1 Wyeth v. Levine, 129 S.Ct. 1187, 1204 (2009).

2 Id. at 1204 (Thomas, J., concurring in the judgment). Justice Thomas, concurring only in the judgment, rejected the entire “obstacle preemption” doctrine used by the five-justice majority. Thomas relied only on the “impossibility preemption” doctrine.

3 Id. at 1204 (Breyer, J., concurring) (internal quotations removed). Breyer's entire concurrence is only one paragraph long.

4 Id.

5 Obviously, the FDA cannot affect this particular case nor deny Ms. Levine relief. However, the FDA may pursue its stated policy (i.e. that its labeling decisions preempt state failure-to-warn claims) and thereby undermine or eliminate the precedential value of Wyeth.

6 Levine v. Wyeth, 944 A.2d 179, 182 (Vt. 2006).

7 Id.

8 Wyeth, 129 S.Ct. at 1224-26.

9 The Phenergan warning label read: “INADVERTENT INTRA-ARTERIAL INJECTION: Due to the close proximity of arteries and veins in the areas most commonly used for intravenous injection, extreme care should be exercised to avoid perivascular extravasation or inadvertent intra-arterial injection. Reports compatible with inadvertent intra-arterial injection of [Phenergan], usually in conjunction with other drugs intended for intravenous use, suggest that pain, severe chemical irritation, severe spasm of distal vessels, and resultant gangrene requiring amputation are likely under such circumstances. Intravenous injection was intended in all the cases reported but perivascular extravasation or arterial placement of the needle is now suspect. There is no proven successful management of this condition after it occurs … .” See Levine v. Wyeth, 944 A.2d at 183 n.1.

10 Wyeth, 129 S.Ct. at 1224-25.

11 Id. at 1226.

12 Id. at 1226.

13 Adam Liptak, Drug Label, Maimed Patient and Crucial Test for Justices, N.Y. Times, Sept. 19, 2008, at A1.

14 Id. Ms. Levine settled the suit with the Hospital and all other parties.

15 Wyeth, 129 S. Ct. at 1194 (“The trial court proceedings established that Levine's injury would not have occurred if Phenergan's label had included an adequate warning about the risks of the IV-push method of administering the drug… . [T]he inadequate label was both a but-for and proximate cause of Levine's injury.”).

16 The Constitution's Supremacy and Commerce Clauses create a powerful authority to preempt and regulate any industry which may impact the national economy. The Supremacy Clause states “This Constitution, and the Laws of the United States which shall be made in Pursuance thereof … shall be the supreme Law of the Land … [and shall bind every State].” U.S. Const. art VI. The Commerce Clause states “The Congress shall have Power … [t]o regulate Commerce with Foreign Nations, and among the several States, and with the Indian Tribes.” U.S. Const. art. I, § 8, cl. 3. See generally Riegel v. Medtronic, 128 S.Ct. 999 (2008) (permitting Congress to delegate preemption authority to FDA relating to Medical Devices); Gibbons v. Ogden, 22 U.S. 1 (1824) (establishing a wide authority to regulate commerce).

17 Riegel, 128 S.Ct. at 1006.

18 Hillsborough County v. Automated Med. Labs., Inc., 471 U.S. 707, 713-14 (1985) (explaining various methods of preemption, all relying on the “intent underlying the federal scheme.”)

19 See Crosby v. Nat’l Foreign Trade Council, 530 U.S. 363, 372 (2000) (explaining express, field, and conflict preemption). Conflict preemption is further broken down into “impossibility” and “obstacle” preemption. See Fidelity Fed. Sav. & Loan Ass’n. v. De la Cuesta, 458 U.S. 141, 153 (1983).

20 Crosby, 530 U.S. at 372.

21 See Riegel, 128 S.Ct at 999 (interpreting the scope of an express preemption clause in the Medical Devices Amendments of 1976).

22 Cippollone v. Liggett Group, Inc., 505 U.S. 504, 516 (1992) (internal quotations and citations omitted).

23 See id. (explaining, “it has been settled that state law that conflicts with federal law is without effect”).

24 Id. at 545 (quoting Hines v. Davidowitz, 312 U.S. 52, 67 (1941)).

25 See Garcia v. San Antonio Metro. Transit Auth., 469 U.S. 529, 546-47 (1985). The Tenth Amendment says, “The powers not delegated to the United States by the Constitution, nor prohibited by it to the states, are reserved to the states respectively, or to the people.” U.S. Const., amend. X.

