The FDA regulates the use of medical drugs and devices. Once a drug or device has been approved for any purpose, physicians may use that drug or device for purposes that have not been approved. Indeed, the medical devices at issue here, screws approved by the Food and Drug Administration for use in long bones, have been lawfully used --in the vertebral pedicle--as "'an "off-label" use--that is, using an approved device for an unapproved indication.

As noted by the Food and Drug Administration, permitting such "unapproved" use defers to the physician's medical judgment: "'In general, a physician who engages in off-label uses has the responsibility to be well informed about the device, and to base the decision to use it on sound medical evidence and a firm, scientific rationale.'" (quoting a Food and Drug Administration document). Although hospitals must give certain information to those of their patients participating in clinical investigations of "off-label" uses of medical devices, the hospital need not give this information to patients who are not part of such an investigation, even though their physicians are treating them with the device in an identical "unapproved" way. Moreover, the duty to get informed consent from a patient rests with the physician and not the hospital. That the "informed consent" is in connection with the "unapproved" use of a medical device that has been approved for other purposes does not alter this principle.

Indeed, the Investigational Devices Exemptions Manual, published by the Food and Drug Administration in June of 1992, recognizes the applicable paradigm:
Good medical practice and patient interests require that physicians use commercially available devices according to their best knowledge and judgment. If a physician uses a device in the practice of medicine for an indication not in the approved labeling, he or she has the responsibility to be well informed about the product, to base its use on a firm scientific rationale and on sound medical evidence, and to maintain records of the product's use and effects. Use of a device in this manner as part of the "practice of medicine" does not require the submission of an [Investigational Devices Exemption], or review by [a hospital Institutional Review Board], unless such review is required by the institution in which the device will be used.