1) the public may be adequately reminded about any health hazards that may be associated with the consumption or abuse of alcoholic beverages through a nationally uniform, nonconfusing warning notice on each container of such beverages; and (2) commerce and the national economy may be (a) protected to the maximum extent consistent with this declared policy, (b) not impeded by diverse, nonuniform, and confusing requirements for warnings or other information on alcoholic beverage containers with respect to any relationship between the consumption or abuse of alcoholic beverages and health, and (c) protected from the adverse effects that would result from a noncomprehensive program covering alcoholic beverage containers sold in interstate commerce, but not alcoholic beverage containers manufactured and sold within a single state. 27 U.S.C. § 215 (1988). Following the surprising decision of the New Jersey Supreme Court in Dewey v. R. J. Reynolds, see infra notes 136-50 and accompanying text, that the Cigarette Packaging and Labeling Act did not preempt state law in New Jersey, the Alcoholic Beverages Industry was silent about how the possible erosion of the preemption principle might affect their own liability under their newly assumed duty to warn about the dangers of alcohol consumption.


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whether federal law preempts state law historically has given the benefit of doubt to the states.


1. Traditional Reluctance to Preempt Federal statutes and regulations requiring DPT vaccination,115 for example, did not insulate the manufacturer from tort liability for failure to warn of adverse reactions in Hurley v. Lederle Laboratories."6 In Hurley, parents of a child who had a severe reaction to a DPT vaccination sued the manufacturer in a products liability action. The Fifth Circuit Court of Appeals reversed the partial summary judgment awarded in district court to the manufacturer, holding that federal regulatory law did not preempt state products liability law.117 "Courts should be reluctant to find that federal law implicitly preempts state law,"118 warned the court. The court found that "FDA regulation does not generally preempt stricter state standards for medical products [or] for the duty to warn of product risks."119 2. State Control of Health and Safety 120

Nor did federal regulation for a national blood supply policy provide a preemptive shield in Hillsborough County v. Automated Medical Laboratories, Inc.nx Automated Medical Laboratories collected blood plasma from donors, separating it into plasma and other blood products by means of plasmapheresis and returning red cells to the donor. The process comes under federal regulation. In 1980, Hillsborough County, Florida, adopted ordinances to impose a license fee and to inspect the premises of plasmapheresis centers. Automated Medical Laboratories challenged the constitutionality of the Hillsborough ordinances in district court seeking both declaratory and permanent injunctions against the county on the grounds that federal regulation preempted the county ordinances. The federal district court found in favor of Automated Laboratories but the Eleventh Circuit reversed. Stating "the presumption that state and local regulation of matters related to health and safety is not invalidated under the Supremacy Clause,"122 the United States 115

See Federal Food, Drug & Cosmetic Act, 2 1 U . S . C . § 301 (1987); Public Health Service Act, 4 2 U . S . C . §§ 247b, 262 (1987). 116 863 F.2d 1173 (5th Cir. 1988). 117 Id. at 1177. 118 Id. at 1176 (emphasis in original). 119 Id. at 1177. 120 See Public Health Service Act, § 351(a), 4 2 U . S . C . § 262(a) (1984). 121 471 U . S . 7 0 7 , 715-23 (1985). 122 Id. at 7 1 5 .

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Supreme Court overturned the appeals court decision, thus allowing Hillsborough County to continue regulating plasmapheresis centers.


3. Significant Absence of Other Remedies Nor did the Atomic Energy Act provide a barrier against punitive damages in Silkwood v. Kerr-McGee Corp.m Karen Silkwood was contaminated by plutonium at Kerr-McGee's Cimmarron plant in Oklahoma. After her death in an automobile accident, her father brought an action in state tort law against Kerr-McGee for allowing Silkwood to become contaminated. The jury verdict, handed down in federal district court, was in favor of Silkwood, awarding compensatory and punitive damages. The defendants appealed, arguing that because their industry came under federal licensing and regulation by the Nuclear Regulatory Commission and the Atomic Energy Act,124 state tort causes of action against KerrMcGee were preempted. The Eleventh Circuit reversed the district court decision on the issue of punitive damages. A narrow majority of the United States Supreme Court reversed the appeals court reinstating the verdict for punitive damages. In a detailed examination of the legislative history of the Atomic Energy Act, the high Court concluded: [T]here is no indication that Congress even seriously considered precluding the use of such [state law] remedies [for those suffering injuries from radiation] either when it enacted the Atomic Energy Act in 1954 or when it amended it in 1959. This silence takes on added significance in light of Congress' failure to provide any federal remedy for persons injured by such conduct. It is difficult to believe that Congress would, without comment, remove all means by judicial recourse for those injured by illegal conduct.125

