Ralph Caccia Offers Compliance Tips for Medical Device Manufacturers

October 16, 2014

Ralph J. Caccia, a partner in Wiley Rein’s White Collar Defense & Government Investigations Practice, gave a presentation at last week’s AdvaMed 2014 conference, and his remarks were covered extensively by Bloomberg BNA’s Medical Devices Law & Industry Report.

Mr. Caccia was featured on a panel that focused on steps medical device manufacturers can take to avoid certain types of compliance failures that have led to enforcement action against some drug companies.  The panel was chaired by Sonali P. Gunawardhana, an attorney in Wiley Rein’s Food & Drug Law Practice.

The U.S. Department of Justice (DOJ) has indicated that its enforcement approach for the pharmaceutical industry “is the model for medical devices,” said Mr. Caccia, a former federal prosecutor.  He added that the DOJ is increasingly relying on whistleblowers to police the medical device industry.

“The single most important thing you can do, and it is not a catchphrase, is establish a culture of compliance,” he said.  “It is really, really, really important that folks feel vested and believe they are working at a company that is committed to doing the right thing.”