Gaeta v. Perrigo Pharmaceuticals Co.
2011 U.S. App. LEXIS 1382
| 9th Cir. | 2011Background
- A.G., a minor, underwent benign mole removal surgery on June 3, 2004, and was given ibuprofen post-op; Perrigo’s generic ibuprofen was used instead of the brand-name version.
- A.G. took 400 mg ibuprofen every 6–8 hours for four days, beginning June 3, 2004.
- A.G. developed fever, renal and liver complications, septic shock, and ultimately required a liver transplant on June 15, 2004, with additional tissue necrosis.
- Gaetas filed state-law claims against Perrigo and other manufacturers of generic ibuprofen, including failure-to-warn, defective design/marketing, warranties, negligence, and deceit by concealment.
- District court granted summary judgment for Perrigo on a preemption theory, holding state-law failure-to-warn claims were preempted by FDA labeling regulations for generics.
- After Wyeth v. Levine, the Ninth Circuit remanded for reconsideration; the court ultimately held no preemption, reversing and remanding to allow state-law warnings to proceed.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Does Levine preemption apply to generic manufacturers? | Gaeta argues Levine's logic should apply to generics. | Perrigo argues Levine does not control generics preemption. | No preemption; Levine guides the analysis. |
| Can a generic manufacturer comply with both state warnings and FDA labeling requirements? | Gaeta claims stronger warning duties are compatible with FDA framework. | Perrigo contends compliance is impossible under FDA constraints. | No impossibility; multiple mechanisms exist for warnings (CBE, prior approval, Dear Doctor letters). |
| Is there clear evidence the FDA would reject stronger hepatotoxicity warnings? | Gaeta asserts FDA would approve liver-toxicity warnings. | Perrigo asserts FDA rejected such warnings. | No clear evidence; FDA reviews in 2002 and 2006 do not prove rejection of proposed warnings. |
| Do warnings on generics obstruct Congress's Hatch-Waxman objectives? | Gaeta argues parity of warnings is permissible under Hatch-Waxman. | Perrigo asserts such warnings would disrupt low-cost generics. | Not an obstacle; Congress preserved state rights and generic labeling can differ if adequately supported. |
Key Cases Cited
- Wyeth v. Levine, U.S. (Supreme Court 2009) (held FDA labeling preemption not absolute for brand-name drugs; allowed CBE evidence framework)
- Demahy v. Actavis, Inc., 593 F.3d 428 (5th Cir. 2010) (supports no complete preemption for generics; CBE and labeling duties remain with manufacturers)
- Mensing v. Wyeth, Inc., 588 F.3d 603 (8th Cir. 2009) (no preemption for generic labels; later affirmed in 2010 en banc considerations)
- Foster v. American Home Prods. Corp., 29 F.3d 165 (4th Cir. 1994) (recognizes state tort remedies alongside FDA regulation in labeling context)