Dual Regulatory Pharmaceutical Labeling Schemes: The Role of the Federal Preemption Doctrine

21 USC §352 (1982).

21 CFR §201.57 (1979).

40 Federal Register 15394 (1975).

37 Federal Register 16504 (1972). Cf, 39 Federal Register 33, 230-31 (1974). FDA requires warnings on drug labels “when there is significant medical evidence of a possible health hazard, without waiting for a causal relationship to be established by definitive standards which, in some instances, may not be feasible or would take many years.”.

Drug Labeling and Products Liability: The Role of the Food and Drug Administration, 41 Food Drug Cosm LJ 233 (Cooper) (1986). [hereinafter cited as Cooper].

Labeling, FDA Requirements, and Restrictions Versus Duty to Warn, Food and Drug Compliance, Practising Law Institute, Handbook Series #326 (Dobbins) (1984).

21 USC §301–392 (1982).

United States v 1,048,000 Capsules (Afrodox), 494 F 2d 1158, 1160 (5th Cir 1974).

21 CFR §10.25 (1979).

The Conflicting Objective of Federal and State Tort Law Drug Regulation, 41 Food Drug Cosm LJ 171 (Walsh & Klein) (1986).

Feldman v Lederle Laboratories, 479 A 2d 374 (NJ 1984).

Wooderson v Ortho Pharmaceutical Corp, 235 Kan 387, 681P2d 1038, cert denied, 105 S Ct 365 (1984).

Morris v Parke Davis, No. 82-5296 (Cal CD) Sep 19, 1985) off'd per curiam No. 86-7115 (9th Cir 1986). Ninth Circuit order let stand District Court decision upholding implied preemption of design defect theory under Public Health Services Act.

Hurley v Lederle Laboratories, 651 F Supp 993, (ED Tex 1986).

“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, anything in the Constitution or laws or any State to the contrary notwithstanding.” US Constitution Art VI cl.2.

Federal Preemption and Food and Drug Regulation: The Practical, Modern Meaning of an Ancient Doctrine, 38 Food Drug Cosm LJ 306 (Taylor) (1983).

Silkwood v Kerr-McGee Corp, 464 US 238, (1984).

San Diego Building Traders Council v Garmon, 359 US 236 (1959).

See, Lockheed Air Terminal, Inc v City of Burbank, 457 F 2d667 (9th Cir 1972) aff'd per curiam, 411 US 624 (1973); Groves v Walton County Board of Education, 300 F Supp 188, (MD Ga 1968), aff'd per curiam, 410 F 2d 1153 (5th Cir 1969).

21 USC §352, 355, 371(a) (1982).

21 CFR §5.10(a)(1) (1985).

21 CFR §314 (1985).

Weinberger v Bentex Pharmaceuticals, Inc, 412 US 645, 654 (1973).

21 USC §301–392 (1982).

21 USC §352(f) (1982).

3 Federal Register 3161, 3168 (1938).

Act of Oct 26, 1951, ch 578 Section 1, 65 Stat 648 [currently codified at 21 USC Section 353(b) (1982)].

Learned Intermediaries, Prescription Drugs, and Patient Information, 30 St Louis ULJ 633, 660 (Gilhooley) (1986).

3 Federal Register, supra note 26.

Public Health Law #87-781, 76 Stat 780.

§21 CFR §211 (1978), §310 et seq (1974) and §600 et seq (1973).

See, United States v 1,048,000 Capsules (Afrodex), 494 F 2d1158 (5th Cir 1974); “Beyond question, the FDA does have authority to promulgate regulations pursuant to 21 U.S.C Section 321(a) which are binding as law.” National Association of Pharmaceutical Manufacturers v FDA, 487 F Supp. 412, 414 (SDNY 1980) citing Weinberger v Hynson, Westcott & Dunning, Inc, 412 US 609 (1973), aff'd per curiam, 637 F 2d 877 (2nd Cir 1981). Also See, National Nutritional Food Association v Weinberger, 512 F 2d688 (2nd Cir 1975) cert denied sub nom, National Nutritional Foods Association v Mathews, 423 US 827 (1975).

