Post
by OfftoNeverNeverland » Thu Feb 28, 2019 3:44 pm
Dear Chicago Granny and Palerider:
I have read many of your posts and really respect your expertise with PAP therapy and especially how to figure out how to manage this gawdawful new lifestyle. I suffer greatly with OA and use a PAP myself. You are to be commended for helping PAP users for years all over this blog and thank goodness for people like you. Please consider that there are some of us out there who may know things related to CPAP issues (not its proper use like you) and such things may NOT be directly in your wheelhouse. I am not a troll (uncalled for insult btw). I would not want you or anyone else to run afoul of the law (federal or otherwise). As I mentioned, the government is highly unlikely to ever take notice of one-off kind of sales of PAP equipment that people sell to one another. It is just like possessing one marijuana joint (in a still prohibited State) rather than moving bales of it, as such activities escapes federal or state law enforcement notice. The couple in the indictment are alleged to have stolen and trafficked in many PAP devices on Craig's List and likely that is how they were noticed and likely an undercover agent purchased such a PAP device in cash from them as evidence of a crime(s) (The "buy." You can watch old Starsky and Hutch reruns on Hulu to see how "buys" are done). It would be safe to assume that the FDA Criminal Enforcement Division and other interested agencies read these blogs too and the same way as they read Craig's List--don't you think?
Instead of Chicago Granny's request that I edit my prior positing, of which I politely decline, I offer you the first 4 pages below of the now public Grand Jury federal indictment in Atlanta of the couple who allegedly stole CPAP/BiPAP/Ventilator equipment, posted them for sale on Craig's List (that is an internet type of buy/sell bulletin board that can be used in various States over boundaries to buy/sell things, viz., the Interstate Commerce aspect of the Indictment for additional federal jurisdiction support). The couple allegedly met and sold same for cash to buyers (the public). The couple were allegedly not licensed to prescribe medical equipment in the FDA Class II realm, i.e., PAP therapy equipment. They allegedly were not authorized to take (steal) pre-retail PAP devices from their DME employer in that part of Georgia and sell them to the public either.
They are now charged (that is not speculation, they are CHARGED and indicted) with well over 10 counts of federal felony crimes, some of which are selling in interstate commerce ("trafficking") Class II devices (PAPs) without being authorized to issue prescriptions for Class II devices (PAPs). They are also charged with selling stolen "pre-retail" Class II devices in interstate commerce (the stolen goods aspect of this matter). They are also charged with working together with knowledge in a conspiracy (serves to pin the same allegations on each defendant). The docket reflects through granted motion, the trial (criminal jury trial) was continued (that means postponed or delayed) until later this year (2019) and both defendants are facing these charges together via an alleged conspiracy. Motions to sever the two defendants through separate trials was apparently denied.
As these criminal trials are open to the public, you are free to attend the trial and certainly are free to obtain the pleadings and documents filed in this case. When you show up in person or hire a document retrieval courier look for case number 1:2018cr00018 in the criminal docket of the Atlanta federal courthouse. You can get copies (copy fees) of documents not under seal. The now PUBLIC grand Jury indictment is pasted below up to page 4 (I did not want to paste all 22 pages--boilerplate). Please read the whole thing before you start responding/posting/insulting. As I mentioned, small potato folks who merely sell a PAP or two to the public are unlikely to get noticed ("burned") by LEOs but I think it is clear that there are more than enough federal criminal statutes on the books that proscribe (that means prohibit or make unlawful) selling any Class II device without authority to write prescriptions for same if somehow you got noticed by LEOs (the acronym "LEOs" means the "heat" or "dah' man". "Burned" means arrested by "set up" or otherwise. See Starsky & Hutch reruns on Hulu). However, if you really want legal advice, hire and speak to an attorney and discuss the alleged facts and law in the indictment in view of any such activities in which you may someday plan to engage in the future. This posting is not trolling (Palerider) but is meant to be a serious contribution to the topics that concern all of us.
______________________________________
IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF GEORGIA ATLANTA DIVISION
V,
KIMVERLEE ADERHOLD ERIC E. RAMEY, JR.
