U.S. courts have ruled that device manufacturer representatives’ presence in the operating room does not make them responsible for the supervision of physicians or liable for the practice of unauthorized medicine.
Douglas E. Paull, MD, MS and Paul N. Uhlig, MD, MPA
Risk managers can help patient-subjects and clinician-researchers make informed novel device implantation decisions in the absence of preclinical trial data.
AMA J Ethics. 2020;22(11):E911-918. doi:
10.1001/amajethics.2020.911.