Cases & Deals

Medical device company defends investigations by U.S. Attorney's Office, FBI and FDA's Office of Criminal Investigation regarding 510K issues and representations to the FDA

Client(s) Medical device company

Jones Day represented a medical device company in an investigation by a U.S. Attorney's Office, in conjunction with the FBI and FDA's Office of Criminal Investigation, regarding representations to the agency and whether the client was distributing unapproved medical devices. After completing the document production in response to subpoenas and agent interviews of many current and former employees, we made presentations to the investigating authorities which resulted in no action against our client or any individual.