St. Louis, Jan. 21 (AP)—A pharmaceutical company has been fined $115,000 and a former executive sentenced to six months in a work-release program for marketing an unapproved drug linked to the death of 38 premature babies.
The sentences were imposed Friday by Judge Clyde Cahill of Federal District Court here, which had jurisdiction in the case because the company, O'Neal, Jones & Feldman Pharmaceuticals, now called O'Neal Inc., is based in the St. Louis suburb of Maryland Heights.
O'Neal was the sole distributor of E-Ferol Aqueous Solution, used for treatment of retrolental fibroplasia, a disease that can cause blindness in premature infants exposed to too much oxygen.
The product, which was never tested by the Food and Drug Administration, was introduced in 1983 and recalled in 1984, after reports of infant deaths associated with its use.
The executive who was sentenced Friday is James B. Madison, a 68-year-old former O'Neal vice president for operations, who had pleaded guilty to wire fraud and mislabeling. In addition to the six months in a work-release program, Judge Cahill sentenced him to three years' probation and ordered him to contribute $10,000 to a charity that helps children.
O'Neal, which had pleaded guilty to charges including mail fraud and failure to obtain approval of a new drug application, was ordered to pay $125,000 in court costs in addition to the $115,000 fine.
The sentences were handed down one day after Judge Cahill imposed a $130,000 fine on the drug's now-defunct manufacturer, Carter-Glogau Laboratories of Glendale, Ariz. Its former president, Ronald M. Carter, and O'Neal's former president, Larry K. Hiland, were sentenced to six months in prison by Judge Cahill, who ordered them to contribute $65,000 each toward research on drug safety.
Carter-Glogau, Mr. Carter and Mr. Hiland had all been convicted of conspiracy, marketing and unapproved drug and misbranding the drug.
The two companies and their insurers have reached settlements totaling millions of dollars with the families of children treated with the drug.
Buckling procedures for retinal detachment caused by retrolental fibroplasia in premature babies.