Published 5/1/2012
B. Sonny Bal, MD, JD, MBA

FDA Regulatory Status and Informed Consent

The doctrine of informed consent is familiar to orthopaedic surgeons who invoke the underlying principles to counsel patients prior to surgery. The basic requirement that a patient must consent to a procedure was established in 1914, in the case of Schloendorff v. Society of New York Hospital. The New York Court of Appeals ruled that absent consent, a surgeon who performs an operation is liable for a medical battery.

The informed consent doctrine was expanded to include discussion of risks and benefits in the 1972 case of Canterbury v. Spence. In its opinion, the U.S. Court of Appeals for the District of Columbia wrote, “We now find, as a part of the physician’s overall obligation to the patient, a … duty of reasonable disclosure of the choices with respect to proposed therapy and the dangers inherently and potentially involved.”

Both case law and legislative statutes govern informed consent, which traditionally includes a candid discussion of all reasonable outcomes, alternatives, and risks of the planned operation. The explosion in medical information available to patients today is testing the limits of informed consent, to determine whether it should include disclosure of physician-specific and other variables—such as the doctor’s alcohol or drug abuse history, experience and success with the planned operation, financial or research conflicts; operative logistics; and information related to the devices to be used—that could affect the outcome of the surgery.

A narrow line of legal cases has dealt with the issue of disclosing whether the medical device to be used has been approved by the U.S. Food and Drug Administration (FDA) for the proposed use. This article will examine relevant legal rulings on this issue.

The FDA’s role
The FDA regulates the marketing and sale of drugs and medical devices in the United States, including requiring that the label of a drug or medical device list specific information. Any use not expressly listed on the label constitutes “physician-directed” or “off-label” use; such use is legal, acceptable, and in many instances, a relatively common practice among clinicians.

Although the FDA has regulatory authority over the manufacturers of drugs and medical devices, it has no authority to regulate physicians and the practice of medicine as such. Physician-directed use has been statutorily approved by some state legislatures, which recognize widespread use and acceptability of the practice in the medical community and may wish to neutralize negative associations with “off-label” use.

The FDA has tried to exert regulatory power over the promotion of off-label uses by manufacturers, but most of these regulations have been struck down by courts on First Amendment free speech grounds.

Product litigation
Off-label use can affect manufacturers as a result of product liability litigation. Several cases have involved products approved for one use that were subsequently popularized and applied for a different use. One such instance involved a pedicle screw system. Originally approved for use in long bones, the screws were also used by orthopaedic surgeons and neurosurgeons in the pedicles of vertebral bones.

In a subsequent lawsuit, the plaintiff alleged a lack of informed consent arising from failure of the surgeon to tell the patient of the regulatory status of the device. The court reviewed the regulatory scheme of the FDA and noted that FDA regulatory classes are not intended to interfere with the practice of medicine. In finding in favor of the defendant, the court added that lawsuits for informed consent are limited to the nondisclosure of medical information and that the FDA classification was not “medical information concerning a material risk.” Accordingly, the doctor has no legal duty to advise the patient of the FDA regulatory status of the pedicle screw system. Several other cases have arrived at the same conclusion when confronted with nearly identical allegations. (See the online version of this article for specific examples.)

A reality of adversarial litigation is that defendants may try to blame each other; thus the manufacturer faced with alleged injury from off-label use of its product will assert that the doctor’s use of its product was unauthorized and unforeseeable. The doctor will claim that the practice of off-label use was well accepted in the community and that the manufacturer was well aware of such use, profited from it, and withheld disclosure of risks known only to the manufacturer.

As with other litigation in which competing claims exist, the outcome depends on the underlying facts, as well as the presentation and analysis of evidence. But case law related to disclosure requirements is clear: the doctrine of informed consent includes no requirement to disclose the FDA regulatory status of a medical device.

