Off-Label Use of Medical Devices in Radiology: Regulatory Standards and Recent Developments

References 

1. Food, Drug, and Cosmetic Act, § 513(a)(1)(C).
2. Food and Drug Administration Modernization Act of 1997, Pub L No 105-115 § 214 (November 21, 1997).
3. Investigational device exemptions. 21 CFR 812 (April 21, 2009).
4. Smith JJ, Berlin L. Malpractice issues in radiology: off-label use of interventional medical devices. AJR Am J Roentgenol. 1999;173:539–542
   • MEDLINE
5. Blinn v Smith & Nephew Richards, 55 F Supp 2d 1353 (MD Fla 1999).
6. Baker v Smith & Nephew Richards, Inc, 1999 WL 811334 (Tex Dist 1999)
7. Berenson A. Lilly settles with 18,000 over Zyprexa. New York Times. January 5, 2007;
8. Femrite v Abbott Northwestern Hosp, 568 NW 2d 535, 542 (Minn App 1997).
9. In re Litig Orthopedic Bone Screw Products Liability Litigation, 1996 WL 107556 (ED Pa 1996).
10. Staudt v Froedtert Mem'l Lutheran Hosp, 580 NW 2d 361, 363 (Wis App 1998).
11. Klein v Biscup, 673 NE 2d 225, 231 (Ohio Ct App 1996).
12. Weaver v Reagen, 886 F 2d 194, 198 (8th Cir 1989).
13. United States v Evers, 453 F Supp 1141, 1149-50 (MD Ala 1978).
14. Iacangelo v Georgetown University, 580 F Supp 2d 111 (DC 2008).
15. Smith JJ, Berlin L. Malpractice issues in radiology: informed consent when using medical devices for non-FDA approved indications. AJR Am J Roentgenol. 1999;173:879–882
    • MEDLINE
16. Halbe v Weinberg, 717 NE 2d 876 (Ind 1999).
17. Foard v Jarman, 387 SE 2d 162 (NC 1990).
18. K.A.C. v Benson, 527 NW 2d 553 (Minn 1995).
19. Sita v Long Island Jewish-Hillside Med Ctr, 22 AD 3d 743, 743-44 (NY App Div 2005).
20. Blazoski v Cook, 787 A 2d 910 (NJ Sup Ct App 2002).
21. Southard v Temple University Hospital, 781 A 2d 101 (Pa 2001).
22. Alvarez v Smith, 714 So 2d 652 (Fla Dist Ct App 1998).
23. Balderston v Medtronic Sofamor Danek, Inc, 152 F Supp 2d 772 (ED Pa 2001).