Officers and directors of Irish and Northern Irish companies whose products would be regulated by the US Food and Drug Administration (life sciences companies, specifically) should be aware of developments on the issue of individual prosecution under the FDCA for company violations of that statute. AGG partner Alan Minsk and associate Alex Foster have written an update that is new to AGG’s Knowledge Center.
The update discusses how two former senior executives were indicted with violations of the Federal Food, Drug, and Cosmetic Act (FDCA) relating to the introduction of adulterated or misbranded medical devices into interstate commerce. The indictment alleges that the two executives marketed a device for uses not approved by the Food and Drug Administration (FDA), i.e., off-label uses. The executives have not been convicted.
The two executives will be prosecuted by the Justice Department, with the assistance of FDA’s Office of Chief Counsel. The case shows that there can be potential individual liability for the adulteration or misbranding of medical devices, and there are many agencies interested in prosecuting these cases. The United States Supreme Court has upheld individual prosecution under the FDCA where the individual defendants are in a position of responsibility to stop the violation.