Tennessee Code 63-6-308 – No private cause of action for harm done to eligible patient resulting from investigational drug, biological product, or device – Part does not affect requirements under section 56-7-2365

(a) This part does not create a private cause of action 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 the investigational drug, biological product, or device for any harm done to the eligible patient resulting from the investigational drug, biological product, or device, if the manufacturer or other person or entity is complying in good faith with the terms of this part and has exercised reasonable care.

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Terms Used In Tennessee Code 63-6-308

Eligible patient: means an individual who meets all of the following conditions:
(A) Has an advanced illness, attested to by the patient's treating physician and confirmed by a second physician. See Tennessee Code 63-6-302
Person: includes a corporation, firm, company or association. See Tennessee Code 1-3-105

(b) This part does not affect any mandatory healthcare coverage for participation in clinical trials under § 56-7-2365.

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Tennessee Code 63-6-308 – No private cause of action for harm done to eligible patient resulting from investigational drug, biological product, or device – Part does not affect requirements under section 56-7-2365

Terms Used In Tennessee Code 63-6-308

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