- 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.
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Oh great so even physical ownership doesn’t even mean you own something anymore
As much as I share this sentiment in general, in this case its probably more likely that this has something to with liability if something goes wrong with the implant. And I would bet the company never released the schematics and code so that aint helpin.
Could prob be solved if implants would be required to be open source so that third party servicing could happen.
Companies that aren’t actively using their IP should be forced to license it to someone who will, or put it in the public domain.
All of their code and specs should be required to be put into escrow in case they go out of business.
That doesn’t seem like the best idea with expiramental implants. I doubt anyone would want to take on the liability for some defunct company’s implant because there’s no upside for them to do so and a lot of downsides.
Doing stuff that makes peoples lives better with no short-term financial incentive? Sounds like a mission for public-funded institutions :)
There’s no real guarantee it’ll make her life better especially if it’s a 1 of 1 implant. They could just as easily try to control it and give her debilitating seizures because they have nothing to test on. I get the sentiment but I don’t think anybody would be willing to take on that risk.
As part of unwinding a company that is going out of business, they usually do sell off their IP. That doesn’t mean that anyone will continue this particular experiment.
The same rule applies to whenever they sell the IP to. Whoever buys the IP should be legally obligated to continue the experiment as a condition of buying it. The alternative—putting the IP in the public domain—doesn’t do a lot for people who need active, ongoing support for a medical device, implanted in their body. I’d make a separate, stricter rule for that case. I don’t have a clear idea what that rule should be, though, because we can’t require a medical experiment to continue indefinitely if we want anyone to develop new medical devices.
If you start adding on mandates to the IP like that, that severely narrows the list of companies that are even capable of buying it. They have to have employees with knowledge of the specific device, which only a small number of people may be using.
Liability could be easily signed away by the patient if she felt that leaving it was a better option. And she/the family can’t sue if the removal makes things worse now, because the company won’t exist. Seems leaving it in was a better risk.
I can’t believe they did a surgery on her without already giving her this option. This is basic bodily autonomy human rights stuff, doctors are not going to do any surgery on a human being because a third party asked them to, and the patient didn’t consent. It’s not something that happens outside of Nazi Germany, with exceptions only in the case where a person’s advance directives are activated; or they are completely incapacitated with no AD.
I suspect they told her the risk of the device killing her or making her life worse was either extremely high, or impossible to judge, and she made the decision on her own to get rid of it. To be clear this is a travesty, and the people running the responsible company should face severe consequences, but I think we’re going off the deep end if anyone believes she was not given an option in this matter. Doctors will straight up leave stuff in you that will kill you if they can’t obtain your consent to fix it.
I suspect they told her the risk of the device killing her or making her life worse was either extremely high, or impossible to judge, and she made the decision on her own to get rid of it.
I also think this was probably what happened, although the article isn’t clear.
To be clear this is a travesty, and the people running the responsible company should face severe consequences
Why do you think so? There’s nothing special about making brain implants which protects a company from going bankrupt. The bankrupt company can neither continue to service the implant nor legally give her the ability to service it herself even if they wanted to.
The FDA won’t let a company that makes medical devices provide anything to patients without proving that it’s safe first. There’s no exception for patients willing to take that risk except in the context of clinical trials that are regulated very strictly. Letting this woman service her own brain implant isn’t just missing official proof of safety; it almost certainly isn’t actually safe.
Letting this woman service her own brain implant isn’t just missing official proof of safety; it almost certainly isn’t actually safe.
This is exactly the point; when this was a clear possibility that there would be no other option for her, they shouldn’t have been able to put the device in a person in the first place.
But there’s always going to be the possibility of that. No company can guarantee that it won’t go bankrupt for at least several decades.
(Plus, it sounds like this woman is better off having the implant and then losing it than she would have been if she never had it.)
I am guessing/hoping that the device needed maintenance and since nobody can maintain it, it’s removed for safety reasons. I think They wouldn’t perform surgery without such a safety need.
The BEST timeline.
Sounds like she was in a trial so probably didn’t pay for it and doesn’t own it.
It’s still kind of fucked up that she has to have surgery to remove it but she probably agreed to these terms before it was installed.
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It must suck to have that confidence, and therefore freedom, taken away.
It does, yeah.
Thanks for the comment, I was sitting here shitting, thinking how exactly did a company force someone to have brain surgery. Very sensationalist indeed.
Did you read it?
She and her husband attempted to fight the demand, attempting to buy the implant outright and, as University of Tasmania ethicist and paper coauthor Frederic Gilbert told the Tech Review, remortgaging their house to do so. They were unsuccessful, and she was the last person to get the Neuravista BCI removed.
