United States: FDA Reaffirms Preemptive Reach of Prescription Drug Regulations in New Labeling Rule

On January 24, 2006, the Food and Drug Administration (FDA) forcefully reiterated its position that state tort law claims based on alleged inadequate warnings in FDA-approved prescription drug labels are preempted by federal law. See FDA Final Rule, "Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products," 71 Fed. Reg. 3922-3997 (Jan. 24, 2006) (hereinafter "January 2006 Statement"). FDA’s extensive preemption analysis – set forth in the preamble to its final rule revising the prescription drug labeling requirements of 21 C.F.R. §§ 201.56 and 201.57 – concludes "that under existing preemption principles, FDA approval of labeling under the act, whether it be in the old or new format, preempts conflicting or contrary State law." Id. at 3933. FDA explains that its January 2006 Statement "represents the government’s long standing views on preemption, with a particular emphasis on how that doctrine applies to State laws that would require labeling that conflicts with or is contrary to FDA-approved labeling." Id. FDA’s preemption analysis expands upon arguments FDA has previously made in amicus briefs in numerous state law actions, and should have a significant impact on both future and pending prescription drug cases.

In this article, I first discuss the analytical basis for preemption in prescription drug litigation upon which the FDA statement is based. I then review the history of preemption arguments in prescription drug litigation and explain how the January 2006 Statement falls squarely within the emerging weight of judicial authority in support of preemption. In the concluding section, I analyze the potential impact of the January 2006 Statement in pending and future prescription drug product liability litigation.

There are three principle theories under which courts will hold state law preempted: (1) "express preemption," where there is a specific preemption provision in a governing federal statute, see, e.g., Cippolone v. Liggett Group, Inc., 505 U.S. 504, 518 (1992); (2) "implied field preemption," where federal law is deemed so extensive as to thoroughly occupy the field, see Rice v. Sante Fe Elevator Corp., 331 U.S. 218 (1947), and (3) "implied conflict preemption," where a state law requirement conflicts with federal law either by making it impossible for a party to comply with both federal and state law requirements or by standing as an obstacle to or frustrating federal objectives. See Geier v. Am. Honda Motor Co., 529 U.S. 861 (2000). The argument for preemption in prescription drug litigation is based upon implied conflict preemption.

Under the learned intermediary doctrine, plaintiffs in prescription drug litigation seek to impose liability on drug manufacturers based upon allegations that the warnings set forth in drug labeling are inadequate. However, drug manufacturers are precluded under federal law from providing labeling that has not been approved by FDA, and the warning language contained in labeling materials is subject to extensive FDA regulation and oversight. Accordingly, state tort law claims in prescription drug litigation run afoul of both arms of the conflict preemption analysis: (1) they make it impossible for a drug manufacturer to comply with both FDA labeling requirements and state common law requirements that would deem the FDA-approved label inadequate, and (2) they stand as an obstacle to FDA’s ability to design scientifically appropriate labeling by inviting lay juries in the 50 states to second guess FDA’s expert regulatory decisions.

To obtain FDA approval to market and sell a prescription drug in the United States, a drug manufacturer must submit voluminous documents to the agency in accordance with statutory requirements set forth in the Food, Drug and Cosmetic Act, 21 U.S.C. § 355 ("FDCA"). These applications – which often consist of documents numbered by the truckload – are subject to detailed regulatory requirements addressing, inter alia, the format and organization of the application, pharmacologic and toxicologic studies, clinical investigation data, case report forms, patent information, and marketing-exclusivity issues. See 21 C.F.R. § 314.50. Once a drug has received FDA approval, the manufacturer remains subject to regulations that require frequent submissions of adverse drug experience reports, see 21 C.F.R. § 314.80, and regular submissions of new studies and numerous other materials relevant to the continued approval of the drug, see 21 C.F.R. § 314.81. FDA retains continuing regulatory control over the content and format of drug labels. See 21 C.F.R. § 201.57; see also 21 C.F.R. Part 201. Further, FDA regulates what manufacturers are permitted to say and do in communicating with physicians about drugs and circumscribes manufacturers’ advertising and marketing activities. See 21 C.F.R. § 200.5 ("Mailing of important information about drugs"); Part 202 ("Prescription Drug Advertising"); Part 203 ("Prescription Drug Marketing"). Any manufacturer who sells a prescription drug with non-FDA approved labeling is subject to regulatory and enforcement actions, including injunctions and criminal prosecution. See 21 U.S.C. § 331 (prohibiting misbranded drugs); § 332 (authorizing federal injunctions to prevent, inter alia, misbranding of drugs), § 333 (authorizing criminal prosecutions); § 334 (authorizing seizure of misbranded drugs).

