Daniel I Wolfson, Harel Deutsch, Christopher J DeWald, Ricardo B V Fontes, John E O'Toole, Vincent C Traynelis, Richard G Fessler
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引用次数: 0
Abstract
The 1990s pedicle screw litigation saga was a pivotal clash between medical innovation, regulatory oversight, and legal accountability. The controversy arose from the widespread use of pedicle screws, which became a standard practice despite lacking explicit Food and Drug Administration approval for spinal applications. This regulatory ambiguity was ignited by a 1993 ABC 20/20 segment that triggered an avalanche of mass tort litigation. This article dissects the landmark legal battle, analyzing the Food and Drug Administration's slow reclassification and the contrasting strategies of key industry players, AcroMed and Sofamor Danek. We evaluate the lasting impact on legal precedents, clinical practice around off-label use, and the regulatory pathways for new devices. This history offers a cautionary tale on the tension between legal accountability and innovation, with enduring relevance for today's debates on medical regulation and patient rights.
期刊介绍：
Neurosurgery, the official journal of the Congress of Neurological Surgeons, publishes research on clinical and experimental neurosurgery covering the very latest developments in science, technology, and medicine. For professionals aware of the rapid pace of developments in the field, this journal is nothing short of indispensable as the most complete window on the contemporary field of neurosurgery.
Neurosurgery is the fastest-growing journal in the field, with a worldwide reputation for reliable coverage delivered with a fresh and dynamic outlook.
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