The Opioid Litigation: The FDA is MIA

24 Pages Posted: 12 May 2020

Date Written: April 5, 2020


Opioid litigation provides a lens through which I explore the role of state and federal courts and the Food and Drug Administration (FDA) in striking the right balance of power. My purpose here is not to resolve the divide among the few courts that have weighed in on the preemption defense in the opioid cases before them; instead, it is to highlight the appropriate inquiry in which the courts should engage. Namely courts should scrutinize the regulatory actions taken by the FDA and evaluate the extent to which state tort law actions fall within or outside of the bounds of the risk analysis already undertaken by the FDA. Such an analysis would put pressure on the FDA to weigh in — either on its own or as invited by the courts — on the balance between its regulatory actions and the need for state tort law causes of action. The courts would then scrutinize input from the agency under “hard look” review. No longer could the FDA remain on the sidelines, as it has to date, amidst a public health crisis that is now playing out in the courts.

Keywords: FDA, opioid, hard look review

JEL Classification: K13, K23, K41

Suggested Citation

Sharkey, Catherine M., The Opioid Litigation: The FDA is MIA (April 5, 2020). 124 Dickinson Law Review (2020), NYU School of Law, Public Law Research Paper No. 20-38, Available at SSRN:

Catherine M. Sharkey (Contact Author)

New York University School of Law ( email )

40 Washington Square South
New York, NY 10012-1099
United States
212-998-6729 (Phone)

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