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Catherine M. Dickenson

Catherine M. Dickenson

Senior Counsel
St. Louis
office: 314.480.1929
fax: 314.480.1505
Overview

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).


Industries

Services

Education

  • J.D., Saint Louis University School of Law
    • cum laude
      • Saint Louis Warsaw Transatlantic Law Journal, Managing Editor
  • B.A., Saint Louis University

Admissions

  • Missouri
  • Illinois
  • Kansas

Professional Associations and Memberships

  • The Bar Association of Metropolitan St. Louis
  • Defense Research Institute
  • The Missouri Bar 
Experience
  • Served on a coordinating counsel team defending the manufacturer of a popular blood thinner.
  • Served on a coordinating counsel team defending the manufacturer of a popular bone density drug.
  • Served on coordinating counsel and trial teams defending the manufacturer of hernia and pelvic mesh products.
  • In her role as National Malpractice Litigation Counsel for a large home-delivery pharmacy:
    • Responsible for all pharmacy malpractice and strict product liability litigation filed throughout the U.S.
    • Audited pharmacies for United States Pharmacopeia and FDA compliance and provided litigation avoidance advice and counsel.
    • Defended HIPAA claims and advised clients on privacy issues.
    • Negotiated and litigated claims for contractual indemnification.
  • Assists numerous device manufacturers with obtaining marketing approval for regulated products.
  • Provides due diligence advice to investors and companies investing in or acquiring drug and/or device companies, licensing agreements and co-marketing agreements.
  • Provides MMSEA compliance advice to Fortune 500 companies, drafted policies and procedures, and provided in-house training.
  • Advises clients on nationwide compliance with various state merchandizing practices and consumer fraud laws.