(a) A healthcare research institution shall be immune from suit and any liability under state law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to, or use by, an individual, including claims from loss caused by, arising out of, relating to, or resulting from the design, development, clinical testing or investigation or manufacture of any countermeasure, unless the loss can be determined to have resulted from the willful misconduct of the healthcare research institution or its employees in accordance with subsection (b).

Terms Used In Tennessee Code 68-11-1902

  • Countermeasure: means a vaccine or the component parts used in the design, development, clinical testing or investigation or manufacture of a vaccine, including seed stocks, cell lines and plasmids, used to diagnose, mitigate, prevent, treat, cure or otherwise limit the harm of an infectious disease that is:
    (A) Approved or cleared under Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U. See Tennessee Code 68-11-1901
  • Evidence: Information presented in testimony or in documents that is used to persuade the fact finder (judge or jury) to decide the case for one side or the other.
  • Healthcare research institution: includes any or all of the parents, subsidiaries, affiliates, successors and assigns of the institution, and any or all individual trustees, officers, directors, employees, and agents of the institution. See Tennessee Code 68-11-1901
  • Plaintiff: The person who files the complaint in a civil lawsuit.
  • Willful misconduct: means an act or omission that is taken:
    (A) Intentionally to achieve a wrongful purpose. See Tennessee Code 68-11-1901
(b) In any action arising under subsection (a), the plaintiff shall have the burden of proving, by clear and convincing evidence, willful misconduct by each healthcare research institution, or employee, against which a claim has been asserted and that the willful misconduct caused death or serious physical injury.
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