This educational guide is based on the linked primary sources. It is not a Court publication, is not affiliated with the Court, and is not legal advice.
In brief
Overview
According to Carter G. Phillips, the case concerns whether state courts may hear tort claims that allege fraud on the FDA in the approval of a drug, an issue previously addressed in the Supreme Court’s decision in Buckman.
According to United States, the dispute raises questions about the balance between state tort law and the federal government’s exclusive authority to police fraud on the FDA.
Background and question before the Court
According to Carter G. Phillips, in Buckman, the Court struck down a state tort based on fraud on the FDA, holding that such a claim would inevitably conflict with the FDA’s responsibility to police fraud.
According to United States, the present case involves a Michigan statute that makes proof of fraud on the FDA a prerequisite for state tort liability, raising the same federal‑state conflict identified in Buckman.
What each side argues
Petitioner (Warner‑Lambert) Position
According to Mr. Joseffer, the petitioner contends that there is no uniform, deeply‑rooted common‑law tradition for state courts to decide whether the FDA would have approved a drug, making such tort claims novel and inappropriate.
Respondent (Kimberly Kent) Position
According to Ms. Zieve, the respondent acknowledges that the Michigan statute treats federal approval as reliable evidence of a drug’s safety, but points out that there are situations where that reliability may be questioned.
What happened at oral argument
Justice Scalia asked whether a statute that simply allowed a state tort action when FDA‑approved marketing conditions were not complied with would be permissible.
According to Justice Souter, justice Souter questioned whether the admissibility of evidence depended on what the FDA would have done.
Justice Stevens asked whether there were reported cases showing the magnitude of the problem to the government.
Justice Alito asked why the petitioner’s argument that a jury should decide what the FDA would have done was incorrect, noting it could seriously interfere with the FDA’s role.
According to Justice Ginsburg, justice Ginsburg questioned whether taking depositions of FDA examiners would disrupt the agency’s functions.
Justice Kennedy asked whether a state could prohibit evidence that a drug was FDA‑approved.
- [1] 5dad40a825f9cd1d7877-r1-5647d6f2d84d86b1.pdf, p. 4
- [2] 5dad40a825f9cd1d7877-r1-5647d6f2d84d86b1.pdf, p. 20
- [3] 5dad40a825f9cd1d7877-r1-5647d6f2d84d86b1.pdf, p. 22
- [4] 5dad40a825f9cd1d7877-r1-5647d6f2d84d86b1.pdf, p. 36
- [5] 5dad40a825f9cd1d7877-r1-5647d6f2d84d86b1.pdf, p. 39
- [6] 5dad40a825f9cd1d7877-r1-5647d6f2d84d86b1.pdf, p. 46
What the Court decided
Why it matters
According to United States, the Michigan statute presents a conflict similar to Buckman because it requires a determination of fraud on the FDA as a necessary predicate for establishing liability, highlighting the tension between state tort law and federal regulatory authority.
Terms to know
No glossary terms are available for this guide.
Primary sources
Read the source materials on the official site or open the immutable repository copy used for this guide.
- 5dad40a825f9cd1d7877-r1-5647d6f2d84d86b1.pdforal argument transcript
Guide generated September 22, 2026. Automated validation accepted this version.