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Tort Litigation and Federal Regulation of Medical Devices—Reply

Tort Litigation and Federal Regulation of Medical Devices—Reply Letters Section Editor: Robert M. Golub, MD, Senior Editor. 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 intent. The overwhelming weight of evidence is that the FDA is a badly weakened agency and does not have the capacity to regulate effectively. This is a view shared by the Institute of Medicine as well as the FDA's own blue-ribbon panel.2,3 In fact, many of the recent high-visibility cases of safety concerns with pharmaceuticals and medical devices have been uncovered not by the agency but during the course of litigation. It is precisely because of the FDA's inability to ensure safety that it is vital to have a backup system through state tort law. This is particularly essential in cases where the manufacturer has concealed data that are indicative of safety problems. The Supreme Court has not merely constrained tort litigation but has virtually eliminated it with respect to medical devices. The court may well do the same for pharmaceuticals during its 2008-2009 term. That would leave injured patients without a remedy and effectively grant immunity to biomedical companies, even in cases where they failed to disclose safety hazards fully and fairly to the FDA, the physician, or the consumer. Piwinski and Fitzpatrick assert that tort actions “will keep the medical community hostage to the opinions of 12 individuals in any locale.” No state system permits juries to decide based on their opinions; rather, the judge determines the relevant law and instructs the jurors to apply it to the facts. The law requires consideration of society-wide impacts as well as the particular circumstances of the plaintiff's injury. This system provides the public with a safety net that is stable yet capable of responding to new, unnecessary threats to the public's health that the political branches have been unwilling or unable to address. Once the FDA has adequate powers and resources to safeguard the public's health and safety, there may be grounds for limiting industry liability, perhaps through a no-fault compensation system. But until that time, I believe that Congress should reverse the Supreme Court by making clear its intent not to interfere with the administration of justice at the state level. Back to top Article Information Financial Disclosures: None reported. References 1. Gostin LO. Public Health Law: Power, Duty, Restraint. 2nd ed. New York, NY: Milbank Memorial Fund and University of California Press; 2008 2. Institute of Medicine. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: National Academy Press; 2006 3. Food and Drug Administration Science Board. Science and Mission at Risk: Report of the Subcommittee on Science and Technology. Washington, DC: Food and Drug Administration; 2007 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 intent. The overwhelming weight of evidence is that the FDA is a badly weakened agency and does not have the capacity to regulate effectively. This is a view shared by the Institute of Medicine as well as the FDA's own blue-ribbon panel.2,3 In fact, many of the recent high-visibility cases of safety concerns with pharmaceuticals and medical devices have been uncovered not by the agency but during the course of litigation. It is precisely because of the FDA's inability to ensure safety that it is vital to have a backup system through state tort law. This is particularly essential in cases where the manufacturer has concealed data that are indicative of safety problems. The Supreme Court has not merely constrained tort litigation but has virtually eliminated it with respect to medical devices. The court may well do the same for pharmaceuticals during its 2008-2009 term. That would leave injured patients without a remedy and effectively grant immunity to biomedical companies, even in cases where they failed to disclose safety hazards fully and fairly to the FDA, the physician, or the consumer. Piwinski and Fitzpatrick assert that tort actions “will keep the medical community hostage to the opinions of 12 individuals in any locale.” No state system permits juries to decide based on their opinions; rather, the judge determines the relevant law and instructs the jurors to apply it to the facts. The law requires consideration of society-wide impacts as well as the particular circumstances of the plaintiff's injury. This system provides the public with a safety net that is stable yet capable of responding to new, unnecessary threats to the public's health that the political branches have been unwilling or unable to address. Once the FDA has adequate powers and resources to safeguard the public's health and safety, there may be grounds for limiting industry liability, perhaps through a no-fault compensation system. But until that time, I believe that Congress should reverse the Supreme Court by making clear its intent not to interfere with the administration of justice at the state level. Financial Disclosures: None reported. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

