Industries: Life Sciences

Government, Regulatory & Criminal Investigations

Life sciences companies, as well as their directors, officers and employees, face ever-increasing potential criminal and civil liabilities in this era of increased government scrutiny and oversight. The vehicles that have contributed to this increased risk include:

• Clearance and protection of trademarks and trade names
• Pro-government and pro-private relator amendments to the False Claims Act by the Fraud Enforcement and Recovery Act of 2009 (FERA) and the Patient Protection and Affordable Health Care Act of 2010
• Drastic increases in the amount of financial resources and government manpower devoted to investigations in the life sciences area
• Creation and expansion of federal and state task forces dedicated to Medicare and Medicaid fraud and abuse
• Incentives to states to adopt False Claims Act legislation and pursue state False Claims Act investigations and lawsuits
• Amendments to the U.S. Sentencing Guidelines designed to reward compliance and punish non-compliance

We have represented companies and individuals in the areas of criminal defense, related regulatory matters, and False Claims Act cases in the life sciences area. Our representations include the areas of non-target third-party investigatory subpoenas and inquiries; federal and state civil False Claims Act cases brought by the government and private relators; interaction with and negotiation of settlements and corporate integrity agreements with federal and state enforcement agencies including the U.S. Department of Justice, Health and Human Services, and state attorneys general; grand jury subpoenas and investigations; and post-indictment proceedings.

Our experience includes matters involving federal and state False Claims Acts; Food and Drug Administration regulations; federal and state anti-kickback fraud and abuse laws; federal and state self referral laws, including Stark; and internal and government-initiated investigations. In addition, our attorneys have represented clients and are well versed in maters involving the Foreign Corrupt Practices Act, government contracting, various securities laws, money laundering, and export controls.

Our ranks include:

• Former U.S. attorney for Virginia
• Former assistant U.S. attorneys
• Former state attorneys general
• Former DOJ task force attorneys
• Former U.S. SEC enforcement attorney

Many of our attorneys have conducted investigations and prosecutions on behalf of federal and state agencies in their roles prior to joining McGuireWoods, and are thereby equipped to bring an increased understanding of the government's deliberative and strategic decision making process to better serve clients. In order to ensure success, our government investigations attorneys also work alongside other practice area lawyers to prevent regulatory inquiries from becoming criminal issues. We regularly advise company management regarding the establishment of compliance programs on all issues.