Nina M. Gussack is a partner in the Litigation Department of Pepper Hamilton LLP and chairs the Health Effects Litigation Practice Group. Ms. Gussack is 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. 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’s representative engagements include serving as:
- national trial counsel for litigation involving antipsychotic medication
- lead trial counsel in state Attorney General actions alleging consumer fraud/unfair trade practices
- national trial counsel for litigation involving diabetes medication
- lead counsel to an academic institution and clinical investigators in civil litigation, governmental investigations, a Congressional investigation and FDA CBER regulatory proceedings that arose from the death of a patient in a gene therapy clinical trial
- national counsel for medical device and pharmaceutical manufacturers in litigation preparation for high-risk products, including review, analysis and strategic guidance regarding regulatory inquiries, prepublication review of medical literature, marketing and DTC materials, consumer complaints and document retention issues
- trial counsel to pharmaceutical companies in Lanham Act litigation
- national counsel in litigation for a number of companies regarding clinical trial adverse events
- counsel to various major medical device and pharmaceutical companies in risk management on R&D and Sales & Marketing
- national trial counsel for litigation involving over-the-counter surgical preparation product
- counsel for various pharmaceutical entities conducting internal investigations and defending against parallel, federal and state, criminal and civil investigation
- counsel for cardiovascular medical devices
- counsel for American College of Neuropsychopharmacology and its members.
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.
Ms. Gussack’s publications include:
- “Plaintiffs’ Playbook Is Shifting,” monograph for DRI (May 2014)
- “The New AG Case: Defending Cases Where There Is an Alliance Between an Attorney General and the Plaintiffs’ Bar” co-author, DRI: The Voice of the Defense Bar (May 2010)
- “Clinical Trial Conflicts Apply to Investigators, Too” co-author, National Law Journal (May 2001)
- “Scrutiny of Scientific Evidence from ‘Daubert’ to ‘Joiner,” monograph for DRI (May 1998).
Ms. Gussack is highly rated at the national level for product liability litigation in Chambers USA: America’s Leading Lawyers for Business, which researches the reputation of leading lawyers across the country. In September 2010 she was named by the national legal newswire Law360 as one of the “10 Most Admired Product Liability Attorneys” in the country. She has been named to Lawdragon’s 500 Leading Lawyers in America, is listed in The Best Lawyers in America, and is recommended in the 2014 edition of The Legal 500 United States. Ms. Gussack was selected as a Life Science Star in LMG Life Sciences in 2012, 2013 and 2014 and she was selected for inclusion on the Pennsylvania Super Lawyers and Top 50 Women Pennsylvania Super Lawyers lists for 2014. Ms. Gussack is listed in Benchmark Litigation as a litigation star in the United States and as a local litigation star in Pennsylvania and was named to Benchmark: Top 250 Women in Litigation 2012-2014. She also is listed in the life sciences and product liability sections of Who’s Who Legal: The International Who’s Who of Business Lawyers, is listed in Who’s Who Legal: Product Liability Defence 2015, and is listed in The International Who’s Who of Liability Defense Lawyers in the area of product liability defense.
Ms. Gussack has earned numerous honors and awards for her leadership and legal ability. In 2014, she was selected for The Legal Intelligencer’s Lifetime Achievement Award, which recognizes “noteworthy individuals…who have helped to shape the law in Pennsylvania.” In 2013, Ms. Gussack received the Rainmaker Award from the Transformative Leadership Awards Committee and Inside Counsel magazine, in recognition of her success as a business generator and her leadership in promoting the advancement of women in the profession.