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| | <blockquote>Physicians may, in their professional judgment, prescribe a drug for a purpose other than that for which it has been approved by the FDA. (''Buckman Co. v. Plaintiffs' Legal Comm.'' (2001) 531 U.S. 341, 351, fn. 5 [148 L.Ed.2d 854, 121 S.Ct. 1012] [“‘Off-label use is widespread in the medical community’”].)</blockquote> | | <blockquote>Physicians may, in their professional judgment, prescribe a drug for a purpose other than that for which it has been approved by the FDA. (''Buckman Co. v. Plaintiffs' Legal Comm.'' (2001) 531 U.S. 341, 351, fn. 5 [148 L.Ed.2d 854, 121 S.Ct. 1012] [“‘Off-label use is widespread in the medical community’”].)</blockquote> |
| | ''T.H. v. Novartis Pharm. Corp.'', 4 Cal. 5th 145, 158 n.1, 226 Cal. Rptr. 3d 336, 342, 407 P.3d 18, 24 (2017) | | ''T.H. v. Novartis Pharm. Corp.'', 4 Cal. 5th 145, 158 n.1, 226 Cal. Rptr. 3d 336, 342, 407 P.3d 18, 24 (2017) |
| | + | <blockquote>Initially we note that although the FDA regulates, among other things, drugs and medical devices, the FDA does not regulate the practice of medicine. The legislative history of the federal Food, Drug and Cosmetic Act reveals that Congress recognized that the act was "not intended as a medical practices act and [would] not interfere with the practice of the healing art ***." S.Rep.No.36l, 74th Cong., 1st Sess. at 3 (1935). |
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| | + | In conformity with this legislative intent, courts addressing FDA regulated drug issues have determined that physicians are permitted to use federally approved drugs as they, in their medical judgment, see fit. This professional latitude was recognized in Weaver v. Reagen (C.A. 8, 1989), 886 F.2d 194, where the court stated at 198: |
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| | + | Contrary to defendants' assertions, FDA approved indications were not intended to limit or interfere with the practice of medicine nor to preclude physicians from using their best judgment in the interest of the patient. *** |
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| | + | The [Food, Drug and Cosmetic] Act does not, *** limit the manner in which a physician may use an approved drug. Once a product has been approved for marketing, a physician may prescribe it for uses or in treatment regimens or patient populations that are not included in approved labeling. "Use of Approved Drugs for Unlabeled Indications," 12 FDA Drug Bulletin 4 (April (1982). |
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| | + | Thus, the decision whether or not to use a drug for an off-label purpose is a matter of medical judgment not of regulatory approval. By analogy, the off-label use of a medical device is also a matter of medical judgment, and as such, subjects a physician to professional liability for exercising professional medical judgment. Off-label use of a medical device is not a material risk inherently involved in a proposed therapy which a physician should have disclosed to a patient prior to the therapy. See Nickel 1, supra. Therefore, since Biscup engaged in off-label use of this medical device he could be subject to professional liability for medical negligence, but in this case those claims have been litigated and are not before us. Accordingly, we conclude failure to disclose FDA status does not raise a material issue of fact as to informed consent.</blockquote> |
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| | + | ''Klein v. Biscup'', 109 Ohio App. 3d 855, 863-64, 673 N.E.2d 225, 231 (1996) |
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| | ===Devices=== | | ===Devices=== |
| | <blockquote>Moreover, the FDA's "approval process generally contemplates that approved [devices] will be used in off-label ways," United States v. Caronia, 703 F.3d 149, 166 (2d Cir. 2012); see also Caplinger v. Medtronic, Inc., 921 F. Supp. 2d 1206, 1218 n.3 (W.D. Okla. 2013) (noting that off-label use is not illegal or disfavored but an accepted and valuable part of the practice of medicine). Off-label use may even be a recognized standard of care. Caronia, 703 F.3d at 153. And congress has prohibited the FDA from "limit[ing] or interfer[ing] with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease." 21 U.S.C. § 396 (2014). Although the Infuse Device was approved as a system, the statutory definition supports our conclusion that each component is a "device" under the FDA that must follow specific federal requirements. See Riley v. Cordis Corp., 625 F. Supp. 2d 769, 780 (D. Minn. 2009) ("It makes no sense—indeed, it would probably be impossible—to pick apart the components of a medical device and apply different preemption analyses to different components."). Consequently, we conclude that the FDA established specific federal requirements for the Infuse Device, even when the Infuse Protein is used alone.