Must surgeons inform patients that a procedure is experimental or investigational? The majority of cases hold that FDA status is not a “medical risk” and thus need not be disclosed in obtaining a patient’s informed consent. See Alvarez v. Smith, 714 So. 2d 652 (Fla. 5th DCA 1998). In Alvarez, Appellants Jose and Mirna Alvarez (the patients) appealed from a final judgment entered pursuant to an adverse jury verdict. The patients’ complaint alleged that during a medical operation metallic screws were implanted in Jose’s spine in a procedure for which the screws had not been approved by the Food and Drug Administration (FDA) and which was classified by the FDA as “experimental or investigational.” At issue was whether the doctors had a duty to inform the patients of the FDA status of the pedicle screws. Prior to trial, the trial court concluded that there was not and granted partial summary judgment for the doctors on this issue. The appellate court agreed.

Initially, the appellate court observed that the doctors’ admission concerning their prevailing professional standard of care could not create an otherwise nonexistent legal duty. The patients alleged that the doctors “admitted” in their pleadings and deposition that they felt they owed such a duty, and that therefore they had a duty as a matter of law.

The court held, however, the doctors’ “custom and practice” of providing information to patients did not in and of itself create an otherwise nonexistent legal duty. The determination of legal questions is for the court rather than the parties.

Regarding the FDA status, the appellate court noted the majority of reported cases hold that as a matter of law doctors are not required to disclose the FDA status of pedicle screws, because such status is not a medical risk of surgery. For example, in In re Orthopedic Bone Screw Products Liability Litigation, 1996 WL 107556 (E.D.Pa.1996), the defendant physicians had used pedicle screws in spinal fusion surgeries as in the instant case. Like Appellants here, the plaintiffs alleged that the defendants failed to inform them that the FDA had not approved the screws for use in the spine and that therefore the doctors should be liable under informed consent law. The court rejected the plaintiffs’ argument and granted the doctors’ motion for partial summary judgment as to FDA regulatory status, noting:

[A] physician is free to use a medical device for an off-label purpose, if, in the physician’s medical judgment, he or she believes that use of the device will benefit the patient. Because the off-label use of a medical device is a matter of medical judgment, a physician may be subject to medical malpractice liability for the exercise of that judgment. That physician cannot, however, be held liable under the doctrine of informed consent for failing to advise a patient that a particular device has been given an administrative or regulatory label by the FDA. The law of informed consent obligates a physician to advise a patient of the medical risks, benefits and alternatives directly related to the patient’s operative procedure. The terms “Class III,” “investigational,” and “significant risk” device are terms adopted by the FDA for administrative or regulatory purposes and cannot be said to be risks of a particular surgical procedure.

1996 WL 107556 at *5. See also Weaver v. Reagen, 886 F.2d 194, 198 (8th Cir.1989) (“[T]he fact that FDA has not approved labeling of a drug for a particular use does not necessarily bear on those uses of the drug that are established within the medical and scientific community as medically appropriate.”); Femrite v. Abbott Northwestern Hosp., 568 N.W.2d 535 (Minn.Ct.App.1997) (granting summary judgment for defendant hospital, finding that the use of the screws in the spine was lawful and did not violate the Food and Drug Act; there was no duty to inform the patient of the investigational nature of the screws because the regulations requiring such disclosure apply only in the context of an investigative study); Klein v. Biscup, 109 Ohio App.3d 855, 673 N.E.2d 225, 231 (1996) (granting summary judgment in favor of the defendant physicians on the issue of informed consent in a pedicle screw case regarding disclosure of FDA status, noting that “the FDA does not regulate the practice of medicine,” “the decision whether to use a drug for an off-label purpose is a matter of medical judgment, not of regulatory approval,” and “[o]ff-label use of a medical device is not a material risk inherently involved in a proposed therapy which a physician should disclose to a patient prior to the therapy”). Other courts, however, have declined to rule as a matter of law that FDA status need not be disclosed.

In Alvarez, the court agreed with the majority of cases, which hold that FDA status is not a “medical risk” and thus need not be disclosed in obtaining a patient’s informed consent.

Although Alvarez was decided 26 years ago, it remains good law in Florida.