PLIVA, Inc. v. Mensing
131 S. Ct. 2567
| SCOTUS | 2011Background
- Metoelopramide Reglan was approved by the FDA in 1980; generic versions followed in 1985.
- Long-term metoclopramide use is linked to tardive dyskinesia, with warnings strengthened over time (1985, 1992, 2004, 2009).
- Glady Mensing and Julie Demahy, prescribed Reglan and then given generic metoclopramide, developed tardive dyskinesia after years of use.
- Mensing and Demahy sued generic manufacturers under Minnesota and Louisiana tort law for failing to provide adequate warnings.
- Gens’ labels were required to match brand-labels under Hatch-Waxman; FDA interpreted to require sameness between generic and brand-name labels.
- Arguments centered on whether federal law (CBE, Dear Doctor letters, and brand/generic labeling rules) prevented state-law labeling duties, thereby pre-empting the claims.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether federal law pre-empts state tort failure-to-warn claims | Mensing and Demahy argue state duties to warn clash with federal sameness rule. | Manufacturers argue impossibility due to federal labeling sameness, pre-empting state claims. | Yes, pre-emption applies; state duty cannot be met without violating federal sameness. |
| Whether CBE and Dear Doctor mechanisms allowed unilateral label changes | CBE and Dear Doctor could enable stronger warnings for generics. | FDA restricts unilateral CBE changes and Dear Doctor letters for generics. | No unilateral changes permitted; these avenues do not defeat pre-emption. |
| Whether FDA’s duty to seek FDA-assisted label changes could reconcile dual duties | If FDA and brand-name label changes could be pursued, states’ duties could be satisfied. | Even if FDA help could occur, it does not satisfy state-duty to warn. | The potential FDA-assisted changes do not remove pre-emption; impossible-to-comply analysis fails here. |
| Whether the Supremacy Clause requires a broader pre-emption framework beyond impossibility | If federal law can block state duties via agency actions, courts should re-consider | Supremacy Clause does not permit speculative reconciliation; existing law blocks state duties. | Impossibility exists; federal law directly conflicts with state duties for generics. |
| Whether the Wyeth framework for brand-name drugs applies to generics | Wyeth shows brand-name could unilaterally change warnings; generics should be same consequence. | Wyeth is distinguishable; brand-name and generic regimes differ under Hatch-Waxman. | Wyeth does not control generics; pre-emption proper for generics due to sameness rule. |
Key Cases Cited
- Wyeth v. Levine, 555 U.S. 555 (U.S. 2009) (brand-name labeling different regime; pre-emption not automatic)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (U.S. 2001) (federal communications with FDA pre-emption context)
- Rice v. Santa Fe Elevator Corp., 331 U.S. 218 (U.S. 1947) (presumption against pre-emption; conflict-analysis framework)
- Crosby v. National Foreign Trade Council, 530 U.S. 363 (U.S. 2000) (conflict pre-emption; standing of private private actors)
- Geier v. American Honda Motor Co., 529 U.S. 861 (U.S. 2000) (obstacle pre-emption and regulatory schemes)