Court Opinion

ID: 9568287
Source: CourtListenerOpinion
Date Created: 2023-08-21 20:02:15.642034+00
Date Added: 2024-06-11T10:24:33.017287
License: Public Domain

AMBRO, Circuit Judge,
dissenting.
The majority opinion describes these cases as situations calling for preemption: the expert agency, the Food and Drug Administration (“FDA”), consults scientific data to generate the optimal warnings (not too lax, not too alarmist) for drug labels— and state tort lawsuits would disrupt this fine system. But there is an important contrary view that has prevailed until recently: state tort law complements FDA provisions on drug warnings, in part by eliciting more information than the FDA would glean otherwise from pharmaceutical manufacturers. This contrary view has, I believe, the better argument in terms of legal doctrine on preemption, congressional intent, and the history of state tort law alongside federal law. Although the majority opinion is well-crafted and responsibly narrow, I would not move even the short distance my colleagues go toward preemption of state-law torts. I thus respectfully dissent.
I. Presumption Against Preemption
The majority opinion begins its analysis where I would, by examining whether we are to apply a presumption against preemption. State tort law, dealing with failure-to-warn claims (like those brought by *277the plaintiffs in our cases), addresses health and safety and thus falls within the states’ traditional police powers. See Medtronic, Inc. v. Lohr, 518 U.S. 470, 485, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996) (describing the presumption against preemption and asserting “the historic primacy of state regulation of matters of health and safety”). As the majority recognizes, the presumption does not always apply; for example, it does not apply to claims alleging fraud on the FDA. See Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 347-48, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001). That the presumption there does not apply — where common sense points to federal law governing exclusively those who seek to defraud a federal agency — is no surprise, and hardly weakens the presumption when it does apply.
The presumption against preemption must inform our analysis of both “whether Congress intended any pre-emption at all” and “the scope of its intended invalidation of state law.” Lohr, 518 U.S. at 485, 116 S.Ct. 2240 (emphasis omitted). When the presumption applies, rebutting it requires a clear expression that Congress intended to preempt. Bates v. Dow Agrosciences LLC, 544 U.S. 431, 449, 125 S.Ct. 1788, 161 L.Ed.2d 687 (2005) (“In areas of traditional state regulation, we assume that a federal statute has not supplanted state law unless Congress has made such an intention clear and manifest.”) (citations and internal quotation marks omitted).
In my view, the majority opinion under-emphasizes congressional intent as the “ultimate touchstone of pre-emption analysis.” Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516, 112 S.Ct. 2608, 120 L.Ed.2d 407 (1992) (citations and internal quotations marks omitted). Our inquiry is “guided” by a focus on gaining “ ‘a fair understanding of congressional purpose.’ ” Lohr, 518 U.S. at 485-86, 116 S.Ct. 2240 (quoting Cipollone, 505 U.S. at 530, 112 S.Ct. 2608) (emphasis in original). As the majority opinion rightly recognizes, the defendants in our cases do not make a serious argument that this case involves express preemption or field preemption. But I would place more significance on the fact that the key conflict preemption cases that the majority opinion relies on involve express statutory preemption provisions. Geier v. American Honda Motor Company, 529 U.S. 861, 864-65, 120 S.Ct. 1913, 146 L.Ed.2d 914 (2000) (evaluating viability of state-tort-law claims in light of a preemption provisión, 15 U.S.C. § 1392(d), and a savings provision, id. § 1397(k), within the National Traffic and Motor Vehicle Safety Act of 1966); Lohr, 518 U.S. at 481, 116 S.Ct. 2240 (evaluating viability of state-tort-law claims in light of the preemption provision of the Medical Devices Act, 21 U.S.C. § 360k(a)).
Even when considering a species of implied preemption — as conflict preemption generally is, see Geier, 529 U.S. at 884, 120 S.Ct. 1913 — we should be asking whether Congress intended to preempt. In our cases, we have no statutory preemption provision to interpret that relates to drug labeling in the Food, Drug and Cosmetic Act (“FDCA”). This fact should push us to hold the presumption against preemption in place, as we lack the best kind of evidence of congressional intent: statutory text.
