Ann regularly counsels food, dietary supplement, medical device, pharmaceutical, pet food, and cosmetic companies on matters governed by the Food and Drug Administration and U.S. Department of Agriculture. As part of her regulatory practice, Ann has helped clients respond to FDA inspector requests, Form 483 findings, and warning letters pertaining to product labeling, good manufacturing practices, record keeping, adverse event reporting, and the marketing of unapproved devices. She has also assisted companies with ongoing corrective actions, FDA and USDA product recalls and market corrections, foreign recalls and withdrawals, consumer complaints, and customs holds and international trade and labeling issues.
Ann has worked with medical device companies on 510k applications, facility registration, product listings, and import issues. She analyzes and prepares FDA inspection plans, recall plans, and supply chain compliance agreements for pharmaceutical, food and beverage manufacturers. She advises clients on risk management, product launch strategy, labeling, marketing and social media, and promotional claims. She has performed regulatory assessments in conjunction with co-counsel on mergers and acquisitions.
In addition, Ann has defended product liability lawsuits and consumer labeling class actions in state and federal courts across the country as national and regional counsel for clients in the pharmaceutical, dietary supplement, and agribusiness industries.
Ann is a member of Shook's Search Committee and is active in the firm's recruiting, mentoring, and business development efforts. She has served as a supervising attorney to law students participating in the firm's summer associate program and acts as a mentor to junior associates as part of the firm's mentoring program. Missouri Lawyers Weekly named Ann to its list of "Up and Coming Lawyers" for her professional accomplishments and "potential to make a difference in the profession, the legal system or the community."
Ann is also a Kauffman Scholars Big Sister through the Big Brothers Big Sisters of Greater Kansas City and a certified guardian ad litem.
During law school, Ann was executive editor of the Iowa Law Review. From 2005 to 2006, she held a judicial clerkship with The Hon. Donald P. Lay of the U.S. Court of Appeals, Eighth Circuit in St. Paul, Minnesota.
Ann P. Havelka & Jara Settles, For High Court, 2 Scoops of Raisins In This Case, Law360, May 8, 2015.
Ann P. Havelka & Jeff Lingwall, Get Ready For The 2nd Wave Of Food Labeling Litigation, Law360, February 20, 2015.
Ann P. Havelka & Jara Settles, FDA Warning Isn't Enough Proof For Takings Claim, Law360, October 17, 2014.
Ann P. Havelka & Ryan K. Farnsworth, USDA Poultry Regulations To Undergo Major Overhaul, Law360, August 18, 2014.
Ann Peper Havelka, Planning and Preparation: Making FDA Inspection a Positive Experience, FDLI Update, September/October 2008, at 59.
Steve Thomas & Ann Peper Havelka, Two Down, One To Go: Last Leg of U.S. Supreme Court’s Preemption Trilogy Has Industry’s Full Attention, SHB Pharmaceutical & Medical Device Litigation Update (FDCC, Tampa, Fla.), May 2008.
Madeleine McDonough & Ann Peper Havelka, Know Your Post-Sale Risks and Opportunities, Pork Exec, September 2007.
Consumer Insight Panel, Kansas City: Our Town, Our Food, Agricultural Business Council of Kansas City & Greater Kansas City Restaurant Association, Kansas City, Missouri, July 2015.
Food and Beverage Industry Litigation Update, Grocery Manufacturers Association Consumer Complaints Management Conference, May 2015.
Food Industry Under Seige, Sosland Publishing’s 36th Annual Purchasing Seminar, Kansas City, Missouri, June 2013.
Food and Beverage Litigation Update, Grocery Manufacturers Association Consumer Complaints Management Conference, San Francisco, California, May 2013.
Introduction to Drug Law and Regulation: How the Government Regulates the Drug Industry, Food & Drug Law Institute/Center for Drug Evaluation and Research In-House Training Course, Silver Spring, Maryland, October 2012.