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.
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.
Physicians’ ethical obligations to disclose conflicts of interest to patients and to obtain their informed consent for treatment are particularly critical when proposed treatments are experimental.