PENNSYLVANIA EMPLOYEES BENEFIT TRUST FUND on behalf of itself and all others similarly situated; Joseph Macken; Commissioner Linda A. Watters, Appellants v. ZENECA INC; AstraZeneca Pharmaceuticals LP.
No. 05-5340.
United States Court of Appeals, Third Circuit.
Argued June 5, 2007. Filed: Aug. 17, 2007.
499 F.3d 239
Jack B. Blumenfeld, Rudolph J. Scaggs, Jr., Lisa K. Whittaker, Morris, Nichols, Arsht & Tunnell, Wilmington, DE; Mark E. Haddad (Argued), Sidley Austin, Los Angeles, CA, Counsel for Appellee.
Before: SMITH, COWEN, and SILER, Circuit Judges.*
OPINION OF THE COURT
SMITH, Circuit Judge.
The Pennsylvania Employees Benefit Trust Fund, Joseph Macken, and Linda Watters (“plaintiffs“) sued Zeneca, Inc. and AstraZeneca Pharmaceuticals, L.P. (collectively referred to as “Zeneca“) in the United States District Court for the District of Delaware, asserting that Zeneca engaged in deceptive conduct in the advertising of its new drug Nexium. Claim One alleged unlawful advertising under the Delaware Consumer Fraud Act (“DCFA“). The second claim alleged violations of the consumer protection statutes of the 50 states for false, misleading, and deceptive
This appeal presents two principal questions: (1) whether the DCFA exemption for advertising regulated by the Federal Trade Commission applies to the facts of this case; and (2) whether federal law preempts the plaintiffs’ state consumer protection claims. The plaintiffs also assert that primary jurisdiction was an improper basis for dismissal, that their unjust enrichment claim was improperly dismissed on the ground that they had not pled individual reliance, and that they should have been allowed to amend their complaint. We will affirm the judgment of the District Court.1
I.
On February 11, 2005, the plaintiffs2 filed a putative class action against Zeneca, alleging that Zeneca‘s marketing campaign for Nexium3 was deceptive because it misleadingly advertised Nexium as an improvement on Prilosec. Nexium and Prilosec are both proton-pump inhibitors, drugs that treat gastroesophageal reflux disease (“GERD“) and erosive esophagitis, conditions that are commonly known as acid reflux disease and frequent heartburn. Prilosec was a profitable drug for Zeneca, and had sales of $6 billion in 2000. The patent for Prilosec was due to expire in 2001, at which point it would be available for sale as the generic drug omeprazole. On February 14, 2001, Zeneca obtained approval from the Food and Drug Administration (“FDA“) for final labeling on Nexium for healing of erosive esophagitis, maintenance of healing of erosive esophagitis, and treatment of symptomatic GERD (i.e., heartburn).
One published clinical study of Nexium compared both 20 mg and 40 mg doses of Nexium to the approved 20 mg dose of Prilosec. The data from this study showed that 40 mg of Nexium had a statistically significant healing rate over 20 mg of omeprazole. This study was among those used to obtain FDA approval of Zeneca‘s new drug application for Nexium. The FDA later determined that Nexium should be approved at recommended dosages of 20 mg or 40 mg once daily, for four to eight weeks, for the healing of erosive esophagitis, and at 20 mg for both maintenance of healing of erosive esophagitis and symptomatic GERD.
In their complaint, plaintiffs alleged that the large-scale promotional campaign for Nexium, which included both physician-directed marketing and direct-to-consumer advertising, was misleading because it incorrectly represented that Nexium was superior to Prilosec. The plaintiffs asserted
We review the grant of a motion to dismiss de novo, accepting all well-pleaded allegations as true and drawing all reasonable inferences in favor of the plaintiffs. In re Adams Golf, Inc. Sec. Litig., 381 F.3d 267, 273 (3d Cir. 2004); In re Alpharma Inc. Sec. Litig., 372 F.3d 137, 146 (3d Cir. 2004). Review of the denial of leave to amend is for abuse of discretion. Hill v. City of Scranton, 411 F.3d 118, 134 (3d Cir. 2005).
II.
The Application of the DCFA Exemption
The first issue raised on appeal is whether FDA approval of prescription drug labeling and regulation of advertising brings the plaintiffs’ claims within the DCFA exemption of “any advertising or merchandising practice” that is compliant with Federal Trade Commission regulations. The purpose of the DCFA is “to protect consumers and legitimate business enterprises from unfair or deceptive merchandising practices in the conduct of any trade or commerce in part or wholly within this State.”
