## Facts

- Claudia Blanco was diagnosed with mitral valve stenosis at age 18 and later underwent surgery in which surgeons implanted a bileaflet mechanical mitral heart valve manufactured by Hemex Scientific, Inc., whose successors included Baxter Healthcare Corporation.
- The valve was a Class III medical device regulated under the federal Medical Device Amendments (MDA).
- Hemex obtained FDA authorization to conduct clinical trials under an Investigational Device Exemption and later sought FDA premarket approval (PMA) for commercial distribution.
- Approximately 15 years after implantation, Claudia died following a problem involving the prosthetic valve.
- Claudia’s heirs sued Baxter and related entities for wrongful death and products liability, alleging a manufacturing defect and asserting negligence, strict liability, and breach of warranty theories under state law.

## Issues

1. Whether state common-law claims alleging a manufacturing defect in an FDA-regulated Class III medical device are expressly preempted by 21 U.S.C. § 360k(a) because they would impose requirements different from, or in addition to, federal requirements established through PMA.
2. Whether plaintiffs avoided preemption by alleging a “parallel” claim based on a violation of specific FDA requirements applicable to the device.

## Decision

- The California Court of Appeal affirmed summary judgment for Baxter.
- The court held plaintiffs’ negligence, strict liability, and warranty claims were expressly preempted by 21 U.S.C. § 360k(a) because the PMA process imposed device-specific federal requirements relating to safety and effectiveness.
- The court held plaintiffs did not plead or support a parallel claim because they failed to identify any specific violation of FDA-imposed requirements.

## Legal Principles

- Under 21 U.S.C. § 360k(a), states may not impose requirements relating to a medical device’s safety or effectiveness that are different from, or in addition to, applicable federal requirements.
- State common-law tort and warranty duties can constitute “requirements” for purposes of § 360k(a) when enforced through damages actions.
- The PMA process for Class III devices can create specific, device-focused federal requirements governing design, manufacturing, and labeling sufficient to trigger § 360k(a) preemption.
- A state-law claim may proceed only if it is genuinely “parallel” to federal requirements—i.e., it seeks to enforce duties that match FDA requirements and is supported by identified, applicable federal violations.

## Conclusion

The court upheld summary judgment because plaintiffs’ state-law manufacturing-defect, negligence, strict liability, and warranty theories would have imposed nonfederal requirements on a PMA-approved Class III heart valve, and plaintiffs failed to plead or prove a parallel claim tied to a specific FDA violation.


Blanco v. Baxter Healthcare Corp., 70 Cal. Rptr. 3d 566 (Cal. Ct. App. 2008)