Gary Giampetruzzi is a partner in the Litigation Department of Paul Hastings, based in the firm's New York office, and is the Global Chair of the Life Sciences Department and one of the Vice-Chairs of the Investigations and White Collar Department, and an active member of the Paul Hastings Litigation Diversity Working Group. Mr. Giampetruzzi routinely advises clients on day-to-day compliance matters, represents corporations in high-profile federal and state investigations, including those involving federal and state False Claims Act (qui tam suits), State Attorney General consumer protection statutes, and the Foreign Corrupt Practices Act ("FCPA"), and oversees other complex civil and criminal litigation matters. While his practice cuts across numerous sectors, including defense, energy, and private equity, Mr. Giampetruzzi possesses particularly deep experience in the life sciences sector, representing many of the world's most prominent biotech, pharmaceutical, and medical device companies.
Prior to joining Paul Hastings, Mr. Giampetruzzi most recently served as Vice President, Assistant General Counsel, and Head of Government Investigations at Pfizer Inc., with responsibility for government investigations across the company's multiple business units and operations globally, as well as associated government litigation with U.S. and international prosecutor offices. He was previously a Deputy Compliance Officer responsible for international compliance investigations and programs with responsibility for the implementation and maintenance of compliance programs and systems across the company's international operations, with an enhanced focus on emerging markets.
Mr. Giampetruzzi has extensive experience with all facets of the anti-corruption and FCPA landscape. He has been a leader in this growing area of practice for approximately two decades, having led the development of cutting edge compliance programs and measures, conducted and overseen hundreds of internal investigations, and been on the ground in more than 40 markets worldwide (including Asia, Africa, Europe, the Middle East, and Latin America). Mr. Giampetruzzi was instrumental in the development of proactive market review approaches that have been incorporated into recent government resolutions, and acquisition due diligence techniques that were cited in the Justice Department's FCPA Guidance document. He has the proven and longstanding ability to provide end-to-end support, from front-end compliance counseling and program build-outs and enhancements, to the efficient conduct of global internal investigations, and the defense of companies before U.S. and international authorities, while keeping an appropriate eye towards the increasing risk of follow-on civil litigation.
On the U.S. healthcare side, Mr. Giampetruzzi provides day-to-day compliance counseling around program design, monitoring, and proactive testing, and conducts internal investigations regarding a variety of issues, including those involving anti-kickback and off-label promotion laws, patient support programs, and specialty pharmacies. He has overseen several of the more significant government investigations in the pharmaceutical industry over the years, as well as the defense and resolution of numerous whistleblower qui tam suits involving claims under the False Claims Act and related state statutes. Mr. Giampetruzzi has more recently been asked by pharmaceutical companies to defend their practices associated with patient support programs and specialty pharmacies in connection with federal investigations by several prominent prosecutor offices. He settled the first opioid prosecution on highly favorable terms, and has achieved several walkaways with state and federal prosecutor offices.
Mr. Giampetruzzi is highly regarded by counsel, healthcare industry insiders, and regulators for his strategic thinking and sound judgment. He understands how to engage appropriately with the regulators, and how to litigate effectively when is needed. He brings unique experience and perspective to each client representation, having himself been the client for more than a decade at one of the largest multi-national corporations in the world. During that time, he partnered closely with business colleagues, and helped navigate a complex organization through some of the most significant compliance and enforcement issues faced in the pharmaceutical industry. As a senior in-house leader, Mr. Giampetruzzi operated at executive leadership team and board levels, and understands from his firsthand experience that the particular needs of each client and circumstance are different, and that the approach and solutions must be too. He genuinely appreciates the pressures and realities facing clients and in-house counsel, and works with them to understand and achieve their specific goals.
Professional and Community Involvement
HERHealthEQ (March 2020 - Present) Working with hospitals, governments, and clinics to provide access to medical device equipment involved in the treatment of the top non-communicable diseases that impact women in the developing world, including cancers and maternal health issues, thereby driving a more equitable standard of care for women worldwide.
