The "new" presumption against preemption

Hastings Law Journal

Volumn 61, Issue 5, 2010, Pages 1217-1256

  Davis, Mary J ^a,b  

^a Administration and Faculty Development Stites and Harbison   (United States)

^b UNIVERSITY OF KENTUCKY   (United States)

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[No Author keywords available]

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EID: 77954604545     PISSN: 00178322     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (386)

1. U.S. CONST. art. VI, cl. 2 ("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 the Judges in every State shall be bound thereby, any Thing in the Constitution or Laws of any state to the Contrary notwithstanding. ").
2. Caleb Nelson, Preemption, 86 VA. L. REV. 225 (2000) (discussing history of the Supremacy Clause and its meaning).
3. Wyeth v. Levine, 129 S. Ct. 1187, 1194-95 (2009) (second and third alterations in original)
4. (quoting Medtronic, Inc. v. Lohr, 518 U.S. 470, 485 (1996)
5. (quoting Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947).
6. This "presumption" has been part of preemption jurisprudence for almost one hundred years.See,e, g N. Y. Cent. R. R. Co.v Winfield, 244 U.S. 147, 155-58 (1917). Much has been written on the presumption.
7. Mary J. Davis, Unmasking the Presumption Against Preemption, 53 S.C. L. REV. 967 (2002) [hereinafter Davis, Unmasking the Presumption]
8. Richard Nagareda, FDA Preemption: When Tort Law Meets the Administrative State, I J. TORT L. (2006), http://www.bepress.com/jtl/vol1/iss1/art4/.
9. Susan Raeker-Jordan, The Pre-Emption Presumption That Never Was: Pre-Emption Doctrine Swallows the Rule, 40 ARIZ. L. REV. 1380 (1998)
10. Catherine M. Sharkey, Products Liability Preemption: An Institutional Approach, 76 GEO. WASH. L. REV. 449, 454 (2008)
11. Sandra Zellmer, Preemption by Stealth, 45 Hous. L. REV. 1659, 1666-72 (2009)
12. Most commentators favor such a presumption as consistent with fundamental notions of concurrent federal and state authority in our federal system of government. See, e.g., Mary J. Davis, The Battle over Implied Preemption: Products Liability and the FDA, 48 B. C. L. REV. 1089, 1141-44 (2007) [hereinafter Davis, Implied Presumption]
13. Raeker-Jordan, supra, at 1428-29
14. Nelson, supra note 2, at 290.
15. Viet D. Dinh, Reassessing the Law of Preemption, 88 GEO. L. J. 2085, 2112-17 (2000) (criticizing the presumption against preemption).
16. Davis, Unmasking the Presumption, supra note 3 (chronicling one hundred years of Supreme Court preemption jurisprudence and references to the presumption against preemption).
17. Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008)
18. Geier v. Am. Honda Motor Co., 529 U.S. 861 (2000).
19. Mary J. Davis, On Restating Products Liability Preemption, 74 BROOK. L. REV. 759, 762 (2009) (noting recent Supreme Court focus on preemption of state tort laws).
20. The Consumer Product Safety Act (CPSA), which is the basis for this example, can be found at 15 U.S.C. §§ 2051-2082 (2006 & Supp. 2008). The CPSA was originally enacted in 1972, see Pub. L. No. 92-573, 86 Stat. 1207, and was substantially amended in 2008.
21. 129 S. Ct. 1187, 1191 (2009). Levine is discussed in more detail infra Part III.
22. Riegel, 128 S. Ct. 999.
23. Medtronic, Inc. v. Lohr, 518 U.S. 470, 485 (1996); see also
24. Retail Clerks Int'l Ass'n, Local 1625 v. Schermerhorn, 375 U.S. 96, 103 (1963) (stating that "[t]he purpose of Congress is the ultimate touchstone" in preemption analysis).
25. Altria Group, Inc. v. Good, 129 S. Ct. 538, 543 (2008)
26. Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516 (1992). For further discussion of determining congressional intent to preempt, see infra Part II.D.
27. For a discussion of occupation of the field preemption, see DAVID G. OWEN, PRODUCTS LIABILITY LAW § 14.4, at 942 (2d rev. ed. 2008)
28. Accord THOMAS O. MCGARITY, THE PREEMPTION WAR 109, 264-65 (2008) ("The Supreme Court has applied field preemption sparingly to state common law claims, and the lower courts have followed suit.")
