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Executive Summary

LILLY ORAFLEX ADVERSE REACTION REPORTING WAS LIMITED TO CASES PUBLISHED in the medical literature, the Justice Dept. stated in an 18-page report. The report outlined the factual basis for Lilly's guilty pleas to 25 misdemeanor counts and ex-exec Ian Sheddin's no contest plea to 15 misdemeanor counts. "Beginning in early 1981, and continuing up to and after April 19, 1982, when the NDA was approved by FDA, unpublished reports of liver dysfunction, kidney dysfunction, jaundice, and liver/kidney syndrome were received by Lilly in the U.K.," the document declared. Justice said that by June 23, 1982, Lilly "knew of approximately 50 unpublished liver and kidney reactions that had occurred in the U.K." but "did not tell FDA about any of the unpublished overseas reactions and discussed only those reactions that had been published in the medical literature." The Justice Dept. said "it was not until July 22, 1982, during the course of a meeting with FDA, that Lilly gave the agency a one-page tabulation of 17 unpublished overseas liver and kidney reactions." Lilly withdrew the drug from the U.S. and world markets on Aug. 5, 1982. While Oraflex was on the market "at least 26 patients in the U.S. died from liver and/or kidney failure" and "more than 200 patients suffered nonfatal liver and kidney failure," the dept. reported. In a further accounting of events, the Justice Dept. noted that on April 24, 1982, Lancet published a letter describing three cases of jaundice observed by physicians whose patients were using Oraflex. In addition, on May 8, 1982, the British Medical Journal published an article reporting five fatalities in Oraflex patients who had cholestatic jaundice and kidney failure. The Justice Dept. said two of the deaths were reported to Lilly in the U.K. as early as February 1982 and the other three were reported on April 7, 1982. "Lilly did not notify the FDA about any of these adverse reactions until May 10, 1982, after they had been published," the dept. stated. Lilly pleaded guilty on Aug. 21 to unintentionally providing inadequate label warnings on 15 shipments of Oraflex made immediately after the drug's approval and being unintentionally late in filing 10 liver or liver-kidney adverse reactions to Oraflex ("The Pink Sheet" Aug. 26, p. 4). The Justice Dept. said the misdemeanors "are not based on any willful, knowing, or intentional violations of the law."

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