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Peter
S.
Spivack
Partner, Washington, D.C.
peter.spivack@hoganlovells.com
Peter Spivack is the Co-Leader of the Investigations, White Collar, and Fraud Practice Area. His experience in the criminal arena includes antitrust, banking, campaign finance, environmental, food and drug, foreign corrupt practices act, healthcare, and government contract matters. Peter has worked with numerous companies and organizations in defending grand jury investigations, as well as conducting compliance audits and internal investigations and monitoring and improving compliance programs. In addition, Peter has handled a wide array of civil matters, including False Claims Act and international trade litigation.
Peter has extensive experience in defending pharmaceutical, biotechnology, and medical device manufacturers in federal healthcare and Food and Drug Administration investigations conducted by the U.S. Department of Justice, the Office of Inspector General of the U.S. Department of Health and Human Services, the Food and Drug Administration, the Government Accountability Office, the U.S. Senate, and the U.S. House of Representatives. The subject matters of these investigations have included Food, Drug & Cosmetic Act compliance, Medicare and Medicaid coding issues, pharmaceutical pricing, the Medicare Anti-Kickback Statute, and the Stark law. Peter also has considerable experience in representing entities and individuals in criminal and civil enforcement matters involving competition and antitrust issues.
From 1988 to 1989, Peter clerked for The Honorable William D. Keller of the U.S. District Court for the Central District of California. The following year, he clerked for The Honorable Arthur Alarcon of the U.S. Court of Appeals for the Ninth Circuit. From October 1990 through March 1997, Peter was a federal prosecutor focusing on the investigation and prosecution of complex white collar criminal matters involving corporations and individuals. Most of his investigations involved parallel enforcement actions by federal and state agencies, including the U.S. Securities and Exchange Commission, as well as parallel federal and state civil litigation. In November 1994, Peter received an award from the U.S. Attorney General for superior performance as an Assistant U.S. Attorney.
Peter writes and speaks frequently on federal criminal issues. He has played an active role in the bar, serving as a past Co-chair of the Health Care Fraud Subcommittee and of the D.C. Region for the ABA White Collar Crime Committee and as a past Co-chair of the Criminal Law and Individual Rights Committee for the D.C. Bar.
REPRESENTATIVE EXPERIENCE
Healthcare and Food & Drug
- Lead counsel for one of the world's largest orthopedic device manufacturers in a criminal investigation involving allegations of off-label marketing under the Food, Drug & Cosmetic Act.
- Lead counsel for a Fortune 500 medical device manufacturer in a criminal investigation involving compliance with the Medical Device Reporting requirements under the Food, Drug & Cosmetic Act.
- Co-lead counsel for a laser ablation device manufacturer in a criminal investigation involving allegations of off-label marketing and clinical trial fraud.
- Counsel to one of the world's leading biotechnology companies in the first criminal prosecution involving off-label marketing.
- Counsel to a major pharmaceutical manufacturer in federal, state, congressional, and administrative investigations of federal and state reimbursement.
- Counsel to a major orthopedics implant manufacturer in an Anti-Kickback investigation regarding its relationship with a major physician customer.
- Counsel to a major university in a civil case involving claims under the False Claims Act for the marketing of an unapproved biologic.
- Lead counsel in internal investigations involving allegations off-label marketing and Food, Drug & Cosmetic Act noncompliance for manufacturers of total joint implants, bone void fillers, neurovascular and endovascular catheters, intravenous antibiotics, blood glucose monitors, and HIV test assays.
- Counsel to numerous individuals in criminal investigations of biotechnology, pharmaceutical, and medical device manufacturers.
Antitrust and Competition
- Lead counsel for a major health care insurer in a criminal price-fixing investigation.
- Lead counsel for an incumbent local exchange carrier in a multistate civil enforcement action under the federal Telecommunications Act of 1996.
- Lead counsel for a competitive local exchange carrier in a civil lawsuit against a municipality for unfair competition.