The act, use or employment by any person of any deception, fraud, false pretense, false promise, misrepresentation, or the concealment, suppression, or omission of any material fact with intent that others rely upon such concealment, suppression or omission, in connection with the sale, lease or advertisement of any merchandise, whether or not any person has in fact been misled, deceived or damaged thereby....
Plaintiffs argue that the exemption should be read more narrowly than the District Court read it, and that, properly construed, the exemption did not protect Zeneca‘s conduct. In particular, plaintiffs assert that (1) the exemption is limited to conduct expressly approved by the FTC; (2) the FDA did not explicitly approve Zeneca‘s marketing campaign; and (3) Zeneca‘s marketing deviated from statements approved by the FDA for Nexium‘s label. Zeneca points to the broad prohibitions in
As a preliminary matter, we decline to read the DCFA exemption to require that an advertisement or merchandising practice must be expressly approved by the
We are left, then, with the thornier question presented by plaintiffs’ assertion that the exemption‘s reach does not extend to matters subject to FDA oversight. By congressional decree, the FTC and the FDA originally shared jurisdiction over prescription drug advertising. See Pub. L. No. 87-781, 76 Stat. 791-92 (1962) (codified as amended at
Even if Zeneca can show that the marketing was almost identical to the specifically authorized labeling, the FDA is not merely acting as the FTC‘s proxy in regulating prescription drug advertising. The FDA has responsibility for regulating the advertising of prescription drugs that is independent of any delegation from the FTC.5
The distinction between labeling and marketing is significant for regulatory purposes. Although there is often a strong correlation between a drug‘s labeling and marketing7, federal approval of labeling does not necessarily authorize marketing practices. Labeling is defined as “all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.”
In contrast, advertisements are published in journals, magazines, and newspapers,
Approval of a new drug application occurs “after [the FDA] determines that the drug meets the statutory standards for safety and effectiveness, manufacturing and controls, and labeling....”
Whether Zeneca is correct in its assertion that the complaint is fundamentally “based on” the labeling is a legal question. The complaint attacks both the actual marketing tactics used by Zeneca, as well as the studies upon which FDA approval was based. To the extent that the complaint alleges that Zeneca marketed Nexium as superior to Prilosec, those claims of superiority might be actionable inasmuch as such comparisons are not supported by the labeling and therefore might be false or misleading. Although we need not decide this question now, we note that the FDA‘s regulations require prescription drug advertisements to comport with approved labeling. See, e.g.,
Congress expressly gave the FDA authority over prescription drug advertising in the FDCA. The FDCA lists a number of required elements of prescription drug advertising and states that “no advertisement of a prescription drug, published after the effective date of regulations issued under this paragraph applicable to advertisements of prescription drugs, shall with respect to the matters specified in this paragraph or covered by such regulations, be subject to the provisions of sections 52 to 57 of Title 15.”
The DCFA became law in 1965. See Brandywine Volkswagen, Ltd. v. State Dept. of Community Affairs and Econ. Dev., Div. of Consumer Affairs, 312 A.2d 632, 633 (Del. 1973) (citing 55 Del.L., Ch. 46.). In enacting this statute, the Delaware General Assembly expressed its intent “to protect consumers and legitimate business enterprises from unfair or deceptive merchandising practices.”
III.
Preemption
The District Court further concluded that the Nexium advertisements that complied with the FDA-approved labeling were not actionable under the state consumer protection laws because those laws were preempted by federal law. The District Court correctly analyzed this issue under the rubric of implied conflict preemption. Plaintiffs assert that the District Court‘s application of federal preemption is incorrect because there is not an irreconcilable conflict between the state consumer fraud laws and the FDCA. In particular, the plaintiffs argue that the approval of Nexium‘s labeling did not extend to an assertion of Nexium‘s superiority over Prilosec.
Implied conflict preemption renders state law “without effect” when, without “express congressional command,” state law conflicts with federal law. See Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516 (1992). As the Supreme Court has explained, “[t]his question is basically one of congressional intent. Did Congress, in enacting the Federal Statute, intend to exercise its constitutionally delegated authority to set aside the laws of a State? If so, the Supremacy Clause requires courts to follow federal, not state, law.” Barnett Bank of Marion County, N.A. v. Nelson, 517 U.S. 25, 30 (1996). The Court has “found implied conflict pre-emption ... where state law ‘stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.‘” Sprietsma v. Mercury Marine, 537 U.S. 51, 64-65 (2002) (quoting Freightliner Corp. v. Myrick, 514 U.S. 280, 287 (1995) (quoting Hines v. Davidowitz, 312 U.S. 52, 67 (1941))). Thus, the question presented here is whether state consumer fraud laws pose an obstacle to the FDA‘s congressionally-mandated regulation of prescription drug advertising.
