No. 20-1087, 2021 U.S. App. LEXIS 18001
District of Columbia Circuit Court
July 6, 2021
Keywords: aggressive self-injurious behavior, developmental disabilities, Electrical Stimulation Device (ESD), Graduated Electronic Decelerator (GED), intellectual disabilities, legal authority, Massachusetts, practice of medicine, United States Food and Drug Administration (FDA)
Update: September 13, 2021 (see under Rulings)
Keywords: Electrical Stimulation Device (ESD), Graduated Electronic Decelerator (GED), United States Food and Drug Administration (“FDA”), aggressive self-injurious behavior, practice of medicine, intellectual disabilities, developmental disabilities, Massachusetts, legal authority
Summary & Facts of the Case
The Judge Rotenberg Educational Center in Massachusetts is a Center for people who have intellectual or developmental disabilities. The Center has, for many years, used a disputed therapy. The therapy uses a type of electrical stimulation device (ESD) called a graduated electronic decelerator (GED) to shock children and adults to try to correct aggressive or self-harm behavior. The Judge Rotenberg Educational Center is the only facility in the United States that uses this therapy.
In March 2020, the United States Food and Drug Administration (FDA) limited the use of the GED claiming the risk of harming people was far greater than any medical benefit.
Parents and guardians of people who are served at The Judge Rotenberg Educational Center sued the FDA in federal court. The lawsuit claimed that the FDA had no authority to ban the use of GED specifically to treat children and adults who are aggressive or harm themselves.
Issues of the Case
- Does the U.S. Food and Drug Administration have authority to ban a specific use of an otherwise legal medical device?
Arguments & Analysis
1. Does the U.S. Food and Drug Administration have authority to ban a specific use of an otherwise legal medical device?
Under the Medical Device Amendments to the Food, Drug, and Cosmetic Act, PL 94-295, 21 U.S.C. § 360f, the FDA can choose to forbid devices or ban them completely for safety reasons. However, under a different federal law, 21 U.S.C. § 396, the FDA does not have authority to interfere with the practice of medicine.
In this case, the FDA did not ban GEDs. Instead, the FDA tried to limit their use on people who have intellectual and developmental disabilities.
The parents and guardians of patients at the Judge Rotenberg Center claimed that the FDA’s ban on specific use of ESDs violated federal law. An authorized legal “ban” for safety reasons is different from a “restriction” on use. A restriction, such as preventing ESDs on specific people, should be left to the professional judgment of physicians.
They also argued that the FDA’s ban on the specific use of GED was contrary to federalism. In the United States, the Federal Government, and in this case the FDA, have limited powers. According to the Tenth Amendment of the U.S. Constitution, powers that are not assigned to the federal government belong to the states. For instance, the Federal Government can coin money, control the economy, and regulate the military. States have powers to create and regulate police and schools. The states also regulate medical practices. In this case, the parents and guardians of patients at the Judge Rotenberg Center claimed the FDA, a federal agency, was regulating a medical practice, a power that belongs to the states.
The U.S. Court of Appeals for the District of Columbia (D.C.) Circuit ruled that the FDA can ban a device, but once a device is approved, the FDA cannot ban specific uses. Controlling how a device is used, and the practice of medicine, is the responsibility of each state, unless specifically authorized by Congress.
Because the FDA did not have the authority to ban GED for specific uses, the U.S. Court of Appeals in a 2-1 decision ruled in favor of the Judge Rotenberg Center families.
On September 13, 2021, the FDA filed a motion to have the full DC Circuit reconsider their decision that struck down the FDA’s ban on electric shock devices. The FDA argues that the ruling restricts their authority to regulate medical devices in the future, preventing them from acting in the best interest of public health. The FDA is citing the “Chevron Deference” an important piece of administrative law that says courts should defer to a federal agency’s decision making as long as it is reasonable and the Congress has not taken up the exact question.
Chief Judge Sri Srinivasan wrote a dissenting opinion. It said because the FDA has authority to ban devices if there is an unreasonable or substantial risk of illness or injury, certain uses could be banned by the FDA depending on the varying risk.
The FDA determined there was a greater risk of harm associated with use of GEDs on people who have intellectual and developmental disabilities than other uses of ESDs – such as treatment for smoking addiction. Chief Judge Srinivasan argued if the FDA has the power to ban devices completely, why would Congress intend to prevent it from using the lesser power of restricting certain use?
Policy & Practice
Federal agencies have limited powers granted to them by Congress and limited by the U.S. Constitution. Federal laws passed by Congress are intended to protect the power of the States, including the power to regulate the practice of medicine.
- Full Case Brief – The Judge Rotenberg Educational Center, Inc. v. United States Food and Drug Administration et al., No. 20-1087, 2021 U.S. App. LEXIS 18001 (D.C. Cir. July 6, 2021) [ PDF ]
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