The Grand Jury further charges:
2A. Under Title 21, United States Code, Sections 352 (a) and 321 (n) in that the labeling for said drug [E-Ferol] was false and misleading in that said drug was recommended and suggested as appropriate for intravenous use in premature infants, when defendants knew of, and failed to reveal in the labeling, the following material facts:
(1) The drug had been reported to defendants to be associated with serious, life threatening injuries to premature infants, even when E-Ferol was used under the conditions of use prescribed, recommended, and suggested in the labeling of the drug product;
(2) No adequate investigation was conducted by the defendants to determine the validity of the associations of E-Ferol to said injuries that had been reported to them;
(3) No scientifically adequate or well controlled studies existed that established that E-Ferol could be safely and effectively used under the conditions of use prescribed, recommended, and suggested in the labeling of the drug product; and
(4) The safety and effectiveness of E-Ferol had not been established for use in premature infants.
The People's Panel: The Grand Jury in the United States, 1634-1941