Judicial review of FDA preemption determinations

Food and Drug Law Journal

Volumn 54, Issue 3, 1999, Pages 367-388

  Frost, Amanda ^a  

^a Public Citizen Litigation Group   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

COURT; DECISION MAKING; DRUG CONTROL; DRUG LEGISLATION; FOOD AND DRUG ADMINISTRATION; GOVERNMENT; POLICY; PRACTICE GUIDELINE; REVIEW; THEORY;

DEVICE APPROVAL; HUMANS; JURISPRUDENCE; LEGISLATION, MEDICAL; STATE GOVERNMENT; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0032756948     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (139)

1. 518 U.S. 470 (1996).
2. Pub. L. No. 102-300, 106 Stat 238 (1992) (codified at 21 U.S.C. §§ 301 note, 321, 331, 334, 346a, 352-353, 356-357, 360c-360d, 360g-360i, 360i notes, 3601, 360mm, 371-372, 372a, 376, 381 (1994); 42 U.S.C. § 262 (1994)).
3. Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified as amended at 21 U.S.C. §§ 301 et seq. (1994)).
4. Compare Mitchell v. Collagen Corp., 126 F.3d 902 (7th Cir. 1997); Papike v. Tambrands, Inc., 107 F.3d 737 (9th Cir. 1997); Lake v. TPLC, 1 F. Supp. 2d 84, 86-87 (D. Mass. 1998), with Goodlin v. Medtronic, Inc., 167 F.3d. 1367 (11th Cir. 1999); Oja v. Howmedica, Inc., 111 F.3d 782 (10th Cir. 1997); Niehoff v. Surgidev, 950 S.W.2d 816, 822 (Ky. 1997); Armstrong v. Optical Radiation Corp., 57 Cal. Rptr. 2d 763 (Cal. App. 1996).
5. 21 C.F.R. § 808.1(d) (1998).
6. 62 Fed. Reg. 65, 384 (Dec. 12, 1997) (amending 21 C.F.R. § 808.1(d)).
7. 63 Fed. Reg. 39, 789 (July 24, 1998).
8. Chevron, U.S.A., Inc. v. Natural Resources Defense Council, 467 U.S. 837 (1984).
9. Medtronic, 518 U.S. at 495.
10. Id. at 512.
11. Id.
12. Id. at 506 (Breyer, J., concurring).
13. See, e.g., Rice v. Santa Fe Elevator Corp., 331 U.S. 218 (1947).
14. See Smiley v. Citibank (South Dakota), NA, 57 U.S. 735, 741 (1996).
15. See Garcia v. San Antonio Metro. Transit Auth., 469 U.S. 528 (1985); New York v. United States, 505 U.S. 144 (1992); see also Cass Sunstein, Law and Administration After Chevron, 90 COLUM. L. REV. 2071, 2099-2100 (1990).
16. Chevron, 467 U.S. at 843-44.
17. Id. at 842.
18. See id. at 843 n.9 (noting that courts should "employ traditional tools of statutory construction" in determining if Congress had an intention on the precise question at issue); Dole v. United Steelworkers of Am., 110 S. Ct. 929, 934 (1990); NLRB v. United Food & Commercial Workers Union, Local 23, 108 S. Ct. 413, 421 (1987); INS v. Cardoza-Fonseca, 480 U.S. 421, 447-48 (1987).
19. Chevron, 467 U.S. at 842-43.
20. Southern Cal. Edison Co. v. FERC, 116 F.3d 507,511 (D.C. Cir. 1997); see also Chevron, 467 U.S. at 844.
21. See, e.g., Blum v. Bacon, 457 U.S. 132, 141 (1982); Union Elec. Co. v. Camp, 401 U.S. 617, 626-27 (1971); Investment Co. Inst. v. Camp, 401 U.S. 246, 256 (1971); see also Chevron, 467 U.S. at 844-45.
22. Sunstein, supra note 15, at 2074-75.
23. 5 U.S. (1 Cranch) 137 (1803).
24. Id. at 177.
25. Sunstein, supra note 15, at 2075.
26. In addition to hundreds of law review articles about Chevron, the case has been cited thousands of times since it was decided in 1984. Id.
27. See, e.g., Kenneth W, Starr, Judicial Review in the Post-Chevron Era. 3 YALE J. REG. 283, 307-09 (1986).
28. See, e.g., Chevron, 467 U.S. at 864.
29. See Starr, supra note 27, at 307-09.
30. The heads of "independent" agencies are appointed for fixed terms and are not subject to plenary removal power, and thus are insulated from influence by the executive branch.
