Opinion ID: 1941660
Heading Depth: 1
Heading Rank: 5

Heading: Obstacle to Federal Purposes and Objectives

Text: ¶ 58. I would further conclude that Wyeth has demonstrated actual conflict preemption by showing that plaintiff's state-law failure-to-warn claim poses an obstacle to federal purposes and objectives. The majority does not address this issue, concluding that Wyeth does not have the option of proving this form of actual conflict preemption. The majority reaches this conclusion by relying on the following clause in the 1962 amendments to the FDCA: Nothing in the Amendments made by this Act to the Federal Food, Drug, and Cosmetic Act shall be construed as invalidating any provision of State law . . . unless there is a direct and positive conflict between such amendments and such provision of State law. Ante, ¶ 26 (quoting Drug Amendments of 1962 (Harris-Kefauver Act), Pub.L. No. 87-781, § 202, 76 Stat. 780, 793 (1962)). Citing Southern Blasting Services, Inc. v. Wilkes County, 288 F.3d 584, 591 (4th Cir.2002), the majority concludes that the provision essentially removes from our consideration the question of whether common-law tort claims present an obstacle to the purposes and objectives of Congress, because the 1962 provision simply restates the principle that state law is superseded in cases of actual conflict with federal law such that compliance with both federal and state regulations is a physical impossibility. Ante, ¶ 27 (internal quotations omitted). In other words, the majority explains, under any circumstances where it is possible to comply with both state law and the FDCA, the state law in question is consistent with the purposes and objectives of Congress. Id. Thus, the majority eliminates the possibility of proving actual conflict preemption independently through the obstacle prong of that standard. ¶ 59. But neither the passage in Southern Blasting on which the majority relies nor the United States Supreme Court decision [8] cited as authority in that passage provide an explanation or even an affirmative statement that the phrase direct and positive conflict in the 1962 amendment eliminates the obstacle prong of the actual conflict preemption standard. Thus, the majority eliminates one of the two means by which Wyeth may show actual conflict based on a single, unclearly-reasoned Fourth Circuit decision that is itself lacking in case law support. There is no basis for eliminating this prong of the actual conflict standard, and I disagree with the majority's conclusion to the contrary. [9] ¶ 60. Assuming, then, that Wyeth may demonstrate actual conflict preemption by showing that state law is an obstacle to federal regulatory purposes and objectives, I believe the facts here support the conclusion that the state tort-law verdict in this case is preempted. The United States Supreme Court's decision in Geier v. American Honda Motor Co., 529 U.S. 861, 120 S.Ct. 1913, 146 L.Ed.2d 914 (2000), is controlling on the question of when state law poses an obstacle to federal purposes and objectives. In that case, the Department of Transportation had issued a safety standard that required automobile manufacturers to equip some but not all of their 1987 vehicles with passive restraints. Id. at 864-65, 120 S.Ct. 1913. Among the optional passive restraints were air bags. Honda was in compliance with this standard. Nonetheless, the plaintiff was seriously injured in a car accident while driving a 1987 Honda that was not equipped with an air bag, but with another form of passive restraint. The plaintiff brought suit, alleging Honda was negligent in failing to install a driver's-side air bag in the car. Honda argued that the federal safety standard preempted the plaintiff's state-law negligence claim. The Supreme Court held that a lawsuit premising negligence on the failure to install an air bag conflicted with the objectives of the federal safety standard and was therefore preempted. Id. at 866, 120 S.Ct. 1913. ¶ 61. In reaching this conclusion, the Court noted that the plaintiff and the dissenting opinion  like the majority in the instant case  viewed the federal regulation as setting a minimum safety standard that states were free to supplement or strengthen. Id. at 874, 120 S.Ct. 1913. However, by examining the comments accompanying the regulation, the Court concluded that a safety standard allowing a choice of passive restraint systems while not mandating any particular system was a deliberate decision that reflected a balance of diverse policy concerns. See id. at 875, 120 S.Ct. 1913 (noting that allowing mix of available safety devices available over time would lower costs, overcome technical safety problems, encourage technological development, and win widespread consumer acceptance). In sum, . . . the 1984 version of [the safety standard] embodies the Secretary's policy judgment that safety would best be promoted if manufacturers installed alternative protection systems in their fleets rather than one particular system in every car. Id. at 881, 120 S.Ct. 1913 (quotations omitted). Accordingly, the Court concluded that the tort action sought to impose a duty on manufacturers to impose air bags, rather than other types of passive restraint systems, and that this state-law requirement was an obstacle to the federal objective of allowing a mix of safety devices. ¶ 62. Application of the Supreme Court precedent in Geier dictates the same result in this case. As with the DOT in Geier, the FDA is primarily concerned with public safety. The conclusion of what is best for public safety is arrived at by considering various policy factors that are sometimes in tension with one another. For example, in developing the safety regulation at issue in Geier, the DOT considered not only which passive-restraint systems were safest on an absolute scale, but which were most cost-effective and which would gain consumer acceptance. Similarly, here the FDA balances its assessment of a drug's safety against concerns for the drug's efficacy, taking into account that a safer but less effective drug is not necessarily best for the public health overall. See 21 U.S.C. § 355(d) (FDA must consider safety and efficacy); 21 U.S.C. § 393(b)(1), (b)(2)(B) (FDA's mission is to protect public from unsafe drugs and to promote public health by approving regulated products in timely manner). In the specific context of warnings on drug labels, the FDA considers not only what information to include, but also what to exclude. As the Eighth Circuit has noted in the medical device context, [t]here are . . . a number of sound reasons why the FDA may prefer to limit warnings on product labels. See Brooks v. Howmedica, Inc., 273 F.3d 785, 796 (8th Cir.2001). For example, [w]arnings about dangers with less basis in science or fewer hazards could take attention away from those that present confirmed, higher risks. Id. ¶ 63. No drug is without risks. The FDA balances the risks of a drug against its benefits to maximize the availability of beneficial treatments. The FDA's decision in approving a drug, its uses and labeling reflect consideration of these and other policy factors. While a state-court jury presumably shares the FDA's concern that drugs on the market be reasonably safe, the jury does not assess reasonableness in the context of public health and the associated risk-benefit analysis. A jury does not engage in a measured and multi-faceted policy analysis. Rather, a jury views the safety of the drug through the lens of a single patient who has already been catastrophically injured. Such an approach is virtually guaranteed to provide different conclusions in different courts about what is reasonably safe than the balancing approach taken by the FDA. In fact, different conclusions were reached in this case. ¶ 64. The jury in this case was instructed that [a] prescription drug is unreasonably dangerous due to inadequate warnings or instructions if reasonable instructions regarding foreseeable risks of harm are not provided to the physician and other medical professionals who are in a position to reduce the risks of harm. Faced with plaintiff's tragic injuries, the jury concluded that allowing Phenergan to be delivered through IV administration was unreasonably dangerous. The jury's verdict conflicts squarely with the FDA's assessment of precisely the same issue: whether Phenergan is safe and effective when delivered through IV administration. The claim is preempted. ¶ 65. For the above reasons, I dissent.