4. Exceptions' Impact on Tobacco Cases in Federal Court In Pennington v. Vistron Corp.,™ a tobacco liability case, plaintiffs attempted to capitalize on the "presumption against preemption that applies to health and safety regulation by the states."127 Kenneth Pennington died of cancer of the esophagus. He had been exposed to several toxic chemicals on the job at the Uniroyal plant in Baton Rouge.128 Pennington's wife appealed the district court's summary judgment in favor of the defendant. 123

464 U.S. 238 (1984). 42 U.S.C. § 2011 (1976 & Supp. V ) . 125 Silkwood, 464 U.S. at 2 5 1 . 126 876 F.2d 414 (5th Cir. 1989). 127 Pennington v. Vistron Corp., 876 F.2d 414 (5th Cir. 1989). See also Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947). 128 Acrylonitrile, a known carcinogen, plus 1, 3 butadiene and styrene were among the chemicals to which Pennington was exposed. Pennington, 876 F.2d at 416. 124



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The Fifth Circuit found the Cigarette Packaging and Labeling Act preempted some of Pennington's claims but not all.129 The court stated that the federal labeling statute "reflects a delicate political balance between two important goals: warning the public of the hazards of cigarette smoking and protecting the national economy."130 Jury verdicts in state courts based on the premise that Congress did not "sufficiently protect the citizens of a state from the risks of smoking would clearly upset this carefully balanced federal scheme."131 Plaintiffs in tobacco products liability suits found hope in the Cippolone court's statement that not "every aspect" of the relationship between cigarettes and health was "brought under the exclusive control of the federal government."132 But the best that could be accomplished, until the surprising result in Dewey v. R. J. Reynolds,133 was the culling out of their pre-1966 claims as seen in Pennington's case.134 5. New Jersey's Supreme Court Reaches Opposite Result In its refusal to accept that state law claims are automatically preempted by the Cigarette Packaging and Labeling Act, the New Jersey Supreme Court in Dewey examined the Silkwood decision.135 The court found "Silkwood . . . relevant because it suggests Congress may be willing to tolerate the regulatory consequences of the application of state tort law even when direct state regulation is preempted."136 The New Jersey Supreme Court, moreover, found the United States Supreme Court's recent decision in English v. General Electric Co.ni to give additional support to the notion that state and federal regulation may coexist without preemption. In English, a state tort action for retaliatory discharge of a nuclear power plant employee was held not preempted even 129

In addition t o complaining of the defendant's failure t o adequately warn of cigarette smoking's dangers, Pennington had argued that cigarettes were unreasonably dangerous per se and that her husband had been harmed by cigarettes prior t o 1966 when the Cigarette Packaging and Labeling Act became effective. The court ruled the complaints of per se danger and pre-1966 harm were not preempted. Id. at 424. However, the court found summary judgment o n the non-preempted claims to b e correct because Pennington did not present "specific facts to show there w a s a genuine issue for trial." Id. at 425. 130 Id. at 4 2 1 . 131 Id. 132 Cippolone, 789 F.2d at 186. 133 121 N . J . 6 9 , 577 A.2d 1239 (1990) (New Jersey Supreme Court held state tort law not preempted by the Cigarette Packaging a n d Labeling Act and state courts a r e not bound b y decisions in federal appeals courts). 134 See Pennington, 8 7 6 R 2 d at 424. See also Kotler v . American Tobacco C o . , 685 F. Supp. 15 ( D . Mass. 1988) (no retroactive preemptive effect). 135 Dewey, 5 7 7 A.2d at 1249. 136 Id. 137 110 S. Ct. 2270 (1990).


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though the Energy Reorganization Act138 provided federal regulations and remedies.139 As additional evidence that state tort law and federal regulation need not necessarily conflict, the New Jersey court cited Ferebee v. Chevron Chemical Co.xw In Chevron, a worker alleged that the manufacturer did not adequately warn employees about the skin exposure danger of paraquat. The manufacturer was regulated by the Federal Insecticide, Fungicide, and Rodenticide Act.141 The Chevron court found that a state could impose stricter standards on an enterprise even though federal regulations also governed the conduct of that enterprise.142 If federal regulation of labeling automatically provided preemption of state tort claims, the New Jersey court reasoned in Dewey, why were causes of action such as the one in MacDonald v. Ortho Pharmaceutical Corp.143 viable? In MacDonald, the 26-year-old plaintiff complained that the manufacturer of Ortho-Novum contraceptive pills did not adequately warn her that the product could cause blood clotting. Following three years use, the plaintiff suffered a stroke destroying 20% of her brain tissue. After a jury ruled in MacDonald's favor, the judge granted the defendant's motion for judgment notwithstanding the verdict on the grounds that the defendant did not owe a duty to MacDonald. The Supreme Judicial Court of Massachusetts reinstated the jury verdict in the plaintiffs favor, finding that even though federal regulation controls warnings accompany oral contraceptives for the purpose of "ensuring] that patients are 'fully informed of the benefits and risks involved'"144 and for the purpose of providing " 'precise and nationally uniform' labeling,"145 manufacturers of oral contraceptives must still face liability in state courts. As a final example of where state and federal regulation are allowed to coexist, the New Jersey court offered Burch v. Amsterdam Corp.146 Burch was injured in an explosion when he failed to turn off the pilot light in a gas stove while he was applying adhesive for a new tile floor. When the Superior Court of the District of Columbia granted the defendant's motion for summary judgment, the plaintiffs appealed to the District of Columbia Court of Appeals, which reversed and remanded the cause of action. The Federal Hazardous Substances Act147 was found to prescribe 138

