Court Opinion

ID: 9601842
Source: CourtListenerOpinion
Date Created: 2023-08-22 01:50:08.64907+00
Date Added: 2024-06-11T15:01:18.332656
License: Public Domain

COWEN, Circuit Judge,
dissenting.
The majority’s conclusion that the FDCA and the implementing regulations displace the Delaware Consumer Fraud Act and the consumer protection statutes of the fifty states “ignore[s] the teaching of th[e] [Supreme] Court’s decisions which enjoin seeking out conflicts between state and federal regulation where none clearly exists.” Huron Portland Cement Co. v. City of Detroit, Mich., 362 U.S. 440, 446, 80 S.Ct. 813, 4 L.Ed.2d 852 (1960). Because the state laws do not “stand[ ] as an obstacle to the accomplishment and execution of the full purposes and objectives” of the federal law, Hines v. Davidowitz, 312 U.S. 52, 67, 61 S.Ct. 399, 85 L.Ed. 581 (1941), I respectfully dissent.
I.
In areas of traditional state regulation, we start with “the assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress.” Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230, 67 S.Ct. 1146, 91 L.Ed. 1447 (1947); see also Medtronic, Inc. v. Lohr, 518 U.S. 470, 485, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996) (“[B]e-cause the States are independent sovereigns in our federal system, [it] ha[s] long [been] presumed that Congress does not cavalierly pre-empt state-law causes of action.”). The protection of consumers against deceptive business practices is an area traditionally regulated by the States. California v. ARC Am. Corp., 490 U.S. 93, 101, 109 S.Ct. 1661, 104 L.Ed.2d 86 (1989) (“Given the long history of state common-law and statutory remedies against ... unfair business practices, it is plain that this is an area traditionally regulated by the States.” (footnote omitted)); Fla. Lime and Avocado Growers, Inc. v. Paul, 373 U.S. 132, 146, 83 S.Ct. 1210, 10 L.Ed.2d 248 (1963) (statute to “prevent the deception of consumers” within scope of state’s *254police powers); Plumley v. Commonwealth of Mass., 155 U.S. 461, 467, 15 S.Ct. 154, 39 L.Ed. 223 (1894) (recognizing state’s power to “prevent[ ] deception or fraud in the sales of property within their respective limits”). Similarly, “[tjhrough-out our history the several States have exercised their police powers to protect the health and safety of their citizens.” Medtronic, 518 U.S. at 475, 116 S.Ct. 2240. As such, a presumption against a finding of preemption clearly applies in this case. Applying the presumption against preemption and general principles of conflict preemption, I cannot agree with the majority’s finding of preemption, as discussed below.
II.
A
My first point of disagreement lies with the majority’s heavy reliance upon the high level of specificity in the federal regulations as a basis for a finding of preemption. While the prescription drug advertising regulations are unquestionably detailed and extensive, it is well-established that a preemption inquiry “cannot be judged by reference to broad statements about the ‘comprehensive’ nature of federal regulation.” Head v. N.M. Bd. of Exam’rs in Optometry, 374 U.S. 424, 429-30, 83 S.Ct. 1759, 10 L.Ed.2d 983 (1963) (citations omitted); English v. Gen. Elec. Co., 496 U.S. 72, 87, 110 S.Ct. 2270, 110 L.Ed.2d 65 (1990) (“Ordinarily, the mere existence of a federal regulatory scheme, even one as detailed as § 210, does not by itself imply pre-emption of state remedies.”); Hillsborough County, Fla. v. Automated Med. Labs., Inc., 471 U.S. 707, 718, 105 S.Ct. 2371, 85 L.Ed.2d 714 (1985) (“[I]f an agency does not speak to the question of pre-emption, we will pause before saying that the mere volume and complexity of its regulations indicate that the agency did in fact intend to preempt.”).13
Despite the volume and specificity of the federal regulations, “state statutes, otherwise valid, must be upheld unless there is found ‘such actual conflict between the two schemes of regulation that both cannot stand in the same area, [ ]or evidence of a congressional design to preempt the field.’ ” Head, 374 U.S. at 430, 83 S.Ct. 1759 (quoting Fla. Lime, 373 U.S. at 141, 83 S.Ct. 1210); Fla. Lime, 373 U.S. at 143, 83 S.Ct. 1210 (finding “no inevitable collision between the two schemes of regulation”).14 As discussed further below, no such actual conflict has been demonstrated or found in this case.
