Eckhardt v. Qualitest Pharmaceuticals, Inc.
2014 U.S. App. LEXIS 8915
5th Cir.2014Background
- Eckhardt allegedly developed tardive dyskinesia after long-term use of metoclopramide prescribed as Reglan by a physician, with a generic substituted at fill.
- Plaintiff sued Brand Defendants (Wyeth, Schwarz) and Generic Defendants (Qualitest, Vintage) on multiple theories including products liability, negligence, and consumer protection claims.
- The district court dismissed all claims against Generic Defendants as preempted or inadequately pled and granted summary judgment to Brand Defendants; Eckhardt appealed.
- Federal labeling rules under Mensing restricted generic labeling changes, prompting preemption of many state-law claims against generics; Texas design-defect claims require a safer alternative design, which cannot exist where labeling cannot be changed.
- Eckhardt did not ingest Brand Defendants’ products; courts have held brand manufacturers owe no duty to consumers who use generics, affecting claims against Brand Defendants.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Are generic-defendant claims preempted? | Eckhardt contends state-law claims survive parallel to FDA labeling. | Mensing precludes state-law warnings and design claims for generics when labeling cannot be changed. | Yes; claims preempted. |
| Do strict-liability design-defect and related claims survive against generics? | Texas law allows design-defect claims if a safer alternative existed. | Federal law forbids changing generic labeling, negating any safer-alternative design. | Preempted; no safer-alternative design exists. |
| Do failure-to-warn and related parallel claims against generics survive? | FDA-approved warnings were not provided; parallel state claims survive. | Warnings were governed by FDA labeling and federally mandated, precluding state-law failure-to-warn claims. | Preempted or inadequately pled; dismissal affirmed. |
| Are Brand Defendants liable given plaintiff did not ingest their products? | Brand makers owe duty to consumers even when generics are used. | Texas law does not recognize a duty to consumers of competitors’ products; Lashley binding on this panel. | No duty recognized; summary judgment affirmed. |
Key Cases Cited
- Pliva, Inc. v. Mensing, 131 S. Ct. 2567 (2011) (federal preemption of state-law failure-to-warn claims for generics)
- Bartlett v. Mutual Pharmaceutical Co., Inc., 133 S. Ct. 2466 (2013) (preemption of strict liability design-defect claim where labeling cannot be changed)
- Morris v. PLIVA, Inc., 713 F.3d 774 (5th Cir. 2013) (preemption of generic-labeling-related breach of warranty claims)
- Kroger Co. v. Elwood, 197 S.W.3d 794 (Tex. 2006) (Texas duty elements for negligence; framework for duty in product cases)
- Timpte Indus., Inc. v. Gish, 286 S.W.3d 306 (Tex. 2009) (Texas strict-liability design-defect standard requires proof of safer alternative design)
- Fed. Land Bank Ass’n of Tyler v. Sloane, 825 S.W.2d 439 (Tex. 1991) (negligence elements; duty requirements for negligent misrepresentation)
- Mayeaux v. La. Health Serv. & Indem. Co., 376 F.3d 420 (5th Cir. 2004) (standard for reviewing denial of leave to amend)