Court Rules on FDA Ban of Electrical Stimulation Treatment

The District of Columbia Circuit Court of Appeals issued a decision Tuesday regarding the Food and Drug Administration’s (FDA) controversial ban of the use of electrical stimulation devices as a treatment for self-harming individuals. The petitioner, the Judge Rotenberg Educational Center, Inc. (the Center), argued that the defendant lacked standing to make decisions regarding the implementation of medical devices in medical practices.

The Center is a facility that “treats patients with severe mental disabilities.” These disabilities can lead to the patients inflicting harm upon themselves, which the Center has sometimes treated using an electrical stimulation device. The device “briefly shocks patients causing them to reduce or cease their self-injurious behaviors.” Around 20% of patients are treated using this method, and the Center is the only facility in the country that uses this treatment on individuals who self-harm, the opinion said.

In early 2016, the FDA proposed banning the aforementioned treatment due to various psychological and physical risks they believed it presented to patients. These risks including depression, fear, escape and avoidance behaviors, panic, aggression, post-traumatic stress disorder, and more. The FDA added that the evidence to the device’s effectiveness was weak at best, leading them to assume legal authority and ban the device as a medical form of treatment for self-harming individuals. The plaintiff’s took issue with the defendant’s assumption of legal authority to ban the device, which they argued was an authority which the FDA did not possess.

There are two important statutes at the center of the dispute. One statute authorizes the FDA to ban medical devices entirely and one statute prohibits them from regulating the practice of medicine. The Center contended that these rules do not authorize the FDA to prohibit specific uses of devices, which is what they had done when they banned the electrical shock device as a specific treatment for self-harming individuals.

After reviewing the arguments of each side, the court concluded that Congress’s statute explaining that the FDA “is not to construe its statute so as to interfere with the practice of medicine,” is valid and is to be upheld. They favored the petitioners and concluded that the FDA could not enact the ban since they lacked the statutory authority to ban a medical device for a particular use.

The petitioners were represented by Eckert Seamans Cherin & Mellott, Hyman, Phelps & McNamara, Todd & Weld LLP, and Paik, Brewington & Deal.