*255B.
My second point of contention is with the majority’s statement, at least within the context of this case, that Congress’s purpose of protecting prescription drug users would be frustrated if plaintiffs were permitted to question the veracity of statements approved by the FDA. It is undisputed that the FDA has not approved the veracity of the particular advertisements in question, and, as discussed in greater detail below, plaintiffs are not attacking, directly or indirectly, the labeling approved by the FDA.15
The majority refers to the “essential affinity” between advertising and labeling in support of its preemption finding. Admittedly, in defining the scope and substance of certain information to be included in drug advertisements, the FDA regulations refer to the information required or permitted in the approved labeling. See, e.g., 21 C.F.R. § 202.1(a)(1) (order of listing of ingredients), (e)(3)(iii) (side effects and contraindications), (e)(6)(xi) (conditions of drug use). Consequently, a state-law claim, alleging that an advertisement consistent with the approved labeling contains inadequate disclosures or warnings regarding such matters as ingredients, side effects, contraindications, and conditions of use, might indirectly present a conflict with the FDA’s labeling determination. That kind of case would present a more difficult preemption question than the one presented here.
In the instant case, on the other hand, plaintiffs claim that advertisements of Nexium contain a false and misleading drug comparison. The labeling of a prescription drug does not contain or require a showing of a drug’s superiority over other drugs on the market. Unsurprisingly, then, the FDA has not rendered an official opinion approving or disapproving a claim of superiority of Nexium over Pri-losec.16 As a result, there is no risk that a successful state-law claim, alleging that Nexium advertisements contain false and misleading drug comparisons, would conflict with the FDA’s approval of the statements in the Nexium labeling.
The FDA’s own prescription-drug advertising regulations demonstrate as much. The regulations categorize as false and misleading any advertisement that “[c]on-tains a drug comparison that represents or suggests that a drug is safer or more effective than another drug in some particular when it has not been demonstrated to be safer or more effective in such particular by substantial evidence or substantial *256clinical experience.” 21 C.F.R. § 202.1(e)(6)(ii). Unlike the labeling-related provisions in the regulation, see, e.g., 21 C.F.R. § 202.1(a)(1), (e)(3)(iii), (e)(6)(xi), the false and misleading drug comparison provision does not turn on the approved labeling, but on the existence of “substantial evidence or substantial clinical experience.” 21 C.F.R. § 202.1(e)(6)(h). The “essential affinity” between advertising and labeling, therefore, does not subsist in a claim attacking a statement of drug superiority in an advertisement.
In summary, because the FDA has not approved or disapproved the veracity of the advertising statements that plaintiffs challenge in this case, and plaintiffs’ particular challenge does not question the veracity of any statements in the labeling approved by the FDA, there is no likelihood that plaintiffs’ claims would conflict with the FDA’s responsibility in protecting prescription drug users. As stated by the late Chief Justice Rehnquist, “merely identifying a purpose is not enough [for conflict preemption]; it must also be shown that the state law inevitably frustrates that purpose.” Jones v. Rath Packing Co., 430 U.S. 519, 545, 97 S.Ct. 1305, 51 L.Ed.2d 604 (1977) (Rehnquist, J., dissenting). Emphasizing that point, he noted:
We must also be careful to distinguish those situations in which the concurrent exercise of a power by the Federal Government and the States or by the States alone may possibly lead to conflicts and those situations where conflicts will necessarily arise. “It is not ... a mere possibility of inconvenience in the exercise of powers, but an immediate constitutional repugnancy that can by implication alienate and extinguish a pre-existing right of (state) sovereignty.”
