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Steven M. Kowal

Steven M. Kowal concentrates in government investigations and complex criminal and civil litigation, particularly antitrust, cartel and trade regulation, enforcement proceedings initiated by the U.S. Food and Drug Administration against pharmaceutical, medical device and food manufacturers, and health care, securities and business matters. He also conducts internal investigations for major corporations.

Steven has extensive federal trial experience. He has successfully defended numerous companies and individuals in many grand jury investigations and criminal prosecutions. He also has defended and successfully resolved numerous government civil enforcement proceedings relating to antitrust, the FDA and the Federal Trade Commission, and he has defended qui tam whistleblower actions. Several matters have involved complex parallel criminal and civil proceedings.

Steven also has significant appellate experience. He has been responsible for criminal and civil appeals in the United States Courts of Appeals for the District of Columbia and Fourth, Seventh, Eighth and Ninth Circuits, for state appellate courts in Illinois, Michigan and Florida, and for the Illinois Supreme Court.

In 2016, the K&L Gates Chicago antitrust and competition group was recognized as the “Cartel & Trade Regulation Law Firm of the Year in Illinois” by the international review and assessment programs of both Corporate INTL Magazine and Global Law Experts.

Prior to private practice, Steven spent seven years as a senior trial attorney in the Antitrust Division of the U.S. Department of Justice, where he prosecuted numerous criminal and civil antitrust cases. In that position, he received several awards for outstanding performance including the Attorney General's Special Commendation.

Steven was an Adjunct Professor at the Northwestern University School of Law from 1997 until 2004, served on the faculty of the Department of Business and Economics at Benedictine University, and is now a member of the Advisory Committee to the dean of Benedictine's graduate business school.

Steven has written more than 130 articles for publication.

Steven is a Fellow of the American College of Trial Lawyers. Fellowship in this prestigious organization is extended by invitation only to those lawyers recognized to have mastered the art of trial advocacy. The college regards its members as the best of the trial bar in the United States and Canada.

In recognition of his experience and success, Steven has been listed as one of The Best Lawyers in America in antitrust law, white collar criminal defense and FDA law. He has been recognized as one of the nation's leading lawyers in white collar criminal defense by Chambers USA, America's Leading Lawyers for Business. He has been selected for inclusion in the Euromoney Institutional Investor's Guide to the World's Leading Competition and Antitrust Lawyers and in the Cross-border Competition Handbook. He has been selected for inclusion in The International Who’s Who of Business Crime Defense Lawyers of the International Bar Association. He has been recognized by Corporate Counsel Magazine as one of the nation's Top Lawyers in antitrust law and white collar criminal defense. Steven has been included in Illinois Super Lawyers and named a Leading Lawyer in Illinois in white collar criminal defense, antitrust law and government regulatory litigation.

Steven was appointed by the ABA's Section of Antitrust Law to chair a special task force to prepare comments to Congress on proposed amendments to the United States Sentencing Guidelines for Organizations. Those comments were adopted as official policy by the American Bar Association's House of Delegates. He also has been appointed to task forces to address issues related to corporate governance, international cartel enforcement, proposed changes in the amnesty program of the European Commission and legislation to increase U.S. penalties for antitrust violations. In 2004 and 2005, he received awards from the ABA for Exceptional Leadership in Preparing Policy Comments on behalf of the Section of Antitrust Law relating to proposed amendments to the Federal Sentencing Guidelines.

  • American Bar Association (White Collar Crime Committee; Co-chair, Antitrust Subcommittee, 2007-2008; Section of Antitrust Law; Chair, Criminal Practice and Procedure Committee, 2001-2005; Co-chair, International Cartel Workshop, 2004)
  • American College of Trial Lawyers (Attorney-Client Relationships Committee 2007-2011)
  • Chicago  Bar Association (Chair, Antitrust Law Committee, 1996)
  • Organization for Economic Cooperation and Development (Working Group on Information Exchanges in International Cartel Investigations, Business and Industry Advisory Committee)
  • Food and Drug Law Institute
  • FDA Enforcement Manual (Editorial Advisory Board)