26 Geier v. Am. Honda Co., 529 U.S. 861, 907 (2000) (Stevens, J., dissenting).

27 Amanda, Frost, Judicial Review of FDA Preemption Determinations, 54 Food & Drug L.J. 367, 373 (1999)Google Scholar.

28 See Hillsborough, 471 U.S. at 713-14.

29 Chicago & N.W. Tr. Co. v. Kalo Brik & Tile, 450 U.S. 311, 317 (1981).

30 See Frost, supra note 27, at 374 (explaining why the Supreme Court's “error” in allowing preemption when Congressional intent is unclear and Congress did not want to preempt is worse than the “error” in failing to preempt when Congressional intent is unclear and Congress did want to preempt).

31 See id.

32 Id. at 374.

33 Id.

34 Id.

35 Id. at 375.

36 Levine v. Wyeth, 944 A.2d 179, 187 (Vt. 2006).

37 Id.

38 Food, Drug, and Cosmetics Act of 1938, Pub. L. No. 75-717, 52 Stat. 1040 (codified as amended at 21 U.S.C. § 301 et. seq. (2000)).

39 See 21 U.S.C. § 355(d) (2009) (“Grounds for refusing [drug] application”).

40 Requirements on Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Prescription Drug Product Labels, 65 Fed. Reg. 81082 (Dec. 22, 2000) (codified at 21 C.F.R. pt. 201).

41 Id. at 81085.

42 Id. at 81090.

43 Id. at 81103.

44 Requirements on Content and Format of Labeling for Human Prescription Drugs and Biological Products, 71 Fed. Reg. 3922, 3969 (Jan 24, 2006) (codified at 21 C.F.R. pt. 201).

45 Id. at 3969.

46 Id. at 3936. The claims important to the Wyeth case are: “(3) claims that a sponsor breached an obligation to warn by failing to include contraindications or warnings that are not supported by evidence that meets the standards set forth in this rule, including §201.57(c)(5) (requiring that contraindications reflect ‘[k]nown hazards and not theoretical possibilities’) and (c)(7); (4) claims that a drug sponsor breached an obligation to warn by failing to include a statement in labeling or in advertizing, the substance of which had been proposed to FDA for including in labeling, if that statement was not required by FDA at the time plaintiff claims the sponsor had an obligation to warn … .” Id.

47 Id. at 3933-36.

48 Id. at 3933 (FDA response to Comment 12).

49 Id. (“The Highlights limitation statement … states that Highlights does not contain all the information needed to prescribe a drug safely and effectively and that practitioners should also refer to the [Full Prescribing Information].”).

50 71 Fed. Reg at 3934.

51 Id.

52 Id. (The preamble fails to identify the cases for which FDA filed these briefs).

53 See, e.g., Mary, J. Davis, The Battle Over Implied Preemption: Products Liability and the FDA, 48 B.C.L. Rev. 1089 (2007)Google Scholar; Christine, H. Kim, The Case for Preemption of Prescription Drug Failure-to-Warn Claims, 62 Food & Drug L.J. 399 (2007)Google Scholar; Catherine, M. Sharkey, Preemption by Preamble: Federal Agencies and the Federalization of Tort Law, 56 DePaul L. Rev. 227 (2007); Robert N. Weiner, Preemption and the FDA Preamble, 878 PLI/Pat 847 (2006)Google Scholar (explaining the arguments made for and against FDA preemption).

54 71 Fed. Reg at 3934.

55 Id.

56 Id.

57 Id. (the FDA claiming that it alone is responsible for regulating the safety and efficacy of drugs).

58 Indeed, the FDA seems to acknowledge that state law may increase labeling requirements if, and only if, there is a new risk never considered by the FDA during the labelapproval process. See Brief for United States as Amicus Curiae Supporting Petitioner at 20, Wyeth v. Levine, 129 S.Ct. 1187 (2009) (No. 06-1249), 2008 WL 2308908 [hereinafter FDA Brief].