42 U.S.C. § 5851 (1990). English, 110 S.Ct. at 2274-81. 140 736 F.2d 1529 (D.C. Cir.), cert. denied, 469 U.S. 1062 (1984). 141 See 7 U.S.C. §§ 136-136y (1990). 142 Ferebee, 736 F.2d at 1540. 143 394 Mass. 131, 475 N.E.2d 65 (1985). 144 Dewey, 577 A.2d at 1251 (quoting 4 3 Fed. Reg. 4220 (1978); 21 C.F.R. § 310.501(a) (1984)). 145 Id. (quoting 21 C.F.R. § 301.501(a)(2)(1) (1984)). 146 366 A.2d 1079 (D.C. 1976). 147 15 U.S.C. §§ 1261-77 (1990). 139



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minimum warnings and "does not immunize the manufacturer of a hazardous product from failure to supply an adequate warning."148 On the basis of these examples, the Dewey court determined the silence of Congress on the subject of preemption of state tort law in the Cigarette Packaging and Labeling Act most significant. "We are convinced that had Congress intended to immunize cigarette manufacturers from packaging, labeling . . . and warning claims, it knew how to do so with unmistakable specificity."149 Whether the conflicting view of the preemptive power of federal labeling statutes held by the New Jersey Supreme Court will be tested against the holdings of the federal appellate courts in the forum of the United States Supreme Court depends on the outcome of the remanded Dewey v. R. J. Reynolds case in New Jersey state court. One defendant has announced the decision will not be appealed until the outcome in the trial court has been determined.150 The fate of the Alcoholic Beverages Industry's supposed preemption protection under the auspices of the Alcoholic Beverages Labeling Act will be inextricably tied to that outcome. D. Are Tobacco Torts and FAS/FAE Torts Parallel? Tobacco plaintiffs' unsympathetic reception by federal courts may hinge on the voluntary nature of their consumption. Because the consumer is directly affected by his or her own free choice to smoke, the courts show little enthusiasm to shape remedies when the federal doctrine of preemption closes the door to state tort remedies. In the case of Fetal Alcohol Syndrome, however, the harmed person, an infant, had no choice. Because of the dramatic difference between who suffers the actual harm in tobacco products liability cases and who suffers the actual harm in FAS/FAE products liability cases, courts may take a different attitude toward shaping remedies within the context of traditional preemption principles. / . Different Attitude Toward the Plaintiff A reflex reaction might be to say that the mother who chooses to drink suffers the loss by being forced to raise a damaged child. But Michael Dorris, in his recent book, The Broken Cord, pointed out that many FAS children are orphaned or abandoned by mothers ill-equipped to deal with the complexities of FAS disabilities.151 Courts will be confronted by deformed infants with brain lesions and 148

Dewey, 5 7 7 A.2d at 1251 (citing Burch, 3 6 6 A.2d at 1085). Id. 150 Zagor, supra note 3 5 , at 3 . 151 " A study of FAS children revealed almost none . . . lived with their birth mothers beyond their third year, if for that long . . . 6 9 percent of their biological mothers were . . . deceased." M . DORRIS, supra note 4 , at 2 3 8 .

149

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life-long prospects of illness and retardation. The courts will hear mothers who insist they never saw the warning label or they did not understand it. Will the courts be as ready to invoke the preemption doctrine and foreclose all remedies to children who will likely become public burdens?