Id. (quoting The Federalist No. 32, p. 243 (B. Wright ed. 1961)). Only if the purpose of the federal law cannot be accomplished — if its operation must be frustrated and its provisions be refused their natural effect — must the state law yield to the regulation of Congress. Savage v. Jones, 225 U.S. 501, 533, 32 S.Ct. 715, 56 L.Ed. 1182 (1912).
While the majority has identified the congressional purpose of protecting prescription drug users, it has not articulated how the state law must inevitably frustrate that purpose. There is certainly no “immediate constitutional repugnancy” between an extra-agency finding that a claim of drug superiority in an advertisement is false and misleading and the congressional purpose of protecting prescription drug users. Jones, 430 U.S. at 545, 97 S.Ct. 1305 (Rehnquist, J., dissenting) (internal quotations marks and citation omitted). As such, I cannot agree with the majority’s finding of preemption on that basis.
C.
My third concern relates to the majority’s finding that Congress’s exclusion of prescription drug advertisements from the scope of 15 U.S.C. § 52 signals a congressional intention to preempt state consumer fraud laws. The text of 21 U.S.C. § 352(n) only excludes coverage under 15 U.S.C. § 52 and does not purport to bar state-law tort actions. Nor does the legislative history to § 352(n) indicate a congressional purpose to supplant state-law actions. See English, 496 U.S. at 88, 110 S.Ct. 2270. Most importantly, the exclusion of prescription drug advertisements from coverage under the federal statute does not approach the required “clear and manifest” congressional purpose to preempt state law. See Rice, 331 U.S. at 230, 67 S.Ct. 1146.
D.
Fourth, I disagree that the majority’s attempt to analogize this case to Buckman *257Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001), where the Supreme Court found preemption based upon specific conflicts between certain FDA objectives and state-law fraud-on-the-agency claims and the interdependency between the state claims and FDCA requirements. In Buckman, the Court found that the plaintiffs’ fraud-on-the-agency claims would have had the effect of deterring beneficial off-label uses, despite the FDA’s objective not to regulate the practice of medicine, and would have caused a deluge of information concerning off-label uses, resulting in administrative burdens and delays. Id. at 350-51, 121 S.Ct. 1012. In addition, the Court found that unlike the traditional state tort claims, the fraud-on-the-agency claims existed solely by virtue of FDCA disclosure requirements, which Congress had given the FDA the exclusive responsibility to enforce. Id. at 352, 121 S.Ct. 1012. For these reasons, the Court held that the plaintiffs’ state-law claims were preempted. Id. at 353, 121 S.Ct. 1012.
Unlike the claims in Buckman, plaintiffs’ claims here do not exist by virtue of a violation of FDCA disclosure requirements. The state consumer protection statutes at issue existed long before the federal enactments. Moreover, the majority does not identify any actual conflicts between the federal regime and the state statutes. There is, for example, no cited risk that the availability of state-law remedies would conflict with a particular federal objective or a careful balancing of interests that the federal government has achieved in policing prescription drug advertising. For these reasons, the claims in this case cannot be reasonably analogized to the claims in Buckman, and, thus, the majority’s use of the reasoning in Buck-man to support its preemption finding is misguided.
E.
Fifth, I disagree with the majority’s finding of preemption to the extent it is based upon the presence of state-law parameters for false and misleading advertisements. As discussed below, the mere presence of state law standards would not inevitably lead to a collision with the federal regime.