- Co-lead counsel to a major environmental remediation firm in a criminal kickback and bid-rigging investigation.
- Counsel to a major defense contractor in a criminal trade secrets investigation.
- Counsel to a marine products manufacturer in a criminal price-fixing investigation.
- Counsel to a ready-mix cement manufacturer in a criminal price-fixing and market allocation investigation.
- Lead counsel for individual executives in criminal investigations in the air cargo, chemicals, LCD television, marine equipment, and other industries.
Hogan Lovells Publications
15 November 2012
"Top seven things you need to know about the new DOJ/SEC FCPA Guide." Investigations, White Collar, and Fraud Alert, Hogan Lovells
31 January 2012
"Hogan Lovells Global Bribery and Corruption Review 2011.", Hogan Lovells
21 December 2011
"An Important Development in the United States' Prosecution of International Bribery: The Indictment of a Former Siemens Board Member and Other High-Ranking Employees.", Hogan Lovells
25 March 2011
"Advice of counsel defense in US v. Lauren Stevens: dismissal of indictment is not necessarily good news for companies." White Collar and Investigations Alert, Hogan Lovells
January 2011
"Global Bribery & Corruption Review 2010." Bribery and Corruption Task Force, Hogan Lovells
21 December 2010
"Sobering developments on federal healthcare program exclusion." Health Alert, Hogan Lovells
20 December 2010
"Order enforcing criminal subpoenas for foreign-originating evidence possessed by U.S. counsel may have far-reaching implications.", Hogan Lovells
21 October 2010
"Pursuing healthcare industry executives and managers: HHS claims broad authority." Health Alert, Hogan Lovells
07 July 2010
"The Supreme Court Limits Applicability of Honest-Services Fraud Statute to Bribery and Kickback Schemes." Litigation and White Collar Alert, Hogan Lovells
June 2010
"False Claims Act Settlement Calls into Question Some Medical Product Rebate Practices." Health Alert, Hogan Lovells
21 June 2010
"Global Update on Bribery and Corruption." Government Contracts Alert, Hogan Lovells
17 November 2008
"Final Federal Acquisition Rule Will Impose Mandatory Disclosure Regime and Significantly Heighten Compliance Obligations." Government Contracts Update, Hogan & Hartson LLP
07 May 2010
"New Amendments to Sentencing Guidelines May Help Reduce Sanctions for Corporate Wrongdoing." SEC Update, Hogan Lovells
04 May 2010
"The United States Sentencing Commission Proposes New Amendments to the Organizational Guidelines." Litigation Alert, Hogan Lovells
26 March 2010
"Transparency Requirements, Health Care Fraud and Abuse Law Changes, and Program Integrity Provisions Enacted as Part of Health Reform Legislation." White Collar and Investigations Update, Hogan & Hartson LLP
17 March 2010
"OIG Predicts Increased Scrutiny and Actions Against Individuals for Wrongdoing." Health Update, Hogan & Hartson LLP
05 December 2008
"U.S. Antitrust Division Revises Language of Conditional Leniency Letters, Issues Comprehensive Written Explanation of Amnesty Program Policies." Antitrust Update, Hogan & Hartson LLP
20 November 2007
"Newly Proposed Regulations Aim to Significantly Expand Compliance and Reporting Requirements Applicable to Organizations That Conduct Business With the Federal Government." Government Contracts and Grants Update, Hogan & Hartson LLP
29 December 2005
"DOJ Settles Two Major Off-Label Cases: Recent Settlements Highlight Array of DOJ Enforcement Inquiries." Pharmaceutical and Biotechnology Update, Hogan & Hartson LLP
16 December 2005
"DOJ Environmental Crimes Enforcement Secures Multi-million Dollar Fines and Sets Sights on New Prosecutorial Initiatives." Environmental Update, Hogan & Hartson LLP
06 December 2005
"Dual Developments in Cartel Enforcement." Antitrust Update, Hogan & Hartson LLP
11 May 2005
"Sentencing Commission Increases Antitrust Penalties." Antitrust Update, Hogan & Hartson LLP
15 February 2005
"The Supreme Court Declares the Sentencing Guidelines Advisory and Opens the Door to More Negotiation of Corporate Sentences." Corporate Governance Update, Hogan & Hartson LLP
30 April 2004
"Amendments to Sentencing Guidelines Highlight Need to Update Compliance Programs." Compliance Update, Hogan & Hartson LLP
Published Works
01 April 2013
"Foreign Corrupt Practices Act Hits its Stride.", Financial Executive
24 January 2013
"Global Bribery and Corruption Review 2012.", Hogan Lovells
January/February 2013
"Top Seven Things You Need to Know About The New DOJ/SEC FCPA Guide." Corporate Governance, Walters Kluwer Law & Business
27 January 2011
"Antitrust case leads to order enforcing criminal subpoenas." International Law Office (ILO) Competition Newsletter, Globe Business Publishing Ltd.
