False Claims Act Litigation & Enforcement

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Schertler Onorato Mead & Sears has extensive experience representing public and private companies, executives, lawyers, sales representatives, quality control and laboratory managers, and government contracting entrepreneurs in federal and state False Claims Act (FCA) investigations conducted by the U.S. Department of Justice (DOJ), U.S. Attorney’s Offices, and State Attorneys General. Our representations have included a broad array of industry sectors and issues, including health care and life sciences (including, but not limited to matters involving the Stark Law, Anti-Kickback Statute (AKS), pharmaceutical and medical device off-label marketing, pharmaceuticals, and food quality), government contracting and procurement, financial services, import/export duties, and grant fraud.

Our firm includes former Assistant U.S. Attorneys, DOJ Trial Attorneys, and Assistant State Attorneys General with extensive experience investigating, defending, and litigating virtually every type of FCA matter. We have experience representing clients on all three sides of the FCA – as defense counsel, relator’s counsel, and government counsel during previous government service – which enables us to advise clients on every aspect of the FCA to generate better strategy, operational efficiencies, and outcomes. The firm has successfully negotiated numerous closings of investigations and intervention declinations with multiple U.S. Attorney’s Offices around the country and with the DOJ Civil Fraud Section. We have also represented numerous clients in settlements and other resolutions of their FCA matters. We have advised clients on strategies for communicating with government contracting officers to mitigate FCA exposure.

Representative FCA matters:

• Represented government contractor in criminal and FCA investigation regarding the usage of Paycheck Protection Program (PPP) loan proceeds, resulting in favorable resolution for client.
• Represented government contractor in criminal and FCA investigation regarding the usage of Paycheck Protection Program (PPP) loan proceeds, resulting in favorable resolution for client.
• Represented outside counsel to major pharmaceutical company in FCA investigation into pharmacy incentive program, successfully presenting advice of counsel defense.
• Represented physician medical director and target of FCA investigation regarding the improper billing of “P-Stim” devices, resulting in U.S. Attorney’s Office closing its investigation.
• Represented physician medical director of MRI facilities in AKS and billing fraud investigation resulting in declination of criminal prosecution and successful settlement for client.
• Represented multiple senior sales representatives for major pharmaceutical company in FCA investigation into off-label marketing allegations, resulting in DOJ ultimately declining.
• Represented multiple senior sales representatives for major dialysis provider in FCA investigation into AKS and billing fraud issues.
• Represented partners running small government contractor that made substantial profits in TSA security services ramp-up after 9/11, resulting in DOJ ultimately declining (despite adverse press coverage).
• Represented minority government contractor in FCA investigation into alleged Trade Agreements Act (TAA)/Buy America Act (BAA) violations, resulting in DOJ declining and dismissal of relator’s case.
• Represented federal grant recipient in internal investigation into suspected FCA violations by sub-grantees and contractors, resulting in mandatory disclosure and favorable outcome for client.
• Represented construction company for possible FCA violations due to the improper receipt of grant funds under Section 1603 of the American Recovery and Reinvestment Act of 2009, resulting in U.S. Attorney’s Office and the DOJ closing its investigation into the client.
• Represented government contractor in internal investigation and successful response to a cure notice, involving a mandatory disclosure regarding potential FCA violations relating to its federal contract.
• Represented owner of government contractor charged with selling substandard fasteners not meeting MIL-SPEC standards, resulting in DOJ dismissal of criminal case during trial with successful FCA settlement preventing disbarment.
• Represented federal grant funds recipient in internal investigation and related state enforcement matter regarding potential FCA and state and federal government grant violations.
• Represented senior quality executives in criminal and FCA investigations involving food quality and contamination issues.
• Represented several former employees of national skilled nursing facility chain in FCA litigation involving allegations of upcoding for medically unnecessary rehabilitation therapy.
• Represented several employees of publicly traded health care provider in various FCA investigations and criminal health care fraud investigations led by the Department of Health and Human Services Office of Inspector General and DOJ.
• Represented multiple quality control/quality assurance executives for major pharmaceutical company in FCA investigation of alleged Food Drug & Cosmetic Act violations of Current Good Manufacturing Practice and Current Good Laboratory Practice regulations.
• Conducted internal investigation into TAA violations by major government contractor, resulting in disclosures to contracting officer to mitigate FCA exposure.
• Represented senior sales executive for major medical device manufacturer in FCA investigation into alleged marketing for unauthorized uses.
• Represented publicly traded medical device manufacturer/federal government contractor in internal investigation and subsequent voluntary disclosure regarding potential government contracting violations, Federal Supply Schedule pricing issues, and FCA violations.
• Represented several employees of publicly traded global supplier of test systems and industrial position sensors/federal government contractor in government contracting and FCA investigation regarding potential violations of the Federal Acquisition Regulation and Defense Federal Acquisition Regulation Addendum.
• Represented drop shipper/federal government contractor in FCA investigation and subsequent settlement for Export Administration Regulations, BAA/TAA, and other government contracting violations involving prohibited items on Government Services Administration schedule contract.