HEALTHCARE ENFORCEMENT QUICK FACTS

Attorneys focused on ensuring that clients in a heavily regulated industry are well-positioned to avoid civil and criminal exposure in several areas, including:

    GMP regulations

    Off-label promotion

    Anti-kickback statutes and Stark laws

    Pharmaceutical pricing

    Foreign Corrupt Practices Act

    False Claims Act

    Qui tam representation

    Whistleblower protection

 

PRACTICE FOCUS

Preventing violations

Compliance

Internal investigations

Civil and criminal defense of organizations and individuals

 

CLIENT FOCUS

Pharmaceutical companies

Hospitals and hospital networks

Insurers and managed care

Long-term and life care

Medical staff organizations

Physician groups

Professional associations

 

Healthcare and Pharmaceutical Enforcement

an agency priority


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. 

Our team

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.

Our approach

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.  

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 multinational pharmaceutical company concerning an alleged failure to report regarding a product. Working with Venable's Legislative group, client also avoided testimony before Congress.
  • Represented 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 with regard to one of the foreign facilities. In addition, the DOJ and FDA pursued a criminal and civil False Claims Act investigation. The investigations resulted in a comprehensive civil, criminal, and administrative settlement that allowed the company to continue to maintain a robust presence in the United States market.
  • Represented an individual pharmaceutical company executive who was advised that he was a witness in an investigation of off-label marketing and anti-kickback violations by FDA and USDOJ. Investigation resulted in no action against the individual.