Diane is a member of the firm's Intellectual Property Practice Group and is the team leader for the firm's Life Sciences Practice Team. She focuses her practice on federal and state regulatory issues, licensing arrangements and related complex litigation matters particular to the Life Sciences Industry and which often stem from regulatory issues under the Food and Drug Administration (FDA), United States Department of Agriculture (USDA), Federal Trade Commission (FTC) and Drug Enforcement Administration (DEA) and related state agencies. Additionally, Diane's practice encompasses representation of clients involved in the tobacco industry and the evolving regulatory issues involving the FDA as a result of the enactment of the Family Smoking Prevention and Tobacco Control Act. Her practice includes negotiating global licensing negotiations, FDA, FTC and USDA regulatory matters, and international arbitration, complex litigation, including preemption claims, misbranding, duty to warn and more generally, product liability/toxic tort cases. Diane has served as vice chair of the American Health Lawyers Association's Committee on Managed Care and Integrated Delivery Systems. She has also served as a member of the Executive Healthcare Council for the Illinois Chamber of Commerce. Prior to joining Troutman Sanders, Diane was a partner at both a national and international law firm.
Diane is a recognized and sought after speaker and author on a variety of topics including life sciences and pharmaceutical industries, the tobacco industry, biotechnology, clinical trials, pediatric drug testing, pharmaceutical compliance, drug advertising and ethical concerns related to those areas. She also lectures and writes on the subjects of risk management and litigation issues affecting hospitals. She routinely addresses Life Sciences conferences in the United States and overseas, including BioPharm America, EuroBio and the two BioEurope meetings.
Prior to entering private practice, Diane served as supervising attorney for the Chicago Board of Education and was an assistant state's attorney for the Criminal Prosecution Division, where she served as a supervisor for the Child Sexual Exploitation Unit. She also was an adjunct professor for the Department of Criminal Justice at Loyola University, and she has served on the State's Attorney Task Force on Mass Molestation, on the Advisory Board on Child Advocacy Centers and on the Chicago Police Department's Task Force on Victimization of Disabled Persons.
Diane earned her LL.M. from Loyola University Chicago School of Law in 1994 and her J.D., with honors, from Northern Illinois University College of Law in 1981. In 1978, she graduated with a B.S., with honors, from Western Illinois University. Diane was admitted to the Illinois bar in 1982.
Representative Experience
Diane's extensive and diverse transactional, regulatory, administrative and litigation experience includes:
Counseling clients on national and international life sciences regulatory matters, including FDA issues, post-marketing concerns, clinical trials, global licensing deals, labeling concerns, product marketing and advertising, related fraud and abuse issues, anti-kickback matters, 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.
Defending pharmaceutical, biotechnology and medical device companies in cases involving product liability claims, pricing issues, False Claims Act matters, contract and fraud claims, consumer and third-party class actions, including multidistrict litigation, whistleblower claims, advertising suits, marketing disputes with regulatory bodies, off-label promotions, and failure-to-adequately-warn claims.
Representing high technology companies in intellectual property matters, including protection of intellectual property, licensing agreements and infringement actions.
Litigating on behalf of traditional health care clients on claims arising from regulatory and contractual issues, including, but not limited to, False Claims Act cases, non-competition disputes and certificate-of-need actions.
Representing hospital networks, other health-system providers and pharmaceutical companies in a wide range of civil and criminal health care matters, including class actions 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.
Other Distinctions
Recognized as Super Lawyer in Illinois (2006-2012).