In its January 2006 Statement, FDA explains how state tort claims conflict with its federal regulatory control over prescription drug approval and labeling:

71 Fed. Reg. at 3934. FDA concludes that state tort claims impermissibly conflict with and frustrate the objectives of the federal regulatory scheme:

Id. at 3969.

While there was limited judicial authority on the issue, preemption arguments in prescription drug litigation prior to 2000 were usually rejected based upon (1) the lack of an express preemption provision in the FDCA applicable to prescription drugs and (2) the assertion that FDA labeling decisions imposed only minimum standards. See, e.g., Motus v. Pfizer, Inc., 127 F. Supp. 2d 1085, 1092 (C.D. Cal. 2000), summary judgment for defendant aff’d on other grounds, 358 F.3d 659 (9th Cir. 2004).² Both of these pillars of the anti-preemption position, however, began showing cracks following two opinions by the United States Supreme Court in which the Court addressed for the first time the proper scope and interpretation of FDA preemption, Medtronic Inc. v. Lohr, 518 U.S. 470 (1996) and Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001). These two Supreme Court opinions lay a new foundation for the arguments in favor of preemption that are set forth in the FDA’s January 2006 Statement.

A. Medtronic Inc. v. Lohr, 518 U.S. 470 (1996) – Specific FDA Regulation Will Give Rise to Preemption.

In Lohr, the manufacturer of a pacemaker approved under the § 510(k) "substantial equivalent" provisions of the Medical Device Act argued that the plaintiff’s state tort law claims were expressly preempted. In one of its classic 4-1-4 decisions, the Supreme Court rejected preemption, with the plurality focusing on the fact that FDA’s § 510(k) review of the medical device did not involve a specific regulatory determination of safety and efficacy that would conflict with state tort law claims:

518 U.S. at 501. In his deciding concurrence, Justice Breyer argued that the issue of preemption should be analyzed in light of basic principles of implied conflict preemption, i.e., would allowing the state tort law claim frustrate or stand in conflict with specific FDA regulatory determinations regarding the product. Justice Breyer explained his reasoning by way of the following example:

Id. at 504.

Following Lohr, a number of federal courts of appeals have been faced with the question whether state tort law claims should be preempted where they involve Class III medical devices. In contrast to the limited regulatory oversight given § 510(k) devices, Class III medical devices are subject to a rigorous FDA safety and efficacy regulatory that mirrors the New Drug Application ("NDA") process for prescription drugs. Based upon Justice Breyer’s concurring opinion and the Lohr plurality’s focus on the specificity of FDA regulatory oversight as dictating the preemption decision, the vast majority of federal appellate courts have held that state tort law claims involving Class III medical devices are preempted. See McMullen v. Medtronic, Inc., 421 F.3d 482 (7th Cir. 2005); Horn v. Theratec Corp. 376 F.3d 163 (3d Cir. 2004); Brooks v. Howmedica, Inc., 273 F.3d 785 (8th Cir. 2001) (en banc); Martin v. Medtronic, Inc., 254 F.3d 573 (5th Cir. 2001); Kemp v. Medtronic, Inc., 231 F.3d 216 (6th Cir. 2000); Mitchell v. Collagen Corp., 126 F.3d 902, 913 (7th Cir. 1997). But see Goodlin v. Medtronic, Inc., 167 F.3d 1367, 1375 (11th Cir. 1999).

While these cases were decided in the context of an express preemption provision of the Medical Device Amendments to the FDCA ("MDA"), 21 U.S.C. § 360k(a)(1), courts have interpreted this provision as being coextensive with the doctrine of implied conflict preemption. See R.F. v. Abbott Laboratories, 745 A.2d 1174, 1192-93 (N.J. 2000) ("An examination of those [MDA] cases discloses that much of the reasoning of the courts is consistent with an implied preemption analysis."). Thus, the MDA preemption opinions often turn on the implied conflict preemption finding that a common law claim involving a medical device would conflict with FDA regulation or interfere with FDA’s regulatory oversight. See, e.g., Horn, 376 F.3d at 179 (finding for plaintiff under state tort law would "stand as an obstacle to the accomplishment and execution of" FDA’s safety and efficacy review of product and "would conflict with the federal requirements" imposed by the FDA); Brooks, 273 F.3d at 794 (holding that state tort law claim involving an FDA-approved medical device "will be preempted in circumstances where a particular state requirement threatens to interfere with a specific federal interest" or where " an actual conflict exists between the state and federal requirements") (quotation omitted).

The conflict between FDA regulation and state common law requiring preemption in Class III medical device cases is equally present in prescription drug litigation. As one court has noted, "[t]he parallels between the premarket approval process for medical devices and the new drug application process with respect to product labeling are striking." Kanter v. Warner- Lambert Co., 122 Cal. Rptr. 2d 72, 83 (Ct. App. 2002). Indeed, in Brooks, the medical device at issue had been approved prior to the adoption of the MDA and accordingly had been approved and initially regulated "as a drug" under the NDA procedures applicable to prescription drugs. See Brooks, 273 F.3d at 788 (explaining that device had been treated by FDA "as a drug" and that the device and its labeling had been approved under the "rigorous" NDA process). The Eighth Circuit’s finding in Brooks of a preemptive conflict accordingly was based upon the exact factual scenario raised in prescription drug litigation.

