Malpractice issues in radiology. Off-label use of interventional medical devices

American Journal of Roentgenology

Volumn 173, Issue 3, 1999, Pages 539-542

  Smith, John J ^a   Berlin, Leonard ^b,c  

^a HARVARD MEDICAL SCHOOL   (United States)

^b RUSH NORTH SHORE MEDICAL CENTER   (United States)

^c RUSH MEDICAL COLLEGE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

UROKINASE; PLASMINOGEN ACTIVATOR;

ADULT; ARTICLE; BLOOD CLOT LYSIS; CASE REPORT; DEEP VEIN THROMBOSIS; DEVICE; ECHOGRAPHY; FEMALE; HUMAN; INTERVENTIONAL RADIOLOGY; LEG EDEMA; MALPRACTICE; MEDICAL LIABILITY; MEDICOLEGAL ASPECT; NUCLEAR MAGNETIC RESONANCE IMAGING; PRIORITY JOURNAL; SAFETY; APPARATUS, EQUIPMENT AND SUPPLIES; FEMORAL VEIN; FIBRINOLYTIC THERAPY; FOOD AND DRUG ADMINISTRATION; INSTRUMENTATION; LEGAL ASPECT; LEGAL LIABILITY; STENT; UNITED STATES; VEIN THROMBOSIS;

ADULT; EQUIPMENT AND SUPPLIES; FEMALE; FEMORAL VEIN; HUMANS; LIABILITY, LEGAL; MALPRACTICE; PLASMINOGEN ACTIVATORS; RADIOLOGY, INTERVENTIONAL; STENTS; THROMBOLYTIC THERAPY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; URINARY PLASMINOGEN ACTIVATOR; VENOUS THROMBOSIS;

EID: 0032858684     PISSN: 0361803X     EISSN: None     Source Type: Journal    
DOI: 10.2214/ajr.173.3.10470876     Document Type: Article

References (10)

1. Johnson v Farmers & Merchants State Bank, 320 NW2d 892 (Minn. 1982)
2. Food, Drug and Cosmetic Act, 21 USCA 321 et seq. (1998)
3. United States v Evers, 453 F Supp 1141 (Middle Dist. Ala. 1978)
4. Preamble to the final rule regarding new drug, antibiotic, and biologic drug regulations, 52 Federal Register 8803 (1987)
5. Nightingale SL. Unlabeled uses of approved drugs. Drug Info J 1992;26:141-147
6. 21 CFR §312.2(d)(1998)
7. Food and Drug Administration Modernization Act of 1997 §214 (to be codified at 21 USC §396)
8. United States Department of Health and Human Services. Investigational device exemptions manual. Rockville, MD: United States Department of Health and Human Services, 1992
9. Femrite v Abbott Northwestern Hospital, 568 NW2d 535 (Minn. App. 1997)
10. Keeton WP, Dobbs DB, Keeton RE, Owen DG. Prosser and Keeton on torts, 5th ed. St. Paul: West Publishing, 1984:695