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illegal??
#21
RE: illegal??
(05-20-2019, 08:19 AM)Sleeprider Wrote: Diotima245, thanks for your post regarding the indictment of the couple charged with "unlawfully selling stolen medical devices that require a prescription without an actual prescription"  I am including more specific cites of the indictment below, and it should be noted that although this indictment was handed down January 30, 2018, there has been no word of a trial or settlement in the case. 
Sleeprider from what I gather what seems to be the more serious charge is that the devices we're alleged to be stolen. I'll do some digging and update if I find anything.
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#22
RE: illegal??
(05-20-2019, 06:28 PM)Diotima245 Wrote:
(05-20-2019, 08:19 AM)Sleeprider Wrote: Diotima245, thanks for your post regarding the indictment of the couple charged with "unlawfully selling stolen medical devices that require a prescription without an actual prescription"  I am including more specific cites of the indictment below, and it should be noted that although this indictment was handed down January 30, 2018, there has been no word of a trial or settlement in the case. 
Sleeprider from what I gather what seems to be the more serious charge is that the devices we're alleged to be stolen. I'll do some digging and update if I find anything.

I used to work in the environmental regulation, enforcement field. Nothing got local, state FBI attention like an easy case of stolen materials, theft by deception or illegal interstate transport was like attracting flies to the manure pile. To them, any charges I could contribute with regard to dumping, emitting, discharging, ended up being leverage for a criminal settlement.  I am not an attorney, however I can safely tell you that the vast majority of prosecution in agencies like EPA or FDA is civil, and most of it never sees a courtroom. 97 percent of Federal cases are settled out of court, and estimates are that 99.99% of grand juries return indictments. While the charges seem serious, and might lead you to think FDA requriements for prescriptions are actually enforced, I can almost guarantee those charges will be given away for a guilty plea on the theft.
Sleeprider
Apnea Board Moderator
www.ApneaBoard.com

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INFORMATION ON APNEA BOARD FORUMS OR ON APNEABOARD.COM SHOULD NOT BE CONSIDERED AS MEDICAL ADVICE. ALWAYS SEEK THE ADVICE OF A PHYSICIAN BEFORE SEEKING TREATMENT FOR MEDICAL CONDITIONS, INCLUDING SLEEP APNEA. INFORMATION POSTED ON THE APNEA BOARD WEB SITE AND FORUMS ARE PERSONAL OPINION ONLY AND NOT NECESSARILY A STATEMENT OF FACT.
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#23
RE: illegal??
don't understand why they say its illegal, other then that lobby groups want to make money selling new ones. I have 2 sitting in the closet (everytime I go to another doctor, they told me I needed a fancier one!, I have a CPAP, a BI-Pap now an ASV! The sleep centers will not even let you give it away so people who cant afford them can have it. I guess they will just end up in the dump.
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#24
RE: illegal??
(05-16-2019, 07:20 PM)OMyMyOHellYes Wrote:
(02-25-2017, 01:46 PM)4speed Wrote: I have two questions. First off, why do I keep finding people saying it is illegal to buy or sell cpap machines outside of an hme or a doctor's prescription?
      
Second, how do you personally clean your heated tube? I know I should not submerge the end with the electrical connector, but should I just use hot water? hot water and a little dish soap?  What have you had the best luck doing?

Because the FDA is run by a bunch of bumblefarts. Or lobbying pressure from the DME/military industrial complex.

bumblefarts - meaning bunches of hot stinky gas roaming around aimlessly Coffee
INFORMATION ON APNEA BOARD FORUMS OR ON APNEABOARD.COM SHOULD NOT BE CONSIDERED MEDICAL ADVICE. ALWAYS SEEK THE ADVICE OF A PHYSICIAN BEFORE SEEKING TREATMENT FOR MEDICAL CONDITIONS, INCLUDING SLEEP APNEA. INFORMATION POSTED ON THE APNEA BOARD WEBSITE AND FORUMS ARE PERSONAL OPINION ONLY AND NOT NECESSARILY A STATEMENT OF FACT.
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#25
RE: illegal??
selling stolen goods is crime, thats the whole gist of that story.
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#26
RE: illegal??
I guess I'm lucky I am currently living abroad.......ordered mine on Amazon.
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#27
RE: illegal??
It looks like they were acquitted as the devices were not in fact Pre-Retail.

