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[20200319_040606 UTC Updated: Editor's note: The original story was updated subsequent to this story submission; an excerpt from the original submission appears here in a <spoiler> followed by the update. --martyb]
A medical device manufacturer has threatened to sue a group of volunteers in Italy that 3D printed a valve used for life-saving coronavirus treatments. The valve typically costs about $11,000 from the medical device manufacturer, but the volunteers were able to print replicas for about $1 (link to a TechDirt piece).
Basically, in Italy battling the wuflu epidemic, a hospital ran out of valve parts used in a treatment equipment, but the supplier weren't able to supply them. So the doctors got the local media to sound out for alternative solutions, and a 3d printing outfit stepped up. They all banged their heads together to produce the needed parts, enabling the hospital to continue treating patients.
The printed parts work to the degree they do, but it would be better to have the part's blueprint with precise specs so the printed parts can fit and function properly. So the 3d printing outfit asked the manufacturer for the blueprint. The manufacturer refused and threatened to sue the 3d printing outfit.
Here are other links covering the story, including the techdirt piece mentioned above:
https://www.techdirt.com/articles/20200317/04381644114/volunteers-3d-print-unobtainable-11000-valve-1-to-keep-covid-19-patients-alive-original-manufacturer-threatens-to-sue.shtml
https://www.businessinsider.com/coronavirus-italian-hospital-3d-printed-breathing-valves-covid-19-patients-2020-3
https://metro.co.uk/2020/03/16/firm-refuses-give-blueprint-coronavirus-equipment-save-lives-12403815/
Update, March 18th 5:30PM ET: A group of Italian volunteers distributed 3D-printed versions of a vital medical device — but it doesn't appear that the original manufacturer threatened a legal crackdown. As we reported earlier, Cristian Fracassi and Alessandro Romaioli used their 3D printer to create unofficial copies of a patented valve, which was in short supply at Italian hospitals. Business Insider Italia quoted Massimo Temporelli, the Italian professor who recruited the pair, saying that the device maker threatened them with an infringement claim.
But in an interview with The Verge, Romaioli denied they'd received threats. He said the company had simply refused to release design files, forcing them to reverse-engineer the valve. "I talked to an operator who told me he couldn't give me the files, but after that we didn't receive anything from the original company — so I can assure you we didn't get any threat," he said. "They said they couldn't give us the file because it's company property, but that's all." While earlier reporting said the original valve cost over $10,000, Fracassi also told Fast Company that this number was inaccurate.
Temporelli gave The Verge a more ambiguous account of the call, which he says he wasn't directly involved in. "The group we asked for the files refused and said it was illegal" to copy the valves, he said. He stopped short of calling the statement a threat. "Let's say the risk to be sued exists since they bypassed a patent, but that's it."
Manufacturing company Intersurgical says it had no intention of making a threat. Managing director Charles Bellm issued a statement to The Verge:
Just to confirm that recent reports from Italy are totally incorrect, we were contacted at the end of last week for manufacturing details of a valve accessory but could not supply these due to medical manufacturing regulations, we have categorically not threatened to sue anyone involved. The valve is an accessory supplied as part of a CPAP Hood system which alone costs a few euros.
Our Italian company has been doing their utmost to supply the hospitals at this time and have been supplying these free of charge in many cases to use with the CPAP Hoods. It is very disappointing that in the current climate this incorrect information is circulating, our focus as a company is to be able to supply the hospitals that require these and many other vital products and we are making every effort to ensure we can do so.
Romaioli and Temporelli have emphasized that both devices serve a purpose: the official product is the better long-term solution, but for now, hospitals can use this printed alternative to fulfill a sudden, drastic demand.
This story, in Italian, has a picture of the part in question: https://it.businessinsider.com/coronavirus-manca-la-valvola-per-uno-strumento-di-rianimazione-e-noi-la-stampiamo-in-3d-accade-nellospedale-di-chiari-brescia/.
(Score: 0) by Anonymous Coward on Thursday March 19 2020, @03:20AM (8 children)
I am the AC submitting the story.
I suggest you lot read the original submission. And I noticed the update, so I was about to add the summary of the update:
Now, read this posted summary. I can't even tell what the fuck it is talking about.
I realize this venture is a volunteer effort, but for fuck's sake, we should be able to recruit some semi-literate talents?
(Score: 2, Insightful) by Anonymous Coward on Thursday March 19 2020, @03:27AM (2 children)
Are you volunteering?
(Score: 0) by Anonymous Coward on Thursday March 19 2020, @03:44AM (1 child)
Good point. And I might if I get sober. But are you rooting for this kinda "editing?"
