Legal ramifications of off-label filler use

Dermatologic Therapy

Volumn 19, Issue 3, 2006, Pages 189-193

  Goldberg, David J ^a,b  

^a FORDHAM UNIVERSITY   (United States)

^b Skin Laser and Surgery Specialists of NY/NJ   (United States)

Author keywords

Dermal fillers; Medical malpractice; Off label use

Indexed keywords

BOTULINUM TOXIN A; FENFLURAMINE; HYALURONIC ACID; OXYCODONE; PHENTERMINE; POLYLACTIC ACID;

ESTHETIC SURGERY; LEGAL LIABILITY; OFF LABEL DRUG USE; REVIEW; SKIN NODULE; TREATMENT INDICATION;

BIOCOMPATIBLE MATERIALS; COSMETIC TECHNIQUES; DERMATOLOGY; DRUG APPROVAL; FACE; HUMANS; HYALURONIC ACID; INJECTIONS; LACTIC ACID; MALPRACTICE; POLYMERS; REJUVENATION;

EID: 33744722156     PISSN: 13960296     EISSN: 15298019     Source Type: Journal    
DOI: 10.1111/j.1529-8019.2006.00073.x     Document Type: Review

References (18)

1. Furrow BF Greaney TL Johnson SH, et al. Liability in Health Care Law, 3rd ed. St. Paul, MN : West Publishing Co., 1997.
2. Beck JM Elizabeth D. FDA, off-label use, and informed consent: debunking myths and misconceptions. Food Drug Law J 1998 : 71 : 58 70.
3. Veronica H. Off-label prescribing: legal implications. J Legal Med 1999 : 20 : 365 378.
4. Final Report on the Activities of the House Comm. on Government and Oversight, 104th Cong. 2d Sess. 104 H. Rep. 874 (Section 2), (January 2, 1997) at 114.
5. Oliphant J. FDA' s new drug war industry fights for alternative uses of approved products. Legal Times, January 10, 2000 at 1.
6. Elliot V. A.H. Robins Co. (In re N.Y. County Diet Drug Litig.), 691 N.Y.S.2d 501 (App. Div. 1999).
7. Rheingold PD Rheingold DB. Offense or Defense? Managing the Off-Label Use Claim, Trial, Mar. 2001, at 52.
8. O'Reilly J Dalal A. Off-label or out of bounds? Prescriber and marketer liability for unapproved uses of FDA-approved drugs. Ann Health Law 2003 : 12 : 295 300.
9. Salbu SR. Off-label use, prescription, and marketing of FDA-approved drugs: an assessment of legislative and regulatory policy. Florida Law Rev 2002 : 51 : 18 21.
10. Ford MA. Another use of oxycontin: the case for enhancing liability for off-label drug marketing. B U L Rev 2003 : 83 : 429 461.
11. Noah L. Informed consent and the elusive dichotomy between standard and experimental therapy. Am J Law Med 2002 : 28 : 361 399.
12. Rhone-Poulenc Rorer Pharms. Inc. v. Marion Merrell Dow Inc., 93 F.3d 511, 514 n.3 (8th Cir. 1996).
13. Food and Drug Administration Modernization Act of 1997: Pub. L. No. 105-115, 111 Stat. 2296.
14. United States General Accounting Office, Off-Label Drugs: Reimbursement Policies Constrain Physicians in Their Choice of Cancer Therapies, Pub. No. GAO/PEMD-91-14, 11, 1991.
15. Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341-351, 2001.
16. Proctor v. Davis, 682 N.E.2d 1203, 1213 (Ill. App), 1997.
17. Use of Approved Drugs for Unlabeled Indications, FDA Drug Bulletin, Apr. 1982, at 4.
18. Hyams AL Shapiro DW Brennan TA. Medical practice guidelines in malpractice litigation: an early retrospective. J Health Pol Policy Law 1996 : 21 : 289 307.