October Term 2012 · Docket 12-142
Can generic drug makers face design-defect liability despite FDA approval?
The dispute centers on whether federal law blocks state design-defect claims against generic drug manufacturers.
Verified source milestones
- — 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
Mutual Pharmaceutical argues federal law requires identical ingredients and warnings.
Bartlett argues New Hampshire law imposes a hybrid design-defect standard.
Justice Sotomayor questioned whether FDA approval creates an absolute liability shield.
Justice Kagan asked how the argument applies to brand-named drugs.
Read the official transcript for this argument · Official argument details
Sources used for this argument breakdown
- Official Supreme Court Transcript — file page 10, lines 11-13 — Transcript, file page 10, lines 11-13
- Official Supreme Court Transcript — file page 18, lines 11-39 — Transcript, file page 18, lines 11-39
- Official Supreme Court Transcript — file page 27, lines 29-29 — Transcript, file page 27, lines 29-29
- Official Supreme Court Transcript — file page 27, lines 31-17 — Transcript, file page 27, lines 31-17
- Official Supreme Court Transcript — file page 3, lines 19-43 — Transcript, file page 3, lines 19-43
- Official Supreme Court Transcript — file page 3, lines 45-33 — Transcript, file page 3, lines 45-33
- Official Supreme Court Transcript — file page 3, lines 7-17 — Transcript, file page 3, lines 7-17
- Official Supreme Court Transcript — file page 5, lines 25-27 — Transcript, file page 5, lines 25-27
- Official Supreme Court Transcript — file page 5, lines 3-19 — Transcript, file page 5, lines 3-19
- Official Supreme Court Transcript — file page 5, lines 41-45 — Transcript, file page 5, lines 41-45
- Official Supreme Court Transcript — file page 6, lines 11-21 — Transcript, file page 6, lines 11-21
- Official Supreme Court Transcript — file page 7, lines 19-27 — Transcript, file page 7, lines 19-27
- Official Supreme Court Transcript — file page 8, lines 17-39 — Transcript, file page 8, lines 17-39
- Official Supreme Court Transcript — file page 8, lines 43-47 — Transcript, file page 8, lines 43-47
- Official Supreme Court Transcript — file page 9, lines 15-23 — Transcript, file page 9, lines 15-23
- Official Supreme Court Transcript — file page 9, lines 37-39 — Transcript, file page 9, lines 37-39
- Official Supreme Court Transcript — file page 9, lines 43-45 — Transcript, file page 9, lines 43-45
A citizen's guide to the whole case
What this case is about
This case tests the scope of federal preemption for generic drugs.
Official sources for this section
- Official Supreme Court Transcript — file page 18, lines 11-39 — Transcript, file page 18, lines 11-39
- Official Supreme Court Transcript — file page 27, lines 29-29 — Transcript, file page 27, lines 29-29
- Official Supreme Court Transcript — file page 27, lines 31-17 — Transcript, file page 27, lines 31-17
- Official Supreme Court Transcript — file page 3, lines 19-43 — Transcript, file page 3, lines 19-43
How the case got here
The Supreme Court heard oral argument in this case on March 19, 2013.
Official sources for this section
- Official Supreme Court Transcript — file page 3, lines 7-17 — Transcript, file page 3, lines 7-17
What each side wants
Mutual Pharmaceutical seeks dismissal of the state design-defect claim.
Bartlett seeks to maintain the state design-defect claim.
Official sources for this section
- Official Supreme Court Transcript — file page 18, lines 11-39 — Transcript, file page 18, lines 11-39
- Official Supreme Court Transcript — file page 27, lines 29-29 — Transcript, file page 27, lines 29-29
- Official Supreme Court Transcript — file page 27, lines 31-17 — Transcript, file page 27, lines 31-17
- Official Supreme Court Transcript — file page 3, lines 19-43 — Transcript, file page 3, lines 19-43
What each side says
Mutual Pharmaceutical argues federal law preempts state design-defect claims.
Bartlett argues state law imposes a distinct design-defect duty.
Official sources for this section
- Official Supreme Court Transcript — file page 18, lines 11-39 — Transcript, file page 18, lines 11-39
- Official Supreme Court Transcript — file page 27, lines 29-29 — Transcript, file page 27, lines 29-29
- Official Supreme Court Transcript — file page 27, lines 31-17 — Transcript, file page 27, lines 31-17
- Official Supreme Court Transcript — file page 3, lines 19-43 — Transcript, file page 3, lines 19-43
What the justices asked
Justice Sotomayor asked if FDA approval bars all tort claims.
