This Is Your Products Liability Restatement on Drugs

Lars Noah, University of Florida Levin College of Law


Lawsuits against the manufacturers of drugs and medical devices have become increasingly important in the last few decades, both in their volume and in the conceptual challenges that they have presented, and courts have created a variety of special rules to accommodate products liability litigation against the sellers of medical technologies. The work of the American Law Institute (ALI) has played an important role in this process, though so far the special provisions of the Products Liability Restatement applicable to prescription drugs and devices have had little discernable impact. These provisions have, however, provoked a great deal of scholarly commentary, and the few courts to consider the issue have uncritically relied upon the published critiques. As explained at length herein, I find little merit in most of these negative assessments, though I point out a number of flaws, ambiguities, and arguable inconsistencies in the new Restatement's special provisions that seemingly no one else has identified.

This Article attempts to offer a comprehensive evaluation of the various facets of the Products Liability Restatement that relate to medical technologies, and it does so from a perspective rooted in the regulatory as opposed to the doctrinal challenges posed by these products. Part II addresses production defects, focusing on the heated debate over what standards to use in deciding whether a prescription drug suffers from a defective design. Part III considers defects related to the information that accompanies prescription drugs, especially those advertised directly to consumers. Finally, Part IV touches on some of the peculiar issues raised by investigational products, generic drugs, prescription medical devices, and the duties of non-manufacturing sellers.