Practice

Healthcare Litigation

Navigating health law while protecting your interests

Given the complex regulatory, technological and policy landscape for the provision of healthcare, providers and payers will inevitably become involved in disputes with contractual counterparties or with the government. Our Healthcare Litigation practice can help you protect your interests in commercial litigation and civil disputes, internal investigations and enforcement actions.

Our experience in navigating these disputes can help you analyze your situation, develop and implement an effective legal strategy and align that strategy with your short- and long-term business goals and minimize your risk and potential disruption.

Foley Hoag’s Healthcare Litigation Practice offers in-depth counsel of litigation, regulatory and investigatory matters, coverage, reimbursement, liability control and risk management issues facing clients in the healthcare industry. Comprised of attorneys with extensive experience in all facets of health law, Foley Hoag is uniquely equipped to advise clients in every phase of the dispute process for all manner of civil disputes.

With special emphasis on compliance, regulatory and transactional legal issues, we have represented:
  • Leading hospitals and health systems
  • Healthcare trade associations
  • Health insurers
  • Pharmaceutical companies
  • Medical device companies
Our healthcare litigators defend clients in disputes alleging kickbacks, overpayments and billing and coding problems as well as matters regarding health information privacy and security. Our representative matters also include lawsuits against the state and federal government including challenges to laws and regulations, payor-provider agreement disputes and other commercial disputes. Foley Hoag also advises clients on how to establish and maintain effective compliance programs to avoid enforcement actions.

Areas of Focus

Our deep experience in healthcare litigation includes:
  • Business and commercial litigation
  • Civil disputes
  • Internal investigations
  • Enforcement actions
  • Regulatory and investigatory matters
  • Coverage
  • Reimbursement
  • Liability control
  • Risk management

Experience

CHALLENGES TO HEALTHCARE STATUTES, REGULATIONS AND POLICIES
  • Represented a national trade association for pharmacy benefit managers in federal litigation, successfully invalidated state law on drug pricing on Medicare Part D preemption grounds. This representation included persuading the Eighth Circuit Court of Appeals to reverse the lower court’s judgment denying preemption under Medicare Part D
  • Represented manufacturer of durable medical equipment in a challenge under the Administrative Procedures Act to Medicare’s decision to retract coding policy for a particular class of durable medical equipmenT
  • Represented a generic drug manufacturer in a challenge under the Administrative Procedures Act to the FDA’s determination that the manufacturer had forfeited its right to 180-day exclusivity for being the first-to-file an Abbreviated New Drug Application
  • Authored amicus briefs in the D.C. Circuit and United States Supreme Court on behalf of hospital trade association opposing a challenge to Medicare Part B payment policies for 340B drugs
  • Authored an amicus brief to the United States Supreme Court on behalf of a coalition of health scholars in support of cert petition by Federally Qualified Health Center regarding payments from Texas Medicaid program

DEFENSE OF HEALTHCARE ENTITIES FACING FEDERAL AND STATE ENFORCEMENT ACTIONS
  • Representing a dental services organization in enforcement action alleging violation of state consumer protection laws
  • Represented healthcare provider in reimbursement appeal arising out of Medicare related-party principles; provider prevailed after administrative hearing
  • Engaged by a Fortune 50 Life Sciences company to represent it in connection with an anti-kickback and off-label promotion investigation by the Department of Justice and the U.S. Attorney’s Office for the District of Tennessee; investigation concluded with a declination by the government and a voluntary dismissal of the Qui Tam complaint by the relator 
  • Successfully defended an independent physician association against claims under the federal anti-kickback statute
  • Represented a Fortune 100 Life Sciences company to coordinate the investigation of suspected FCPA (bribery) violations in India, Ukraine, China and Brazil, and to advise the company’s Internal Audit Department on conducting FCPA audits to ensure compliance

MANAGEMENT OF FEDERAL AND STATE INVESTIGATIONS, SUBPOENAS AND RELATED INQUIRIES  
  • Successfully resolved State Attorney General investigation of home health agency related to allegations of overbilling
  • Represented a midsize pharmaceutical company in an anti-kickback/False Claims Act investigation by the Department of Justice and the U.S. Attorney’s Office for the Southern District of New York related to speaker programs
  • Engaged to represent several current and former employees of a Life Sciences company under investigation for alleged violations of the Food, Drug and Cosmetic Act and alleged violations of Good Manufacturing Practices
  • Represented corporate executives at subsidiaries of a multinational dialysis company in Spain, Portugal, Morocco and Germany in connection with a DOJ/SEC FCPA (anti-bribery) investigation
  • Engaged to represent the CEO of a Heart Monitoring company in a False Claims Act investigation by the Department of Justice and the U.S. Attorney’s Office in New Jersey; no charges brought against our client

DISPUTES REGARDING HEALTHCARE PAYMENT AND POLICIES
  • Negotiated favorable settlement for large health care payor in litigation arising under the Federal Employees Health Benefits Act 
  • Representation of health insurer in response to litigation seeking reinstatement for a terminated provider
  • Represented a national health insurance company in responding to an investigation and lawsuit by a state attorney general’s office
  • Counsel for national health insurance marketplace and individual health insurer in litigation brought by state attorney general regarding health insurance products and sales practices regarding those products

INTERNAL INVESTIGATIONS AND MONITORSHIPS FOR HEALTHCARE PROVIDERS
  • Conducted internal investigation for regional healthcare system related to high-profile incident of patient who was unable to access the emergency department
  • Conducted internal investigation for academic medical center related to allegations of impropriety in physician training
  • Represented a multinational medical device company in connection with an internal investigation related to the distribution of certain lab tests and a submission to the FDA regarding same to stave off a potential referral to DOJ to investigate potential FDCA violations
 
ADVICE REGARDING COMPLIANCE PROGRAMS
  • Conducted review and analysis of health care compliance plan of publicly-held pharmaceutical company with over $2 billion in annual revenues and 8,500 employees
  • Advised medical device and pharmaceutical manufacturers on federal and state "sunshine" laws regarding payments to physicians
  • Counsel for state-wide integrated home health organization in responding to annual Medicaid audits
  • Advised regional hospital system regarding improvements to its compliance program in connection with and in advance of potential settlement
  • Conducted a global FCPA (anti-bribery) compliance review for a multinational pharmacy chain following its acquistion of a global competitor, including directing forensic reviews of the acquiree’s operations in the Middle East, Asia and Europe