29. The Supreme Court has rarely found Congress to have impliedly occupied a field. But see United States v. Locke, 529 U.S. 89 (2000) (finding field preemption of state regulation of oil tankers)
30. Because of its relative rarity to date as a significant facet of preemption doctrine, field preemption will not be discussed in detail in this Article. Some have advocated its use in certain limited contexts, however
31. Richard A. Epstein, The Case for Field Preemption of State Laws in Drug Cases, 103 Nw. U. L. REV. 463 (2009).
32. OWEN, supra note 12, at 942 n.30 (quoting Hines v. Davidowitz, 312 U.S. 52, 67 (1941)).
33. Wyeth v. Levine, 129 S. Ct. 1187, 1204-17 (2009) (Thomas, J., concurring in the judgment) (arguing against any form of obstacle preemption as contrary to federalism principles)
34. Nelson, supra note 2, at 277 (stating that obstacle preemption requires "imaginative reconstruction" of congressional intent).
35. Davis, Unmasking the Presumption, supra note 3.
36. Id. at 1014-21.
37. 129 S. Ct. at 1194 (noting that preemption analysis is guided by "two cornerstones, " one of which is the presumption against preemption).
38. Id.; Altria Group, Inc. v. Good, 129 S. Ct. 538 (2008)
39. Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008).
40. Altria Group, 129 S. Ct. at 538;
41. Geier v. Am. Honda Motor Co., 529 U.S. 861 (2000)
42. Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)
43. Cipollone v. Liggett Group, Inc., 505 U.S. 504 (1992).
44. Preemption: Memorandum for the Heads of Executive Departments and Agencies, 74 Fed. Reg. 24, 693 (May 20, 2009) ("The purpose of this memorandum is to state the general policy of my Administration that preemption of State law by executive departments and agencies should be undertaken only with full consideration of the legitimate prerogatives of the States and with a sufficient legal basis for preemption.").
45. Colacicco v. Apotex, Inc., 521 F.3d 253 {3d Cir. 2008)
46. vacated, 129 S. Ct. 1578 (2009)
47. (vacating in light of Levine, 129 S. Ct. 1187).
48. In response to Levine, the United States withdrew as amicus in Colacicco and notified the Third Circuit that the United States "does not take a position on whether [the state-law failure-to-warn claims] are preempted" and "has not yet conducted the sort of reexamination of various preemption issues following the Supreme Court's decision in [Levine] that would be necessary to inform a position of the United States in this case." Letter from Sharon Swingle, U.S. Dep't of Justice, to Marcia M. Waldron, Clerk, U.S. Court of Appeals (Apr. 28, 2009), available at http://www.ahrp.org/cms/index2. php?option=com-content&do-pdf=I&id=583.
49. Catherine M. Sharkey, Preemption by Preamble: Federal Agencies and the Federalization of Tort Law, 56 DEPAUL L. REV. 227 (2007) (chronicling the recent trend of federal agencies issuing statements supporting preemption)
50. Davis, Implied Preemption, supra note 3, at 1094-96 (discussing the change in position at the FDA in the early 2000s regarding preemption by regulation in the pharmaceutical context). 23
51. 331 U.S. 218, 230 (1947).
52. 39 Stat. 486 (1916) (codified as amended at 7 U.S.C. §§ 241-256, 2006
53. 331 U.S. at 223-24.
54. 331 U.S. at 224-29 (including such matters as rates, discrimination, mixing grain, and maintenance of elevators).
55. Id. at 230
56. (citing Hines v. Davidowitz, 312 U.S. 52 (1941) (federal immigration laws)
57. N.Y. Cent. R.R. Co. v. Winfield, 244 U.S. 147 (1917), railroad regulations
58. Id. at 230, 232.
59. Id. at 234-35. 29
60. 359 U.S. 236, 241 (1959).
61. Id. at 237.
62. Id. at 237-38.
63. Id. at 240.
64. "By the Taft-Hartley Act, Congress did not exhaust the full sweep of legislative power over industrial relations given by the Commerce Clause. Congress formulated a code whereby it outlawed some aspects of labor activities and left others free for the operation of economic forces. As to both categories, the areas that have been pre-empted by federal authority and thereby withdrawn from state power are not susceptible of delimitation by fixed metes and bounds.... [The Act] leaves much to the states, though Congress has refrained from telling us how much. This penumbral area can be rendered progressively clear only by the course of litigation."
65. Id. (citation omitted)
66. (quoting Weber v. Anheuser-Busch, Inc., 348 U.S. 468, 480-81 (1955)) (internal quotation marks omitted).
67. Id. at 237.
68. Id. at 241-43.
69. Id. at 240.
70. Id. at 242.
71. Id. at 247.
72. Id. at 244.
73. Id. at 40
74. 464 U.S. 238 (1984).
75. 42 U.S.C §§ 2011 to 2297h-13 (2006).
