Company threatens to sue volunteers who 3D-printed valves for coronavirus aid
theverge.com
theverge.com
Think of it this way, a hospital could buy 10 valves or hire a physician for a year. Are these valves typically re-used? Are they going through them faster because they don't want to risk infecting other people?
Either which way, typical healthcare profiteering is not going to end well here. There is simply too much on the line to allow people to block or threaten progress.
Nope. Sorry. Not buying that argument this time. I accept that argument for patent exclusion periods and high prices on medication, because the R&D has enormous risk costs when medications don't work or don't get approval. Allowing pharmaceutical companies to recoup those costs is vital to innovation and public health. This is a piece of plastic that's part of a larger machine. There was no enormous R&D budget required to develop the replaceable component. By all means let them make money on the machine, but the argument doesn't hold up for this simple maintenance component.
https://www.medtronic.com/covidien/en-gb/products/mechanical...
So why is a valve $10k? Note that a replacement battery for the above ventilator costs < $1k.
Is the valve a disposable part (at 20% cost of the whole unit?) Is it some special valve that is the core IP (that other medical valves can't replace?) Is it made from some special material? Do they have to make each one from scratch? Does individual certification cost a fortune (and maybe this is a fixed cost regardless of what you're testing)? How much does a similar replacement valve cost for a similar ventilator?
Bear in mind that $10k implies a $3k cost to the company, at a typical hardware engineering markup.
I don't think we can handwave "Rnd" or some mystical "compliance" cost without knowing more details.
Seems like a valve for anaesthesiology is a Class II medical device, which may be a start?
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFR...
I'm guessing the valves are single-use (due to contamination), so the cost is passed along to the customer. They can't charge every customer for a battery (I mean, they could prorate it, but that's not how medical billing works). The hospital doesn't care what a valve costs if they're passing-along 100% of the cost to you.
And big companies take advantage of their position as the only ones who can navigate such a system to justify their sky high prices, and then they lobby to maintain that position.
The valve in question looks to be for IV drug delivery, which is not a new technology. It's probably just a simple check valve.
This is something most people don't comprehend. People tend to think that it's the government putting in place these regulations and the companies are against them, but more often than not the regulations exist at the behest of the incumbents to constrain competition.
Are you sure about this? Just because it is one small part of a complex device doesn't make it low cost.
> By all means let them make money on the machine
Ok...so the machine becomes (for example) $1m instead of $10k. The financial cost to use the machine remains the same.
How can one justify this kind of vicious exploitation of publicly funded healthcare?
Each part is traceable from all raw materials to finished product
Each part is manually tested/calibrated
Each part may be tested with non-destructive testing (x-ray, ultrasound, dye crack inspection etc)
For every lot of parts, several parts will be tested destructively
Each part comes with liability, so the manufacturer will likely purchase liability insurance
Also, the regulatory costs are paid years in advance of a single unit being sold. Once the device is approved (that is, if it's approved at all), the units are sold slowly over years. So the regulatory costs must be financed.
Absolutely. Why does the "financing" in this case have to go through a hospital's purchasing department? The obvious reason for why they charge such incredible amounts per unit is because they can. If there was any amount of competition or marketplace for it, it would be cheaper. There clearly isn't.
Explain to me how this way of doing things is not holding the public hostage.
Seems like these things that were 3D printed could be. At least at a marginal cost.
There are tons of medical devices that are low enough volume that most hospitals don't even have a single unit. There's a reason why we have hospitals with varying levels of status, capabilities, and specialties. There are fairly common surgeries that require equipment that only exists in 2 or 3 digit quantities in the entire world.
They are hideously expensive because so few are bought.
My point is that people saying that it is overpriced don't understand the input costs of medical devices.
That's two numbers relating to the cost of production. The second is the cost that a 3D printer doing one off prints actually costs (it's in the article, as a rough estimate.) The first number is a deliberately chosen "insane" example figure to show the absurdity of an $11,000 part. A medical test n license for a single part of a device does not cost anything like $100M.
Now as to the market for these things - the third number. Nearly 8,000 people have died so far. I can't be arsed to extrapolate further but I recall reading that these are single use devices.
And the fact that they are threatening to sue for something they couldn't sell is disgusting.
And yeah, it costs a ton of money to get regulatory approval.
