In 2020, the FDA banned “electric stimulation devices” (ESDs), that is, devices delivering an electric shock to the skin and used to control self-harming and aggressive behavior in humans. The Judge Rotenberg Educational Center (JRC), a Massachusetts school for children and adults with emotional and psychiatric problems, intellectual disabilities, and autism spectrum disorder, many of whom are non-verbal, is the only place in the world currently using such a device and is thus the only entity affected by the ban.
JRC and some supportive parents petitioned the U.S. Court of Appeals for the D.C. Circuit to vacate (that is, overturn) the ban and, in a decision criticized by disability advocates, the Court recently held that the FDA lacked the authority to ban the device.
The overturned FDA ban applied only to electric shock devices used for aggressive and self-harming behavior. It did not ban such devices when used for smoking cessation, for example. The ban is only the third ever issued for a medical device by the FDA (the others were for prosthetic hair fibers and powdered gloves) and the first to be challenged in court.
The Court’s decision is just the latest chapter in a years-long battle between, on the one hand, the Judge Rotenberg Educational Center and parents who support using an electric shock device as a behavioral modification tool for special needs students and, on the other hand, government authorities, advocacy groups, and medical experts who consider this method ineffective, unsafe, and even torture.
Today, we’ll take a look at the JRC’s “graduated electronic decelerator” (GED), an electric shock device invented at the school, and its disturbing history, along with previous attempts to stop its use. Then we’ll see how the FDA used its power to regulate medical devices to issue the ban. Finally, we’ll find out why a two-judge majority of the Court ruled that the FDA did not have the authority to enact this ban, a conclusion criticized in a cogent dissent by one judge who highlights the ridiculous practical result of the ruling, a dissent with which I wholly agree.
But first, by way of background, a shallow dive into the extremely complex subject of medical device regulation. The FDA clears medical devices depending on the intended use of the device and its indications for use which, in turn, governs the type of regulation the device is subject to, based in part on its potential for harm to the patient. For example, tongue depressors aren’t cleared for just anything, they are cleared as a “device intended to displace the tongue to facilitate examination of the surrounding organs and tissues”. Further complicating this scenario is the fact that, once cleared, a medical device (just like an FDA-approved drug) can legally be used “off-label” for other purposes. Off-label use is considered “the practice of medicine” and therefore subject only to state, not federal, regulation. So, your doctor could legally use the tongue depressor off-label in other orifices (although that might raise different issues).
A shocking history
According to a 2018 news report in The Guardian, Matthew Israel, a psychologist and JRC’s founding director, came up with the idea of using “aversives” to control behavior after reading a book about a fictitious utopian community “where positive behavior is encouraged and negative behavior thwarted”. Israel began applying these “aversives” to JRC’s students in 1971, including spanking and pinching. In the 1990s, he switched to electric shocks, inventing his own electricity generator, naming it the “graduated electronic decelarator”, or GED for short. (Israel was forced to resign in 2011 as part of a plea deal to avoid prosecution for destroying evidence of abuse.) Based on its similarity to devices first approved by the FDA in 1979, the original GED was cleared by the FDA in 1994, although subsequent iterations were apparently not appropriately cleared and JRC received FDA warning letters.
In its current iteration, GEDs are carried in students’ backpacks, delivering up to 41 milliamps, 10 times the amperage used in most stun guns, according to a recent NBC News report. Shocks lasting up to two seconds are administered by staff using remote controls with the intention of causing pain and thereby discouraging unwanted behavior. The remotes hang on the staffs’ belts, labeled with photos to identify the applicable remote for the offending student.
In 2011, certain procedural safeguards were instituted by the State of Massachusetts before the GED could be used, but these apply only to students enrolled prospectively, not those currently under care plans, although those plans can be in effect for years.
JRC, which charges up to $275,000 per student per year (much of it paid by government funds), defends its methods by pointing to the fact that it accepts students with profound disabilities and those who are seriously troubled, refusing no one, even those who have been repeatedly thrown out of other facilities. It says the shocks are used only to intervene when students engage in the most dangerously aggressive and self-injurious conduct, such as head-banging, eye gouging, and tearing at their own flesh, and for whom other forms of therapy have proved ineffective.
Some parents and guardians of the students support the school in its use of the GED. One mother whose son has resided at the Center for two decades said he was a drugged “zombie” before coming to JRC and being subjected to the GED, which, she claims, stopped his aggression. Other family members of students who have struggled to find care, some of whom have a history of severe self-harm, defend the school and its methods and credit it with saving their children’s lives.
