Madeleine began a five-year term as Chair of Shook, Hardy & Bacon on January 1, 2017. A former clinical pharmacist, she represents multinational companies in a range of industries: pharmaceutical, animal health, medical device, food, cosmetics and beverage.
Shook’s pharmaceutical company clients have described Madeleine as “a true visionary and trusted counsel” and “one of the finest lawyers I have ever worked with—brilliant, innovative, with enormous integrity."
During her tenure as Chair of Shook’s Pharmaceutical and Medical Device Practice, the firm represented dozens of major pharmaceutical clients, including each of the top-10 pharmaceutical companies worldwide.
Madeleine has also served as Co-Chair of the Agribusiness and Food Safety Practice, and Co-Chair of the Life Sciences and Biotechnology Practice. She was elected to serve four three-year terms on the firm’s Executive Committee.
Madeleine advises organizations on preventative litigation approaches, policy and governance issues, emerging international legal developments, creative resolution strategies, risk management, corporate social responsibility and crisis management.
The National Law Journal named Madeleine one of the nation's top-50 Litigation Trailblazers & Pioneers in its inaugural 2014 class. She has been named a leading product liability attorney by Who’s Who Legal: The International Who’s Who of Business Lawyers and a Life Science Star by LMG Life Sciences. Madeleine has also been listed in The Legal 500 United States. In 2013, Missouri Lawyers Weekly honored her as a Mentor of the Year for her long-standing dedication to advising younger colleagues, law students and high school students with an interest in the law. She is also an American Bar Foundation fellow.
Madeleine is a lecturer in the Global Health Law LLM program at the Georgetown University Law Center in Washington, D.C. Before her legal career, Madeleine worked as a clinical pharmacist in a large university teaching hospital and brings her pharmaceutical background to her representation of pharmaceutical, medical device, food, and cosmetics manufacturers in product liability, regulatory and related legal issues.
Madeleine served as editor-in-chief of the Kansas Law Review. She earned her LLM in Global Health Law from Georgetown University Law Center. She chairs the Community Advisory Board of KCUR-FM, a National Public Radio affiliate in Kansas City.
Publications and Media
A Conversation with Madeleine McDonough, Grow KC: A Bimonthly Newsletter of the Greater Kansas City Chamber of Commerce, January 2017.
The Black Book Executive Profile: Madeleine McDonough, Ingram's, November 2016.
Legal Industry Outlook Assembly: Lawyers Anticipate Looming Agents of Change, Ingram's, November 2016.
A Quick Chat With the Newest Woman Leader in The Am Law 200, Law.com, June 15, 2016.
Rikin Mehta, Madeleine McDonough & Jara Settles, Chapter 10: Khasin v. Hershey Co., Top 20 Food and Drug Cases, 2014 and Cases to Watch, 2015.
Rainmaker Spotlight: An Interview with Madeleine M. McDonough, Sharing Success: The Newsletter of DRI’s Women in the Law Committee, December 12, 2014.
Madeleine McDonough, Rikin Mehta & Jennifer Stonecipher Hill, Chapter 20: Dronkers v. Kiss My Face LLC, Food and Drug Law Institute's Top 20 Food and Drug Cases, 2013 & Cases to Watch, 2014.
Madeleine M. McDonough & Lael A. Awong, Chapter VI: Human Food Safety, Food and Drug Law Institute Primer: FDA’s Regulation of Veterinary Drug Products, 2013.
Madeleine McDonough, Rikin Mehta & Jennifer Stonecipher Hill, Chapter 22: Significant Settlements, Food and Drug Law Institute's Top 20 Food and Drug Cases, 2012 & Cases to Watch, 2013.
Madeleine McDonough, Rikin Mehta & Jennifer Stonecipher Hill, Chapter 3: Walton v. Bayer Corp., Food and Drug Law Institute's Top 20 Food and Drug Cases, 2011 & Cases to Watch, 2012.
‘All Natural’ Class Action Wave May Be Short-Lived, Law360, October 19, 2011.
