Peter S Spivack
Lawyer biography
Peter Spivack practices in the areas of white collar criminal litigation, governmental enforcement actions, and complex civil litigation. His experience in the criminal arena includes antitrust, banking, campaign finance, environmental, food and drug, foreign corrupt practices act, health care, 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 health care 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 the current Co-chair 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
Health care 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.
- 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.
- 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.
Hogan Lovells Publications
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
17 November 2008
"Final Federal Acquisition Rule Will Impose Mandatory Disclosure Regime and Significantly Heighten Compliance Obligations." Government Contracts Update, Hogan & Hartson LLP
Published Works
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
Practices
- Litigation, Arbitration and Employment
- Corporate Governance
- Investigations, White Collar and Fraud
- Electronic Discovery and Information Risk Management
Industry Sectors
- Life Sciences and Healthcare
Areas Of Focus
- Criminal Defense
- Internal Investigations and Corporate Compliance
- Governmental Enforcement Actions
- Regulatory Litigation
Education
- J.D., Order of the Coif, University of California, Los Angeles School of Law, 1988
- B.A., Stanford University, 1984
Memberships
- Co-chair, White Collar Crime Committee, D.C. Region for the American Bar Association
- Steering Committee, D.C. Bar Committee on Criminal Law and Individual Rights
- Member, Criminal Justice Act Criminal Appeals Panel, District of Columbia Circuit Court of Appeals
- Member, America Bar Association
- Member, White Collar Crime Subcommittee, American Bar Association
Awards / Rankings
- Washington, D.C. Super Lawyers, 2007-2009
- PLC Life Sciences Cross-border Handbook, Government Investigations, 2006-2007
- PLC Which Lawyer? Handbook, Life Sciences: Regulatory, 2006
Bar Admissions / Qualifications
- California
- District of Columbia
Court Admissions
- Court of International Trade
- U.S. Court of Appeals, District of Columbia Circuit
- U.S. Court of Appeals, Ninth Circuit
- U.S. District Court, Central District of California
- U.S. District Court, District of Colorado
Updates
Competition & Antitrust
Antitrust case leads to order enforcing criminal subpoenas
USA | 27 January 2011A recent Ninth Circuit decision confirmed that the risks associated with bringing foreign-originating evidence into the United States – even for what is believed to be a limited purpose – are very real and could result in that evidence being subpoenaed for use in a criminal investigation.
White Collar Crime
World Bank investigations arm sets anti-corruption priorities for 2021
International | 21 December 2020This article examines the World Bank Group's (WBG's) recently published third Sanctions System Annual Report FY2020, which covers 1 July 2019 to 30 June 2020. The report provides a detailed look at the recent activities of the three units of the WBG's sanctions system: the Integrity Vice Presidency (INT), the Office of Suspension of Debarment and the Sanctions Board. It also provides important insight into INT's priorities for fiscal year 2021.
Individual prosecutions under FCPA: more trials and more case law
USA | 07 September 2020Individual prosecutions under the Foreign Corrupt Practices Act (FCPA) have markedly increased over the past five years. This increase in case law will help to better define local, regional and international enforcement. In addition, more FCPA case law shedding clarity on open issues will be a boon to lawyers, judges and scholars seeking to understand the contours of a complex statute – the elucidation of which has previously been almost the sole province of enforcers.
DOJ updates roadmap to effective compliance programmes
USA | 06 July 2020The US Department of Justice (DOJ) has updated its guidance on the Evaluation of Corporate Compliance Programmes, providing increased clarity on some of the key questions that prosecutors ask in assessing the adequacy of corporate compliance programmes when making charging, sentencing and plea and settlement decisions. The guidance helps companies to proactively create or enhance their compliance programmes and effectively advocate before the DOJ in criminal investigations.
DOJ memorandum provides clarified guidance on corporate inability-to-pay claims
USA | 11 November 2019The US Department of Justice (DOJ) has issued a new guidance memorandum entitled "Evaluating a Business Organisation's Inability to Pay a Criminal Fine or Criminal Monetary Penalty". This memorandum aims to provide greater clarity, transparency and uniformity as to how the DOJ's Criminal Division evaluates companies' claims that they cannot pay a proposed criminal fine or monetary penalty.
Court expresses concern with government's outsourcing of corporate internal investigations
USA | 27 May 2019A court has expressed concern with the government's "routine outsourcing" of investigations to the targets of those investigations seeking cooperation credit. The court noted the corporate target's "uniquely coercive position" over its employees, who may also be potential targets of the investigation. The decision may profoundly affect the structure and scope of cooperation agreements between the government and the corporate targets of criminal investigations.
Justice Manual and FCPA enforcement
USA | 18 March 2019Throughout 2018 the Department of Justice (DOJ) continued to ring the clarion call for cooperation and sought to provide some certainty, consistency and coordination regarding the incentives offered to companies that provide voluntary disclosures. In particular, the DOJ centralised its guidance memoranda into what is now known as the Justice Manual. The DOJ's goals were to identify redundancies, clarify ambiguities, eliminate surplus language and update the manual to reflect current law and practice.
DOJ aims for good, not perfect: review of updated corporate cooperation policy
USA | 24 December 2018Government attorneys now have additional discretion in False Claims Act civil cases to award cooperation credit to a corporation that meaningfully assists the investigation without necessarily identifying every individual person outside of senior management involved in the alleged misconduct. The new policy reflects the reality of modern corporate investigations and encourages realistic cooperation efforts without compromising the Department of Justice's policy of holding individuals accountable.
Artificial intelligence and data analytics in fraud and corruption investigations
USA | 16 July 2018When a legal team needs to find the facts behind fraud and corruption allegations in a government investigation, technology can drive substantial new efficiencies. By filtering and evaluating vast amounts of information, artificial intelligence can effectively sort text messages, audio files, emails and other unstructured data into manageable groups; identify potential relationships between parties accused of fraud or corruption; and recognise patterns of frequency or timing, which may support a client's defence.
Impact of In Re Kellogg Brown & Root, Inc on privilege concerns in internal investigation
USA | 28 July 2014While companies can breathe a sigh of relief following the District of Columbia Circuit Court's recent unanimous ruling in In Re Kellogg Brown & Root, Inc, overturning the district court's decision in US, ex rel Barko v Halliburton Co, companies should take some precautions to reduce the risk of disclosure of privileged materials generated during internal investigations.
Does attorney-client privilege survive in corporate compliance investigation?
USA | 09 June 2014The US District Court for the District of Columbia recently issued an opinion that has the potential to disrupt the manner in which companies conduct compliance investigations, particularly in regulated sectors such as the defence industry. Although there are certain flaws in the court's reasoning, this decision – if widely adopted – could cause significant disruption in existing corporate compliance and investigation programmes.