The absence of a relevant preemption provision in the FDCA does not, of course, resolve whether the presumption against preemption is overcome by something else. The Supreme Court has “held repeatedly that state laws can be pre-empted by federal regulations as well as by federal statutes.” Hillsborough County v. Automated Med. Labs., 471 U.S. 707, 713, 105 S.Ct. 2371, 85 L.Ed.2d 714 (1985). Although initial approval of drug labeling involves *278both statutory and regulatory provisions, FDA regulations primarily govern the continuing oversight of drug-label revisions. These regulations, at the time relevant to this litigation, required drug manufacturers to revise labeling “to include a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug,” 21 C.F.R. § 201.57(e), and to submit supplemental information in the event that they “add or strengthen a contraindication, warning, precaution, or adverse reaction,” id. § 314.70(c). The defendants in our cases rely primarily on their continuing obligations under these FDA regulations for their conflict-preemption argument.
Yet the mere presence of a comprehensive regulatory scheme such as the FDA’s for drug labeling does not itself unseat the presumption against preemption. Hillsborough County, 471 U.S. at 717, 105 S.Ct. 2371 (“We are even more reluctant to infer pre-emption from the comprehensiveness of regulations than from the comprehensiveness of statutes.”).22 Because our focus must remain on congressional intent, we should remember in deciding questions of regulatory preemption that any inferences regarding congressional purpose typically will be indirect. Congress enacted the FDCA, which in turn enabled the FDA to adopt its regulations regarding continuing (i.e., post-approval) drug labeling. To overcome the presumption against preemption, the defendants in our cases must show that Congress implicitly intended to allow the FDA to adopt regulations that preempt failure-to-warn lawsuits under state law. Cf. Fidelity Federal Sav. & Loan Ass’n v. de la Cuesta, 458 U.S. 141, 162, 102 S.Ct. 3014, 73 L.Ed.2d 664 (1982) (holding that Federal Home Loan Bank Board regulations preempted state law where “the statutory language suggests that Congress expressly contemplated, and approved, the Board’s promulgation of regulations superseding state law” after also inquiring into the Board’s own intent to preempt).
The majority opinion closes its discussion of the presumption against preemption by describing a “tension” between the presumption as outlined in Lohr and some seemingly contrary language in Geier. But the Geier side of this doctrinal tug-of-war has slippery footing. The quoted language — “[0]ne can assume that Congress or an agency ordinarily would not intend to permit a significant conflict,” Geier, 529 U.S. at 885, 120 S.Ct. 1913-appears as a dictum in the context of a larger discussion of whether an agency must adopt a clear statement of preemptive intent for a conflict between federal regulation and state law to exist.23 This sentence does *279not create a counter-presumption in favor of preemption, for the very next sentence in Geier states that “a court should not find pre-emption too readily in the absence of clear evidence of a conflict.” Id. That is a restatement of the presumption against preemption, suggesting that we should not interpret Geier to muddy the presumption or to dilute its effect.24
When a federal court undertakes a conflict-preemption analysis, a “significant conflict” between federal and state law might be the kind of “clear evidence” that could rebut the presumption against preemption. Geier, 529 U.S. at 885, 120 S.Ct. 1913. We can assume Congress or the FDA had awareness of products-liability law when legislating or regulating. So if we find a genuine conflict, we may conclude that Congress intended to preempt state law. But in situations involving less obvious conflicts, the presumption against preemption will be more difficult to overcome.
I would apply the presumption against preemption here. The plaintiffs’ failure-to-warn claims stand near the heart of the states’ police powers over matters of health and safety. And the existence and detailed nature of the federal scheme does not change our imperative to require clear congressional intent (whether expressed directly in a preemption provision or implied by an authorizing statute enabling an agency to act) to preempt state tort law.
