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.
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.
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.
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.
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.
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.
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:
Medtech Insight | January 06, 2022
Boston partner Hannah Bornstein, deputy leader of the Government Investigations & White-Collar Defense practice group, is quoted extensively throughout this article exploring takeaways from the trial and conviction of Theranos founder and former CEO Elizabeth Holmes.
Law360 | December 08, 2021
This article covers a significant litigation win, in which a federal judge dismissed a nearly decade-long False Claims Act lawsuit against Johnson & Johnson entities over allegedly defective hip replacement devices, noting that two whistleblower physicians used confidential information in their complaint. The article mentions Boston partners Mark Seltzer and Hannah Bornstein and associate Colin Missett, and Washington, DC partner Adam Tarosky—all of the Government Investigations & White-Collar Defense group—for representing J&J and its related entities.
The Wall Street Journal | November 19, 2021
This article, focusing on Theranos Inc. founder and CEO Elizabeth Holmes’s trial for allegedly defrauding patients and investors about the capabilities of her blood-testing startup, quotes Boston partner and Government Investigations & White-Collar Defense deputy leader Hannah Bornstein on the risks of putting Holmes on the stand and the possible strategy behind lengthy defense cross-examinations.
Food Business News | March 16, 2021
Government Investigations & White-Collar Defense deputy practice group leader and Boston partner Hannah Bornstein is quoted in this article on cannabidiol in food and beverage products for her outlook on therapeutic and marketing claims made by F&B manufacturers as areas of concern for the Food and Drug Administration.
Law360 | March 06, 2020
This article mentions Boston Government Investigations and White-Collar Defense partners Hannah Bornstein and Mark Seltzer for their representation of the defendants in a False Claims Act suit centering on faulty hip replacement devices. The defendants have argued the suit should be dismissed on the grounds that confidential information was used in the complaint.
Modern Healthcare | September 07, 2019
This article discussing the 21st Century Cures Act’s ongoing impact on the Food and Drug Administration’s approval process quotes Boston Government Investigations and White Collar Defense partner Hannah Bornstein and Chicago Health Care partner Valerie Montague.
Government Investigations & White Collar Alert | 01.31.22
Life Sciences Alert | 08.27.20
Government Investigations & White Collar Defense Alert | 06.11.20
Government Investigations & White Collar Defense Alert | 06.05.20
Government Investigations & White Collar Defense Alert | 05.21.20
Government Investigations & White Collar Law Alert | 05.06.20
Government Investigations & White Collar Defense Alert | 04.22.20
Government investigations & White Collar Defense Alert | 04.15.20
12.07.21 | Virtual Presentation
02.18.21 | Virtual Event
12.16.20 | Virtual Event
12.12.19 | Washington, DC
09.12.19 | Cambridge, MA
Indiana University, J.D., magna cum laude
Brandeis University, B.A., cum laude
In 2015, Hannah received a pro bono award from the Lawyers’ Committee for Civil Rights and Economic Justice for commitment to public service. Hannah received the 2014 Outstanding Pro Bono Mentor Award from the Political Asylum/Immigration Representation Project.
Hannah currently serves on FDLI’s Enforcement, Litigation, and Compliance Conference Planning Committee, a position she has held since 2018.
Hannah is a member of the Boston Bar Association and formerly co-chaired its Immigration Asylum Committee.
Hannah has significant experience representing pro bono asylum clients. She has represented clients from Cameroon, Rwanda, Uganda, Nepal, Syria and the Dominican Republic in matters before the Boston Asylum Office and the Boston Immigration Court. Hannah was also a volunteer attorney for the Clemency Project 2014 initiative.
Hannah is also a three-time Boston Marathon finisher, having successfully completed the 2016, 2017, and 2018 Boston Marathons on behalf of the Political Asylum/Immigration Representation Project.