Government and Internal Investigations, Litigation, and Fraud, Waste and Abuse Compliance
Counsel that helps you navigate and defend government investigations or enforcement actions
Capabilities at a glance
- Full-service governmental investigation responses, including document requests, subpoenas, employee interviews, settlement negotiation and defense of regulatory enforcement actions.
- A substantial, nationally recognized team of more than 50 attorneys with experience in nearly every health care sector.
- Strong relationships with regulators from the DEA, DOJ, FDA, OIG/HHS, state attorneys general offices and more.
- A deep bench of attorneys that allows us to counsel clients through a 360-degree representation strategy, providing first-hand industry experience and an insider's view on risk identification, regulatory compliance and liability mitigation.
Ensuring our clients are prepared and proactive when responding to government investigations
At Quarles, we understand the health care industry is steeped in regulations that often create obstacles for even the most well-intentioned organizations and individuals. As the regulatory landscape changes, we help you stay proactive and prepared so you are ready to comply with new mandates and avoid regulatory missteps. We also analyze the risks and benefits to voluntarily disclosing any potentially false claims made to the government. In the event that you are facing potential prosecution or an enforcement action, we will help you develop a strategic response, including assessing risks and mitigation actions to any inquiries or subpoenas. We also help you carry out internal investigations to identify risks before they arise. Our attorneys have deep understanding of the health care and pharmaceutical industries as well as experience with state attorneys general offices, the DEA, DOJ, FDA and OIG/HHS, among other agencies.
Health care industry attorneys with broad and deep experience
The world of health care compliance, litigation, fraud and abuse can seem like a maze, and you need attorneys with the confidence and contacts to help you navigate it. Our team's diverse background includes former high-level government officials, former prosecutors from state attorneys general offices, the U.S. Attorney’s Office and the Department of Justice (DOJ), former agency lawyers from the U.S. Department of Health and Human Services (HHS), Office of the Inspector General (OIG), the Drug Enforcement Administration (DEA) and the Food and Drug Administration (FDA), in addition to industry experts and former health care professionals such as pharmacists, nurses and therapists.
Our clients include organizations from nearly every health care sector, including:
- Hospitals and health systems
- Pharmaceutical retailers, wholesalers, distributors and manufacturers
- Medical technology and device manufacturers and distributors
- Retail and wholesale pharmacies
- Durable medical equipment suppliers
- Physician clinics
- Long-term care facilities
- Home health agencies
- Behavioral health entities, including substance abuse providers
- Pharmacy benefit managers
- Clinical laboratories
- Insurance companies
Experience
- False Claims Act investigations and defense of subpoenas and whistleblower actions
- Internal investigations
- Self-disclosures to HHS-OIG
- Fraud and abuse risk analyses, compliance and defense
- Advice on HHS suspension and exclusion regulations
- Regulatory compliance investigations involving the DEA and other state and federal agencies
- Regulatory compliance advice and analysis of FDA regulations and laws
- HIPAA compliance and governmental enforcement actions
- Pharmaceutical and medical device manufacturers involved in commercial and tort litigation
- Professional liability and disciplinary licensing proceedings
- General business litigation for health care clients in courts and arbitration
Successes
- Provided pharmaceutical law guidance to defend a Fortune 100 company under investigation pursuant to the False Claims Act. Achieved a favorable settlement with the U.S. Attorney’s Office, SDNY, multiple states and relator.
- Supervised the collection and review of millions of documents in a federal OIG administrative subpoena in a Medicare fraud qui tam investigation, interfaced with assistant U.S. attorney to reduce scope of subpoena, managed production issue and reduced risk to client after government declined to intervene and relator voluntarily dismissed fraud claims with prejudice.
