Hannah Bornstein

Hannah Bornstein is a litigator, trusted advisor, and the deputy practice group leader for Government Investigations & White Collar Defense. She is also a member of the firm’s Life Sciences team. She represents individuals and multi-national companies in regulatory compliance matters, investigations, and litigation. She is experienced in healthcare industry matters involving the False Claims Act; the Food, Drug and Cosmetic Act (FDA); and the Anti-Kickback Statute.

My focus

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.

Looking aheadInnovation 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.