Atty. 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.
Profile Summary
About Hannah Bornstein at a glance
Hannah Bornstein is a criminal defense and white collar attorney based in Boston, Massachusetts, practicing at Nixon Peabody LLP. Admitted to practice in Massachusetts, Massachusetts Bar Association. Educated at Indiana University Maurer School of Law (J.D., 2007). Recognitions include Best Lawyers in America — Criminal Defense: White-Collar (2026), Best Lawyers in America — Additional Areas of Practice: (2026), and Best Lawyers in America — Criminal Defense: General Practice (2026). Serands clients in Boston, MA and the surrounding metropolitan area.
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Über uns
- 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
Practice Areas Explained
Hannah Bornstein's Areas of Practice
Each practice area below reflects the types of cases Hannah Bornstein handles, with a brief overview of what that area of law covers.
A criminal defense attorney protects your rights from arrest through trial. Find experienced lawyers handling DUI, drug, federal, theft, and violent-crime charges.
Hannah Bornstein is one of 214,270 criminal defense attorneys indexed nationally. Browse criminal defense attorneys in Massachusetts →
Hannah Bornstein is one of 20,025 white collar attorneys indexed nationally. Browse white collar attorneys in Massachusetts →
Jurisdictional Context
Why local counsel matters in Massachusetts
Practicing law in Massachusetts. Legal matters in Massachusetts are governed by state-specific rules of civil and criminal procedure, statutes of limitations, and substantive law. Cases originating in Boston are typically filed in the local municipal court or the appropriate Massachusetts state district court, depending on subject matter and amount in controversy. An attorney licensed in Massachusetts brings working knowledge of local procedural deadlines, judicial practices in this andnue, and the substantive law that applies to cases brought here. Out-of-state attorneys generally cannot represent clients in Massachusetts courts without local counsel or pro hac vice admission.
Looking for additional Massachusetts attorneys? Browse all attorneys in Boston or all attorneys in Massachusetts.
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