Government enforcement agencies have long been focused on healthcare providers, pharmaceutical companies, and medical device manufacturers. Those efforts are likely to continue and expand as healthcare spending takes up a growing portion of government spending and the U.S. economy. The Food and Drug Administration, Department of Justice, Securities and Exchange Commission, and state attorneys general have poured resources into vigorous investigation and prosecution of fraud and abuse, and all signs point to an expanding commitment to this area of enforcement.
Venable's team combines seasoned enforcement lawyers, including former federal and state prosecutors, with subject matter specialists whose experience ranges across the entire spectrum of healthcare delivery in the United States. Our investigations and enforcement group, all of whom have substantial experience in defending against government investigations and conducting internal investigations, includes former prosecutors from the Department of Justice (including former assistant U.S. attorneys, and the Food and Drug Administration, including a former general counsel of the FDA) and former officials from the Enforcement Division of the Securities and Exchange Commission and other federal and state enforcement agencies.
We 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, and Securities and Exchange Commission, and work hand in glove with our substantive law experts. Venable has been advising healthcare clients for more than 40 years on matters ranging from Stark investigations (anti-kickback in government programs) to fraud claims, violations of cGMP, off-label sales and marketing practices, the False Claims Act, HIPAA, and the full range of parallel state laws. We bring a thorough understanding of the highly regulated healthcare landscape in which companies and individuals operate to all of our engagements.
If an allegation surfaces through an internal audit or the actions of a whistleblower, our attorneys will conduct a thorough internal investigation, sensitive to the need to find the truth while not disrupting the business operations of the client. We understand the stress and disruption that an internal investigation can cause for employees and management. Accordingly, we strive to conduct investigations in a timely manner that respects the organization's business needs, with as little impact on the organization's day-to-day operations as possible. We know the importance of investigations that are focused and thorough, yet discreet, yielding readily understandable results that enable our clients to formulate effective responses. We have extensive 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 the allegation arises in a government investigation or enforcement action, our attorneys prepare and guide companies and their employees through the unique hazards involved in civil and criminal investigations and enforcement processes. We recognize the complexities of multi-agency investigations that may include defending against federal, state, congressional, and international civil/criminal regulatory enforcement matters – often more than one of these occurs simultaneously. Finally, our team includes seasoned trial attorneys who are prepared to provide a vigorous defense in court or other proceedings, should circumstances necessitate such a course.
- Preventing violations
- Internal investigations
- Civil and criminal defense of organizations and individuals
- Pharmaceutical companies
- Hospitals and hospital networks
- Insurers and managed care
- Long-term and life care
- Medical staff organizations
- Physician groups
- Professional associations