Notice & Comment

Auer Federalism: Preemption and Agency Deference, by Catherine Sharkey

An August 13, 2016 New York Times article reports that “Mr. Obama will leave the White House as one of the most prolific authors of major regulations in presidential history.” Putting to one side the detail that agencies authorized by Congress—not the President—promulgate regulations, the article looks behind the widespread public perception that “President Obama has sought to reshape the nation with a sweeping assertion of executive authority and a canon of regulations that have inserted the United States government more deeply into American life.”

Chief Justice Roberts, in a vehement dissent in City of Arlington v. FCC (2013), cast these sweeping regulations as an unfortunate development, warning of “the danger posed by the growing power of the administrative state,” involving “hundreds of federal agencies poking into every nook and cranny of daily life.” The late Justice Scalia, in a dissent in EPA v. EME Homer City Generation, L.P. (2014), similarly lamented that “[t]oo many important decisions of the Federal Government are made nowadays by unelected agency officials exercising broad lawmaking authority, rather than by the people’s representatives in Congress.”  And, in a concurrence in Perez v. Mortgage Bankers Ass’n (2015), Justice Thomas unleashed perhaps the most heated invective against the expansion of the administrative state, which he believed has been fueled by a misguided “belief that bureaucrats might more effectively govern the country than the American people.”

A. Revisiting Auer Deference

Justice Scalia was the author of the unanimous decision in Auer v. Robbins (1997). But sixteen years later in his partial dissent in Decker v. Northwest Environmental Defense Center (2013), he described the doctrine as “a dangerous permission slip for the arrogation of power.” More pointedly, Justice Scalia proclaimed: “When the legislative and executive powers are united in the same person, . . . there can be no liberty; because apprehensions may arise, lest the same monarch or senate should enact tyrannical laws, to execute them in a tyrannical manner.” The thrust of Justice Scalia’s challenge to Auer deference—drawing heavily from the intellectual foundation laid by John Manning—is that if an agency is allowed to interpret its own regulations, it wields the power both to write the law (a legislative function) and to interpret and enforce the law (an executive function), thus raising serious separation-of-powers concerns.

Chief Justice Roberts (joined by Justice Alito) made it plain in his separate concurrence in Decker that he too would welcome the opportunity to revisit Auer deference. Two years later, in his concurrence in Perez, Justice Thomas criticized Auer deference as “a transfer of the judge’s exercise of interpretive judgment to the agency,” and analogized the threat to individual liberty posed by the administrative state to that of the 17th century English King and Parliament, when the theory of separation of powers was put forth to counter “the dangers of tyrannical government posed by each.” In a separate concurrence, Justice Alito, likewise “concern[ed] about the aggrandizement of the power of administrative agencies,” also signaled an interest in revisiting Auer in an appropriate case. And, in his separate concurrence, the late Justice Scalia did not mince words: “I would . . . restore the balance originally struck by the APA [Administrative Procedure Act] with respect to an agency’s interpretation of its own regulations . . . by abandoning Auer.”

B. The Puzzling Persistence of Auer Deference in Preemption

Many commentators have focused on various aspects of this attack on Auer deference, including that it was gaining momentum at the U.S. Supreme Court at the time of Justice Scalia’s untimely death. Others have situated the attack on Auer deference within a broader framework of antipathy towards the administrative state.

Here instead, drawing from my recent article in the Emory Law Journal, I probe an ostensible paradox: the persistence of doctrines of agency deference in the Supreme Court’s “conservative core’s” preemption jurisprudence, notwithstanding those very same Justices’ call for their demise as part and parcel of wider distaste for and distrust of the administrative state.

Consider, for example, the vehement dissent of Justice Alito (joined by the Chief Justice and the late Justice Scalia) in Wyeth v. Levine (2009). In Levine, the Court’s majority held that a plaintiff’s state law failure-to-warn claim against a brand name drug manufacturer was not preempted, even though the FDA had specifically approved the warning on the drug. The dissent accused the majority of “turning a common-law tort suit into a ‘frontal assault’ on the FDA’s regulatory regime for drug labeling”—adopting the position (and “frontal assault” terminology) put forth by the United States (representing the FDA) as Amicus Curiae supporting the drug manufacturer. The dissent further chastised the majority for not “relying on the FDA’s explanation of its own regulatory purposes.”