II. Deference to the FDA’s View on Preemption
At the end of its conflict-preemption analysis — even after addressing the plaintiffs’ arguments — the majority opinion considers the FDA’s own view regarding the preemptive effect of its drug-labeling regulations. In 2006, the preamble to an FDA revision of its drug-labeling regulations stated that failure-to-warn claims are preempted if, at the time of injury, the substance of the alternative warning proposed by plaintiffs (1) had already been submitted to the FDA and (2) had not been adopted. 71 Fed.Reg. 3922, 3936 (Jan. 24, 2006). The FDA also filed an amicus brief in the Colacicco case before us, arguing that “federal law preempts a state tort claim arising out of drug manufacturers’ alleged failure to provide a warning that FDA determined was not scientifically supported.” FDA Br. 16. The FDA emphasizes that it strives for the optimal strength of warning. Anything less or more than the FDA-approved and FDA-monitored warning, in the agency’s view, would be “false or misleading.” See 21 U.S.C. §§ 331(a)-(b), 352(a); Br. of Amicus Curiae United States at 2.
We must decide what weight we should give to these FDA views before analyzing the purported conflict in this case. I agree with the majority opinion that we should apply Skidmore deference to the FDA’s informal position contained in its 2006 preamble and its amicus brief in Colacicco. See Geier, 529 U.S. at 883, 120 S.Ct. 1913 (placing “some weight” on the Department of Transportation’s interpretation of its own airbag regulation); Skidmore v. Swift & Co., 323 U.S. 134, 139, 65 S.Ct. 161, 89 L.Ed. 124 (1944) (giving the Department of Labor’s “interpretive bulletin” regarding the calculation of working hours a level of deference based on “all those factors which give it power to persuade, if lacking power to control”). The formulation in Mead, which cites Skidmore and which the majority opinion quotes, *280designates the following factors for consideration: “the degree of the agency’s care, its consistency, formality, and relative expertness, and to the persuasiveness of the agency’s position.” United States v. Mead Corp., 533 U.S. 218, 228, 121 S.Ct. 2164, 150 L.Ed.2d 292 (2001).
I disagree with the majority opinion, however, in its application of the standards articulated in Skidmore and Mead. Comparing FDA statements from 1979 and 2006, my colleagues discern “no inconsistency” between them.25 I suggest a better analysis of inconsistency would take a more detailed view of the FDA’s position^) during the 27 intervening years.26 For instance, only slightly more than seven years ago the FDA disavowed any “federalism implications” or preemptive effect of changes to its requirements for prescription drug labeling. 65 Fed.Reg. 81,-082, 81,103 (Dec. 22, 2000). Rather than maintaining a consistent position, the FDA now undertakes a “180-degree reversal.” David A. Kessler & David C. Vladeck, A Critical Examination of the FDA’s Efforts to Preempt Failure-to-Wam Claims, 96 Geo. L.J. 461, 474 n. 59 (2008) (internal quotation marks omitted). Its current position is novel rather than longstanding. See id. at 462 (“For most of its seventy-seven-year history [since receiving the name “Food and Drug Administration” in 1930], the [FDA] has regulated the drugs sold in the United States without any significant interaction with the world of state-law damages litigation.”). I thus conclude that the FDA’s position regarding preemption deserves little deference by way of its inconsistency.
The majority opinion relies on another of the Skidmore and Mead factors: agency expertise. Undoubtedly, the FDA has special expertise in evaluating the scientific evidence on pharmaceuticals’ safety and efficacy. That expertise should contribute to any consideration of the proper mix of legal institutions used to regulate drug labeling. But, as my colleagues note, “[w]e would ordinarily be leery of an agency’s view of what is essentially a legal issue.” The FDA is not an expert on federalism concerns. Nor is the agency the only Government institution that should bring its perspective to bear on the relationship between the executive branch and state courts; Congress, federal courts, and state courts each have a constitutional responsibility under the Supremacy Clause to evaluate such issues. Thus, I would consider the FDA’s expertise only a mild positive in our calculation of how much deference to apply in these cases.
