Manufacturers' Immunity: The FDA Compliance Defense

Administrative Law Practice Group

Faced with the rising costs of prescription drugs, in 1995 the Michigan legislature passed a statute that created an "FDA compliance" defense, effectively restricting claims against companies that had followed FDA labeling requirements. Other states have created related statutes: a rebuttable presumption of validity for drugs that complied with FDA requirements; statutes that allow introduction of "FDA compliance" as evidence during trial; statutes that prohibit companies from proffering evidence of an "FDA compliance" defense. Though these state statutes have been upheld constitutionally, it was not until February, 2004, that a federal court in Texas acknowledged an absolute "FDA compliance" defense. The court reasoned that the placement of an additional State label, warning against the possibility of suicide, would run afoul of the Constitution's Supremacy Clause. Neither the United States Courts of Appeals nor the Supreme Court has addressed the validity of an absolute "FDA compliance" defense in products liability claims.

Should patients be prevented from bringing claims against companies whose labels met FDA requirements? Does the Supremacy Clause bar such product liability claims? What avenues should patients have in pursuing claims against FDA-approved drugs? Is an FDA "compliance defense" the best remedy for the rising costs of prescription drugs?

Panelists include:

  • Hon. Daniel Troy, Sidley Austin Brown and Wood, and former General Counsel, FDA
  • Dr. Michael Greve, The American Enterprise Institute
  • Prof. Peter Hammer, Wayne State University Law School
  • Prof. Lars Noah, University of Florida, Fredric G. Levin College of Law
  • Dean Bernard Dobranski, Ave Maria School of Law -- Moderator