31. Chevron, 467 U.S. at 865-66.
32. Id. at 843-44.
33. Antonin Scalia, Judicial Deference to Administrative Interpretations of Law, 1989 DUKE L.J. 511, 516-17.
34. See id.
35. Chevron, 467 U.S. at 865.
36. Id. at 844.
37. United States v. Shimer, 367 U.S. 374 (1961).
38. Chevron, 467 U.S. at 865.
39. See INS v. Cardoza-Fonseca, 480 U.S. at 446-48; see also Young v. Community Nutrition Inst., 476 U.S. 974, 984-88 (1986) (Stevens, J., dissenting).
40. Sunstein, supra note 15, at 2074-76.
41. Id.; Steven Breyer, Judicial Review of Questions of Law and Policy, 38 ADMIN. L. REV. 363, 373 (1986); Clark Byse, Judicial Review of Administrative Interpretation of Statutes: An Analysis of Chevron's Step Two, 2 ADMIN. L. REV. 255, 260-61 (1988); Cynthia Farina, Statutory Interpretation and the Balance of Power in the Administrative State, 89 COLUM. L. REV. 452, 475-78 (1989).
42. Id.; Steven Breyer, Judicial Review of Questions of Law and Policy, 38 ADMIN. L. REV. 363, 373 (1986); Clark Byse, Judicial Review of Administrative Interpretation of Statutes: An Analysis of Chevron's Step Two, 2 ADMIN. L. REV. 255, 260-61 (1988); Cynthia Farina, Statutory Interpretation and the Balance of Power in the Administrative State, 89 COLUM. L. REV. 452, 475-78 (1989).
43. Id.; Steven Breyer, Judicial Review of Questions of Law and Policy, 38 ADMIN. L. REV. 363, 373 (1986); Clark Byse, Judicial Review of Administrative Interpretation of Statutes: An Analysis of Chevron's Step Two, 2 ADMIN. L. REV. 255, 260-61 (1988); Cynthia Farina, Statutory Interpretation and the Balance of Power in the Administrative State, 89 COLUM. L. REV. 452, 475-78 (1989).
44. See, e.g., Public Citizen Health Research Group v. Food and Drug Admin., 997 F. Supp. 56, 66(D.D.C. 1998) (noting that litigating positions may be unreliable evidence of an agency's policy); see also KENNETH C. DAVIS & RICHARD J. PIERCE, ADMINISTRATIVE LAW TREATISE § 3.5 (3d ed. 1994).
45. See The Bus. Roundtable v. Securities and Exch. Comm'n, 905 F.2d 406, 413-14 (D.C. Cir. 1990); New York Shipping Ass'n v. Federal Maritime Comm'n, 854 F.2d 1338, 1363 (D.C. Cir. 1988). The Supreme Court has been unclear about whether courts should defer to agencies on jurisdictional questions. See, e.g., Mississippi Power & Light Co. v. Mississippi, 108 S. Ct. 2428 (1988); Adams Fruit Co. v. Barrett, 110 S. Ct. 1384, 1391 (1990).
46. See, e.g., Kent v. Dulles, 357 U.S. 116, 130 (1958); DeBartolo Corp. v. Florida Gulf Coast Bldg. & Constr. Trades Council, 485 U.S. 568, 574-75 (1988); Industrial Union Dep't v. American Petroleum Inst., 448 U.S. 607, 645-46 (1980); NLRB v. Catholic Bishop, 440 U.S. 490, 507 (1979). 45 See, e.g., Teper v. Miller, 82 F.3d 989, 998 (11th Cir. 1996).
47. Paul E. McGreal, Same Rice With Your Chevron?: Presumption and Deference in Regulatory Preemption, 45 CASE W. RES. L. REV. 823 (1995); Damien J. Marshall, The Application of Chevron Deference in Regulatory Preemption Cases, 87 GEO. L.J. 263 (1998).
48. Paul E. McGreal, Same Rice With Your Chevron?: Presumption and Deference in Regulatory Preemption, 45 CASE W. RES. L. REV. 823 (1995); Damien J. Marshall, The Application of Chevron Deference in Regulatory Preemption Cases, 87 GEO. L.J. 263 (1998).
49. See THE FEDERALIST NO. 9 (Alexander Hamilton) (referring to the "sovereign power" of the states), NO. 45 (James Madison) (affirming that the states will retain a significant degree of sovereignty), No. 51 (James Madison) (assuring the preservation of the states as "distinct governments") (B. Wright ed., 1961).