76. Silkwood, 464 U.S. at 241-43. She later died in an unrelated car accident.
77. Id. at 242.
78. Id. at 243.
79. Id. at 241, 243, 245.
80. Ch. 724, 68 Stat. 919 (1954) (codified as amended in scattered sections of 42 U.S.C).
81. 42 U.S.C § 2021(a)(1), (c)(4);
82. Pac. Gas & Elec. Co. v. State Energy Res. Conservation & Dev. Comm'n, 461 U.S. 190, 206 (1983) ("[U]ntil 1954... the use, control, and ownership of nuclear technology remained a federal monopoly.").
83. 42 U.S.C. § 2021(c)(4);
84. Pac. Gas & Elec. Co., 461 U.S. at 206.
85. Silkwood, 464 U.S. at 251;
86. id. at 263 (Blackmun, J., dissenting);
87. id. at 279-80 (Powell, J., dissenting).
88. Id. at 251 (majority opinion);
89. id. at 263 (Blackmun, J., dissenting) ("Because the Federal Government does not regulate the compensation of victims, and because it is inconceivable that Congress intended to leave victims with no remedy at all, the pre-emption analysis established by Pacific Gas comfortably accommodates-indeed it compels-the conclusion that compensatory damages are not preempted whereas punitive damages are." (footnote omitted)).
90. Id. at 256 (majority opinion). The term "historic police powers" is not well defined though often used. It can be considered for our purposes to mean general state power to protect the citizenry in its health and welfare. For a discussion of the history of the term and its various meanings
91. The term "historic police powers" is not well defined though often used. It can be considered for our purposes to mean general state power to protect the citizenry in its health and welfare. For a discussion of the history of the term and its various meanings, see D. Benjamin Barros, The Police Power and the Takings Clause, 58 U. MIAMI L. REV. 471, 484 (2003).
92. Judges and legal scholars have made many attempts to define the police power or to draw boundaries around its scope. Writers of early treatises tried to explain the police power in terms of the common law theories reflected in cases that upheld police regulations. Courts have often defined the police power by reference to the acknowledged legitimate ends of the power, such as the promotion of the polity's health, safety, and morals, and some commentators have attempted to limit the police power to the pursuit of these ends. Many more commentators have attempted to define the police power by reference to political theory.
93. Id; see also Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947).
94. Silkwood, 464 U.S. at 251.
95. Silkwood, 464 U.S., Id.
96. Id. at 250-51. The primary area of contention in Silkwood was whether punitive damages were preempted and, on this issue, the Court was divided. Three Justices-Blackmun, Marshall, and Powell-dissented from the finding of no preemption of the punitive damages claim.
97. See id. at 258 (Blackmun, J., dissenting)
98. id. at 274 (Powell, J., dissenting).
99. OWEN, supra note 12, at 945-47
100. Davis, Unmasking the Presumption, supra note 3, at 983-97 (exploring the Court's struggle with implied and express preemption pre-1990).
101. OWEN, supra note 12, at 947.
102. Examples of this effort resulted in the prominent preemption cases that made their way to the Supreme Court in the 1990s, such as Cipollone v. Liggett Group, Inc., 505 U.S. 504 (1992)
103. and Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).
104. Symposium, Regulatory Compliance as a Defense to Products Liability, 88 GEO. L. J. 2049 (2000).
105. OWEN, supra note 12, § 14.3, at 929
106. RESTATEMENT (THIRD) OF TORTS: PRODUCTS LIABILITY § 4(b) (1998); RESTATEMENT (SECOND) OF TORTS § 288C (1965).
107. 2 AM. LAW INST. REPORTERS' STUDY, ENTERPRISE RESPONSIBILITY FOR PERSONAL INJURY: APPROACHES TO LEGAL AND INSTITUTIONAL CHANGE 94 (1991).
108. Mary J. Davis, The Supreme Court and Our Culture of Irresponsibility, 31 WAKE FOREST L. REV. 1075 (1996) (discussing the Supreme Court's products liability cases in the 1980s, particularly
109. East River Steamship v. Delaval Corp., 476 U.S. 858 (1986)
110. Boyle v. United Technologies Corp., 487 U.S. 500 (1988), both of which limited the reach of tort liability in some federal cases).
111. 505 U.S. at 508-09 (applying Federal Cigarette Labeling and Advertising Act of 1965
112. Pub. L. No. 89-92, 79 Stat. 282
113. Public Health Cigarette Smoking Act of 1969, 15 U.S.C §§ 1331-1341 (1988).
114. Id. at 508.
115. Id. at 508-10.
116. Cipollone v. Liggett Group, Inc., 789 F.2d 181, 187 (3d Cir. 1986). State courts had found otherwise.
117. Dewey v. R. J. Reynolds Tobacco Co., 577 A.2d 1239, 1255 (N. J. 1990) (finding no implied obstacle preemption by cigarette labeling laws).