For purposes of this case, the critical characteristic of the FDCA is that it regulates the safety of drugs. The FDCA states that the mission of the FDA is to “(1) promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner; (2) with respect to such products, protect the public health by ensuring that ... (B) human ... drugs are safe and effective.”
Section 352(n) lists three items that prescription drug advertising must include: (1) the actual name of the drug, if a trade or brand name is used; (2) the ingredient list and quantitative formula for each ingredient; and (3) a brief summary of side effects, contraindications, and effectiveness. The subsection is called the “brief summary” provision. It requires a true statement of these three items in the brief summary included in advertisements. The statute explains that, to the extent that an advertisement complies with subsection (n) in listing the three items, it is not subject to the false advertising provisions of the FTCA. However, as noted above,
Pursuant to its regulatory authority over prescription drug advertising, the FDA promulgated regulations that lay out the specific requirements for advertising prescription drugs. See
[F]alse or misleading with respect to side effects, contraindications, or effectiveness; or [i]t fails to present a fair balance between information relating to side effects and contraindications and information relating to effectiveness of the drug in that the information relating to effectiveness ... is not fairly balanced by a presentation of a summary of true information relating to side effects and contraindications of the drug ...; [or] [i]t fails to reveal facts material in the light of its representations or material with respect to consequences that may result from the use of the drug as recommended or suggested in the advertisement.
The degree of discretion inherent in the regulations demonstrates that the FDA envisioned itself occupying an ongoing and extensive role in the supervision of prescription drug advertising. See, e.g., 60 Fed. Reg. at 44210 (“In order to carry out the public health protection purposes of the act, FDA: ... (3) monitors drug labeling and prescription drug advertising to help ensure that they provide accurate information about drug products.“); Direct-to-Consumer Advertising of Prescription Drugs; Withdrawal of Moratorium, 50 Fed. Reg. 36,677, 36,677 (Sept. 9, 1985) (“FDA will continue to regulate prescription drug advertising, regardless of its intended audience, in accordance with
The central tenet of preemption analysis is that “‘[t]he purpose of Congress is the ultimate touchstone’ in determining whether state law is preempted.” Cipollone, 505 U.S. at 516 (quoting Retail Clerks v. Schermerhorn, 375 U.S. 96, 103 (1963)).11 However, the Supreme Court has long indicated that agency regulations are also a source of preemptive law. See, e.g., Louisiana Public Serv. Comm‘n v. FCC, 476 U.S. 355, 369 (1986) (“Pre-emption may result not only from action taken by Congress itself; a federal agency acting within the scope of its congressionally delegated authority may pre-empt state regulation.“). In Medtronic, Inc. v. Lohr, 518 U.S. 470,
Similarly, in Geier v. American Honda Motor Co., Inc., 529 U.S. 861, 120 S. Ct. 1913, 146 L. Ed. 2d 914 (2000), the Court examined whether the National Traffic and Motor Vehicle Safety Act of 1966, and a standard promulgated under it by the Department of Transportation, preempted a state common law tort action “in which the plaintiff claims that the defendant auto manufacturer, who was in compliance with the standard, should nonetheless have equipped a 1987 automobile with airbags.” Id. at 865. The Court concluded that “the Act, taken together with FMVSS 208 [the agency-promulgated standard], pre-empts the lawsuit.” Id. (emphasis added). Both Medtronic and Geier suggest the sort of confluence between congressional purpose and agency purpose that had previously been recognized in Fidelity Federal Savings and Loan Association v. de la Cuesta, 458 U.S. 141, 102 S. Ct. 3014, 73 L. Ed. 2d 664 (1982):
Federal regulations have no less pre-emptive effect than federal statutes. Where Congress has directed an administrator to exercise his discretion, his judgments are subject to judicial review only to determine whether he has exceeded his statutory authority or acted arbitrarily. United States v. Shimer, 367 U.S. 374, 381-82 (1961). When the administrator promulgates regulations intended to pre-empt state law, the court‘s inquiry is similarly limited.