Outside of the school and its parent defenders, shocking special needs students as a means of behavior modification is pretty much universally condemned and has resulted in this years-long efforts to stop it through litigation and other methods, including appeals to the U.N. and the Organization of American States.
News reports and a Wikipedia history of the school belie the school’s claim that the GED is a method of last resort, used judiciously and only for the most harmful behavior. A former student reported that, beginning at age 8, electrodes were strapped to his legs and a 12-volt battery draped over his shoulders in a backpack. The electrodes, he says, remained there 24/7 for a decade, during which time he was shocked for relatively minor infractions like swearing, screaming, or refusing to follow directions, and even during his sleep. In 2002, another student was tied to a restraint board for seven hours and shocked 33 times, causing burns on his skin. In 2007, a student was shocked 77 times in one night when a prank caller pretended to be a staff member and instructed other staff to do so. (An extremely disturbing video of an incident came out in a 2012 civil trial. You can see a clip of the video, as well as students wearing the electrodes and backpack here.)
The FDA’s own investigation, reported in a 2016 proposed rule banning these devices, turned up additional evidence of the potential for, as well as actual, psychological and physical injuries in the medical literature, and from scientific experts, state authorities who had investigated complaints of injuries at JRC, health care professionals, and disability rights advocates, as well as from former JRC students and family members. This led the FDA to conclude there was either actual or potential risk of depression, fear, panic, aggression, catatonia, self-injury, burns, tissue damage, PTSD, learned helplessness, suicidal ideation, and heart palpitations, among others. There is also, of course, pain, which the FDA considers a negative but JRC sees as a feature, not a bug.
In a 2013, the U.N. special rapporteur on torture, Juan Mendez, presented a report to the U.N.’s Human Rights Council on so-called “treatments” for drug addiction and autism that he labeled “tantamount to torture or cruel, inhuman or degrading treatment.” The report singled out JRC, saying that
the rights of the students of the JRC subjected to . . . electric shock and physical means of restraints have been violated under the U.N. Convention against Torture and other international standards.
According to a Time article on the Mendez report, the U.S. Department of Justice (DOJ) was also investigating JRC. This was spurred by a 2009 letter to DOJ signed by 31 disability organizations asserting that JRC’s use of shock and other methods violated the Americans with Disabilities Act. Per the FDA’s review, the DOJ ultimately found the devices harmful and of uncertain effectiveness but decided not to proceed further.
Because the state funded students attending the school, officials in New York investigated as well. A 2006 report by the New York State Education Department found that the device was regularly used when there was no threat of serious physical harm or injury, including for such minor acts of noncompliance as failing to be neat, wrapping one’s foot around the leg of a chair, stopping work for more than ten seconds, and closing one’s eyes for more than five seconds.
In a matter not directly related to the electric shock device, but nevertheless indicating a lack of adherence to standards, Massachusetts fined the school almost $30,000 in 2009 for allowing 14 unlicensed clinicians to call themselves “psychologists”. Bills have been proposed in the Massachusetts legislature banning using electric shocks on students but they’ve not passed. To at least control, if not eliminate, the damage, Massachusetts authorities tried to restrict the use of the GED to fewer situations but, in another court victory, a state judge ruled in 2018 that JRC’s activities were legal and could continue.
In 2018, a coalition of advocacy groups tried yet another tack, this time writing to the Organization of American States, calling on it to demand that the U.S., one of 35 member states, impose a federal ban on shocking students.
The FDA’s ban
In 2016, the FDA issued a proposed rule banning these electric stimulation devices, which are, as noted, devices that deliver a shock to a person’s skin, when used to reduce or cease self-injurious behavior (SIB) or aggressive behavior (AB). The FDA finally issued a rule banning ESDs in March, 2020, after having reviewed hundreds of comments, both pro and con, received in response to its 2016 proposed rule. The “con” comments came almost exclusively from JRC staff, parents and guardians of students, and some former students. The “pros” came from everyone else.
Per the federal Food, Drug, and Cosmetic Act (FD&C Act) the FDA has the authority to ban a medical device presenting an “unreasonable and substantial risk of illness or injury”. Its analysis asks
whether the risks the device poses to individuals are important, material, or significant in relation to its benefits to the public health . . . and compares those risks and benefits to the risks and benefits posed by alternative treatments being used in current medical practice.
