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David Rosenberg & Adeyemi Adediran, Strengthening the Power of Healthcare Insurers to Regulate Medical Device Risks, in The Future of Medical Device Regulation: Innovation and Protection (I. Glenn Cohen, Timo Mindsen, W. Nicholson Price II, et al. eds., 2022).

Abstract: Relying chiefly on the combination of costly, unsystematic, and unreliable FDA monitoring and state negligence actions, the current postapproval system for controlling medical device risks falls far short of assuring optimal levels of safety. The reform proposal we advance comprehensively addresses these law enforcement deficiencies. The contemplated changes are straightforward and simple to implement yet would substantially reduce cost while increasing the effectiveness of both FDA monitoring and civil liability deterrence. Monitoring would be improved by requiring first-party insurers to investigate and report to the FDA the potential existence of a causal connection between the personal injury for which they are funding treatment and the patient’s (insured’s) use of or exposure to a medical device. The FDA would be authorized to enlist DOJ Civil Division enforcement of a federal cause-based strict liability action against the medical device manufacturer. The manufacturer would bear liability in full, with no reduction for risk contributions from the injured patient or other parties and would pay damages in total to the US Government. We explain the regulatory advantages of this new regulatory rule of cause-based strict liability relative to conventional rules of negligence and strict liability.