The remaining factors listed in Mead weigh against giving the FDA’s view on preemption much deference. With respect to “formality,” the FDA has not engaged *281in notice-and-comment rulemaking on this issue, instead promulgating its views in a preamble to a regulation and a series of amicus briefs in cases like these. As the majority notes, notice-and-comment rule-making is not required to find conflict preemption. See Geier, 529 U.S. at 885, 120 S.Ct. 1913. But the lack of notice-and-comment rulemaking should, all else equal, reduce the level of deference we give the FDA’s position. Similarly, the lack of institutional formality suggests a relatively low “degree of care” taken to outline its reasoning.27 In my view, a high degree of care on issues of preemption would involve scholarly, scientific, and public-health28 research into the complex matters of law and policy that these cases implicate. I see no evidence in the record that the FDA conducted or commissioned independent research of this nature in preparing the 2006 preamble.
In summary, the Mead factors counsel us to give the FDA’s position a relatively low level of deference. The ultimate test under Skidmore is nonetheless whether the FDA’s (and the defendants’) view has the “power to persuade,” 323 U.S. at 139, 65 S.Ct. 161, an evaluation I take up in Part III.
III. Conflict Preemption.
The defendants’ argument is that labeling that satisfies the FDA is both the minimum and the maximum amount of labeling they may do. Under this view, the FDA believes it has struck the proper balance between safety and efficacy, that is, between avoiding unintended injuries to patients because of insufficient warnings while not deterring too many patients from using drugs that would benefit them because of unjustified over-warnings. Adding additional warnings unsupported by medical evidence would subject the defendants to FDA sanctions for false labeling. Conflict preemption must apply to block state-law claims for failure to warn, according to the defendants, since stronger warnings for Paxil and Zoloft — the drugs within the category of selective serotonin reuptake inhibitors (“SSRIs”) involved in these cases — would violate FDA regulations. This makes it impossible, defendants continue, for them to have complied with both state and federal law. Alternatively, imposing an overlay of tort liability would frustrate the federal objective of having the FDA strike the safety-efficacy balance.
For the reasons I describe below, I disagree with this characterization of the interaction of FDA regulation and state tort law. Informed by the presumption against preemption, I see the federal and state constructs as complementary, as they have been since the 1930s. The majority opinion’s holding of preemption in these cases, despite an apparently narrow construction, threatens the institutional framework we have for balancing safety and efficacy in *282the pharmaceutical industry while compensating victims of wrongful injuries.
A. Absence of an Actual Conflict
None of the drug manufacturers in these cases attempted to enhance a warning and received an FDA sanction in response. The majority opinion correctly states that hypothetical conflicts can give rise to conflict preemption. But the hypothetical in question must be convincing for us to allow this. The conflict the defendants raise relies, at its heart, on the FDA punishing drug manufacturers for over-warning. But a heightened warning would likely have its source in new information that the FDA had not previously known. Thus, I find it hard to believe that, if a drug manufacturer augmented its warning in response to or in anticipation of a state tort lawsuit, the FDA would sanction the manufacturer for over-warning consumers under 21 U.S.C. §§ 331(a)-(b) and 352(a).
Indeed, drug manufacturers have authority to strengthen warnings without advance permission from the FDA. The plain language of 21 C.F.R. § 314.70 permits unilateral additions to warnings, subject to subsequent FDA approval: “[T]he holder of an approved application may commence distribution of the drug product involved upon receipt by the agency of a supplement for the change,” including such changes as “add[ing] or strengthening] a contraindication, warning, precaution, or adverse reaction.” 21 C.F.R. §§ 314.70(c)(6), (c)(6)(iii)(A). The motivation for additional warnings, which the regulation does not address, need not come from inside the pharmaceutical company in question or FDA prodding. In particular, that motivation may come from a failure-to-warn lawsuit or the threat of one.
Drug manufacturers have the best information about the safety of their products. The FDA does not conduct its own drug trials and “does not have sufficient authority to require additional clinical trials after drug approval.” Mary J. Davis, The Battle Over Implied Preemption: Products Liability and the FDA 48 B.C. L.Rev. 1089, 1149 (2007). Thus, to avoid discouraging the party with the best safety information from coming forward, 21 C.F.R. § 314.70 permits a manufacturer to alter a drug label before the FDA has evaluated and approved the change.