Justice Kagan asked about the scope of the argument for brand drugs.
Official sources for this section
- Official Supreme Court Transcript — file page 10, lines 11-13 — Transcript, file page 10, lines 11-13
- Official Supreme Court Transcript — file page 3, lines 45-33 — Transcript, file page 3, lines 45-33
- Official Supreme Court Transcript — file page 5, lines 25-27 — Transcript, file page 5, lines 25-27
- Official Supreme Court Transcript — file page 5, lines 3-19 — Transcript, file page 5, lines 3-19
- Official Supreme Court Transcript — file page 5, lines 41-45 — Transcript, file page 5, lines 41-45
- Official Supreme Court Transcript — file page 6, lines 11-21 — Transcript, file page 6, lines 11-21
- Official Supreme Court Transcript — file page 7, lines 19-27 — Transcript, file page 7, lines 19-27
- Official Supreme Court Transcript — file page 8, lines 17-39 — Transcript, file page 8, lines 17-39
- Official Supreme Court Transcript — file page 8, lines 43-47 — Transcript, file page 8, lines 43-47
- Official Supreme Court Transcript — file page 9, lines 15-23 — Transcript, file page 9, lines 15-23
- Official Supreme Court Transcript — file page 9, lines 37-39 — Transcript, file page 9, lines 37-39
- Official Supreme Court Transcript — file page 9, lines 43-45 — Transcript, file page 9, lines 43-45
Why it matters
This case defines the boundary between federal drug regulation and state tort law.
Official sources for this section
- Official Supreme Court Transcript — file page 18, lines 11-39 — Transcript, file page 18, lines 11-39
- Official Supreme Court Transcript — file page 27, lines 29-29 — Transcript, file page 27, lines 29-29
- Official Supreme Court Transcript — file page 27, lines 31-17 — Transcript, file page 27, lines 31-17
- Official Supreme Court Transcript — file page 3, lines 19-43 — Transcript, file page 3, lines 19-43
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 10, lines 11-13 — Transcript, file page 10, lines 11-13
- Official Supreme Court Transcript — file page 3, lines 45-33 — Transcript, file page 3, lines 45-33
- Official Supreme Court Transcript — file page 3, lines 7-17 — Transcript, file page 3, lines 7-17
- Official Supreme Court Transcript — file page 5, lines 25-27 — Transcript, file page 5, lines 25-27
- Official Supreme Court Transcript — file page 5, lines 3-19 — Transcript, file page 5, lines 3-19
- Official Supreme Court Transcript — file page 5, lines 41-45 — Transcript, file page 5, lines 41-45
- Official Supreme Court Transcript — file page 6, lines 11-21 — Transcript, file page 6, lines 11-21
- Official Supreme Court Transcript — file page 7, lines 19-27 — Transcript, file page 7, lines 19-27
- Official Supreme Court Transcript — file page 8, lines 17-39 — Transcript, file page 8, lines 17-39
- Official Supreme Court Transcript — file page 8, lines 43-47 — Transcript, file page 8, lines 43-47
- Official Supreme Court Transcript — file page 9, lines 15-23 — Transcript, file page 9, lines 15-23
- Official Supreme Court Transcript — file page 9, lines 37-39 — Transcript, file page 9, lines 37-39
- Official Supreme Court Transcript — file page 9, lines 43-45 — Transcript, file page 9, lines 43-45
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 18, lines 11-39 — Transcript, file page 18, lines 11-39
- Official Supreme Court Transcript — file page 27, lines 29-29 — Transcript, file page 27, lines 29-29
- Official Supreme Court Transcript — file page 27, lines 31-17 — Transcript, file page 27, lines 31-17
- Official Supreme Court Transcript — file page 3, lines 19-43 — Transcript, file page 3, lines 19-43
- Official Supreme Court Transcript — file page 18, lines 11-39 — Transcript, file page 18, lines 11-39
- Official Supreme Court Transcript — file page 27, lines 29-29 — Transcript, file page 27, lines 29-29
- Official Supreme Court Transcript — file page 27, lines 31-17 — Transcript, file page 27, lines 31-17
- Official Supreme Court Transcript — file page 3, lines 19-43 — Transcript, file page 3, lines 19-43
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.