"At the top of her game." - Chambers USA 2016
Nina M. Gussack is a partner in the Litigation Department of Pepper Hamilton LLP. Ms. Gussack is past chair of the Health Effects Litigation Practice Group and past chair of Pepper’s Executive Committee, the firm’s governing body.
Ms. Gussack’s trial practice is concentrated in civil litigation, with a primary emphasis in the defense of pharmaceutical and medical device companies regarding marketed products, investigational new drugs, medical devices and over-the-counter drug products. Ms. Gussack serves as national coordinating and trial counsel and as regional counsel in pharmaceutical litigation, including class actions and multi-district litigation.
Ms. Gussack also represents pharmaceutical manufacturers, consultants and academic institutions in civil and criminal actions in related complex litigation involving health care fraud and abuse, and the defense of individual and class actions. She has conducted internal corporate investigations, audits and negotiations with government agencies, as counsel to pharmaceutical companies in grand jury proceedings and multistate investigations. Her practice includes counseling regarding regulatory issues governing clinical trials and compliance in promotional activities, as well as Lanham Act claims in the pharmaceutical industry.
Ms. Gussack is former Chair of the Defense Research Institute’s (DRI) Drug and Medical Device Committee, and she is a member of the Product Liability Advisory Council and the International Association of Defense Counsel. She also serves on the Ethics Committee of Wills Eye Hospital in Philadelphia.
Ms. Gussack is a frequent writer and lecturer on medical, pharmaceutical and medical device issues, and has given presentations at ACI, PhRMA, DRI, Drug Information Association (DIA), Food and Drug Law Institute (FDLI) and American Law Institute-American Bar Association (ALI-ABA) programs on fraud and abuse issues, federal preemption, off-label promotion, minimizing civil liability risks during pendency of a government investigation, clinical trials, Daubert challenges, informed consent, and risk management in the pharmaceutical industry.