Aline Fairweather is Senior Health Sciences Counsel in the firm's Health Sciences Department. A partner from 2006 through 2017, she has many years of experience in complex litigation involving health sciences as well as regulatory and risk management counseling. Ms. Fairweather counsels and defends manufacturers of pharmaceutical products and medical devices, as well as life science companies with products in development. She brings to her practice a particular focus on complex scientific evidence and FDA regulation. Ms. Fairweather has previously served on the firm’s Hiring Committee.
Ms. Fairweather has substantial experience representing pharmaceutical and medical device manufacturers in multidistrict federal litigation and state coordinated proceedings, and in responding to government investigations and inquiries. She has identified, developed and deposed experts in fields ranging from endocrinology, oncology and molecular biology to FDA regulation of drugs and medical devices.
Ms. Fairweather provides advice to FDA-regulated companies of all sizes and product development stages on regulatory compliance and litigation risk in matters involving clinical trials, regulatory enforcement, labeling, advertising and promotion, responses to agency inquiries, and new and emerging regulatory developments. She has assisted clients in preparing responses to FDA inquiries and advised on regulatory issues in connection with commercial transactions.
Ms. Fairweather is a frequent writer and speaker on issues impacting health sciences clients, including topics such as labeling and promotion of pharmaceuticals and medical devices, off-label promotion, Daubert challenges to expert testimony and best practices in communications with investors about product development. She is a contributing author to the Drug and Medical Device Product Liability Deskbook (J. Beck and A. Vale, eds.).
In her pro bono practice, Ms. Fairweather provides post-conviction representation to criminal defendants. She represented an intellectually disabled death row prisoner in one of the first successful challenges to a death sentence in Pennsylvania following the U.S. Supreme Court’s landmark decision in Atkins v. Virginia.
Before joining Pepper, Ms. Fairweather practiced with Simpson Thacher & Bartlett LLP in New York, and Dechert LLP in Philadelphia.