So where do you think all that money comes from? Think maybe they have to build that into the price of the ventilator, so maybe it's not so "overpriced" at all? Maybe?
From then on, which should be like after a week, every single dollar is profit.
On top of that, you have to account for the potential lawsuit if your 3D-printed knockoff respirator valve fails and someone dies.
The aviation law: https://www.law.cornell.edu/cfr/text/14/91.3
In that case, the alternative was a few people over there going to die by slow asphyxiation, so the 3D-printed knockoffs were a really good thing, even if some of them failed.
Where does this meme that companies get sued for parts made by completely independent third parties come from?
The most obvious reason that wouldn't be true is that without a patent on the part or similar, companies generally have no right to prevent third parties from making replacement parts for their equipment. It would be pretty silly to impose liability for something they have no control over.
"Meme"?
Where does your your that malpractice lawsuits are just "memes" come from? Because I can assure you that they exist in the real world. As do massive fines for using equipment that hasn't been FDA approved.
What's the name of the manufacturer?
You're wrong. We're not living in some capitalist cartoon. Even the greediest CEO doesn't want to be a villain in a lifesaving story like this.
"Now, despite the country battling an unprecedented health crisis, there is potential for a legal battle with local media reporting that the manufacturers of the valves are refusing to share their blue print for further production and could potentially sue for copyright breaches."
So they may have the option to sue?
Which links to https://it.businessinsider.com/coronavirus-manca-la-valvola-..., in Italian, and I don't understand Italian.
Basically doesn't add anything - the company isn't named.
It's a really nice story though, a bright spot in very dark times.
"having received a negative remarry - indeed they also received threats of complaint for patent infringement"
Coming from Massimo Temporelli, so checks out
Wat?
> risposata negativa
"Risposata" is "remarry." Presumably they wanted "risposta," which is "response." Probably just a typo.
I guess the parent post was to illustrate in a humorous manner the limitations of machine translation.
Which company is suing over the 3D-printed valves? We need to name and shame. If we're unwilling to call out monopolists putting profits over even human life, then we, too, are complicit.
On another note, I'm of the increasingly-strong belief that patent suits should be deemed automatically dismissed if the "infringement" is a response to either an inability or unwillingness of the patent holder to actually use that patent productively (i.e. produce something using that patent). In this case, if the original manufacturer is out of stock, 3D printing replacements should be fair game. Likewise, if we don't have enough testing kits, making and distributing more should be fair game.
This part seems less than optimally ethical. If it's a choice between helping other hospitals to save lives and to avoid additional legal liability, this seems like a good hill to go bankrupt on.
But...if someone slipped the file to me I wouldn't publish it either. So I can't fault them for being as faulty as me.
FM is between parties to a contract. FM clauses allocate the risk of unforeseen events to the parties as per the language in the contract.
If FM is in play at all, it would probably protect the manufacturer by relieving it of its promise (if any) to provide the valves.
Note, I have no idea how contract law works in Italy or the EU.
However, in this case, there is probably an Italian or EU law that shields the hospital from liability. Especially if the hospital is part of a government health system. (The US has such laws)
I think "Necessity" is more applicable https://en.wikipedia.org/wiki/Necessity_(criminal_law)
In italian: "Stato di necessità" https://it.wikipedia.org/wiki/Stato_di_necessit%C3%A0
Rough translation: Cannot punish someone for something if he did it to save himself or others from a grave damage, due to a danger he did not cause voluntarily, and not avoidable in other ways, if the thing done is proportional to the danger
(IANAL)
35 USC 271: Except as otherwise provided in this title, whoever without authority makes, uses, offers to sell, or sells any patented invention, within the United States or imports into the United States any patented invention during the term of the patent therefor, infringes the patent.
(July 19, 1952, ch. 950, 66 Stat. 811; Pub. L. 98–417, title II, § 202, Sept. 24, 1984, 98 Stat. 1603; Pub. L. 98–622, title I, § 101(a), Nov. 8, 1984, 98 Stat. 3383; Pub. L. 100–418, title IX, § 9003, Aug. 23, 1988, 102 Stat. 1563; Pub. L. 100–670, title II, § 201(i), Nov. 16, 1988, 102 Stat. 3988; Pub. L. 100–703, title II, § 201, Nov. 19, 1988, 102 Stat. 4676; Pub. L. 102–560, § 2(a)(1), Oct. 28, 1992, 106 Stat. 4230; Pub. L. 103–465, title V, § 533(a), Dec. 8, 1994, 108 Stat. 4988; Pub. L. 108–173, title XI, § 1101(d), Dec. 8, 2003, 117 Stat. 2457; Pub. L. 111–148, title VII, § 7002(c)(1), Mar. 23, 2010, 124 Stat. 815.)