21 CFR §1, 201 (1975); 50 Federal Register 51108 (1985).

Cosmetic, Toiletry and Fragrance Association, Inc v Minnesota, 440 F Supp 1216 (D Minn 1977), aff'd per curiam 575 F 2d 1256 (8th Cir 1978).

Hurley, supra note 14 at 997.

Pacific Gas & Electric Co v State Energy Resources Conservation and Development Commission, 461 US 190, (1982); Jones v Rath Packing Co, 430 US 519,525, (1977); See also, Cipollone v Liggett Group, Inc, 789 F 2d 181 (3rd Cir 1986).

Silkwood, supra note 17.

Fidelity Federal Savings and Loan Assoc v De La Cuesta, 458 US 141, 153 (1982), quoting Rice v Santa Fe Elevator Corp, 331 US 218, 230, (1947).

Head v New Mexico Board of Examiners in Optometry, 374 US 424 (1963).

Pacific Gas & Electric Co v Energy Resources Conservation & Development Commission, 461 US 190, 204 (1982).

Florida Lime & Avocado Growers Inc v Paul, 373 US 132, 142 (1963).

Hurley, supra note 14, citing Northern States Power Co v State of Minnesota, 447 F 2d1143, (8th Cir 1971), aff'd per curiam, 405 US 1035 (1972); KVUE Inc v Austin Broadcasting Corp, 709 F 2d922 (5th Cir 1983), aff'd sub nom, Texas v KVUE Inc, 465 US 1092 (1982).

Hurley, supra note 14, at 998.

21 USC §355(b)(1) (1982 & Supp 1984).

21 CFR §314.70 (1985).

21 CFR §314.70 (c) (1985).

Cooper, supra note 5 at 235.

Hurley, supra note 14 at 999 referring to 21 USC Section 331.

50 Federal Register 51403 (1985).

See, Wooderson, supra note 12.

Gilhooley, supra note 28 at 693.

789 F 2d181 (3rd Cir 1986).

15 USC Section 1331–1340 (1982).

Hurley, supra note 14 at 1000.

528 P 2d522 (Ore 1974).

21 CFR §314.70 (c)(2)(i) (1985).

Predecessor to current 21 CFR §314.70(c).

Cooper, supra note 5 at 235.

479 A 2d374 (1984).

Walsh and Klein, supra note 10 at 186.

Lederle brand, tetracycline.

Supra note 11 at 390.

235 Kan 387, 681 P 2d1038 (1984), cert denied 105 S Ct 365 (1984).

400 F Supp 1216 (D Minn 1977), Aff'd on opinion below, 575 F 2d1256 (8th Cir 1978).

Failure to Warn in Drug Cases: Are Punitive Damages Justifiable?, 27 For The Defense 12,19 (Fern & Sichel) (June 1985).

231 California Reporter 396 (Ct App 5 Dist 1986) appeal pending Cal N. F005525.

231 California Reporter 396, 403–404.

IUD's are regulated as both a drug, 21 CFR §310.502 (1985), and as a medical device, 21 CFR §801.428 (1985) possibly to avoid litigation concerning its proper classification.

Collins, supra note 66 at 406.

See for example, Sears, Roebuck & Co v Stiffel Co, 376 US 225 (1964) (state common claims for unfair competition preempted by the federal patent laws); City of Chicago v General Motors Corp, 467 F 2d1262, 1265 (7th Cir 1972) (since Congress intended to preempt the field of automobile emission regulation pursuant to the National Emissions Standard Act, “Chicago cannot seek to enforce through the federal courts different standards purportedly based on Illinois common law.”.

Morris, supra note 13.

Hurley, supra note 14.

Morris, supra note 13.

42 USCA §262.

Hurley, supra note 14.

Hurley, supra note 14 at 1003.

21 USC Sections 331(d), 333(a), 335(a) (1982); Id. note 2 citing Toner v Lederle Laboratories, 779 F 2d1429 (9th Cir. 1986).

Hurley, supra note 14 at 1006.

Hurley, supra note 14 at 999.

Hurley, supra note 14 at 1000.

Fern, supra note 65 at 20.

Dobbins, supra note 6.