(Score: 2) by NickM on Thursday March 19 2020, @03:52AM
I foot for almost every kind of error¹ , the more the merrier 🦄
1- I practice segregation against factuals errors, those are bad and they should use a separate bus!
I a master of typographic, grammatical and miscellaneous errors !
(Score: 0) by Anonymous Coward on Thursday March 19 2020, @03:55AM (1 child)
Seems pretty straightforward to me. I'm not sure what the issue is.
(Score: 0) by Anonymous Coward on Thursday March 19 2020, @04:04AM
I give the editors for checking the links, the update, and reflect that in the post. I give props for that.
(Score: 2) by martyb on Thursday March 19 2020, @04:03AM (2 children)
Try as I may, I cannot read what you were "about to add".
As we always endeavor to do, I read the linked story. The update at the top of that story was almost entirely opposite to the thrust of the submitted story. (They apparently updated it after the original submission — that happens surprisingly often!) I retained part of the submission and used <del> ... </del> to show context that was being removed for what the retraction (which followed) was about.
Secondly, below the <hr> horizontal rule, is a link to the original submission.
Thirdly, I suspect you may have not seen his comment, but one of our editors lives in a small town where the coronavirus has been detected. His age and his wife's medical condition (for which he is the primary provider), has utterly upset his schedule so be is basically on hiatus atm. That leaves two editors who are volunteering of their spare time to keep stories here 24/7. This is on top of another editor moving away and being unable to contribute as he previously did. So, what would once require 3-4 stories per day per editor has now worked up to being supported by essentially just two editors.
As it is, I am nearing the age where I should be watchful of the virus, and have underlying medical conditions so that makes it doubly so.
So, please forgive us for being human and occasionally making a mistake under the load. I would suggest that coming at us with all-barrels-blazing is... counter productive. "I noticed that these paragraphs got chopped out; I'm curious as to why and would you consider putting them back in?" That approach would go over much better and tend to be more successful.
If you thought the first line of this comment was a bit "snitty", then you have a feel for how your reply was taken.
That all said, I have looked back over the submission and updated the story to include two paragraphs that had been accidentally deleted beyond what I had intended.
Wit is intellect, dancing.
(Score: 0) by Anonymous Coward on Thursday March 19 2020, @04:19AM (1 child)
Forget the "two paragraphs." Let's recruit more editors. I would volunteer if I wasn't an alcoholic deadbeat. I am sure there are plenty talents, even among the loser crowd colloquially called "millenials."
(Score: 0) by Anonymous Coward on Thursday March 19 2020, @04:52AM
I would volunteer if I wasn't an alcoholic deadbeat.
Be my friend?... Godfather?
(Score: 3, Insightful) by Bot on Thursday March 19 2020, @11:39AM (2 children)
> but [manufacturer] could not supply these [blueprints to produce valves] due to medical manufacturing regulations
suuuure because you gonna get sued for that, breaching regulation to let a guy print a valve for people dying, I mean what if something goes wrong and the guy gets infected or worse, dies? errrr
who would have the courage to sue? oh wait we are talking about pharma...
Account abandoned.
(Score: 2) by bzipitidoo on Thursday March 19 2020, @04:57PM (1 child)
Yeah, the "it's against regulations" excuse. I noticed that too. They use that one a lot.
In the US, it's HIPAA that gets a great deal of unfair blame for why a medical provider can't do something. They think they can't tell a caller even very basic info like whether a person is in their facility, and is or is not conscious. HIPAA says no such thing. I checked.
The nursing home where my aunt is at was so obstructive and nasty, refusing to tell me anything whatsoever over the phone, that I feared they just might retaliate against me by hurting her. I don't check on her often, but still. They blamed HIPAA. They wouldn't accept my assurances that HIPAA does not forbid them from answering my questions, nor check for themselves, and became angry with me for arguing that point. They also said they couldn't tell anyone but family, as if I was not family. Didn't have a come back went I reminded them that nephews and nieces are family. Just shifted to another argument, next saying it was against company policy. After that call, I asked the police to do a welfare check, to put the nursing home on notice, as well as confirm that she was still there and doing okay. I also contacted the parent company, and in response they changed their policy to stop blaming HIPAA.
(Score: 2) by Bot on Friday March 20 2020, @02:23AM
Such things are beginning to happen here too. In a classic overton window scheme, the state is mediating family relationships. Red socialists, or righty socialists, doesn't matter, the trend continues. All a matter of control, as usual.
Account abandoned.
