Drug studies on patients can provide great medical benefits to the general population, though they do carry risks to the patients being studied. For a variety of legal and moral reasons, no drug study can be performed on a patient without their knowledge and consent. Apparently, Chicago area's Advocate Healthcare forgot or ignored this requirement when they performed a drug study on numerous patients without their knowledge or consent. In doing so, the healthcare provider has exposed itself to potential medical malpractice and other potential civil actions including battery.
Before any drug study can be performed on patients in the US, the party seeking to conduct the study must comply with various safety regulations. This includes presenting the study to the Institution Review Board or IRB, the body responsible for overseeing research on human patients. The IRB must then check the study against FDA regulations. In addition, the FDA reviews the proposed study on their own to determine whether the study meets certain guidelines including those related to patient safety. If the IRB and FDA sign off on the drug study, there is one additional and critical hurdle which must be complied with before the study can be performed: knowledge and consent from the patient.
In the case of Advocate Healthcare, the medical group did obtain permission to perform the study from the IRB and the FDA. However, according to the FDA, Advocate then went ahead and performed the study on 122 patients at their Oak Lawn hospital without telling them about it, let obtaining their permission. Specifically, Advocate injected patients with one of two drugs, etomidate or midazolam, before intubating the patients. Intubation involves inserting a tube down a patient's windpipe typically to maintain an airway. Both etomidate and midazolam are sedatives. The former was used by Advocate as an experimental drug for possible use in emergency room cases requiring intubation. By failing to obtain consent from the patients' (or their representative) before performing the drug study on them, Advocate likely subjected itself to civil liability including for medical malpractice and battery.
To recover for in medical malpractice lawsuit, a patient must prove a defendant owed the plaintiff a duty of care, a violation of that duty of care or standard of care, and resulting damages. Here, the standard of care required Advocate to first properly inform and request each patient's permission before conducting an experimental drug study on them. Based on initial reports, Advocate violated the standard of care in this case when they allegedly failed to say anything to the patients or their representative's about the drug study before they injected the patients with the drug being studied. As for damages, it is unclear at this point whether any patient was physically harmed by the drug study. However, at a minimum, the patients would be entitled to damages for emotional distress for being subjected to an experimental drug study without their knowledge or consent.
Battery is the unwanted harmful or offensive contact of a person. Although rare, battery actions are occasionally permitted by a patient against a healthcare provider in Illinois where, for example, a procedure is performed on them without their permission. In this case, Advocate could be found guilty of battery for allegedly injecting patients with an experimental drug without their permission or consent. Unlike in medical malpractice cases, battery could permit patients to recover punitive damages--in addition to compensatory damages. Punitive damages are only available in certain cases where a defendant's conduct is more egregious than negligence. Without more facts, it is too early to tell whether such a lawsuit would be successful in this instance.
Chicago Tribune, FDA: Advocate Healthcare Conducted Drug Study Without Patients' Consent, June 15, 2012.