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## § 54.1-3442.4 – Limitation of liability

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A. Notwithstanding any other provision of law to the contrary, a health care provider as defined in § 8.01-581.1 who recommends an investigational drug, biological product, or device to a person who meets the criteria set forth in subsection A of § 54.1-3442.2 shall be immune from civil liability for any adverse action, condition, or other outcome resulting from the person’s use of the investigational drug, biological product, or device.

B. Notwithstanding any other provision of law to the contrary, a manufacturer, distributor, administrator, health care provider as defined in § 8.01-581.1, sponsor, or physician who manufactures, supplies, distributes, administers, prescribes, or recommends an investigational drug, biological product, or device to a person who meets the criteria set forth in § 54.1-3442.2 shall be immune from suit and liability caused by, arising out of, or relating to the design, development, clinical testing and investigation, manufacture, labeling, distribution, sale, purchase, donation, dispensing, prescription, recommendation, administration, efficacy, or use of such investigational drug, biological product, or device made available to such person.

C. No claim or cause of action against a manufacturer, distributor, administrator, health care provider as defined in § 8.01-581.1, sponsor, or physician who manufactures, supplies, distributes, administers, prescribes, or recommends an investigational drug, biological product, or device to a person who meets the criteria set forth in § 54.1-3442.2 shall exist in any state court for claims of property, personal injury, or death caused by, arising out of, or relating to the design, development, clinical testing and investigation, manufacture, labeling, distribution, sale, purchase, donation, dispensing, prescription, recommendation, administration, efficacy, or use of such investigational drug, biological product, or device made available to such person.

D. No health care provider as defined in § 8.01-581.1 who recommends, prescribes, administers, distributes, or supplies an investigational drug, biological product, or device to a person who meets the criteria set forth in § 54.1-3442.2 shall be deemed to have engaged in unprofessional conduct, or shall be adversely affected in any decision relating to licensure, on such grounds.

E. Nothing in this article shall require a person to violate or act in contravention of any federal or state law as such law relates to the prescribing, dispensing, administration, or use of an investigational drug, biological product, or device.