Program Faculty, Seton Hall Law School, U.S. Healthcare Compliance Program, "The Foreign Corrupt Practices Act," (2008 - Present)
Adjunct Faculty, DePaul University School of Law, "Special Topics in the Law: Global Anti-Corruption Law & Practice" (Fall 2019)
Recognition and Industry Leadership
The Legal 500, Leading Lawyer for Healthcare: Life Sciences (2021)
The Legal 500, Dispute Resolution-Corporate Investigations and White-Collar Criminal Defense: Advice to Corporates (2021)
The National Law Journal, Healthcare/Life Sciences Trailblazer (2021)
Mr. Giampetruzzi brings creative lawyering to bear on each of his client's challenges, with some of the compliance approaches he developed having become a best practice (e.g., proactive FCPA market reviews, now routinely in government resolutions), and even being cited in the U.S. government's FCPA guidance document (e.g., FCPA acquisition due diligence)
Recognized as "A Name to Know" by Global Investigations Review in recognition of Paul Hastings as a Top 10 firm, GIR's Top 100
Ethisphere, "Attorneys Who Matter," Specialists - Private Practice
LMG Life Sciences, Practice Leader in White Collar & Government Investigations
The Legal 500, Healthcare/Life Sciences (Firm Ranked Band 3), Noted Practice Leader for Investigations and White-Collar Defense Matters
Organizer/Co-Leader of the European Investigations Forum for Pharmaceutical and Medical Device Companies in Europe (2017-2020)
Organizer/Co-Leader of Pharmaceutical and Medical Device Manufacturer United States Compliance Investigations Forum (2020-Present)
Co-Leader of the Rare Disease Compliance Consortium (leading rare disease companies/CCOs focused on compliance thought leadership)
St. John's University School of Law, J.D., 1993
New York Institute of Technology, B.S.E.E., 1990
Mr. Giampetruzzi is a frequent and well-recognized speaker at industry conferences on a variety of white collar defense topics, including global compliance programs, government investigations, state and federal U.S. healthcare enforcement, and the Foreign Corrupt Practices Act.
Co-author,Telehealth Considerations for Medical Device Manufacturers During and After COVID-19, Medical Device + Diagnostic Industry (MD+DI) (October 20, 2020)
Co-author,Key Takeaways From the Novartis $345 Million FCPA Settlement, Paul Hastings (July 1, 2020)
Co-author,7 COVID-19 Compliance Areas for Health, Life Sciences Cos., Law360 (May 4, 2020)
Co-author,How Life Sciences Cos. Can Adapt to Remote Compliance, Law360 (April 23, 2020)
Co-author,Compliance in the Era of COVID-19 - Where and How Life Sciences and Healthcare Companies Should Focus in the Era of Social Distancing, Paul Hastings (April 22, 2020)
Co-author,Paul Hastings COVID-19 Client Alert Series: Rethinking Approaches to Detecting and Investigating for Life Sciences Companies, Paul Hastings (April 13, 2020)
Co-author,Blowing the Whistle: Tackling Misconduct in the Life Sciences Sector, European Pharmaceutical Review (February 20, 2020)
Co-author,The Path to a Stable Reporting Culture for Life Sciences Cos., Law360 (January 2, 2020)
Co-author,New EU Directive Enhancing the Protection of Whistleblowers, Paul Hastings (October 17, 2019)
Co-author, Pharmaceutical and Medical Device Compliance Manual, Second Edition, American Health Lawyers Association (September 2019)
Co-author,4 Tips for Global Patient Support Compliance: Part 2, Law360 (April 16, 2019)
Co-author,4 Tips for Global Patient Support Compliance: Part 1, Law360 (April 11, 2019)
Co-author,The Rise of Anti-Corruption Whistleblowers in Latin America, Global Investigations Review (December 6, 2018)
Co-author,Life Sciences Cos. Should Assess Charitable Donations Programs, Law360 (June 20, 2018)
Co-author,How Companies Can Foster Internal Whistleblowing, Law360 (April 19, 2018)
Author,In Light of Digital Realty and the Largest Ever Dodd-Frank Whistleblower Award, Whistleblower Risks Are Up and Company Compliance Programs Are Under Pressure, Paul Hastings (April 19, 2018)
Co-author,Bracing for a Life Sciences Enforcement Zeitgeist: Part 2, Law360 (November 3, 2017)
Co-author,Bracing for a Life Sciences Enforcement Zeitgeist: Part 1, Law360 (November 2, 2017)
Co-author,Does Your Research Compliance Need a Refresh? China's Highest Court Sends a Warning to Life Sciences Companies, Paul Hastings (October 9, 2017)
Author,Is Small Pharma Next for DOJ Enforcement?, The FCPA Blog (September 28, 2017)
