Practice Area
Sophisticated Defense for Regulated Product Manufacturers and Distributors
Morris Duffy Alonso Faley & Pitcoff provides experienced and strategic defense to clients in the pharmaceutical, medical device, and food product industries. These sectors operate under intense regulatory scrutiny and are frequently targeted in complex, high-stakes litigation, and our attorneys have the legal, scientific, and procedural knowledge to navigate this challenging environment effectively. We represent manufacturers and distributors of prescription and over-the-counter drugs, medical device companies, suppliers of dietary and nutritional supplements, and retailers and marketers of FDA-regulated products.
We partner with clients early, often in the risk management phase, to anticipate exposure, review medical literature, evaluate regulatory issues, and build preventive strategies. Our defense approach is grounded in deep knowledge of FDA regulations and compliance standards, familiarity with relevant statutory and case law, close collaboration with scientific, academic, and medical experts, and extensive experience handling Multidistrict Litigation (MDL) and coordinated defense strategies. Our team is also trained to handle the demands of complex discovery, preemption defenses, Daubert challenges, and expert witness coordination, and we emphasize early evaluation, efficiency, and organization in every phase of litigation.
We have successfully defended clients in litigation involving prescription drug manufacturers, hip and knee implants, shoulder pain pumps, orthotic and electrical stimulation devices, emergency response monitoring systems, surgical tools and devices, investigational medical devices pending FDA approval, and nutritional and dietary supplements. Our litigation team includes attorneys with backgrounds in medical and scientific fields, providing the technical fluency needed to understand your product and effectively communicate complex concepts to judges, juries, and regulators.
MDAFP attorneys remain current on the evolving legal and regulatory landscape through active participation in the Defense Research Institute (DRI), the Food and Drug Law Institute (FDLI), and the International Association of Defense Counsel (IADC). We have a proven track record of securing favorable outcomes through summary judgment, pretrial motion practice, and trial, and whether the objective is early resolution or full defense through verdict, we have the experience and commitment to deliver results.