Bruce A. Levy is a Partner in HDRB&B’s White-Collar Criminal Defense and Litigation Departments. He has over 30 years of experience as a trial attorney and litigator representing and defending individual and high profile corporate clients, particularly in the healthcare industry, including pharmaceutical and medical device manufacturers, hospitals, durable medical equipment suppliers, physician group practices, billing companies and others in connection with internal investigations as well as administrative civil and criminal fraud allegations brought by Federal and State law enforcement and whistleblowers.

Bruce served as the Assistant U.S. Attorney and Health Care Fraud Coordinator at the U.S. Attorney’s Office, District of New Jersey where he prosecuted criminal jury trials including general crimes, bank fraud, tax fraud and health care fraud. As the Health Care Fraud Coordinator, he worked closely with federal and state agencies including the FBI, HHS-OIG, FDA, IRS, DCIS and the State Attorney General’s Office and State Medicaid Fraud & Abuse Control Unit. Bruce’s work in the public sector informs his practice and gives him unique insight when building a defense for his clients to result in the best possible outcome.

Bruce has been selected to the highly regarded New Jersey Super Lawyers® list for 12 years, and the prestigious legal ranking guide, Chambers USA, says, “Bruce Levy is a “great lawyer” with expertise in a broad array of healthcare litigation. He is experienced at handling criminal and civil fraud cases and regulatory enforcement matters.”

Bruce has served as an Adjunct Professor at Seton Hall Law School teaching courses on healthcare fraud and abuse. He is frequently called upon to lecture and moderate panels for the American Bar Association (“ABA”), the New Jersey Corporate Counsel Association, The New Jersey Association of Mental Health Agencies, the American Conference Institute and, NJ ICLE. Bruce has also published content in the Pharmaceutical and Medical Device Compliance Manual published by FDLI and the American Health Lawyers Association in conjunction with Seton Hall Law School.

Bruce serves as the Co-Chair, Mid-Atlantic Region Subcommittee for the ABA White Collar Crime Committee, the NJSBA, the American Health Lawyers Association and the Health Care Compliance Association.

Professional Affiliations

  • New Jersey State Bar Association
  • American Health Lawyers Association
  • Health Care Compliance Association
  • American Bar Association
    • ABA White Collar Crime Committee, Co-Chair, Mid-Atlantic Region Subcommittee (2010-present)

Honors & Awards

  • Listed in Super Lawyers®
    • New Jersey Criminal Defense: White Collar, 2007, 2009, 2012 – 2021
  • Chambers USA Guide

Awards Methodology

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Publications

  • Pharmaceutical and Medical Device Compliance Manual, Published by FDLI, American Health Lawyers Association, and Seton Hall Law School, Author of Chapter 4: “Advertising, Labeling & Promotion”

Speaking Engagements

  • Presenter, ABA National Institute on White Collar Crime, Northeast Regional Panel, “Significant Developments in Health Care Fraud”
  • Moderator, 23rd Annual ABA Health Care Fraud Conference, “Implications Of The Caronia Decision on DOJ and FDA Off-Label Enforcement”
  • Presenter, 22nd Annual ABA Health Care Fraud Conference, “Anti-Kickback Statute: Recent Trends and Developments”
  • Presenter, ABA Criminal Justice Section, White collar Crime Committee, Mid-Atlantic Region, “Strict Liability For Officers And Managing Employees At Pharmaceutical & Device Manufacturers”
  • Presenter, 21st Annual ABA Health Fraud Conference, “Federal Sentencing Guidelines and Criminal and Civil Damages”
  • Presenter, New Jersey Corporate Counsel Association, “A Practical Primer: Avoiding Problems With Company Sponsored Educational and Professional Meetings”
  • Presenter, American Conference Institute, “The Anti-Kickback Statute: Avoiding Problems With Company Sponsored Educational and Professional Meetings”
  • Presenter, American Conference Institute, “FDA/SEC Procedure For Centralized Referrals – Safe Harbors and Their Impact on Governance”
  • Presenter, New Jersey ICLE, “Industry Under Siege: Fraud & Abuse Issues – The PhRMA Code, The OIG Guidance & Beyond”
  • Instructor, New Jersey Association of Mental Health Agencies: “HIPAA Compliance”
  • Presenter, American Conference Institute Pharmaceutical Fraud Conference, “Developing A Compliance Program: Challenges for Pharmaceutical Companies”