118. Cipollone, 505 U.S. at 517
119. (quoting Malone v. White Motor Corp., 435 U.S. 497, 505 (1978).
120. Id. at 516.
121. Davis, Unmasking the Presumption, supra note 3, at 995-97.
122. 505 U.S. at 516-17
123. id. at 531 (Blackmun, J., concurring in part, concurring in the judgment in part, and dissenting in part)
124. id. at 545-46 (Scalia, J., concurring in the judgment in part and dissenting in part)
125. Id. at 514 (majority opinion) (quoting Federal Cigarette Labeling and Advertising Act of 1965
126. Pub. L. No. 89-92, §5, 79 Stat. 282).
127. Id. at 515 (quoting Pub. L. No. 91-222, § 5(b), 84 Stat. 87 (1969).
128. Id. at 516 (quoting Malone v. White Motor Corp., 435 U.S. 497, 505 (1978)).
129. Id. at 517.
130. Id. at 518. In addition, the Court found that the purposes and the regulatory context of the Act also supported a narrow reading.
131. id. at 519.
132. Id. at 515 (quoting Pub. L. No. 91-222, § 5(b)).
133. Id. at 521-24 (plurality opinion) (discussing change in preemption provision from the 1965 Act to the 1969 Act).
134. Id. at 521 ("The phrase '[n]o requirement or prohibition' sweeps broadly and suggests no distinction between positive enactments and common law, to the contrary, those words easily encompass obligations that take the form of common-law rules." (alteration in original)).
135. supra notes 29-39 and accompanying text (discussing Garmon).
136. Cipollone, 505 U.S. at 536
137. (Blackmun, J., concurring in part, concurring in the judgment in part, and dissenting in part) ("More important, the question whether common-law damages actions exert a regulatory effect on manufacturers analogous to that of positive enactment... is significantly more complicated than the plurality's brief quotation from San Diego Building Trades Council v. Garmon would suggest. The effect of tort law on a manufacturer's behavior is necessarily indirect." (citation omitted)). Justice Blackmun recognized that the Court's earlier cases assessing preemption of common law damages actions had "declined on several recent occasions to find the regulatory effects of state tort law direct or substantial enough to warrant preemption."
138. Id. at 537
139. (referring to, among others, Silkwood v. Kerr-McGee Corp., 464 U.S. 238 (1984)).
140. 49 U.S.C § 30103 (b)(1) (2006).
141. 514 U.S. 280, 289 (1995).
142. Id. at 288-89 ("The fact that an express definition of the pre-emptive reach of a statute 'implies'-i.e., supports a reasonable inference-that Congress did not intend to pre-empt other matters does not mean that the express clause entirely forecloses any possibility of implied preemption. ... At best, Cipollone supports an inference that an express pre-emption clause forecloses implied pre-emption; it does not establish a rule.").
143. 518 U.S. 470 (1996).
144. Pub. L. No. 94-295, 90 Stat. 539 (1976).
145. Medtronic, 518 U.S. at 476-80.
146. id. at 484-85
147. id. at 503 (Breyer, J., concurring in part and concurring in the judgment)
148. id. at 509 (O'Connor, J., concurring in part and dissenting in part).
149. 21 U.S.C. § 360k (2006).
150. Medtronic, 518 U.S. at 476-80.
151. Id. at 493-94. He stated: "[W]e used a 'presumption against the pre-emption of state police power regulations' to support a narrow interpretation of such an express command in Cipollone. That approach is consistent with both federalism concerns and the historic primacy of state regulation of matters of health and safety."
152. Id. at 485 (citation omitted)
153. (quoting Cipollone v. Liggett Group, Inc., 505 U.S. 504, 518, 523 (1992)).
154. Id. at 487 (plurality opinion).
155. Id. at 501-02 (majority opinion).
156. Id. at 501. Justice Breyer's concurring opinion gave the Court its judgment in the case, and he interpreted the word "requirement" to include common law damages actions in some circumstances, but not in this case.
157. Id. at 503-04 (Breyer, J., concurring in part and concurring in the judgment).
158. 21 C.F.R. § 808.I(d)(2) (2008) (no preemption of state or local requirements that are "equal to, or substantially identical to, requirements imposed by or under the [MDA]")
159. id. § 808.I(d)(I) (no preemption of "State or local requirements of general applicability").
160. 518 U.S. at 495-96 (agency regulations "substantially inform" interpretation of statute)
161. id. at 505-06 (Breyer, J., concurring in part and concurring in the judgment)
162. id. at 511-12 (O'Connor, J., concurring in part and dissenting in part).
