Opinion ID: 1941660
Heading Depth: 2
Heading Rank: 2

Heading: Conflict Preemption in Other Jurisdictions

Text: ¶ 14. In light of the leeway created by § 314.70(c) for drug manufacturers to add warnings, courts have been nearly unanimous in holding that state failure-to-warn tort claims do not conflict with federal law. See, e.g., McNellis, 2005 WL 3752269, at  ([T]he FDCA and the FDA's regulations do not conflict with New Jersey's failure to warn law because those federal regulations merely set minimum standards with which manufacturers must comply.). McNellis is the latest in a series of recent cases addressing this issue as it relates to the anti-depressant Zoloft, which allegedly increases the risk of suicide in some patients. See id. at -7-8 (denying summary judgment and rejecting conflict preemption in Zoloft case); accord Zikis v. Pfizer, Inc., 2005 WL 1126909, at -3 (N.D.Ill.); Witczak v. Pfizer, Inc., 377 F.Supp.2d 726, 729-30 (D.Minn.2005); Motus v. Pfizer, Inc., 127 F.Supp.2d 1085, 1096-1100 (C.D.Cal.2000); see also Cartwright v. Pfizer, Inc., 369 F.Supp.2d 876, 882 (E.D.Tex.2005) (With little exception, courts that have considered this exact issue have concluded that state failure to warn claims are not preempted by the FDCA and its attendant regulations.). Contra Needleman v. Pfizer, Inc., 2004 WL 1773697, at  (N.D.Tex.) (granting summary judgment to the defendant on basis of conflict preemption). ¶ 15. The Zoloft cases are representative of a general rule that FDA approval of a drug's label does not preempt state failure-to-warn claims. See, e.g., Eve v. Sandoz Pharm. Corp., 2002 WL 181972, at -3 (S.D.Ind.) (rejecting conflict preemption of failure-to-warn claim regarding the drug Parlodel); Caraker v. Sandoz Pharm. Corp., 172 F.Supp.2d 1018, 1032 (S.D.Ill.2001) (same); Bryant v. Hoffmann-La Roche, Inc., 262 Ga.App. 401, 585 S.E.2d 723, 725 (2003) (heart medication); Bell v. Lollar, 791 N.E.2d 849, 854-55 (Ind.Ct.App.2003) (prescription pain medication); Kurer v. Parke, Davis & Co., 2004 WI App 74, ¶ 21, 272 Wis.2d 390, 679 N.W.2d 867 (oral contraceptive). But see Ehlis v. Shire Richwood, Inc., 233 F.Supp.2d 1189, 1198 (D.N.D.2002) (granting summary judgment to defendant on basis of conflict preemption of claim regarding the drug Adderall). ¶ 16. Defendant cites two cases, Needleman and Ehlis, that support the preemptive effect of the FDCA in failure-to-warn cases regarding prescription drug labels. Needleman, 2004 WL 1773697, at ; Ehlis, 233 F.Supp.2d at 1198. Needleman is not particularly helpful under the circumstances here. Its holding relied on the facts of the Zoloft litigation, particularly an FDA statement that the warning advocated by the plaintiff would have been misleading. 2004 WL 1773697, at . The courts in the other Zoloft cases took a different approach to the FDA's statement, in part because the FDA's statement was not an official agency position, and in part because the FDA later retracted its position regarding the link between Zoloft and suicide. See, e.g., Witczak, 377 F.Supp.2d at 730. Here, the FDA has not indicated that a stronger warning would be misleading, so the reasoning of Needleman appears inapplicable to this case. Ehlis interpreted § 314.70(c) as allowing unapproved changes to a label only temporarily, and only under limited circumstances. 233 F.Supp.2d at 1197-98. We can find no support for this interpretation in the language of the regulation, which appears to allow unilateral changes to drug labels whenever the manufacturer believes it will make the product safer, and places no limit on the duration of pre-approval warnings unless the FDA disapproves of the change. 21 C.F.R. § 314.70(c). ¶ 17. Defendant next attempts to draw a comparison to the regulation of medical devices under the FDCA, citing medical device cases in which state tort law has been preempted. See Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 348, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001) (holding that fraud-on-the-FDA claim relating to device regulated by Medical Device Amendments to FDCA was preempted); Horn v. Thoratec Corp., 376 F.3d 163, 177 (3d Cir.2004) (holding that failure-to-warn claim was preempted by Medical Device Amendments). We find this analogy unpersuasive. Neither Buckman nor Horn weakens the force of the drug-labeling cases cited above. The claim that was preempted in Buckman was for fraud on the FDA, not failure to warn; the Court held that the presumption against preemption applies only when a claim implicates `the historic primacy of state regulation of health and safety,' which is not the case when the claim arises from a federal statute. 531 U.S. at 347-48, 121 S.Ct. 1012 (quoting Medtronic, 518 U.S. at 485, 116 S.Ct. 2240). Plaintiff's negligence and product-liability claims fall squarely within the scope of traditional state regulation, so it is appropriate to apply the presumption against preemption here. In Horn, the Third Circuit relied on an express preemption clause in the FDCA that relates only to medical devices. 376 F.3d at 176. Because no such clause exists for prescription drugs, Horn 's reasoning does not apply to this case. ¶ 18. Finally, defendant cites a third group of cases relating generally to the United States Supreme Court's recent use of conflict preemption in other fields. This argument relies primarily on Geier v. American Honda Motor Co., 529 U.S. 861, 120 S.Ct. 1913, 146 L.Ed.2d 914 (2000). In Geier, the Court held that state tort claims based on the production of automobiles without airbags conflicted with federal regulations making airbags one of several permissible safety equipment options. 529 U.S. at 881, 120 S.Ct. 1913. Geier, however, rested on the conclusion that the Department of Transportation's intent in drafting the regulation at issue was to provide a range of different safety options, thus precluding any state determination that a specific type of equipment should be required. Id. The history of the regulation at issue indicated that the agency intended to phase in automobile safety requirements gradually, allowing the public to choose between mandatory seatbelt laws at the state level and a federal passive-restraint requirement. Id. at 880-81. Allowing state tort claims based on the lack of a particular safety mechanism would have conflicted with both the agency's phase-in plan and its intent to provide consumers with a range of safety options. Id. at 881, 120 S.Ct. 1913. The Court explicitly stated that in a different context an agency could promulgate regulations that provided a floor, but not a ceiling, for state regulation. Id. at 870, 120 S.Ct. 1913. ¶ 19. The FDA's labeling requirements are exactly that type of regulation. Section 314.70(c) does not allow us to interpret FDA approval of a drug label as anything but a first step in the process of warning consumers. When further warnings become necessary, the manufacturer is at least partially responsible for taking additional action, and if it fails to do so, it cannot rely on the FDA's continued approval of its labels as a shield against state tort liability. While a state common-law duty may encourage departure from a label that the FDA has approved in great detail, such a duty does not create a conflict with federal requirements because the FDA and the state share the purpose of encouraging pharmaceutical companies to alter their drug labels when they are inadequate to protect consumers. We agree with the significant majority of courts that state failure-to-warn claims are generally not preempted by federal labeling requirements. ¶ 20. We must now apply this reasoning to defendant's two original contentions: (1) notwithstanding the fact that it is generally possible for manufacturers to comply with both federal and state law through the procedures created by § 314.70(c), the FDA's specific actions with respect to Phenergan made it impossible for defendant to comply with both federal and state law; and (2) even if plaintiff's claim and the cases cited above do not make it impossible for manufacturers to comply with both state and federal law, they present an obstacle to federal objectives.