Sign Up for Audioconference: Off-Label Marketing Enforcement and Risks for Medical Device Companies and Service Providers
Join me and Michael Ruggio on May 31, 2012, at 11:30 AM for an audio conference Off-Label Marketing Enforcement and Risks for Medical Device Companies and Service Providers.
Headline after headline reports corporate settlements and criminal prosecutions against medical device companies and health care providers for off-label marketing violations. This audio conference will update the current trends and compliance strategies relating to off-label marketing of medical devices, and the publicity and purchasing oversight implications for healthcare providers. The speakers will provide participants with an explanation of the legal basis for the off-label marketing prohibition, current enforcement activities and risks relating to off-label marketing conduct, and provide helpful insights on anticipated trends in this important enforcement and compliance area.
The risk to medical device companies and service providers is increasing, and the government is developing new approaches to investigate and prosecute medical device companies and service providers. This the audio conference outline effective compliance strategies for companies operating in the health care industry.
This audio conference covers:
- Current enforcement and prosecution tactics targeting medical device companies and health care service providers for off-label marketing violations
- The specific risks for medical device companies
- The specific risks for service providers
- The importance of proactive compliance programs
- The need for new and innovative compliance programs
About the speakers:
Michael Volkov is a shareholder at the law firm of LeClair Ryan. His practice focuses on white collar defense, corporate compliance, internal investigations, and regulatory enforcement matters. He is a former federal prosecutor with almost 30 years of experience in a variety of government positions and private practice. Michael served for more than 17 years as a federal prosecutor in the US Attorney’s Office in the District of Columbia; for five years as the Chief Crime and Terrorism Counsel for the Senate Judiciary Committee, and Chief Crime, Terrorism and Homeland Security Counsel for the Senate and House Judiciary Committees; and as a trial attorney in the Antitrust Division of the US Department of Justice. He has extensive trial experience and has been lead attorney in more than 75 jury trials.
Michael Ruggio is a shareholder at the law firm of LeClair Ryan. He focuses his practice on healthcare litigation and healthcare matters with an emphasis on representing hospitals and other healthcare providers, including medical device and pharmaceutical corporations and their respective officers and directors, in matters relating to FDA procurement and litigation, as well as institutional and physician integrative medicine representation and healthcare fraud and abuse. He has extensive experience in healthcare antitrust matters, anti-kickback, Stark and HIPAA. He has been involved in numerous pharmaceutical, e-health technology, and bio-health cases concerning average wholesale pricing issues, reimbursement fraud, medical necessity and other related matters. Michael represents medical device and pharmaceutical companies in product liability litigation and FDA compliance. He serves as outside general counsel for the American Association of Health Freedom and Optimal Health, P.C. He also advises corporations in issues relating to compliance with the Foreign Corrupt Practices Act.