Well here we go my first real blog post, and it is a doozy!
Let me start with a reminder that I am not a lawyer.
Why am I writing on this subject then?
Because it hits too close to home, I have two people in my life that I love dearly that are neurodivergent, and several others that mean the world to me. So, yes, this is in my realm of reality.
So on to the crux of the situation; this is my understanding of what appears to me to be a rather narrow reading of a law. At odds is the only institution left in the United States that still uses electrical impulses to dissuade inappropriate behaviors, principally in neurodivergent individuals, and the FDA’s power to regulate medical devices.
The case was heard before the US District Court of Appeals District of Columbia on April 23, 2021 and was ruled on July 6, 2021 (USCA Case #20-1087 Document #1905079) Opinion for the court written by Senior Circuit Judge, Sentelle. Dissent written by Srinivasan
From the FDA’s ban notice:
The Food and Drug Administration (FDA, the Agency, or we) is finalizing a ban on electrical stimulation devices (ESDs) for self-injurious or aggressive behavior. FDA has determined that these devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling. This ban includes both new devices and devices already in distribution and use; however, this ban provides transition time for those individuals currently subject to ESDs for the identified intended use to transition off ESDs under the supervision of a physician.
From the Summery A: Purpose of the final rule:
The ban’s effective date was April 6, 2020 with a window open until September 2, 2020 for those already in use to transition.
So who did this rule affect?
FDA is banning ESDs for self-injurious behavior (SIB) or aggressive behavior (AB). ESDs are aversive conditioning devices that apply a noxious electrical stimulus (a shock) to a person's skin to reduce or cease such behaviors. SIB and AB frequently manifest in the same individual, and people with intellectual or developmental disabilities exhibit these behaviors at disproportionately high rates.
From executive summery:
Why did they need the ban?
Although the available data and information show that some individuals subject to ESDs exhibit an immediate interruption of the targeted behavior, the available evidence has not established a durable long-term conditioning effect or an overall-favorable benefit-risk profile for the devices. The medical literature shows that ESDs present risks of a number of psychological harms including depression, posttraumatic stress disorder (PTSD), anxiety, fear, panic, substitution of other negative behaviors, worsening of underlying symptoms, and learned helplessness (becoming unable or unwilling to respond in any way to the ESD); and the devices present the physical risks of pain, skin burns, and tissue damage.
From the Summery A: Purpose of the final rule:
How can this type of device cause these issues?
The effects of the shock are both psychological (including suffering) and physical (including pain), each having a complex relationship with the electrical parameters of the shock. As a result, the subjective experience of the person receiving the shock can be difficult to predict. Physical reactions roughly correlate with the peak current of the shock delivered by the ESD. However, various other factors such as sweat, electrode placement, recent history of shocks, and body chemistry can physically affect the sensation. As a result, the intensity or pain of a particular set of shock parameters can vary from person to person and from shock to shock. Possible adverse psychological reactions are even more loosely correlated with shock intensity. The shock need only be subjectively stressful enough to cause trauma or suffering. Trauma becomes more likely, for example, when the recipient does not have control over the shock or has developed a fear of future shocks, neither of which is an electrical parameter of the shock.
From the Summery A: Purpose of the final rule:
Is there an alternative to these devices? Yes, and the FDA made it clear in their ban.
In light of scientific advances, out of concern for ethical treatment, and in an attempt to create generalizable interventions that work in community settings, behavioral scientists have developed safer, successful treatments for SIB and AB. The development of the functional behavioral assessment, a formalized tool to analyze and determine triggering conditions, has allowed providers to formulate and implement plans based on positive behavioral techniques. As a result, multielement positive interventions (e.g., paradigms such as positive behavior support or dialectical behavioral therapy) have become state-of-the-art treatments for SIB and AB. Such interventions achieve success through environmental modification and an emphasis on teaching appropriate skills. Behavioral intervention providers may also recommend pharmacotherapy (the use of medications) as an adjunctive or supplemental method of treatment. Positive-only approaches have low risk and are generally successful even for challenging SIB and AB, in both clinical and community settings. The scientific community has recognized that addressing the underlying causes of SIB or AB, rather than suppressing it with painful shocks, not only avoids the risks posed by ESDs, but can achieve durable, long-term benefits.
Based on all available data and information, FDA has determined that the risk of illness or injury posed by ESDs for SIB or AB is substantial and unreasonable and that labeling or a change in labeling cannot correct or eliminate the unreasonable and substantial risk of illness or injury.
From the Summery A: Purpose of the final rule:
Now that we have the ban accounted for let’s get into the court ruling. Most of it is very dry quoting of statute and precedent so for a non-lawyer it was kind of tedious. (In disclosure I am a Master-Craftsman HVAC/R technician, I am fluent in OSHA and EPA compliance as well as electrical shocks having had many inadvertent ones myself over the decades.)
This first paragraph really to me is the entire ruling:
S ENTELLE , Senior Circuit Judge: The Judge Rotenberg Educational Center and the parents and guardians of its patients both petition for review of a Food and Drug Administration (FDA) rule banning electrical stimulation devices used to treat aggressive or self-injurious behavior. In its rule, the FDA determined that the devices present an unreasonable and substantial risk of illness or injury, but only when used to treat aggressive or self-injurious behaviors. The petitioners contend that banning a medical device for a particular purpose regulates the practice of medicine in violation of 21 U.S.C. § 396. We agree, grant the petitions for review, and vacate the FDA’s rule.