59 Id. at 17 (quoting 71 Fed. Reg. at 3935) (internal quotations removed).

60 Id.

61 Id. at 19-20.

62 Id.

63 Id.

64 Chevron, U.S.A., Inc. v. Natural Res. Def. Council, Inc., 467 U.S. 837 (1984).

65 Id. at 842-43.

66 See FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 127 (2000).

67 Chevron, 467 U.S. at 843.

68 Id.

69 U.S. v. Mead Corp., 533 U.S. 218, 226 (2001).

70 See, e.g., id. (withholding deference to U.S. Customs Service's tariff classification ruling because the ruling did not have the “force of law”); Smiley v. Citibank, 517 U.S. 735 (1996) (deferring to U.S. Comptroller of the Currency's interpretation of “interest” in National Bank Act of 1864); Hillsborough County, FL v. Automated Med. Labs., Inc., 471 U.S. 707, 714 (1985) (citing Chevron, 467 U.S. at 842-45) (“The FDA's statement is dispositive on the question of implicit intent to pre-empt unless either the agency's position is inconsistent with clearly express congressional intent, … or subsequent developments reveal a change in that position.”).

71 Chevron, 467 U.S. at 843-44.

72 Id. at 844.

73 Frost, supra note 27, at 383 (citing Antonin Scalia, Judicial Deference to Administrative Interpretations of Law, 1989 Duke L.J. 511, 516-517 (1989)).

74 Id.

75 Id.

76 Id. (discussing the unique problems clear Congressional intent plays in questions of state preemption due to the presumption against preemption inherent in the U.S. government's Federalist system).

77 Smiley v. Citibank, 517 U.S. 735, 740-41 (1996).

78 See Hillsborough County v. Automated Med. Labs., 471 U.S. 707, 714 (1985) (finding the FDA's position on pre-emption “dispositive”).

79 Chevron, U.S.A., Inc. v. Natural Res. Def. Council, Inc., 467 U.S. 837, 865 (1984).

80 Id. at 844. See also Frost, supra note 27, at 370.

81 Scalia, supra note 73, at 514.

82 Medtronic v. Lohr, 518 U.S. 470, 505 (1996) (Breyer, J., concurring).

83 Chevron, 467 U.S. at 865.

84 Thomas Merrill, Capture Theory and The Courts: 1967-1983, 72 CHI.-KENT L. REV. 1039 (1997).

85 Id. at 1050 (detailing “The Capture Theory Era”).

86 Id. at 1044.

87 Id. at 1091.

88 See, e.g., Christina, Marie Martin, Hugs and Drugs: Research Ethics, Conflict of Interest, and Why the FDA's Attempt to Preempt Pharma Failure-to-Warn Claims is a Dangerous Prescription, 6 Ave Maria L. Rev. 587 (2008)Google Scholar (arguing that the Court should recognize and industry influence exception to Chevron). Such an exception is in some ways comparable to the “agency capture” theory of judicial precedents, but is fundamentally flawed because a caseby- case determination of which decisions were so influenced as to destroy the agency's claim to deference would inherently overturn Chevron's framework.

89 See Merrill, supra note 84, at 1053 (Describing “The Public Choice Era”).

90 See Christopher S. Yoo, et al., The Unitary Executive in the Modern Era, 1945-2004, 90 Iowa L. Rev. 601, 604 (2005).

91 Evan, J. Criddle, Chevron's, Consensus, 88 B.U.L. Rev. 1271, 1289 (2008)Google Scholar.

92 See id. (explaining the difficulties of the President in exercising control over Federal agencies).

93 Auer v. Robbins, 519 U.S. 452, 457 (1997).

94 There appears to be no Supreme Court decision that held a statute ambiguous, and that the agency interpretation “unreasonable.” See Kristine Cordier Karnezis, Construction and Application of “Chevron Deference” to Administrative Action by United States Supreme Court, 3 A.L.R. Fed. 2d 25, §11 (2005) (listing cases deferring to “reasonable” interpretations, but none determining agency construction “unreasonable).

95 U.S. v. Mead, Corp., 533 U.S. 218 (2001).

96 Id. Mead imported day planners, three-ring binders, and calendars, among other office supplies.

97 Id. at 221.

98 Id. at 226-27.

99 Id. at 227.

100 Id. at 228 (internet citations omitted).

101 See Criddle, supra note 91, at 1305 (“The last six years [since Mead] have witnessed the fulfillment of Justice Scalia's prophesy [that lower courts would be unable to consistently decide when to apply Chevron].”).

102 Wyeth v. Levine, 129 S.Ct. 1187, 1201 (2009).

103 Id. at 1204 (Breyer, J., concurring) (highlighting the fact that the agency interpretation did not have the “force of law”).

