Glover v. Bausch & Lomb, Inc.

Summary

The Second Circuit certified two questions to the Connecticut Supreme Court regarding federal preemption of state tort claims arising from injuries caused by a medical device (intraocular lenses). The court asked whether Connecticut law recognizes a cause of action for a manufacturer's failure to report adverse events to the FDA or comply with post-approval safety requirements, and whether the Connecticut Product Liability Act's exclusivity provision bars a Connecticut Unfair Trade Practices Act claim based on deceptive marketing of a product known to present a substantial risk of injury. The decision turns on the "narrow gap" between express preemption under the Medical Device Amendments and implied preemption under Buckman, requiring a state-law duty that parallels federal requirements without existing solely by virtue of the FDCA.

Holdings

1. The court held that the issues on appeal turn on unsettled questions of Connecticut law for which no controlling authority exists, and certification to the Supreme Court of Connecticut is appropriate.

Questions Presented

1. Whether the negligence and failure-to-warn claims under the Connecticut Product Liability Act are preempted by federal law, specifically whether Connecticut law recognizes a duty to warn a regulator or comply with post-approval requirements.
2. Whether the Connecticut Unfair Trade Practices Act claim is barred by the exclusivity provision of the Connecticut Product Liability Act.

Disposition

other