"The substantial similarity between the premarket approval process and new drug application processes compels the conclusion that the latter also establishes a federal requirement with respect to labeling that can have preemptive effect." Kanter, 122 Cal. Rptr. 2d at 83. Thus, a number of courts have recognized that the reasoning in the MDA preemption cases applies equally to prescription drugs and requires preemption of prescription drug product liability claims as well. See Dusek v. Pfizer Inc., No. Civ. A. H-02-3559, 2004 WL 2191804, *9 n.34 (S.D. Tex. Feb. 20, 2004), appeal pending; Ehlis v. Shire Richwood, Inc., 233 F. Supp. 2d 1189, 1198 (D.N.D. 2002), aff’d on other grounds, 367 F.3d 1013 (8th Cir. 2004); Kanter, 122 Cal. Rptr.2d at 83. In Ehlis, for example, the court explained that any attempt to distinguish between Class III medical devices and prescription drugs for preemption purposes is unfounded:

B. Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001) – State Law Claims Are Impliedly Preempted If They Interfere With FDA’s Delicate Balancing of Its Statutory Objectives.

In Buckman, the Supreme Court addressed a split in the Circuits whether state law claims of fraud on the FDA involving a medical device were preempted. Ignoring the express preemption provision of the MDA, the Court focused on whether fraud on the FDA allegations are impliedly preempted because of a conflict with FDA regulatory authority and flexibility. The Court’s finding in favor of implied preemption establishes the strength and bases of implied preemption arguments involving FDA approved products.

The Court explained the dangers that state common law can pose to FDA’s ability "to achieve a somewhat delicate balance of statutory objectives" of protecting the public against unsafe products while at the same time ensuring that medical products are "on the market within a relatively short period of time" and not intruding upon patient care decisions "statutorily committed to the discretion of health care professionals." Buckman, 531 U.S. at 348-50. In finding plaintiffs’ fraud on the FDA claims impliedly preempted, the Court warned how state common law claims can stand as an obstacle to FDA’s accomplishment of its balance of statutory obligations. First, allowing states to impose their own requirements through state common law would limit FDA’s flexibility in crafting balanced statements regarding approved products that guarantee both the safety and availability of such products without interfering with the practice of medicine. See id. at 349 ("This flexibility is a critical component of the statutory and regulatory framework under which FDA pursues difficult (and often competing) objectives."). Second, allowing state common law claims based on different state juries’ weighing of the evidence would frustrate FDA’s ability to enforce its determinations by placing "FDA’s detailed regulatory regime in the shadow of 50 States’ tort regimes." Id. at 350.

The Supreme Court rejected the argument that there should be a presumption against preemption of state common law claims involving FDA-approved products. Where a defendant’s action were prompted by the FDCA "and the very subject matter of petitioner's statements were dictated by that statute['s] [provisions] . . . federalism concerns and the historic primacy of state regulation of [health and safety]" do not apply and "no presumption against pre-emption obtains." Id. at 341 (internal quotation omitted). The Court also explained that "[i]n light of the likely impact" of state common law claims "on the administration of the [FDA’s] duties," individual cases can have "a direct impact on the United States" and cannot be treated by courts as isolated matters involving individual claimants. Id. at 351 n.6.³

While Buckman involved a medical device, its implied preemption analysis has been extended to cases addressing a variety of state law claims involving prescription drugs. See Garcia v. Wyeth-Ayerst Laboratories, Inc., 265 F. Supp. 2d 825 (E.D. Mich. 2003), aff’d, 385 F.3d 961 (6th Cir. 2004); Flynn v. Am. Home Prods. Corp., 627 N.W.2d 342 (Minn. Ct. App. 2001).

C. FDA’s January 2006 Statement Is Fully In Accord with Supreme CourtTeaching on FDA Preemption.

FDA’s analysis of the preemptive scope of its regulatory review of prescription drugs in January 2006 Statement is in full accord with the reasoning of Lohr and Buckman, and their progeny. As FDA recognizes, the central flaw in prior arguments against prescription drug preemption is the characterization of FDA labeling decisions as imposing only "minimum standards." This argument is contrary to the Supreme Court’s recognition of FDA’s "delicate balance of statutory obligations" in Buckman and to the holding of post-Lohr appellate decisions addressing the virtually identical question of FDA labeling decisions involving Class III Medical Devices. See, e.g., Brooks, 273 F.3d at 796 ("There are ... a number of sound reasons why the FDA may prefer to limit warnings on product labels.").

