Legal Eagle Eye Newsletter for the Nursing Profession(4)11 Aug 96PDF Version
Quick Summary: A patient contracted Creutzfeldt-Jacob disease from cadaver dura mater material used as a graft in surgery to remove a cholesteatoma. The dura tissue sample had been acquired by the hospital from a German corporation operating in Canada, according to the court record.
In an apparent attempt to avoid non-compliance with U.S. FDA regulations, the carton containing the tissue sample had been shipped into the U.S. labeled "For Investigational Use Only," "For Use In Canada Only," and "Laboratory Sample - For Testing Only."
In ruling in favor of the patient in his lawsuit against the hospital, the Appellate Court of Connecticut stated that, under these circumstances, this patient would not be required to present expert testimony in court to establish that the tissue graft should not have been used on him. That question presented no "esoteric or uniquely medical issue" in this case.
The warnings with which the carton containing the tissue had been labeled placed the hospital on notice that the tissue sample could not be considered safe, without the hospital making its own independent inquiries to ascertain that the tissue product itself had been approved by U.S. FDA authorities for use in the U.S., and, if so, whether the particular supplier had been approved by U.S. authorities to supply the product in the U.S.
It was not appropriate, according to the court, for the hospital to have assumed the product was legal for use in Canada, or that being legal under Canadian laws would render a product or device subject to U.S. FDA regulation acceptable by U.S. courts for use in the U.S.Bourquin vs. Melsungen, 670 A. 2d 1322 (Conn. App., 1996).