2. Effective Alcohol Warning May Be Impossible Products liability cases against the Industry for FAS/FAE injuries are inevitable because the alcoholic beverages warning label cannot effectively warn.152 Nowhere has the case for warning labels' ineffectiveness been more convincingly argued than by the various spokespersons for the Industry in the Senate Hearings.153 Warning labels are not cost efficient, one Industry representative asserted.154 Warning labels are misleading because they suggest general "dire effects" when moderate alcohol consumption may be beneficial, the Industry has argued.155 The warning label approach diverts attention from more comprehensive solutions to alcohol abuse, cautioned Industry representatives.156 The most dramatic difference between cigarette and alcohol labeling is the fact that many consumers of alcohol, especially women, never handle the package that displays the warning.157 Each time a smoker handles a cigarette, he or she is likely to see the warning label on the package. However, beer and wine are often consumed in the absence of the container or package, especially in bars or restaurants, thus reducing the likelihood that the consumer will be exposed to the warning with every use of the product.

152 "[X]here is not a single scientific study which would indicate that health warning labels o n containers of alcoholic beverages would . . . raise the public's awareness." 1988 Hearings, supra note 2 6 , at 159 (statement of David J. Pittman, Professor of Sociology, Washington University). AnheuserBusch's spokesman quoted a consultant to NIAAA, W. Kipp Viscusi, that the extent of the risk is unknown, that precautionary action is not well defined and that a warning cannot accurately be conveyed in a warning label. Id. at 164. T h e spokesman for the Beer Institute suggested warning labels m a y be "counter-productive" because " t h e public is generally feeling 'over-warned' by the government." Id. at 167. 153 In comments submitted to BATF in 1978, Distilled Spirits Council of the United States (DISCUS) categorically stated "[w]arning labels are substantially ineffective." 1978 Hearings, supra note 2, at 2 7 7 . 154 Id. at 282. DISCUS estimated a cost of $24.44 per pregnancy to warn. 155 Id. at 284. Augustus H . Hewlett, President of the Alcohol Policy Council, suggested in the 1988 Hearings that warning labels would cause "debilitating anxiety" and even hysteria among pregnant women. 1988 Hearings, supra note 2 6 , at 129. 156 Id. at 285-86. Ronald R. Rumbaugh, President of the National Beer Wholesalers' Association, said people w h o need warnings most are most likely to ignore them. 1988 Hearings, supra note 2 6 , at 156. Ten years earlier, the argument was made for physician education and general dissemination of information in lieu of warning labels. 1978 Hearings, supra note 2 , at 287-88. 157 1978 Hearings, supra note 2, at 280.


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3. Quandary for the Alcoholic Beverages Industry In the absence of evidence that warning labels work, Congress took the approach that warning labels could do no harm.158 In reality, however, the imposition of a duty to warn on the Alcoholic Beverages Industry can do plenty of harm.159 The Industry now finds itself with a statutory duty to warn, which it successfully avoided at common law. But the Industry also finds itself with a statutorily imposed method of warning that probably is ineffective.160 FAS plaintiffs will compare the Alcoholic Beverages Labeling Act of 1988 with the Cigarette Labeling Act in search for loopholes. The "purpose and policy" statement of the Alcoholic Beverages Labeling Act has an ominous shadow cast across it by the Senate report of its predecessor, the failed 1986 amendment161 that stated the intent of the bill was not preemptive.162 In the Congressional bargaining that eventually produced the final version,163 the Alcoholic Beverages Labeling Act became a near mirror

158

See 1988 Hearings, supra note 2 6 , at 164 & n. 11 (statement of a representative of Anheuser-Busch, Inc.). 159 " j f individuals are warned about hazards through overly broad warning labels that lack believability then these efforts diminish the credibility of all warnings programs." 1988 Hearings, supra note 2 6 , at 90 (statement of W. Kipp Viscusi). 160 " T h e warning label itself will do more harm than good. The [American Council on Alcoholism]'s opinion [is labels will erode] the disease concept." 1988 Hearings, supra note 2 6 , at 101 (statement of Robert C . Lloyd, Vice-Chair of Directors, American Council on Alcoholism). 161 S. 2595. See supra note 3 2 . 162 W h e n Senator Thurmond first introduced the amendment in 1986 which w a s t o become the Alcoholic Beverages A c t of 1988, the Senate Report contained a clear statement that the measure w a s not designed o r intended to preempt state law. Finally, the Committee wants to emphasize that by including provisions in S.2595 which requires health warnings on alcoholic beverage containers for alcoholic beverages, and by preempting State and local laws requiring additional health warnings, it does not intend t o preempt a State's ability to control the promotion and advertising of alcoholic beverage products and does not intend to preempt product liability suits in State or Federal courts based on failure to warn. 1986 Senate Report, supra note 3 2 , at 14 (emphasis added). 163 T h e originally proposed bill did contain a savings clause that stated: "Nothing in this section shall be construed to relieve any person from liability under Federal or State law to any other person." 1988 Hearings, supra note 2 6 , at 1 1 . T h e savings clause w a s removed by the time S. 2047 reached the floor. T h e caveat against preemption w a s significantly watered down in the Senate Report for the 1988 version: The Committee emphasizes that the bill, as reported, preempts State law requiring the imposition of statements relating to alcoholic beverages and health o n any container or b o x , carton, or other package which contains the container. T h e provision should not be read to indicate that the states do not have the authority to impose standards to protect the health and safety of their citizens from hazards associated with the products they consume. Therefore, the bill should not be construed to affect other requirements of the States with regard to alcoholic beverages or other products (e.g., warning posters or notices in bars or other establishments). 1988 Senate Report, supra note 2 6 , at 7 (emphasis added).


