Mark L. Josephs Of Counsel

     

Contact

   

Mark Josephs focuses his practice on white collar criminal defense and government investigations; health care law, particularly pharmaceutical and medical device enforcement defense, litigation and compliance; commercial litigation; and advertising and marketing statutes and regulations affecting retailers. Mark formerly served more than 15 years as a federal prosecutor and civil litigator at the United States Department of Justice, where his prosecution and civil enforcement work often focused on high-profile health care, financial and consumer-related fraud. Mark has substantial federal court trial experience in the criminal and civil arenas and has argued more than 20 federal appeals. Mark also practiced at large law firms in Boston and Washington, DC. 

During his time at the Department of Justice, Mark received many awards for his work, including the Attorney General’s Award for Exceptional Service, the highest DOJ award; the United States Attorneys Director’s Award; and significant commendations from the Food and Drug Administration and the Federal Trade Commission. Mark also has broad teaching experience, including most recently a course on White Collar Crime at the Boston University School of Law.  In addition, he frequently served as an instructor at the National Advocacy Center at the Department of Justice training center, providing instruction in trial advocacy, criminal and civil pretrial litigation, and negotiations.  

Within the community, Mark is heavily involved in the Brookline Youth Baseball organization, and he raised substantial funds for the Tenacity program by running the 2016 Boston Marathon. Tenacity is a nonprofit that uses literacy, tutoring, and tennis and other fitness activities to assist and mentor low-income students, opening the door to opportunities for post-secondary success. While living in Washington, DC, Mark spent several years as a mentor for various participants in Capitol Partners for Education, a program that assists low-income students throughout their high school education with the goal of entering a four-year college or university after graduation.

Areas of Focus

Government Investigations & White Collar Defense
As a former federal prosecutor, Mark is uniquely qualified to assess a government investigation, whether it involves a regulatory enforcement effort or a grand jury investigation. He has appeared before numerous federal grand juries and is experienced in the workings of key federal government agencies, including not only the Department of Justice but also the Food and Drug Administration, other parts of the Department of Health and Human Services, and the Federal Trade Commission. Mark can draw on his years of government experience to inform clients subject to investigations of the motivations for and goals of investigations to which clients are subject. 

Many of the criminal prosecutions Mark pursued in the government involved parallel civil proceedings brought by other federal agencies or by other parts of DOJ under, for instance, the False Claims Act.  Mark is familiar with important considerations faced by entities or individuals involved in such parallel proceedings. He also has the knowledge to assess potential criminal exposure when an entity or individual is already subject to a government regulatory or civil action. 

Health Care Law and Pharmaceuticals & Medical Devices
Mark’s experience relating to FDA laws and regulations governing pharmaceuticals and medical devices was honed over 10 years of working closely with the FDA on criminal prosecutions and civil enforcement matters. Mark also has substantial experience with the False Claims Act, as well as anti-kickback and Stark statutes and regulations. In addition to the FDA, Mark worked with the Department of Health and Human Services Office of Inspector General on several important matters, including the prosecution of companies that ultimately entered into Corporate Integrity Agreements. 

Mark brings this unique background to advise companies subject to FDA and HHS regulation in circumstances of regulatory inquiries or enforcement. Whether the issues involve deficiencies in pharmaceutical manufacturing practices; problems following medical device quality system regulations; or issues with marketing and promotion, Mark has the experience to assist companies in addressing agency concerns and remain in regulatory compliance. 

Commercial Litigation
Mark brings years of first-chair experience in complex commercial litigation, on both the defendant and plaintiff sides, to assist clients embroiled in civil disputes. Mark’s first priority in this regard is to understand the business and financial needs of the client determine under what terms avoidance of litigation is preferable, and if such terms are unavailable for any reason, the best possible litigation strategy. Mark has been extremely successful in the matters he has taken to trial before both judges and juries, and he has taught civil trial and pre-trial advocacy at the distinguished Department of Justice National Advocacy Center.  

Retail
Mark worked closely with the Federal Trade Commission (FTC) for a decade, focusing primarily on advertising- and marketing-related civil enforcement matters and criminal prosecutions. He is intimately familiar with the Federal Trade Commission Act and related regulations, as well as the regulatory structure and priorities of the FTC. Mark also is familiar with the enforcement and regulation by state attorneys general of state consumer protection laws and regulations, which typically are closely patterned after the statutes and regulations enforced by the FTC. 

Mark currently advises companies selling and distributing products and/or services to the public on their compliance with FTC regulations and policies relating to advertising and marketing. As part of these services, Mark reviews advertising and marketing language and copy and advises clients regarding government inquiries or regulatory actions. He does so with the knowledge of the priorities and practices of the government and, when appropriate, by obtaining information from officials with whom he has long-standing relationships.