https://thebluenotes.blog/2019/12/06/acq...rywhere-2/
Quote:Next we head to Atlanta where the victory took a little longer. The two defendants were represented by Brian Mendelsohn and Courtney O’Donnell (on behalf of Kimverlee Aderhold) and Esther Panitch, Crystal Bice, and Victoria Brunner (on behalf of Eric Ramey, Jr.). Both were charged with several counts of theft of pre-retail medical products, such as CPap and portable oxygen concentrators, and misbranding those products by distributing them without a prescription. On the third day of trial, the defense filed a 26-page Rule 29 motion, which resulted in all of the theft counts getting dismissed because the products were not “pre-retail.” And although the Rule 29 was denied on the misbranding counts, it played a role in the jury instructions that were given and what the government could argue in closing. The jury started deliberating on Friday at about 3:30 p.m. and were serious about their task. As the hours passed, they refused pizza and continued deliberating even after the heat was turned off. Finally at about 8:00 p.m., they asked a question about intent. The government gave its proposed response and then Judge Totenberg turned to the defense. In what Esther describes as an Olympic baton handoff in winter coat and Uggs, all four members of the defense teams, argued against the government’s proposal. And then less than an hour later, the jury returned “not guilty” verdicts not only on the felony misbranding counts, but even on lesser-included misdemeanor offenses.
What is mis-branding?
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#28
RE: illegal??
To mislabel or advertise in a false manner. I am not familiar with this case but I'm guessing that the defendants were trying to sell used machines as new.
Crimson Nape
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INFORMATION ON APNEA BOARD FORUMS OR ON APNEABOARD.COM SHOULD NOT BE CONSIDERED AS MEDICAL ADVICE. ALWAYS SEEK THE ADVICE OF A PHYSICIAN BEFORE SEEKING TREATMENT FOR MEDICAL CONDITIONS, INCLUDING SLEEP APNEA. INFORMATION POSTED ON THE APNEA BOARD WEB SITE AND FORUMS ARE PERSONAL OPINION ONLY AND NOT NECESSARILY A STATEMENT OF FACT.
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#29
RE: illegal??
Thanks for the update. Looks like the Feds went to the wall and lost.
Sleeprider
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INFORMATION ON APNEA BOARD FORUMS OR ON APNEABOARD.COM SHOULD NOT BE CONSIDERED AS MEDICAL ADVICE. ALWAYS SEEK THE ADVICE OF A PHYSICIAN BEFORE SEEKING TREATMENT FOR MEDICAL CONDITIONS, INCLUDING SLEEP APNEA. INFORMATION POSTED ON THE APNEA BOARD WEB SITE AND FORUMS ARE PERSONAL OPINION ONLY AND NOT NECESSARILY A STATEMENT OF FACT.
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#30
RE: illegal??
The issue for Apnea Board is that:

1.  CPAP machines and associated parts are classified as "Class II Medical Devices" (prescription-required) by the FDA.

2.  To legally transfer Class II Medical Devices, there must be two items that the seller must have--
   A) An Official DME license and
   B) A copy of the patient's prescription on file for that device.

The burden of the law falls to the seller of a CPAP machine, not the buyer.  If you can get a seller to sell you a machine without one or both of the above items, fine.  They won't come after you.  But start selling a large inventory of CPAP machines without both of those items, and you'll likely get onto the FDA radar screen.  And there is no distinction in the law between new and used medical devices.  The law applies to all of them.   The specific regs that require those 2 items are a distribution regulation, not a manufacturing regulation (the FDA regulates both). And, there are two areas of jurisdiction in the laws - the federal regs (primarily FDA) and each individual state's regs (a myriad of laws that vary by state).

That said, FDA enforcement action, (especially on the secondary used CPAP market) is pretty lax, perhaps even non-existent (at this time).  There's not much legal risk to you as a patient when you're buying one without a prescription, nor is there a legal risk to the patient if the seller doesn't hold a current DME license.

Because it's a clear violation of law to sell CPAP machines (or their component parts) without a DME license or the patient's script, Apnea Board isn't willing to take the risk of being on the FDA's radar screen as a "facilitator of an illegal sale, trade or transfer of regulated Class II Medical Devices".  It's not the buying part that gets you in trouble, it's the selling part - and that's why we have a forum rule that states "No member may use their forum account to solicit or facilitate the sale, trade, or transfer of any prescription-required items..." And this applies to everyone here, regardless of location-- as our rules state:  "Apnea Board is based in the U.S. and must comply with U.S. regulations and laws regarding prescription-required items, regardless of where our members are physically located."

If you can buy via Craigslist or any other person-to-person source, more power to you.  However, if you have one to sell, you are in that case "the seller" and those FDA regs would apply to you.  If Apnea Board were to allow an unlicensed seller to advertise a Class II Medical devices for sale, trade or transfer using their forum account, we technically could be in violation of the law, since that could be perceived as "facilitating" an illegal sale.

We'd like Apnea Board to remain online, of course.  And if for some reason an over-zealous FDA regulator decided to come after us for facilitating an illegal sale, we quite simply would have to close the doors here, since we have no budget to fight any sort of legal battle.

Of course, we've had folks say "If it's illegal, then how come http://www.CPAP-whatever.com is selling CPAPs with no prescription required?"  I would have to refer you to the owners of that store or website.  They've chosen to violate the law.  It's their business, not ours.  But just because a few people are out there violating the law is no reason to allow Apnea Board to be used to violate the law.  The childish "everyone else is doing it" defense will not hold up in a court of law... trust me on that.

Some folks don't like that, but we're actually protecting the very existence of this forum and website.  While we may nor may not be "caught" if someone uses their forum account to do such things - we are NOT willing to take that risk.  If you want to sell Class II Medical Devices without those two requirements (DME license & prescription), then go for it-- just don't use your forum account here to do it or you risk being banned. 

I've had people say "It's no big deal to allow it here, it happens on other forums all the time!".  My answer is always the same - it's easy to say such things when it's not your own legal existence that's on the line.  Go out and purchase a $1 million legal defense insurance policy to protect Apnea Board in case the FDA comes after us, and then we might consider allowing it.  But first you'd have to convince an insurance company that we're not doing anything illegal when we allow prescription-required items to be sold here without a DME license or patient prescription.  Good luck with that part.

Coffee
SuperSleeper
Apnea Board Administrator
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INFORMATION ON APNEA BOARD FORUMS OR ON APNEABOARD.COM SHOULD NOT BE CONSIDERED AS MEDICAL ADVICE. ALWAYS SEEK THE ADVICE OF A PHYSICIAN BEFORE SEEKING TREATMENT FOR MEDICAL CONDITIONS, INCLUDING SLEEP APNEA. INFORMATION POSTED ON THE APNEA BOARD WEB SITE AND FORUMS ARE PERSONAL OPINION ONLY AND NOT NECESSARILY A STATEMENT OF FACT.


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