Debra S. Dunne has joined the Philadelphia office of Shook, Hardy & Bacon L.L.P. as a partner.
Previously the chair of Stradley Ronon’s Life Sciences Regulatory/Compliance Practice Group, Dunne brings to SHB significant experience in food and drug law, counseling companies regulated by the Food and Drug Administration on regulatory and compliance issues from pre-approval to post-launch with a focus on risk evaluation and mitigation strategies, labeling, advertising and promotional activities, reimbursement, good manufacturing practices, product recalls, and warning letters. With experience addressing the intersection of unique litigation risks with government safety and regulatory oversight, Dunne provides exceptional strategic guidance and legal counsel to her drug, medical device, food, dietary supplement, and cosmetics industry clients. She has defended complex product-liability claims and has served as science and coordinating counsel in mass-tort litigation. Dunne has also written and spoken extensively on prescription-drug marketing and off-label issues.
Admitted to the Pennsylvania Bar and the U.S. District Court for the Eastern District of Pennsylvania, Dunne is a member of the Food and Drug Law Institute, Women in Bio and Attention Deficit Disorder Association Advisory Board. She served as a Pennsylvania Supreme Court Disciplinary Board Hearing Examiner from 2002-2008. Dunne received her J.D. from the Ohio Northern University Pettit College of Law and her B.S. from Duquesne University. Before she pursued a legal career, Dunne worked as a registered pharmacist in Pennsylvania and Ohio.
“We are delighted to welcome Debra to the firm,” said SHB Pharmaceutical & Medical Device Litigation Practice Chair Madeleine McDonough. “The range of her accomplishments, legal expertise, and practical experience will complement and enhance the services that we have long provided to our industry clients.”
SHB Philadelphia Managing Partner Sean Wajert said, “I have known Debra for many years and recognize how clients have come to value her insight and guidance on complex regulatory questions. We are excited to have her join us in Philadelphia and believe her FDA and Life Sciences expertise fits well with our existing practice, including serving many leading pharmaceutical and food clients in the Delaware Valley and tri-state area.”
