No-Fault (Strict) Liability for Injuries From Innovative Treatments: Fairness or Also Efficiency
Law, Innovation and Technology, Forthcoming
29 Pages Posted: 16 Dec 2018
Date Written: 2018
Innovative treatments (ITs) have a distinct SIROT pattern: they often show, and are expected to show, significantly improved results over time. Of the four IT categories discussed, two stand out: SIROT treatments which are currently not in the patient’s best interest (BI) but will become superior treatment over time (category 3), and treatments which are already arguably BI but will clearly become the superior option as they improve with time (category 2).
There is a strong fairness argument to compensate patients injured from ITs because their injury led to improved knowledge benefitting future patients. By analogy to private necessity, IT patients should be considered ‘rescuers’ entitled to costs reimbursement, since future patients receive an incontrovertible benefit inextricably linked to their loss. Crucially, category 2 patients also deserve compensation, notwithstanding that their treatment was BI.
From an efficiency perspective, patients should avoid only irresponsible ITs (category 4) but they are not well-placed to identify such treatments. Patients’ incentives to submit to ITs are no worse, and perhaps slightly improve under strict liability (SL): SL might incentivise patients to undergo a treatment whose prospect as BI is in doubt but is likely to be SIROT. Finally, while under SL (but not negligence) category 2 cases yield liability, which may deter physicians from offering ITs, reputation loss under SL is lessened, so physicians’ incentives may improve (and they also have strong non-legal incentives to offer ITs).
Keywords: negligence, restitution, rescue, private necessity, clinical research
Suggested Citation: Suggested Citation