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Code · Alaska · Title 9 · Chapter 65

Sec. 09.65.325. Immunity relating to use or nonuse of investigational drugs, biological products, and devices.

309 words·~1 min read·/ak/title-9/chapter-65/09-65-325

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Sec. 09.65.325. Immunity relating to use or nonuse of investigational drugs, biological products, and devices.
(a)A person is not liable in an action for damages for the injury or death of a patient with a terminal illness resulting from the patient's use of an investigational drug, biological product, or device for the purpose of sustaining the patient's life if the person, acting in good faith and with reasonable care, is a
(1)physician or member of the medical team who prescribed, dispensed, or administered the investigational drug, biological product, or device, or provided related treatment, to the patient and, before prescribing, dispensing, or administering the drug, product, or device, or providing related treatment, the physician or member of the medical team
(A)obtained the informed consent of the patient in writing after presenting to the patient all treatment options currently approved by the United States Food and Drug Administration for treatment of the patient's terminal illness; and
(B)provided to the patient written notice of the immunity provided under this section; or
(2)manufacturer, importer, or distributor of the investigational drug, biological product, or device and, before providing the drug, product, or device to the patient's physician, presented to the physician all treatment options currently approved by the United States Food and Drug Administration for treatment of the patient's terminal illness and provided to the patient written notice of the immunity provided under this section.
(b)A person, acting in good faith and with reasonable care, is not liable in an action for damages solely for declining to
(1)prescribe, dispense, or administer an investigational drug, biological product, or device to a patient; or
(2)provide an investigational drug, biological product, or device to a patient's physician.
(c)In this section, “investigational drug, biological product, or device” and “terminal illness” have the meanings given in AS 08.64.367 .
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