When companies face product liability and toxic tort litigation or need advice on compliance, they turn to Kate for sage counsel.
Representing clients in the manufacturing and healthcare industries, Kate defends product liability and toxic tort cases across the United States. She represents pharmaceutical and medical device manufacturers in complex cases, many involving multidistrict litigation. Kate also represents manufacturers and refineries in toxic tort cases in some of the nation’s most notorious jurisdictions.
Kate’s regulatory practice involves compliance advice on Food and Drug Administration (FDA) and state regulations governing pharmaceutical and medical device manufacturers, wholesalers, distributors and pharmacies. She works with pharmaceutical and device manufacturers to prepare and submit 510Ks and NDAs/ANDs; draft and revise product labeling (PIs and IFUs); register establishments; comply with FDA and state good manufacturing requirements; submit and manage adverse event reports; and maintain appropriate licensure in the states where they market and distribute their products.
She also provides compliance advice on food and beverage storage, transportation and safety under the Food Safety Modernization Act (FSMA).