Justice Thomas refused to join the dissent in Levine; unlike the rest of the conservative core, in a separate concurrence, he held firm to the position that “no agency . . . can preempt a State’s judgment by merely musing about goals or intentions not found within or authorized by the statutory text.” Notably, Justice Thomas stood apart from his conservative brethren in Levine and staked out his own position that vests his hostile attitudes towards agencies with a consistency that his conservative colleagues’ approach lacks.

But, there is a chink in even Justice Thomas’ armored resistance to the administrative state: his puzzling adoption of Auer deference in the context of so-called implied impossibility preemption. In PLIVA, Inc. v. Mensing (2011), Justice Thomas, joined by his fellow conservative core Justices (and Justice Kennedy), held that state tort law failure-to-warn claims against a generic drug manufacturer were preempted. Central to this holding is the requirement that the generic drug manufacturer must use the exact same label as that of the corresponding brand-name drug, making it “impossible” for a generic drug manufacturer to add any additional warning to its label. To reach this conclusion, the majority deferred to the FDA’s interpretation of its generic drug regulations: “The FDA . . . tells us that it interprets its regulations to require that the warning labels of a brand-name drug and its generic copy must always be the same—thus, generic drug manufacturers have an ongoing federal duty of ‘sameness.’” Here, Justice Thomas cited the Brief for the United States (representing the FDA) as Amicus Curiae and repeatedly invoked Auer in deferring to the agency’s interpretation of its regulations, emphasizing that “[t]he FDA’s views are ‘controlling unless plainly erroneous or inconsistent with the regulation[s]’ or there is any other reason to doubt that they reflect the FDA’s fair and considered judgment.”

The conservative core Justices (again joined by Justice Kennedy), implicitly rallied behind Auer deference in a subsequent generic drug preemption case, Mutual Pharmaceutical Co. v. Bartlett (2013), once more showing no qualms where the doctrine’s application meant preempting common law tort claims. Justice Alito penned the majority opinion , which (quoting Mensing) relies on federal drug regulation “as interpreted by the FDA” in deeming state law preempted.

C. Common Law Tort (and Juries) as Least-Favored Regulator

Why are the Justices’ fears of the behemoth administrative state—and more specifically, their calls to revisit Auer—suddenly allayed when it comes to deferring to FDA interpretations of its own drug regulations?

The conservative core is ostensibly quite comfortable with the encroachment of the federal regulatory state, at least where the encroachee is the common law of torts. Justice Alito’s conviction, expressed in his Levine dissent, that “juries are ill equipped to perform the FDA’s cost-benefit balancing function” echoed that of the late Justice Scalia in his majority opinion in Riegel v. Medtronic (2008), an express preemption case arising under specific statutory provisions for medical devices. In Riegel, Justice Scalia extolled the comparative advantage of the FDA, whereas “[a] jury, on the other hand, sees only the cost of a more dangerous design, and is not concerned with benefits; the patients who reaped those benefits are not represented in court.”

Those representing business interests before the Court confront the same tension between agency deference and preemption. According to the U.S. Chamber of Commerce, the “U.S. business community has become increasingly concerned in recent years about the consequences of courts granting too much deference to regulatory decisions made by federal agencies.” But when it comes to the prospect of common law torts as an additional regulator, companies (such as those represented by PhRMA and BIO, as well as the Chamber) have rallied behind preemption on the ground that one regulator (the FDA) is superior to two and thus have favored wiping out tort law—wielding Auer deference in service of this goal.

Auer deference remains a cornerstone of preemption in the generic drug context. Their fates are intertwined—and may pull conservatives (on the Supreme Court and in the business community) in opposite directions.

Catherine Sharkey is the Crystal Eastman Professor of Law at New York University School of Law. This blog post draws from her article, The Administrative State and the Common Law: Regulatory Substitutes or Complements? 65 Emory L.J. 1705 (2016), and is the subject of a forthcoming piece to be written for a symposium on “Business in the Roberts Court” at Case Western Reserve University School of Law.


This post is part of an online symposium entitled Reflections on Seminole Rock: The Past, Present, and Future of Deference to Agency Regulatory Interpretations. You can read the entire series here.

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