As an initial matter, the majority characterizes plaintiffs’ claims as both interposing state-law standards and vindicating federal requirements. Implicit in this dual characterization is, necessarily, the recognition that the state standards and federal requirements are not inconsistent. Yet, it is well-established that the mere presence of state-law claims that parallel federal requirements is not sufficient to support a preemption finding. See Medtronic, 518 U.S. at 495, 116 S.Ct. 2240 (“The presence of a damages remedy does not amount to the additional or different ‘requirement’ that is necessary under the statute; rather, it merely provides another reason for manufacturers to comply with identical existing ‘requirements’ under federal law.”); Cipollone v. Liggett Group, Inc., 505 U.S. 504, 529, 112 S.Ct. 2608, 120 L.Ed.2d 407 (1992) (“State-law prohibitions on false statements of material fact do not create ‘diverse, nonuniform, and confusing’ standards. Unlike state-law obligations concerning the warning necessary to render a product ‘reasonably safe,’ state-law proscriptions on intentional fraud rely only on a single, uniform standard: falsity.”).
On a number of occasions, the Supreme Court has upheld state laws that provide remedies parallel to the remedies provided by the federal law. See, e.g., Silkwood v. Kerr-McGee Corp., 464 U.S. 238, 257, 104 S.Ct. 615, 78 L.Ed.2d 443 (1984) (“Paying both federal fines and state-imposed punitive damages for the same incident would *258not appear to be physically impossible. Nor does exposure to punitive damages frustrate any purpose of the federal remedial scheme.”); Hayfield N. R.R. Co. v. Chi. and N.W. Transp. Co., 467 U.S. 622, 636, 104 S.Ct. 2610, 81 L.Ed.2d 527 (1984) (“Although it may seem unfair to allow a shipper a ‘second bite at the apple’ in state condemnation proceedings ..., that second opportunity does not frustrate the purpose of the federal valuation scheme.”); Kewanee Oil Co. v. Bicron Corp., 416 U.S. 470, 484, 94 S.Ct. 1879, 40 L.Ed.2d 315 (1974) (“[T]he patent policy of encouraging invention is not disturbed by the existence of another form of incentive to invention.”). As explained by the Supreme Court, “state causes of action are not pre-empted solely because they impose liability over and above that authorized by federal law.” California, 490 U.S. at 105, 109 S.Ct. 1661; English, 496 U.S. at 89, 110 S.Ct. 2270 (same). But see Capital Cities Cable, Inc. v. Crisp, 467 U.S. 691, 706, 104 S.Ct. 2694, 81 L.Ed.2d 580 (1984) (“Since the Oklahoma law ... compels conduct that federal law forbids, the state ban clearly stands as an obstacle to the accomplishment and execution of the full purposes and objectives of the federal regulatory scheme.” (internal quotation marks and citation omitted)); Franklin Nat. Bank v. New York, 347 U.S. 373, 378, 74 S.Ct. 550, 98 L.Ed. 767 (1954) (finding a “clear conflict” between federal law, which authorized national banks to receive savings deposits but did not specifically permit — much less require — advertising by such banks, and New York law, which forbade them from using the word “savings” in their advertising or business).
The state statutory damages remedies for false and misleading advertisements would not frustrate the federal policy of protecting prescription drug consumers. The veracity of drug advertisements is essential to the protection of consumers. As stated in the legislative history to 21 U.S.C. § 352(n), “when a doctor is misled his patient’s health is endangered.” S. Rep. No. 87-1744 (1962), reprinted in 1962 U.S.C.C.A.N. 2884, 2904. Given that there are limitations to the FDA’s oversight over prescription drug advertisements — both congressionally-imposed limitations, such as the lack of authority to require preap-proval, 21 U.S.C. § 352(n), and practical limitations attendant to the sheer volume of drug advertisements in the media, see Donna U. Vogt, CRS Report for Congress: Direct-to-Consumer Advertising of Prescription Drugs 20 (Congressional Research Service, The Library of Congress 2005) (noting that in 2003 alone, the FDA received 38,000 advertisements from drug sponsors) — the supplementation of state-law remedies would seem to aid the FDCA’s objectives and purposes, not frustrate them.
For these reasons, I cannot agree that the mere presence of state law standards for false and misleading advertisements would present a conflict with the federal law.
F.
