Hannah Bornstein is a litigator and the deputy practice group leader for Government Investigations & White Collar Defense. She is also a member of the Life Sciences and Arts & Cultural Institutions teams. She represents individuals and multi-national companies in compliance matters, investigations and litigation. She is experienced in health care industry matters involving the False Claims Act; the Food, Drug and Cosmetic Act; and the Anti-Kickback Statute.
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.
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.
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.
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.
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.
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:
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.
Indiana University, J.D., magna cum laude
Brandeis University, B.A., cum laude
Massachusetts
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.
