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Taylor v. Smithkline Beecham Corp.3/26/2003
ectly decided in light of the law's subsequent development in this area . . . ." Ante at 19-20.
I disagree with this approach and prefer to square the "independently significant standard" doctrine with our precedent by limiting the doctrine as Dearborn would have limited it. That is, we should hold it constitutionally acceptable to adopt by reference independent decisions of a foreign body as long as the foreign body's standards are "established and essentially unchanging."
The present statute fails the test. The natures of both science and the drug approval process are of the sort that the FDA's standards must evolve over time. Accordingly, FDA determinations are not "essentially unchanging" and a statute that incorporates them perpetrates an unlawful delegation.
The majority rejects this analysis, saying that the determination of a statute's constitutionality "cannot rationally depend on a court's perception of the relative permanence of the actions adopted." Ante at 17. To the contrary, I believe that courts are able to make that assessment with great accuracy. Courts can distinguish between static standards and evolving standards. For example, the standard by which the Naval Observatory calculates the passage of time reasonably can be expected not to change. Contrast that with the manner in which the FDA determines the safety and efficacy of a drug, an evolving standard.
Distrust of the judiciary's ability to distinguish standards is an inappropriate basis for upholding an unconstitutional statute and discarding the precedents of this Court.
III
Some characterize MCL 600.2946(5) as a tort-reform statute that adopts a foreign body's standards while maintaining the consumer's ability to bring suit in the event of fraud or bribery. It is of interest that, after MCL 600.2946(5) was enacted, the United States Supreme Court decided the case of Buckman Co v Plaintiff's Legal Committee, 531 US 341; 121 S Ct 1012; 148 L Ed 2d 854 (2001). Under Buckman and its progeny, a plaintiff's allegations of fraud or bribery are preempted by federal law. Only the FDA may determine whether it was defrauded or bribed when it approved a drug.
MCL 600.2946(5) precludes a person who claims to have been injured by an FDA-approved drug from suing the manufacturer in a Michigan court. When read in conjunction with the Buckman decision, this simple tort-reform statute becomes elevated to a "tort-elimination" statute.
IV.
In sum, I would affirm the judgments of the Wayne Circuit Court and the Court of Appeals holding MCL 600.2946(5) unconstitutional. The majority misconstrues my position. The conclusiveness of the FDA's decisions does not undermine the statutes's constitutionality. What undermines it is the fact that the FDA's decisions are founded on shifting standards. It is only when the standards are "established and essentially unchanging" that a statutory reference to the products of the standards should be ruled a constitutional delegation of the legislative power. The holding I advocate would accord with logic and this Court's precedent, while adopting with appropriate restriction the "independently significant standard" doctrine.
Marilyn Kelly
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