Karen Firstenberg provides strategic counsel to life sciences companies on product liability, toxic torts, and compliance matters. Karen represents pharmaceutical, biotech, materials science and medical device manufacturers, designers, and distributors, including Fortune 500 and 300 companies. She has led nationwide mass tort drug and device litigation in both state and federal courts, winning favorable jury verdicts in multi-million-dollar claims. She strategically handles every aspect of litigation, including claim assessment, depositions, expert discovery, first-chair trial work, and more. Karen works closely with clients to develop and execute strategies to achieve client goals.
Karen has defended medical devices ranging from surgical robots and ortho-biologics to pain pumps and prosthetic devices, surgical mesh, toxic tort as well as intra-operative warning devices, lasers, medical durable equipment, and more. To prevent litigation and enforcement, she also advises on U.S. Food and Drug Administration (FDA) compliance issues for medical device, Material Safety Data Sheets, and other regulatory products. Karen also regularly advises clients on Medicare compliance and reporting issues. In addition, Karen has ample experience assessing and drafting company policies and procedures for FDA and statutory compliance.
In addition to complex product liability claims, Karen litigates class actions, contract issues, unfair business practice claims, medical malpractice, and personal injury litigation. She has won defense verdicts on multi-million-dollar claims and summary judgment rulings and has served as first chair in binding arbitrations. Karen is particularly skilled in offensive discovery, counseling clients on how to identify facts supporting potential claims, and defenses.