Tennessee: Oppose a backdoor assault on informed consent and patient rights
Our Stand: At-A-Glance
This analysis of HB 0192 (SB 0282) is provided by James Lyons-Weiler, PhD., biomedical research scientist. Dr. Lyons-Weiler is an advocate of Compassionate Use and Right-to-Try laws, however, as his analysis shows, this bill as written “eviscerates patient rights, removes all legal protections, and grants corporations full control over investigational medicine—all while pretending to be a bill about expanding access.” Dr. Lyons-Weiler’s full analysis can be read here.
- Tennessee’s HB0192 (bill text here), deceptively titled the “Individualized Investigational Treatment Act,” is nothing more than a legislative workaround designed to erode safeguards of informed consent, financially exploit vulnerable patients, and protect manufacturers from accountability. It masquerades as a bill to expand patient choice but, in reality, undermines fundamental medical ethics and shifts all risk onto patients while allowing corporations to profit unchecked.
- Claims to require “written, informed consent” (Section 63-6-1302(6)), yet it fails every ethical test for legitimate consent.
- Rather than fostering innovation through ethical and fair access, HB0192 turns experimental medicine into a pay-to-play system where only the wealthy can afford hope.
- If a patient suffers harm or even death from an investigational treatment, the manufacturer is fully shielded from liability (63-6-1308(a)).
- The bill does not require tracking or reporting of patient outcomes, meaning there is no way to measure whether these treatments actually help people or cause harm.
- Patients are expected to sign away their rights and release the treating physician, manufacturer, and hospital from all liability (63-6-1302(6)(E)), effectively making them test subjects with no protections.
- Because these treatments are aimed at patients with life-threatening or severely debilitating conditions, this bill targets the most desperate and vulnerable individuals, exploiting their fear, hope, and financial resources.
- There is no provision restricting what patients can be charged for these treatments.
- Final Verdict: HB0192 Is a Trojan Horse for Medical Exploitation
- ACTION: Tell the House Health Subcommittee to Vote NO on this backdoor assault on informed consent and patient rights.