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image of the Cigarette Packaging and Labeling Act.164 The new law had no savings clause and contained a preemption of state regulations governing warning labels on containers, the two prerequisites that the Palmer court took as permission to look for implied preemption. The Alcoholic Beverages Labeling Act seemed in 1988 to offer the Industry a chance to firmly close the door of state tort liability for injuries resulting from consumption. The peculiar elements present in the Cigarette Packaging and Labeling Act—absence of a "savings clause" and a dual purpose emphasizing economic protection as well as warning—had combined to afford the Tobacco Industry insulation from state tort claims as a matter of law. By agreeing to accept a federal labeling statute with all of the key elements that could be relied upon to add up to a finding of implied preemption in federal court, the Alcoholic Beverages Industry looked forward to a restoration of the defensive wall provided by summary judgment that decisions in Ron v. Stroh,165 Brune v. Brown Forman Corp.,166 and Thorp v. James A. Beam Distilling Co.161 had penetrated. Since 1988, however, the very argument in support of implied preemption upon which both the Tobacco and the Alcoholic Beverages Industries have relied for state tort protection has been called into serious question by the New Jersey Supreme Court in its Dewey v. R. J. Reynolds16* decision. Even if the preemption principle outlined by federal courts in the tobacco cases withstands assault by the New Jersey Supreme Court's reasoning when, and if, the issue reaches the forum of the United States Supreme Court, fundamental differences between tobacco and FAS/FAE suits regarding the nature of the harm, the identity of the victim, and the inherent efficacy of warnings may yet render the Alcoholic Beverages Industry vulnerable to suit under state tort law. The grounds for implied preemption are not solid, so even minor differences may penetrate the preemptive wall. IV. A LOOK TO THE FUTURE The obvious intention of the drafters of the Alcoholic Beverages Labeling Act was to produce legislation that would mirror the Cigarette Packaging and Labeling Act, especially for those key elements federal courts found essential to invoke implied preemption of state tort claims. The Pennington v. Vistron Corp.169 decision gives a clue that federal courts, even 164 165 166 167

168 169

See Rubin, supra note 6 8 , at 8. 834 R 2 d 510 (3rd Cir. 1987). See supra notes 47-50 and accompanying text. 758 S.W.2d 827 (Tex. App. 1988). See supra notes 51-56 and accompanying text. N o . C87-157 (11th Cir. May 17, 1989) (unpublished order). See supra notes 59-64 and accompanying text. 121 N . J . 6 9 , 577 A . 2 d 1239 (1990). See supra notes 136-50 and accompanying text. 876 F.2d 414 (5th Cir. 1989). See supra notes 126-31 and accompanying text.



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while supporting the concept of preemption, are likely to strictly limit the scope of that preemption to the precise wording of the legislation. In Pennington, the court found only those claims directly covered by the warning label language of the Cigarette Packaging and Labeling Act were preempted; other claims, such as the allegation that cigarettes are per se dangerous, were not preempted.170 The Alcoholic Beverages Labeling Act overlooks two areas for potential claims that are not covered by precise language of its mandate for the presence and wording of the warning label. Those two areas are label placement and use of alternate media to issue warnings. A. Syllogism of State Tort Liability The enactment of the Alcoholic Beverages Labeling Act itself imposes a duty to warn on the Industry that had not been found at common law. The critical question is whether that new duty is general, requiring the Industry to be certain the consumer is warned of the potential dangers of alcohol consumption, or whether that new duty is specific, requiring the Industry merely to label its products with warnings. If the statute only imposes the latter specific duty, that duty is empty because by admission of the Industry itself, the labeling of alcoholic beverages is not likely to deliver the warning to the consumer effectively. The chance of the consumer seeing the warning label is reduced by the manner in which alcohol is served and, according to the Industry, even when the label is seen, the likelihood of it being understood or heeded is low. The question left unanswered is whether the duty continues to exist even when the means provided to fulfill the duty are ineffective. The Industry is in an impossible situation; it is compelled to warn of a recognized danger but the warning it is compelled to give cannot in all probability be effective. / . Imposition of General Duty Is the Major Premise If, on the other hand, the duty imposed by the federal labeling statute is a general duty, then the reasoning of the court in Pennington v. Vistron would allow plaintiffs, in an effort to hold manufacturers liable, to examine issues of warning not specifically addressed by the Alcoholic Beverages Labeling Act and thus outside the Act's preemptive shield. A well-settled principle of tort law is the concept that violation of a statute may be taken at the very least as evidence of negligence even if not

170

Id. at 424-25.


