Supreme Court to Confront FDA Pre-emption and the Consequences of 'Overwarning'

In 2008, the U.S. Supreme Court will likely decide a key question that has driven FDA pre-emption debates over the past decade: whether ' as plaintiffs' counsel maintain ' warning labels for FDA-approved drugs and medical devices provide only 'minimum standards,' or whether ' as the FDA insists ' they provide a balanced judgment of the FDA, setting both a floor and a ceiling on safety warnings. This article reviews the legal issues facing the Court in a series of FDA pre-emption cases before it. It then discusses the central flaw in plaintiffs' 'minimum standards' argument, drawing on a series of recent scientific and medical developments that highlight how 'overwarnings' can have significant, real-world, adverse consequences with respect to public health.