Moore v. Zydus Pharmaceuticals (USA), Inc.
277 F. Supp. 3d 873
E.D. Ky.2017Background
- Plaintiff Cathy Moore was prescribed generic amiodarone (Zydus) for atrial fibrillation and alleges she developed amiodarone toxicity leading to blindness.
- Moore alleges off-label promotion and inadequate warnings/medication guide distribution by manufacturer(s); she originally sued both Wyeth (brand) and Zydus (generic), later dismissing Wyeth.
- Zydus moved to dismiss under Rule 12(b)(6), arguing federal preemption (PLIVA/Mensing framework) and that Moore seeks to enforce FDCA duties that afford no private right of action.
- The FDA requires generics to match brand labeling (“duty of sameness”) and mandates Medication Guides for certain drugs; pharmacies (not manufacturers) must provide the guide to patients at dispensing.
- Moore pleaded negligence, gross negligence, strict products liability (failure to warn), negligent failure to warn, breach of implied and express warranty, and fraud/off-label marketing.
- The court dismissed Counts 1–6 as preempted or otherwise deficient, granted leave to amend Count 7 (fraud/off-label marketing) as to Zydus.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether state-law failure-to-warn/design-defect claims against a generic are preempted | Moore: claims are not preempted because Zydus could have provided Medication Guides and otherwise complied with state law without violating federal law | Zydus: Mensing/Bartlett preempt state-law duties that would require changing generic labeling or warnings due to the duty of sameness | Held: Preempted — failure-to-warn and design-defect claims (Counts 3–4) dismissed under Mensing/Bartlett framework |
| Whether a private claim may enforce FDCA-based duties (Medication Guide distribution) | Moore: Zydus had a non-delegable duty to ensure patients received Medication Guides; failure caused her harm | Zydus: FDCA provides no private right of action; enforcement is federal (Buckman) | Held: Moore’s Medication Guide claim is barred as it seeks to privately enforce FDCA duties; claim dismissed |
| Whether negligence and gross negligence claims survive | Moore: alleges negligent promotion, concealment, failure to provide Medication Guide, and knowledge of risks | Zydus: claims rest on federally dictated labeling/warning duties and federal-law violations (preempted); negligence per se on federal regs not available under Kentucky law | Held: Negligence and gross negligence (Counts 1–2) dismissed as preempted or legally deficient |
| Whether fraud/off-label marketing claim pleads fraud with particularity | Moore: alleges fraudulent off-label promotion and concealment; seeks leave to amend to add specificity | Zydus: complaint lumps Wyeth/Zydus, fails Rule 9(b) particularity for Zydus-specific acts | Held: Court denied dismissal of Count 7; granted Moore leave to amend Count 7 to plead specific allegations against Zydus under Rule 9(b) |
Key Cases Cited
- PLIVA, Inc. v. Mensing, 564 U.S. 604 (federal implied preemption bars state-law failure-to-warn claims against generic manufacturers)
- Mut. Pharm. Co. v. Bartlett, 570 U.S. 472 (state-law design-defect claims that would require changing generic labeling are preempted)
- Buckman Co. v. Plaintiffs Legal Comm., 531 U.S. 341 (FDCA enforcement is federal; no private right to enforce FDCA)
- Strayhorn v. Wyeth Pharm., Inc., 737 F.3d 378 (Sixth Circuit: warranty and failure-to-warn claims premised on inadequate generic warnings are preempted)
- Smith v. Wyeth, Inc., 657 F.3d 420 (Sixth Circuit: state-law tort claims against generic manufacturers preempted under Mensing)
- In re Darvocet, Darvon, & Propoxyphene Prod. Liab. Litig., 756 F.3d 917 (Sixth Circuit applying Mensing/Bartlett preemption analysis)