Diane J. Romza-Kutz

Diane Romza-Kutz counsels life sciences companies across the globe to proactively address U.S. and E.U. regulatory roadblocks and to navigate the framework of crisscrossing federal, state, and local regulations. She is experienced in representing life science clients from a broad spectrum of industries, including food and food ingredients, dietary supplements, animal health, pharmaceuticals, medical devices, tobacco and agribusiness as well as biologics.

Diane partners with her clients to craft sound business strategies that account for the complex interplay among regulators. She closely monitors and counsels clients throughout a product's lifecycle on matters pertaining to the:

• U.S. Food and Drug Administration
• U.S. Department of Agriculture
• Federal Trade Commission
• Drug Enforcement Administration

Diane also advises clients regarding legal business issues that arise within her clients' operations, including global licensing agreements, co-development arrangements, good manufacturing compliance, litigation involving pre-emption claims, misbranding, duty to warn, and licensing and infringement.

Diane is also experienced in counseling cannabis businesses on how to navigate the tension between the federal government's regulatory position and states that have legalized marijuana use. She has represented cannabis companies with cannabis operations in several states as well as those companies providing goods and services to cannabis companies. She has also counselled clients on the impact of the Hemp Amendment to the Farm Bill.

Representative Matters

Biotech/Pharma

Counsels 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.

Defends 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).

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

Medical Devices/Bioinformatics

Counsels clients on registration requirements, 510(k) and PMA applications and compliance with other FDA regulations.

Counsels clients on the FDA requirements related to software, security of that software, and other cybersecurity risks as outlined by the FDA.

Health Care

Litigates 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.

Represents 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.

Creates joint ventures for corporate healthcare providers, drafts hospital compliance programs and trains clients on their implementation, reviews and drafts policies and procedures, negotiates business agreements for hospitals and advises on economic credentialing.

Animal Health

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.

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

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

Prior Experience

• Thompson Coburn LLP, Partner

Awards

Chicago Business Journal Woman of Influence, 2015

Illinois Super Lawyers, 2006-2015

Professional & Community Involvement

Defense Research Institute

American Bar Association

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