Articles on Law, Science, and Engineering

Public Policy and the Preemption of State Tort Claims against Medical Device Manufacturers

by Edward P. Richards and Charles Walter, 15 IEEE Engineering in Medicine and Biology Magazine #1, pg. 121 (Jan/Feb 1996)

Introduction

In 1993, this column first discussed the theory that the Medical Device Amendments of 1976 (MDA) preempted state tort claims against medical device manufacturers.[1] Since that time, two things have happened that make it timely to revisit this issue. First, the medical device industry has been visited with the largest settlement in products liability history - the proposed settlement of the litigation over silicone breast implants. The size of this settlement alone would make it important. It especially frightening because it is in the face of substantial medical evidence that silicone poses no significant risk of injury.

The second factor is that in the last two years there has been an avalanche of cases involving claims that the MDA preempts state tort claims against medical device manufacturers. The courts reviewing these cases have not been able to agree over the scope of preemption under the MDA, so this dispute will go to the United State Supreme Court. This article discusses the policy behind preemption under the MDA and why the United State Supreme Court should resolve this dispute in favor of medical device manufacturers.

INDEX

• Medical Devices in Modern Medicine
• Standards for Medical Device Safety
• How does the Tort System Improve Safety?
• The Tort System Must Fail at Medical Device Regulation
• Why Not Treat Medical Devices the Same as Prescription Drugs?
• How are Medical Devices Different from Prescription Drugs?
• The Special Problems of Clinical Trials
• Preemption and Summary Judgment
• What about Compensating Plaintiffs?
• Conclusions