(Score: 2) by bzipitidoo on Thursday March 19 2020, @12:21PM (1 child)
The first version of this story that I saw was on another site, and it was the dramatized clickbait version that a lawsuit had been threatened. They compared the patent holder to Martin Shkreli of Big Pharma price gouging infamy. I believed it. Shame on the media for the misleading headline that fooled me and many others.
However, it was believable. The patent holder does have grounds to sue. That's not really their fault, and they said they weren't going to sue. If they didn't already know better than to try a lawsuit, they surely do now. It's the fault of our crazy patent system, and that's a problem.
Patent monopolies are too powerful. Patent holders should not have the right to ask for the moon, or the right to refuse to deal at any price whatsoever. Makes it too easy to bury a rival technology or price gouge. Perhaps what could help is a mechanism to determine a fair price, and force the patent holder to accept that price. If nothing else will do, patents have, I believe, been nationalized before.
One thing the patent holder could have done is share the blueprints. That's one of the points of the patent system. In exchange for sharing the details, the patent holder receives legal protection. If they won't share, they should not continue to receive legal protection for their patents.
And that's another problem with the whole idea of patents. People think engineering work is gold. Overvalue it significantly. Underestimate the ease with which most anything can be reverse engineered. The mere existence of a system for protecting inventions makes inventions seem more valuable than they really are. Copyright does the same with writing, and other forms of art. For example, I've gotten into it with a dentist's office over some forms. The jackasses had the original Word document right there on their computers, but somehow they just couldn't share that, oh no. Acted like they didn't understand what I was talking about when I asked for a means of filling in the form electronically. Would only give me a PDF that didn't have fillable entries. When I learned of the Word document in spite of their efforts to conceal its existence, and pressed them to give me that, they protested that other dentists might be able to copy their forms. Oh, the horror! As if the forms couldn't be easily reverse engineered anyway from the PDF. Might not get the fonts exactly correct down to the pixel level, but so what? That reluctance to share even such a trivial thing as a one page form, containing no engineering specs of any sort at all, is the kind of thinking that the patent system promotes, and why it should be changed. Or abolished. This, by the way, was the dentist's minions making that decision, not the dentist himself. He was busy. How very typical. I took my business elsewhere.
That the clickbait version was so believable is both an indictment of the patent system, and the greed of medical providers. Why would there be only two greedy price gouging presidents of medical providers, Martin Shkreli and Heather Bresch of $600 EpiPen infamy? Besides, we know Big Pharma is chock full of greed. Price gouging for medicine is everywhere. Those two cases are merely extremes.
(Score: 0) by Anonymous Coward on Thursday March 19 2020, @11:08PM
"Underestimate the ease with which most anything can be reverse engineered."
I think they underestimate the ease which which anything can be independently invented by others. Everyone thinks they're special and no one else is smart enough to come up with this great idea or design.
Where patents make sense is where expensive R&D is needed to make something.
(Score: 2) by nishi.b on Thursday March 19 2020, @12:37PM
I was wondering whether it would be possible to build a ventilator in case the number of available ones would be insufficient, even if it means using non-validated designs and materials, as I have an arduino with some sensors, motors and propellers.
Fortunately it seems more qualified people are designing solutions like that it we reach that stage:
https://www.theregister.co.uk/2020/03/18/diy_ventilator_shortage/ [theregister.co.uk]
https://www.dailymail.co.uk/sciencetech/article-8127281/Engineers-develop-share-open-source-designs-DIY-ventilators.html [dailymail.co.uk]
https://interestingengineering.com/diy-ventilators-might-ease-supply-shortage-amid-coronavirus-pandemic [interestingengineering.com]
Designs and files:
https://hackaday.io/project/170189-pandemic-pressure-control-ventilator [hackaday.io]
https://engineersassemble.tribe.so/feed/design-concepts [tribe.so]
(Score: 0) by Anonymous Coward on Thursday March 19 2020, @11:03PM
"But in an interview with The Verge, Romaioli denied they'd received threats. He said the company had simply refused to release design files, forcing them to reverse-engineer the valve. "I talked to an operator who told me he couldn't give me the files, but after that we didn't receive anything from the original company — so I can assure you we didn't get any threat," he said. "They said they couldn't give us the file because it's company property"
Isn't part of the point of a patent to create transparency? So shouldn't the patent be on the design files themselves? If they aren't releasing those design files and the thing had to be reverse engineered then what is the patent on (it's probably too broad to be useful which isn't the purpose of patents).
If the information is released via the patent it's company 'property'. If not and it's either independently invented or reverse engineered then it's not.
Also it's interesting they're not suing right now. Maybe they want to wait for it to be mass produced and then sue after the fact because by then they have a larger lawsuit.