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Off-label (view source)

Revision as of 20:20, September 25, 2022

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<blockquote>It recognized that "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." Id. (citing Staudt v. Froedtert Mem'l Lutheran Hosp., 217 Wis. 2d 773, 580 N.W. 2d 361, 362-63 (Wis. Ct. App. 1998)).</blockquote>
 
<blockquote>It recognized that "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." Id. (citing Staudt v. Froedtert Mem'l Lutheran Hosp., 217 Wis. 2d 773, 580 N.W. 2d 361, 362-63 (Wis. Ct. App. 1998)).</blockquote>
 
''Seavey v. Globus Med., Inc.'', No. 11-2240 (RBK/JS), 2014 U.S. Dist. LEXIS 65985, at *47-48 (D.N.J. Mar. 11, 2014)
 
''Seavey v. Globus Med., Inc.'', No. 11-2240 (RBK/JS), 2014 U.S. Dist. LEXIS 65985, at *47-48 (D.N.J. Mar. 11, 2014)
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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>
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''Blazoski v. Cook'', 346 N.J. Super. 256, 272, 787 A.2d 910, 919-20 (Super. Ct. App. Div. 2002)
    
== See also ==
 
== See also ==
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