Sharkey on The Perils of Pesticide Preemption

Catherine M. Sharkey (New York University School of Law) has posted The Perils of Pesticide Preemption (Wake Forest Law Review, Volume 62, No.2, 2026) on SSRN.  Here is the abstract:

Congress sometimes enacts federal statutes with express preemption provisions, directing that federal regulatory requirements be exclusive—maximum, not minimum, standards—and thus oust common law state safety standards. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Medical Device Amendment (MDA) to the Food Drug and Cosmetic Act (FDCA) are two such statutes that, moreover, have nearly identical express preemption provisions, directing that no state may impose any “requirements” (via common law or positive state law) “in addition to” or “different from” any federal requirements. In Riegel v. Medtronic, the U.S. Supreme Court held that a design defect claim asserted under state law was preempted under the MDA; although the Court (via an 8-1 majority opinion authored by Justice Scalia) rested its holding primarily on textual analysis of the preemption provision, it also explained that the FDA had conducted a thorough, painstaking pre-market safety review, which there was no need to allow a state tort jury to revisit.

But what if a textualist analysis of the preemption provision and the degree of regulatory stringency point to opposite conclusions? Monsanto v. Durnell, the Court’s most recent FIFRA case involving allegations of failure to warn of cancer-causing glyphosate in the Roundup pesticide, provided such a test case. As in Riegel, the language of the express preemption provision points towards preemption of the state law failure to warn claim. But the EPA’s ex ante regulatory review during pesticide registration is far less stringent than the FDA’s safety and efficacy review with respect to medical devices (as well as pharmaceutical drugs). Moreover, pesticides are products (similar to drugs) where the emergence of post-approval risk evidence is likely.

The Supreme Court followed its textualist leanings in Durnell. Nevertheless, given the context, there are serious health and safety concerns. In this Essay, I give voice to those concerns, finding inspiration in the pioneering work by Professor Mike Green in the realm of tort law and the regulatory compliance defense. Federal preemption of state tort law is the regulatory compliance defense in its bluntest form: Whereas compliance with federal regulations may be evidence of non-negligence in a state tort lawsuit, federal preemption knocks the state tort claim out altogether. With the threat of tort liability removed, the manufacturer of the pesticide or medical device is no longer forced to take into account “new risk” evidence after regulatory approval. And public health and safety are imperiled—the most significant effect of the Court’s having “close[d] the courthouse doors to state tort plaintiffs like Durnell.”

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