Deborah M. Eng, MS, MA and Scott J. Schweikart, JD, MBE
A just culture perspective suggests that punitive responses to those who err should be reserved for those who have willfully and irremediably caused harm.
AMA J Ethics. 2020;22(9):E779-783. doi:
10.1001/amajethics.2020.779.
This process of developing EBM-based guidelines and applying them to clinical care highlights the tension between generating unbiased knowledge based on statistical aggregation and the application of this information to individual patients.
Elderly persons should not be excluded from participation in clinical trials for cardiovascular drugs since that population comprises the largest number of patients with cardiovascular disease.
The Supreme Court’s ruling in Riegel v. Medtronic, Inc., may prevent consumers injured by medical devices that have FDA premarket approval from receiving compensation.