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   3Steven M. KowalChicago(312) 807-4430steven.kowal@klgates.comsteven.kowal@klgates.comK&L Gates LLPwww.klgates.comwww.klgates.comKowalSteve.jpgAntitrust LawCommercial LitigationCriminal Defense Law: White CollarFalse Claims Act/Whistle Blower LawFederal Regulatory Law
Steven M. Kowalsteven.kowal@klgates.com
K&L Gates LLPhttp://www.klgates.com
70 W Madison St Ste 3300
Chicago IL 60602-4284
Ph.(312) 807-4430 Fx.(312) 827-8009
Recommended by peers in:
Antitrust Law
Commercial Litigation
Criminal Defense Law: White Collar
False Claims Act/Whistle Blower Law
Federal Regulatory Law
Advisory Board Member
County:  Cook
Litigator:  Yes

Practice Description:  
Mr. Kowal concentrates in 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.


Notable Cases and Results:  
  • Represented companies and individuals from the United States, Australia, Canada, Germany, Japan, Korea, the Netherlands, the Philippines and the United Kingdom in criminal antitrust and cartel matters.

  • Represented major corporations and executives in criminal investigations and proceedings initiated by FDA.

  • 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 an internal investigation for an international pharmaceutical company related to allegations of improper off-label promotion of prescription drugs.

  • Represented a senior executive of a major pharmaceutical company in hearings conducted by a congressional subcommittee.
  • Represented senior executives in health care and securities investigations and prosecutions.

  • 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.

  • Represented a company's outside retained lawyer in a criminal securities fraud case and obtained a full acquittal after trial.


  • Bar Admissions:  
    Illinois
    U.S. Court of Appeals for the Seventh Circuit
    U.S. District Court for the Northern District of Illinois
    U.S. Supreme Court


    Date of Birth:  1949

    Law School:  Northwestern University School of Law, J.D., 1974
    Law School Honors/Involvement:  Graduated cum laude. Recipient of a Northwestern University Scholarship

    Undergraduate School:  St. Procopius College, now known as Benedictine University, B.A. 1971
    Undergraduate School Honors/Involvement:  Class valedictorian; graduated magna cum laude; Excellence Scholarship

    Employment History:  
    Member at the law firm of Bell, Boyd & Lloyd LLC since December 1998; Bell, Boyd & Lloyd LLC merged with K & L Gates in 2009
    Shareholder in the law firm of Burditt & Radzius, Chtd. from April 1981 to November 1998
    Senior trial attorney at the Antitrust Division of the United States Department of Justice from September 1974 to April 1981
    Recipient of a Special Commendation Award from the United States Attorney General in 1981


    Bar/Professional Association Involvement:  
    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
    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


    Community Involvement:  
    Adjunct professor at the Northwestern University School of Law since 1997; served on the faculty of the Department of Business and Economics at Benedictine University; member of its Advisory Committee to the Dean of the Graduate School of Business.


    Published Legal Writing:  
    He has written more than 100 articles on criminal defense and regulatory enforcement issues. During the last five years, these have included:

    "Internal Corporate Investigations - Anticipating Possible Voluntary Disclosure," Practicing Law Institute, Internal Investigations 2008,June 2008. An excerpt from this article was featured in the PLI All-Star Briefing Newsletter for October 9, 2008

    "Responding to the Commencement of a Criminal Antitrust Investigation," ABA White Collar Crime National Institute, March 2008

    "Developments in FDA Criminal Enforcement," FDLI?s 6th Annual Conference on Enforcement and Litigation, February 2008

    "Government Enforcement Policy is Beginning to Draw Critical Review," FDLI Update, November/December 2006

    "Companies Trapped Between a Rock and a Hard Place," FDLI Update, September/October 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

    "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

    "Government Health Care Investigations: Be Prepared For An Ambush Interview," Chicago Hospital News, April 2005

    "Fraud and Abuse Investigations: Time For Some Restraint," FDLI Update, March/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


    Legal Lectures:  
    Mr. Kowal has participated in more than 75 presentations throughout the country on criminal litigation and government enforcement topics for groups such as the American Bar Association, the Chicago Bar Association, Illinois State Bar Association, Food and Drug Law Institute, Regulatory Affairs Professionals Society, the Corporate Counsel Institute of the Northwestern University School of Law, the Practising Law Institute and the law departments of several major corporations. During the last five years, these have included:

    "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?' 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


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