Shane Katz explores liability, consent, access, and the future of brain implants
This article was produced in partnership with Singer Kwinter
On Aug. 27 and Sept. 3, two Canadian patients with spinal cord injuries became the first in the country to receive Elon Musk’s Neuralink wireless brain chip implants. As part of the first clinical trial outside of the United States, electrodes were inserted into the motor areas of their brains. Other companies, such as New York-based Synchron, are also conducting clinical trials with brain-computer interface (BCI) devices.
The rapid advancement of these technologies offers new hope for people living with life-altering spinal cord injuries. For personal injury lawyers who work with clients who have often lost the use of their extremities, the potential is especially exciting.
“If it works, it’s wonderful in terms of giving people back some independence, control, and quality of life,” says Shane Katz, personal injury lawyer at Singer Kwinter. “It’s important that companies are encouraged to develop products that do that for seriously injured people. But if someone suffers significant harm through negligence, they’re entitled to pursue compensation for it — and our role in that as personal injury lawyers remains unchanged.”
Balancing hope and risk: The personal injury lawyer’s role
As hopeful as these advancements are, they are not without risk. As with any new medical technology, there’s the potential for complications. Should any arise, personal injury lawyers will be at the forefront of addressing the legal implications and advocating for those affected.
While lawyers can apply proven tools from medical malpractice and product liability cases, Katz warns there’s still an element of unchartered territory — and many avenues could potentially be pursued if something goes wrong with this type of product.
First is the liability aspect. Implanting BCI devices like Neuralink requires highly skilled neurosurgeons — and finding qualified experts to speak to such a specialized area of medicine can be challenging. The procedure also may include the services of other health care providers who manage ongoing supervision, maintenance, and care of the patient.
If complications arise either during the implantation or later, determining responsibility becomes complex due to the interplay between medical malpractice and product liability. Injuries could stem from the device itself (raising product liability issues) or from how doctors implant or care for it (raising malpractice concerns). Like what the personal injury bar is grappling with when it comes to fully autonomous vehicles causing injuries, the potential for lawsuits against both medical professionals and device manufacturers is there.
“You're probably going to have to sue everybody and see how the case unfolds, similar to other malpractice situations where the doctor claims the medical device was the cause of the injury or the harm,” Katz explains.
Beyond the complexities of determining fault, another legal hurdle looms: the use of liability waivers. If something were to go wrong and the patient suffered significant harm, the question of whether such a waiver is enforceable becomes complicated. Waivers can be upheld by courts if they are explicitly and clearly articulated regarding the procedure and its potential risks. However, as established in Zaky v. 2285771 Ontario Inc., there are exceptions.
A waiver may not be enforceable if the principle of non est factum applies. Enforceability can also be challenged if the patient’s signature was induced by fraud or misrepresentation, or if the defendant (such as a doctor or clinic) knew or ought to have known that the patient did not intend to be bound by the waiver and therefore had a duty to bring its terms to the patient’s attention. These exceptions highlight the importance of transparency and clarity in the waiver process.
“If liability waivers are involved in the process of getting these electrodes, you must make sure the client fully understood they were giving up their legal rights to sue anyone involved in the process for any harm — that’s a big hurdle for the distributor and the doctors involved,” Katz says. “The language of the waver should be very clear and the risks of serious harm properly explained, especially regarding a very new technology like the Neuralink. The courts will enforce these waivers, but it must be reasonable.”
Access and affordability, the next frontier
While the legal side of the advent of BCI devices takes shape, another set of pressing questions remains. Even if these devices prove safe and effective after the clinical trials, will public health insurance or private insurers cover the costs, or will access be limited to those who can afford to pay out-of-pocket?
For many, the answers to these questions will determine whether the promise of restored independence can become a reality. Katz is interested to see how the cost of BCI devices will eventually be covered, noting it’s likely an expensive treatment given the brain surgery and technology involved.
Because Canada has a public health care system, whenever there are new healthcare initiatives the question of funding is always at the forefront. If somebody pursues this treatment after suffering injuries in a car accident, will their car insurance company pay for it? Will OHIP cover it? If somebody's negligence causes an injury and during the recovery phase, the plaintiff decides to get these electrodes, can the defendant be made to pay the cost of them through the negligence lawsuit?
“These considerations will need to be addressed so that the people who really need this technology to improve their quality of life can get it,” Katz says, adding that it’s part of his job to monitor developments that are meaningful to clients — and figure out a way to ensure it’s covered.
“It's important that a lawyer representing a seriously injured person who could benefit from this treatment look at all possible avenues for funding.”
Embrace innovation, ensure accountability
Katz is clear that the threat of legal action should not stifle progress but underscores that innovation and patient well-being must go hand in hand.
With a balanced approach that embraces innovation while ensuring accountability, personal injury lawyers are well-positioned to ensure that life-changing advances truly benefit those who need them most. That’s the core responsibility of those in this practice area, and it remains steadfast.
“When it comes to litigation, make sure you’re doing thorough initial investigations to make sure you have all proper and necessary parties involved in the claim,” Katz emphasizes. “Continue to apply the tools developed in the product liability and medical malpractice worlds to these new technologies. In short, cover all your bases: that won’t change here.”
