A leading pharmaceutical manufacturer may face a rare criminal prosecution for suppressing reports os serious and fatal liver damage in users of Selacryn, a drug prescribed for high blood pressure until its removal from the market 18 months ago.
Smith Kline & French Laboratories and the Food and Drug Administration confirmed separately yesterday that the FDA referred the case to the Justice Department within the last few weeks.
A spokesman for the parent SmithKline Corp. of Philadelphia, which ranked 203rd in sales on Fortune magazine's 1980 list of the 500 largest industrial corporations, said the company cannot predict the ultimate outcome but "continues to believe that no further action is warranted."
Over the past several months, the company has settled or tried to settle numerous lawsuits brought by or in behalf of Selacryn users who developed serious or fatal liver damage. The drug was on the market only eight months.
A criminal prosecution was requested by Dr. Sidney M. Wolfe, director of the Health Research Group (HRG), a Washington-based affiliate of the nonprofit Public Citizen Inc., on Jan 24, 1980.
In November, 1979, the company in a routine quarterly report to the FDA listed 12 cases of liver damage. Each adverse reaction of such seriousness is required by law to be reported individually within 15 days. At a January, 1980, meeting with the FDA, however, SmithKline unexpectedly revealed 40 new cases, five of them fatal.