A cursory review of the conflicting decisions being rendered across the country reveals that courts are fairly split over the issue of federal preemption of failure to warn strict liability claims in pharmaceutical litigation. The FDA directly addressed the issue in the Preamble to the Final Rule (“Preamble”) published January 24, 2006.

FDA believes 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. . . . FDA interprets the act to establish both a “floor” and a “ceiling,” such that additional disclosures of risk information can expose a manufacturer to liability under the act. . . . State law actions also threaten FDA’s statutorily prescribed role as the expert Federal agency responsible for evaluating and regulating drugs. . . . FDA believes that State laws conflict with and stand as an obstacle to achievement of the full objectives and purposes of Federal law. 71 Fed. Reg. 3934-35 (2006).

Since the release of the Preamble, many decisions have turned on the level of deference accorded to FDA’s position. To some courts and commentators, this interpretation seems inconsistent with former FDA statements suggesting that state law actions were not preempted. Since the Preamble is not part of the promulgated rules, it is an advisory opinion that is not definitively binding, but merely expresses the FDA’s interpretation of its regulations. Rather than settling the debate, this statement has added another layer of controversy – namely, what level of deference FDA’s statement is entitled to.

The Chevron Case

In the seminal case Chevron v. Natural Resources Defense Council, the Supreme Court held that “considerable weight should be accorded to an executive department’s construction of a statutory scheme it is entrusted to administer” noting that the “principle of deference to administrative interpretations ‘has been consistently followed by this Court whenever decision as to the meaning or reach of a statute has involved reconciling conflicting policies.’” Chevron v. Natural Res. Def. Council, 467 U.S. 837, 844 (1984). In Chevron, a case involving statutes promulgated by the Environmental Protection Agency, the debate concerned the meaning of a term not expressly defined in the Clean Air Act. The Court ruled that absent an express directive from Congress, the agency’s interpretation would be heeded; so long as it was based on a permissible interpretation of the statute. When the subject matter “depend[s] upon more than ordinary knowledge,” id. at 844, and “the regulatory scheme is technical and complex,” an agency’s interpretation is considered “controlling unless plainly erroneous or inconsistent with the regulation.” Weiss v. Fujisawa Pharm. Co., 2006 U.S. Dist. LEXIS 86179, 11 (Nov. 28, 2006). Essentially, Chevron stands for the principle of affording the highest level of deference to an agency’s interpretation of its own rules, provided that Congress has conferred the requisite authority upon the agency. Consequently, interpretations made outside an agency’s rulemaking authority are still “‘entitled to respect’ . . . but only to the extent that those interpretations have the ‘power to persuade,’” and are thus accorded limited deference. Weiss, 2006 U.S. Dist. LEXIS 86179 at 11.

Mistaken Conclusions

Since Congress has historically given FDA broad authority to regulate prescription drug manufacture and distribution, with a particular emphasis on regulating the labeling of drugs, the FDA’s interpretation of its promulgated regulations is clearly within its rulemaking authority as the expert federal agency vested with authority to govern this field. However, several courts have mistakenly concluded that the FDA’s interpretation does not warrant Chevron deference and have only accorded it very limited or no deference, finding no federal preemption of state tort failure to warn claims. The opinions primarily cite two reasons for their disregard of the Preamble’s instruction.

First, although the Preamble “represents the FDA’s formal position on a matter and obligates the agency to follow it until amended or revoked,” since it is an advisory opinion, some courts have reasoned it is “entitled only to limited deference because it is not subject to notice and comment procedures.” Weiss, 2006 U.S. Dist. LEXIS 86179, 16. However, these courts fail to recognize that Chevron speaks to the authority that has been conferred to the agency, not how the agency chooses to communicate that authority, and has further instructed that, “the question for the Court is whether the agency’s answer is based on a permissible construction of the statute.” Chevron, 467 U.S. at 843. The Supreme Court has expressly condoned preamble statements. “[A]gencies . . . can speak through a variety of means, including regulations, preambles, interpretative statements, and . . . they will make their intentions clear if they intend for their regulations to be exclusive.” Hillsborough County v. Automated Med. Labs., 471 U.S. 707, 718 (1984). Thus, as here, where the expert federal agency has made its position known through one of the methods by which it may communicate that position, it is improper to accord that position anything less than full deference.

The second reason some courts have overruled the FDA’s express Preamble statement is due to repeated misinterpretation of the Supreme Court’s suggestion that “the consistency of an agency’s position is a factor in assessing the weight that position is due,” Good Samaritan Hosp. v. Shalala, 508 U.S. 402, 417 (1993), and an “interpretation . . . which conflicts with the agency’s earlier interpretation is ‘entitled to considerably less deference than a consistently held agency view.’” INS v. Cardoza-Fonseca, 480 U.S. 421, 448 (1987). These statements, which endeavor to divest the FDA’s authority, are simply misapplied in the pharmaceutical labeling context. Arguably, if the FDA’s position were inconsistent to the extent of being arbitrary, courts may be hesitant to pay deference to whatever the position at any given time may be. Here, however, the FDA has merely changed its position once. The plain language of Chevron shows that even more than one change in position is both anticipated and permissible. “The fact that the agency has from time to time changed its interpretation . . . does not . . . lead us to conclude that no deference should be accorded the agency’s interpretation of the statute. An initial agency interpretation is not instantly carved in stone. On the contrary, the agency, to engage in informed rulemaking, must consider varying interpretations and the wisdom of its policy on a continuing basis.” Chevron, 467 U.S. at 863-64.

Conclusion

The reasoning and holding of Chevron resonates strongly in the current preemption debate. It is evident that the FDA has dutifully considered the purposes and consequences of its “policy on a continuing basis”, and determined that its rules should preempt all state law. With regard to the consistency of its position, it should be noted that the FDA has merely changed its view one time. Since the Supreme Court has contemplated that agency positions may change, and has pointed out that an “initial agency interpretation is not instantly carved in stone” there is no reason that why one change should detract from the deference accorded the FDA’s position. Rather, a change in position evidences ongoing and informed rulemaking.

Deference to an agency’s interpretation of its statutes should not be lightly disregarded. Public policy considerations demand that the law of federal agencies which exist and operate under congressional authority be adhered to with consistency and conformity. In Chevron, the Supreme Court has clearly and unequivocally announced a policy of paying the highest level of deference to agency interpretations. Although some courts have selectively cited small quips of Chevron’s language to support their rejection of the FDA’s Preamble, their positions are simply not supported by precedent. The rules of deference require that the FDA’s Preamble admonitions be heeded, and therefore, all state tort claims against drug manufacturers must be preempted by the federal regulatory scheme that governs the content of pharmaceutical warning labels.

Judi Abbott Curry
Judi Abbott Curry, a member of the New York office of Harris Beach PLLC is co-leader of its Medical and Life Science Industry Team. Her practice focuses on product liability claims, as well as mass and toxic tort litigation, MDLs and class actions.

Jodie M. Gross
Jodie M. Gross is an associate whose practice focuses on product liability and general negligence.

Reprinted with permission from the September 2007 edition of ALM Law Journal Newsletters Product Liability Law and Strategy. © 2007 ALM Properties, Inc. All rights reserved. Further duplication without permission is prohibited.