Medical Device Product Liability Defense: Unavoidably Unsafe Product
In numerous medical device product liability cases, the defense of an “unavoidably unsafe product” has been raised. This defense typically applies to products that may be inherently hazardous but offer substantial benefits. But who decides what qualifies as inherently dangerous? And who determines whether the benefits of the device outweigh the risks?
Manufacturer Liability for Medical Device Defective Products: When Are Companies Held Accountable?
Manufacturers are liable for injuries caused by defective products, even if they were not used negligently. A manufacturer can be held accountable if a product is defectively designed, manufactured, or lacks adequate warnings, making it unreasonably dangerous to consumers. However, in the U.S. Supreme Court case concerning the Restatement (Second) of Torts (Section 402A, Comment k), for products that are inherently dangerous and unavoidably unsafe, the manufacturer may not be strictly liable if the benefits of the product outweigh the risks. This exception is especially relevant for medical devices, where risks cannot be entirely eliminated but are justified by the product’s societal value—such as life-saving or life-sustaining devices, or even a wheelchair—if it can be shown that the benefits significantly outweigh the potential risks.
In Riley v. Cordis Corporation (1995), a claim involving a defectively designed stent that caused injury was dismissed because the device was deemed “unavoidably unsafe.” The Nebraska Supreme Court ruled that the product was designed and manufactured in accordance with the current state of the art, that adequate warnings about the device’s risks were provided, and most importantly that the benefits of the product significantly outweighed the inherent risks to patients. This case emphasized the importance of demonstrating that manufacturers who follow industry standards, design products to minimize known risks, and provide clear warnings may not always be held liable for injuries caused by a medical device.
The Role of Medical Device Quality Expert Witness Services
Having a medical device expert witness with a strong background in risk management, particularly in the use of ISO 14971 (the international standard for risk management in medical devices), is crucial when utilizing this defense. ISO 14971 is internationally acknowledged and widely adopted in the industry, not only to fulfill regulatory requirements but also to ensure the safety of a medical device. The medical device expert witness can review the manufacturer’s risk management file to ensure elements of the standard have been appropriately applied, including:
- The risk management process has been followed
- Appropriate risk analysis has been carried out, including those involved with intended use and reasonably foreseeable misuse
- Risk analysis includes the identification of characteristics related to safety, hazards and hazardous situations that have been identified
- Risk has been appropriately estimated and evaluated
- Risk mitigation and controls have been identified and implemented
- Residual risk has been identified and evaluated
Looking Ahead: The Future of Medical Device Litigation
Most importantly, an independent medical device expert witness can help show that any benefit-risk assessments generated by the medical device manufacturer for any risks considered unacceptable speak to the intent of Restatement (Second) of Torts (Section 402A, Comment k). Enlisting an independent medical device risk management expert to help build your case could be key to winning and demonstrating that the manufacturer is not liable.
About The Author
Denise Holliday leads the medical device regulatory consulting division at Capwell Consulting Group. She offers strategic support and expert testimony for medical device litigation. Ms. Holliday is widely respected for her deep expertise in quality management systems, international regulatory compliance, and medical device risk management.
About Capwell Consulting Group
Capwell Consulting Group is a nationally recognized litigation support and risk mitigation consulting firm specializing in highly regulated industries. Our firm provides industry-leading guidance, research, reporting, and expert witness testimony for legal proceedings involving employment screening & negligent hiring, FCRA litigation, drug & alcohol testing, and medical device quality and regulatory compliance matters. With over three decades of industry experience, Capwell Consulting Group is a trusted advisor to employers, attorneys, and consumers around the globe.
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