FDA Regulations vs. Products Liability Law: Preserving Products After an Adverse Event

Previously Recorded on August 27, 2015

Life sciences companies must deal with returned product in a variety of contexts, and must have procedures in place for product preservation, disposal, and/or destruction for each. In creating these procedures, companies are  guided by both the FDA’s Quality System Regulations and related guidances as well as considerations aimed at avoiding products liability. One circumstance in which these two regimes may be difficult to reconcile is in the case of products returned after their involvement in adverse events.

In this webinar Beth Rose, Member of Sills Cummis & Gross, discusses best practices for dealing with returned product—especially those that are the subject of a customer complaint or adverse event—and provide guidance for life sciences companies in balancing the occasionally competing concerns of the FDA and products liability avoidance.

Beth Rose is a Member of Sills Cummis & Gross, where she is Chair of the Product Liability Practice Group and a Co-Chair of the Litigation Practice Group. She has tried complex product liability cases to verdict in state and federal courts throughout the country. Ms. Rose is the lawyer to whom General Counsel turn when they need an aggressive but practical approach to “bet the company” product liability matters. Clients rely on her expertise to develop successful and cost-effective strategies consistent with their business goals.

Ms. Rose has over 25 years of experience successfully defending complex product liability matters for a variety of regulated products including pharmaceuticals, medical devices, consumer products, foods, chemicals (asbestos, silica and benzene) and construction/industrial machines. She also has experience defending product liability cases which arise from clinical trials and catastrophic workplace accidents. Her practice ranges from single plaintiff cases, to state coordinated proceedings, multi-district litigation and class actions. During her career, Ms. Rose has served as national counsel to several companies, including those in the pharmaceutical, medical device and contract research organization spaces, defending mass tort litigation. She has also served as New Jersey counsel to entities defending complex product liability claims in New Jersey’s Multi-County Litigation system.

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