Lawyers / Professionals

 
Kristian A. Werling       
Associate
77 West Wacker Drive
Suite 4100
Chicago, Illinois 60601-1818
T: 312.750.8695
F: 312.558.4382
kwerling@mcguirewoods.com
 

Mr. Werling concentrates in corporate healthcare transactional work and regulatory matters for all participants in the healthcare and life science industry. His experience includes representation of healthcare providers including hospitals, health systems, specialty hospitals, ambulatory surgery centers, specialty pharmacies, pharmaceutical companies, multi- and single-specialty medical practices, and a variety of healthcare industry entrepreneurs.

He has represented these clients in sales and acquisitions, joint ventures, general corporate matters, contracting, and regulatory matters including the negotiation and drafting of transaction documents, and counseling with regard to the legal aspects of day-to-day operations, state and federal regulatory compliance, fraud and abuse and Stark issues, compliance with the Food, Drug and Cosmetic Act, self-referral, corporate practice of medicine, and certificate of need and licensure requirements, as well as tax issues involving Internal Revenue Code Sections 501(c)(3) healthcare providers.

From 2005-2006, Mr. Werling served as in-house counsel to Hospira, Inc., a generic specialty pharmaceutical and medical device manufacturer in Lake Forest, Ill. He worked with commercial and healthcare compliance and regulatory issues for Hospira. He regularly counsels life science clients in transactional and regulatory issues with a particular focus in negotiating contract manufacturing agreements, supply agreements, group purchasing organization (GPO) agreements and the compliance and regulatory issues facing medical affairs and marketing departments.

Mr. Werling serves as co-author of TheHealthcareInvestor.com, a blog covering business and legal issues that impact investments in healthcare and life sciences business.


Practices & Industries
Honors
  • Member, Journal of Law and Technology Policy

Previous Experience
  • Counsel, Commercial & Compliance, Hospira, Inc., 2005-2006

Publications
  • "The Impact of Healthcare Reform on Medical Device Companies," (co-authored with Holly Carnell and Drew McCormick), Health Care Law Monthly, July 2010
  • "Update: State Disclosure and Transparency Laws for Pharmaceutical and Medical Device Manufacturers," McGuireWoods News, June 22, 2010
  • "Health Care Reform Includes Significant Transparency and Disclosures Initiatives" (co-authored with Holly Carnell), BNA's Health Care Fraud Report, April 7, 2010
  • "Understanding Life Science Partnership Structures," (co-authored with Bart Walker and Jessica Smith), America Health Lawyers Association, March 2009
  • "Key Compliance Concerns for the Generic Pharmaceutical Industry" (co-authored with Amanda Enyeart), Health Care Law Monthly, July 2009
  • "Strategic Alliances for Life Sciences Companies," (co-authored with Bart Walker and Jessica Smith), TechJournal South, May/June 2009
  • "AdvaMed's Updated Code of Ethics and Its Impact on the Medical Devices Industry" (co-authored with Kimberly J. Kannensohn, Daniel Soldato and Ronald Lundeen), Medical Devices Law & Industry Report, March 11, 2009
  • "Medical Device Manufacturers and Distributors in State Regulators' Crosshairs," BNA Medical Devices Law & Industry Report, September 24, 2008
  • "Clinical Trials: Life Science Investigator-Initiated Trial Grant Program Compliance," Corporate Law Journal, Summer 2007, Vol. 2, No. 3
  • "Pharmaceutical Regulation: The 340B Drug Pricing Program: An Opportunity for Savings, if Covered Entities Such as Disproportionate Share Hospitals and Federally Qualified Health Centers Know How to Interpret the Regulations," Co-authored with Sarah Abraham and Jessica Strelec, Corporate Law Journal, Summer 2007, Vol. 2:362
  • "Comparative Advertising Tips for Medical Device Manufacturers," BNA Medical Devices Law and Industry Report, September 12, 2007, Vol. 1, No. 14
  • "Drug Manufacturer Settles Allegations of Kickbacks Paid to Pharmacy Benefit Manager," (co-authored with Kim Kannensohn), Food and Drug Law, American Health Lawyers Weekly, April 20, 2007
  • "8 Keys to Compliance for Medical Science Liaisons," (co-authored with Gretchen Heinze), Health Care Law Monthly, April 2007
  • "Outpatient Services Market: Identifying Key Issues," (co-authored with Morgan Moran), Health Care Private Equity, Business and Legal Issues, McGuireWoods LLP, Winter 2005
  • "HEALTH LAW ANALYSIS: Investing In Healthcare Entities In Today's Private Equity Dominated Market," (co-authored with Scott Becker and Rob Marks), Health Lawyers News , Volume 8, Number 11, November 2004
  • "Federal Trade Commission and the Department of Justice Come Out in Favor of Competition in Health Care," Health Care Law Monthly , October 2004
  • "CMS Releases Stark Act Final Rules -- A 25 Point Primer" (co-authored with Scott Becker), McGuireWoods LLP, September 30, 2004
  • "Managing the Hospital Legal Department--Combining Quality and Efficiency" (co-authored with Scott Becker), Chicago Hospital News , August 2003
  • Chapter Co-author, "Health Care Law, A Practical Guide"
  • "Illinois to Retain Health Planning," Ross & Hardies Health Care Legal Update, June 2003
  • "Legal Compliance - Five Current Concepts for the Hospital CEO," Chicago Hospital News , May 2003
  • "Six Keys to Compliance," Chicago Hospital News, April 2003
  • "Hospitals Examine Competitive Alternatives to Physician Owned Facilities," Chicago Hospital News, March 2003
  • "Rough Stuff," Cover Story, Outpatient Surgery Magazine, March 2003
  • "Further OIG Guidance on Inducement to Patients," Ross & Hardies Health Care Legal Update, March 2003
  • "OIG Guidance on Inducements to Patients," Ross & Hardies Health Care Legal Update, October 2002

