Today’s guest post is from Dechert’s Chris McKeon who updates us on a rare application of the political question doctrine. As always, our guest posters deserve 100% of the praise (and any of blame) for their posts. Not that we expect the latter.

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In our earlier post, we explored whether the political question doctrine can supply a jurisdictional off-ramp for design-defect claims against FDA-approved prescription drugs.  The district court in Caston embraced that idea in a seemingly novel way, holding that “pharmaceutical design defect claims challenging active ingredients necessarily implicate a nonjusticiable political question” because re-evaluating—years after the fact—FDA’s safety and efficacy determinations is “heavily scientific, and indeed economic and political, but not judicial.”  Caston I, 729 F. Supp. 3d 930, 946 (N.D. Cal. 2024). 

The Ninth Circuit has now weighed in.  In an unpublished and nonprecedential decision, the panel affirmed in part, vacated in part, and remanded—rejecting the district court’s political-question dismissal, affirming dismissal for lack of personal jurisdiction against one set of Defendants, and giving Plaintiffs a chance to re-plead Article III standing for their medical-monitoring theory against the remaining Defendants.  Caston II, No. 24-2920, 2025 WL 3205856 (9th Cir. Nov. 17, 2025).  The opinion returns this case to the well-trodden battlegrounds of products liability: jurisdiction, preemption, and standing.

The panel began by characterizing the political question doctrine as a “narrow exception” that applies only when adjudication will “certainly and inextricably” require courts to decide issues constitutionally committed to another branch.  Caston II, 2025 WL 3205856, at *1.  Citing Zivotofsky v. Clinton and Cooper v. Tokyo Electric Power, the panel held: “The district court erred in dismissing [Plaintiffs’] products-liability claims under the political question doctrine based on the FDA’s approval of mefloquine.”  Id.

Next, the panel leaned on a numbers-based approach, asserting that “[f]ederal and state courts have consistently adjudicated design-defect and failure-to-warn claims regarding FDA-approved pharmaceuticals without treating them as nonjusticiable.”  Id.  The panel pointed to Bartlett, Wyeth v. Levine, and Mensing—all cases that addressed preemption, not justiciability.  Id.  The takeaway is clear: in the panel’s view, the mere fact that a product is subject to FDA regulation does not convert ordinary tort claims into political questions, though the panel’s citations tally decisions rather than engage in the justiciability analysis.

What about the military overlay?  The panel was cautious: “It would be premature to invoke the political question doctrine based on the military’s approval of mefloquine.  [Plaintiffs] argue that their claims rest on [Defendants’] own conduct without requiring judicial review of military judgments.  At this stage, it is speculative to consider how the military dimension of the political question doctrine might come into play. The district court may revisit the issue at a later stage of this litigation.”  Id.  That leaves room for a properly developed government-contractor defense or a Baker v. Carr analysis if the record later shows that adjudication would intrude on the military’s decisions.  But the panel refused to assume that intrusion now.

At the very least, the panel affirmed dismissal of claims against the Roche Defendants for lack of personal jurisdiction.  Caston II, 2025 WL 3205856, at *2.  On specific jurisdiction, the panel emphasized the locus of ingestion and injury: “[Plaintiffs’] claims arise from their ingestion of mefloquine overseas and at East Coast military bases—not in California.”  Id.  Thus, Plaintiffs could not show that their injuries “arise out of or relate to” California-directed conduct by Roche.  In addition, allegations of national distribution and a California presence by a military agency were insufficient: “mere placement of a product into the stream of commerce, without more, is not purposeful direction toward the forum.”  Id. (citation omitted).

The panel held that Plaintiffs’ medical-monitoring allegations did not establish Article III standing but remanded to permit amendment “to clarify how the requested monitoring program would likely redress their alleged injuries.”  Id. (citation omitted).  Finally, the Greentech Defendants cannot obtain dismissal on preemption grounds—at least not under Mensing—as Greentech is not a generic manufacturer.  Id. at *3.

Bottom line, FDA regulation does not make routine pharma torts nonjusticiable, and without a record showing adjudication would certainly and inextricably intrude on another branch—military issues included—the political question doctrine inquiry is premature; the district court’s ruling will not stand, and Caston returns to familiar terrain where the ultimate outcome will turn on facts, other legal bases, and careful framing.