163. Norfolk & S. Ry. v. Shanklin, 529 U.S. 344, 356 (2000) (discussing preemption under Federal Railroad Safety Act, and debating relevance of agency position)
164. CSX Transp. Inc. v. Easterwood, 507 U.S. 658, 670 (1993).
165. 518 U.S. at 492-94.
166. But see Riegel v. Medtronic, Inc., 128 S. Ct 999, 1009 (2008). Riegel is discussed infra regarding the FDA's change in position on this issue.
167. 529 U.S. 861 (2000). Geier is a five-to-four opinion
168. Justice Breyer wrote for the majority and was joined by Chief Justice Rehnquist and Justices O'Connor, Scalia, and Kennedy. Justice Stevens, the author of both the Cipollone and Lohr plurality and majority opinions, dissented in an opinion in which Justices Souter, Thomas, and Ginsberg joined.
169. Id. at 865 (discussing the National Traffic and Motor Vehicle Safety Act of 1966, 80 Stat. 718 (codified as amended at 49 U.S.C. §§ 30101-30169 (2006))).
170. 49 U.S.C. § 30102(a)(9) ('"'[M]otor vehicle safety standard' means a minimum standard for motor vehicle or motor vehicle equipment performance.").
171. Id. § 30103(b)(I).
172. 15 U.S.C. § 1397(k) (1988).
173. 49 C.F.R. § 571.208 (1984).
174. For a discussion of the tortured administrative history, see Geier, 529 U.S. at 875-77
175. id. at 889-92 (Stevens, J., dissenting);
176. and see also Ralph Nader & Joseph A. Page, Automobile-Design Liability and Compliance with Federal Standards, 64 GEO. WASH. L. REV. 415, 443-46(1996).
177. Geier, 529 U.S. at 865.
178. Id. at 867.
179. Geier, 529 U.S., Id.
180. Geier, 529 U.S., Id.
181. See id. at 868.
182. Id. at 867-68.
183. Id. at 868.
184. Geier, 529 U.S., Id.
185. Geier, 529 U.S., Id.
186. Id. at 872.
187. id. at 870.
188. Id. at 873-74.
189. Id. at 881.
190. A similar concern was raised in Medtronic, Inc. v. Lohr, 518 U.S. 418, 495-97 (2000).
191. 529 U.S. at 881.
192. Id. at 874-80.
193. Id. at 875-77.
194. Id. at 881 (quoting Brief for the United States as Amicus Curiae Supporting Affirmance at 25
195. Geier, 529 U.S. 861 (No. 98-1811)).
196. id. at 877-81.
197. id. at 906-07 (Stevens, J., dissenting).
198. id. at 881-82 (majority opinion).
199. id. at 871.
200. id. at 874. The idea of a "special burden" stemmed from Justice Stevens's dissenting opinion, in which he criticized the Court's overly broad implied obstacle preemption analysis.
201. id. at 898-99 (Steven, J., dissenting).
202. Id. at 880-81 (majority opinion). Many scholars have discussed the importance of agency position in preemption analysis.
203. Nina Mendelson, Chevron and Preemption, 102 MICH. L. REV. 737 (2004);
204. Sharkey, supra note 22.
205. Geier, 529 U.S. at 883.
206. Id. at 884-85.
207. See 518 U.S. 470, 495-96 (1996). Justice Breyer concurred, agreeing that "the relevant administrative agency possesse[d] a degree of leeway to determine which rules, regulations, or other administrative actions will have pre-emptive effect."
208. Id. at 505 (Breyer, J., concurring in part and concurring in the judgment).
209. See 529 U.S. at 883.
210. See generally Samuel Issacharoff & Catherine Sharkey, Backdoor Federalization, 53 UCLA L. REV. 1353 (2006) (describing trend toward limiting operation of state tort law by federal agency action);
211. Sharkey, supra note 22.
212. 537 U.S. 51, 62-63 (2002).
213. 46 U.S.C. §§ 4301-4311(2006).
214. 537 U.S. at 60-61.
215. Id. at 64-66.
216. Id. at 65-66.
217. Id. at 53.
218. 544 U.S. 431 (2005).
219. 7 U.S.C. § 136 (2006).
220. Bates, 544 U.S. at 440-42 (noting the importance of the history of the legislation and the role of tort litigation as a "common feature of the legal landscape").
221. Id. at 452.
222. Id. at 449.
223. Id. at 450. The Court continued: "If Congress had intended to deprive injured parties of a long available form of compensation, it surely would have expressed that intent more clearly."