As FDA explains in its January 2006 Statement,

71 Fed. Reg. at 3934-35.

FDA also rejects the argument that state tort law claims should not be preempted because drug manufacturers purportedly can add or revise warning language on product labels without securing FDA approval. FDA explains that while a drug manufacturer can after notifying FDA implement certain labeling changes prior to FDA approval, "the determination whether labeling revisions are necessary is, in the end, squarely and solely FDA’s under the act." Id. at 3934. Accordingly, drug manufacturers do not in practice make labeling changes without prior FDA approval, because to do so might "subject the manufacturer to enforcement" action if FDA disagrees with the change. Id. Again, FDA’s January 2006 Statement is squarely in line with post-Lohr appellate decisions that have reached the same conclusion in medical device cases involving a virtually identical labeling regulation.⁴ See Brooks, 273 F.3d at 796 (while FDA regulations "permit manufacturers to make temporary changes in the interest of safety ... such changes are valid only after the manufacturer has submitted a Supplemental PMA and only during the pendency of that application. Once the Supplemental PMA has been approved, modified, or denied, the manufacturer must comply with the FDA’s decision."); McMullen, 421 F.3d at 489 (to same effect).

FDA’s January 2006 preemption analysis is not new. FDA has made very similar arguments in a number of amicus briefs over the past five years, most notably in cases involving SSRI prescription drugs.⁵ However, for at least two reasons, FDA’s statement of its preemption position in the preamble of its Final Labeling Rule should significantly bolster preemption arguments in prescriptions drug litigation.

First, while regulatory positions set forth in amicus briefs are entitled to deference, see Geier, 529 U.S. at 883 (deferring to agency position on implied preemption as expressed in Solicitor General’s amicus brief), some courts have discounted these briefs as setting forth "nothing more tha[n] legal argument by counsel." Zikis v. Pfizer, Inc., No. 04-C8104, 2005 WL 1126909 (N.D. Ill. May 9, 2005). FDA’s statements in the preamble of its Final Labeling Rule cannot be so easily dismissed. FDA set forth its preemption position pursuant to Executive Order 13132, which specifically charged FDA with analyzing the preemptive scope of its labeling regulations, see 71 Fed. Reg. at 3967, and it issued its January 2006 Statement following a five-year review and comment period on its earlier proposed labeling rule, in which it had specifically invited comment on the impact of FDA regulation of prescription drugs on state tort law claims. See Proposed Rule, 65 Fed. Reg. 81,082, at 81,083 & 81,086. The United States Supreme Court has repeatedly explained that federal agency preemption positions set forth in regulatory preambles and responses to comments are entitled to significant deference absent unambiguous statutory language to the contrary. See Fid. Federal Savings & Loan Ass’n. v. de la Cuesta, 458 U.S. 141, 158 (1982) (relying on preamble to Federal Home Loan Bank Board regulation in finding preemption); Hillsborough County v. Automated Med. Laboratories, Inc., 471 U.S. 707, 718 (1985) (FDA can properly communicate its preemptive intent through statements in "regulations, preambles, interpretive statements, and responses to comments"); Lohr, 518 U.S. at 506 (Breyer, J., concurring) (quoting Hillsborough).

Second, while FDA’s arguments in its amicus briefs could be construed as being limited to the facts at issue in those cases, FDA makes clear in its January 2006 Statement that preemption should be the rule in prescription drug litigation generally. While it notably does not set forth a comprehensive list of situations in which state tort law claims should be preempted, FDA states that "at least" the following six types of claims impermissibly conflict with its regulation of prescription drugs:

71 Fed. Reg. at 3936. FDA also makes clear that its preemption analysis applies both to future cases involving new labeling pursuant to the requirements set forth in its January 18, 2006 Final Rule and to future and pending cases involving prescription drugs under the old labeling regime. See id. at 3934 ("FDA believes that under existing preemption principles, FDA approval of labeling under the act, whether it be the old or new format, preempts conflicting or contrary State law.").

FDA suggested only one narrow circumstance in which FDA regulation of drug labeling will not preempt State law actions: where the obligations imposed under state common law are parallel to federal FDA requirements. Id. at 3936. Even here, however, FDA indicates that the determination whether FDA regulations had been violated – and accordingly whether a state law claim could proceed – must be determined in the first instance by FDA pursuant to its primary jurisdiction over prescription drugs. Id.

FDA’s clear statement of the preemptive scope of its regulation of prescription drugs is certain to play a significant role in prescription drug product liability litigation. While the exact scope of preemption will be hammered out in cases across the country in the coming years, FDA has set forth a clear path to a more coherent and balanced legal regime where prescription drug labeling decisions are properly placed in the hands of experts charged with protecting the public health at large rather than juries guided by the natural, but often myopic, sympathies aroused in individual tort claims.

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