Co-author,Against the Backdrop of a 'National Emergency,' Are Opioid Manufacturers Ready for the Enforcement Spotlight?, Bloomberg Law Pharmaceutical Law & Industry Report (August 25, 2017)
Co-author,HCP Roundtable Anyone? South Korea's Ministry of Health and Welfare Imposes a $48 Million Fine on Novartis Korea and Suspends Insurance Reimbursement, Paul Hastings (May 8, 2017)
Co-author,A Special Type of Government Scrutiny: Pharmaceutical Manufacturer Relationships With Specialty Pharmacies: Part II, Bloomberg Law Pharmaceutical Law & Industry Report (April 7, 2017)
Co-author,A Special Type of Government Scrutiny: Pharmaceutical Manufacturer Relationships With Specialty Pharmacies: Part I, Bloomberg Law Pharmaceutical Law & Industry Report (March 29, 2017)
Co-author,Growth Opportunities Come With Danger: As Japanese Life Sciences Companies' Outward Bound Investments Continue to Grow, So Do the Significant Compliance and Enforcement Risks, Bloomberg BNA Life Sciences Law & Industry Report (December 9, 2016)
Co-author,Teva Pharmaceuticals Announces a Reserve of $520M in View of What Stands to Be the Fourth Largest FCPA Resolution to Date, Paul Hastings (November 17, 2016)
Co-author,AstraZeneca and the SEC's Focus on Life Sciences, Law360 (September 9, 2016)
Co-author,Not Guilty, Again: Individual Corporate Liability After Reichel, Law360 (June 20, 2016)
Co-author,Ever Active and Perhaps Not So New - The SEC Awards Three Dodd-Frank Whistleblowers, Paul Hastings (June 9, 2016)
Co-author,Will Your Employees Go to You or the Gov't?, Law360 (June 13, 2016)
Co-author,4 Steps to Effective FCPA Acquisition Due Diligence, Law360 (May 10, 2016)
Co-author,6 Takeaways From Novartis FCPA Case, Law360 (April 7, 2016)
Co-author,Olympus: Another Life Sciences Company Gets Hit Hard, Law360 (March 21, 2016)
Author,What Comes Next? Against the Backdrop of the Yates Memo, Novartis Announces a $390M Healthcare Settlement, Paul Hastings (November 2, 2015)
Co-author,Your Joint Venture in Fact Can Be Your Problem: Bristol Meyers Squibb Pays $14M to Resolve FCPA Allegations, Paul Hastings (October 12, 2015)
Co-author,Inside Out: The SEC Awards $1 Million Plus to Yet Another Compliance Professional Turned Whistleblower, Paul Hastings (May 6, 2015)
Co-author,Not Finished With You Yet - The U.S. Government Extends Its Deferred Prosecution Agreement With Biomet, Inc., Again Underscoring the FCPA Risks in Life Sciences, Paul Hastings (March 26, 2015)
AHLA/FDLI Compliance Pharmaceutical and Medical Device Compliance Manual, Second Edition. Foreign Corrupt Practices Act (2015)
Co-author,Here We Go Again - The U.S. Government Brings Home Another FCPA Case Against a Life Sciences Company, Paul Hastings (November 12, 2014)
Co-author,SEC Sends a $30 Million-Plus Warning to Companies: Beware of the Foreign Whistleblower, Paul Hastings (September 30, 2014)
Co-author,Legislative Reform of China's Healthcare Sector Targets Corruption: Implications for Multinational Companies, Paul Hastings (August 28, 2014)
Co-author, Global Compliance Challenges for Drug and Device Entities and Their Counsel, AHLA Seminar Papers, Volume 2009, Issue 5 (June 2009)
Author,Raped Once, But Violated Twice: Constitutional Protection of a Rape Victim's Privacy, St. John's Law Review, Vol. 66, No. 1 (1992)
General Compliance Counseling
Conducted multiple culture and compliance assessments for a major multinational pharmaceutical company to evaluate the state of compliance within China and develop mitigation measures for identified risks.
Developed or reviewed and enhanced corporate policies and procedures regarding the handling of internal reporting channels and conduct and documenting of all aspects of internal investigations for multiple smaller biotech and larger pharmaceutical and medical device companies.
Conducted multiple general and targeted risk assessments of business operations and compliance programs for smaller biotech and larger pharmaceutical and medical device companies, and the ensuing compliance enhancement planning to address the findings associated with these efforts.
U.S. Investigations and Enforcement
Represented a small pharmaceutical company in connection with FDA and government investigations across multiple prosecutor offices into drug registry, off-label promotion, and patient support program issues. Resolved the first manufacturer opioid case for US$7.55 million on a civil-only basis.
