Morris v. PLIVA, Inc.
2013 U.S. App. LEXIS 3167
5th Cir.2013Background
- Penny Morris used metoclopramide (Reglan) from 2006 to 2008, exceeding label warnings.
- Morris alleges defective construction, defective design, breach of express warranty, and inadequate warning.
- Plaintiffs’ claims were stayed pending the Supreme Court’s Mensing decision on preemption of generic-warnings claims.
- Mensing held state-law failure-to-warn claims against generic manufacturers are preempted by federal law requiring sameness with brand-name labels.
- District court dismissed the complaint as preempted; Morrises appealed Rule 59(e) denial and dismissal.
- Court affirms: most theories fail due to preemption; only potential thrust—breach of warranty—is also preempted.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Mensing preempts failure-to-warn claims against generics | Morris argues warnings can be communicated; not preempted. | PLIVA/teva argue duty of sameness preempts unilateral warnings. | Preemption affirmed; failure-to-warn claims barred. |
| Whether TEVA as RLD holder imposes brand-name-style duty to warn | TEVA’s RLD status creates brand-like duties. | RLD status does not impose unilateral labeling changes by TEVA. | Claim rejected; no direct RLD-based duty to warn. |
| Whether non-failure-to-warn claims survive preemption | Testing, reporting, and FDCA violations sustain claims. | FDCA has no private right; state-law claims preempted; warranty claims fail too. | Non-failure-to-warn claims rejected; warranty claim preempted. |
Key Cases Cited
- Mensing v. Wyeth, Inc., 131 S. Ct. 2567 (U.S. 2011) (drug-label sameness precludes generic warnings)
- Wyeth, Inc. v. Levine, 555 U.S. 555 (U.S. 2009) (brand-name liability for failure-to-warn distinct from generics)
- Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (U.S. 2001) (federal labeling authority preemption considerations)
- Demahy v. Schwarz Pharma, Inc., 702 F.3d 177 (5th Cir. 2012) (breach-of-warranty-based labeling claims rejected)
- Jebaco, Inc. v. Harrah's Operating Co., 587 F.3d 314 (5th Cir. 2009) (pleading standards for Rule 12(b)(6) reviewed de novo)
- Bartlett v. Mutual Pharm. Co., 678 F.3d 30 (1st Cir. 2012) (cited as related to labeling and warranty theories)