Failure Analysis, Product Recalls and Liability

Preventing the FDA and Plaintiffs’ Bar from Knocking on Your Door…

The current regulatory and litigation environments in the United States require that potential safety issues and problems with mass-produced products be vigorously investigated and quickly remedied. How well a company manages a recall situation or deals with compliance problems, identified, for example in a FDA Form 483 or Warning Letter, can affect not only the future viability of the product and the company’s liability and financial status, but the company’s reputation and "brand equity”. The company’s success in responding to FDA concerns, and communicating with the agency, customers and health-care professionals, can significantly impact public perceptions and potential liability. In addition, determining whether a device failure has occurred, and identifying and correcting its cause, are critical to avoiding government-imposed shut-downs, getting a product back on the market after a recall, and helping to avoid litigation.

We invite you to join Exponent, a leading consulting firm providing design, failure analysis and recall support to biotech companies, and Crowell & Moring, LLP, a trusted and respected international law firm with deep and broad expertise in FDA compliance and products liability counseling and litigation defense, for an interactive discussion on these medical device/biotech design analysis, regulatory compliance and liability issues.

Speakers

Jorge A. Ochoa, PhD, PE is a Principal Engineer at Exponent with over 25 years of broad experience in all R&D related areas of new product realization, from concept phase to market readiness. His specific expertise encompasses design of surgical instruments and techniques, as well as biomechanics, engineering biomaterials, and preclinical testing strategy. Dr. Ochoa specializes in the major aspects of medical device specific product development: technology forecasting, design control, risk analysis, biomaterials selection, verification/validation testing, failure analysis and intellectual property issues related to strategy, validity and infringement, post market surveillance, and recalls and forensic failure analysis of medical devices. He has served as an expert witness in product liability cases.

John H. Fuson, Esq. is a partner in Crowell & Moring, LLP’s Health Care, Product Risk Management and White Collar and Regulatory Enforcement groups in Washington, DC, specializing in U.S. Food and Drug Administration (FDA) enforcement and counseling matters. Before joining Crowell & Moring, John served as associate chief counsel at the FDA, with broad law enforcement responsibilities, from 2007-2012. John has experience handling all types of major enforcement actions brought by the FDA, including seizure actions, injunction actions, actions for civil money penalties, and contempt actions. His cases have involved drugs, devices, food, and veterinary drugs.

Kevin C. Mayer, Esq. is a partner and trial attorney in the Los Angeles office of Crowell & Moring LLP. Kevin's national practice focuses on products liability, complex commercial and mass tort litigation, construction, toxic tort, OSHA, and environmental litigation. He has counseled and represented numerous clients in the pharmaceutical, medical products, oil and chemical, mining, manufacturing, entertainment, construction, and financial industries in federal, state, territorial and tribal courts, and before government agencies and administrative bodies.