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In Reply: Dr Piwinski and Mr Fitzpatrick offer a strong critique of tort litigation but missed the central point of the Commentary. My goal was not to advocate for tort litigation, as I recognize the costs of litigation as well as benefits.¹ Rather, I advocate for the maximization of patient safety within the existing legal system. Ideally, the FDA would have the powers and resources to conduct thorough and systematic evaluations of pharmaceuticals and medical devices for FDA approval and postmarket surveillance. The main point of my Commentary was that Congress (1) has not given the FDA these powers and resources and (2) has not displaced the protections provided by the civil justice system, which complement rather than frustrate the current limited federal protections. Thus, the Supreme Court's decision in Riegel v Medtronic, Inc not only severely compromises patient safety; it does so based on an erroneous interpretation of congressional . . . [Full Text of this Article]

Lawrence O. Gostin, JD
gostin@law.georgetown.edu
O’Neill Institute for National and Global Health Law
Georgetown University
Washington, DC

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RELATED LETTER

Tort Litigation and Federal Regulation of Medical Devices
Stephen Piwinski and Shawn Fitzpatrick
JAMA. 2008;300(16):1881-1882.
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