- cross-posted to:
- science@beehaw.org
- cross-posted to:
- science@beehaw.org
A woman whose epilepsy was greatly improved by an experimental brain implant was devastated when, just two years after getting it, she was forced to have it removed due to the company that made it going bankrupt.
As the MIT Technology Review reports, an Australian woman named Rita Leggett who received an experimental seizure-tracking brain-computer interface (BCI) implant from the now-defunct company Neuravista in 2010 has become a stark example not only of the ways neurotech can help people, but also of the trauma of losing access to them when experiments end or companies go under.
As a nurse I find it very problematic that they could force her to have brain surgery to retrieve their property.
It might be understandable that they turn it off or stopp support, if it was experimental and the device didn’t pass the necessary aprovals.
But forcing her to have an invasive procedure on her brain with so many dangerous risks. This should be illegal.
Yeah theres a lot here that stinks, I’m going to have to find more sources on it.
This clearly violates informed consent, and a whole bunch of study related laws, and laws involving patient care and risks of invasive procedure.
She had to agree to the surgery to remove it at some point, and it could not have been in informed consent documentation, because she could have revoked that agreement before the surgery.
I doubt this story. I really doubt this.
However, I don’t know shit about fuck about Australian law.
One relevant detail is that this was not a self contained device, it was for monitoring likelihood of seizures and had an external wireless interface. So my guess (this is pure speculation) on what happened is, the company owned the monitoring device, and the signals from the in-brain device were proprietary and encrypted. They couldn’t force her to have surgery but they could take back the external interface which was their property, and without that the in-brain device did nothing. Then the patient agreed to surgery because there was no further benefit to keeping it in her head and probably greater health risks to doing so.
I’m sure if she revoked the informed consent they never would have done the implant to begin with. It’s an experimental procedure so you kind of need to agree to being expiramented on to participate.
You can revoke your informed consent agreement at any time, including after a study has concluded, though it doesn’t usually do you much good after it’s done. it specifically means that you no longer agree to understanding the risks and benefits.
I found a paper that someone wrote on the subject and it appears that the woman did consent to having it removed, though she ultimately did wish she could have kept it. From the OPs article, it sounds like she was forced to have the craniotomy against her will which isn’t the case.
https://www.brainstimjrnl.com/article/S1935-861X(23)01910-1/fulltext
That checks out. Thank you.
An awful lot of EULAs (software or otherwise) include odious clauses or terms easily misused. I daresay even most, since US and international contract law is heavily biased towards industrial corporations being permitted to include and enforce such terms.
Often, court cases are about arguing that a clause in question is, in fact, odious and unenforceable without causing undue suffering.
If the patient dies or suffers permanent health effects from the extraction surgery, I anticipate a wrongful death lawsuit may well follow.
Such EULAs are often pointless in Australia, and she is Australian, as it is impossible for an Australian to sign away any of their rights.
I mean if she agreed to it by contract there’s not much to argue.
You can’t just put anything in a contract and say you can’t argue it.
You can. They can do the surgery or they can be sued, it’s a binary choice.
Morals are a different story but legally no, it’s quite clear and arbitration agreements are pretty literally sections of contracts that say you can’t argue certain things in certain ways.
No, you can’t. A contract doesn’t magically supersede law. For instance, you can’t sign a contract saying I can murder you.
And arbitration clauses are not magical statements either. They’re enabled and restricted by law. It’s not even settled law. You have California trying to ban them and lots of courts ruling on various points and exceptions of the law.
No that’s what severance clauses are for. Anything not legal can’t be enforced but the contract minus those sections stands. Similarly she was not forced to have the surgery in any way at all. She has to return the device that she agreed to return, the surgery was optional.
They sorta are though boss and this wasn’t in California iirc.
Ed:
The ai wasn’t supported any longer and both external and internal devices were no longer useful. Whoever buys the company would be buying the ai and the rights to the device, at that point they could have restored the device if the electrodes weren’t removed. It seems they’re quite confident that wouldn’t happen anytime soon and so opted to have the electrodes removed.