Mark C. Levy
Mark Levy is a litigator and trial attorney who has represented Fortune 500 companies in complex commercial litigation in state and federal forums across the country. He has spent most of his career defending pharmaceutical and medical device companies, defense contractors, transportation companies, and manufacturers of products in heavily-regulated industries in claims made by federal, state, and local law enforcement agencies. Corporations and individuals charged with violations of federal criminal law often turn to Mark for guidance. He has handled investigations into alleged criminal and civil violations of federal statutes and regulations, including the False Claims Act; Food, Drug and Cosmetic Act; Clean Streams and Clean Air Acts; Medicare and Medicaid regulations; and Federal Acquisition Regulation. Mark has also conducted internal investigations, from routine to serious, for companies in the pharmaceutical, medical device, oil and gas, and heavy manufacturing industries.
Mark regularly provides risk-management advice to businesses that manufacture and sell products for consumer use. This includes developing, expanding, and implementing corporate compliance programs in highly regulated environments, evaluating risk exposure to toxic tort litigation, and assessing the risks of litigation costs in complex, multi-party litigation. His interest in risk management and corporate defense began prior to his joining private practice, when he was the lead paralegal for Ford Motor Company in the civil and criminal defense of Ford arising from alleged product defects in the Ford Pinto automobile. Mark has provided counsel to many businesses seeking to assess or avoid claims risk. He has also counseled pharmaceutical and medical device companies as well as other manufacturers on product recalls.
A former professional soccer player and elite rower, Mark continues to represent athletes in controversies arising from the oversight by the governing bodies of several sports and sporting events, including the NCAA and the United States Olympic Committee.
After graduating law school, Mark served as law clerk to the Honorable James T. Giles, Chief Judge, United States District Court for the Eastern District of Pennsylvania.
- Represented several medical device manufacturers in responding to government inquiries into alleged illegal marketing practices.
- Represented pharmaceutical manufacturer in responding to government inquiries into alleged fraud and abuse.
- Represented individual executives of pharmaceutical manufacturer into allegations of fraud and abuse as well as alleged unlawful off-label use.
- Represented railroad in one of the largest investigations into alleged violations of environmental laws.
- Represented largest service provider in United Kingdom in dispute with USAID over the provision of services related to the reconstruction of Iraq.
- Internal investigations for medical device manufacturers on marketing practices and issues arising from off-label use.
- Internal investigations for pharmaceutical companies on issues arising from marketing practices.
- Internal investigations for oil company of contracting practices.
- Internal investigation for waste handling company of minority contracting issues.
- Internal investigation for transportation company arising from waste disposal issues.
- Represented medical device manufacturers in developing compliance programs to address recent areas of government enforcement.
- Assisted international aid/health program in revisions to its global compliance program.
- Represented specialty oil producer in responding to request for worldwide recall.
- Represented numerous medical device manufacturers in products liability actions.
- Represented pharmaceutical manufacturers in defense of products liability actions, commercial litigation arising from contractual disputes, and intellectual property claims.
- Food and Drug Law Institute (FDLI) Board, Medical Products Committee, Medical Devices Committee, and 2021 Advertising and Promotion Conference Committee
- Philadelphia Bar Association Professional Responsibility Committee
- Philadelphia Bar Association Judicial Evaluation Committee, Investigatory Panel Member
- Philadelphia Volunteers for the Indigent Program, President and Board Member
- Monographs, FDLI, Editorial Advisory Board Member
- Citizens Crime Commission, Board of Directors
Awards and Recognition:
- American Bar Foundation, Fellow
- Selected for inclusion in Pennsylvania Super Lawyers
- National Institute for Trial Advocacy (NITA)
- Attained an AV® Preeminent™ rating from Martindale-Hubbell
- Named to the First Judicial District 2016 Pro Bono Honor Roll, Philadelphia
News and Insights
- “Preparing for when the government comes knocking,” Eckert Seamans’ Construction Law Update, Spring 2014.
- “Developments in Enforcement of Off Label Promotional Activities,” Food and Drug Law Institute Update, September /October 2012.
- “Off-Label Communications: A Guide to Sales and Marketing Compliance: Third Edition,” The Food and Drug Law Institute, August 2012.
- “The Responsible Corporate Officer Doctrine – The Doctrine No Longer Sleeps for Drug and Device Companies,” Food and Drug Law Institute Update, July/August 2010.
