Internal and Government Investigations

• Representation of in vitro diagnostic testing company in connection with Federal and state inquiries related to potential violations of U.S. and state kickback, false claim, and Stark law statutes 
• Representation of mulltinational rolling stock manufacturer before the DOJ and South African regulators involving alleged violations of the U.S. FCPA and local corruption and money laundering statutes 
• Representation of multi-national medical device manufacturer in connection with a voluntary disclosure to the U.S. Department of Justice related to potential violations of the Foreign Corrupt Practices Act in China and various other jurisdictions
• Representation of multi-national rare disease pharmaceutical company in connection with an investigation into potential violations of the Foreign Corrupt Practices Act in Europe, Japan, and Latin America by the U.S. Department of Justice and Securities and Exchange Commission
• Representation of pharmaceutical company in connection with a U.S. Department of Justice subpoena and investigation into its patient support program, drug pricing, and specialty pharmacy relationships
• Representation of pharmaceutical company in connection with a U.S. Department of Justice subpoena and investigation into manufacturer rebates to pharmacy benefit managers
• Representation of a senior executive of a biopharmaceutical company in connection with a U.S. Department of Justice subpoena and investigation into donations to copay assistance charities
• Representation of an opioid manufacturer in connection with a multi-district federal investigation and a qui tam complaint focusing on promotional practices and alleging potential violations of the anti-kickback statute and False Claims Act, resulting in a $7.55 million civil-only settlement in the District of New Jersey
• Conducted internal investigation on behalf of a pharmaceutical company into whistleblower allegations of potential Anti-Kickback Statute violations related to company-sponsored clinical trials, investigator-initiated studies, and advisory boards

• Conducted internal investigation on behalf of a pharmaceutical company into allegations of pre-approval promotion, off label promotion, and other improper sales and marketing practices

Risk Assessments and Diligence

• Conducted global anti-bribery and anti-corruption compliance program assessment on behalf of multi-national pharmaceutical company
• Conducted proactive compliance market reviews on behalf of multinational pharmaceutical company in European markets
• Conducted anti-bribery and anti-corruption diligence on high-risk distributors in the Middle East, Asia-Pacific, and Latin America
• Conducted proactive compliance reviews of manufacturer patient support and assistance programs in view of U.S regulator guidance and enforcement on behalf of Fortune 100 pharmaceutical company

Compliance Counseling

• Enhanced and implemented global anti-bribery and anti-corruption compliance programs on behalf of multinational pharmaceutical and medical device companies
• Developed and implemented numerous corporate policies and procedures addressing interactions with healthcare professionals in the U.S. and abroad and due diligence and risk management of third parties