New plan could aid injured brain implant patients
Patients harmed by high-risk brain implants could receive automatic compensation under a new proposal aimed at protecting those taking part in experimental trials.
The scheme would introduce a “no-fault” compensation model for people fitted with brain-computer interfaces (BCIs) – devices implanted in the brain to treat conditions such as epilepsy or paralysis.
BCIs may offer life-changing benefits, but they also carry serious risks including seizures, strokes or death. When complications arise, patients often have no route to compensation or legal support.
The proposed approach, published today, was developed by Dr Judy Illes, a professor of neurology at the University of British Columbia, in collaboration with Dr Zelma Kiss at the University of Calgary.
Dr Illes said: “People who agree to try these devices are often out of options. They’re brave, they’re hopeful and they deserve a safety net if things don’t go as planned.”
Legal protections for device manufacturers were expanded in 2008, when the US Supreme Court ruled in Riegel v. Medtronic that patients could not sue for injuries caused by devices approved by the Food and Drug Administration.
Since that decision, most lawsuits involving high-risk implants have been dismissed.
According to the article, only 12 per cent of such cases have favoured the patient, leaving many individuals to deal with the consequences of serious harm on their own.
The researchers propose a system modelled on existing compensation programmes – such as those for vaccine injuries in the US and medical injuries in New Zealand – that would provide timely, accessible support without requiring proof of negligence.
Dr Illes said: “Instead of fighting in court, patients could focus on healing.
“And companies could keep innovating without the fear of being sued for every unexpected outcome.”
The proposed scheme would be funded by contributions from device manufacturers, with smaller companies receiving government support.
Patients who suffer serious, long-term harm – such as brain damage caused by a device moving inside the skull – would automatically qualify for compensation.
An expert panel would review complex cases.
Unlike the vaccine programme in the US, patients would retain the right to pursue legal action if they wished.
The researchers argue this approach would protect patients while encouraging medical innovation, and also help sustain clinical trials by offering reassurance to participants.
Dr Kiss said: “People are excited about the future of brain technology.
“But we can’t ignore the risks. We need to make sure that when things go wrong, we don’t leave people behind.”
Companies including Neuralink and Synchron have recently begun human clinical trials of BCIs.