- “Top 20 Food and Drug Cases, 2009 & Cases to Watch, 2010,” co-author, The Food and Drug Law Institute, January 2010.
- “Off-Label Promotion: Government Theories of Prosecution and Facts that Drive Them,” Food and Drug Law Journal, Volume 65, Number 3.
- “Defending a Pharmaceutical, Medical Device, or Biotechnology Client in a Government Investigation: Key Issues for Clients and Attorneys, Agencies in Food and Drug Law,” Aspatore Books, June 2009.
- “Product Design and Safety: Preempting Problems and Avoiding Product Liability Issues, Bringing Your Medical Device to Market: Second Edition,” The Food and Drug Law Institute, 2006.
- “Compliance Training Handbook for Medical Device Sales Representatives ,” ePharmaceuticals, 2006.
- “Keeping The Attorney-Client Privilege In-House,” The Corporate Counselor, Volume 19, Numbers 5 and 6, October and November 2004 (two-part series).
- “A Records Retention Policy in the Electronic Era,” The Corporate Counselor, Volume 18, Number 8, January 2004.
- “Inter-Agency Enforcement Updates and Priorities,” moderator, Food and Drug Law Institute Advertising and Promotion Conference, October 2021.
- “Violations, Enforcement, and International Issues,” co-presenter, Food and Drug Law Institute course, Introduction to Drugs, Biologics and Biosimilars Law and Regulation, August 2020.
- “FSMA Enforcement Actions Begin: Trends and Unanswered Questions,” presented at the Food and Drug Institute’s Enforcement Litigation, and Compliance Conference, December 2019.
- “Medical Product Off-Label Use and Marketing: How to Conduct an Internal Investigation,” FDA News Webinar, October 2019.
- “How is 3D Printing Revolutionizing the Medical Device Industry?” panelist, Food and Drug Law Institute’s Conference on Medical Devices: FDA Regulation in the Era of Technology and Innovation, San Francisco, June 2019.
- “Machine Learning, AI, and Digital Health” panel presenter, as part of the Food and Drug Law Institute’s Annual Conference in Washington, D.C., on May 2-3, 20.19
- “Inspections in the FSMA Environment,” presented at the FDA Food Enforcement and Compliance Conference, April 2018.
- “Compliance issues with the Food Safety Modernization Act Enforcement,” presented at the Litigation and Compliance Conference for the Drug, Device, Food and Tobacco Industries, December 2017.
- “The New Normal — 3D Printing and Digital Manufacturing: Making Sense of New FDA Guidance and Product Liability,” an FDA News Webinar, August 2016.
- “Current Issues in Medical Device Litigation,” panelist, Food and Drug Law Institute Annual Conference (Washington, D.C.), May 2015.
- “Pharmaceutical and Medical Device Advertising and Promotion: First Amendment Issues and the Future of FDA Regulation,” co-presenter, Enforcement, Litigation, and Compliance Conference (Washington, D.C.), Food and Drug Law Institute, December 8-9, 2014.
- “Trends and Priorities in Enforcement from the Federal Government,” panelist, 25th Advertising and Promotion Conference, Food and Drug Law Institute (Washington, D.C.), September 30, 2014.
- “Meeting the Challenge: Managing Internal Investigations in Today’s Regulatory Framework and Pro-Enforcement Environment,” co-presented with Richard Wiedman, Eckert Seamans’ Continuing Legal Education Seminar, August 2014.
- Panel Presentation with Janet Woodcock, CDER, Roundtable on CDER issues (Social Media Guidance and First Amendment Issues), Food and Drug Law Institute Annual Meeting, April 2013.
- “Enforcers’ Roundtable: Identifying Specific Off-Label Activities Likely to Trigger Government Scrutiny,” Eighth Advanced Summit on Off-Label Communications, American Conference Institute, June 2012.
- “Preemption, Failure to Warn, the Learned Intermediary Doctrine and the First Amendment–Confusion or Consensus,” 18th Annual Health Law Institute, Pennsylvania Bar Institute, March 2012.
- “Introduction to Food and Drug Law, Theories of FDA Enforcement and Hot Topics in Government Prosecution,” Food and Drug Law Institute, October 6, 2011.
- “Government Enforcement: A Prosecutor’s View,” Annual Conference on Off-Label-Use, American Conference Institute, March 2011.