Dana McSherry advises healthcare and life sciences companies in criminal and civil government enforcement matters and in related civil litigation, including civil False Claims Act litigation. She advises clients concerning all aspects of civil and criminal investigations relating to Medicare and Medicaid billing and other government contracting issues, including negotiating with the government and managing clients’ responses to civil investigative demands and large-scale investigative subpoenas. Dana also assists clients in conducting internal investigations and counsels clients across the healthcare industry on compliance and risk management issues.
In late 2018, Dana successfully defended a pharmacist charged with racketeering, mail fraud, and Food, Drug and Cosmetics Act (FDCA) violations. Following a two-month jury trial in the US District Court for the District of Massachusetts, Dana’s client was acquitted of all charges.
In addition to her life sciences practice, Dana also represents individual clients in securities fraud related government enforcement matters, both civil and criminal.
Dana also maintains an extensive pro bono practice. In 2019, Dana successfully represented a parent in a Hague child custody case that involved a week-long trial in the US District Court for the District of Massachusetts. She also successfully represented a civilly committed individual in a civil rights action.
Dana serves as the hiring partner for the Boston office.
Representing pharmaceutical company in state and federal investigations relating to patient support services
Represented pharmaceutical company in industry-wide investigation by the US Attorney’s Office in Massachusetts and the DOJ into donations to charitable assistance foundations that provide financial assistance to Medicare patients
Successfully defended a pharmacist charged with RICO, mail fraud, and Food, Drug and Cosmetics Act violations; following a two-month trial, the client was acquitted of all charges
Represented individual in US Securities and Exchange Commission (SEC) investigation relating to improper revenue recognition and interactions with auditors
Represented individual and hedge fund in SEC and criminal investigations into issues associated with performance and risk disclosures in marketing materials and obstruction of justice
Represented biotechnology company in qui tam suits and concurrent federal and state investigation into alleged off-label promotion and violations of the Anti-Kickback Statute and price reporting regulations
Represented biotechnology company in multistate consumer protection investigation stemming from alleged off-label promotion
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