Where does the line fall between good faith and criminal intent? That was the question that a Massachusetts federal jury faced in July as it deliberated criminal charges against William Facteau and Patrick Fabian, ex-Acclarent executives, who were indicted on multiple charges of fraud and misbranding a medical device. Acclarent's device, the Relieva Stratus Microflow Spacer ("Stratus"), was cleared by the FDA for use as a spacer to maintain an opening in the sinus. Although the FDA expressly rejected Acclarant's request to expand the indicated use of the device to include delivery ...
Blog Editors
Recent Updates
- Medical Clinic’s Use of NDAs to Suppress Negative Online Reviews Violates Federal Consumer Review Fairness Act, Washington Federal Judge Finds
- Breaking Down the Legal Challenges Surrounding State Licensure Restrictions for Telehealth Providers
- Interested in Opening a Medical Spa? Here’s What You Need to Know
- Podcast: Key Changes in Finalized Antitrust Merger Guidelines – Diagnosing Health Care
- FDA Releases Draft Guidance on New Dietary Ingredient Notification Master Files for Dietary Supplements