As companies such as Elon Musk's Neuralink begin human trials of high-risk brain implants, a new proposal calls for a major change in how the U.S. handles injuries caused by the devices.
The article published today in Science suggests a "no-fault" compensation program to help patients harmed by devices like brain-computer interfaces (BCIs)—even when no one is legally at fault.
These devices, which are implanted in the brain to treat serious conditions like epilepsy or paralysis, can offer life-changing benefits. But they also come with serious risks such as seizures, strokes or even death. And when something goes wrong, patients often have no way to get help or compensation.
"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." said senior author Dr. Judy Illes, a professor of neurology whose UBC team collaborated on the proposal with Dr. Zelma Kiss at the University of Calgary.
A legal gap that leaves patients behind
The problem began in 2008, when the U.S. Supreme Court ruled that patients couldn't sue device makers if the product had been approved by the Food and Drug Administration (FDA). That decision, known as Riegel v. Medtronic , made it nearly impossible for patients to win lawsuits—even when they were seriously harmed.
Since then, most legal cases involving high-risk devices have been dismissed. According to the article, only 12 per cent of such cases favoured the patient. That means many people who suffer injuries from these devices are left to deal with the consequences on their own.
A new way forward
To fix this, the researchers propose system that would allow injured patients to receive money for medical bills, lost wages and other costs without having to prove that anyone did anything wrong.
This kind of system already exists for vaccine injuries in the U.S. and for medical injuries in countries like New Zealand. The idea is to make the process faster, fairer and less stressful for patients.
"Instead of fighting in court, patients could focus on healing," said Dr. Illes. "And companies could keep innovating without the fear of being sued for every unexpected outcome."
How it would work
The plan would be funded by contributions from device manufacturers, with help from the government for smaller companies. Patients who suffer serious, long-term harm—like brain damage caused by a device moving inside the skull—would be automatically eligible for compensation.
The system would also include expert panels to review more complicated cases. And unlike the vaccine program, it would still allow patients to go to court if they choose.
Balancing innovation and justice
The researchers say this approach would protect patients while still encouraging new medical breakthroughs. It would also help keep clinical trials going by giving volunteers peace of mind.
"People are excited about the future of brain technology," said Dr. Kiss. "But we can't ignore the risks. We need to make sure that when things go wrong, we don't leave people behind."
Neuralink and Synchron are just two examples of companies that have recently begun human clinical trials of these devices. As the technologies become more common, the need for fair and reliable patient protections is more urgent than ever.
