Hannah Bornstein

What do you focus on?

I counsel life sciences companies through a range of FDA compliance, enforcement, and litigation matters. Whether assessing a potential product approval pathway, conducting due diligence in a transaction, or responding to a government investigation, I help clients navigate myriad complex government regulations and oversight.

I represent clients in high-stakes crisis matters, including responding to government inquiries or investigations conducted by the FDA, the United States Attorney’s Office, and the Department of Justice, among others. I bring my experience in enforcement matters to my clients’ compliance and transactional matters, helping them anticipate—and avoid—potential pitfalls.

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

Regulatory and Compliance Matters

I guide companies through a wide range of regulatory and compliance matters, including questions relating to product approval pathways, promotion and advertising, and overall regulatory and agency strategy. I work with clients in a variety of areas, including the digital health, in vitro diagnostics (IVDs), dietary supplements, CBD, pharmaceutical, and medical device spaces.

Transactional Due Diligence

I work with our transactional deal teams in providing advice and analysis on FDA-related due diligence matters. My work in this space includes the pharmaceutical, digital health, medical device, and food areas.

What do you see on the horizon?

Innovation is fast outpacing the legal and regulatory framework in many areas, particularly in areas such as digital health and CBD. In areas where the applicable legal and regulatory framework is unclear and not well-developed, companies are well-advised to seek counsel early in their decision-making processes in order to make their best, good-faith assessments on how to proceed. A demonstrated commitment to compliance will pay dividends as companies grow and mature.

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
• Represent pharmaceutical manufacturer in novel FDA enforcement matter, and advise client on navigating complex government, customer, and media concerns
• Represent investors in connection with FDA due diligence reviews regarding potential investment in FDA-regulated pharmaceutical, medical device, health technology, and food companies
• Provide compliance advice to a range of life sciences companies on a variety of FDA compliance and approval pathway questions, including areas related to digital health, diagnostics and laboratory-developed tests, dietary supplements, COVID-19 products, and promotion questions
• 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

Publications

• “Negotiating False Claims Act Settlements,” in Health Law Handbook, Thomson Reuters, 2021 (co-author)