The Bionic Plaintiff and the Cyborg Defendant: Liability in the Age of Brain-to- Computer Interface
43 Pages Posted: 1 Jul 2021
Date Written: June 18, 2021
Human-enhancing devices via machine interface are rapidly approaching mass marketability. These devices include, for example, exoskeletons that allow functionality for those neurologically impaired are powered hydraulically, mechanically, or electrically. Newer devices, recently approved by the FDA, power such devices via brain waves transmuted into electrical signals. This Brain to Computer Interface (BCI) technology has been utilized in advanced designs, such as controlling a stylus or robotic arms, and more mundane contraptions, such as wheelchairs, via brain waves signaling intention. All are governed under Class II FDA designation for devices posing low and moderate risks.
Of concern are studies that have recorded the existence of a readiness potential that precedes brainwaves involved in conscious movement, recordable shortly before intent to move -- or even awareness of such intent -- is acknowledged by the user. This raises the question regarding whether BCI technology can mobilize devices based on unconscious or subconscious thoughts – creating the possibility of “unintended” harm, calling into question the legal definition of “intent” needed to prove assault and battery. The BCI devices also render it nearly impossible to divine relative contribution of fault in the event of an accident: was it due to the intent (conscious or not) of the user- or product malfunction, the subject, perhaps, of a product liability suit against the manufacturer? It appears the technology is poised to throw the tort system into disarray.
Here I postulate that FDA Class III regulation is warranted for BCI devices. This would assure greater oversight and protection – not just for the user- but for bystanders and the public at large for devices allowing remote movements engineered by pure thought. I further suggest that enhanced testing is warranted – and that failure to pursue such testing might render the manufacturer liable in tort breaching pre-emption bars, thereby furnishing double protection: deterrence via lawsuit, plus FDA oversight. This double protection, I suggest, is warranted in such potentially dangerous situations. Finally, I highlight the difficulties in assessing fault and recklessness in law when actions are committed without full awareness.
Keywords: wheelchair, exoskeleton, cyborg, bionic, bci, brain to computer interface, brain to brain interface, intent, tort, negligence, recklessness, FDA, preemption, Class II, Class III, public health
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