Of final note, Congress’s failure to provide a private remedy for persons injured by false and misleading advertisements further convinces me that the state law remedies are not preempted. As the Supreme Court stated in Silkwood, “[i]t is difficult to believe that Congress would, without comment, remove all means of judicial recourse for those injured by illegal conduct.” 464 U.S. at 251, 104 S.Ct. 615; see also Bates v. Dow Agrosciences LLC, 544 U.S. 431, 450, 125 S.Ct. 1788, 161 L.Ed.2d 687 (2005) (“[I]t seems unlikely that Congress considered a relatively obscure provision like § 136v(b) to give pesticide manufacturers virtual immunity from certain forms of tort liability.”).
*259In addition, where the state law in question provides a long available form of compensation, it would be expected that Congress would express an intent to deprive injured parties of that compensation even more clearly. See Bates, 544 U.S. at 449, 125 S.Ct. 1788. Here, the long history of state consumer protection statutes in this country (which, incidentally, were modeled after and coexisted with the FTCA, the FDCA’s predecessor insofar as prescription drug advertising is concerned) adds force to the basic presumption against preemption. See id. at 449-50, 125 S.Ct. 1788. That presumption has not been rebutted in this case.
In summary, because congressional intention to remove all judicial recourse for parties injured by deceptive business practices is far from clear, a finding of preemption is not permitted under Supreme Court precedent.
III.
Based upon the foregoing, I respectfully dissent, insofar as the majority concludes that the state claims are preempted.17

. Incidentally, the assertion that the mere "volume and complexity” of agency regulations demonstrates an implicit intent to displace all state law in a particular area is a field preemption argument, Geier v. Am. Honda Motor Co., 529 U.S. 861, 884, 120 S.Ct. 1913, 146 L.Ed.2d 914 (2000), which was never raised in this case.

. This is not an area of the law inherently requiring national uniformity and ousting all related state law. As the Supreme Court has explained, "every subject that merits congressional legislation is, by definition, a subject of national concern. That cannot mean, however, that every federal statute ousts all related state law.” Hillsborough, 471 U.S. at 719, 105 S.Ct. 2371. Thus while prescription drug advertising merits national concern, Congress has not taken drug advertising from a health and safety issue into a field of inherently national concern. See id. at 720-22, 105 S.Ct. 2371 (federal regulations governing collection of blood plasma do not preempt local ordinances on the same subject matter). Indeed, even the FDA has acknowledged that "regulation of drug labeling will not preempt all State law actions.” See Labeling Rule, 71 Fed.Reg. 3922, 3934 (Jan. 24, 2006) (to be codified at 21 C.F.R. pts. 201, 314, 601) (emphasis added).

. Even assuming arguendo that Congress wanted labeling statements approved by the FDA to be immune to attack, that federal interest would be served by preempting state law to the extent that it afforded recovery to plaintiffs attacking the labeling. Similarly, if Congress wanted advertisements approved by the FDA to be immune to attack, that federal interest would be served by preempting state law to the extent that it afforded recovery to plaintiffs attacking the advertisements. Here, plaintiffs are not attacking the labeling of Nexium. There is also no record evidence that the FDA approved the Nexium advertisements which they are challenging. Specifically, the FDA has not determined the veracity of advertisements touting Nexium’s effectiveness as "compared with Prilosec” and indicating the benefits of Nexium in "efficacy in short-term healing” and "system control” in head-to-head studies with Prilo-sec.

. To be sure, the approved labeling for Nexi-um reproduces the results of clinical studies comparing the two treatments. According to FDA guidelines, however, the Clinical Studies section of labeling is intended to "facilitate an understanding of how to use the drug safely and effectively.” Inclusion of the clinical studies are not intended to serve as an implicit agency determination about the superiority of one drug over another.

. Apart from my general disagreement with the majority's preemption analysis, 1 also disagree with the majority’s summary conclusion that the FDA’s prescription drug advertising regulations preempt the plaintiffs’ claims to the extent based upon false and misleading presentations and “detailing,” as it is not clear that the regulations apply to those kinds of promotional activities.