104 Mead, 533 U.S. at 234; Skidmore v. Swift & Co., 323 U.S. 134 (1944).

105 Mead, 533 U.S. at 221.

106 Id. at 241 (Scalia, J., dissenting) (internal quotations omitted).

107 Colacicco v. Apotex, Inc., 521 F.3d 253, 275 (3d Cir. 2008) (involving the same issues as the Wyeth case, the court deferred under Skidmore analysis). Colaccio has been vacated and remanded in the aftermath of Wyeth. Colaccicco v. Apotex, Inc., ___ S.Ct. ___, 2009 WL 578682 (U.S.), 77 USLW 3229.

108 Auer v. Robbins, 519 U.S. 452, 457 (1997).

109 Id. at 452 (citing Chevron U.S.A. Inc, v. Natural Res. Def. Council, Inc., 467 U.S. 837, 842-43 (1984)) (internal quotations omitted).

110 Id. at 462.

111 Kim, supra note 53, at 417 (citing Sprietsma v. Mercury Marine, 531 U.S. 51 (2002)).

112 Frost, supra note 27, at 371 n.44 (citing DeBartolo Corp. v. Florida Gulf Coast Bldg. & Constr. Trades Council, 485 U.S. 568, 574-75 (1988)).

113 Id.

114 5 U.S. 137 (1803).

115 Hillsborough County v. Automated Med. Labs., Inc., 471 U.S. 707, 713-14 (1985).

116 Chevron U.S.A. Inc, v. Natural Res. Def. Council, Inc., 467 U.S. 837, 844 (1984) (“considerable weight should be accorded to an executive department's construction of a statutory scheme it is entrusted to administer … .”) (footnote omitted) (emphasis added).

117 See United Parcel Serv., Inc. v. NLRB, 92 F3d 1221, 1226 (D.C. Cir. 1996).

118 See Timothy, Armstrong, Chevron, Deference and Agency Self-Interest, 13 Cornell J.L. & Pub. Pol’y 203, 208 n.11 (2004) (citing Bowen v. American Hosp. Ass’n, 476 U.S. 610, 642 (1986))Google Scholar.

119 Wyeth v. Levine, 129 S.Ct. 1187, 1194 (2009).

120 Id. at 1199.

121 FDA Brief, supra note 58, at 21; Brief for Petitioner at 29, Wyeth v. Levine, 129 S.Ct. 1187 (2009) (No. 06-1249), 2008 WL 2273067.

122 21 C.F.R. §314.105(b) (2008).

123 21 C.F.R. §314.70.

124 21 C.F.R. §314.70(c)(6).

125 21 C.F.R. §314.70(c)(6)(iii)(A) & (C), respectively.

126 21 C.F.R. §314.70(c)(6)(iii).

127 Wyeth v. Levine, 129 S.Ct. 1187, 1197 (2009) (quoting Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices, 73 Fed. Reg. 49603 (Aug. 19, 2008) (to be codified at 21 C.F.R. pts. 314, 601, 814)) (internal quotations removed).

128 Id.

129 Id.

130 Brief for Petitioner, supra note 121, at 16.

131 Id.

132 There is some interesting procedural information about whether the proposed label was stronger. Levine, during trial, argued that the proposed label would have been adequate to warn the nurse of the possible adverse effects. The trial court and the Vermont Supreme Court held that the proposed label did not strengthen the warning at all. Thus, if Levine's argument was believed, then it is more likely that Wyeth could successfully argue that it was impossible to comply with FDA regulations through the CBE process. Wyeth, 129 S.Ct. at 1199 n.5.

133 Id. at 1197.

134 Brief for Respondent at 43, Wyeth v. Levine, 129 S.Ct. 1187 (2009) (No. 06-1249), 2008 WL 3285388.

135 Wyeth, 129 S.Ct. at 1209 (Thomas, J., concurring).

136 Id.

137 Id. at 1199.

138 See id. at 1205 (Thomas, J., concurring) (“I have become increasingly skeptical of this Court's ‘purposes and objectives’ pre-emption jurisprudence.”).

