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Hannah Bornstein



Hannah Bornstein is a litigator and a member of the Government Investigations & White Collar, 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.

What do you focus on?

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.

Federal 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 clients in matters before the Federal Election Commission (FEC) and in matters involving federal campaign finance law.

Compliance Matters and Internal Investigations

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.

Attorney General Litigation

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.

What do you see on the horizon?

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.

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
  • 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

Attorneys reflect on Escobar's FCA impact 2 years later

Law360 | June 18, 2018

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.

Law360 names attorneys who moved up the firm ranks in Q1

Law360 | May 07, 2018

In 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.

J&J won't get high court look at FCA 'particularity' rule

Law360 | April 16, 2018

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.

U.S. Supreme Court declines to review whistleblower case against J&J's DePuy

Reuters Legal | April 16, 2018

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.

J&J unit wants whistleblower docs in hip implant FCA suit

Law360 | April 12, 2018

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.

What do you love about the Boston Marathon?

BBA Week | April 13, 2017

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.

J&J asks 1st Circ. to halt hip implant FCA suit

Law360 | December 06, 2016

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.

Beyond the billable: Pro bono spotlight: Nixon Peabody associates volunteer with PAIR project

BBA Week | October 13, 2016

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.

Groundbreaking False Claims Act Decision: Unanimous Supreme Court Upholds ‘Implied False Certification' Theory Under Certain Circumstances

Westlaw Journal Government Contract | July 18, 2016

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.

Contact

Hannah Bornstein

Partner

Boston

Phone: 617-345-1217


Fax: 877-387-0943

NP Profiles: Hannah Bornstein

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

Read more about Hannah Bornstein as part of our monthly series
profiling members of our 2018 partner class.

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 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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