Tina Johnson v. Teva Pharmaceuticals USA, Inc., et
2014 U.S. App. LEXIS 13242
5th Cir.2014Background
- Plaintiff Tina Johnson took generic metoclopramide from 2002–2009 and alleges she developed tardive dyskinesia from long‑term use.
- Johnson sued both generic manufacturers (Teva, Qualitest, Generics Bidco) under the Louisiana Products Liability Act (LPLA) for inadequate warning, design defect, and breach of express warranty.
- She also sued brand‑name manufacturers (Wyeth, Schwarz, Alaven) for misrepresentation, fraud, breach of warranty, and LUTPA violations, alleging misleading warnings about long‑term risks.
- District court dismissed brand‑name claims under Rule 12(b)(6) (brand companies did not make the product Johnson consumed), stayed and then granted judgment for generics under Rule 12(c) after Mensing, and denied leave to amend.
- Fifth Circuit affirmed: generic claims largely preempted by federal law (duty of sameness); brand claims barred by the LPLA (exclusive remedy and no recovery against a manufacturer that did not produce the offending product).
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Are Johnson's failure‑to‑warn claims against generic manufacturers viable under Louisiana law? | Johnson: generics provided inadequate warnings and could have warned/do more. | Generics: federal “duty of sameness” forbids unilateral stronger warnings; state claims conflict with federal law. | Held: Preempted by federal law (Mensing); judgment on the pleadings for generics. |
| Can Johnson add failure‑to‑warn theories (failure to communicate FDA update; one‑year delay in adopting label)? | Johnson: generics failed to send "Dear Doctor" notices and delayed label update causing injury. | Generics: such communication/updates are preempted (dependent on brand warnings); amendment would be futile. | Held: Leave to amend denied; both proposed claims preempted / futile. |
| Is Johnson’s design‑defect claim against generics viable? | Johnson: risks outweigh benefits; alternative design or product exists. | Generics: federal law requires same composition/labeling as brand, so state design claims conflict; stop‑selling not required. | Held: Preempted under Bartlett; judgment for generics. |
| Can Johnson sue brand‑name manufacturers for injuries from a generic product they did not make? | Johnson: brand communications/labels misled physicians/consumers; liability should attach. | Brands: LPLA is exclusive, and recovery unavailable if manufacturer didn’t produce offending product; brands owe no duty to generic consumers. | Held: Dismissal affirmed; LPLA bars non‑LPLA claims and precludes recovery against brand manufacturers who didn’t make the product. |
Key Cases Cited
- PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (U.S. 2011) (federal “duty of sameness” for generic labels can preempt state failure‑to‑warn claims)
- Mut. Pharm. Co., Inc. v. Bartlett, 133 S. Ct. 2466 (U.S. 2013) (state design‑defect claims against generics conflict with federal requirements for sameness)
- Demahy v. Schwarz Pharma, Inc., 702 F.3d 177 (5th Cir. 2012) (LPLA precludes claims against brand manufacturers for injuries from a generic product)
- Morris v. PLIVA, Inc., 713 F.3d 774 (5th Cir. 2013) (communications‑based failure‑to‑warn claims against generics preempted when brand did not disseminate warning)
- Lashley v. Pfizer, Inc., 750 F.3d 470 (5th Cir. 2014) (communications and labeling claims against generics preempted by federal law)
- Eckhardt v. Qualitest Pham., Inc., 751 F.3d 674 (5th Cir. 2014) (applying Mensing/Bartlett preemption principles to defeat state claims against generics)
- Gentilello v. Rege, 627 F.3d 540 (5th Cir. 2010) (standard for Rule 12(b)(6) / Rule 12(c) review)