Robert Perez v. Nidek Co., Ltd.
2013 U.S. App. LEXIS 5878
9th Cir.2013Background
- Perez, Art, and Harbach received LASIK with a Nidek EC-5000 laser and allege lack of disclosure about FDA status for hyperopic use.
- They claim no injuries or efficacy failure, but would not have consented had they known the device wasn't approved for farsighted corrections.
- Plaintiff class seeks claims under the California Human Subjects Act and CLRA, plus common-law fraud by omission, conspiracy, and aiding-and-abetting against Nidek entities and physicians.
- The Laser is a Class III device; PMAs allowed nearsighted use since 1998–2000, but farsighted use was approved only in October 2006 and restricted outside approved investigations.
- FDA issued letters and an Import Alert about unapproved hyperopic use and alleged tampering with device software; Perez alleges continued off-label use despite FDA actions.
- Court evaluates standing first, then California Human Subjects Act interpretation and MDA/FDCA preemption of fraud-by-omission claims.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Standing of non-surgery doctors | Perez asserts conspiratorial injury traceable to all doctors. | Traceability fails; claims are too conclusory. | No standing for the second group; standing deficient. |
| California Human Subjects Act applicability | LASIK constituted medical experimentation requiring informed consent. | Procedures were therapeutic and fell outside 'medical experiment'. | LASIK for hyperopia not a medical experiment under §24174(a)/(b). |
| Fraud by omission preemption under MDA/FDCA | Defendants failed to disclose FDA status; not preempted. | State-law fraud claims conflict with FDCA and are preempted. | Express preemption under §360k(a) applies; fraud-by-omission claim expressly preempted; implied preemption also discussed. |
| CLRA standing and preemption | CLRA injunctive relief available for ongoing harm. | Preemption and lack of ongoing threat defeat CLRA standing. | Perez lacks standing under CLRA; independent preemption analysis supports dismissal. |
Key Cases Cited
- Lohr v. Medtronic, Inc., 518 U.S. 470 (1996) (FDA safeguards preempt state-law duties lacking device-specific requirements)
- Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (PMAs create device-specific federal requirements; state claims preempted if they concern safety/effectiveness)
- Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341 (2001) (fraud-on-the-FDA claims impliedly preempted when they conflict with federal scheme)
- Stengel v. Medtronic, Inc., 704 F.3d 1224 (2013) (clarified MDA preemption for state-law duties parallel to federal duties)
- In re Medtronic, Inc. Spring Fidelis Leads Prods. Liab. Litig., 623 F.3d 1200 (8th Cir. 2010) (illustrates preemption boundaries for FDCA-related claims)
- Easter v. American W. Fin., Inc., 381 F.3d 948 (9th Cir. 2004) (standing is a threshold jurisdictional issue)
- Daum v. Spinecare Medical Group, Inc., 52 Cal. App. 4th 1285 (Cal. Ct. App. 1997) (distinguishes IDE/FDCA clinical-trial context for informed-consent claims)
- Mylan Laboratories, Inc. v. Matkari, 7 F.3d 1130 (4th Cir. 1993) (limits private enforcement of FDCA; fraud claims cannot encroach FDCA scheme)
- Summit Tech., Inc. v. High-Line Medical Instruments Co., 922 F. Supp. 299 (C.D. Cal. 1996) (limits on using Lanham Act to enforce FDA/Federal requirements)