01 December 2010
"Enforcement Focus on Individuals: The HHS OIG’s Multifaceted Assault." Health Care Fraud Report, Bureau of National Affairs, Inc.
12 November 2010
"Risky Business: The Pursuit Of Healthcare Industry Executives And Managers." Health Lawyers Weekly, Vol. VIII, Issue 44, American Health Lawyers Association
28 October 2010
"Targeting Health Care Execs And Managers." Law360, Portfolio Media, Inc.
December 2008
"New FAR Rule Imposes Mandatory Disclosure Regime, Heightens Compliance Obligations for Universities, Research." Medical Research Law & Policy Report, BNA, Inc.
05 June 2008
"Off-Label Promotion Under Scrutiny by DOJ." Genetic Engineering & Biotechnology News
Spring 2008
"Regulating the 'New Regulators': Current Trends in Deferred Prosecution Agreements." American Criminal Law Review, Vol. 45, Featured Essay, 2008 Annual Survey of White Collar Crime, Georgetown University Law Center
03 December 2007
"U.S. Contracts in Iraq: Increased Government Oversight and Investigations of Fraud." Government Contract Litigation Reporter, Thomson/West
01 September 2006
"What You Don't Know Can Hurt You: Government E-discovery in Criminal Investigations." 3rd Annual Advanced E-Discovery Institute: A Practical Guide to Implementation of the New Federal Rules, GeorgetownCLE: Institute, Georgetown University Law Center
01 June 2006
"DOJ Teaches a Lesson in Healthcare Marketing." Inside Litigation
20 March 2006
"Crackdown on 'Off-label' Pitches." The National Law Journal
24 February 2006
"DOJ Settles Two Major Off-Label Cases: Recent Settlements Highlight Array of DOJ Enforcement Inquiries." Health Lawyers Weekly, AHLA
01 September 2005
"An Ounce of Retention is Worth a Pound of Cure: Subpoena Compliance in the New Age." National Association of Criminal Defense Lawyers CLE program: Defending the White Collar Case, Georgetown University Law Center
01 March 2003
"The Onset of a Government Investigation: Is Your Company Prepared to Respond?" Hogan & Hartson L.L.P. Litigation Manual For In-House Counsel, Hogan & Hartson LLP
01 September 2002
"The Sentencing of Organizations, Chapter 15." Federal Sentencing for Business Crimes, Volume 2., Matthew Bender
12 July 2002
"Protecting Your Flank: Resolving Parallel Proceeding When Your Client Faces an Environmental Crimes Investigation." The Environmental Counselor
02 January 2000
"Understanding the Anti-Kickback Statute." Orthopedics Today
01 May 1999
"Finding a Safe Harbor: Anti-Kickback Implications of Medical Device Consulting Agreements." Medical Device & Diagnostic Industry
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