Healthcare Investigations/Enforcement Litigation HEALTHCARE AND PHARMACEUTICALS

WilmerHale’s investigations and criminal litigation practice is second to none. We regularly represent clients in the healthcare industry in government investigations and litigation alleging conspiracy, fraud and abuse, including violations of the Food Drug & Cosmetic Act (FDCA), the Anti-kickback Statute (AKS), the False Claims Act (FCA) and the Foreign Corrupt Practices Act (FCPA). Our lawyers have represented clients in criminal, civil and administrative investigations and in criminal and civil litigation brought by federal and state authorities, both at trial and on appeal. On behalf of our corporate clients, we also have conducted hundreds of internal investigations and provided compliance advice.

Our team includes two former Deputy Attorneys General of the United States, a former Assistant Attorney General in charge of the Justice Department’s Civil Division, a former US Attorney, two former Deputy US Attorneys, more than a dozen former Assistant US Attorneys, a State Attorney General and a State Deputy Attorney General who were responsible for supervising, investigating and litigating significant criminal and civil enforcement matters, including whistleblower claims, during prior government service. This enables us to approach each matter with an informed understanding of the government’s enforcement perspective, objectives and alternatives. We can assist clients in demonstrating why the government should not pursue any charge or claim, in negotiating civil resolutions of allegedly criminal conduct, and, where appropriate, in globally resolving criminal, civil and administrative claims to avoid potential collateral consequences. We have successfully resolved grand jury investigations of allegations of criminal wrongdoing prior to indictment. We also have obtained the early dismissal or resolution of FCA suits brought by qui tam plaintiffs and the government by focusing on precedent-setting legal defenses. Where cases have gone to trial, our experienced courtroom advocates have tried and won them.


Our notable healthcare investigations and enforcement litigation work has included:

  • Representation of multi-national pharmaceutical and medical device companies, as well as senior executives and sales and marketing personnel, in numerous criminal and civil FCA investigations of alleged off-label marketing and kickbacks
  • Obtaining dismissal of FCA cases against major pharmaceutical companies
  • Representation of a medical device manufacturer in connection with the defense and resolution of government claims that it had breached a deferred prosecution agreement
  • Representation of a laboratory company in a government investigation of allegations of Medicare/Medicaid fraud
  • Representation of a company in an inquiry by Senator Grassley into whether several companies in a particular healthcare sector have engaged in Medicaid fraud or otherwise failed to comply with applicable laws
  • Defense of an Internet search and technology company in a grand jury investigation of alleged aiding and abetting of unlawful conduct by Canadian online pharmacies and the negotiation of a non-prosecution agreement that resulted in the closing of the investigation and a release of claims
  • Defense of a company in a grand jury investigation of alleged kickbacks and obstruction in which the government declined prosecution
  • Defense of a grand jury investigation of allegations that a medical device manufacturer had violated the AKS and negotiation of a global resolution of the government’s criminal, civil and administrative claims
  • Representation of a healthcare company in an FCA matter in which the Justice Department was persuaded not to proceed against the company, and the company settled on favorable terms with the Department of Health and Human Services
  • Representation of a third-party billing company in connection with the civil resolution of parallel criminal and civil investigations of alleged Medicare and Medi-Cal fraud
  • Winning dismissal of a qui tam action filed by a former employee alleging that a major pharmaceutical company had misrepresented the relative potency and cost of two of its medications
  • Obtaining a global civil resolution on behalf of a medical device manufacturer in an investigation by a US Attorney’s Office arising from a former employee’s allegations that the company had maintained an inadequate complaint reporting system under the FDCA and had misrepresented the quality of numerous medical devices
  • Securing the government’s dismissal of all criminal charges against a biomedical sales manager after opening statements and less than one day of trial testimony
  • Representation of a device manufacturer in a grand jury investigation in which the government ultimately declined to pursue any criminal charges
  • Numerous internal investigations, on behalf of pharmaceutical, device and other life sciences companies, of alleged violations of the FDCA, the AKS and the FCPA, including internal investigations of activities in the United States, China, Korea, India, Japan, Mexico, Russia and Poland
  • Compliance counseling to multiple clients, including global pharmaceutical and device manufacturers, a clinical research organization, and a health insurance company, regarding anti-bribery risk assessments, compliance policies and compliance training
  • Representation of a global medical device manufacturer in an FCPA investigation by the Justice Department and the SEC

Publications & News


October 29, 2012

The Exclusion Illusion: Fixing a Flawed Health Care Fraud Enforcement System

Year after year, the government announces historic settlements in the area of health care fraud. During the last decade, the annual fines imposed on pharmaceutical companies have increased more than 800 percent, approaching a total of $25 billion.