Steven has participated in more than 80 presentations throughout the country on criminal litigation and government enforcement topics for groups such as the American Bar Association, American Conference Institute, Association of Corporate Counsel, Chicago Bar Association, Illinois State Bar Association, Food and Drug Law Institute, Regulatory Affairs Professionals Society, Corporate Counsel Institute of the Northwestern University School of Law, Practising Law Institute, Washington Legal Foundation and the law departments of several major corporations. Also he has been a frequent commentator on criminal antitrust and international cartel topics of the Global Competition Review. During the last few years, these presentations have included:

  • “Business Risks and Mitigation Strategies for Japanese Companies in an Era of Increased Antitrust Enforcement,” K&L Gates Event, Chiyoda-ku, Tokyo, September 2016 (co-presenter)
  • “Business Risks and Mitigation Strategies in an Era of Increased Antitrust Enforcement,” K&L Gates Event, Chicago, November 2015 (co-presenter)
  • “Cartel and Criminal Practice Update,” ABA Section of Antitrust Law, Cartel and Criminal Practice Committee, March 2015
  • “Advanced FDA Criminal Enforcement Issues,” FDLI Annual Conference on FDA Enforcement, Litigation and Compliance, December 2014
  • "Developments in Criminal Enforcement,” FDLI 11th Annual Conference on FDA Enforcement, Litigation and Compliance, December 2013
  • "Developments in Criminal Enforcement," FDLI 10th Annual Conference on FDA Enforcement, Litigation and Compliance, December 2012
  • "International Enforcement," FDLI 9th Annual Conference on FDA Enforcement and Litigation, December 2011
  • "Off-Label Promotion and FDA Criminal Enforcement," ACI FDA Boot Camp, New York, March 2011
  • “Aggressive FDA Criminal Enforcement for Medical Devices,” OCTANe Presentation, Irvine, CA., February 2011
  • "Target on Pharma and Medical Devices: A New Enforcement Environment," K&L Gates Webinar, December 15, 2010
  • “Health Care Reform – Enforcement Expansion,” FDLI 8th Annual Conference on Enforcement and Litigation, October 2010
  • "Representing and Prosecuting the Individual in the Criminal Antitrust Process," ABA Section of Antitrust Law, Cartel and Criminal Practice Committee, March 25, 2010
  • "Government Antitrust Enforcement, Now and in the Future," K&L Gates Webinar, by Douglas F. Broder, Vanessa Edwards, Kenneth L. Galzer, Friedrich L. Hausman, Steven M. Kowal, Scott Mendel, James R. Weiss, December 8, 2009
  • "The Government’s Prosecution of Lawyers, Compliance Officers and Others with FDA-Regulated Companies," FDLI, 7th Annual Conference on Enforcement and Litigation, October 2009
  • "Antitrust Developments: Criminal Enforcement," ABA Antitrust Section, Corporate Counseling Committee, September 2009
  • "Enforcement Redux: FDA's New Vigor Under New Leadership," ABA Annual Meeting, August 2009
  • "Important Regulatory Developments: FDA's Reportable Food Registry and Other Reporting Obligations," K&L Gates Webinar, by Robert G. Hibbert, Steven M. Kowal. July 28, 2009
  • "Yes you Can! Top 10 Ways to Leverage Internal Investigations to Reduce Costs and Mitigate Risks," Association of Corporate Counsel, June 2009
  • Current & Future Regulatory Issues for the Medical Device, Drug and Food Industries: Afternoon Session focused on Enforcement and USDA/Food Issues, K&L Gates Event, by Steven M. Kowal, Anthony T. Pavel. May 28, 2009
  • Corporate Vicarious Criminal Liability, Washington Legal Foundation, by Steven M. Kowal. April 7, 2009
  • "Commencing the Investigation," PLI, Internal Investigations 2008: Legal, Ethical & Strategic Issues, June 2008
  • "U.S. Antitrust Law and Global Enforcement," ABA, White Collar Crime Committee, May 2008
  • "Responding to Criminal Investigations," Corporate Counsel Forum, Liability Implications of the Subprime Mortgage and Credit Crisis – Tremor or Earthquake?, May 2008
  • "Criminal Antitrust Enforcement," ABA, National Institute on White Collar Crime, March 2008
  • "Criminal Cases and Corporate Integrity Agreements," FDLI, 6th Annual Conference on Enforcement and Litigation, February 2008