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as per se proof of negligence.171 A statute establishes a community standard of care predicated upon an underlying duty. From the very imposition of a standard of care, such as the requirement of a warning label, must be inferred the underlying duty to warn. That Congress imposed upon the Alcoholic Beverages Industry a general duty to warn follows logically from this well-settled principle of tort law. The Cigarette Packaging and Labeling Act, for example, has been found not to preempt claims pre-dating its enactment, suggesting that a common-law duty to warn pre-existed the Act and that the very passage of the Act was evidence of that duty's preexistence.172 If the Industry's duty to warn is general, the language of the Alcoholic Beverages Labeling Act provides preemptive protection only to complaints grounded in the presence of the label, the wording of the label, and the size and style of the lettering. Missing from the Act's language is a precise direction for the placement of the label. Also missing from the language of the Alcoholic Beverages Labeling Act is any direction about the obligation to warn in other media besides the label, particularly in advertising. 2. One Minor Premise—Negligent Label Placement Throughout the text of the Alcoholic Beverages Labeling Act, the location of the warning is prescribed merely to be "on the container."173 Although size and wording of the label are prescribed by the statute, the placement of the label is left to the manufacturer with the caveat that it be "conspicuous and prominent" and separate from other information on the label.174 If the supposition is true, as the Industry has argued, that warning

171

See Zalut v. Anderson & Assocs., I n c . , 186 Mich. A p p . 229, 236, 463 N.W.2d 236, 239 (1990) (violation of occupation safety statute used as evidence of employer's negligence). Accord Batteast v. Wyeth Laboratories, Inc., 137 Ill. 2d 175, 193, 5 6 0 N . E . 2 d 315, 323 (1990) (violation of F D A regulations not necessarily prima facie evidence of manufacturer's negligence). See generally M . M A D D E N , supra note 5 7 , § 12.3, at 497-501. 172 See Pennington v . Vistron, 876 F.2d 4 1 4 (5th Cir. 1989); Kolter v . American Tobacco C o . , 685 F. Supp. 15 ( D . Mass. 1988). 173 See 27 C.F.R. § 16.21 (1990). 174 T h e language of the accompanying regulation leaves considerable leeway to the manufacturer concerning the placement of the label: Similarly, with this temporary rule, the Bureau [of Alcohol, Tobacco a n d Firearms] is adopting regulations which will require the health warning statement prescribed in Title II t o appear on the brand label or separate front label, or on a back or side label, separate and apart from all other information, readily legible and on a contrasting background. Furthermore, the label upon which the health warning statement appears must b e firmly affixed to the container. The Bureau believes that these regulations provide flexibility to producers of alcoholic beverages with respect to the placement of the warning statement and also comply with the requirement that the warning statement b e "conspicuous and prominent." Implementation, supra note 4 1 , at 7 1 6 1 .



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labels are ignored by most consumers,175 then no matter how conspicuous the placement, the warning will not work. Thus, manufacturers may be open to complaints of negligence in the placement of the warning label. Granted, presence of the warning on the container fulfills the statutorily imposed duty to warn. The question remains, however, whether a strict construction of this placement language would allow a claim asserting that location of the label on the container is grounds for a tort action. Are warnings more likely to be seen and heeded if separate from the product label or if incorporated with the brand name label? Are warnings more likely to be seen and heeded if near the container's opening or near where the consumer's hand is likely to be placed when pouring the contents? Perhaps a requirement of a warning physically attached to the container is not the end of the obligation but rather just the beginning. 3. Another Minor Premise—Alternate Media Courts may decide that as far as warning labels physically attached to the containers go, the Alcoholic Beverages Labeling Act does preempt any additional requirement concerning the actual placement on the container. But that preemption may not prevent the requirement of additional warnings of another, more effective variety than labels on the containers.176 The Industry has suggested that incentives to medical personnel, pamphlets distributed by government agencies, and a general public awareness media campaign would be more effective than inert labels on packages that may never be seen by the consumer.177 Moreover, unlike the tobacco warning statutes, the Industry is not required to attach any warning to its powerful advertising which, also unlike the tobacco industry, still has access to television. Plaintiffs may insist that aggressive advertising,178 especially of beer, must be counterbalanced with advertised warnings less euphemistic than "Know When to Say When."179 4. Inescapable Conclusion—Liability Remains "Let's hope the Act is never judicially tested," said a spokesperson for the Distilled Spirits Council of the United States.180 The odds, however, 175 "A fear message may cause individuals to feel overly threatened and, as a result, to screen out the message—to be 'turned o f f by it." 1988 Hearings, supra note 2 6 , at 152 (statement of Dr. Ruth C . Engs). 176 See 1988 Senate Report, supra note 2 6 , at 7 . 177 1978 Hearings, supra note 2 , at 260-61 (statement of DISCUS). 178 " N e a r l y $2 billion a year [is spent] b y the alcohol industry to glamorize that product." 1988 Hearings, supra note 2 6 , at 16 (statement of Senator Thurmond). 179 See generally 1988 Hearings, supra note 2 6 , at 103 (statement of Robert C . Lloyd, American Council on Alcoholism). 180 Telephone interview from Washington, D . C . with an executive of the Distilled Spirits Council of the United States, J a n . 2 , 1990.