50. See, e.g., Garcia, 469 U.S. at 528; New York v. United States, 505 U.S. 144 (1992); United States v. Lopez, 514 U.S. 549 (1995); Printz v. United States, 521 U.S. 898 (1997). See also DAVID L. SHAPIRO, FEDERALISM: A DIALOGUE (1995).
51. "It is basic to this constitutional command that all conflicting state provisions be without effect." Maryland v. Louisiana, 451 U.S. 725, 746 (1981) (citing McCulloch v. Maryland, 4 Wheat 316, 427 (1819)).
52. See, e.g., Gregory v. Asheroft, 501 U.S. 452 (1991) (holding that the federal Age Discrimination in Employment Act does not preempt state law requiring mandatory retirement of appointed state judges at 70); Cipollone v. Liggett Group, 505 U.S. 504 (1992).
53. See Tafflin v. Levitt, 493 U.S. 455, 459 (1990).
54. This Constitution, and the laws of the United States which shall be made in Pursuance thereof; and all Treatise 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, and any Thing in the Constitution or Laws of any State to the Contrary notwithstanding. U.S. CONST. art VI, cl. 2.
55. Gibbons v. Ogden, 9 Wheat 1, 211 (1824); see also Wisconsin Pub. Intervenor v. Mortier, 501 U.S. 597, 604 (1991).
56. U.S. CONST. art. 1, § 8. The Constitution also guarantees certain rights to the states with which Congress cannot interfere. See, e.g., U.S. CONST. art IV, § 3 (guaranteeing states territorial integrity).
57. Hillsborough County v. Automated Med. Labs., 471 U.S. 707, 713 (1985); Irving v. Mazda Motor Corp., 136 F.3d 764, 767 (11th Cir. 1998); see also Cipollone, 505 U.S. at 516.
58. Hillsborough County, 471 U.S. at 713 ("[W]hen acting within constitutional limits, Congress is empowered to preempt state law by so stating in express terms.").
59. Hines v. Davidowitz, 312 U.S. 52, 67 (1941); English v. General Elec. Co., 496 U.S. 72, 79 (1990).
60. See, e.g., Silkwood v. Kerr-McGee Corp. 464 U.S. 238, 248 (1994).
61. See, e.g., Medtronic, 518 U.S. at 485.
62. See Silkwood, 464 U.S. at 248; McGreal, supra note 46, at 832.
63. Florida Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132, 142-43 (1963).
64. This hypothetical is borrowed from Justice Breyer. Medtronic, 518 U.S. at 504.
65. Silkwood, 464 U.S. at 248; see also Hines, 312 U.S. at 67.
66. See California Fed. Sav. & Loan Ass'n v. Guerra, 107 S.Ct. 683, 689 (1987); Rice, 331 U.S. at 241 (Frankfurter, J., dissenting); Cloverleaf Butter Co. v. Patterson, 315 U.S. 148, 172-73 (1942) (Stone, C.J., dissenting).
67. See, e.g., Teper, 82 F.3d at 993.
68. Rice, 331 U.S. at 231. A forceful argument is made here for the view that the Illinois regulatory scheme should be allowed to supplement the Federal Act and that the Illinois Commission should not be prevented from acting on any of the matters covered by Rice's complaint, unless what the Commission does runs counter in fact to the federal policy. That is to say, the actual operation of the state system may be harmonious with the "measure of control" over warehousemen which the Federal Act imposes. That, it is said, can only be determined after the Illinois Commission has acted. . . . [U]ntil it is known what the Commission will do, no conflict with the Federal Act can be shown. Id. (citations omitted).
69. See Rice, 331 U.S. at 229-30 ("It is clear that since warehouses engaged in the storage of grain for interstate or foreign commerce are in the federal domain, Congress may, if it chooses, take unto itself all regulatory authority over them, share the task with the states, or adopt as federal policy state scheme of regulation.") (citation omitted). James Madison told the members of the First Congress "Interference with the power of the States was no constitutional criterion of the power of Congress. If the power was not given, Congress could not exercise it; if given, they might exercise it, although it should interfere with the laws, or even the Constitution of the states," 2 ANNALS OF CONG. 1897 (1791).
70. See Garcia, 469 U.S. at 547.
71. McGreal, supra note 46, at 846-47.
72. L. TRIBE, AMERICAN CONSTITUTIONAL LAW § 6-25, at 479; see also Chicago & N. W. Tr. Co. v. Kalo Brick & Tile, 450 U.S. 311, 317 (1981); Florida Lime & Avocado Growers, 373 U.S. at 142.
