901 F. Supp. 2d 716
M.D. La.2012Background
- Plaintiff alleges tardive dyskinesia from metoclopramide, including a generic form made by Pliva, Inc.
- Plaintiff ingested Pliva metoclopramide (NDC 50111-0430) from July 2005 to January 2007.
- Plaintiff alleges injuries also caused by Generics Bidco I, LLC dba Qualitest Pharmaceuticals (NDC 00603-4615) from May 2008 to July 2010.
- Defendants marketed metoclopramide for nausea, GERD, and gastroparesis per FDA-approved labeling.
- This case was stayed administratively pending Supreme Court action in related cases, then vacated after Mensing; Defendants now move for judgment on the pleadings.
- Plaintiff asserts state-law (LPLA) claims and preemption-based defenses under PLIVA v. Mensing about generic-label requirements and warnings.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether state-law warnings are preempted by federal labeling requirements | Mensing narrowly allows warnings but not changes to content | Federal labeling prevents independent label changes by generics | Preemption applies; state-law warnings precluded by federal rules |
| Whether Plaintiff’s LPLA claims survive given preemption | LPLA design and warranty claims viable despite preemption | Design/warranty claims fail due to preemption and lack of factual support | LPLA claims dismissed; failure-to-warn preempted; judgment on pleadings granted |
| Whether communications to physicians/public can satisfy state duties without violating labeling | Warnings via Dear Doctor letters or other communications possible | Such communications cannot contradict approved labeling | Such communications cannot remedy preemption; rejected as contrary to labeling |
Key Cases Cited
- PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (Supreme Court 2011) (preemption of generic-warnin g labels; cannot change labeling to warn)
- Wyeth v. Levine, 555 U.S. 555 (Supreme Court 2009) (implied conflict when state law requires different warning)
- Freightliner Corp. v. Myrick, 514 U.S. 280 (Supreme Court 1995) (impossibility to comply with both state and federal requirements)
- Bartlett v. Mutual Pharmaceutical Co., 678 F.3d 30 (1st Cir. 2012) (discussed by plaintiff but not sufficient to remove preemption)