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.

View text of lawsuit here.

ECT Victims Sought

If you or someone you know has been been injured by electroconvulsive therapy in California, contact DK Law at (805) 498-1212 or by email at ECT@dk4law.com.

In addition, all ECT survivors (whether injured in California or not) are encouraged to fill out the ECT Justice questionnaire.  ECT Justice will attempt to notify you as we learn of opportunities to participate in legal actions in other states and countries.

WASHINGTON, Aug. 24, 2017 /PRNewswire/ — Attorney Jonathan Emord and his co-counsel Kendrick Moxon have filed a Supplement to their Citizen Petition of August 2016, protesting the FDA’s Proposed Order to reclassify and make more readily available the Electroconvulsive Therapy (ECT) Device used to give “shock-treatment.”  The reclassification would make it easier for doctors to give the treatment.

Shock treatment is well-known as the punishment given actor Jack Nicholson in the movie One Flew Over the Cuckoo’s Nest.  More recently it was portrayed in the TV series Homeland when given to the star, destroying her memory and intelligence. Memory loss and brain damage are the central issue in the attorneys’ filing.

This is shaping up to be a David and Goliath scenario with individuals damaged by ECT on one side and the FDA, under pressure from the industry that profits from ECT, on the other.

Click here to read entire article.

WASHINGTON, Aug. 25, 2016 /PRNewswire/ — In December 2015, the FDA issued a proposed order to down-classify the device used to deliver electroshock therapy. Today, Attorney Jonathan Emord filed a Citizens Petition with the FDA on behalf of 5 individuals who were damaged by electroshock.

I hope this is the beginning of the path to do away with shock [ECT]. Hopefully it’ll go the way of lobotomies, another ‘miracle treatment’.
ECT survivor, shocked as a teenager.

Most people surveyed thought electroshock therapy, also called electroconvulsive therapy or ECT, did go the way of lobotomies. In fact, a conservative estimate is that over 100,000 individuals receive electroshock therapy each year in the U.S. Actual numbers are not available because there is no tracking of this.

Click here to read complete article.