PLIVA, Inc. v. Mensing
564 U.S. 604
SCOTUS2011Background
- Consolidated state tort suits claim generic metoclopramide warnings were inadequate, causing tardive dyskinesia after long-term use.
- FDA-approved brand Reglan label existed since 1980; generics must match brand labeling under Hatch-Waxman framework.
- State duties require drug makers to provide adequate warnings; plaintiffs allege brands and generics failed to warn.
- Federal regime ties generic labels to the brand label and limits unilateral label changes for generics (no CBE or Dear Doctor changes).
- FDA interpretations: generics cannot unilaterally strengthen warnings; changes must align with brand labeling or await FDA action.
- Court held federal law pre-empts state-law failure-to-warn claims for these generics because real-world compliance with both would be impossible.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether federal law pre-empts state failure-to-warn claims | Mensing and Demahy claim state duty to warn conflicts with federal sameness requirement. | Federal labeling regime makes it impossible to satisfy state duty while keeping labels identical. | Yes; pre-empted. |
| Role of CBE and Dear Doctor in allowing label changes for generics | CBE and Dear Doctor could permit stronger warnings independently. | FDA interprets CBE and Dear Doctor as not allowing unilateral changes for generics. | CBE and Dear Doctor changes not available to generics. |
| Whether FDA's duty to seek FDA assistance could enable compliance with both laws | FDA/brand-name collaboration could cure the inconsistency between laws. | Even with FDA involvement, state duty to warn would not be met without independent action. | No; reliance on FDA/brand-action does not save state-duty compliance. |
| Existence of an express saving clause pre-emption for generics | No express saving clause preserving state tort claims for generics. | Hatch-Waxman-like regime may implicitly pre-empt. | Text does not foreclose implied pre-emption here; but decision rests on impossibility. |
| Impact on Wyeth precedent and brand-name vs generic distinction | Wyeth allows unilateral label strengthening for brand-name; should extend to generics analogously. | Wyeth is distinguishable; generics face different regime; cannot extend Wyeth to generics. | Wyeth distinguishable; generics pre-empted. |
Key Cases Cited
- Wyeth v. Levine, 555 U.S. 555 (2009) (brand-name warning claims not pre-empted; CBE allowed unilateral changes)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001) (federal pre-emption in FDA communications context)
- Crosby v. National Foreign Trade Council, 530 U.S. 363 (2000) (conflict pre-emption and supremacy clause interpretation)
- Rice v. Norman Williams Co., 458 U.S. 654 (1982) (impossibility pre-emption and counterfactual considerations)
- Florida Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132 (1963) (impossibility pre-emption standard requiring inevitable collision)
- Geier v. American Honda Motor Co., 529 U.S. 861 (2000) (pre-emption where federal regulation interacts with state requirements)
- Gade v. National Solid Wastes Management Assn., 505 U.S. 88 (1992) (concurrence on state-federal interaction in pre-emption context)
- Nelson, Preemption (article), 86 Va. L. Rev. 225 (2000) (theoretical framing of non obstinate Supremacy Clause interpretation)