Tort Litigation and Federal Regulation of Medical Devices—Reply

JAMA , Volume 300 (16) – Oct 22, 2008

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Publisher
American Medical Association
Copyright
Copyright © 2008 American Medical Association. All Rights Reserved.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.2008.507
Publisher site
See Article on Publisher Site

Abstract

Letters Section Editor: Robert M. Golub, MD, Senior Editor. 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 intent. The overwhelming weight of evidence is that the FDA is a badly weakened agency and does not have the capacity to regulate effectively. This is a view shared by the Institute of Medicine as well as the FDA's own blue-ribbon panel.2,3 In fact, many of the recent high-visibility cases of safety concerns with pharmaceuticals and medical devices have been uncovered not by the agency but during the course of litigation. It is precisely because of the FDA's inability to ensure safety that it is vital to have a backup system through state tort law. This is particularly essential in cases where the manufacturer has concealed data that are indicative of safety problems. The Supreme Court has not merely constrained tort litigation but has virtually eliminated it with respect to medical devices. The court may well do the same for pharmaceuticals during its 2008-2009 term. That would leave injured patients without a remedy and effectively grant immunity to biomedical companies, even in cases where they failed to disclose safety hazards fully and fairly to the FDA, the physician, or the consumer. Piwinski and Fitzpatrick assert that tort actions “will keep the medical community hostage to the opinions of 12 individuals in any locale.” No state system permits juries to decide based on their opinions; rather, the judge determines the relevant law and instructs the jurors to apply it to the facts. The law requires consideration of society-wide impacts as well as the particular circumstances of the plaintiff's injury. This system provides the public with a safety net that is stable yet capable of responding to new, unnecessary threats to the public's health that the political branches have been unwilling or unable to address. Once the FDA has adequate powers and resources to safeguard the public's health and safety, there may be grounds for limiting industry liability, perhaps through a no-fault compensation system. But until that time, I believe that Congress should reverse the Supreme Court by making clear its intent not to interfere with the administration of justice at the state level. Back to top Article Information Financial Disclosures: None reported. References 1. Gostin LO. Public Health Law: Power, Duty, Restraint. 2nd ed. New York, NY: Milbank Memorial Fund and University of California Press; 2008 2. Institute of Medicine. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: National Academy Press; 2006 3. Food and Drug Administration Science Board. Science and Mission at Risk: Report of the Subcommittee on Science and Technology. Washington, DC: Food and Drug Administration; 2007 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 intent. The overwhelming weight of evidence is that the FDA is a badly weakened agency and does not have the capacity to regulate effectively. This is a view shared by the Institute of Medicine as well as the FDA's own blue-ribbon panel.2,3 In fact, many of the recent high-visibility cases of safety concerns with pharmaceuticals and medical devices have been uncovered not by the agency but during the course of litigation. It is precisely because of the FDA's inability to ensure safety that it is vital to have a backup system through state tort law. This is particularly essential in cases where the manufacturer has concealed data that are indicative of safety problems. The Supreme Court has not merely constrained tort litigation but has virtually eliminated it with respect to medical devices. The court may well do the same for pharmaceuticals during its 2008-2009 term. That would leave injured patients without a remedy and effectively grant immunity to biomedical companies, even in cases where they failed to disclose safety hazards fully and fairly to the FDA, the physician, or the consumer. Piwinski and Fitzpatrick assert that tort actions “will keep the medical community hostage to the opinions of 12 individuals in any locale.” No state system permits juries to decide based on their opinions; rather, the judge determines the relevant law and instructs the jurors to apply it to the facts. The law requires consideration of society-wide impacts as well as the particular circumstances of the plaintiff's injury. This system provides the public with a safety net that is stable yet capable of responding to new, unnecessary threats to the public's health that the political branches have been unwilling or unable to address. Once the FDA has adequate powers and resources to safeguard the public's health and safety, there may be grounds for limiting industry liability, perhaps through a no-fault compensation system. But until that time, I believe that Congress should reverse the Supreme Court by making clear its intent not to interfere with the administration of justice at the state level. Financial Disclosures: None reported.

Journal

JAMAAmerican Medical Association

Published: Oct 22, 2008

References