  • "Preventing the Erosion of Attorney-Client and Work-Product Protections: Strategies to Preserve Privilege in Products and Related Cases," Drug and Medical Device Litigation, June 2006
  • "Antitrust Due Diligence In Handling Criminal Investigations," ABA, Managing Antitrust Matters In The Modern Corporate Governance Era, May 2006
  • "Responding to FDA’s Enforcement Muscle," FDLI, 4th Annual Enforcement and Litigation Conference, December 2005
  • "Conducting Internal Investigations," CBA, December 2005
  • "Current Developments in Criminal Antitrust Enforcement," ABA, June 2005
  • "Will the FDA Let You Keep Your Secrets? Erosion of Legal Privileges & Protections During an FDA Investigation," Thompson Publishing, June 2005
  • "The Wolf in Sheep’s Clothing: Corporate Investigations Have Become A Tool of the Government," FDLI, 48th Annual Conference, April 2005
  • "The Erosion of Privileged Communications," PhRMA Annual Meeting, April 2005
  • Criminal Practice and Procedure Committee Program, ABA, Section of Antitrust Law Spring Meeting, March 2005
  • "International Cooperation In Antitrust Investigations," ABA/CBA, February 2005
  • "Criminal Enforcement," FDLI, Conference on Fakes and Imports, May 2004
  • "Criminal Developments," FDLI, 47th Annual Conference, April 2004
  • Criminal Practice and Procedure Committee Program, ABA, Section of Antitrust Law Spring Meeting, April 2004
  • "The Joint Defense," ABA, Section of Antitrust Law International Cartel Workshop, February 2004
  • Government Enforcement Policy is Beginning to Draw Critical Review, FDLI Update, November/December 2006
  • The Government Has Added Fuel to the Qui Tam Explosion, FDLI Update, July/August 2006
  • The Government Seeks to Erode the Ability to Defend, FDLI Update, May/June 2006
  • Companies Trapped Between a Rock and a Hard Place, FDLI Update, September/October 2006
  • Enforcement Against Off-label Promotion Requires a Clear Policy Pronouncement, FDLI Update, March/April 2006
  • Disclosures to Auditors and Privilege Waivers: Another Headache, FDLI Update, January/February 2006
  • Application of the Attorney-Client Privilege to Former Employees: Less Than You Might Think, FDLI Update, November/December 2005
  • FDA Can Compel Disclosure Of A Lawyer’s Notes, FDLI Update, September/October 2005
  •  The Government’s Focus Now Includes A Company’s Culture, FDLI Update, May/June 2005
  • Court Protects Defendant’s Due Process Rights In Criminal Antitrust Case, Washington Legal Foundation Counsel’s Advisory, April 8, 2005
  • Developments In FDA Criminal Enforcement, FDLI’s 48th Annual Educational Conference, Washington, D.C., April 2005
  • Fraud and Abuse Investigations: Time For Some Restraint, FDLI Update, March/April 2005
  • Government Health Care Investigations: Be Prepared For An Ambush Interview, Chicago Hospital News, April 2005
  • Corporate Deferred Prosecution: Showing Some Concern For The Shareholders, FDLI Update, January/February 2005
  • Sentencing Turmoil And Corporate Compliance Programs, FDLI Update, November/December 2004
  • Criminal Antitrust Enforcement: A Global Challenge, Washington Legal Foundation, October 15, 2004
  • False Statements During An Internal Investigation Can Become A Federal Crime, FDLI Update, September/October 2004
  • Attorney’s Confidential Communications: The Continued Assault, FDLI Update, July/August 2004
  • The Risk of Public Comment: FDA’s Coordination with the SEC, FDLI Update, May/June 2004
  • FDA Criminal Enforcement: Prosecution and Defense Issues, Food and Drug Law Institute’s 47th Annual Educational Conference, Washington, D.C., April 2004
  • Pharmaceutical Executive or Mafia Kingpin? Charging Decisions Can Reflect Little Difference, FDLI Update, March/April 2004
  • Developments in the Law Relating to Joint Defense Agreements and Waiver of Attorney-Client Privilege, ABA Section of Antitrust Law, International Cartel Workshop, New York, February 2004
  • Charging Decisions: Will the Government Overplay its Hand, FDLI Update, January/February 2004
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