Taylor v. SmithKline Beecham Corp., 468 Mich. 1

Summary

The Michigan Supreme Court considered whether MCL 600.2946(5), which provides an FDA-approval defense to certain prescription-drug products-liability claims, unconstitutionally delegated legislative authority to the federal Food and Drug Administration. The Court held that the statute was a constitutional referral statute because the FDA's safety and efficacy determinations have independent significance and merely serve as a measuring device for legal consequences established by the Michigan Legislature. The Court reversed the Court of Appeals.

Holdings

1. MCL 600.2946(5) is a constitutional exercise of legislative authority. The statute does not delegate lawmaking power to the FDA; it uses FDA determinations of safety and efficacy, made for purposes independent of Michigan tort law, as a factual measuring device to which the Michigan Legislature attached specified legal consequences.
2. The constitutionality of a referral statute does not depend on whether the external agency's standards or determinations are permanent or essentially unchanging. Stability of the external finding is not an element of the independently significant standard.

Questions Presented

1. Whether MCL 600.2946(5), which makes FDA approval and compliant labeling conclusive on the absence of defect, unreasonable danger, liability, and due care in specified drug products-liability cases, unconstitutionally delegates legislative power to the FDA.
2. Whether the statute's reliance on FDA determinations violates the nondelegation doctrine because FDA standards may change over time.

Disposition

reversed