73. Rice, 331 U.S. 218 (1947)
74. Id. at 230.
75. Jones v. Rath Packing Co., 430 U.S. 519, 525 (1977) (citations and quotations omitted) (citing United States v. Bass, 404 U.S. 336, 349 (1971)).
76. See Bruce Ackerman, Liberating Abstractions, 69 U. CHI. L. REV. 317, 322 (1992) (describing how the Court's abstraction of commercial competition allowed Congress to place "all significant human activity" within the constitutional grasp of the Commerce Clause); see also McGreal, supra note 46, at 827 n.22 ("Given the presently expansive reading of the Commerce Clause, it is hardly conceivable that the Court would deny Congress the power to regulate a subject matter because it was unrelated to interstate commerce,").
77. Printz, 521 U.S. at 898; Lopez, 514 U.S. at 549; New York, 505 U.S. at 144.
78. After noting that the Supreme Court no longer enforces the nondelegation doctrine with much vigor, Professor Sunstein writes that "in the wake of the downfall of that doctrine, the use of constitutionally based clear statement principles serves as a narrower and more targeted means of ensuring that Congress, rather than bureaucrats, will deliberate on questions that raise serious constitutional difficulties or intrude into constitutionally sensitive areas." Sunstein, supra note 15, at 2111-12.
79. See, e.g., Symens v. SmithKline Beecham Corp., 152 F.3d 1050, 1055 (8th Cir. 1998) (stating that it is "most reluctant" to infer a preemptive intent that would leave vaccine purchasers and users without any remedy); Medtronic, Inc. v. Lohr, 518 U.S. 470, 486-87 (1996) (plurality opinion); Silkwood, 464 U.S. at 251.
80. See, e.g., New York Blue Cross Plans v. Travelers Ins., 514 U.S. 645, 655 (1995); Hawaiian Airlines, Inc. v. Norris, 512 U.S. 246, 252 (1994); Hillsborough County v. Automated Med. Labs., Inc., 471 U.S. 707, 715 (1985); Rice, 331 U.S. at 230.
81. Rice, 331 U.S. at 230
82. Id.
83. SHAPIRO, supra note 47, at 3.
84. Rice, 331 U.S. at 230.
85. DeBartolo, 485 U.S. at 575; NLRB, 440 U.S. at 499-501.
86. DeBartolo, 485 U.S. at 575.
87. Id. ("The courts will therefore not lightly assume that Congress intended to infringe constitutionally protected liberties or usurp powers constitutionally forbidden it.").
88. The issue is not whether Congress intended to preempt, but whether it has the power to preempt; then the question is analyzed under the clear statement rule for questionable congressional enactments.
89. TRIBE, supra note 70, §§ 5-7, 5-8, 5-20-5-23, 6-26.
90. 469 U.S. at 528.
91. Id. at 552.
92. Id. at 551; U.S. CONST. art I, § 3, art. V.
93. THE FEDERALIST NO. 62, at 408 (James Madison) (B. Wright ed., 1961).
94. U.S. CONST. art I, § 2.
95. THE FEDERALIST NO. 46, at 332 (James Madison) (B. Wright ed., 1961).
96. Garcia, 469 U.S. at 468.
97. Id. at 469.
98. See Medtronic, 116 S. Ct. at 2245 ("Throughout our history the several States have exercised their police powers to protect the health and safety of their citizens." Because these are "primarily, and historically, . . . matter[s] of local concern. . . . "); Hillsborough County, 471 U.S. at 719 ("States traditionally have had great latitude under their police powers to legislate as to the protection of the lives, limbs, health, comfort and quiet of all persons.").
99. See, e.g., Rice, 331 U.S. at 230.
100. Capital Cities Cable, Inc. v. Crisp, 467 U.S. 691, 699 (1984).
101. Fidelity Fed. Sav. & Loan Ass'n v. De La Cuesta, 458 U.S. 141, 154 (1982) ("A pre-emptive regulation's force does depend on express congressional authorization to displace state law.") (citing United States v. Shimer, 367 D.S. 374, 381-83 (1961)).
102. See, e.g., Alan B. Morrison, The Administrative Procedure Act: A Living and Responsive Law, 72 VA. L. REV. 253, 254-60 (1986).