FDA Offers Clues to How It Will Pave the Way to Getting Biosimilars on the Market, GEN Magazine: Genetic Engineering & Biotechnology News, September 20, 2011.
Rikin Mehta, Madeleine McDonough & Jennifer Stonecipher Hill, Chapter 5: Centocor, Inc. v. Hamilton, Food and Drug Law Institute's Top 20 Food and Drug Cases, 2010 & Cases to Watch, 2011.
Madeleine McDonough & Jennifer Stonecipher Hill, Learning from Our Neighbors about Regulation of Biosimilar Drugs, The National Law Journal's Food & Drug Practice: Special Report, March 14, 2011.
Class Action Lawsuit Against McDonald's Attacks Marketing to Children, Inside Counsel, March 1, 2011.
Holly Pauling Smith & Madeleine McDonough, Chapter 3: A New Frontier: Health-Claims Class Actions, The International Comparative Legal Guide to: Class & Group Actions 2011 (Global Legal Group Ltd., London).
Supply Chain Crisis: SHB Attorneys 'Go Distance,' Feedstuffs, June 7, 2010.
James L. Michalowicz & Madeleine M. McDonough, You Can't Always Get What You Want . . . But If You Focus on the Case and Follow the Rules, You Can Get What You Need, BNA's Digital Discovery and E-Evidence Report, March 1, 2009.
Madeleine McDonough & Ann Peper Havelka, Know Your Post-Sale Risks and Opportunities, Pork Exec, September 2007.
Madeleine M. McDonough, Food Law Update – Litigation and Legislation, Food Liability – New Issues, New Strategies, Defense Research Institute, 2006.
Madeleine M. McDonough, Preparation and Preparedness: The Next Ten Years in Emerging Food Issues, Food Liability – Law, Science and Risk Management, Defense Research Institute, 2005.
Madeleine M. McDonough, Criminalizing Tort Law: Efforts to Develop Criminal Theories Relating to the Design, Marketing and Prescription of Pharmaceutical Products, Drug & Medical Device Litigation, Defense Research Institute, 2004.
Federal Courts Will Alter Production of Electronic Evidence, Kansas City Business Journal, October 2006.
Food Regulation and Litigation Is Expanding: How Companies Can Cope, Lawyers Weekly USA, June 2005.
Who Pays When E-Discovery Gets Expensive?, Corporate Legal Times, January 2005
Lawyers of the Year 2004, Madeleine McDonough: E-Discovery Pioneer, Missouri Lawyers Weekly, January 2005.
Council Helps Women Lawyers Get a Leg Up on Partnership Ladder, Kansas City Business Journal, February 2004.
Making a Difference Through Corporate Giving, AIDS Service Foundation of Greater Kansas City’s World AIDS Day 2016 Community Luncheon, Kansas City, Missouri (November 2016).
Navigating Key Regulatory Agencies for the Food Industry: Comprehending the Jurisdiction, Function, Organization and Interplay of the FDA, USDA, FTC and Local Health Agencies, ACI’s Food Law and Regulation Boot Camp, Chicago, Illinois (November 2016).
Panel Discussion on Diversity, Equality and Inclusion in Today’s Global Law Firm, The Chicago Bar Association and Institute for Inclusion in the Legal Profession CLE, Lausanne, Switzerland (March 2016).
Roundtable on Becoming a Leader in Business, Drinks Among Friends' Women's Legal Leadership Development Workshop, Kansas City, Missouri (September 2015).
Diversity and Inclusion Roundtable: What Works and What Doesn’t, Symposium on the State of Diversity and Inclusion in the Legal Profession, Institute for Inclusion in the Legal Profession, Bank of America Center, Charlotte, North Carolina (June 2015).
Trends in Food and Beverage Class Action Litigation, Shook, Hardy & Bacon’s Colorado Litigation Roundtable, Denver, Colorado (June 2015).
