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
Background and question before the Court
What each side argues
Merck Sharp & Dohme Corp.
According to Merck Sharp & Dohme Corp., according to Merck Sharp & Dohme Corp., merck argues that if a manufacturer informs the FDA of a possible risk and unsuccessfully asks to revise its label in light of that risk, failure‑to‑warn claims based on that risk are pre‑empted as a matter of law.
Merck says the FDA’s rejection letter should have clearly stated the reason for rejecting the proposed label addition.
According to Merck, the manufacturer should first look to the letter itself for clarity on the FDA’s decision.
Merck questions what the manufacturer knew at a particular point in time and what the FDA understood about that risk.
According to Mr. Dvoretsky, the PAS submission included 132 studies about the risk, and the FDA was not misled.
- [1] dde36653a337b0d5fb0d-r1-dd12b39ad5175049.pdf, p. 4
- [2] dde36653a337b0d5fb0d-r1-dd12b39ad5175049.pdf, p. 24
- [3] dde36653a337b0d5fb0d-r1-dd12b39ad5175049.pdf, p. 24
- [4] dde36653a337b0d5fb0d-r1-dd12b39ad5175049.pdf, p. 44
- [5] dde36653a337b0d5fb0d-r1-dd12b39ad5175049.pdf, p. 44
- [6] dde36653a337b0d5fb0d-r1-dd12b39ad5175049.pdf, p. 66
Respondents (Doris Albrecht et al.)
According to Merck Sharp & Dohme Corp., respondents argue that the FDA, fully informed of the risk of atypical femoral fractures, ignored that risk and its statutory responsibilities because it disliked the way Merck phrased its proposed warning.
What happened at oral argument
The oral argument began at 10:05 a.m.
The case was submitted at 11:08 a.m.
Justice Kagan asked a hypothetical about a warning for major fractures versus stress fractures and whether the manufacturer would be immune from suit if the FDA rejected it.
Justice Kagan asked how to understand what the FDA knows at any given moment and whether it is impossible for Merck to change its label.
According to Justice Alito, justice Alito quoted Merck’s definition of a stress fracture as a partial or complete fracture occurring with normal or increased activity but without an identifiable external traumatic event.
Justice Sotomayor asked about the manufacturer’s duty to work with the FDA to ensure the label is correct and whether that duty is the manufacturer’s burden.
Justice Sotomayor asked how the manufacturer’s duty translates into practical obligations.
- [1] dde36653a337b0d5fb0d-r1-dd12b39ad5175049.pdf, p. 2
- [2] dde36653a337b0d5fb0d-r1-dd12b39ad5175049.pdf, p. 68
- [3] dde36653a337b0d5fb0d-r1-dd12b39ad5175049.pdf, p. 5
- [4] dde36653a337b0d5fb0d-r1-dd12b39ad5175049.pdf, p. 24
- [5] dde36653a337b0d5fb0d-r1-dd12b39ad5175049.pdf, p. 48
- [6] dde36653a337b0d5fb0d-r1-dd12b39ad5175049.pdf, p. 65
- [7] dde36653a337b0d5fb0d-r1-dd12b39ad5175049.pdf, p. 57
What the Court decided
Why it matters
Terms to know
- stress fracture
- A stress fracture (also known as an insufficiency fracture) is defined as a partial or complete fracture occurring with either normal or increased activity but without an identifiable external traumatic event.
Primary sources
Read the source materials on the official site or open the immutable repository copy used for this guide.
- dde36653a337b0d5fb0d-r1-dd12b39ad5175049.pdforal argument transcript
Guide generated September 26, 2026. Automated validation accepted this version.