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are not in the Industry's favor. Five thousand babies are born per year with full-blown FAS; as many as 50,000 are born with the lesser degree but nevertheless debilitating FAE.181 As medical research becomes increasingly accurate in pinpointing flaws in babies that are related to alcohol intake, disappointed parents will not wait for gross deformities to make a case for damages. Likewise, less frequent and lower levels of alcohol consumption are now implicated in the occurrence of FAS/FAE,182 potentially bringing into court mothers for whom there will be greater sympathy. The most alarming fact is that the critical period in pregnancy when alcohol may do the most damage appears to be very early. This period may be earlier than the time at which a woman can be sure she is pregnant and earlier than most women, even under the best prenatal care regimen, have their first consultation with a physician.183 An additional duty may arise to warn the woman who may "suspect" she is pregnant. B. Hypothetically Ideal Plaintiff The scenario for a successful test case to establish a common-law duty to warn not preempted by the Act would involve a pregnant woman who, during her first trimester, ate her meals at a restaurant, splitting a pitcher of beer with a companion and thus drinking two or three eight-ounce glasses at lunch and repeating that level of consumption with dinner.184 A defendant brewer should not be able to avoid a duty to warn where federal law establishes such an obligation. Yet, the plaintiff will never see the warning because the beer was served to her without its container. Moreover, because only she knew or suspected she was pregnant, she could not effectively be warned by restaurant employees or her physician. Should her baby be born 181 182

183

184

See 134 C O N G . R E C . S5549 (daily ed. M a y 12, 1988) (statement of Senator Thurmond). "[N]cmalcoholic women [who drink] o n e to t w o ounces of absolute alcohol a day during their pregnancy [have an] 11 percent [chance of producing babies with] prenatal effect of alcohol [FAE]." 1988 Hearings, supra note 2 6 , at 5 6 (statement of Kenneth Jones, Professor of Pediatrics, University of California, San Diego School of Medicine). Most women d o not confirm their pregnancy by medical testing before the fourth week. T h e first visit of the prenatal series may not b e scheduled for three weeks after the test results. A n exchange between Dr. Kenneth Jones and Senator Gore during t h e 1988 Senate Hearings d e scribed another, though similar, scenario: N o w , to put o n e to t w o ounces of absolute alcohol into some practical terms, that translates into two to four shots of whiskey. N o w , two to four shots of whiskey a day sounds like a lot of whiskey. But it also translates into t w o to four glasses of wine. Senator G O R E . O r t w o to four beers? Dr. J O N E S . O r t w o t o four beers. S o , w e are talking here about a woman w h o is making dinner at night and, as she does so, she drinks a glass of wine. Her husband comes home and they sit down for dinner, and she has another glass of wine with h e r husband. She has n o w had o n e ounce of absolute alcohol. S o , if she consumes any more alcohol during the e v e ning, she fits into this group . . . , a group in which she has an 11 percent chance of having a baby with a prenatal effect of alcohol. 1988 Hearings, supra note 2 6 , at 5 6 (testimony of Dr. Kenneth Jones).