Represented a mid-sized pharmaceutical company in connection with a multi-year, federal civil and criminal investigation into patient support program, pricing, and specialty pharmacy issues. No action taken by the federal prosecutors.
Represented a mid-sized pharmaceutical company in connection with a federal civil investigation into Pharmaceutical Benefits Manager (PBM) related pricing and kickback issues. No action taken by the federal prosecutors.
Representing a mid-sized pharmaceutical company in connection with a State AG inquiry into patient support program and related pricing issues, as related to PBM relationships.
As in-house counsel, oversaw the negotiations, finalization of terms, and preparations for the announcement of the landmark US$2.3 billion Bextra civil and criminal, off-label promotion and kickback investigations with the Boston, Philadelphia, and other U.S. Attorney's Offices, Main Justice, HHS OIG, and State Medicaid Fraud Control Units (largest criminal case in history at the time), and associated CIA negotiations.
As in-house counsel, oversaw the US$491 million Rapamune civil and criminal, off-label promotion investigation with the Western District of Oklahoma U.S. Attorney's Office, Main Justice, HHS OIG, and State Medicaid Fraud Control Units, and associated CIA negotiations.
As in-house counsel, oversaw the negotiation and resolution of the grand jury investigation into the promotion of the drug Protonix-which saw US$10 billion in sales-by the Boston U.S. Attorney's Office, achieving a civil-only resolution entailing US$55 million in disgorgement under the Food, Drug, & Cosmetics Act.
FCPA Investigations and Enforcement
Representing a leading rare disease company as compliance counsel before the U.S. Department of Justice and SEC in connection with an ongoing FCPA matter, the first rare disease enforcement case of its kind.
Representing a leading ex-U.S. medical device company before the U.S. Department of Justice in connection with an ongoing FCPA matter, involving one of the first voluntary disclosures out of this critical market.
Representing a leading multinational pharmaceutical company as strategic counsel in connection with various government-facing FCPA matters, including board-facing counsel regarding overall matter oversight.
As in-house counsel, oversaw internal investigations and associated voluntary disclosures under the FCPA involving numerous markets around the world to the U.S. Department of Justice and SEC, and certain foreign authorities, beginning in 2004 and concluding in 2012. Secured a full declination for the parent company, a deferred prosecution agreement for the relevant corporate subsidiary, no imposition of an independent monitor, and explicit government recognition of the company's compliance efforts.
As in-house counsel, oversaw the acquisition due diligence, resultant internal investigations in numerous markets, and associated voluntary disclosures to the U.S. Department of Justice and SEC, which resulted in a full declination for the parent company and subsidiaries, and a purely civil resolution.
As in-house counsel, defended a pharmaceutical company against government inquiries and investigations by the Chinese Administration of Industry and Commerce ("AIC") in Beijing, Shanghai, and other cities and provinces across China, as well as related inquiries.
As in-house counsel, oversaw the successful resolution of several individual State AG and multi-state AG coalition matters, including the US$33 million consumer protection settlement with a coalition of 44 states around the promotion of Geodon, and the US$45 million consumer protection settlement with a coalition of 34 states around the promotion of Zyvox and Lyrica.
Transactional Compliance Diligence
Represented one multinational rare disease company in connection with its global anti-corruption/FCPA due diligence associated with its landmark US$32 billion acquisition of another leading rare disease company.
Conducted a gap assessment of the integration of the compliance program and systems of one medical device company acquired by another leading medical device company against industry and regulator standards.
Represented a multinational pharmaceutical company in connection with its global anti-corruption/FCPA due diligence associated with its US$16 billion acquisition of another pharmaceutical and medical device company.
Represented a multinational pharmaceutical company in connection with its global anti-corruption/FCPA due diligence associated with its US$16 billion acquisition of the vaccines business of another pharmaceutical company, divestiture of its oncology business, and a consumer healthcare joint venture.
Private Equity Compliance
Developed enhanced online anti-corruption training curriculum and revised global anti-corruption policies and procedures for a global private equity firm, and provide counsel on portfolio company management.
Conducted transactional compliance, AML, and sanctions diligence for a leading private equity firm in connection with higher-risk healthcare investments, including in hospitals, in emerging growth markets, including China.
Acting as de facto independent monitor for a leading private equity firm to provide monitor oversight of higher-risk investments in emerging markets.