On September 11, 2017, DK Law Group LLP filed a class action in federal court against the manufacturers of Electroconvulsive Therapy devices (ECT) on behalf of every person who has been injured by electroconvulsive therapy in California since May of 1982. The lawsuit is based on traditional state-law negligence principles, and the manufacturers’ failure to comply with their obligations to the FDA.
ECT has been around for nearly eighty years, since about 1938. Since then, the practice has become widespread, even though the psychiatric community has never conclusively established any particular mechanism of action through which ECT treats any type of mental illness.
Medical Device Regulation
Medical devices in the United States are strictly regulated by the FDA under the
- Food, Drug & Cosmetic Act (FDCA),
- Medical Device Amendments of 1976 (MDA),
- and Safe Medical Devices Act of 1990 (SMDA).
The Medical Device Amendments determined that medical devices would be classified into three categories based on their safety and effectiveness.
Devices that present significant risks are classified into Class III, and these devices typically must satisfy a strict “premarket approval” process, which requires that manufacturers provide a strong showing of safety and effectiveness before such devices can be placed on the market. ECT Devices are classified as Class III.
ECT Devices “Grandfathered in”
When the Medical Device Amendments were passed in 1976, there were many existing devices, including ECT, which were allowed on the market without satisfying the premarket approval standard. Instead, they were “grandfathered in” as devices marketed before the MDA, or devices substantially similar to such pre-amendment devices.
Failure to Report
Despite being granted access to the market, manufacturers of devices that have been “grandfathered in” still must furnish certain information to the FDA. For example, under the MDA and SMDA, such manufacturers must report to the FDA all information reasonably known when their devices may have contributed to a death or serious injury. The “reasonably known” standard is broad, and requires a manufacturer to seek out information pertaining to adverse events resulting from use of their devices, instead of passively waiting for the information to reach them.
The DK Law Group’s lawsuit alleges that the manufacturers of ECT devices failed to meet these requirements, and as a result, placed a dangerous product on the market without an adequate warning.
ECT Victims Sought
If you or someone you know has been been injured by electroconvulsive therapy in California since May of 1982, please fill out our questionnaire to potentially participate in this class action. Victims injured by ECT in other states are also encouraged to fill out the questionnaire in anticipation that the class action will soon expand beyond California.