ALLENTOWN, Pa. -- SmithKline Beckman Corp. pleaded guilty to charges of failure to disclose lethal side effects of the blood pressure drug, Selacryn, in the first case of its kind against a pharmaceutical firm.
In addition, one former and two current SmithKline executives pleaded no contest to charges at a hearing Wednesday before U.S. District Judge Edward Cahn.
The case marks the first time a pharmaceutical firm has been charged with violating reporting requirements for new drugs that are specified by the federal Food and Drug Act, said Assistant U.S. Attorney Peter Smith.
SmithKline pleaded guilty to 14 counts of failing to inform authorities of the effects of Selacryn, which has been linked to at least 25 deaths, and 20 counts of mislabeling the drug, Smith said.
Philip Tannenbaum, 54, vice president and medical director; Ralph Myerson, 65, group director of medical affairs; and Theodore Selby, 58, former associate director of medical affairs, all pleaded no contest to failure to inform charges.
As part of a plea bargain agreement, mislabeling charges against the three and a fourth executive will be dismissed, Smith said. The executives all are doctors.
'This is not a renegade company,' Selby's lawyer, Donald Goldberg, said at the hearing. 'It's a company that tries to do right.'
The executives each could be jailed for up to a year and fined $1,000 on each count. SmithKline could be fined up to $34,000 following its guilty pleas to all 34 counts, Smith said. No sentencing date had been set.
SmithKline spokesman Jeremy Heymsfeld said the company would have no comment until all court proceedings were concluded.
The director of a consumer advocate group in Washington, D.C. said a $34,000 fine would amount to a 'slap on the wrist.'
'For a company with 1983 profits of $490 million, a $34,000 penalty, the maximum amount of a money Judge Cahn can order, is a cruel joke,' said Sidney Wolfe, of the Public Health Research Group, founded by Ralph Nader.
Wolfe said his group has compiled figures showing 36 deaths and over 500 serious injuries related to use of the drug.
SmithKline withdrew Selacryn eight months after it was on the market in January 1980, following reports of liver damage and deaths among its estimated 300,000 users.
A study of 526 patients published this year showed 340 'likely or possible' cases of liver damage, including 25 deaths, associated with the use of Selacryn, said William Grigg, an FDA spokesman.
