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

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)

Memberships

  • Maryland State Bar Association

    District of Columbia Bar Association

    American Bar Association

    Defense Research Institute – Drug and Medical Device Committee
T +1 410.528.2842
F +1 410.244.7742
 

Kathleen S. Hardway

Partner

Kathleen Hardway represents pharmaceutical and medical device manufacturers in product liability and mass tort litigation 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. She is the co-chair of the Venable's Product Liability and Mass Torts practice group, which is ranked by Chambers USA as one of the leading practice groups in the country.

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.

Kathleen has been part of multiple national representations in mass tort proceedings for pharmaceutical companies. 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, infectious disease and pain management.

Prior to and during law school, Kathleen 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

Pharmaceutical & Vaccine Industry
  • Representation of a vaccine manufacturer in nationwide litigation involving allegations that the vaccine did not prevent against 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.
  • Representation of a vaccine manufacturer in a False Claims Act case. Prepared and defended several company witnesses and deposed, developed, and defended numerous expert witnesses.
  • Representation of a manufacturer of an anti-epileptic medication in nationwide litigation involving allegations that the medication caused various birth defects. Deposed, developed, and defended numerous expert witnesses, prepared and defended several company witnesses, and assisted in case work-up by deposing prescribing physician depositions.
  • 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.
  • Representation of vaccine manufacturer in personal injury case involving allegations that a vaccine caused plaintiff's significant neurological injuries. Prepared company witnesses and experts for depositions.
  • 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.

Medical Device Industry
  • Responsible partner for all aspects of defense of case involving allegations of brain damage to a pediatric patient due to infusion pump use.
  • Responsible partner for all aspects of defense of wrongful death case involving patient-controlled analgesic pump, including arguing discovery, Daubert and summary judgment motions.
  • 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.

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

Kathleen was Co-Chair of Venable's Diversity and Inclusion Committee from 2013-2018, and a member of the Firm's Evaluation Committee from 2013-2018.

Kathleen continues her legal education and training through various CLE courses, and is a graduate of the IADC Trial Academy at Stanford Law School.

She is on the Board of Directors for Port Discovery, one of the nation's top children's museums.