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Sunday, March 30, 2003
 

On March 26, the Michigan Supreme Court issued a decision in the Taylor cases (a series of "Fen-phen" product liability cases against a number of drug manufacturers, consolidated on appeal), upholding the constitutionality of the provisions of MCL 600.2946(5).  That statute limits liability on the part of drug manufacturers when the FDA has approved a drug for safety and efficacy, and when the drug is labeled in conformance with FDA standards.  Except when it can be shown that the manufacturer intentionally withheld information from or misrepresented information to the FDA, bribed an FDA employee, or sold the product after its approval was withdrawn, the prohibition against imposition of liability is absolute.

The Court overruled a decision by the Court of Appeals finding that the statute impermissibly delegated legislative authority to the FDA.  Instead, the Court ruled, FDA action may be properly regarded as an "act of independent significance", and under this well-established doctrine, the nondelegation rule is not offended:

We deal here with the latter type of statute. MCL 600.2946(5) is a statute that refers to factual conclusions of independent significance, i.e., the FDA conclusion regarding the safety and efficacy of a drug, that once made causes, at the Michigan Legislature’s direction, Michigan courts to find as a matter of law that the manufacturer or seller acted with due care. The FDA decision is, in Dean LeDuc’s formulation, simply a "measuring device."

Taylor v Gate Pharmaceuticals, et al. [PDF link]

The following are links to the Supreme Court's pages providing access to the briefs filed by the parties in these cases.  Note that the briefs were scanned from the paper sources and thus are quite large: 1 | 2 | 3 | 4


8:56:14 AM    


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