Julie Demahy v. Wyeth, Incorporated
2012 U.S. App. LEXIS 22195
5th Cir.2012Background
- Demahy sued Wyeth, Schwarz, and Actavis in Louisiana state court for injuries allegedly caused by generic metoclopramide; case removed to the Eastern District of Louisiana on diversity grounds.
- FDA approved Reglan in 1980; generic metoclopramide has been marketed since 1985 by various manufacturers including Actavis; brand-name holders Wyeth and Schwarz held rights to Reglan at different times.
- Label warnings history includes años of warnings for tardive dyskinesia and a 12-week usage limit; the 2009 FDA black-box warning stated longer use should be avoided.
- In 2008 Demahy filed suit; Wyeth and Schwarz were dismissed without prejudice; Actavis moved to dismiss all claims as preempted by federal law; district court denied; Fifth Circuit affirmed denial of Actavis’ motion to dismiss the failure-to-warn claims in 2010; Supreme Court then held in Mensing (2011) that generic-label changes are preempted, remanding for judgment in Actavis’ favor.
- On remand, the district court entered judgment in Actavis’ favor (Aug. 30, 2011). Demahy then filed Rule 60(b)(5) and Rule 59(e) motions seeking relief from the judgment; the district court denied, citing the mandate from the appellate court; Demahy timely appealed.
- The court reviews Rule 60(b) and Rule 59(e) denials for abuse of discretion and interprets appellate mandates de novo.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Did Mensing alter governing law to permit Rule 59(e) relief against Wyeth/Schwarz | Mensing changed Louisiana tort-law expectations; relief warranted | Mensing did not modify Louisiana law; no basis for amendment | No; Mensing did not alter Louisiana law; no abuse of discretion |
| Did the district court correctly follow the mandate re Actavis claims | District court exceeded the mandate by addressing non-failure-to-warn claims | Mandate limited to failure-to-warn claims; dismissal appropriate | District court properly followed the mandate; no reversible error |
| Do any post-Mensing non-failure-to-warn claims against Actavis survive | Possible design-defect or warranty claims not preempted | Most non-failure-to-warn claims are preempted after Mensing | Only potential design-defect claim would be preempted; overall, claims against Actavis affirmed as preempted |
Key Cases Cited
- Foster v. American Home Products Corp., 29 F.3d 165 (4th Cir. 1994) (duty of care not owed to consumers of non-manufactured products; foundations for preemption discussions)
- Mensing v. Pliva, Inc., 131 S. Ct. 2567 (Supreme Court 2011) (federal labeling requirement preempts state-law failure-to-warn claims against generics)
- Solomon v. Walgreens Co., 975 F.2d 1086 (5th Cir. 1992) (reiteration of applying state law in multiple contexts; limitations on extending duty to non-manufacturers)
- LULAC v. City of Boerne, 675 F.3d 433 (5th Cir. 2012) (law-of-the-case and mandate-rule principles in appellate remands)
- Picco v. Global Marine Drilling Co., 900 F.2d 846 (5th Cir. 1990) (mandate and scope of remand directions)
- United States v. Lee, 358 F.3d 315 (5th Cir. 2004) (law-of-the-case and mandaterule interpretations)
- Nat’l Sur. Corp. v. Charles Carter & Co., 621 F.2d 739 (5th Cir. 1980) (recalls/recisions of mandates to prevent injustice)
- Briggs v. Penn. R.R., 334 U.S. 304 (1948) (mandate-rule foundational principle)