The defendants and the FDA do not cite even one example of the FDA punishing a drug manufacturer for over-warning. See Oral Argument Tr. 82, Dec. 10, 2007 (statement of FDA counsel that she was “not aware of any instance” in which the FDA “told a manufacturer who added an increased warning that that warning was unsubstantiated and caused the drug to be misbranded”).29 At oral argument, counsel for GlaxoSmithKline mentioned that, in 2004, the FDA required additional language in response to a strengthened warning by Wyeth Pharmaceuticals in a “changes being effected” supplement under 21 C.F.R. § 314.70. Merely requiring a clarification of or addition to warning language does not strike me as close to being close to a true conflict. On the contrary, the Wyeth example shows that the FDA typically engages in a back-and-forth discussion with drug manufacturers about warnings. In the event of a state tort lawsuit resulting in a warning that conflict*283ed with the FDA’s previous judgment, a commonplace dialogue between the manufacturer and the FDA could produce a warning complying with both federal regulations and state tort law.
B. Harmony Between Tort Law and FDA Regulation
Tort law and FDA regulation do not have conflicting goals. Both seek to strike a safety-efficacy balance. Under a negligence standard, most state courts balance the cost of care owed to a patient against the prospective harm. See, e.g., La Russa v. Four Points at Sheraton Hotel, 360 N.J.Super. 156, 821 A.2d 1168, 1173-74 (2003) (quoting Judge Learned Hand’s formula from United States v. Carroll Towing Co., 159 F.2d 169, 173, reh’g denied, 160 F.2d 482 (2d Cir.1947), which compares the cost of precautions with the expected loss); cf. Stephen G. Gilies, On Determining Negligence: Hand Formula Balancing, The Reasonable Person Standard, and the Jury, 54 Vand. L.Rev. 813, 816-22 (2001) (describing widespread use of, as well as complications in applying, the Hand formula).
Properly understood, the cost of additional warnings includes the consequences of over-warning that the defendants emphasize and that the FDA similarly takes into account.30 In reaching its holding of conflict preemption, the majority focuses on the hypothetical scenario of differing (and presumably conflicting) results of the FDA regulatory process and state tort lawsuits. Because we are dealing with hypothetical situations, however, I would focus on the essential harmony of the standards applied by the FDA and state courts rather than the disharmony conjured about the results. Both institutions seek to balance safety and efficacy. If it turns out those results actually conflict, then it is time for Congress to step in or at least for the FDA to propose a rule followed by public comment before proclaiming preemption.
Allowing multiple institutions to investigate the difficult question of how strong to make a warning can have important benefits. State courts provide a cheek on agency power. Our society relies on the FDA to an enormous degree to monitor the safety of pharmaceuticals. But the FDA’s toolkit is imperfect and incomplete by design. The FDA relies on the information provided by drug manufacturers (to repeat, it does no independent testing), and will always lack the inside perspective on clinical trials and data analyses stemming from those trials. Moreover, the FDA is limited as to the additional clinical trials it may require post-approval, Davis, supra, at 1149 & n. 444, and even “the reporting process for postapproval adverse reaction events ... is too weak,” id. at 1149 & n. 443. Also, as they play their parts in the post-approval process the drug manufacturer and the FDA will not necessarily ask the right questions. The citizen-petition administrative process was used here unsuccessfully to seek an FDA requirement of stronger warnings for SSRIs. Discovery in state tort lawsuits provides a different way for third parties to raise questions about new and existing drugs. Given this context, I would not eliminate the poten*284tially valuable information-gathering tools of state tort law.
To make all this real, I would point out that the regulatory process at the FDA, even if it allows for submission of citizen petitions, does not compensate the families of alleged victims like Lois Colacicco and Theodore DeAngelis. The availability of damages in state tort lawsuits can give injured citizens the incentive to come forward and share potentially valuable information. Even if an injury or death turns out not to have been caused by a drug or an insufficient warning, that information, too, can have social value. And the prospect of paying damages can sharpen drug manufacturers’ incentives to place appropriate weight on safety as they strike the safety — efficacy balance. We should not lightly assume this balance now preempted — and by a single recently adopted preamble at that.