However, the US gov can infringe at will without any court orders or special laws.
If a US gov agent (any low level CDC or health agency employee could do it) told the hospital to print valves, there is nothing the patent holder can do about it except get paid for the value of the valves sometime later.
Here: "US law is more strict. It forbids anyone from making, using or selling the invention, even when the use is strictly personal." - https://www.iusmentis.com/patents/crashcourse/rights/
Most likely it is a trivial variation on an already approved design, varied solely for the purposes of obtaining a new patent, and of getting an exclusive requirement for it to be used on the machine.
There is no defensible reason to presume good faith on the part of a medical equipment manufacturer, even though a few do have it.
I agree and I also think it's incredibly shitty of a medical company to threaten to sue in these trying times. Really exposes what they are all about. I was just trying to see the coin from the other side, trying to understand.
It's not the unit cost, it's the R&D that's expensive.
The $5000 screwdriver definitely is a thing, if you need 5 Engineers to design it but only ever make 5 of them, to be used on the Space Shuttle for example.
For drugs, it's something like $2 billion up front before you sell a single pill. For medical devices it's not as much, but still can be in the tens to hundreds of millions.
Production costs don't really enter into it. The actual breakdown is probably more like:
Production costs: $25 FDA approval: $100 million dollars
This site has turned into a tech-flavored subreddit of Think Progress.
Their is no way this valve cost $11,000. A quick google search for PEEP valves for respirators sow that they sell for a few dollars, 20 at most.
It seems unlikely that any company would sue in such circumstances, it would be a PR nightmare.
If the story was true prices would most likely be listed in euros.
When this 3d printed valves story appeared a few days ago those exact figures were cited on Reddit as a joke.
How they ended up presented as "Facts" on TheVerge is anyone's guess.
There is a captive market here and the seller can sell at any price they want and make any markup they want because they can. There are some very honourable people and companies who do not price gouge in the field. But it seems that these are a very small minority.
Now mind you, this kind of price gouging occurs anywhere there is a captive market. But some industries are more susceptible to it than others.
If companies who suddenly find themselves in a strategic position don't get what they need to do, then the Government needs to take control using emergency powers, and use any available production capacity in the country to ramp up production, fast.
We'll also need to do many other things. We should adopt a wartime mentality, focus on solving the problems at hand, and stop wasting time. At least in Italy they get this now.
[1] https://craphound.com/overclocked/Cory_Doctorow_-_Overclocke....
[2] E-book download: https://www.gutenberg.org/ebooks/19000
The rules are basically if lives are in danger, anything goes.
The system itself is broken and should be abolished, as has been long and well argued.
"A patent owner (patentee) may be precluded from enforcing its patent against an alleged infringer after a period of time from the first notice identifying the patent and possible infringement (e.g., 4 ½ years) if the following conditions are met:
Misleading Conduct/Silence: The patent owner, through misleading conduct (or silence), leads the alleged infringer to reasonably infer that the patentee does not intend to enforce its patent against the alleged infringer (e.g., by sending a cease-and-desist letter followed by years of silence); Reliance: The alleged infringer relies on that conduct; and Prejudice: The alleged infringer will be materially prejudiced if the patent owner is allowed to proceed with its claim (e.g., alleged infringer has continued selling and expanding product lines). This legal doctrine known as patent equitable estoppel applies on a case-by-case basis to each patent asserted by the patent owner. Therefore, a patent owner may have other patents to enforce which may not be barred by equitable estoppel." - http://www.patenttrademarkblog.com/consequences-of-patent-ow...
Again I am getting downvotes for reporting facts. I guess mob opinion rules.
1. provided the STL files for the plastic valve when the hobbyist 3D printer asked for them
2. granted a no-cost patent licence.
That way the requirement by law to defend the patent does not arise in the first place.