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Litigation, insurance, and implantable devices: good-bye progress
Medical Instrumentation
|March 1, 1982
Summary
Strict liability for defective product design shifts focus from negligence to foreseeability of misuse. This legal shift significantly increases product liability insurance costs, potentially limiting the development of new medical devices.
Area of Science:
- Medical Device Development
- Product Liability Law
Background:
- The legal landscape of product liability has evolved significantly.
- The shift from negligence to strict liability has altered manufacturer responsibilities.
Purpose of the Study:
- To analyze the impact of strict liability on product design and its associated costs.
- To explore the potential consequences for the development of new medical devices.
Main Methods:
- Legal analysis of product liability doctrines.
- Economic assessment of insurance cost trends.
Main Results:
- Strict liability mandates manufacturers design for intended use and foreseeable misuse.
- Increased prevalence of strict liability has led to dramatic rises in product liability insurance costs.
Conclusions:
- The rising costs associated with strict liability may deter innovation.
- Fewer implantable devices may be developed and marketed due to these economic pressures.