C. Backdoor Federalization
The FDA’s position in these cases is an instance of “backdoor federalization,” a descriptive term commentators have recently used to describe a trend in the federal courts toward finding state law preempted. On the positive side, centralized federal control can facilitate uniform regulation of a national market (like that for pharmaceuticals) and prevent states from interfering with the affairs of other states. Samuel Issacharoff & Catherine M. Sharkey, Backdoor Federalization, 53 UCLA L.Rev. 1353 (2006).
Unfortunately, the trend toward federalization is not fully benign. While the FDA seeks to keep private plaintiffs out of state court (or federal court applying state law in diversity actions), a separate line of jurisprudence has limited private rights of action. There is a “troublesome” contrast in the way courts now tend to “grant agencies expansive discretion to interpret or declare the preemptive scope of the regulations they promulgate, whereas agencies are not given corresponding latitude to infer private rights of action under those same regulations.” Catherine M. Sharkey, Preemption by Preamble: Federal Agencies and the Federalization of Tort Law, 56 DePaul L.Rev. 227, 258-59 (2007).
Although the FDA should have a strong voice in the debate among government institutions about preemption of state tort law, by executive order it must consult with state and local governments about the consequences of its regulations. See id. at 252-55 (citing Exec. Order No. 13,132, 64 Fed.Reg. 43,255, 43,257 (Aug. 10, 1999)). But nothing in the record suggests a dialogue between federal and state officials has occurred regarding preemption of failure-to-warn lawsuits.
I would interpret the absence of an express preemption statute, the text of the actual FDA regulations, and the late arrival of the FDA’s statement on preemption in a preamble, as evidence that state tort law is not displaced. Tort lawsuits can generate useful information that the FDA can inject into its regulatory process. And tort damages can aid the FDA in aligning drug manufacturers’ incentives to find the right balance between safety and efficacy. In any event, the choice to preempt state tort law is best left to Congress, should it wish to do so. In these cases, I do not see the kind of conflict that implies Congress has made that choice.
IV. Conclusion
The plaintiffs allege that SSRIs increase the risk of patients committing suicide. They further allege that the drug manufacturers knew or should have known this, but failed to label their products appropriately. The defendants would have us halt any inquiry into their alleged negligence before it starts. They contend that, in the *285area of drug labeling, state tort law renders compliance with federal provisions impossible, or at least stands as an obstacle to federal objectives.
The FDA, which relies on information provided by others, seeks to stop one avenue of information-that gathered from suits under state tort law theories. But should an earlier series of FDA decisions indicating that the previous warnings were adequate, when they might be inadequate, preclude the operation of state tort law? The majority suggests that the plaintiffs’ claims border on claiming fraud on the FDA. But the underlying issue in these preemption cases is the structure of federal-state relations. We must decide whether the FDA will be the sole decision-maker. Without a clear statement from Congress or clear evidence that state law “stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress,” Hines v. Davidowitz, 312 U.S. 52, 67, 61 S.Ct. 399, 85 L.Ed. 581 (1941), I am reluctant to say that the defendants’ claim of a conflict has scaled the presumption against preemption.
A holding of no preemption in these cases would not suggest in any way that the defendant drug manufacturers should be liable for plaintiffs’ injuries. Like my majority colleagues, I express no view regarding the relationship between SSRIs and adult suicide. Allowing the plaintiffs’ cases to proceed beyond the motion-to-dismiss stage means instead that the state courts and federal district courts applying state tort law may evaluate — provide a check on — whether the FDA struck the right balance in the precautions and warnings it required for SSRIs.
To review the history of this issue, the FDA has for over three-quarters of a century viewed state tort law as complementary to its warning regulations. Only for the last two years has it claimed otherwise. This “sea change,” Sharkey, supra, at 242, in the FDA’s conception of the relationship between federal and state law has not appeared in a regulation subject to notice and comment, but in a preamble to a regulation. With this background, I believe courts should fear to tread where Congress has not given us a clear statement. Because I see sound legal and policy reasons to hold that the presumption against preemption is not overcome, I would allow the plaintiffs’ suits to go forward. I respectfully dissent.

