A liability framework for high-risk neural devices

High-risk medical devices are integral to modern health care, but unexpected adverse events from performance failures or malfunctions may leave patients irreversibly harmed. Consumers in the US who incur injuries from products can ordinarily seek relief under the product liability laws of their state. However, a 2008 US Supreme Court decision against patient complainants restricted this legal pathway, raising concerns of patient abandonment. With the emergence of implantable brain-computer interfaces (iBCIs) exposing vulnerable patients to a new suite of unknowns and potential physical and neurocognitive impacts, policy-makers must revisit the commitment to justice at the forefront of innovation. Focusing on the case example of intracranial neurotechnology, we describe a no-fault compensation scheme that may offer relief to injured patients in the US. Its potential advantages may also hold relevance in countries where civil litigation remains the only pathway to patient recourse.