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Steven M. Kowal

Partner
+1.312.807.4430
Fax +1.312.827.8009

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.

Mr. Kowal 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.

Mr. Kowal 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.

Professional Background

Prior to private practice, Mr. Kowal 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.

Mr. Kowal 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.

Mr. Kowal has written more than 130 articles for publication.

Achievements

Mr. Kowal 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, Mr. Kowal 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. Mr. Kowal 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.

Mr. Kowal 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.

Professional/Civic Activities

  • 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)

Speaking Engagements

Mr. Kowal 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:
  • "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
  • Represented companies and individuals from the United States, Australia, Canada, Germany, Japan, Korea, the Netherlands, the Philippines, Thailand and the United Kingdom in criminal antitrust and cartel matters. Recent engagements have involved automotive parts and components, airline passenger and cargo fares, building construction, computer memory chips, computer monitors and displays, electronic capacitors, electronic components, oil and gas energy exploration, food and grocery products, manufacture and sale of ice, and municipal and public finance.
  • Represented an investment banker in the criminal antitrust investigation focused on bid-rigging related to the issuance of municipal bonds. Despite a strong recommendation by the investigative staff to pursue a multi-count criminal indictment, the senior decision-makers in the Antitrust Division were persuaded to decline prosecution. There were no criminal or civil enforcement proceedings.
  • Represented a large Japanese electronic component manufacturer in a criminal antitrust investigation in the United States and Canada, and in the civil damage litigation that followed in the United States.
  • Represented an agricultural chemicals company from Australia in a civil investigation and litigation conducted by the Federal Trade Commission in the United States. The case was resolved through a favorable agreement.
  • Represented major corporations and executives in criminal investigations and proceedings initiated by FDA.
  • Represented a company's outside retained lawyer in a criminal securities fraud case and obtained a full acquittal after trial.
  • Represented a major medical device manufacturer in a joint criminal and civil investigation focusing on numerous deaths related to a product's performance. The government was persuaded to decline prosecution and there were no criminal or civil enforcement proceedings.
  • Represented a major pharmaceutical company in a joint criminal and civil investigation conducted by the Department of Defense, the Office of Inspector General for the U.S. Department of Health and Human Services, and the U.S. Attorney in Philadelphia, based on a whistleblower's allegations. The government was persuaded to decline prosecution and there were no criminal or civil enforcement proceedings.
  • Conducted several internal investigations for pharmaceutical and medical device companies related to allegations of improper off-label promotion of prescription drugs and devices.
  • Conducted an internal investigation for the Audit Committee of an international electronics company concerning suspected accounting irregularities.
  • Represented a senior executive of a major pharmaceutical company in hearings conducted by a congressional subcommittee.
  • Represented senior executives and physicians in health care investigations and prosecutions.
  • Represented senior executives in securities fraud investigations.
  • Represented a large private equity investment company and its president in a high-profile public corruption investigation in Chicago. The government was persuaded to decline prosecution.