Additional factors related to the surgeon or the medical device may influence judicial opinion away from the premise that FDA regulatory status is detached from the practice of medicine. For example, the participation of the patient in a clinical investigation requires the additional disclosure of the investigational status of a product pursuant to FDA regulation.

Another strategy by which FDA regulatory status may relate to physician disclosure during informed consent is by invoking the standard of care prevailing at the time of surgery, as evidenced by expert testimony. In other words, if expert witness testimony can establish that disclosure of FDA status was required by the prevailing standard of care because of unusual circumstances related to device use or related variables, then nondisclosure may be a factor considered by the jury. Alternatively, courts may permit examination of evidence related to FDA status pursuant to the rules of procedure used in that jurisdiction.

Analysis and clinical tips
Physician-directed off-label use of medical devices and drugs is acceptable and legal as long as such use is within the standard of care applicable to that community and has a rational basis grounded in clinical judgment. If any concerns or reservations about a device have been raised, disclosure and discussion with the patient is prudent. If the physician has financial ties and benefits related to the off-label use of a medical device or drug, disclosure of such ties and of the intended off-label use is similarly prudent and ethical. Disclosure is mandatory if the drug or device to be used in an off-label manner is part of a clinical investigation or other experimental study.

If in doubt, physicians can ask themselves if they, in the patient’s shoes, would deem the information material and relevant to making an informed choice about surgery. The off-label status, as discussed and as confirmed by judicial rulings, is unrelated to medical practice, and is therefore outside the realm of required disclosures under the informed consent doctrine. In fact, characterizing the routine use of an otherwise beneficial and proven device as “unapproved” or “off-label” may lead to patient anxiety, confusion, and perhaps rejection of an otherwise beneficial operation.

But are there other considerations that the patient probably should know about? These might include payments from the manufacturer related to the off-label use, promotional activity at meetings on behalf of the manufacturer, knowledge of complications specific to the contemplated use, and lack of personal and/or medical community experience with outcomes related to off-label use of the device. The bottom line is that if the physician, as the patient, would want to know these things to make an informed decision, then these issues should be part of the discussion and disclosure during the informed consent process.

B. Sonny Bal, MD, JD, MBA, is an associate professor of orthopaedic surgery at the University of Missouri School of Medicine in Columbia, Missouri. He can be reached at BalB@health.missouri.edu

Editor’s Note: Articles labeled Orthopaedic Risk Manager are presented by the Medical Liability Committee under the direction of contributing editor David H. Sohn, MD.

Articles are provided for general information and are not legal advice; for legal advice, consult a qualified professional.

Email your comments to feedback-orm@aaos.org or contact this issue’s contributors directly.

Court cases dealing with off-label use and informed consent
Schloendorff v. Society of New York Hospital
(1914)—The patient agreed to an examination of a fibroid tumor under ether anesthesia, to find out if it was malignant. The surgeon determined that the tumor was indeed malignant and removed it, contrary to the patient’s consent, which had been limited to an examination only. The court said that absent consent, a surgeon who performs an operation is liable for a medical battery.

Canterbury v. Spence (1972)—The plaintiff was seriously injured after spinal surgery for a herniated disk. The surgeon had not discussed the risk of paralysis with the patient, rationalizing his decision on the basis of minimal risk and concern that discussion of paralysis would needlessly provoke anxiety that might contribute to a dangerous postponement of a needed operation. The court disagreed; its opinion said that “true consent to what happens to one's self is the informed exercise of a choice, and that entails an opportunity to evaluate knowledgeably the options available and the risks attendant upon each…. The context in which the duty of risk-disclosure arises is invariably the occasion for decision as to whether a particular treatment procedure is to be undertaken. …it is the prerogative of the patient, not the physician, to determine for himself the direction in which his interests seem to lie.”

