Given the extent of government spending on healthcare, it is not surprising that the Food and Drug Administration, Department of Justice, and Securities and Exchange Commission have identified the healthcare industry as a focus for vigorously investigating and preventing fraud. The agencies continue to devote significant resources to this proposition and are expanding their respective taskforces.

Our team

Our former Assistant U.S. Attorneys, former officials in the Enforcement Division of the Securities and Exchange Commission, and former officials of the Department of Justice and the Food and Drug Administration, regularly advise clients on all aspects of investigation and litigation by the Department of Justice, Department of Health and Human Services, Food and Drug Administration or Securities and Exchange Commission.

Venable has been advising healthcare clients for more than 40 years. Our attorneys help clients avoid problems with Stark (anti-kickback in the government programs) matters, fraud claims, the False Claims Act, HIPAA and, if necessary, other parallel state laws. We also understand the highly regulated landscape in which companies and individuals operate in the healthcare arena.

Our approach

Our attorneys prepare and guide companies and their employees through parallel civil and criminal investigations. We recognize the complexities of multi-agency investigations that may include defending against federal, state, Congressional, and international civil/criminal regulatory enforcement matters and have represented companies regarding alleged violations of Good Manufacturing practices, Anti-kickback statutes, the False Claims Act, the Foreign Corrupt Practices Act, and sales and marketing practices. If a violation is alleged, our attorneys also have broad experience conducting domestic and international internal investigations to assess the validity of a claim and advise on remedial steps, including whether to self-report the conduct to the government. If necessary, we vehemently defend our clients in court or other proceedings.

REPRESENTATIVE EXPERIENCE

• Represented a client in state litigation in connection with Average Wholesale Price, Medicaid Rebate pricing and sales and marketing practices for a pharmaceutical manufacturer, and obtained a favorable settlement.
• Received a declination letter regarding a joint DOJ/FDA investigation of the Chief Medical Officer of a multi-national pharmaceutical company concerning an alleged failure to report regarding a product, and avoided Congressional testimony.
• Assisted a large generic drug manufacturer based overseas, but with a U.S. manufacturing and market presence, in wide-ranging criminal and civil investigations by the U.S. Department of Justice, coupled with administrative enforcement actions by the Food and Drug Administration. Among the issues involved in the case, the FDA issued warning letters and an Import Alert for the company's foreign facilities, and invoked the Application Integrity Policy as to one of the foreign facilities. In addition, the DOJ and FDA pursued a criminal and civil False Claims Act investigation.
• Represented an individual pharmaceutical company executive who has been advised that he is a witness in an investigation of off-label marketing and anti-kickback violations by FDA and USDOJ.