October Term 2010 · Docket 09-993
Can state law force generic drug makers to change FDA-approved labels?
Plaintiffs claim generic makers ignored safety risks. Defendants argue federal law blocks such claims.
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
Mr. Lefkowitz argued federal law requires identical generic labels.
Mr. Bograd argued the makers ignored inadequate warnings.
Mr. Kneedler argued Hatch-Waxman does not absolve safety duties.
Read the official transcript for this argument · Official argument details
Sources used for this argument breakdown
- Official Supreme Court Transcript — file page 24, lines 49-17 — Transcript, file page 24, lines 49-17
- Official Supreme Court Transcript — file page 4, lines 19-37 — Transcript, file page 4, lines 19-37
- Official Supreme Court Transcript — file page 4, lines 39-43 — Transcript, file page 4, lines 39-43
- Official Supreme Court Transcript — file page 4, lines 7-17 — Transcript, file page 4, lines 7-17
- Official Supreme Court Transcript — file page 44, lines 11-25 — Transcript, file page 44, lines 11-25
- Official Supreme Court Transcript — file page 5, lines 11-19 — Transcript, file page 5, lines 11-19
- Official Supreme Court Transcript — file page 5, lines 49-3 — Transcript, file page 5, lines 49-3
- Official Supreme Court Transcript — file page 6, lines 35-37 — Transcript, file page 6, lines 35-37
- Official Supreme Court Transcript — file page 6, lines 39-47 — Transcript, file page 6, lines 39-47
- Official Supreme Court Transcript — file page 6, lines 9-15 — Transcript, file page 6, lines 9-15
- Official Supreme Court Transcript — file page 7, lines 17-29 — Transcript, file page 7, lines 17-29
- Official Supreme Court Transcript — file page 7, lines 41-49 — Transcript, file page 7, lines 41-49
- Official Supreme Court Transcript — file page 8, lines 43-5 — Transcript, file page 8, lines 43-5
- Official Supreme Court Transcript — file page 8, lines 5-11 — Transcript, file page 8, lines 5-11
- Official Supreme Court Transcript — file page 9, lines 19-27 — Transcript, file page 9, lines 19-27
- Official Supreme Court Transcript — file page 9, lines 41-11 — Transcript, file page 9, lines 41-11
A citizen's guide to the whole case
What this case is about
This case tests whether state tort law can override federal drug labeling rules.
Official sources for this section
- Official Supreme Court Transcript — file page 24, lines 49-17 — Transcript, file page 24, lines 49-17
- Official Supreme Court Transcript — file page 4, lines 19-37 — Transcript, file page 4, lines 19-37
- Official Supreme Court Transcript — file page 44, lines 11-25 — Transcript, file page 44, lines 11-25
How the case got here
The Supreme Court heard oral argument in this case on March 30, 2011.
Official sources for this section
- Official Supreme Court Transcript — file page 4, lines 7-17 — Transcript, file page 4, lines 7-17
What each side wants
Plaintiffs want damages for alleged failure to warn.
Defendants want dismissal of the state-law claims.
Official sources for this section
- Official Supreme Court Transcript — file page 24, lines 49-17 — Transcript, file page 24, lines 49-17
- Official Supreme Court Transcript — file page 4, lines 19-37 — Transcript, file page 4, lines 19-37
- Official Supreme Court Transcript — file page 44, lines 11-25 — Transcript, file page 44, lines 11-25
What each side says
Plaintiffs argue the makers ignored known safety risks.
Defendants argue federal law mandates identical labels to brand drugs.
Official sources for this section
- Official Supreme Court Transcript — file page 24, lines 49-17 — Transcript, file page 24, lines 49-17
- Official Supreme Court Transcript — file page 4, lines 19-37 — Transcript, file page 4, lines 19-37
- Official Supreme Court Transcript — file page 44, lines 11-25 — Transcript, file page 44, lines 11-25
What the justices asked
Justice Sotomayor asked if the makers disavow FDA reporting duties.