Blazoski v. Cook (2002)—The surgeon used a pedicle screw system for internal fixation during spinal fusion surgery, even though the device had not been approved by the FDA for use in the spine, and did not inform the patient of the regulatory status of the device. At the time of the surgery, pedicle screw systems were classified as Class III devices, which refers to “experimental devices of unproven safety and efficacy.” The surgeon admitted that at the time of use, he was aware that the FDA has not approved the use of pedicle screws for that indication. The court held that the doctrine of informed consent does not require the physician to advise the patient of FDA regulatory status for devices.

Alvarez v. Smith (1998)—The case involved the alleged implantation of surgical screws in the patient’s spine, even though the screws were not FDA-approved for use in the procedure. The court found for the defendant surgeon and noted that the terms ‘Class III,’ ‘investigational,’ and ‘significant risk’ pertaining to the device are terms adopted by the FDA for administrative or regulatory purposes and cannot be extrapolated to specific risks of the surgical procedure. In other words, these terms do not imply that a surgeon did something wrong, or outside the standard of care, because in the FDA regulatory scheme, these terms are used for regulatory, nonmedical purposes.

Klein v. Biscup (1996)—In a similar case involving the off-label use of bone plates and screws, the court expressly declined to expand the physicians’ duty to inform to include FDA status. The court found that such use was not a material risk that required disclosure before obtaining informed consent.

Southard v. Temple University Hospital (2001)—The Supreme Court of Pennsylvania revisited the nondisclosure of the FDA regulatory status of bone screws and rods. The court affirmed previous case law, stating that the category into which the FDA places the device for marketing and labeling purposes simply does not enlighten the patient as to the nature or seriousness of the proposed operation.

Osburn v Goldman (2004)—This case involved a dermatologist who injected silicone into a patient over a 5-year period to remove facial lines and wrinkles; 4 years later, complications developed. Because the patient was statutorily barred from bringing a medical negligence suit, the allegation cited fraud instead. The physician contended that he had used injections in an off-label manner for cosmetic purposes, believing that they were safe. Testimony showed that although the FDA had not approved silicone injections for cosmetic use, it had not banned them either. Existing literature at the time extolled the virtues of silicone injections for cosmetic uses, and a few papers reported the relative rarity of complications. The defendants routinely informed their patients that the injections were not approved by the FDA for cosmetic purposes, but that the defendants considered them safe. The appellate court upheld the trial court’s summary judgment in favor of the defendants.

Corrigan v. Methodist Hospital (2004)—A federal trial court in Pennsylvania heard the claims of a patient injured from lumbar spine surgery in which a plate and pedicle screws were used. The patient argued that informed consent was not obtained since she was not advised of either the investigational nature of the system or the physician’s financial interest in the manufacturer of the system. The patient further claimed that the surgery was unnecessary and that the physicians failed to correctly diagnose a spinal tumor. The court found that the undisclosed risk of the investigational status of the bone screws raised an issue of material fact that should be referred to the jury.

Shadrick v. Centennial Medical Center (1996)—A Tennessee court considering a pedicle screw case found a disputed issue of material fact as to whether the prevailing standard of care at the time of patient injury required a disclosure of the lack of FDA approval and the experimental nature of the use of pedicle screws. The court refrained from discussing FDA regulatory status; the importance of this ruling is that FDA status pertaining to the device could be presented before the jury by the plaintiff, in addition to other disputed facts.

Richardson v. Miller (2000)—In this case, the court said that although FDA-approved drug labeling is not itself prima facie evidence of the prescribing physician’s standard of care, it can nonetheless provide assistance in finding the relevant standard of care, and is therefore admissible at trial, along with expert testimony, to assist the jury in its fact finding.

Columbia Medical Center v. Sangounchitte (2008)—A neurosurgeon used metal rods in an “off-label” use for cervical spine surgery contrary to the manufacturer’s warning; hardware migration and spinal and brain damage resulted. At issue was whether or not the hospital was vicariously liable for surgeon conduct that included an off-label use of a surgical device. The appellate court upheld judgment against the hospital for negligence in credentialing the surgeon. At trial, the jury awarded the plaintiff damages in excess of $10 million.