If you wanted quick medical advice, you’d ask your friend with an MD or BSN. Not a JD. Likewise, if you wanted to know how to regulate nitrogen oxide under the Clean Air Act, you’d probably trust the scientists at Environmental Protection Agency (EPA) over the judges on a court that referred to the gas as nitrous oxide (laughing gas). But under the Supreme Court’s recent opinion in Loper Bright Enterprises v. Raimondo, a 6-3 conservative majority ruled that courts get the final say on such matters.
Loper Bright was a blockbuster decision, though not unexpected. Here, I’ll discuss what it might mean for health agencies like the EPA, U.S. Food and Drug Administration (FDA), and Department of Health Human Services (HHS).
Loper Bright overturned Chevron v. Natural Resources Defense Council, a cornerstone of U.S. law for 40 years and one of the most cited and discussed Supreme Court decisions ever. Though famous for its two-step framework, the 1984 Chevron decision was less a doctrinal revolution than a theoretical innovation. Doctrinally, Chevron wasn’t too different from its predecessor, Skidmore (1944): Chevron said courts should defer to reasonable agency interpretations when a statute they administer is ambiguous, which is not too different from Skidmore’s wisdom that courts should consider an agency’s experience and informed judgments when construing statutes. Indeed, Eskridge and Baer found that agency win rates under Chevron and Skidmore were almost identical, at around 75%.
But Chevron was theoretically important because the Court recognized three things: (i) statutes include both explicit and implicit delegations to agencies; (ii) when a statute isn’t clear, we should give agencies breathing room to make policy based on their superior expertise and experience; and (iii) such breathing room is valid because agencies are politically accountable, while courts are not.
Loper Bright tore down this cornerstone because, per the majority, the Administration Procedure Act in 1946 said that courts are to decide “all relevant questions of law.” Of course, it’s not easy to disentangle questions of law from questions of policy and discretion. It may very well be that deciding when an alpha amino acid polymer is a “protein” to be regulated by the FDA is not simply a question of statutory interpretation, but also a question of science and policy. The majority doesn’t register such distinctions, which might invite courts to decide more science and policy questions after Loper Bright.
The majority also makes heroic assumptions about the capacity of Congress to both foresee and address ambiguities when drafting statutes. But inevitably, the question will arise: if Congress doesn’t definitively address a question by statute, who’s in a better position to do so, agencies or courts?
Agencies now must confront the reality that courts might consider themselves on equal or better footing. So, what does this reality look like after just two months? Consider:
- A self-described “Post-Chevron Working Group” of Republican Senators has asked HHS and other agencies to explain how they’ll adhere to Loper Bright.
- Final rules that are even minimally controversial might be reconsidered by potential litigants. For example, many view the FDA’s recent final rule governing laboratory developed tests, long an area of confusion and controversy in FDA circles, to be susceptible under Loper Bright.
- Virtually any large, ambitious program will be challenged, too, particularly if the statute isn’t crystal clear. To wit, the Inflation Reduction Act authorized CMS, for the first time, to directly negotiate drug prices. It’s a new statute that requires quite a bit of interpretive work to implement, and is so controversial that drug makers are “throwing the kitchen sink” at it.
- The Affordable Care Act is always a target for litigation (roughly 2,000 lawsuits since 2010). HHS policies will no doubt be challenged under Loper Bright. One such effort is a recent suit challenging HHS rules under ACA section 1557 and its prohibition against discrimination in health care.
- The Air Force disregarded an EPA order to address synthetic PFAS compounds (“forever chemicals’) under the Safe Drinking Water Act, citing Loper Bright.
And this is just the beginning.
Some scholars believe courts will remain reluctant to substitute their judgment for the judgment of expert agencies like the FDA. For example, Catherine Sharkey and Daniel Kenney, in a forthcoming article, FDA Leads, States Must Follow, suggest that courts will stay in their lane when it comes to the FDA’s science-based decisions like new drug approvals. Indeed, recent studies have found the FDA’s record under Chevron to be pretty ironclad. And some likewise expect that courts will remain deferential on specialized matters even after Loper Bright.
Doctrinally, they’re right – insofar as Loper Bright reverts back to a standard in Skidmore that isn’t too different from Chevron Step Two.
But Loper Bright is more powerful as a signal. It tells lower courts that they need not defer to agency expertise and, in fact, can discount it when they see fit. Consider the extraordinary (pre-Loper Bright) opinion by Judge Matthew Kacsmaryk that invalidated the FDA’s decision 20 years ago to approve mifepristone and the agency’s later decisions to relax certain postmarketing controls. (Consider also the Fifth Circuit’s credulous opinion on appeal, before the Supreme Court in FDA v. Alliance for Hippocratic Medicine ruled that the plaintiffs lacked standing.) In a world where hyper-partisan judges are given cover by a hyper-partisan Supreme Court, these signals matter.
Doctrinally, not much should change with Loper Bright. Thirty years ago, things probably would not have changed so much. Even before Loper Bright, citations of Chevron had decreased. Indeed, the Supreme Court hadn’t cited Chevron in over three years. But ideologically-bent courts can and probably will use Loper Bright to flex on agencies, in the guise of “deciding all relevant questions of law.” JDs should brush up on the health sciences.
Nathan Cortez is Callejo Endowed Professor of Law, Gerald J. Ford Research Fellow, and Co-Director of the Tsai Center for Law, Science, & Innovation at SMU Law School in Dallas.
