Medical device maker Chief of Sales of Acclarant Inc. convicted by federal jury for distributing misbranded med devices

William Facteau, 47, and Patrick Fabian, 49,The former Chief Executive Officer and Vice President of Sales of Acclarent, Inc., a medical device company, were convicted by a Boston federal jury in connection with distributing adulterated and misbranded medical devices. Œ The jury concluded that Facteau and Fabian caused the unlawful distribution of a medical device known as the Relieva Stratus Microflow Spacer (“Stratus”) for uses not cleared or approved by the U.S. Food and Drug Administration.Œ Despite the fact that the company had told the FDA that the Stratus was a medical device intended to maintain an opening to a patient’s sinus, Facteau and Fabian launched the product intending it to be used as a steroid delivery device.Œ The FDA, however, had specifically refused Acclarent’s request to clear the Stratus for marketing as a drug delivery device without further submissions to support that use.

The evidence at trial demonstrated that Facteau and Fabian sought to quickly develop and market products, including the Stratus as a drug delivery device, to create a projected revenue stream that would make Acclarent an attractive business for either an initial public offering or acquisition.

The charge of violating the Food, Drug and Cosmetics Act provides for a sentence of no greater than one year in prison on each count, one year of supervised release and fine of $100,000 or twice the gross gain or loss.ΠActual sentences for federal crimes are typically less than the maximum penalties.ΠSentences are imposed by a federal district court judge based upon the U.S. Sentencing Guidelines and other statutory factors.

United States Attorney Carmen M. Ortiz; Harold H. Shaw, Special Agent in Charge of the Federal Bureau of Investigation, Boston Field Division; Jeffrey Ebersole, SpecialŒ Agent in Charge of the U.S. Food and Drug Administration, Office of Criminal Investigations, New York Field Office; Phillip Coyne, Special Agent in Charge of the U.S. Department of Health and Human Services, Office of the Inspector General, Office of Investigations; Craig Rupert, Special Agent in Charge of the Department of Defense, Office of Inspector General, Defense Criminal Investigative Service, Northeastern Field Office; and Jeffrey Hughes, Special Agent in Charge of the U.S. Department of Veterans Affairs, Office of Inspector General, Northeast Field Office.Œ The case is being prosecuted by Assistant U.S. Attorneys Sara Miron Bloom, Patrick Callahan and William Weinreb of Ortiz’s Criminal Division with the assistance of Trial Attorney Raquel Toledo of the Justice Department’s Consumer Protection Branch and Beth Weinman of the FDA’s Office of General Counsel.

Jeffrey Newman represents whistleblowers