Articles
Speaking Engagements
  • "Healthcare Reform: The Impact on Medical Device Manufacturers," BNA Webinar, May 25, 2010
  • Panelist, McGuireWoods Medical Device Symposium, November, 2009
  • Advamed 2009: Executive Workshop Leader: Strategies for Developing & Maintaining Compliant Industry-Referral Source Relationships, Washington, D.C., October 2009
  • AdvaMed Webinar: "After the Implementation - Next Steps for Building an Effective Compliance Program," September 2009
  • "Life Sciences Sales and Marketing Compliance Update," McGuireWoods Webinar, March 2009
  • "Legal and Regulatory Risks in Grant Funding Practices for Investigator Initiated Studies," ExL 9th Successful Compliance Investigator-Initiated Trials Conference, February 2009
  • "Strategies for Life Sciences Firms in a Bear Market," McGuireWoods Webinar, December 2008
  • "Government Investigations Workshop," AdvaMed 2008, Washington, D.C., September 2008
  • "Bringing Your Medical Device to the United States," Informa Life Science Medical Device Law and Compliance Conference, Brussels, Belgium, September 2008
  • "Current Issues in Off-Label Promotion," Practising Law Institute Briefing, July 2008
  • "Off-Label Promotion: Recent Regulatory Developments and Enforcement Actions Affecting Pharmaceutical and Medical Device Companies," McGuireWoods Webinar, April 2008
  • "Be Ready for Medicare's New ASC Payment System," Keynote Speaker, Improve Billing, Coding & Profitability for Freestanding ASCs Conference, Las Vegas, Nevada, October 15-16, 2007
  • "Compliance Compass: How to Navigate the Risks when Growing Your Business," Improve Billing, Coding & Profitablility for Freestanding ASCs Conference, Las Vegas, Nevada, October 15-16, 2007
  • "Grant Funding Practices for Investigator Initiated Studies," Workshop Leader, Bio/Pharmaceutical Medical Device Grants Conference, May 17-18, 2007
  • "Current Issues in Off-Label Promotion," McGuireWoods Sales Force Compliance Conference, May 15, 2007
  • "Update of Fraud and Abuse Provisions in the Deficit Reduction Act of 2005," Pricing Transparency & Other Compliance Issues Affecting the Pharmaceutical Industry, Webinar, March 20, 2007
  • "The Role of MSL: Fostering Sponsor/Investigator Partnerships to Pave the Way for Compliant IITs," Panelist, 5th Successful Compliant Investigator Initiated Trial Programs, February 8-9, 2007
  • "Finding and Evaluating Private Equity Opportunities in the Health Care Space," McLean, Virginia, February 2005
  • "Structuring Compliance Plans for Group Practice Owned ASCs," Medical Group Management Association, San Francisco, California, October 2004
  • "Outpatient Services Market: Identifying Issues and Attractive Niche Investments," Chicago, Illinois, September 2004
  • Springfield and Certificate of Need Update, 2003 Illinois Midwest Hospital Strategies Conference, November 2003

Professional Affiliations
  • American Health Lawyers Association
    • Vice Chair, Life Sciences Practice Group, 2010-2011
  • Advisory Board Member, BNA Medical Devices Law and Industry Report
 

EDUCATION

Northwestern University Kellogg School of Management, Masters of Business Administration, 2010

University of Illinois College of Law, Champaign, Illinois, J.D., magna cum laude, 2002

North Park University, Chicago, Illinois, B.A., cum laude, 1999

 
 

ADMITTED

Illinois 2002