South Carolina Code 44-137-60. No private right of action against manufacturer of investigational drug, biological product, or device
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Terms Used In South Carolina Code 44-137-60
- Eligible patient: means an individual who:
(a) has a terminal illness, attested to by a treating physician;
(b) has, in consultation with a treating physician, considered and exhausted all other treatment options currently approved by the United States Food and Drug Administration;
(c) has received a recommendation from the treating physician for use of an investigational drug, biological product, or device for treatment of the terminal illness;
(d) has given informed consent in writing to use the investigational drug, biological product, or device for treatment of the terminal illness or, if the individual is a minor or is otherwise incapable of providing informed consent, the parent or legal guardian has given informed consent in writing to use the investigational drug, biological product, or device; and
(e) has documentation from the treating physician that the individual meets all of the criteria for this definition, including an attestation from the treating physician that the treating physician was consulted in the creation of the written, informed consent required under this chapter. See South Carolina Code 44-137-10
No private right of action may be brought against a manufacturer of an investigational drug, biological product, or device, or against any other person or entity involved in the care of an eligible patient using an investigational drug, biological product, or device, for any harm caused to the eligible patient resulting from the use of the investigational drug, biological product, or device as long as the manufacturer or other person or entity has made a good-faith effort to comply with the provisions of this chapter and has exercised reasonable care in actions undertaken pursuant to this chapter.