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Hannah Bornstein
Partner / Deputy Practice Group Leader, Government Investigations & White Collar Defense
Introduction
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.
Representative experience
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
Looking ahead
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.
Insights
- “Understanding the Scope of FDA Enforcement Authority and Actions,” FDA Boot Camp, September 21, 2023
- “Negotiating False Claims Act Settlements,” in Health Law Handbook, Thomson Reuters, 2021 (co-author)
In the news
- Reuters
J&J secures dismissal of whistleblower case over misuse of confidential info
June 1, 2023This article covers the US Court of Appeals for the First Circuit affirming a district court’s dismissal of a False Claims Act case against DePuy Orthopaedics, DePuy Inc., and Johnson & Johnson related to hip replacement devices. The story mentions NP for representing the defendants in the case, with the team including Washington, DC Government Investigations & White-Collar Defense partner and False Claims Act team leader Adam Tarosky, and Boston GIWC partners Mark Seltzer and Hannah Bornstein, GIWC deputy practice leader.
- Medtech Insight
Ex-Theranos CEO Elizabeth Holmes sentenced to 11-year prison term
Nov 23, 2022Boston partner Hannah Bornstein, deputy leader of the firm’s Government Investigations & White-Collar Defense practice, provides third-party commentary throughout this article on the sentencing of former Theranos CEO Elizabeth Holmes. Hannah discusses the significance of Holmes’ sentence and the potential impact of the Theranos case on the life sciences and venture capital industries.
- Law360
Holmes faces uphill battle fighting 11-year prison term
Nov 21, 2022This article, which follows up on ex-Theranos CEO Elizabeth Holmes’ sentencing, quotes from a related client alert written by Boston Government Investigations and White-Collar Defense partners Brian French and Hannah Bornstein, deputy leader of the practice group.
- Pratt’s Government Contracting Law Report
First circuit adds to circuit split over governments dismissal of False Claims Act litigation
Government Investigations & White-Collar Defense partners Hannah Bornstein and Brian French, of the Boston office, and Adam Tarosky, of the Washington, DC office, co-authored this article covering a circuit court ruling that offers a new standard of review for the government’s dismissal of False Claims Act whistleblower claims.June 10, 2022 - Massachusetts Lawyers Weekly
Go-to lawyers: Healthcare/life sciences
Boston partner Hannah Bornstein, deputy leader of the Government Investigations & White-Collar Defense group, was named by the publication as one of Massachusetts’ go-to lawyers for healthcare and life sciences clients. Hannah’s profile provides background details on her practice, noting that she “counsels life sciences companies through a wide range of FDA compliance, enforcement, and litigation matters.”May 30, 2022 - Medtech Insight
Attorneys mull takeaways from conviction of Theranos founder Holmes
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.Jan 6, 2022 - Law360
J&J hip implant FCA case tossed over secret info use
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.Dec 8, 2021 - The Wall Street Journal
Elizabeth Holmes's trial reaches turning point: Will she testify?
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.Nov 19, 2021 - Food Business News
Regulatory and taste issues slow CBD formulation efforts
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.March 16, 2021 - Law360
Doctors say no secret info used in FCA suit against J&J
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.March 6, 2020 - Modern Healthcare
21st Century Cures Act driving FDA changes
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.Sep 7, 2019 - Law360
Attorneys reflect on Escobar's FCA impact 2 years later
Boston government investigations and white collar defense partner Hannah Bornstein is quoted in this article discussing how the Supreme Court’s ruling in Universal Health Services v. Escobar has impacted False Claims Act litigation.June 18, 2018 - Law360
Law360 names attorneys who moved up the firm ranks in Q1
May 7, 2018In this roundup of promotions to partner and firm management positions, 14 attorneys from Nixon Peabody are highlighted. The 11 attorneys promoted to partner are Ellie Altshuler, Mark Beaudoin, Erik Birkeneder, Hannah Bornstein, Chris Browning, Barry Carrigan, Keri McWilliams, Matt Mullen, Steven Richard, Charles Tamuleviz and Alison Torbitt. In addition, Kenneth C. Lind was promoted to leader of the firms’ public finance practice group, Justin Thompson was promoted to office managing partner in LA, and Aaron Yowell was promoted to chief innovation officer.
