Kathleen S. Hardway
Kathleen has been part of multiple national representations in mass tort proceedings for pharmaceutical companies and has served on nationwide trial teams. She has worked with numerous attorneys from around the country to coordinate overall strategy and the day-to-day handling of individual cases, and has led expert development teams, working with experts in the areas of Food and Drug Administration (FDA) regulations, endocrinology, genetics, neurology, neuroradiology, orthopedic surgery, allergy and immunology, epidemiology, virology, immunology, geriatrics, and pain management. She has argued Daubert motions, presented at Science Days in both state and federal courts, and taken and defended numerous expert witness depositions. She has also managed the development of the regulatory and sales and marketing company case – including preparing company witnesses for deposition.
Kathleen 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; dispositive and Daubert 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.
Related Practices
Related Industries
Experience
Representative Matters
Pharmaceutical & Vaccine Industry
- Representing a vaccine manufacturer in nationwide litigation involving allegations that the vaccine did not prevent its intended illness, but rather, increased the likelihood of contracting the virus, if taken. Leads expert development team and contributes to overall litigation strategy and case management
- Represented a vaccine manufacturer in a False Claims Act case. Prepared and defended several company witnesses and developed, deposed, and defended numerous expert witnesses
- Represented a manufacturer of an anti-epileptic medication in nationwide litigation involving allegations that the medication caused various birth defects. Developed, deposed, and defended numerous expert witnesses; prepared and defended several company witnesses; and deposed prescribing physician depositions to assist with case work-up
- Represented 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 depositions related to sales and marketing
- Represented a pharmaceutical manufacturer in nationwide litigation involving allegations that a narcotic pain medication was addictive. Assisted in the development of strategy for numerous cases in state and federal courts, and assisted in the development of experts in pain management
- Represented a vaccine manufacturer in a personal injury case involving allegations that a vaccine caused plaintiff’s significant neurological injuries; prepared company witnesses for deposition and developed, deposed, and defended numerous expert witnesses
- Represented a manufacturer of an anesthetic medication in nationwide litigation involving allegations that the medication causes the development of chondrolysis; developed strategy; directly managed hundreds of cases; and assisted in developing experts in orthopedic surgery
Medical Device Industry
- Responsible partner for defense of wrongful death case involving a patient-controlled analgesic pump, including arguing discovery, Daubert, and summary judgment motions
- Partner responsible for defense of case involving allegations of brain damage to a pediatric patient due to infusion pump use, resulting in favorable resolution for the manufacturer
- Defended a wrongful death case involving a patient-controlled analgesic pump, resulting in summary judgment for the manufacturer
- Handled more than 15 cases alleging wrongful death or serious injury involving a patient-controlled analgesic pump; all cases resulted in dismissals for the manufacturer
Additional Notable Matters
- Represented a cellular phone company in a case involving allegations that cellular phone use caused brain cancer. Participated in extensive Daubert briefing and in a week-long Daubert hearing, resulting in exclusion of all plaintiff’s experts and scientific testimony; assisted in expert and scientific development in the fields of neurology and neuro-oncology
- Represented a commercial landlord and property manager in litigation brought by workers in one of the earliest "sick building" cases in the country. Conducted 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 to plaintiffs allegedly resulting from "toxic" exposures that occurred while they worked in the building. The ruling was one of the first of its kind in mold exposure and "sick building" cases
Insights
Credentials
Education
- J.D. University of Maryland School of Law 1997
- B.A. Political Science cum laude Bucknell University 1992
- Academic All-American, 1991 (Volleyball)
- Alvin F. Jackson Memorial Senior Scholar Athlete Award, 1992
- Patriot League Scholar Athlete, 1992 (Volleyball)
Bar Admissions
- District of Columbia
- Maryland
Court Admissions
- U.S. District Court for the District of Colorado
- U.S. District Court for the District of Columbia
- U.S. District Court for the District of Maryland
- U.S. Court of Appeals for the District of Columbia Circuit
- U.S. Supreme Court
Professional Memberships and Activities
- Member, American Bar Association
- Member, District of Columbia Bar Association
- Member, Defense Research Institute, Drug and Medical Device Committee
- Member, Maryland State Bar Association
- Graduate, IADC Trial Academy, Stanford Law School
- Member, Venable Evaluations Committee, 2013 – 2018
- Co-chair, Venable Diversity and Inclusion Committee, 2013 – 2018
Recognition
- The Best Lawyers in America, 2021 – 2025
- Legal 500, Dispute Resolution – Product Liability, Mass Tort and Class Actions: Pharmaceuticals and Medical Devices – Defense, 2019 – 2024
- Benchmark Litigation
- Local Litigation Star, 2023 – 2024
- Future Star, Maryland, 2013 – 2016
- Top 250 Women in Litigation, 2012
- Martindale-Hubbell, AV® Preeminent Rated
Community
Pro Bono
- Representing prisoner assaulted in Illinois state penitentiary in Failure to Protect case
Volunteerism
- Member, Board of Directors, Port Discovery Children's Museum