October Term 2018 · Docket 17-290
Can a jury punish a drug maker for failing to warn when the FDA rejected the proposed label change?
Merck argues federal law blocks state failure-to-warn claims when the FDA rejects a proposed label change. Albrecht argues state law still allows such claims.
Verified source milestones
- — An official oral-argument transcript was verified.
- — An official oral-argument transcript was verified.
The arguments, in order
This case may have been argued more than once. Each entry below uses that session's official transcript. Later arguments do not erase earlier ones.
Argument 1 ·
What happened at the argument
Mr. Stewart argued the Court must distinguish between two types of confusion.
Mr. Dvoretzky argued the FDA ignored the risk because it disliked Merck's phrasing.
Mr. Frederick argued brand-name drug makers must keep labels up to date at all times.
Justice Gorsuch asked about the period after the March 2010 letter when the FDA launched an investigation.
Read the official transcript for this argument · Official argument details
Sources used for this argument breakdown
- Official Supreme Court Transcript — file page 11, lines 27-43 — Transcript, file page 11, lines 27-43
- Official Supreme Court Transcript — file page 12, lines 29-35 — Transcript, file page 12, lines 29-35
- Official Supreme Court Transcript — file page 14, lines 15-47 — Transcript, file page 14, lines 15-47
- Official Supreme Court Transcript — file page 15, lines 45-15 — Transcript, file page 15, lines 45-15
- Official Supreme Court Transcript — file page 16, lines 53-37 — Transcript, file page 16, lines 53-37
- Official Supreme Court Transcript — file page 18, lines 25-31 — Transcript, file page 18, lines 25-31
- Official Supreme Court Transcript — file page 19, lines 31-39 — Transcript, file page 19, lines 31-39
- Official Supreme Court Transcript — file page 20, lines 11-23 — Transcript, file page 20, lines 11-23
- Official Supreme Court Transcript — file page 21, lines 17-35 — Transcript, file page 21, lines 17-35
- Official Supreme Court Transcript — file page 32, lines 37-45 — Transcript, file page 32, lines 37-45
- Official Supreme Court Transcript — file page 4, lines 11-21 — Transcript, file page 4, lines 11-21
- Official Supreme Court Transcript — file page 4, lines 23-19 — Transcript, file page 4, lines 23-19
- Official Supreme Court Transcript — file page 5, lines 21-29 — Transcript, file page 5, lines 21-29
- Official Supreme Court Transcript — file page 6, lines 55-41 — Transcript, file page 6, lines 55-41
- Official Supreme Court Transcript — file page 66, lines 13-49 — Transcript, file page 66, lines 13-49
- Official Supreme Court Transcript — file page 67, lines 51-53 — Transcript, file page 67, lines 51-53
- Official Supreme Court Transcript — file page 8, lines 27-25 — Transcript, file page 8, lines 27-25
- Official Supreme Court Transcript — file page 9, lines 43-7 — Transcript, file page 9, lines 43-7
A citizen's guide to the whole case
What this case is about
This case tests whether federal law preempts state failure-to-warn claims. Merck argues the FDA rejected its proposed warning. Albrecht argues state law still allows the claim.
Official sources for this section
- Official Supreme Court Transcript — file page 21, lines 17-35 — Transcript, file page 21, lines 17-35
- Official Supreme Court Transcript — file page 32, lines 37-45 — Transcript, file page 32, lines 37-45
- Official Supreme Court Transcript — file page 4, lines 23-19 — Transcript, file page 4, lines 23-19
- Official Supreme Court Transcript — file page 66, lines 13-49 — Transcript, file page 66, lines 13-49
How the case got here
The Supreme Court heard oral argument in this case on January 7, 2019.
Official sources for this section
- Official Supreme Court Transcript — file page 4, lines 11-21 — Transcript, file page 4, lines 11-21
- Official Supreme Court Transcript — file page 67, lines 51-53 — Transcript, file page 67, lines 51-53
What each side wants
Merck wants the Court to bar the state failure-to-warn claim.
Albrecht wants the Court to allow the state failure-to-warn claim.
Official sources for this section
- Official Supreme Court Transcript — file page 21, lines 17-35 — Transcript, file page 21, lines 17-35
- Official Supreme Court Transcript — file page 32, lines 37-45 — Transcript, file page 32, lines 37-45
- Official Supreme Court Transcript — file page 4, lines 23-19 — Transcript, file page 4, lines 23-19
- Official Supreme Court Transcript — file page 66, lines 13-49 — Transcript, file page 66, lines 13-49
What each side says
Merck argues federal law preempts the state claim because the FDA rejected the warning.
Albrecht argues state law permits the claim because the FDA did not approve the warning.
Official sources for this section
- Official Supreme Court Transcript — file page 21, lines 17-35 — Transcript, file page 21, lines 17-35
- Official Supreme Court Transcript — file page 32, lines 37-45 — Transcript, file page 32, lines 37-45
- Official Supreme Court Transcript — file page 4, lines 23-19 — Transcript, file page 4, lines 23-19
- Official Supreme Court Transcript — file page 66, lines 13-49 — Transcript, file page 66, lines 13-49
What the justices asked
Justice Kagan asked about the data provided regarding ovarian cysts.