Panel Discussion with FDA Center for Veterinary Medicine Director Bernadette Dunham, Food and Drug Law Institute’s 2015 Annual Conference, Washington, D.C. (April 2015).
What’s on the Horizon? Emerging Legal Trends, ABA Life Sciences Legal Summit, San Francisco, California (February 2014).
Alternative Billing, ABA Section of Litigation’s Women in Products Liability Workshop, New York, New York (November 2013).
The Brain: Making Decisions and 'Judging' Others, 2013 Annual Conference of the Council of Chief Judges of the State Courts of Appeal, St. Louis, Missouri (October 2013).
Lawyers Are From Mars, PR Pros Are From Venus: The Challenges of Crisis and Reputation Management, Personal Care Products Council 2013 Legal and Regulatory Affairs Conference, Montreal, Canada (May 2013).
Best Practices for Working with Experts, American Bar Association Litigation Section Annual Conference, Chicago, Illinois (April 2013).
Hot-Button Issues in Food Safety, American Bar Association Tort Trial & Insurance Practice Section CLE, 22nd Annual Spring CLE Meeting, Phoenix, Arizona (April 2013).
Investing Private Industry in Global Health Governance May Strengthen WHO and Improve Global Health, O’Neill Institute, Georgetown University Law Center, Washington, D.C. (March 2013).
Food Manufacturers Under Fire: Anticipate, Engage, Protect, Defend, Learn, and… Prosper, Grocery Manufacturers Association's 2013 Litigation Conference, Miami, Florida (February 2013).
The Evolving Role of eDiscovery Counsel, Advanced eDiscovery Institute, Georgetown University Law Center, Washington, D.C. (December 2012).
Access to Water Considerations in Global Health Law, Georgetown University, Medical School Graduate Program, Washington, D.C. (December 2012).
Preemption Fundamentals: Overview of Recent Case Decisions and How to Successfully Assert Federal Preemption, ACI's FDA & USDA Compliance Boot Camp Conference, Chicago, Illinois (October 2012).
Roundtable on Actors and Institutions in Contemporary Global Health Governance, O’Neill Institute Summer Program on Global Health Law and Governance, Georgetown University Law Center, Washington, D.C. (June 2012).
The United States Regulatory Landscape: Focusing on the CPSC and the FDA, ABA's Doing Business in the United States: What You Need to Know About Investing, Product Liability and Dispute Resolution, Beijing, China (April 2012).
Minimizing Downstream Risk and Exposure to Consumer Fraud Litigation Based on Claims of False and Deceptive Advertising, ACI's 2nd Advanced Legal & Regulatory Summit on Food & Beverage Marketing & Advertising, Washington, D.C. (March 2012).
Creating Exit Strategies for Mass Torts and Selecting the Most Advantageous Settlement Model, ACI’s 16th Annual Drug and Medical Device Litigation Conference, New York, New York (December 2011).
Consumer Fraud Claims, ABA Section of Litigation’s Women in Products Liability Workshop, Nashville, Tennessee (October 2011).
Legal and Public Policy Implications of Global Infectious Diseases, Georgetown University Medical School, Washington, D.C. (October 2011).
From the Beltway: Are You Ready? Brace Your Legal Team for the Impact of Biosimilars, Nanotechnology, and Sustainability/Reputational Risks, ACC-SoCal’s Sizzling Topics in Pharmaceutical & Medical Devices MCLE, Irvine, California (September 2011).
So You Thought You Were Done? Beyond Federal Regulation: State Consumer Laws and Consumer Class Actions Related to Packaging, Labeling and Marketing in the Food Industry, ABA Section of Litigation's Food & Supplements Workshop, Atlanta, Georgia (February 2011).
What the Client Needs: Key Issues Facing Local Counsel, DRI’s Best Practices for Law Firm Profitability Seminar, New York, New York (November 2010).
The New Drug Approval Process: NDA Submission and Review, Food and Drug Law Institute’s Introduction to Drug Law and Regulation: How the Government Regulates the Drug Industry, Washington, D.C. (November 2010).