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with FAS or FAE, the critical question will be who should bear the loss—the loss of money necessary to provide special services to the disabled child for a lifetime and the loss of the expectation of a normal child? Such a plaintiff might persuade a court to fashion a way around preemption, a detour mapped by the New Jersey Supreme Court in Deweym to follow the routes taken in the Hurley,1*6 Hillsborough,™ and Silkwoodm cases. If one plaintiff can find a way to circumvent the new wall of preemption upon which the Industry is depending for protection against state tort claims of FAS/FAE, thousands more claimants will surely open a thoroughfare.189 C. Recommendations The Industry should brace for the potential litigation designed to identify the route to circumvent preemption. As plaintiffs watchfully await the outcome of the New Jersey Supreme Court's departure from the previously accepted rationale in favor of federal preemption under the Cigarette Packaging and Labeling Act, the Alcoholic Beverages Industry may use the temporary lull in products liability litigation for failure to warn in order to strengthen its defenses. The most practical initial move would be to increase its liability insurance coverage before such litigation becomes imminent. Another precautionary move would involve the addition of language to broaden the scope of the legislation in order to expand the corresponding scope of preemption. Now that the Alcoholic Beverages Labeling Act is on the books, it might be easier to lobby Congress to amend it with a more explicit preemption clause in exchange, perhaps, for a requirement to include the warning in advertising. Whether or not mandated by law, the Industry should launch an aggressive education campaign aimed at women of childbearing age with special emphasis on beer drinkers.190 The Industry has shown that such targeted education campaigns have significant impact.191 In addition, the Industry also should augment its educational programs with clear support for innovative research involving FAS/FAE. 185

121 N . J . 6 9 , 5 7 7 A . 2 d 1239 (1990). 863 F.2d 1173 (5th Cir. 1988). See supra notes 115-19 and accompanying text. 187 471 U . S . 7 0 7 (1985). See supra notes 120-22 and accompanying text. 188 4 6 4 U . S . 2 3 8 (1984). See supra notes 123-25 and accompanying text. 189 " T h e fetal alcohol case [Thorp v. James A . Beam Distilling, supra notes 59-62] w a s viewed as having national significance. If Jim Beam . . . had lost, lawyers said, many other such cases might have been filed against liquor companies." Hagedorn & Marcus, Legal Beat: Jim Beam Sues Its Insurer over Legal Fees in Fetal Alcohol Suits, Wall St. J . , Sept. 18, 1989, at B 8 . 190 1988 Hearings, supra note 2 6 , at 131 (statement of Augustus H . Hewlett). 191 Statistics presented by the Beer Institute suggest that abuse of alcohol is declining, at least in terms of measurable physiological effects. T h e Beer Institute offered the statistics t o counter the "assertion that current, legitimate educational efforts are failing—and that, therefore warning labels a r e needed." 1988 Hearings, supra note 2 6 , at 168 (statement of a representative of the Beer Institute). 186


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As a matter of self interest, the Industry should encourage researchers to explore why some babies are affected by their mothers' alcohol consumption while others are not. The answer to this puzzle may reveal a superseding cause that would break the chain of causation so convincingly forged by teratologists to date. Lastly, the Industry could demonstrate its civic responsibility by providing grants to support the education and supervision of FAS/FAE children, large numbers of whom live in deprived circumstances.192 In an atmosphere of public opinion that endorses such programs for the disabled as "Special Olympics," the Industry could significantly counter opprobrium by providing grants for research and development into ways to help FAS/ FAE children and adults achieve more productive and enjoyable lives. CONCLUSION The perfectly healthy baby who will grow up to be "above average" is an expectation Americans increasingly regard as a natural outcome of pregnancy. The child with a debilitating birth defect, moreover, is no longer a private family tragedy, an occurrence to be hidden with shame but rather a burden to be shared with the public. Social services agencies charged with assuming the burden of these disabled children struggle under increasing budgetary stress. Given the pressure of parents' expectations for normal infants, the increasing public sympathy for disabled children, and the rapidly rising costs of providing services to disabled children and adults, courts may be only too willing to press the Industry into carrying the burden of the FAS/ FAE child. The Industry may find the Alcoholic Beverages Labeling Act of 1988 provides little more than a temporary preemptive lull in the struggle against these invading theories of liability for failure to warn. 192 "The lifetime cost of care and treatment (remedial education; hearing, vision, and speech correction; institutionalization and home care) for these children was conservatively estimated at $245,388 per child in 1987." 1988 Hearings, supra note 26, at 36 (statement of William J. McCord, Director of South Carolina Commission on Alcohol and Drug Abuse). See generally M. DORRIS, supra note 4, at 236 (American Indian population already in difficult socioeconomic condition is especially prone to large numbers of FAS/FAE births); A. STREISSGUTH, R. LADUE, & S. RANDELS, A MANUAL ON ADOLESCENTS AND ADULTS WITH FETAL ALCOHOL SYNDROME WITH SPECIAL

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Renal anomalies in the fetal alcohol syndrome.

Effect of alcohol and alcoholic beverages on meal-stimulated pancreatic secretion in humans.

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E.E.G. component of fetal alcohol syndrome.

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