Whether a drug company which is medically monitoring the participants of its drug study has a duty under federal regulations to exercise its independent power to stop a clinical study and refer a participant to medical care when it is aware that the participant is suffering from a life-threatening medical condition making him or her unsuitable to participate in the study or whether, as the California Court of Appeal, Second Appellate District, Division Five held, the study sponsor has no obligation to intervene even when it is aware that the clinical investigator it hired to conduct the clinical trial has failed to exercise reasonable care in making decisions about the enrollment of the test subject and has maintained the test subject in the study despite clear evidence of the test subject's failing health.

Whether a drug company has a duty to stop a clinical study and refer a participant to medical care when it is aware the participant is suffering from a life-threatening condition