No. 1:2018cr00018
Criminal Indictment
THE GRAND JURY CHARGES THAT:
Count One
INTRODUCTION
1. The FDA is the federal agency responsible for protecting the health and safety of the American public by ensuring, among other things, that medical devices are safe and effective for their intended uses and bear labeling that contains true and accurate information. FDA's responsibilities include regulating the manufacture and distribution of medical devices shipped or received in interstate commerce, as well as the labeling of such medical devices. FDA carries out its responsibilities by enforcing the FDCA and other pertinent laws and regulations.
2. The FDCA defines a medical device as, among other things, "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is . . . intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man
or other animals, or intended to affect the structure or function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes." 21 U.S.C. §§321(h)(2), 321(h)(3).
3. A prescription device is a device which, because of its potential for harmful effects, methods of use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to direct the use of such device. 21 C.F.R. § 801.109.
4. Under the FDCA, devices are deemed to be "misbranded" unless their labeling bears adequate directions for use. 21 U.S.C. § 352(f)(1). Under regulations promulgated by the FDA, "adequate directions for use" is defined as directions under which a layman can safely use a drug or device for its intended uses. 21 C.F.R. § 801.5.
5. Prescription devices by their very nature are safe for use only under the supervision of a licensed practitioner. See 21 C.F.R. § 801.109. Adequate directions for use, therefore, cannot be written for prescription devices, and prescription devices are per se misbranded under 21 U.S.C. § 352(f)(1). To allow for the lawful movement of prescription devices in interstate commerce, FDA regulations exempt prescription devices from the adequate directions for use requirement, but only if certain conditions are met. See 21 C.F.R. §§ 201.100 (drugs) and 801.109 (devices).
6. Two such conditions require that the device is: (a) in the possession of a person, or his agents or employees, regularly and lawfully engaged in the manufacture, transportation, storage, or wholesale or retail distribution of such device; and (b) is to be sold only to or on the prescription or other order of such practitioner for use in the course of his professional practice. See 21 C.F.R. § 801.109(a)(l)(i) and (2).
7. Under the FDCA, the doing of any act to a device, after the device or its components have moved in interstate commerce and while such device is held for sale, which results in the device being misbranded, is prohibited. 21 U.S.C, § 331(k).
DEVICES AT ISSUE
8. Continuous positive airway pressure (CPap) and Bi-level positive airway pressure (BiPap) machines are devices that deliver air through a tube into a mask that fits over the nose. While CPap machines generally deliver a single air pressure, BiPap machines deliver two-levels of air pressure - an inhale pressure and an exhale pressure. CPap and BiPap machines are both used to treat sleep apnea. BiPap machines are often also used to treat conditions other than sleep apnea, such as certain pulmonary conditions like chronic pulmonary obstructive disorder (COPD) or cardiac conditions like congestive heart failure. CPap and BiPap machines are both prescription devices under the FDCA.
9. Portable oxygen concentrators (POC) are portable medical respiratory therapy devices that deliver concentrated oxygen to a respiratory patient. POC takes ambient air and filters out everything except for the oxygen. POCs are prescription devices under the FDCA.
The Conspiracy and Its Objects
10. Beginning on or before September 15, 2016, and continuing until on or about September 5, 2017, in the Northern District of Georgia and elsewhere, defendants, KIMVERLEE ADERHOLD and ERIC E. RAMEY, JR., did knowingly and willfully combine, conspire, confederate, agree, and have a tacit understanding with each other to commit the following offenses:
a. In and using means and facilities of interstate commerce, to steal, and by fraud and deception obtain, and knowingly and unlawfully take, carry away, and conceal pre-retail medical products, that is CPap, BiPap, and POC devices, in violation of Title 18, United States Code, Section 670(a)(1); and
b. In and using means and facilities of interstate commerce, knowingly to possess, transport, and traffic in pre-retail medical products, that is CPap, BiPap, and POC devices, that were involved in a violation of Title 18, United States Code, Section 670(a)(1), in violation of Title 18, United States Code, Section 670(a)(3).