103. Marshall, supra note 45, at 278.
104. Compare Medtronic, 518 U.S. at 505-07 (Breyer, J., concurring) (stating that absent clear congressional command as to preemption, administrative agencies have a "degree of leeway" to determine which administrative actions has preemptive effect) with 518 U.S. at 512 (O'Connor, J., dissenting) (stating that Chevron deference is unwarranted).
105. Id. at 2250 (quoting Cipollone, 505 U.S. at 530 n.27) (emphasis in original).
106. Chevron, 467 U.S. at 865.
107. Garcia, 469 U.S. at 550-51.
108. See TRIBE, supra note 70, at 480 ("to give the state-displacing weight of federal law to mere congressional ambiguity would evade the very procedure for lawmaking on which Garcia relied to protect states' interests") (emphasis in original); The Supreme Court, 1987 Term - Leading Cases, 102 HARV. L. REV. 143, 296 (1988) ("A rule that distills displacement of state law from congressional silence divests states of even Garcia's slender procedural guarantee.") (emphasis in original). Cf. California State Bd. of Optometry v. Federal Trade Comm'n, 910 F.2d 976, 981-82 (D.C. Cir. 1990) (refusing to defer to the Federal Trade Commission's argument that it could issue rules interfering with sovereign acts of states in the face of congressional silence because to do so would "short-circuit the protections offered States by the political process").
109. See id.
110. Silkwood, 464 U.S. at 251 (finding Congress' silence on the preemption question to be significant).
111. Chevron, 467 U.S. at 865.
112. Tax Analysts v. Internal Revenue Serv., 117 F.3d 607, 613 (D.C. Cir. 1997) (quoting Auer v. Robbins, 117 S.Ct. 905, 912 (1997)).
113. Id.
114. See id.
115. 458 U.S. at 141.
116. Id. at 158.
117. 800 F.2d 1232 (3d Cir. 1980).
118. Id. at 1238.
119. Id. at 1239. Without noting any conflict with its previous decision in Walter Dunlop & Sons, a split panel of the Third Circuit preempted state law on the ground that it conflicted with an interpretive rule issued by the Secretary of Health and Human Services. See, e.g., Elizabeth Blackwell Health Ctr. for Women v. Knoll, 61 F.3d 170, 182 (3d. Cir. 1995). The majority defended its decision by noting that Chevron deference applies to informal, as well as formal, agency action, but failed to consider the possibility that deference to agency preemption determination taken without notice and comment, even if appropriate in other contexts, is at odds with the rationale underlying the presumption against preemption. See id. at 182, 196 (Nygaard, J., dissenting).
120. Deference is appropriate even when Congress "simply did not consider the question at this level" or when "Congress was unable to forge a coalition on either side of the question." Chevron, 467 U.S. at 865.
121. See supra notes 33-34 and accompanying text.
122. Courts do not owe deference to an agency's interpretation of statutes that are "outside the agency's particular expertise and special management charge to administer." Professional Reactor Operator Soc. v. U.S. NRC, 939, F.2d 1047, 1051 (D.C. Cir. 1991) (rejecting deference for NRC's interpretation of the Administrative Procedure Act).
123. See Cooper v. Aaron, 358 U.S. 1, 19 (1958).
124. See, e.g., Murdock v. City of Memphis, 87 U.S. (20 Wall.) 590 (1875) (holding that a state's highest courts are final interpreters on questions of state law).
125. See, e.g., Indiana ex rel. Anderson v. Brand, 303 U.S. 95 (1938); Broad River Power Co. v. South Carolina, 281 U.S. 537, 540 (1930); Standard Oil Co. v. Johnson, 316 U.S. 481 (1942).
126. See Michael Wells, Why Professor Redish is Wrong About Abstention, 19 GA. L. REV. 1097 (1985).
127. See Davies, Pullman and Buford Abstention: Clarifying the Roles of Federal and State Courts in Constitutional Cases, 20 U.C. DAVIS L. REV. 1, 9-10 (1986).
128. Hines, 312 U.S. at 396, 500.
129. Pub. L. No. 95-95, 91 Stat. 685.
130. See Teper, 82 F.3d at 993.
131. 21 C.F.R. § 808.1(d); Brief for the United States as Amicus Curiae supporting respondent/cross-petitioner, Lohr, 518 U.S. 470.
132. 21 C.F.R. § 808.1(d).
133. Id. § 808.1(e).
134. 21 U.S.C. § 360k(b).
135. 43 Fed. Reg. 18,661, 18,663 (1978).
136. 42 Fed. Reg. 30,383, 30,385 (June 14, 1977).
137. Id. at 30,385.
138. Id.
139. Id.