Kate has extensive experience in product and toxic tort liability cases, as well as providing FDA and state regulatory compliance and advice. She devotes a significant portion of her practice to pharmaceutical product liability work, toxic tort and consumer product defense work.
Representing clients in the manufacturing and healthcare industries, Kate regularly defends product liability cases pending throughout the United States. Kate has defended a number of pharmaceutical and medical device manufacturers in complex litigations, many involving Multidistrict Litigations. She has also acted as national counsel for a large mail order pharmacy in their product liability and dispensing dispute cases.
Kate’s regulatory practice involves compliance advice concerning FDA and state regulations governing pharmaceutical and medical device manufacturers, wholesalers and 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 within the various states they market and distribute their products. Kate also provides compliance advice concerning food and beverage storage, transportation and safety under the Food Safety Modernization Act (FSMA). She works with manufacturers, distributors, wholesalers and retailers to submit and maintain appropriate facility registrations to establish policies and procedures to ensure compliance with the FSMA.
Kate dedicates a significant portion of her practice to assisting clients with the Medicare reporting mandates under Section 111 of the Medicare, Medicaid and SCHIP Extension Act (MMSEA) and Medicare conditional payment claims under the Medicare Secondary Payer Act (MSP).