- Law360
J&J won't get high court look at FCA 'particularity' rule
In the following coverage, Boston government investigations and white-collar defense partners Mark Seltzer and Hannah Bornstein are mentioned for their ongoing representation of Johnson & Johnson and its subsidiary DePuy Orthopaedics Inc. in a False Claims Act case. The Supreme Court recently declined to review the First Circuit’s ruling in the case.April 16, 2018 - Reuters Legal
U.S. Supreme Court declines to review whistleblower case against J&J's DePuy
In the following coverage, Boston government investigations and white-collar defense partners Mark Seltzer and Hannah Bornstein are mentioned for their ongoing representation of Johnson & Johnson and its subsidiary DePuy Orthopaedics Inc. in a False Claims Act case. The Supreme Court recently declined to review the First Circuit’s ruling in the case.April 16, 2018 - Law360
J&J unit wants whistleblower docs in hip implant FCA suit
Boston government investigations and white-collar defense partners Mark Seltzer and Hannah Bornstein are mentioned in this article for representing Johnson & Johnson Services Inc. and its subsidiary DePuy Orthopaedics in a suit alleging violations of the False Claims Act.April 12, 2018 - BBA Week
What do you love about the Boston Marathon?
Boston government investigations and white collar defense associate Hannah Bornstein is quoted in this column asking attorneys what they like best about the Boston Marathon.April 13, 2017 - Law360
J&J asks 1st Circ. to halt hip implant FCA suit
Boston government investigations and white collar defense partners Mark Seltzer and Danielle Pelot and associate Hannah Bornstein are listed as counsel representing Johnson & Johnson and its subsidiary DePuy in a First Circuit case. This article notes their argument to uphold the dismissal of a False Claims Act lawsuit.Dec 6, 2016 - BBA Week
Beyond the billable: Pro bono spotlight: Nixon Peabody associates volunteer with PAIR project
This piece profiles Nixon Peabody’s pro bono work and highlights Boston Government Investigations & White Collar Defense associate Hannah Bornstein and IP Litigation associate Troy Lieberman’s involvement with the Political Asylum/Immigration Representation (PAIR) project and why they’re both passionate about it.Oct 13, 2016 - Westlaw Journal Government Contract
Groundbreaking False Claims Act Decision: Unanimous Supreme Court Upholds ‘Implied False Certification' Theory Under Certain Circumstances
This column discussing an important United States Supreme Court decision regarding False Claims Act liability was co-authored by Boston partners Brian French and Fred Kelly, Boston associates Hannah Bornstein and Sydney Pritchett, and Washington, DC, associate Emily Harlan.July 18, 2016 - Boston Business Journal
People on the Move
This news brief notes that Boston Government Investigations & White Collar Defense associate Hannah Bornstein earned the 2014 Outstanding Pro Bono Mentor Award from the Political Asylum/Immigration Representation Project (PAIR) for her pro bono commitment to representing asylum-seekers.June 12, 2014
Admitted to practice
Massachusetts
Education
Brandeis University, B.A., cum laude
Indiana University, J.D., magna cum laude
Professional activities
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.
Recognition
- Selected, through a peer-review survey, for inclusion in The Best Lawyers in America® 2024 in the field of Criminal Defense: White-Collar; listed in Best Lawyers since 2023
- Recommended in The Legal 500 United States 2022 editorial for practice focus—Dispute resolution - Corporate investigations and white-collar criminal defense
- Received the Lawyers’ Committee for Civil Rights and Economic Justice pro bono award for commitment to public service (2015)
- Received the Outstanding Pro Bono Mentor Award from the Political Asylum/Immigration Representation Project (2014)
Pro bono services
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.
Insights And Happenings
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Partner / Practice Group Leader, Government Investigations & White Collar Defense- Boston
- Office:617.345.1335
- rfisher@nixonpeabody.com
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