Ms. Diane J. Romza-Kutz

Partner
Chicago,  IL  U.S.A.
Phone312.526.1569

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Practice Areas

  • Healthcare
  • Life Sciences & Pharmaceuticals
  • Food & Agribusiness
  • Animal Health
  • Intellectual Property
  • Pharmaceuticals
  • Public Policy
  • Regulatory & Government Affairs
 
Contact InfoTelephone: 312.526.1569
Fax: 312.655.1501
http://www.huschblackwell.com/diane-romzakutz/
 
University Western Illinois University, B.S., with honors, 1978
 
Law SchoolNorthern Illinois University College of Law, J.D., with honors, 1981; Loyola University Chicago School of Law, LL.M., 1994
 
Admitted1982, Illinois
 
Memberships 

Professional Associations and Memberships

American Health Lawyers Association (AHLA), Committee on Managed Care and Integrated Delivery Systems, vice chair

•Illinois Chamber of Commerce, Executive Healthcare Council

 
Biography

With particular emphasis in the healthcare and life sciences sectors, Diane counsels and defends life science companies, medical providers, innovators, emerging companies and their financial backers. She effectively guides clients through the elaborate regulatory environment of the Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), the Federal Trade Commission (FTC), the Drug Enforcement Administration (DEA) and related state agencies. In the intellectual property arena, Diane negotiates global licensing agreements and litigates in matters of pre-emption claims, misbranding, duty to warn, licensing and infringement.

A member of the Healthcare, Life Sciences & Pharmaceuticals team, Diane is a recognized speaker and author on a variety of topics, including the life sciences and pharmaceutical industries, biotechnology, clinical trials, pediatric drug testing, and drug advertising. She also lectures and writes on the subjects of risk management and litigation issues affecting life science companies, food companies and hospitals and routinely addresses life sciences conferences in the United States and overseas.

Before joining the firm, Diane was a Partner at Troutman Sanders and at Mayer Brown. Previously, she was the managing partner for the Chicago office of Epstein Becker & Green. Before entering private practice, Diane was supervising attorney for the Chicago Board of Education and also served as an assistant state's attorney for the Criminal Prosecution Division, where she supervised the Child Sexual Exploitation Unit. In addition, she taught criminal justice and domestic violence courses as well as guest lectured on FDA matters at Loyola University.

Awards and Recognitions

Illinois Super Lawyers, 2006-2013

Civic Involvement

Chicago Police Department, Task Force on Victimization of Disabled Persons

•Cook County State's Attorney's Office, Task Force on Mass Molestation

•Illinois Attorney General Task Force on development of a Comprehensive Health Insurance Program for the Chronically Ill

Experience



Regulatory

•Counseling clients on national and international life sciences regulatory matters, including FDA and FTC issues; post-marketing concerns; clinical trials; global licensing deals; labeling concerns; product marketing and advertising; filing of New Drug Applications (human and animal); product recalls (both voluntary and involuntary); FTC and FDA investigations into misbranding, adulterated products; mislabeling and marketing claims; creating, enacting and training in corporate compliance programs; in-and-out licensing strategies; evaluating projects for venture investments; alternative dispute resolution; and structuring joint ventures. She also counsels clients on USDA and DEA compliance and regulatory matters.

Product Liability

•Defending pharmaceutical, biotechnology and medical device companies in cases involving product liability claims, pricing issues, False Claims Act matters, contract and fraud allegations, consumer and third-party class action cases. Cases involved multidistrict litigation, whistleblower claims, advertising lawsuits, marketing disputes with regulatory bodies, off-label promotions and failure-to-adequately-warn claims (including consumer class actions).

Intellectual Property

•Representing high-technology and life science companies in intellectual property matters, including licensing agreements and infringement actions.

•Clients include: Biotechnology companies; pharmaceutical companies; food companies (human and animal); veterinary medicine companies; animal feed companies; medical device companies; dietary supplement companies; bioinformatics companies; agribusiness companies.

Healthcare Law and Litigation

•Litigating on behalf of traditional healthcare clients on claims arising from regulatory and contractual issues, including, but not limited to, False Claims Act cases, noncompetition disputes and certificate-of-need actions.

•Representing hospital networks, other health-system providers and pharmaceutical companies in a wide range of civil and criminal healthcare matters, including class action cases and government investigations.

•Creating joint ventures for corporate healthcare providers, drafting hospital compliance programs and training clients on their implementation, reviewing and drafting policies and procedures, negotiating business agreements for hospitals and advising on economic credentialing.

Food and Agribusiness

•Served as Food and Drug Administration (FDA), United States Department of Agriculture (USDA) and Federal Trade Commission (FTC) regulatory counsel to animal health companies in their regulatory filings and compliance programs.

•Serving as FDA regulatory counsel for international and domestic animal health companies as they prepare for US initial public offerings (IPOs).

•Served as intellectual property and licensing counsel for a domestic animal health company as it prepared for IPO.

Business Insights



Featured Insights

7.03.14 New FDA Current Good Manufacturing Processes Rule Expected for Animal Food Manufacturers Food & Agribusiness Blog

Business Insights

7.03.14 New FDA Current Good Manufacturing Processes Rule Expected for Animal Food Manufacturers Food & Agribusiness Blog

6.26.14 Update: The Changing Landscape of Mobile Medical App Regulation, Less Than One Year Later Healthcare, Life Sciences & Pharmaceuticals Blog

6.06.14 The Nutrition Facts Panel Gets a Makeover and Food Manufacturers Get The Bill Food & Agribusiness Blog

5.22.14 Spotlight on Licensing: Navigating the Regulatory Environment
Food & Agribusiness Seminar Kansas City, MO

5.20.14 Mobile Medical Apps: The FDA Regulates an Entire New Industry Healthcare, Life Sciences & Pharmaceuticals Blog

4.29.14 Healthcare Horizon Webinar Series: Medical Mobile Apps: Regulation and Risks
Healthcare, Life Sciences & Pharmaceuticals Webinar

In The News

1.13.14 Illinois Super Lawyers and Rising Stars 2014 Names Five Husch Blackwell Partners in Chicago
News Release

7.26.13 Husch Blackwell Adds Intellectual Property Partner Diane Romza-Kutz to Represent Life Sciences and Pharmaceutical Companies
Healthcare, Life Sciences & Pharmaceuticals News Release

 
ISLN902038200
 

Documents by this lawyer on Martindale.com

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New FDA Current Good Manufacturing Processes Rule Expected for Animal Food Manufacturers
Diane J. Romza-Kutz,Fredric E. Roth, July 9, 2014
As part of the Food Safety Modernization Act (FSMA) passed in March of 2011, the FDA was given a mandate to update its regulations to create a new set of regulations/rules that enables it to prevent the introduction of adulterated food into the human and animal food supply in the U.S., as opposed...

Mobile Medical Apps: The FDA Regulates an Entire New Industry
Diane J. Romza-Kutz,Fredric E. Roth, May 29, 2014
Smartphones and tablets are quickly becoming the ubiquitous tool for both personal and business activities. The convenience of the platforms, their mobility, and their ability to tie into the Internet means not only is the adoption rate of these devices outpacing the adoption of standard PCs...


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Office Information

Ms. Diane J. Romza-Kutz

120 South Riverside Plaza, Suite 2200
ChicagoIL 60606-3912




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