State-Level Protection for Good-Faith Pharmaceutical Manufacturers

Former FDA General Counsel Daniel Troy has written a white paper [37 pp. pdf] discussing a particular tort reform measure undertaken in the State of Michigan. Michigan created by statute an "FDA compliance" defense, restricting product liability claims against companies that meet FDA labeling and production requirements. Other states have passed similar legislation. Should patients be limited in bringing claims against companies who met FDA requirements? Does the Supremacy Clause bar such product liability claims? Dan Troy discusses these and other legal and policy issues in his paper.

You can also view a webcast of his presentation of the paper.