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Preemption Is a Defense, Not a Basis for Jurisdiction

By Bexis on July 1, 2026
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If preemption were an independent basis for federal subject matter jurisdiction, almost all of our drug, device, and vaccine product liability litigation would be in federal court.  We’ve long been resigned that preemption is a defense, not grounds for jurisdiction.   E.g., Merrell Dow Pharmaceuticals, Inc. v. Thompson, 478 U.S. 804, 811 (1986).  A recent decision, United States v. California, ___ F. Supp.3d ___, 2026 WL 784514 (C.D. Cal. March 18, 2026), confirmed that distinction in a rather unusual manner.  It’s worth paying attention to.  If the result in US v. CA had been different, it could have been a very big deal.

In US v. CA the United States, that is to say the current federal regime, was the plaintiff.  It sued the state of California, that is to say a current state regime, over state legislation “prohibit[ing] the sale of eggs from hens confined under certain ‘cruel’ conditions.”  Id. at *1.  The constitutionality of this type of statute was recently affirmed by the United States Supreme Court in National Pork Producers Council v. Ross, 598 U.S. 356, 376 (2023), holding that the “dormant commerce clause” doesn’t “question . . . the ability of a State to project its power extraterritorially” so long as they don’t discriminate.

So, the federal government took another approach in US v. CA.  The feds claimed that the state egg statute was preempted by a federal statute, the Egg Products Inspection Act.  This preemption claim, the government argued, created a basis for it to sue California – even though the government itself was not damaged in the slightest by the California law.  That would have  been a big change.  Imagine our clients being able to bring a federal claim – or a counterclaim (in a public nuisance suit) – based solely on federal preemption.

However, the lack of any particularized injury caused dismissal of US v. CA for lack of standing.  “Under Article III of the Constitution, a plaintiff needs a ‘personal stake’ in the case.”  2026 WL 784514, at *2 (citation and quotation marks omitted).  That includes the federal government as a plaintiff.

This principle extends to the federal government at large, which similarly must establish its standing to bring a civil suit in federal court.  Because the United States is not the target of the challenged government action, as it does not allege it is a participant in the . . . marketplace to which the subject [state] laws and regulations apply, the federal government’s ability to bring suit is substantially more difficult to establish.

Id.  There is no such thing as governmental standing by reason of “injury to its sovereignty.”  Id. at *3.  “[T]he mere existence of a preempted state law” has never “create[d] a sovereign injury to the federal government.”  Id. (footnote omitted) (emphasis original).  The government did not argue that “enforcement” of the state statute actually “impeded” its “operations or functions” – only that the statute was preempted.  Id.

Instead, preemption can be pursued as a defense to enforcement by persons harmed by the statute in question.

[P]reemption provisions . . . should be read to confer on private entities a federal right to engage in certain conduct subject only to certain (federal) constraints.  This is because preemption principles derived from the Supremacy Clause provide a rule of decision, not an independent grant of legislative power to Congress.

Id. at *4 (citations and quotation marks omitted).  A preemption clause “is neither directed to nor violable by any State, and the Supremacy Clause does not itself conjure a substantive right that Congress or the United States may vindicate through suit.”  Id. (citation omitted).

Moreover, the jurisprudential ramifications of converting preemption into an affirmative cause of action were significant.  The government could involve itself as a party in any private litigation (such as prescription medical product liability litigation) where preemption is at issue.  Id.  Worse – and probably the actual motivation of this particular suit – “[t]he potential for abuse of the federal courts for political purposes is manifest.”  Id.

[S]uppose the executive or the decisionmakers at the Department of Justice simply do not like a state law because it is in tension with their policies.  Without requiring the United States to show some redressable injury, the federal government might initiate a campaign of preemption suits under the aegis of its sovereignty to bring state laws in line with its own political agenda.

Id.

We don’t know whether there are other similar federal attempts out there seeking to convert preemption into an affirmative basis for jurisdiction.  If we find any, we’ll of course let our readers know.  Because anything that the federal government may succeed in asserting regarding preemption certainly bears analysis to see if our clients could make the same, or analogous arguments.

Photo of Bexis Bexis

JAMES M. BECK is Reed Smith’s only Senior Life Sciences Policy Analyst, resident in the firm’s Philadelphia office. He is the author of, among other things, Drug and Medical Device Product Liability Handbook (2004) (with Anthony Vale). He wrote the seminal law review…

JAMES M. BECK is Reed Smith’s only Senior Life Sciences Policy Analyst, resident in the firm’s Philadelphia office. He is the author of, among other things, Drug and Medical Device Product Liability Handbook (2004) (with Anthony Vale). He wrote the seminal law review article on off-label use cited by the Supreme Court in Buckman v. Plaintiffs Legal Committee. He has written more amicus briefs for the Product Liability Advisory Council than anyone else in the history of the organization, and in 2011 won PLAC’s highest honor, the John P. Raleigh award. He has been a member of the American Law Institute (ALI) since 2005. He is the long-time editor of the newsletter of the ABA’s Mass Torts Committee.  He is vice chair of the Class Actions and Multi-Plaintiff Litigation SLG of DRI’s Drug and Device Committee.  He can be reached at jmbeck@reedsmith.com.  His LinkedIn page is here.

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  • Posted in:
    Business and Commercial, Personal Injury
  • Blog:
    Drug & Device Law
  • Organization:
    Drug & Device Law Blogging Team
  • Article: View Original Source

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