Partner, King & Spalding LLP
A partner in the FDA and Life Sciences practice at King & Spalding LLP, Marisa Maleck focuses on litigation, regulatory matters and public policy, with a focus on consumer products. As a former senior counsel at a bio-tech company and in private practice, Marisa has substantial experience with and is skilled in providing creative solutions in the face of uncertainty.
Marisa represents clients in a variety of matters with a focus on FDA-regulated products like food, beverages, pharmaceuticals, medical devices, wellness products, cosmetics, tobacco and cannabis. As a former senior counsel at an FDA-regulated biotech company and as a former partner in King & Spalding’s Litigation and Global Disputes practice group, she handled hundreds of suits in a multi-district litigation, multiple agency inquiries, an FTC lawsuit and 10+ state Attorney Generals actions. With a special focus on consumer fraud, social-media marketing and personal injury/wrongful death lawsuits, Marisa has successfully drafted and/or argued appellate briefs and critical motions in numerous cases—including class actions and complex litigation—before the U.S. Supreme Court, federal and state courts of appeals, and federal and state trial courts. She has also advocated tirelessly for her clients through engagement with agencies and policy-makers. She also advises her clients about legal risk (and how to avoid it) in investigations, enforcement actions, private litigation and private-equity investments.
Marisa also advocates for her clients’ interests in the court of public opinion. She is often solicited for her balanced legal analysis by members of the media. Marisa has appeared on (tv/radio) MSNBC, MSN, CNBC and NPR, and in (print) Newsweek, the National Law Journal, The Wall Street Journal, The Washington Post and Politico.
In addition, Marisa has an active pro-bono practice representing indigent defendants through federal appellate appointments as part of the Criminal Justice Act program and as a screener for the Mid-Atlantic Innocence Project.
Associate Professor of Law, Center for Intellectual Property and Entrepreneurship, University of Missouri School of Law
Professor Lietzan researches, writes, and teaches primarily in the areas of food and drug regulation, intellectual property, and administrative law. Some of her recent scholarship has focused on the nature and purpose of the new drug approval system, federal regulation of fecal microbiota transplantation, federal regulation of products derived from cannabis, the political economy of the Hatch-Waxman (generic drug) statute, and incentives to study already approved drugs for new uses. She is an award-winning teacher, and she has been an elected member of the American Law Institute since 2006.
Professor Lietzan brings to her scholarship and teaching eighteen years of private practice experience, eight of them as a partner in the food and drug group at Covington & Burling in Washington, DC. In practice, she handled a wide range of complex legal problems and broader legislative and regulatory policy questions affecting FDA-regulated companies. This work included lifecycle management and strategy issues, regulatory strategy and advocacy, white collar defense, congressional investigations, briefing in products liability cases, and international regulatory policy work. She was involved in every major amendment to the Federal Food, Drug, and Cosmetic Act (FDCA) between 1997 and 2014 and was deeply immersed for more than a decade in the development of the Biologics Price Competition and Innovation Act of 2010. She has been consistently identified by her peers in private practice as a “Best Lawyer in America” in the categories of FDA law (since 2013) and Biotechnology Law (since 2007).
Professor Lietzan has held one leadership position or another at the Food and Drug Law Institute (FDLI) since 2004, including a stint on its Board of Directors from 2008 to 2012. She also held leadership positions in the American Bar Association’s Section of Science and Technology Law for fourteen years.
Professor Lietzan received a bachelor’s degree from the University of North Carolina, where she graduated with honors in history. She holds a master’s degree in history from UCLA and a law degree with high honors from Duke Law School.
The Misapplication of eBay v. MercExchange, LLC
Marisa Maleck
Note from the Editor: This article discusses the Supreme Court’s decision in eBay Inc. v....
A Second Look at the CREATES Act: What’s Not Being Said
Erika Lietzan
Note from the Editor: This article critically discusses the CREATES Act, which is currently pending...