Charlotte Kennedy was treated with Zyderm Collagen Implant (Zyderm) for soft tissue skin defects. Following her treatment, Mrs. Kennedy developed systemic lupus erythematosus (SLE), an auto-immune disease. Charlotte and Robert Kennedy sued Collagen, alleging state common law negligence, strict liability, breach of warranty, battery, conspiracy, and loss of consortium.

The district court granted summary judgment for Collagen because the state common law claims were preempted by the Medical Device Amendments (MDA). The Kennedys appealed, claiming the MDA did not preempt their state common law claim and genuine issues of material fact existed in the case.

On appeal, the Ninth Circuit began with a review of the legislative history of the MDA. Congress, the court noted, passed the MDA to ensure medical products are safe and effective. The accompanying Food and Drug Administration (FDA) regulations provide that state and local laws are preempted only when the MDA contains specific counterpart regulations or requirements applicable to the specific device at issue. Thus, the court determined the MDA does not preempt laws of general applicability such as state common law claims. The Ninth Circuit reversed the district court's granting of summary judgment for Collagen and remanded the case.

The concurring opinion was written to give a more comprehensive definition of the word "requirement" in the MDA. The concurrence argued that if a state common law requirement has the same effect on a device or product as it does on all other devices and products, that requirement is not preempted by the MDA.