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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).
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.