Risks and Threats Added Along with the Ingredients, International Association for Food Protection 2010 Annual Meeting, Anaheim, California (August 2010).
Pre-Litigation Risk Management Strategies, Grocery Manufacturers Association's 2010 Consumer Complaints Conference, Washington, D.C. (April 2010).
Pre-Litigation Risk Management for Consumer Products Companies, Grocery Manufacturers Association's 2009 Food Claims & Litigation Conference, Rancho Mirage, California (February 2009).
Regulatory Challenges to eDiscovery Around the World (EU, Russia, Middle East & Asia), LegalTech New York 2009 (February 2009).
Clinical Trials Registries and Results Databases: Complying with FDAAA and Varying State Laws, American Conference Institute's 10th National Conference on Managing Legal Risks in Structuring & Conducting Clinical Trials, Boston, Massachusetts (September 2008).
Setting Up Your Systems: E-Discovery/Risk Management and Preservation Obligations, BNA Conference on E-Discovery for the Enterprise: Preparing Your Corporate Clients for the Realities of the Post Rules Amendment World, Arlington, Virginia (September 2008).
Food Liabilities: From China to Chinese Restaurants, What American Insurers Need to Know, Swiss Re Claims Conference, Chicago, Illinois (June 2008).
Practical Considerations in Defending Corporate E-Discovery Programs and Reducing the Risk That E-Discovery May Improperly Be Used as Leverage, Electronic Discovery and Document Storage: Management and Litigation Issues in Missouri and Kansas – Including a View from the Bench, Kansas City, Missouri (June 2008).
Downgrading Data to Inaccessible Format: Risky Business?, BNA Audio Conference, Washington, D.C. (June 2008).
Electronic Discovery, 27th Annual Corporate Counsel Institute, St. Louis, Missouri (May 2008).
Clinical Trials: Developments in Human Subject Protection, FDLI & FDA Annual Conference, Washington, D.C. (March 2008).
Protect Your Biomedical Discoveries and Reduce Litigation Risks, University of Kansas (March 2008).
From Here to China – Domestic and Foreign Supply Chain Issues, Agricultural Business Council of Kansas City (January 2008).
Critical Privacy Issues in Electronic Discovery, The Center for Business Intelligence Summit on Pharmaceutical Global Data Security and Privacy, Washington, D.C. (September 2007).
Post-Sale Considerations for the Food Industry, American Bar Association Tort Trial & Insurance Practice Section CLE, American Bar Association Annual Meeting, San Francisco, California (August 2007).
Food Law Update – Litigation and Legislation, Defense Research Institute Food Liability – New Issues, New Strategies Seminar, Chicago, Illinois (November 2006).
Recent Litigation Developments in E-Discovery, Institute of Validation Technology Conference on Electronic Records Management, Philadelphia, Pennsylvania (December 2005).
Preserving and Destroying Documents in the Electronic Age, The Missouri Bar Ethics & Litigation CLE (December 2005).
Food Litigation in the Next Decade, Defense Research Institute Food Liability – Law, Science and Risk Management Seminar, St. Louis, Missouri (May 2005).
Best Practices in E-Discovery Preparedness: Invest Reasonably Now to Avoid Paying Dearly Later, Product Liability Advisory Council Spring Conference on E-Discovery & Records Management, San Antonio, Texas (April 2005).
Food Safety Litigation Trends, Agricultural Business Council of Kansas City (January 2005).
E-Discovery Is Improperly Used as Leverage, Shook, Hardy & Bacon National Forum on Electronic Discovery and Corporate Compliance (November 2004).
Emerging Issues in Agribusiness, Greater Kansas City Chamber of Commerce Centurions Leadership Program (November 2004).
Criminalizing Tort Law: Efforts to Develop Criminal Theories Relating to the Design, Marketing and Prescription of Pharmaceutical Products, Defense Research Institute Drug and Medical Device Seminar, San Francisco, California (May 2004) .