Mark Levy is a litigator and trial attorney. He has represented Fortune 500 companies in complex commercial litigation in state and federal forums across the country. From medical device manufacturers and healthcare providers to industrial manufacturers of farm equipment and oil refiners and producers, Mark has handled a wide variety of statutory and common law claims at the pre-claim, trial and appellate stages of litigation. His experience in the courtroom ranges from defense verdicts in favor of multinational product manufacturers to a jury verdict in favor of a prominent civil rights attorney charged with legal malpractice.
Mark also 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, conducting internal investigations, evaluating loss 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 been asked to perform studies of risk exposure in many areas including toxic tort and mass tort litigation and product recalls. He has counseled pharmaceutical companies and medical device manufacturers on product recalls.
Additionally, corporations charged with violations of federal criminal law often turn to Mark for guidance. He has handled investigations into alleged government procurement fraud, healthcare fraud, and environmental crimes.
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.
Representative Matters
· Represented medical device manufacturer in responding to government inquiry into alleged off-label use of its products;
· Represented medical device manufacturers in developing compliance programs to address recent areas of government enforcement;
· Represented specialty oil producer in responding to request for worldwide recall;
· Represented largest service provider in United Kingdom in arbitration to resolve issues over contract to provide airport services in Iraq through USAID;
· Represented railroad in one of the largest investigations into alleged violations of environmental laws;
· Represented one of world's largest oil producers in defense of personal injury and property claims arising from explosion;
· Represented one of the largest suppliers of gas products in defense of personal injury and property damage claims arising from fire;
· 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.
Professional AffiliationsMember, Philadelphia Bar Association Professional Responsibility Committee Investigatory Panel Member, Philadelphia Bar Association Judicial Evaluation Committee President and Board Member, Philadelphia Volunteers for the Indigent Program Editorial Advisory Board Member, Monographs, Food and Drug Law Institute (FDLI)
Community InvolvementMember, Board of Directors, Citizens Crime Commission
Special RecognitionFellow, American Bar Foundation Selected for inclusion in Pennsylvania Super Lawyers National Institute for Trial Advocacy (NITA)
Articles/Speeches/Presentations
· "Preemption, Failure to Warn, the Learned Intermediary Doctrine and the First Amendment--Confusion or Consensus," presented at the Pennsylvania Bar Institute's 18th Annual Health Law Institute, March 2012.
· "Introduction to Food and Drug Law, Theories of FDA Enforcement and Hot Topics in Government Prosecution," presented at the Food and Drug Law Institute (FDLI),October 6, 2011.
· "Government Enforcement: A Prosecutor's View," presented at ACI's Annual Conference on Off-Label-Use, March 2011.
· "The Responsible Corporate Officer Doctrine - The Doctrine No Longer Sleeps for Drug and Device Companies," Food and Drug Law Institute Update, July/August 2010.
· "Cases to Watch in 2010, Top 20 Food and Drug Cases," a book chapter for 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, 2010.
· Off-Label Communications: A Guide to Sales and Marketing Compliance, The Food and Drug Law Institute, August 2009 (2d Ed.).
· 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, The Food and Drug Law Institute (2d Ed. 2006).
· Compliance Training Handbook for Medical Device Sales Representatives, ePharmaceuticals, Copyright 2006 HCPro, Inc.
· "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.