139 Id. at 1220 (Alito, J., dissenting) (citing Geier v. American Honda Motor Co., 529 U.S. 861, 884-85 (2000)).

140 Cippollone v. Liggett Group, Inc., 505 U.S. 504, 545 (1992).

141 Brief for Wyeth, supra note 121, at 40. The FDA supports the same view. See FDA Brief, supra note 58, at 11.

142 Wyeth v. Levine, 129 S.Ct. 1187, 1199-200 (2009).

143 Id. at 1200.

144 Id.

145 The first step in Chevron is whether a statute is ambiguous. Statutory ambiguity may be widely defined. See Scalia, supra note 73, at 520 (“Chevron becomes virtually meaningless, it seems to me, if ambiguity exists only when the arguments for and against the various possible interpretations are in absolute equipoise … If Chevron is to have any meaning, then, congressional intent must be regarded as ‘ambiguous’ not just when no interpretation is even marginally better than any other, but rather when two or more reasonable, though not necessarily equally valid, interpretations exist.”).

146 Wyeth, 129 S.Ct. at 1220 (Alito, J., dissenting).

147 Requirements on Content and Format of Labeling for Human Prescription Drugs and Biological Products, 71 Fed. Reg. 3934 (Jan. 24, 2006) (codified at 21 C.F.R. pt. 201).

148 529 U.S. 861 (2000).

149 Id.

150 See Wyeth, 129 S.Ct., at 1222 (Alito, J., dissenting).

151 Id. at 1999 nn.5 & 6.

152 The FDA addressed this concern. See FDA Brief, supra note 58, at 25 (“The agency could not reasonable be expected to expressly reject every possible variant of approved labeling as part of its decisional process.”).

153 Wyeth, 129 S.Ct. at 1228 (Alito, J., dissenting).

154 Id.

155 Geier v. Am. Honda Co., 529 U.S. 861, 871 (2000).

156 Id.

157 21 U.S.C. § 355(b)(1)(A) (2009).

158 Wyeth, 129 S.Ct. at 1229 (Alito, J., dissenting).

159 Id. at 1215 (Thomas, J., concurring).

160 Id. at 1207.

161 Id. (Article I, section 7 details the procedures for creating laws).

162 Id.

163 Id. at 1215.

164 Michael Kinsley, Drug Regulators in the Jury Box, Wash. Post, March 13, 2009, at A17.

165 See FDA Brief, supra note 58.

166 Id. at 26.

167 Id.

168 Id.

169 Wyeth v. Levine, 129 S.Ct. 1187, 1201 (2009).

170 Hillsborough County v. Automated Med. Labs., Inc., 471 U.S. 707, 714-15 (1985).

171 Geier v. Am. Honda Co., 529 U.S. 861, 908 (2000).

172 Id.

173 Id. at 884.

174 Wyeth, 129 S.Ct. at 1201.

175 Id.

176 See U.S. v. Mead Corp., 533 U.S. 218, 232 (2001).

177 Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices, 73 Fed. Reg. 2848 (Jan. 16, 2008) (to be codified at 21 C.F.R. pt. 314).

178 See supra, Part IV.A.1.a “Impossibility Preemption” for a description of the change being effected to the regulations.

179 73 Fed. Reg. at 2848-49.

180 73 Fed Reg. at 2853 (citing Hines v. Davidowitz, 312 U.S. 52, 67 (1941)) (internal quotations omitted) (emphasis added).

181 Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices, 73 Fed. Reg. 49603 (Aug. 19, 2008) (to be codified at 21 C.F.R. pts. 314, 601, 814).

182 73 Fed. Reg. 49603; 73 Fed. Reg. 49605 (incorporating amicus brief from Wyeth in Comment 2); 73 Fed. Reg. 49606 (reaffirming preamble in Comment 7)

183 Reply Brief for Petitioner at 7, Wyeth v. Levine, 129 S.Ct. 1187, 1201 (2009) (No. 06- 1249), 2008 WL 4264481.

184 U.S. v. Mead Corp., 533 U.S. 218, 230-31 (2001).

185 Id.

186 The FDA, of course, could issue a new rule and cut short this analysis as well, but has not done so.

187 Diane Levine was injured in April 2000, resulting in a nine-year legal battle.

188 See Geier v. Am. Honda Co., 529 U.S. 861, 883 (2000) (finding a 1984 agency regulation, foreshadowed in 1976, “longstanding”).

189 See National Cable & Telecomm. Assoc. v. Brand X Internet Services, 545 U.S. 967, 982 (“A court's prior judicial construction of a statute trumps an agency construction otherwise entitled to Chevron deference only if the prior court decision holds that its construction follows from the unambiguous terms of the statute and thus leaves no room for agency discretion.”)

190 Kim, supra note 53, at 417.

191 Colacicco v. Apotex, Inc., 521 F.3d 253, 274-75 (3d Cir. 2008).

192 Id. at 275.