Chief Justice Roberts asked where the record mentions atypical fractures during the back-and-forth exchanges with the FDA.
Official sources for this section
- Official Supreme Court Transcript — file page 11, lines 27-43 — Transcript, file page 11, lines 27-43
- Official Supreme Court Transcript — file page 12, lines 29-35 — Transcript, file page 12, lines 29-35
- Official Supreme Court Transcript — file page 14, lines 15-47 — Transcript, file page 14, lines 15-47
- Official Supreme Court Transcript — file page 15, lines 45-15 — Transcript, file page 15, lines 45-15
- Official Supreme Court Transcript — file page 16, lines 53-37 — Transcript, file page 16, lines 53-37
- Official Supreme Court Transcript — file page 18, lines 25-31 — Transcript, file page 18, lines 25-31
- Official Supreme Court Transcript — file page 19, lines 31-39 — Transcript, file page 19, lines 31-39
- Official Supreme Court Transcript — file page 20, lines 11-23 — Transcript, file page 20, lines 11-23
- Official Supreme Court Transcript — file page 5, lines 21-29 — Transcript, file page 5, lines 21-29
- Official Supreme Court Transcript — file page 6, lines 55-41 — Transcript, file page 6, lines 55-41
- Official Supreme Court Transcript — file page 67, lines 51-53 — Transcript, file page 67, lines 51-53
- Official Supreme Court Transcript — file page 8, lines 27-25 — Transcript, file page 8, lines 27-25
- Official Supreme Court Transcript — file page 9, lines 43-7 — Transcript, file page 9, lines 43-7
Why it matters
This case defines the boundary between federal drug regulation and state tort law. It determines whether patients can sue drug makers for inadequate warnings when the FDA rejects proposed label changes. The outcome shapes the balance between federal oversight and state consumer protection.
Official sources for this section
- Official Supreme Court Transcript — file page 21, lines 17-35 — Transcript, file page 21, lines 17-35
- Official Supreme Court Transcript — file page 32, lines 37-45 — Transcript, file page 32, lines 37-45
- Official Supreme Court Transcript — file page 4, lines 23-19 — Transcript, file page 4, lines 23-19
- Official Supreme Court Transcript — file page 66, lines 13-49 — Transcript, file page 66, lines 13-49
What happens next
This article currently covers the argument record. Use the official docket link for later case activity.
Official sources for this section
- Official Supreme Court Transcript — file page 11, lines 27-43 — Transcript, file page 11, lines 27-43
- Official Supreme Court Transcript — file page 12, lines 29-35 — Transcript, file page 12, lines 29-35
- Official Supreme Court Transcript — file page 14, lines 15-47 — Transcript, file page 14, lines 15-47
- Official Supreme Court Transcript — file page 15, lines 45-15 — Transcript, file page 15, lines 45-15
- Official Supreme Court Transcript — file page 16, lines 53-37 — Transcript, file page 16, lines 53-37
- Official Supreme Court Transcript — file page 18, lines 25-31 — Transcript, file page 18, lines 25-31
- Official Supreme Court Transcript — file page 19, lines 31-39 — Transcript, file page 19, lines 31-39
- Official Supreme Court Transcript — file page 20, lines 11-23 — Transcript, file page 20, lines 11-23
- Official Supreme Court Transcript — file page 4, lines 11-21 — Transcript, file page 4, lines 11-21
- Official Supreme Court Transcript — file page 5, lines 21-29 — Transcript, file page 5, lines 21-29
- Official Supreme Court Transcript — file page 6, lines 55-41 — Transcript, file page 6, lines 55-41
- Official Supreme Court Transcript — file page 67, lines 51-53 — Transcript, file page 67, lines 51-53
- Official Supreme Court Transcript — file page 8, lines 27-25 — Transcript, file page 8, lines 27-25
- Official Supreme Court Transcript — file page 9, lines 43-7 — Transcript, file page 9, lines 43-7
Official Court provenance
Official docket and case history · Official Supreme Court oral-argument detail page
Title and summary sources
- Official Supreme Court Transcript — file page 21, lines 17-35 — Transcript, file page 21, lines 17-35
- Official Supreme Court Transcript — file page 32, lines 37-45 — Transcript, file page 32, lines 37-45
- Official Supreme Court Transcript — file page 4, lines 23-19 — Transcript, file page 4, lines 23-19
- Official Supreme Court Transcript — file page 66, lines 13-49 — Transcript, file page 66, lines 13-49
- Official Supreme Court Transcript — file page 21, lines 17-35 — Transcript, file page 21, lines 17-35
- Official Supreme Court Transcript — file page 32, lines 37-45 — Transcript, file page 32, lines 37-45
- Official Supreme Court Transcript — file page 4, lines 23-19 — Transcript, file page 4, lines 23-19
- Official Supreme Court Transcript — file page 66, lines 13-49 — Transcript, file page 66, lines 13-49
Revision history
- Revision 1 · Official Transcript ·
Correction: Rewritten to the concise citizen-facing editorial standard.
- Revision 2 · Official Transcript ·
Correction: Migrated to the dated official Court activity contract without model use.