Representative Matters

  • Co-lead defense counsel for biotech division of Johnson & Johnson in a federal investigation relating to allegations of off-label promotion and kickbacks to physicians in connection with several marketing programs including preceptorships, speaker programs, advisory boards and CME. Led an investigation team of attorneys, paralegals, and consultants that reviewed thousands of documents and conducted dozens of interviews.  Persuaded U.S. Attorney’s Office for the District of New Jersey to decline both criminal and civil prosecution.
  • Lead defense counsel for Physiotherapy Associates, a division of Stryker, operating more than 400 physical therapy centers across the country, in connection with a federal investigation relating to alleged improper billing and coding for physical therapy services. Led an investigation team of more than a dozen individuals, including attorneys, a consulting firm and a document collection team. Persuaded the U.S. Attorney’s Office for the District of Massachusetts to decline criminal prosecution and negotiated a $17 million civil settlement agreement in addition to successfully litigating whistleblower wrongful discharge claims with co-counsel in federal courts in Memphis and Boston.
  • Lead defense counsel for Vice President of Marketing for Bristol-Myers Squibb in a federal criminal investigation relating to sales and accounting practices. Successfully persuaded the U.S. Attorney’s Office for District of New Jersey not to prosecute VP and successfully defended the same individual before the SEC in a parallel proceeding arising from the same alleged conduct.
  • Lead defense counsel for several EBI employees, a division of Biomet, in connection with a civil False Claims Act investigation by the U.S. Attorney’s Office for the District of Massachusetts concerning allegations of improper marketing that resulted in miscoding of its medical device.
  • Lead defense counsel for Stryker in a federal civil investigation concerning alleged kickbacks to physicians and successfully negotiated a civil settlement while avoiding imposition of a Corporate Integrity Agreement.
  • Lead defense counsel for executives at several pharmaceutical and device manufacturers in connection with civil False Claims Act off-label promotion investigations brought by U.S. Attorney’s Offices in Massachusetts, New York, Philadelphia and New Jersey.
  • Lead defense counsel for Hackensack Meridian Health defending antitrust, discrimination and various claims pursued by plaintiffs in both federal and state courts. Successful motion to dismiss resulted in dismissal of all federal claims and all state law claims dismissed on summary judgment.
  • Lead defense counsel for Catholic Health East, chain of more than twenty hospitals, in a national investigation brought by Commercial Litigation Branch of DOJ and The U.S. Attorney’s Office for the Southern District of Florida relating to billing for alleged medically unnecessary implantable cardioverter defibrillators. Successfully negotiated an $11 million civil settlement while avoiding imposition of a Corporate Integrity Agreement.
  • Lead defense counsel for Saint Michael’s Medical Center in a federal investigation by U.S. Attorney for District of New Jersey concerning billing for alleged medically unnecessary cath lab procedures. Successfully negotiated a $500,000 civil settlement.
  • Lead defense counsel for a community hospital. Led and organized a team of consultants and in-house hospital personnel in a compliance review concerning potential improper coding and billing errors relating to hospital admissions. Directed a voluntary disclosure resulting in repayments while avoiding significant fines and penalties.
  • Lead defense counsel for the largest and oldest physician-owned multispecialty practice in New Jersey with more than 500 practitioners in False Claims Act litigation concerning alleged improper billing and coding of in-patient admissions, observation and discharges to skilled nursing facilities. Successfully obtained dismissal of a large percentage of claims in the Complaint and negotiated a $1.2 million settlement.
  • Lead defense counsel for the VP of Sales for Maxim Healthcare, a target in a criminal investigation brought by the US Attorney’s Office for the District of New Jersey. Successfully persuaded the U.S. Attorney’s Office to decline prosecution in a case where the Company entered a Deferred Prosecution Agreement and reached a $61 million civil settlement with a Corporate Integrity Agreement.
  • Lead defense counsel for PricewaterhouseCoopers (PwC) in connection with criminal and civil investigations by the New Jersey Attorney General’s office concerning alleged false cost reports submitted on behalf of New Jersey hospitals and persuaded the State to decline both criminal and civil prosecutions. Defense counsel for PwC in related civil RICO litigation brought in federal court by the hospitals and successfully negotiated a nominal settlement.
  • Lead defense counsel for PwC in DOJ investigation concerning allegations that PwC improperly advised hospitals to inflate charges for inpatient and outpatient care, making cases appear costlier than they were in order to get outlier reimbursements. Persuaded DOJ not to pursue civil case.
  • Lead defense counsel for prominent cardiology group practice in a federal investigation concerning alleged medically unnecessary diagnostic tests. Successfully negotiated $3.7 million settlement as well as terms of an Integrity Agreement with The Office of the Inspector General.

Prior Experience

  • Gibbons, P.C., Newark, NJ, Director, 2001 – 2021
  • United States Attorney’s Office, District of New Jersey
    • Assistant U.S. Attorney, 1995 – 2001
    • Health Care Fraud Coordinator, 1995 – 2001
  • Anderson Kill & Olick P.C., New York, NY, Junior Litigation Attorney, 1988 – 1990

Education

  • New York University School of Law, J.D., 1988
    • Juvenile Rights Clinic
    • Moot Court Board
  • Brandeis University, B.A., Politics, cum laude, 1984

Admissions

  • New Jersey
  • New York
  • U.S. District Court, District of New Jersey
  • U.S. Court of Appeals, Third Circuit