State-Level Protection for Good-Faith Pharmaceutical Manufacturers
March 6, 2006Daniel E. Troy
In 1996, the Michigan legislature enacted a common-sense proposition into law: drug-safety determinations should be made by the Food and Drug Administration (FDA), rather than by judges or juries hearing tort cases. This statute, Michigan Compiled Law § 600.2946(5) (the Michigan FDA Shield Law), provides that, with certain exceptions, drugs approved by FDA and in compliance with FDA requirements cannot be held to be "defective or unreasonably dangerous" in a state-law tort action. Nevertheless, misconceptions regarding the operation of the Michigan FDA Shield Law and the FDA drug-approval process have led some to attack this sensible and well-considered measure.