DK Law Group LLP has just filed a class action in federal court in the Central District of California against the manufacturers of electroconvulsive therapy (ECT) devices on behalf of every person who has been injured by electroconvulsive therapy in California since May of 1982. Our 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.

This lawsuit is premised on the fact that the manufacturers had an obligation to perform research and clinical trials, report on the safety and effectiveness of their products, and accordingly, to educate the medical profession and the public about the safety of their devices. Marketing these devices despite a lack of professional and public knowledge about their inherent risks rendered them legally defective. To this day, there is no clinically established mechanism of action by which ECT treats mental illness.

Medical devices in the United States are fairly strictly regulated by the FDA under the Food, Drug & Cosmetic Act (FDCA), the Medical Device Amendments of 1976 (MDA), and the 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, with Class I devices as the least dangerous, and Class III as the most. Class III devices typically must satisfy a strict “premarket approval” or “PMA,” process, which requires that manufacturers provide a strong showing of safety and effectiveness before such devices can be placed on the market. However, when the Medical Device Amendments were passed in 1976, there were many existing devices, including ECT devices, that 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. This is called the “510(k)” process, which “clears” a device for access to the market, but does not technically render it “approved” by the FDA.

Despite being cleared for 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” whenever 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.

Our 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, in violation of federal law. Moreover, the lawsuit asserts that principles of state tort law required the manufacturers to comply with their federal reporting requirements by both reporting adverse events to the FDA and refraining from the manufacture and sale of their products after failing to submit applications for FDA approval. We also assert that a remedy of damages under state law is appropriate when medical device manufacturers cause harm to patients by violating those federal reporting requirements.

The majority of the states recognize an analogous state law cause of action, but grouping too many states into one lawsuit could threaten our ability to persuade a court to grant us certification as a class action lawsuit. This is because of the “predominance” requirement in federal class actions, which requires that common questions that are appropriately resolved through class-wide treatment predominate over individual issues. Therefore, in our view, the best way to proceed is to enlist the help of firms from other states in bringing numerous statewide class actions, or “mass torts” (groups of individual actions).

State and federal courts will inevitably vary in their willingness to certify class actions such as this. For example, here in California, while we hope to be granted class certification right off the bat in the lower federal district court, we are planning for the very real possibility of being denied class certification, and subsequent review of that denial by the Ninth Circuit Court of Appeals. Success in each case depends upon the state product liability law and the federal class action law in which the action is brought. There are no guarantees in this business, but we think the current federal laws in the Ninth Circuit, as well as the state laws of most of the states, potentially allow for class actions in these circumstances.

The FDA’s medical device regulations are designed to ensure that the devices used on patients are thoroughly studied and entirely safe. We hope that this lawsuit will serve as an impetus for manufacturers of ECT and other medical devices to take more seriously the FDA’s information reporting requirements, in order to ensure the safety and trust of consumers and patients throughout the nation.

If you or someone you know has been harmed by ECT at a medical or psychiatric facility, please contact our firm so that you can participate in this action. The California portion will be the first to proceed, but we are in contact with firms from other states that are willing to help file separate lawsuits based on the same legal theories shortly thereafter. You can reach us by phone at (805) 498-1212 or email us at [email protected]. In addition, to expedite your participation in this lawsuit, ectjustice.com has posted an ECT questionnaire through which you can recount and communicate to us your ECT experience.