. The majority opinion suggests that, because Hillsborough County considered field preemption in analyzing the municipal ordinances at issue, the operation of the Supreme Court's application of the presumption against preemption in that case “is not clear.” I disagree with this suggestion. Hillsborough County’s discussion of the presumption against preemption appears in Part III of that opinion. 471 U.S. at 714-16, 105 S.Ct. 2371. The field-preemption analysis in Sections IV.A and IV.B, and the conflict-preemption analysis in Section IV.C, follow. Id. at 716-20, 105 S.Ct. 2371. In my view, the Court's purpose in setting out the presumption against preemption in Part III was to indicate that the presumption should guide the analysis in all sections of Part IV.

. That discussion in Geier settles the issue: an agency need not do so for a conflict to exist. 529 U.S. at 884-85, 120 S.Ct. 1913. Even without express statutory preemption or a clear agency statement on preemption, a court may find that state law "actually] conflicts]” with federal law under the facts of a particular case. Id. at 884, 120 S.Ct. 1913 (quoting English v. Gen. Elec. Co., 496 U.S. 72, 79, 110 S.Ct. 2270, 110 L.Ed.2d 65 (1990)). I address the broader issue of how much deference we owe an agency's position on preemption below. See infra Part II.

. In contrast, the majority opinion never again mentions the presumption against preemption after Section IV.A of its opinion, suggesting that the presumption is performing virtually no analytical work.

. Importantly, the majority opinion's quote from the 1979 regulation is taken out of context. Rather than contemplating the FDA's relation to state courts, the quoted sentence discusses the FDA’s relation to panels of experts from which the agency seeks advice: "Although FDA often refers questions of whether a warning should be included in the labeling of a drug to its standing advisory committees, the decision as to whether a warning is legally required for the labeling of a drug must rest with the agency.” 44 Fed. Reg. 37,434, 37,447 (June 26, 1979) (emphasis added). Thus there is no support I can find in the record for the proposition that, in 1979, the FDA viewed its drug-labeling regulations as preemptive of state tort law.

. Some Supreme Court cases suggest that inconsistency is no bar to deference. See, e.g., Motor Vehicle Mfrs. Ass’n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 103 S.Ct. 2856, 77 L.Ed.2d 443. 42 (1983). But others have language suggesting that inconsistency counts against the agency’s position. See, e.g., Bates, 544 U.S. at 449, 125 S.Ct. 1788 (finding a preemption argument "particularly dubious” in light of the EPA's change in position within five years).

. By making this point I do not mean to criticize FDA counsel’s efforts in writing its amicus brief in this case or at oral argument. On the contrary, counsel performed admirably in both regards. My focus here is in-depth institutional research on law and policy preceding the recent “about face” on agency preemption.

. A group of public health researchers writes that "[¡Indirect regulation of the pharmaceutical industry by tort litigation is an important complement to the regulation of drug safety by the FDA.” Br. of Amicus Curiae Curt D. Furberg, M.D., Ph.D., ei al. at 6. This view — • based on various scholarly, peer-reviewed articles — does not receive any attention in the 2006 preamble or in the FDA's amicus brief. Notice-and-comment rulemaking would provide a forum for such research to be considered, but, as noted, the FDA has not undertaken that administrative process on the issue of preemption of state tort law.

. The majority opinion emphasizes a different fact: that the FDA, in response to citizen petitions and approvals of new uses for existing SSRIs, considered requiring a strengthened warning and declined. I agree that inaction of this kind is a form of agency action. But more important to me is that the FDA may never have sanctioned a drug manufacturer that strengthened a warning without prior FDA approval. This additional example of FDA inaction suggests that the conflict complained of is not an actual conflict.

. Advocates of preemption in these cases point to the danger of "over-warning” and imply that over-warning will result from jury decisions biased toward plaintiffs. Br. of Amicus Curiae Product Liability Advisory Council, Inc. at 14-23. This argument assumes that juries do not understand that the cost of care, including the cost of talcing too much care, is part of determining negligence. I presume, for the purposes of analyzing a hypothetical conflict between federal and state law, that state-court judges will properly instruct juries about the negligence standard.