We’ve previously reviewed the risks. As for benefits, the FDA concluded both that the available evidence did not establish a durable conditioning effect for ESDs for this type of behavior and that
state-of-the-art treatments for SIB and AB are positive-based behavioral approaches along with pharmacotherapy, as appropriate. The medical community now broadly recognizes that conducting careful functional assessments and addressing the underlying causes of SIB and AB rather than suppressing behaviors with shocks not only avoids the risks posed by ESDs, but can achieve durable, long-term benefits.
In this regard, the FDA noted that
the overwhelming majority of patients exhibiting SIB or AB throughout the country are being treated without the use of EBD.
The FDA found, disturbingly, that the record belied JRC’s claim that the GED was used only when other methods failed. One expert testified that JRC’s methods of diagnosing individuals were outdated, did not include important information on how diagnoses were made, and were “kind of cut-and-paste”. The FDA found that formal functional behavioral assessments of students subjected to electric shocks were in many cases either not done or were inadequate. These assessments, the FDA said, were critical to implementing “empirically derived, individualized behavioral interventions”. Nor do the records adequately detail what interventions were attempted, how long they were tried, or what the effects were. The FDA particularly singled out JRC’s opposition to pharmacological therapies and its lack of effort in using them before employing electric shocks. In sum, without a proper diagnosis and functional assessment, an appropriate treatment plan could not be implemented and, in any event, evidence-based therapies were given insufficient consideration before JRC resorted to shocking its students.
JRC and parents and guardians of some students petitioned the U.S. Court of Appeals for the D.C. Circuit to vacate the ban. The petitioners argued that the evidence did not support the FDA’s decision, that the FDA lack the legal authority to issue the ban, and that the FDA had violated their constitutional rights in its decision-making process.
An impressive group filed a brief supporting the FDA, arguing the ban is well-supported by the evidence: the American Academy of Pediatrics, American Association on Intellectual and Developmental Disabilities, American Academy of Developmental Medicine and Dentistry, International Association for the Scientific Study of Intellectual and Developmental Disabilities, National Association of State Directors of Developmental Disabilities Services, National Association of State Directors of Special Education, and National Association for the Dually Diagnosed.
The Court begins its opinion with a curiously benign recitation of the facts, citing the procedural safeguards that must be met prior to using the GED. However, the Court fails to note that many of these safeguards do not apply to all students, nor does it raise any questions about whether these procedures are actually followed. The opinion does reveal that JRC “treats approximately 20% of its patients with this treatment at any one time”.
The Court, however, avoided reaching the question of supporting evidence by deciding the case based on an interpretation of the FDA’s authority to ban medical devices under the FD&C Act. Even though the statute clearly allows the FDA to approve medical devices for a particular use, and even though the statute clearly allows the FDA to ban a medical device, the Court ruled that the FD&C Act does not permit the FDA to ban a medical device if that ban applies only to a particular use, instead of for all uses. (Recall that the FDA’s ban applied only to using ESDs for SIB and AB, but not for other behaviors, like smoking.)
Why? Because of a provision in the FD&C Act which says
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 allows the previously noted off-label use medical devices. But as the FDA and the dissenting opinion point out (and I believe they are correct) this section applies only to the FDA’s authority over devices legally on the market, not to the section which specifically permits the FDA to ban a device. To read the FD&C Act otherwise leads to absurd results.
In essence, under the Court’s ruling, once a medical device is approved by the FDA for multiple uses, it cannot be banned for one use, no matter the evidence of harm or ineffectiveness, unless the FDA bans it for all purposes. Thus, a device that is proven dangerous and ineffective when used in a particular manner stays on the market. On the other hand, if a device cleared for only one use is later shown to present unreasonable risks, even if physicians are employing it off-label for other, effective and safe uses, banning it is no problem.
This dichotomy makes no sense, as the dissent points out, given the fact that the overarching goal of the FD&C Act is to protect consumers from unsafe medical devices. How does leaving a device on the market that the FDA specifically finds meets the standard Congress set for banning a device serve this purpose? And how does totally banning a device that physicians may well be using off-label for safe and beneficial purposes serve to safeguard the practice of medicine from FDA’s interference in cases where a partial ban is all that is needed to protect the public?
The FDA has 45 days to petition the U.S. Court of Appeals for the D.C. Circuit for a rehearing of the case en banc, that is, by all of the judges of the Court. The agency has 90 days to file a petition with the U.S. Supreme Court to review the Court of Appeals ruling. Given the rarity with which the FDA bans medical devices, it may choose to let the ruling stand and this barbaric practice will continue. The near-universal condemnation of this shocking device, on the other hand, should weigh in favor of seeing that it is banned for good.
