Corruption and FCPA Violations in the Medical Device Industry
1 Hour Video | Peter S. Spivack, Hogan Lovells US LLP
FCPA and worldwide anti-corruption enforcement activities in the life science industry are receiving increased attention with over $142 million in fines collected by DOJ and the SEC in 2012 alone. The current list of FCPA-related investigations for medical device companies is lengthy and penalties are substantial, with Johnson & Johnson having paid out the largest settlement resulting in approximately $70 million in fines. These activities demonstrate an ongoing trend that industry legal and regulatory professionals are well aware of – they have and will continue to be subject to heavily stringent FCPA oversight. The following presentation will provide attendees with further insight into the scope, nature and influence of corruption in the life science industry, while assessing the government and regulators’ capacity to manage and mitigate corruption within the US healthcare system.
- Update on current regulatory and enforcement activities
- Where are FCPA violations occurring and why
- Analysis of recent court cases and their impact – United States v. Esquenazi and United States v. Straub
- Framing compliance programs for best practices
- Recommendations for risk mitigation and compliance enhancement
Participants that will find this webinar most beneficial will be those involved in medical device companies. Job titles of attendees that will be most applicable for this session will be:
- Regulatory Affairs
- Legal Counsel
This webinar has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for up to 1.5 credits towards a participant’s RAC recertification upon full completion.
Peter Spivack is the Co-Leader of the Investigations, White Collar and Fraud Practice Area. His experience in the criminal arena includes antitrust, environmental, Foreign Corrupt Practices Act (FCPA), government contract, and healthcare matters. Peter has worked with numerous companies and organizations in defending grand jury investigations, as well as conducting compliance audits and internal investigations and monitoring and improving compliance programs. In addition, Peter has handled a wide array of civil matters, including False Claims Act and international trade litigation.
Peter has extensive experience in working with multi-jurisdictional investigations, including matters involving allegations of bribery and corruption under the FCPA, the UK Bribery Act, and other anti-bribery laws. He has represented companies and individuals in investigations brought by multilateral institutions such as the World Bank and Inter-American Development Bank. Peter also has considerable experience in representing entities and individuals in criminal and civil enforcement matters involving healthcare, government contracts, competition, and antitrust issues.
From 1988 to 1989, Peter clerked for The Honorable William D. Keller of the U.S. District Court for the Central District of California. The following year, he clerked for The Honorable Arthur Alarcon of the U.S. Court of Appeals for the Ninth Circuit. From October 1990 through March 1997, Peter was a federal prosecutor focusing on the investigation and prosecution of complex white collar criminal matters involving corporations and individuals. Most of his investigations involved parallel enforcement actions by federal and state agencies, including the U.S. Securities and Exchange Commission, as well as parallel federal and state civil litigation. In November 1994, Peter received an award from the U.S. Attorney General for superior performance as an Assistant U.S. Attorney.
Peter writes and speaks frequently on federal criminal issues. He has played an active role in the bar, serving as a past Co-chair of the Health Care Fraud Subcommittee and of the D.C. Region for the ABA White Collar Crime Committee and as a past Co-chair of the Criminal Law and Individual Rights Committee for the D.C. Bar.