Justice Kennedy asked if this involves the take-steps doctrine.
Official sources for this section
- Official Supreme Court Transcript — file page 4, lines 39-43 — Transcript, file page 4, lines 39-43
- Official Supreme Court Transcript — file page 5, lines 11-19 — Transcript, file page 5, lines 11-19
- Official Supreme Court Transcript — file page 5, lines 49-3 — Transcript, file page 5, lines 49-3
- Official Supreme Court Transcript — file page 6, lines 35-37 — Transcript, file page 6, lines 35-37
- Official Supreme Court Transcript — file page 6, lines 39-47 — Transcript, file page 6, lines 39-47
- Official Supreme Court Transcript — file page 6, lines 9-15 — Transcript, file page 6, lines 9-15
- Official Supreme Court Transcript — file page 7, lines 17-29 — Transcript, file page 7, lines 17-29
- Official Supreme Court Transcript — file page 7, lines 41-49 — Transcript, file page 7, lines 41-49
- Official Supreme Court Transcript — file page 8, lines 43-5 — Transcript, file page 8, lines 43-5
- Official Supreme Court Transcript — file page 8, lines 5-11 — Transcript, file page 8, lines 5-11
- Official Supreme Court Transcript — file page 9, lines 19-27 — Transcript, file page 9, lines 19-27
- Official Supreme Court Transcript — file page 9, lines 41-11 — Transcript, file page 9, lines 41-11
Why it matters
This dispute defines the boundary between state safety laws and federal drug regulation.
Official sources for this section
- Official Supreme Court Transcript — file page 24, lines 49-17 — Transcript, file page 24, lines 49-17
- Official Supreme Court Transcript — file page 4, lines 19-37 — Transcript, file page 4, lines 19-37
- Official Supreme Court Transcript — file page 44, lines 11-25 — Transcript, file page 44, lines 11-25
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 4, lines 39-43 — Transcript, file page 4, lines 39-43
- Official Supreme Court Transcript — file page 4, lines 7-17 — Transcript, file page 4, lines 7-17
- Official Supreme Court Transcript — file page 5, lines 11-19 — Transcript, file page 5, lines 11-19
- Official Supreme Court Transcript — file page 5, lines 49-3 — Transcript, file page 5, lines 49-3
- Official Supreme Court Transcript — file page 6, lines 35-37 — Transcript, file page 6, lines 35-37
- Official Supreme Court Transcript — file page 6, lines 39-47 — Transcript, file page 6, lines 39-47
- Official Supreme Court Transcript — file page 6, lines 9-15 — Transcript, file page 6, lines 9-15
- Official Supreme Court Transcript — file page 7, lines 17-29 — Transcript, file page 7, lines 17-29
- Official Supreme Court Transcript — file page 7, lines 41-49 — Transcript, file page 7, lines 41-49
- Official Supreme Court Transcript — file page 8, lines 43-5 — Transcript, file page 8, lines 43-5
- Official Supreme Court Transcript — file page 8, lines 5-11 — Transcript, file page 8, lines 5-11
- Official Supreme Court Transcript — file page 9, lines 19-27 — Transcript, file page 9, lines 19-27
- Official Supreme Court Transcript — file page 9, lines 41-11 — Transcript, file page 9, lines 41-11
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 24, lines 49-17 — Transcript, file page 24, lines 49-17
- Official Supreme Court Transcript — file page 4, lines 19-37 — Transcript, file page 4, lines 19-37
- Official Supreme Court Transcript — file page 44, lines 11-25 — Transcript, file page 44, lines 11-25
- Official Supreme Court Transcript — file page 24, lines 49-17 — Transcript, file page 24, lines 49-17
- Official Supreme Court Transcript — file page 4, lines 19-37 — Transcript, file page 4, lines 19-37
- Official Supreme Court Transcript — file page 44, lines 11-25 — Transcript, file page 44, lines 11-25
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.