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The liabilities and consequences of medical device development
Journal of Biomedical Materials Research
|April 1, 1987
Summary
Medical product manufacturers face increasing litigation. Implementing robust product safety programs can significantly reduce liability risks and ensure product quality, safety, and reliability.
Area of Science:
- Medical Device Law
- Product Liability
- Biomaterials Science
Background:
- Medical product liability litigation has surged over the last 40 years, targeting drug and device manufacturers.
- The medical technology and chemical industries are frequent targets.
- Juries often have lower tolerance for product failure rates compared to healthcare professionals.
Purpose of the Study:
- To analyze the impact of increased medical product liability litigation on manufacturers.
- To identify strategies for manufacturers to mitigate product liability risks.
- To emphasize the importance of product safety programs.
Main Methods:
- Review of legal trends in medical product liability.
- Analysis of factors contributing to litigation.
- Examination of manufacturer control over product quality and safety.
Main Results:
- Litigation flood impacts drug and device manufacturers significantly.
- High litigation costs and damage awards can force products off the market.
- Product safety programs are key to reducing manufacturer liability.
Conclusions:
- Manufacturers can substantially decrease product liability exposure through effective safety programs.
- Control over design, testing, manufacturing, and labeling is crucial.
- Prioritizing quality, safety, and reliability is essential for market sustainability.