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If a patient’s procedure uses a device that is not FDA-approved, or is FDA-approved for another purpose, or is experimental, must the patient be so advised by the physician to provide appropriate informed consent? Courts have wrestled with this matter in a number of legal opinions.
Dr. Cosmetic has a highly successful cosmetic dermatology practice. He is known for both the quality and innovative nature of his work. Three years ago he injected a hyaluronic acid filler agent into the décolleté of a markedly sun damaged 56-year-old woman. She had the same filler injected into her nasolabial folds some 10 years earlier, but had received no filler injections since that time. For reasons unclear to Dr. Cosmetic, his patient developed multiple erythematous papule and nodules at many of the injection sites, as well as at the original nasolabial sites that had not been injected for a decade.
Dr. Cosmetic injected his patient with a series of hyaluronidase injections without much response. After a year of repeated injections, his patient filed a medical malpractice case against him. Dr. Cosmetic, knowing that almost all hyaluronic acid injection adverse sequelae get better with time was not terribly worried until he saw the basis of the lawsuit. The lawsuit alleged that Dr. Cosmetic, in treating the chest of his patient, used the device (hyaluronic acid) in a non-FDA-cleared manner. Should he be worried?
It is established laws that a patient enrolled in an experimental study concerning a device not yet approved by the U.S. Food and Drug Administration (FDA) is entitled to full disclosure of the experimental nature of both the study and the device. However, if a patient’s procedure uses a device that is not FDA-approved, or is FDA-approved for another purpose, or is experimental, must the patient be so advised by the physician to provide appropriate informed consent?
Courts have wrestled with this matter in a number of legal opinions.
In Orthopedics Bone Screw Products Liability Litigation, a Florida court held that disclosure of FDA status is not required, because such status was not a medical risk of surgery. This reasoning was also discussed in Alvarez v. Smith, another Florida case in which the complaint alleged that surgical screws were implanted in the patient’s spine during a procedure that the screws were not FDA-approved for. In favor of the physician, the court ruled that the terms “Class III,” “investigational,” and “substantial risk” pertaining to the involved device were for administrative or regulatory purposes and could not be extrapolated to specific risks of that procedure. Similarly, in a nearly identical case, a New Jersey court held that disclosure of FDA status was not required during informed consent. In Klein v. Biscup, an Ohio court considered off-label use and found that such use was not a material risk that required disclosure before obtaining informed consent.
In contrast to the previously mentioned cases, in Corrigan v. Methodist Hospital, a federal court heard a claim in which a patient informed consent was not obtained because she was not advised of the investigational nature of the system nor of the physician’s financial interest in the system’s manufacturer. The court ruled that the undisclosed risk of the investigational device was an issue in that case. The court noted that FDA regulatory status is not a risk of a procedure; participation in a clinical investigation did require disclosure of investigational status by way of FDA regulations - not by state informed consent law.
It should be noted, though, that although FDA regulatory status may not be required for appropriate informed consent, FDA status can be admissible into evidence as one factor to be considered by a jury. In Shadrick v. Centennial Medical Center, a Tennessee court ruled that the fact as to whether the prevailing standard of care at the time of patient injury required disclosure of the lack of FDA approval could be admitted as a material fact.
In summary, although the majority of court opinions related to disclosure of FDA status of a medical device have clarified that FDA classifications are for regulatory purposes only, Dr. Cosmetic can expect that, if his case goes to trial, the off-label use of the filler will be admitted as a piece of evidence. However, it is unlikely that this fact alone will cause him to lose the case.