Kathleen Hardway is a partner in the firm’s Products Liability and Mass Torts Practice Group and Co-Chair of Venable’s Diversity Committee. For more than ten years, she has represented pharmaceutical and medical device manufacturers in state and federal courts nationwide. She has also represented chemical and consumer products manufacturers in personal injury cases, and has represented premises owners and property managers in mold exposure, “sick building” and lead paint cases.
Ms. Hardway has managed all aspects of medical device cases involving allegations of wrongful death or serious injury, including expert development; factual analysis and development of the company case; expert, corporate, and fact witness depositions; motions practice; and pre-trial preparation. She has had primary responsibility for expert and scientific development in the fields of biomedical engineering, human factors engineering, pediatric neurology, pediatric psychology, pediatric cardiology, nursing, toxicology and forensic pathology.
In the pharmaceutical context, Ms. Hardway has been part of multiple national representations. In that capacity, she has worked with numerous attorneys from around the country to coordinate overall strategy and the day-to-day handling of individual cases, managed the development of the sales and marketing and regulatory company case – including preparing company witnesses for deposition – and developed and worked with experts in the areas of FDA regulations, endocrinology, genetics, neurology, orthopedic surgery, allergy and immunology, epidemiology, and pain management.
Prior to and during law school, Ms. Hardway worked for a Fortune 500 insurance company, where she managed toxic tort and chemical exposure claims and lawsuits made against insureds. In this position, she worked with defense counsel, environmental and remediation consultants, in-house counsel, agents, brokers and risk managers. She also performed complex coverage and liability analyses and investigations, and negotiated settlements and cost-sharing agreements with other insurance companies.
Significant Matters
Medical Device
Responsible partner for all aspects of defense of case involving allegations of brain damage to a pediatric patient due to infusion pump use.
Primary responsibility for all aspects of defense of wrongful death case involving patient-controlled analgesic pump resulting in summary judgment for the manufacturer.
Primary responsibility for over fifteen cases involving allegations of wrongful death or serious injury involving patient-controlled analgesic pump, all resulting in dismissals for the manufacturer.
Pharmaceutical
Representation of a manufacturer of an anesthetic medication in nationwide litigation involving allegations that the medication causes the development of chrondrolysis. Responsible for developing strategy in and managing and/or direct handling of hundreds of cases, and assisted in the development of experts in the field of orthopedic surgery.
Representation of a manufacturer of an osteoporosis medication in nationwide litigation involving allegations that the medication causes osteonecrosis of the jaw and atypical femur fractures, including developing experts and preparing company witnesses for deposition in the areas of sales and marketing.
Representation of pharmaceutical manufacturer in nationwide litigation involving allegations that a narcotic pain medication was addictive. Assisted in the development of strategy of numerous cases in state and federal courts and assisted in the development of experts in the field of pain management.
Additional Notable Matters
Representation of a cellular phone company in case involving allegations that cellular phone use caused brain cancer. Participated in extensive Daubert briefing and in week-long Daubert hearing resulting in exclusion of all plaintiff’s experts and scientific testimony. Assisted in expert and scientific development in the field of neurology and neuro-oncology.
Representation of a commercial landlord and property manager in litigation brought by workers in one of the earliest “sick building” cases in the country. Primarily responsible for briefing that resulted in exclusion of plaintiffs’ experts’ testimony regarding multiple chemical sensitivity, “sick building syndrome,” chronic fatigue syndrome, fibromyalgia, neuropsychological and memory impairment, and other permanent, disabling injuries allegedly resulting from “toxic” exposures while working in the building. The ruling was one of the first of its kind in mold exposure and “sick building” cases.
Activities
Ms. Hardway is actively involved in the firm’s Hiring Committee and as a mentor to both summer and incoming associates.
She continues her legal education and training through various CLE courses, and is a graduate of the IADC Trial Academy at Stanford Law School.
Ms. Hardway is an active member of the PTA at her daughter’s school, where she volunteers both in the classroom and for various PTA-sponsored events.
