
Legal Liability in Using Nonapproved Materials
JAMES R. RAYMOND, MD
Oshkosh, Wis
Arch Otolaryngol Head Neck Surg. 1987;113(11):1238-1239.
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To the Editor.—The article by Wells and Gernon1 in the June issue of the ARCHIVES concerning use of 2-cyano-butyl-acrylate (Histoacryl) was most interesting. The results would appear to indicate that the medication can be used successfully, at least on animal models. The authors also mention that the medication has not been approved by the Food and Drug Administration, although it is widely used in Europe. I am writing to further caution that use of this drug may cause much legal difficulty. I am personally aware of a case in which cyano-acrylate was used in a dental oral procedure and suit was brought against the dentist. The suit was settled out of court because of the fact that a nonapproved drug had been used. Therefore, I think that even though the drug appears to work well on test models, it should not be used by otologic surgeons in
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