Weston v. Kim's Dollar Store

Summary

The South Carolina Supreme Court reviewed a partial summary judgment ruling in a product-liability action involving prescription decorative contact lenses. The court held that the lenses were subject to device-specific FDA requirements through the premarket approval process, and that state-law claims imposing requirements different from or additional to those federal requirements were expressly preempted. The court affirmed in part and remanded claims that could parallel federal requirements, including a manufacturing-negligence claim.

Holdings

1. The FreshLook Colors UV piano lenses were subject to device-specific federal requirements because the FDA approved PMA supplements authorizing incorporation of an ultraviolet absorber and describing the UV-absorbing component.
2. Claims that would impose common-law requirements different from or additional to the requirements imposed through the PMA process are expressly preempted under 21 U.S.C. § 360k(a).
3. State claims premised on violations of FDA requirements that parallel, rather than add to, those requirements are not preempted and may proceed.
4. The partial summary judgment order could not stand insofar as it dismissed the negligent-manufacture claim, because CIBA conceded that claim survived summary judgment.

Questions Presented

1. Whether the FreshLook Colors UV piano contact lenses were subject to device-specific federal requirements through the FDA's pre-market approval process.
2. Whether Weston's state common-law and statutory claims were expressly preempted under the Medical Device Amendments because they would impose requirements different from or additional to FDA requirements.
3. Whether claims that parallel applicable FDA requirements, including the conceded negligent-manufacture claim, could proceed.

Disposition

remanded