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.
arbitration agreements are pretty literally sections of contracts that say you can’t argue certain things in certain ways.
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:
But it wasn’t to last. In 2013, NeuroVista, the company that made the device, essentially ran out of money. The trial participants were advised to have their implants removed. (The company itself no longer exists.)
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.
She and her husband attempted to fight the demand, attempting to buy the implant outright…
It was compulsory brain surgery for a repo.
In other words the company interests superceded the patient’s
This is the sort of inciting incident that triggers cyberpunk dystopian adventures that conclude in a blaze of electrical grid collapses, warehouse explosions and mass spiritual awakening. Then the protagonist moves to Amsterdam.
It was compulsory brain surgery for a repo. … This is the sort of inciting incident that triggers cyberpunk dystopian adventures
That was my first thought as well. Glad to see it posted, because it’s sort of a niche cult classic.
I still can’t believe how good it is.
Paris Hilton is a good actress in this film.
Fuckin’ wild.
Fingers crossed this woman doesn’t end up with a Zydrate addiction. It comes in a little glass vial, you know.
A little glass vial?
A little glass vial.
Reminds me of repo, the generic opera.
I feel like maybe research on medical implants like this should be done by the state.
At least, when the company goes defunct, they should be forced to sell it to a company that’s required to maintain the upkeep for products using the IP they bought or the government should eminent domain
So should a lot of research, for public benefit. Medical absolutely, space absolutely.
The problem with that model is no one acquires immoral levels of wealth, which means those that set policy don’t get as large of bribes.
And as a species, our actions have spoken on no uncertain terms, we’d literally rather destroy our only habitat and ourselves then let go of the dream of living like modern Pharoahs on the backs of others.
You’re not wrong, and I hate that about your comment.
Take your upvote and go.
What could possibly go wrong with your idea
It got us to the moon.
Then we decided to sell off our society for private profit under the lie that we’d all benefit.
Biggest reason this country has gotten this cartoonishly shitty, why our commons like bridges are literally collapsing.
Public research was slower and more considered, as it didn’t have the very unscientific sole goal of “how do we monetize this half-baked discovery NOW?!” with no other consideration let alone to societal consequences, but publically funded research yielded social benefits we all reaped through the commons. Reckless growth/metastasis for private profit is giving us technologies that make us miserable and that only truly benefit private shareholders at our expense. Plus you know, the whole reverse terraforming our only world against us, again for short term private profit.
OK, good point. Research yes. Somebody still needs to control and manage the things. That concerns me. I’m not imagining a medical /brain implant version of nasa. My problem is when politicians start imposing politics to the situation. I don’t want the governments or private companies dicking around in my brain imposing fad or outrage of the day changes. Standards good, control, not so good.
For-Profit Medical Corporations would miss out on some lowest effort, unethical, low margins for their extreme profiteering opportunities?
I’m kind of in that boat. I mean not really, and it’s not life-changing like it is for the lady, but it’s the same sort of issue.
I have implants inside of me. They’re RFID and NFC transponders of various kind made by Dangerous Things. They’re not essential to my life in the sense that I could very well do without them, but they’re immensely useful and handy on a day-to-day basis.
One of them is a payment implant. The implant was made in 2020 and is not in fact allowed by Mastercard - meaning if the payment processor figures out it’s under my skin, they’ll strike it off the EMVCo network and I’ll lose the ability to make payments with my hand. It expires in 2029, and I already know after that date that there probably won’t be a replacement available. So I will lose that ability in 2029.
And you know what? It really does feel like a loss: this is my second payment implant because the first one failed a year in, and that’s what it felt like. Similarly, I have other implants that I use all the time to open doors and authenticate with online services, and when those fail (and some of them did, I had to have them replaced), it does feel like losing a bodily function too.
I’m an amputee, so I know what it feels like to lose bits of myself, and when one of my implant fails, it feels very similar. Not the same and not as terrible of course, but it’s the same kind of feeling: you feel less yourself and less able than you used to be.
The other question that arises is whether implants become part of your body, and whether anybody is legally allowed to take them away from you. In other words, nobody is legally allowed to remove your heart or your spleen without your consent, but are implants treated the same way?
Like for example, suppose I go to court and a judge reckons my cryptographic implant was used to encrypt evidence on my computer: can the judge order it removed from my body against my will to send it to a forensic lab? I mean after all, it’s now part of my body and providing me with a new bodily ability of sorts: it could be argued that removing my implant can be construed as disabling me - which, as I said, really does feel a bit like that.
This has never come up in court, and I’m an honest, nice guy so I won’t be the one breaking that particular ground. But the question is intriguing.
