Imagine clicking through this website without lifting a finger. Moving a computer cursor with the brain alone was demonstrated in 2004, and even done wirelessly in 2021. But as high-risk medical devices advance, an unknown slate of adverse effects and potential injuries — and legal implications — may follow.
An article published in Science by UBC researchers at Neuroethics Canada proposes a no-fault compensation scheme in the face of injury. This allows patients to be compensated for their injuries while companies avoid lawsuits, preserving both innovation and justice.
Ari Rotenberg, UBC alum and first author on the paper, said he came across this topic by accident, as he was looking through medical device injury cases while putting together a search algorithm for cases of infringement.
“I found the pattern that, due to some rule that I had never heard of, virtually each of the examples I came across were decided in favour of the company rather than the injured patient,” Rotenberg said.
Brain-computer interfaces (BCIs) take signals from the brain, decode them and use that information to operate external technology. For patients with quadriplegia or amyotrophic lateral sclerosis — a disease that affects the neurons in the brain and spine, causing gradual loss of muscle movement — BCIs “restore, if not physical function, [then] a certain quality of life to patients who have these debilitating conditions,” said Rotenberg.
Neurotechnology is expanding, with the first non-US clinical trial for Neuralink’s wireless BCI chip having taken place recently in Canada. Policies on BCIs are in development, according to the Government of Canada.
Implantable BCIs fall under the category of high-risk medical devices, which are regulated by the Food and Drug Administration (FDA) in the US. Because of the Medical Device Amendments of 1976, lower levels of American government can’t have separate or additive regulations for medical devices.
This was the case in Riegel v. Medtronic, where Charles Riegel’s Medtronic balloon catheter ruptured in his coronary artery, leading to an emergency bypass surgery.
Riegel and his wife, Donna, sued medical device company Medtronic under New York’s common law, alleging negligent design, inadequate warnings and manufacturing defects. However, because the catheter had received proper approval from the FDA, the suit could not go forward because it relied on state law requirements that conflicted with federal approvals. The case was decided by the US Supreme Court.
“As long as the manufacturer abides by all federal laws, they cannot be held liable for these injuries,” said Rotenberg.
Rotenberg explained that the current US legal framework is tipped in favour of manufacturers. Patients must prove the device breaches federal law, which poses the obstacle of gathering information, let alone what information is accessible to the patient. Sixty-five per cent of decisions made during medical device lawsuits post-Riegel to April 2025 favoured manufacturers, while 12 per cent favoured complainants.
Rotenberg emphasized that American law doesn't encourage manufacturers to prioritize safety. “There's no real reason to go above and beyond the federal standards which are … minimum requirements. We would prefer if every manufacturer exceeded the basic standards for safety and effectiveness, but by taking away the private course of action, there are many fewer incentives,” he said.
The proposed no-fault compensation program is based on the US Vaccine Injury Compensation Program (VICP), developed in the 1980s in response to overwhelming lawsuits against vaccine companies. Some manufacturers stopped production, which created vaccine shortages and risked the nation’s health.
Under the VICP, instead of suing companies directly, individuals who believe they’ve been injured by a vaccine can file a petition with a special master in the US Court of Federal Claims. If their injury matches one on the VICP’s Vaccine Injury Table, then compensation is awarded, no lawsuit necessary.
A similar table would be curated in the proposed no-fault compensation program. Experts “who stay on top of the industry and who monitor trends in public health data about device injuries,” according to Rotenberg, would compile a list of injuries. If an injury fits the criteria in the table, the injured patient could avoid legal hurdles and receive compensation more efficiently.
Vaccine producers fund the VICP through a small internal tax on each dose, so they’re protected from runaway lawsuits and the supply of vaccines can remain stable. However, Rotenberg notes that the proposed model can’t work in the same way. “With these medical devices, you're making many fewer, and the production of each one is a lot more expensive, so an excise tax system or an excise tax model would just be a massive increase in the price of each single device.”
From there, the researchers take inspiration from the Price-Anderson Act of 1957, which requires nuclear facilities to have private insurance as a first recourse for accidental harm. If the costs exceed that, a second pool of operator-contributed funds makes up the rest.
The no-fault compensation program seeks to reverse the system so that the multi-funded pool is accessed first and risk-based private insurance is a secondary layer to keep industries accountable and increase capacity for payment. Rotenberg said that having a public pool as the first means of compensation can allow more government control over the technology, depending on which areas they subsidize.
“[This] would be helpful if there's a public health crisis and disease is important to treat, but the devices needed to treat it aren't particularly lucrative,” he said. “Subsidies would be able to change that by making it a much more attractive offer to innovate in a certain area.”
Potential concerns around the model are that innovation may be less incentivized and the public would still have to “shoulder the burden” of medical costs. “I would suggest that the public is already shouldering the burden, at least in the US, through Medicare, and Medicaid in Canada, through our public health system, which we pay into,” Rotenberg said. “Having it go through the manufacturers would [at least] have this semblance of accountability, instead of just the government and the taxpayer directly picking up the check.”
“Science and innovation … don't exist in a vacuum. And I think we need to be conscious about the levers and the incentives that drive this larger structure, not individual products or research programs,” said Rotenberg.
“What direction are we going in, and is it the right one?”
With files from Stuti Sheth
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