</blockquote> | | <blockquote>Moreover, the FDA's "approval process generally contemplates that approved [devices] will be used in off-label ways," United States v. Caronia, 703 F.3d 149, 166 (2d Cir. 2012); see also Caplinger v. Medtronic, Inc., 921 F. Supp. 2d 1206, 1218 n.3 (W.D. Okla. 2013) (noting that off-label use is not illegal or disfavored but an accepted and valuable part of the practice of medicine). Off-label use may even be a recognized standard of care. Caronia, 703 F.3d at 153. And congress has prohibited the FDA from "limit[ing] or interfer[ing] with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease." 21 U.S.C. § 396 (2014). Although the Infuse Device was approved as a system, the statutory definition supports our conclusion that each component is a "device" under the FDA that must follow specific federal requirements. See Riley v. Cordis Corp., 625 F. Supp. 2d 769, 780 (D. Minn. 2009) ("It makes no sense—indeed, it would probably be impossible—to pick apart the components of a medical device and apply different preemption analyses to different components."). Consequently, we conclude that the FDA established specific federal requirements for the Infuse Device, even when the Infuse Protein is used alone.</blockquote> |
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| | <blockquote>What is clear is that the FDA's concern is to regulate the marketing and labeling of medical devices, not to intrude upon the practice of medicine or redefine the doctrine of informed consent. Significantly, the FDA does not prohibit off-label use of pedicle screws. In essence, physicians have the right, exercising reasonable medical judgment, to use medical devices for off-label purposes that are not FDA approved, provided that the FDA has approved the device for some other purpose. Staudt v. Froedtert Mem'l Lutheran Hosp., 217 Wis. 2d 773, 580 N.W.2d 361, 362-63 (Wis.Ct.App.1998). In this case defendant testified, without contradiction, that the use of pedicle screws was generally accepted in the field of spinal surgery in 1990. Of course, "'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. . . .'" Femrite v. Abbott Northwestern Hosp., 568 N.W.2d 535, 542 (Minn.Ct.App.1997) (quoting FDA document dated February 17, 1994, entitled "Update on the Regulatory Status of Pedicle Screws").</blockquote> | | <blockquote>What is clear is that the FDA's concern is to regulate the marketing and labeling of medical devices, not to intrude upon the practice of medicine or redefine the doctrine of informed consent. Significantly, the FDA does not prohibit off-label use of pedicle screws. In essence, physicians have the right, exercising reasonable medical judgment, to use medical devices for off-label purposes that are not FDA approved, provided that the FDA has approved the device for some other purpose. Staudt v. Froedtert Mem'l Lutheran Hosp., 217 Wis. 2d 773, 580 N.W.2d 361, 362-63 (Wis.Ct.App.1998). In this case defendant testified, without contradiction, that the use of pedicle screws was generally accepted in the field of spinal surgery in 1990. Of course, "'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. . . .'" Femrite v. Abbott Northwestern Hosp., 568 N.W.2d 535, 542 (Minn.Ct.App.1997) (quoting FDA document dated February 17, 1994, entitled "Update on the Regulatory Status of Pedicle Screws").</blockquote> |
| | ''Blazoski v. Cook'', 346 N.J. Super. 256, 272, 787 A.2d 910, 919-20 (Super. Ct. App. Div. 2002) | | ''Blazoski v. Cook'', 346 N.J. Super. 256, 272, 787 A.2d 910, 919-20 (Super. Ct. App. Div. 2002) |
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| | + | <blockquote>(not a quote) lack of FDA approval does not prohibit a physician from "off label" use</blockquote> |
| | + | Kirkman v. Sofamor, S.N.C., 1998 U.S. Dist. LEXIS 13357, 1998 WL 666706 at *4 (W.D. N.C. July 21, 1998) |
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| | == See also == | | == See also == |