Liar. You’re not a dullard at all.
This is a fascinating perspective, thanks for sharing your experience. It makes me really happy to hear first hand how this new technology does improve quality of life for people.
Holy shit. What an amazing story you have. Have you written more in depth about your life and all these things?
On the bright side, she no longer has Johnny Silverhand living in her head and complaining about all her decisions.
The fun thing is that half the time Johnny complains, you gain approval with him anyway. He may bitch about you stopping to save random folks and talk about how it won’t actually change anything, but he still approves deep down. He also approves if you call him on his bullshit, which is a nice change from most RPGs requiring you to be absurdly supportive of your party’s awful decisions to top off that approval meter.
WaKe Up SaMuRaI
wait do you guys not have that?? i dont have johnny but it’s just whatever fictional thing im currently obsessed with /genq
Forced? What are the logistics there, what if she runs, and forcefully refuses? Are they going to literally get ppl to hunt her down and drag her to the operation room?
Even worse. They would sue the crap out of her.
The implant explodes if she goes too far from their base.
So the government can force you to go into surgery to remove something from your brain now?
It’s not the government though. It looks like the company.
This was a trial and the implant likely required to communicate with their servers and without them it wasn’t able to work.
The real issue is that probably anything that’s installed in humans needs to have schematics and software made public domain when company goes out of business so someone else could maintain it to avoid these issues.
Always could.
How though? The government literally couldn’t force people into getting a vaccine because that was too damaging for bodily autonomy. How is brain surgery in any way less invasive?
The article isn’t clear on if they didn’t have enough money to buy it or if the company refused for liability and safety reasons.
Regardless, we really need stringent laws about this. Anything needing surgery should irrevocably become yours, both hardware and software wise, and the company should be setting up trusts for maintenance in case of bankruptcy.
For instance if your hip implant manufacturer went out of business you wouldn’t expect them to come take your hip.
What should have happened it would have been regulatory capture where when they went out of business the government should have stepped in and taken their source code and made it public domain.
I’m sure some enterprising people would have been glad to host whatever servers were needed to keep this woman’s seizures from working and her brain implant operational.
I think the difference is likely that this is a trial. The woman likely didn’t pay for it, and they didn’t want her to because they don’t want anyone owning their tech while it’s being developed.
I mean yes but you also have to consider the face of it.
This whole thing is basically them saying sorry, we didn’t make 800 million dollars so we’re going to cut your head open and throw away what we find in there.
I don’t give a shit what the company wants or think it’s entitled to; the device was implanted inside a human body. That means the human it’s implanted in owns it, and fuck any psychopath who claims it could ever be otherwise!
That’s not what regulatory capture means. Regulatory capture is when the industry being regulated basically owns the agency writing and enforcing the regulation. Nothing they don’t want regulated gets regulated and they can use regulation to prevent new competitors. How the FAA in the US defers to airlines and airplane manufacturers is often used as an example.
Okay, so I used the wrong phrase but I think we all agree about the spirit of what I was attempting to communicate, right?
Yeah.
We need orphan technology program like for orphan drugs. I can’t imagine it would be very costly to keep this one woman’s device running, but it does take someone somewhere being responsible for it.
I expect it would in fact be hugely expensive to keep the woman’s implant going: anything medical is even more expensive that aeronautical stuff. And also, who bears responsibility when the company tanks and the woman has an issue with her implant?
But here’s what I think: innovative startups that want to run tests of experimental implants (looking at you Elon) should be legally required to set money aside to support the test subjects’ implanted hardware until the end of their natural life or until the implant fails, whichever comes first, if the company tanks.
The money should pay for a skeletal crew of the original engineers working for a government-owned company set up and dedicated solely to that support after the original company disappears, and it should pay for the test subjects’ medical expenses related to their implants.
But here’s what I think: innovative startups that want to run tests of experimental implants (looking at you Elon) should be legally required to set money aside to support the test subjects’ implanted hardware until the end of their natural life or until the implant fails, whichever comes first, if the company tanks.
I wouldn’t trust psychopaths like Elon to not try to make those shorter.
Anyone remember repo men? Getting a bit tired of fiction becoming reality…
Kinda similarly, my brother was taking a drug (interferon) for treatment of a rare cancer that not many people need anymore (a better drug replaced the main use case the drug was developed for, which is different from my brother’s use case). The manufacturer discontinued the drug and noone makes it anymore so my brother and others who were relying on it simply lost access. I never knew this could happen.
If a drug manufacturer stops making a drug they still have the patent for, they should be required to give up the patent; then ideally, the government (‘a Crown Corporation’ where I’m from) should start producing it
Repo man isn’t fiction.
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