Healthcare Litigation & Enforcement
McGuireWoods’ Healthcare Litigation & Enforcement Practice Group includes former U.S. attorneys and other federal prosecutors, enforcement officials with direct agency experience, federal and state appellate and trial court clerks, arbitration neutrals and trial lawyers with years of experience in the healthcare industry.
Our nationally recognized team of trial lawyers and white collar litigators focuses on the healthcare industry, handling disputes in state and federal courts, regulatory agencies, and mediations and arbitrations.
We represent healthcare and life sciences companies subject to government fraud enforcement investigations and actions. The team includes top attorneys from our nationally recognized Government Investigations & White Collar Litigation Practice Group and our Chambers-ranked Healthcare Department,.
We offer insight into government tactics and policy and, through the relationships our team established, and our credibility, often persuade prosecutors and agency officials to decline prosecution or avoid action in criminal, civil, qui tam and regulatory enforcement matters.
We understand the investigatory process and advise clients on how to respond properly to investigators and agents. Our attorneys have handled hundreds of trials throughout the United States. And the team’s experience includes declinations to prosecute under the FCA and criminal statutes as well as dismissal of charges post-indictment.
The group combines litigation and enforcement strength with McGuireWoods’ leading regulatory capabilities across the healthcare sector. This multidisciplinary offering, along with our lawyers’ dedication to and knowledge of clients’ businesses and the issues they face, means we provide practical advice and representation to address legal challenges that may arise.
Our clients include:
- managed care and health insurance companies;
- health systems, academic medical centers and hospitals;
- large physician groups;
- ambulatory surgery centers;
- medical device manufacturers;
- pharmaceutical manufacturers;
- dialysis facilities and renal providers;
- pharmaceutical distributors;
- skilled nursing facilities;
- laboratories;
- compounding pharmacies;
- home health and hospice companies;
- durable medical equipment providers; and
- clinical research firms.
How We Help
The team’s focus areas include:
- federal False Claims Act, Anti-Kickback Statute, Stark Law and analogous state laws;
- government audits and investigations;
- enforcement proceedings;
- compliance matters, including internal investigations, training, program establishment, and adoption of policies and procedures;
- managed care disputes, including claims disputes and provider disputes;
- Medicare and Medicaid fraud, reimbursement and billing issues;
- overpayment recoveries;
- joint venture disputes;
- medical licensure and privileging issues;
- noncompete disputes
- healthcare RICO;
- class actions;
- pharmaceutical pricing and distribution disputes;
- ERISA litigation;
- antitrust challenges;
- labor and employment litigation;
- federal and state criminal fraud and abuse provisions;
- federal and state privacy laws, including HIPAA;
- corporate practice of medicine restrictions;
- telehealth regulations;
- research misconduct and clinical trial fraud;
- drug and device manufacturing, distribution, and promotion;
- drug and device recalls and safety reporting;
- drug diversion and the Drug Supply Chain Security Act;
- Food and Drug Administration inspections, Form 483s and warning letters;
- nursing home care fraud;
- Medicare and Medicaid conditions of participation;
- Tricare; and
- federal procurement laws and regulations.
We advise clients on matters initiated or overseen by federal and state agencies including:
- Centers for Medicare and Medicaid Services and its intermediaries;
- Office of Inspector General and the Department of Health and Human Services Office of Research Integrity;
- Drug Enforcement Agency;
- Department of Labor;
- Department of Energy;
- Food and Drug Administration;
- Department of Justice; and
- state health departments, attorneys general, boards of pharmacy and professional licensing boards.
Representative Experience
- Fortune 500 Medicaid and Medicare Advantage managed care organization in provider payment and overpayment disputes around the country, including arbitrations, state courts and federal courts;
- Owners of compounding pharmacy in securing dismissal of a federal indictment for alleged drug diversion and money laundering;
- Medical device company executive in connection with a qui tam lawsuit alleging kickbacks and overcharging on Medicare-related payments;
- North Carolina academic health system in a medical malpractice claim, winning affirmance for the client, preserving the judgment that dismissed all claims against the health system on personal jurisdiction grounds;
- Large independent medical practices in a tortious interference action seeking relief from a noncompete with a competitor for a group of physicians wanting to join the client’s practice;
- Health plan as lead counsel defending a class and collective action alleging misclassification of approximately 900 care management employees;
- Pharmaceutical company focused on pain medicines, as special counsel for opioid litigation, helping lead the company through litigation and government investigations;
- Former owners of a pharmacy company in a joint federal and state FCA investigation and federal criminal investigation related to allegations of improper provision of pharmaceuticals to nursing home patients and illegal kickbacks in connection with customer contracts and sale of business;
- Largest private operator of healthcare facilities in defense of allegations by a qui tam plaintiff that the company fraudulently billed Medicare and Medicaid for unnecessary medical procedures; and
- Physician practice that had a relationship with a local health system that allegedly violated the Anti-Kickback Statute and False Claims Act.
McGuireWoods’ Healthcare Litigation & Enforcement Practice Group guides clients through bet-the-company litigation and advises them on compliance, fraud and abuse, and other regulatory and statutory hurdles.
Ranked in North Carolina, Virginia and Pittsburgh for litigation: general commercial, and in Virginia for litigation: white-collar crime and government investigations.
– CHAMBERS USA
Ranked nationally in corporate investigations and white collar criminal defense.
– THE LEGAL 500 U.S.
