(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.

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.
  Previous section
Next section  
 Part 3 Contents