Id. at 153-54; see also Hillsborough County, Fla. v. Automated Med. Labs., Inc., 471 U.S. 707, 713 (1985) (“[S]tate laws can be pre-empted by federal regulations as well as by federal statutes.“). Medtronic and Geier add to the pre-emption analysis by suggesting that state laws are preempted when they frustrate regulations that have been promulgated following a specific inquiry into a particular area of agency authority. Leslie C. Kendrick, FDA‘s Regulation of Prescription Drug Labeling: A Role for Implied Preemption, 62 FOOD & DRUG L.J. 227, 240-41 (2007).
Following Medtronic and Geier, the Supreme Court examined conflict preemption in Buckman Company v. Plaintiffs’ Legal Committee, 531 U.S. 341, 121 S. Ct. 1012, 148 L. Ed. 2d 854 (2001). The Court determined that fraud-on-the-FDA claims in state tort law were preempted by the Medical Device Amendments,
An even stronger case for preemption occurs when FDA-approved labeling is the basis for allegedly fraudulent representations made in prescription drug advertising. The essential affinity between advertising and labeling is clear in the composition of the FDCA and its associated regulations.
Implied conflict preemption of state consumer fraud laws is required in this setting because both the FDCA and FDA regulations provide specific requirements for prescription drug advertising. Congress specifically determined that “all proceedings for the enforcement, or to restrain violations, of [the FDCA] shall be by
IV.
Leave to Amend
The decision whether to grant leave to amend is within the discretion of the district court. Rolo v. City Investing Co. Liquidating Trust, 155 F.3d 644, 654 (3d Cir. 1998). The Supreme Court has explained that
In the absence of any apparent or declared reason—such as undue delay, bad faith or dilatory motive on the part of the movant, repeated failure to cure deficiencies by amendments previously allowed, undue prejudice to the opposing party by virtue of allowance of the amendment, futility of amendment, etc.—the leave sought should, as the rules require, be ‘freely given.’
Foman v. Davis, 371 U.S. 178, 182 (1962). The District Court did not rule on appellants’ request for leave to amend.
The plaintiffs amended their complaint once in response to a motion to dismiss dated March 31, 2005 that advanced the same arguments presented in the motion to dismiss at issue here. Plaintiffs had an opportunity to revise their complaint in response to the renewed objections, but failed to cure the deficiencies. Additionally, although the plaintiffs suggest that some additional facts might be pled in order to cure the defects of the complaint, amendment would be futile. In particular, the plaintiffs state that they could allege that “in negotiations between the FDA and AstraZeneca regarding Nexium labeling, the FDA stated it would not approve any representations by AstraZeneca that Nexium is more effective than Prilosec, and AstraZeneca responded it would not make any such statement.” This will not overcome the deficiencies in the complaint because the advertisements are not subject
V.
The DCFA exemption for advertisements or merchandising practices which are subject to and compliant with the rules and regulations of, and the statutes administered by, the FTC,
Although the DCFA exemption does not bar the plaintiffs’ suit, their state consumer fraud claims are preempted by federal law. By specifically excluding advertisements covered by
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 (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 (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 (1947); see also Medtronic, Inc. v. Lohr, 518 U.S. 470, 485 (1996) (“[B]ecause 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 (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 (1963) (statute to “prevent the deception of consumers” within scope of state‘s
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 (1963) (citations omitted); English v. Gen. Elec. Co., 496 U.S. 72, 87 (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 (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 pre-empt.“).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 (quoting Fla. Lime, 373 U.S. at 141); Fla. Lime, 373 U.S. at 143 (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.
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.,
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 Prilosec.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]ontains 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
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 (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 (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 (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
D.
Fourth, I disagree that the majority‘s attempt to analogize this case to Buckman
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 Buckman 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 (“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 (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 (1984) (“Paying both federal fines and state-imposed punitive damages for the same incident would
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
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.” Id. at 251; see also Bates v. Dow Agrosciences LLC, 544 U.S. 431, 450 (2005) (“[I]t seems unlikely that Congress considered a relatively obscure provision like
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
ROBERT E. COWEN
UNITED STATES CIRCUIT JUDGE
Notes
An advertisement may be false, lacking in fair balance, or otherwise misleading ... if it ... [f]ails to present information relating to side effects and contraindications with a prominence and readability reasonably comparable with the presentation of information relating to effectiveness of the drug, taking into account all implementing factors such as typography, layout, contrast, headlines, paragraphing, white space, and any other techniques apt to achieve emphasis.