224. Id. (citing Silkwood v. Kerr-McGee Corp., 464 U.S. 238, 251 (1984)).
225. Id.; see also id. at 459
226. (Thomas, J., concurring in the judgment in part and dissenting in part) ("Today's decision thus comports with this Court's increasing reluctance to expand federal statutes beyond their terms through doctrines of implied pre-emption. This reluctance reflects that preemption analysis is not '[a] freewheeling judicial inquiry into whether a state statute is in tension with federal objectives, ' but an inquiry into whether the ordinary meanings of state and federal law conflict." (alteration in original) (citations omitted)
227. (quoting Gade v. Nat'l Solid Wastes Mgmt., 505 U.S. 88, 111 (1992) (Kennedy, J., concurring in part and concurring in the judgment)).
228. Id. at 445 (majority opinion).
229. Id.
230. Id. at 452.
231. Id. at 446.
232. See id. at 436-37 & n.7, 449.
233. Id. at 449.
234. Id. at 451.
235. Id. at 451-52.
236. Id. at 454 (Breyer, J., concurring)
237. id. at 455, 457 (Thomas, J., concurring in the judgment in part and dissenting in part).
238. 552 U.S. 312 (2008).
239. Id. The second time was in Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341, 352 (2001), involving a so-called fraud-on-the-agency theory that the Court found was not expressly preempted by the MD A's express preemption provision but was impliedly preempted because policing fraud on an agency is a uniquely federal matter.
240. Riegel, 552 U.S. at 322-26.
241. See id. at 324-25.
242. Riegel, 552 U.S., Id.
243. Id. at 325. For a more thorough discussion regarding Congress's intent
244. see id. at 333 (Ginsburg, J., dissenting). Justice Stevens, the author of Cipollone, Lohr, Sprietsma, and Bates, concurred on the scope of "requirements" because he considered it consistent with the result in Lohr.
245. See id. at 330-33 (Stevens, J., concurring in part and concurring in the judgment).
246. Id at 325 (majority opinion).
247. Riegel, 552 U.S., Id.
248. id. at 326.
249. Id. at 326-27.
250. Id. at 327 ("But of course the agency's earlier position... is even more compromised, indeed deprived of all claim to deference, by the fact that it is no longer the agency's position.").
251. See, e.g., Catherine M. Sharkey, What Riegel Portends for FDA Preemption of State Law Products Liability Claims, 102 Nw. U. L. REV. COLLOQUY 415, 415 nn.3-4 (2008), http://calloquy.law.northwestern.edu/main/2008/07/what-riegel- por.html.
252. See Davis, supra note 6, at 771-73 (2009) (discussing importance of the debate in Riegel to the larger discussion of the importance of tort law).
253. The discussion in Riegel may now also be moot because of an effort in Congress to undo the result. See Legislation: Supporters, Opponents Debate Measure To Overturn High Court's Preemption Ruling, 37 Prod. Saf. & Liab. Rptr. (BNA) 866 (Aug. 10, 2009).
254. 129 S. Ct. 538, 542 (2008).
255. Id. at 549 ("In sum, we conclude now, as the plurality did in Cipollone, that 'the phrase "based on smoking and health" fairly but narrowly construed does not encompass the more general duty not to make fraudulent statements.'")
256. (quoting Cipollone v. Liggett Group, Inc., 505 U.S. 504, 529 (1992) (plurality opinion)).
257. 505 U.S. at 552-54 (Scalia, J., concurring in the judgment in part and dissenting in part).
258. 129 S. Ct at 552-54 (Thomas, J., dissenting)
259. see also id. at 545 n.7 (majority opinion).
260. Id. at 545 n.7.
261. See id. at 543.
262. 129 S. Ct. 1187, 1191(2009).
263. Ch. 675, 52 Stat. 1040 (1938) (codified as amended in scattered sections of 21 U.S.C).
264. See Levine, 129 S. Ct. at 1195-96.
265. See 71 Fed. Reg. 3922, 3934 (Jan. 24, 2006)
266. Davis, Implied Preemption, supra note 3, at 1090 (chronicling the history of the change in FDA preemption policy)
267. see also Sharkey, supra note 22, at 238-42.
268. See, e.g., Colacicco v. Apotex, Inc., 521 F-3d 253 (3d Cir. 2008)
269. vacated, 129 S. Ct. 1578 (2009)
270. (vacating in light of Levine, 129 S. Ct 1187)
271. Knipe v. SmithKline Beecham, 583 F. Supp. 2d 553 (E.D. Pa. 2008)
272. Tucker v. SmithKline Beecham'r?., 596 F. Supp. 2d 1225 (S.D. Ind. 2008).
273. See 129 S. Ct. at 1191.
274. 129 S. Ct., Id.
