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    Legal and Regulatory Aspects of Implant Performance and Failure

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    The present and future influences of products liability litigation and federal regulation in reducing risks stemming from the use of surgical implants are analyzed by focusing on the determination of the sources or causes of implant failure in addition to the mechanisms of failure. Where risk levels can be shown to be currently low, monitoring sources of failure rather than regulating by standards or premarket approval is recommended. Current trends in products liability litigation and federal regulation are reviewed and shown to reveal a tendency toward requiring a more open disclosure of source-of-failure information and also a tendency toward the development of performance standards for informational, as well as level-setting, purposes. A seriated trial format is proposed for use in products liability cases involving medical devices, both to increase the quality of litigation and to eliminate nonmeritorious negligence per se actions as well. The use of litigation results and field-failure experience in developing performance tests for hip nails is presented and shown to be useful in providing information to surgeons and in stimulating device improvements.


    implant materials, orthopedic implants, products liability litigation, FDA regulation, Medical Device Amendments of 1976, failure analysis, risk assessment, voluntary consensus standards, performance testing, hip nails, medical devices, medical malpractice litigation

    Author Information:

    Piehler, HR
    Professor, Carnegie-Mellon University, Pittsburgh, Pa

    Committee/Subcommittee: F04.19

    DOI: 10.1520/STP35953S