(a) This chapter shall not be construed to 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 an 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 chapter and has exercised reasonable care.(a.1) This chapter shall not be construed to create a private cause of action against a physician who refuses to recommend an investigational drug, biological product, or device for any otherwise eligible patient.(b) Any person or entity providing treatment to an eligible patient using an investigational drug, biological product, or device shall not be liable for injury or death to such eligible patient as a result of the investigational drug, biological product, or device under Code Section 51-1-27 or 51-4-1, et seq., unless it is shown that the person or entity failed to obtain written informed consent in compliance with Code Section ug, biological product, or device under Code Section 51-1-27 or 51-4-1, et seq., unless it is shown that the person or entity failed to obtain written informed consent in compliance with Code Section 31-52-5.(c) This chapter shall not be construed to affect any required health care coverage under Title 33 for patients in clinical trials.Added by 2016 Ga. Laws 422,§ 1, eff. 7/1/2016.
Georgia Legal Code