275. 129 S. Ct., Id.
276. Id. at 1192.
277. Id at 1193.
278. Levine v. Wyeth, 944 A.2d 179, 194 (Vt. 2007).
279. See Levine, 129 S. Ct at 1193-94.
280. Id at 1191.
281. Id at 1194-95 (quoting Medtronic, Inc. v. Lohr, 518 U.S. 470, 485 (1996)).
282. Id at 1195 n.3.
283. Id.
284. Id.
285. Id. at 1197.
286. Id.
287. Id. at 1197-98.
288. Id at 1198-99.
289. Id. at 1199.
290. Id. at 1198 ("But absent clear evidence that the FDA would not have approved a change to Phenergan's label, we will not conclude that it was impossible for Wyeth to comply with both federal and state requirements.").
291. Id.
292. Id.
293. Id. at 1198-99.
294. Id at 1197-98.
295. Id. at 1199.
296. Id. at 1199
297. see also Davis, Implied Preemption, supra note 3, at 1132-34 (synthesizing implied conflict preemption principles).
298. Levine, 129 S. Ct. at 1200.
299. Id. at 1199 (quoting Brief for Petitioner at 46
300. Levine, 129 S. Ct. 1187 (No. 06-1249)).
301. 129 S. Ct., Id.
302. 129 S. Ct., Id.
303. 129 S. Ct., Id.
304. Id at 1200. Congress had not expressly preempted state tort law claims as it had in other contexts, such as in the Medical Device Amendments.
305. See id.
306. Id. Further, "[Congress] may also have recognized that state-law remedies further consumer protection by motivating manufacturers to produce safe and effective drugs and to give adequate warnings."
307. Id. at 1199-1200.
308. Id. at 1200.
309. Id at 1200-01.
310. Id at 1201.
311. Id.
312. Id. at 1201-02.
313. Id. at 1202
314. ("State tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly. They also serve a distinct compensatory function that may motivate injured persons to come forward with information. Failure-to-wara actions, in particular, lend force to the FDCA's premise that manufacturers, not the FDA, bear primary responsibility for their drug labeling at all times.").
315. Id. at 1203.
316. Id.
317. Id. at 1203-04.
318. Id.
319. Id at 1204 (Breyer, J., concurring).
320. Id. at 1205 (Thomas, J., concurring in the judgment). Justice Alito dissented in an opinion in which the Chief Justice and Justice Scalia joined.
321. See id. at 1217-31 (Alito, J., dissenting).
322. See 544 U.S. 431, 449 (2005).
323. See Riegel v. Medtronic, Inc., 128 S. Ct. 999, 1014-19 (2008) (Ginsburg, J., dissenting).
324. 42 U.S.C. §§ 30oaa-I to-34 (2006).For additional history on the National Childhood Vaccine Injury Act
325. see Lainie Rutkow et al., Balancing Consumer and Industry Interests in Public Health: The National Vaccine Injury Compensation Program and Its Influence During the Last Two Decades, III PENN ST. L. REV. 681, 683-84 (2007).
326. With the swine flu episode a not-so-distant memory, Congress fashioned a no-fault, ideally non-adversarial system to compensate the families of children who were injured after receiving a vaccination. It took Congress over three years to pass the final legislation that created the National Vaccine Injury Compensation Program (VICP); the program has remained in effect for nearly twenty years. During the last few years, when the government has considered massive vaccine campaigns for seasonal influenza and smallpox, the VICP has served as a model program for congressional members.
327. Id. (footnotes omitted).
328. 42 U.S.C. § 30oaa-II(a)(2)(A);
329. see also Rutkow et al., supra note 224, at 684-87 (describing the Program)
330. Mary Beth Neraas, Comment, The National Childhood Vaccine Injury Act of 1986: A Solution to the Vaccine Liability Crisis?, 63 WASH. L. REV. 149, 156-58 (1988) (explaining the compensation mechanism).
331. For the history and structure of the Act, see Bruesewitz v. Wyeth, Inc., 561 F.3d 233, 235-36 (3d Cir. 2009)
332. cert granted, 78 U.S.L.W. 3521 (U.S. Mar. 8, 2010) (No. 09-152).
333. Rutkow et al., supra note 224, at 684-86 (describing the Program in detail).
334. 42 U.S.C.§30oaa-II(c)
335. see also Rutkow et al., supra note 224, at 684.
336. Rutkow et al., supra note 224, at 688.
337. 42 U.S.C. §30oaa-22(a).
338. Id. § 30oaa-22(b)(I).
339. 668 S.E.2d 236, 237-38 (Ga. 2008).
