Hannah Bornstein - Government Investigations & White Collar Defense - Nixon Peabody LLP

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.

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)

Attorneys mull takeaways from conviction of Theranos founder Holmes

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.

J&J hip implant FCA case tossed over secret info use

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.

Elizabeth Holmes's trial reaches turning point: Will she testify?

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.

Regulatory and taste issues slow CBD formulation efforts

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.

Doctors say no secret info used in FCA suit against J&J

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.

21st Century Cures Act driving FDA changes

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.

Contact

Hannah Bornstein

Partner
Deputy Practice Group Leader, Government Investigations & White Collar Defense

Boston

Phone: 617-345-1217


Fax: 877-387-0943

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.

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