Hannah Bornstein

What do you focus on?

I guide clients through all facets of complex government investigations, from the initial government inquiry through final resolution of the matter. I also advise clients on compliance matters and internal investigations.

Federal Investigations and Related Litigation

I represent multi-national companies, including pharmaceutical and medical device companies, in responding to governmental inquiries or investigations conducted by the United States Attorney’s Office and the Department of Justice, among others. I have advised companies in responding to grand jury subpoenas, HIPAA subpoenas and civil investigative demands (CIDs), as well as informal requests for information. In instances where the government declines to intervene in an investigation, I represent companies in subsequent litigation that is driven by the whistleblowers or relators. I also represent numerous individuals, who are often current or former employees of a company, in connection with government investigations.

I also represent clients in matters before the Federal Election Commission (FEC) and in matters involving federal campaign finance law.

Compliance Matters and Internal Investigations

I assist companies in conducting internal investigations into potentially problematic conduct within a company. During the course of an internal investigation, I frequently analyze the effectiveness of a company’s compliance program. I also assist companies by providing pro-active compliance advice, including compliance with FDA regulations.

Attorney General Litigation

I represent companies in matters initiated by the Massachusetts Attorney General’s Office involving False Claims Act investigations or Consumer Protection Act (“Chapter 93A”) litigation.

What do you see on the horizon?

Government agencies, including the Department of Justice and the FDA, will continue to prioritize matters that may raise patient safety concerns or high drug pricing. Recent cases such as the New England Compounding case highlight the government’s emphasis on pursuing matters where patient safety is at risk due to noncompliance with CGMPs or other regulatory standards. Despite rhetoric in Washington about “deregulation,” companies in the health care or life sciences space should remain vigilant and proactive about implementing effective compliance programs, as both the government and whistleblowers continue to aggressively pursue False Claims Act litigation and related enforcement matters.

Representative Matters

Hannah’s representative matters have involved government inquiries relating to possible “off-label” promotion and whether a drug or device was marketed in accordance with its approved intended use; possible false or misleading advertising; compliance with the Anti-Kickback Statute; and compliance with CGMP standards, including investigations that follow FDA 483 warning letters. Her representative matters include the following:

• Represent medical device company in False Claims Act investigation and litigation regarding manufacture and sale of medical device
• Represented pharmaceutical company in defense of a United States Attorney’s Office investigation regarding company’s manufacturing practices and CGMP compliance
• Represent pharmaceutical company in defense of a United States Attorney’s Office investigation regarding company’s compliance with manufacturing and compliance procedures
• Represent various pharmaceutical companies in matters involving compliance with the Anti-Kickback Statute
• Represent senior executives and managers of medical device company in defense of a United States Attorney’s Office investigation of possible violations of the Food, Drug & Cosmetic Act
• Represent physician advisors of medical device company in defense of a United States Attorney’s Office investigation of possible violations of the Food, Drug & Cosmetic Act
• Provide advice to physician client regarding marketing and labeling claims
• Represented pharmaceutical company in Consumer Protection Act litigation brought by Massachusetts Attorney General’s Office
• Represented pharmaceutical company in defense of a United States Attorney’s Office investigation into alleged off-label promotion and kickback activity in connection with company’s contractual relationships with specialty pharmacy companies
• Represented public company in False Claims Act investigation brought by Massachusetts Attorney General’s Office
• Represented pharmaceutical company in defense of a United States Attorney’s Office investigation into alleged off-label promotion
• Represented pharmaceutical company in defense of a United States Attorney’s Office investigation into alleged kickback activity in connection with company’s grant-making processes
• Represented medical device company in defense of a United States Attorney’s Office investigation into alleged kickback activity in connection with company’s contractual relationships with customers
• Represented former senior executive of a pharmaceutical company in defense of a United States Attorney’s Office investigation into alleged kickback activity in connection with pricing and discounting practices
• Represented retailer in connection with an SEC investigation relating to the company’s accounting practices