Kathleen S. Hardway

Partner
Hardway Kathleen
Kathleen Hardway, co-chair of Venable's Product Liability and Mass Torts Group, represents pharmaceutical, vaccine, 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 premises owners and property managers in mold exposure, "sick building," and lead paint cases. 

Kathleen has been part of multiple national representations in mass tort proceedings for pharmaceutical companies. She has worked with numerous attorneys from around the country to coordinate overall strategy and the day-to-day handling of individual cases, and managed the development of a sales and marketing and regulatory company case – including preparing company witnesses for deposition. She has also developed and worked 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. 

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. 

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 chrondrolysis; developed strategy; directly managed hundreds of cases; and assisted in the 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 field 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
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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
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  • Recognized in Legal 500, Dispute Resolution - Product Liability, Mass Tort and Class Actions: Pharmaceuticals and Medical Devices - Defense, 2019
  • Included in Benchmark Litigation "Future Stars" for Maryland, 2013 - 2016, 2019
  • Included in Benchmark Top 250 Women in Litigation, 2012
  • AV® Preeminent Rated by Martindale-Hubbell

Community
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Pro Bono

  • Representing prisoner assaulted in Illinois state penitentiary in Failure to Protect case 

Volunteerism

  • Member, board of directors, Port Discovery Children's Museum