From: USCA Case #20-1087 Document #1905079
https://www.govinfo.gov/content/pkg/USCOURTS-caDC-20-01087/pdf/USCOURTS-caDC-20-01087-0.pdf
Now why did the court come to this opinion? Simply semantics of language and the way congress worded the laws governing the FDA.
Section 360f, which Congress passed in the Medical Device Amendments
of 1976 to the Food, Drug, and Cosmetic Act, grants the FDA authority
to ban medical devices. The section provides: “Whenever the
Secretary finds . . . that a device intended for human use presents
substantial deception or an unreasonable and substantial risk of
illness or injury,” and that risk cannot be “corrected or
eliminated by labeling,” the Secretary “may initiate a proceeding
to promulgate a regulation to make such device a banned device.” 21
U.S.C. § 360f(a).
From: Section II Analysis USCA Case #20-1087 Document #1905079
https://www.govinfo.gov/content/pkg/USCOURTS-caDC-20-01087/pdf/USCOURTS-caDC-20-01087-0.pdf
Now part two of the issue is the clincher in my opinion.
Section 396 constrains the FDA’s authority by prohibiting it from regulating the practice of medicine. In the Food and Drug Modernization Act of 1997, Congress provided:
Nothing in this chapter shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship. This section shall not limit any existing authority of the Secretary to establish and enforce restrictions on the sale or distribution, or in the labeling, of a device that are part of a determination of substantial equivalence,
established as a condition of approval, or promulgated through regulations.
https://www.govinfo.gov/content/pkg/USCOURTS-caDC-20-01087/pdf/USCOURTS-caDC-20-01087-0.pdf
Basically to me it says: “So long as the device is legal a doctor can prescribe it and the FDA can’t say anything about it.” Now I could be wrong, but that’s what it sounds like to me. Now the FDA believes (and I agree) that once they banned the device it was no longer “legally marketed.” The issue is they didn’t outright ban the device only a narrow use of the device and this is where the petitioner bases their argument on affecting their medical practice, something clearly prohibited in Section 396.
So why can’t the FDA ban certain uses and allow others? Good question, simple answer is the law does not clearly say they can.
We begin our analysis of the scope of the FDA’s banning authority with section 360f, the statute that authorizes banning in the first instance. The statute states that the FDA may make “such device a banned device,” and the natural reading of that language suggests a device either is banned or it is not. It speaks of no authority to place a device in an intermediate state of “banned in some uses.” But the statute also requires the FDA to determine whether the risks a device presents are reasonable, presumably in light of the benefits that the device provides to individuals that use it. If a device has multiple possible uses, each use will present a different benefit-risk profile. The risks a device presents could therefore be reasonable for some uses but not for others. Focusing on “reasonable” in the statute echoes the FDA’s reasoning that it should be permitted to tailor a ban to those circumstances in which it applies its expertise to find an unreasonable risk.
However, section 396 expressly denies the FDA authority to construe any part of the Food, Drug, and Cosmetic Act, including its authority to ban devices under section 360f, to permit the FDA to “limit[] or interfere[]” with practitioners’ authority to prescribe or administer “legally marketed device[s]” to patients. The questions for us then, are whether a ban “limits or interferes,” and whether a device that the FDA has attempted to ban for a particular purpose is “legally marketed.”
From: A. Statutory analysis USCA Case #20-1087 Document #1905079
https://www.govinfo.gov/content/pkg/USCOURTS-caDC-20-01087/pdf/USCOURTS-caDC-20-01087-0.pdf
The FDA’s alternative interpretation of “legally marketed device” is unpersuasive. The agency argues that because the Act requires a device to have a use, the appropriate construction of “device” is a pairing of a particular instrument with a particular use. It would follow that an electrical stimulation device for self-injurious and aggressive behavior is not a “legally marketed device” once the FDA bans that pairing of an instrument and use. Congress potentially had such an interpretation in mind, as legislative history contains references to the FDA being permitted to treat multiple “use[s] . . . as constituting a different device for purposes of classification or other regulation.” H.R. Rep. No. 94-853, at 14–15 (1976). That is not an appropriate interpretation.
First, that construction would allow the FDA to escape the constraints of section 396 whenever it bans a device. If Congress wished to have section 396 apply to everything except the FDA’s banning authority, it could have done so. Instead, the statute begins “Nothing in this chapter shall be construed,” mandating that this section constrain the FDA’s banning authority. Next, interpreting the definition of “device” as requiring a pairing of an instrument with a particular use is inconsistent with the definition of “device” itself. Section 321 defines “device” by reference to “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article,” focusing on the physical item itself rather than any particular intended use.
From: A. Statutory analysis USCA Case #20-1087 Document #1905079
https://www.govinfo.gov/content/pkg/USCOURTS-caDC-20-01087/pdf/USCOURTS-caDC-20-01087-0.pdf
So what can we do?
Option one: We could petition the FDA to outright ban the entire class of ESDs, but some that do have proven uses in adults with full cognitive function and the ability to communicate effectively would also be banned.
Option two: We lobby congress to amend section 396 to allow the narrow ban or approval of medical device usage and to prevent “off label” usage of such devices.
The use of these devices that are sometimes auto initiated and/or remotely actuated at the will of a third party on individuals with impaired cognitive ability, sometimes with little or no communication skills to me comes across as barbaric and inhumane. A society should be judged on how it treats the least of its people and by that standard we should be ashamed of how the law has failed in this ruling.
Was this judicial over-reach? No, it was congressional under-reach. The law says what it says and the court ruled on that syntax.
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