Degelmann v. Advanced Medical Optics, Inc.
659 F.3d 835
9th Cir.2011Background
- Degelmann and Lin represent a putative class of MoisturePlus purchasers alleging misrepresentation under California UCL and FAL.
- The class members did not contract AK or discard unused MoisturePlus due to a recall; they allege economic harm from false advertising.
- FDA/CDC reports in 2007 linked AK to MoisturePlus, prompting a recall and refunds.
- The district court granted summary judgment for AMO on standing and did not reach preemption.
- The Ninth Circuit reviews de novo; it addresses standing and whether California law is preempted by the MDA.
- The court ultimately concludes the district court erred on standing and that the claims are preempted, affirming summary judgment on that basis.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Standing under U.S. Constitution | Degelmann/ Lin suffered injury in fact from misrepresentation. | AMO argues lack of injury because class members didn’t contract AK or discard product. | Standing found; economic injury shown from misrepresentation. |
| Federal preemption under MDA § 360k(a) | California UCL/FAL claims not preempted by FDA requirements. | FDA labeling requirements preempt state-law claims about disinfecting labeling. | Preemption applies; California claims are expressly preempted. |
Key Cases Cited
- Kwikset Corp. v. Superior Court, 51 Cal.4th 310 (Cal. 2011) (economic harm from mislabeling suffices for standing under UCL/FAL)
- Dandridge v. Williams, 397 U.S. 471 (U.S. 1970) (court may affirm on any ground supported by the record)
- Papike v. Tambrands, Inc., 107 F.3d 737 (9th Cir. 1997) (FDA labeling requirements can be a preemption anchor for class II devices)
- Lohr v. Medtronic, Inc., 518 U.S. 470 (U.S. 1996) (Class II device regulation via special controls; FDA §510(k) process context)
- Riegel v. Medtronic, Inc., 552 U.S. 312 (U.S. 2008) (preemption framework for medical device FDA requirements)