Experience
Negotiation of Settlement in Misbranding Law Matter
We represented a physician who had been designated as a “target” of a federal grand jury investigation focusing on FDA allegations of misbranding. The client along with other oncologists potentially faced numerous felony charges. We successfully defended the physician, resulting in a plea agreement to a single misdemeanor, favorable resolution of all civil matters including false claims act violations and no debarment of physician.
Validation Study
Crafted the terms and operation of a post-market surveillance validation study for an orthopaedic implant manufacturer. Worked with Beacon, the coordinating hospital and the FDA to organize, coordinate and facilitate the study, as well as negotiated the terms of the study and the reporting of data and study results. Also worked with client to put together an institutional review board and ensured that privacy rights and other compliance matters were handled accordingly throughout study.