340. Id. at 240.
341. See id. at 238-39.
342. 561 F.3d 233, 245-46 (3d Cir. 2009)
343. cert granted, 78 U.S.L.W. 3521 (U.S. Mar. 8, 2010) (No. 09-152).
344. Id. at 246-47.
345. See Brief for the United States as Amicus Curiae at 21, Am. Home Prods. Corp. v. Ferrari, No. 08-1120 (Jan. 29, 2010).
346. 78 U.S.L.W. 3521.
347. See 42 U.S.C. § 30oaa-22(b)(I) (2006).
348. The Restatement of Torts states, "There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use, " one of which is a vaccine, for which sellers cannot be held liable if they are "properly prepared and marketed" and accompanied by a "proper warning." RESTATEMENT (SECOND) OF TORTS § 402A cmt. k (1965)
349. cf. Lars Noah, This Is Your Products Liability Restatement on Drugs, 74 BROOK. L. REV. 839, 842-43 (2009) (describing case law under comment k as "unintelligible" and having produced confusion among courts and commentators).
350. See Brief for the United States as Amicus Curiae, supra note 236, at I. The White House's recently announced position restricting executive agencies to preemption positions "with full consideration of the legitimate prerogatives of the States and with a sufficient legal basis, "
351. Preemption: Memorandum for the Heads of Executive Departments and Agencies, 74 Fed. Reg. 24, 693 (May 20, 2009)
352. (citing Exec. Order No. 13, 132, 3 C.F.R. 206 (1999)
353. reprinted in 5 U.S.C. § 601)), is relevant but does not take a very strident position either for or against preemption generally. The United States's brief in Ferrari, filed January 29, 2010, takes the position that Congress did intend to preempt design defect claims in the vaccine cases and has asked the Court to accept certiorari in Bruesewitz.
354. See Brief for the United States as Amicus Curiae, supra note 236, at 7.
355. See supra notes 172-86 and accompanying text.
356. 15 U.S.C. § 2074(a).
357. See, e.g., Moe v. MTD Prods., Inc., 73 F.3d 179 (8th Cir. 1995)
358. (applying 15 U.S.C. § 2075);
359. BIC Pen Corp. v. Carter, 251 S.W.3d 500 (Tex. 2008) (same).
360. See supra notes 194-201 and accompanying text.
361. See supra notes 210-13 and accompanying text.
362. 521 F.3d 253 (3d Cir. 2008)
363. vacated, 129 S. Ct. 1578 (2009)
364. (vacating in light of Wyeth v. Levine, 129 S. Ct. 1187 (2009)).
365. Id. at 256
366. see also Davis, Implied Preemption, supra note 3, at 1095-98 (exploring history of warnings on selective serotonin re-uptake inhibitors, or SSRIs, like Paxil).
367. Colacicco, 521 F.3d at 256.
368. Id. Cases against generic pharmaceutical manufacturers are pending nationwide and involve claims of implied conflict preemption similar to those involving the brand name manufacturers.
369. See, e.g., Kellogg v. Wyeth, 612 F. Supp. 2d 437, 441 (D. Vt. 2009) ("Thus, although the Levine decision did not definitively dispose of the issues in this case, its statement that '[f]ailure-to-warn actions, in particular, lend force to the FDCA's premise that manufacturers, not the FDA, bear primary responsibility for their drug labeling at all times, ' Levine does not appear to permit the caveat, 'except for generic drug manufacturers.'" (citation omitted)
370. (quoting Levine, 129 S. Ct. at 1202)
371. (citing Stacel v. Teva Pharms., 620 F. Supp. 2d 899, 906-07 (N.D. III. 2009);
372. Schrock v. Wyeth, Inc., 601 F. Supp. 2d 1262, 1265-66 (W.D. Okla. 2009))).
373. Colacicco, 521 F.3d at 269.
374. Id. at 271.
375. Id.
376. Id. at 272.
377. Wyeth v. Levine, 129 S. Ct. 1187, 1197-98 (2009).
378. See Colacicco, 521 F.3d at 268, 268-71 ("The FDA has actively monitored the possible association between SSRIs and suicide for nearly twenty years.").
379. See Davis, Implied Preemption, supra note 3, at 1148-51. For a case involving SSRIs finding no implied conflict preemption post-Levine, consistent with application of the presumption against preemption articulated in this Article
380. see Mason v. SmithKline Beecham Corp., 596 F.3d 387 (7th Cir. 2010).
381. See supra notes 205-07 and accompanying text.
382. 539 F.3d 237, 241 (3d Cir. 2008).
383. Id. at 241-42.
384. Id. at 250.
385. Id. at 251-55.
386. Id. at 245.