Alexandra M Gorman represents pharmaceutical, medical device and biotech companies, and healthcare providers in connection with civil and criminal investigations, as well as in litigation, enforcement and regulatory matters.
Ms Gorman has represented numerous pharmaceutical and medical device manufacturers, health maintenance organisations and corporations in False Claims Act and criminal or civil investigations and litigation by the US Department of Justice. She has significant experience conducting internal investigations relating to the federal and state anti-kickback statutes, off-label promotion, Stark law, Medicare and Medicaid reimbursement, and other allegations of healthcare fraud and abuse. Ms Gorman has counseled healthcare companies and individuals in connection with the Foreign Corrupt Practices Act, Food and Drug Administration, Office of Inspector General and other agency regulations. Ms Gorman regularly advises clients on regulatory compliance matters, including voluntary disclosure of potential statutory and regulatory violations to appropriate government agencies and compliance with federal regulations regarding sales, marketing and pricing practices, medical affairs and clinical research. She also has managed discovery, settlement and pretrial proceedings on behalf of pharmaceutical clients in products liability actions in Massachusetts.