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 Ms. Zieve, Donna S. Riegel, as petitioner, alleges that Medtronic’s catheter labeling was inadequate and misleading because it listed conflicting pressure limits for balloon inflation.
Background and question before the Court
According to Ms. Zieve, the dispute centers on a catheter that the plaintiff claims was labeled with contradictory instructions about the maximum inflation pressure, potentially endangering patients.
What each side argues
Petitioner Position
According to Ms. Zieve, petitioner contends that the labeling was misleading because it listed a burst‑pressure limit of eight atmospheres in one place, allowed inflation up to thirteen atmospheres in a chart, and elsewhere instructed inflation to “nominal pressure.”
Respondent Position
According to Edwin S. Kneedler, the United States, as amicus curiae, supports the respondent’s view that state legislatures cannot impose labeling requirements that conflict with FDA approval.
What happened at oral argument
Justice Scalia asked whether a manufacturer could market an improved product without further FDA action.
According to Justice Kennedy, justice Kennedy inquired whether, under state law, a jury must weigh the potential risks of injury against the probable health benefits to the patient.
Justice Breyer asked for details about the specific design defect alleged in the catheter.
According to Justice Kennedy, justice Kennedy raised a hypothetical where a label approved under PMA is later misread by doctors, creating danger.
What the Court decided
Why it matters
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.
- 73db1eca149ee3454191-r1-5db4516f2ccd18a8.pdforal argument transcript
Guide generated September 22, 2026. Automated validation accepted this version.