Shameless: 1995's 10 Worst Corporations
Warner-Lambert's Guilty Plea
Fortune 500 Warner-Lambert Company pled guilty in November 1995 to a felony count and was sentenced to pay a $10 million criminal fine for fraudulently failing to notify the federal government about persistent problems that it had with certain drugs maintaining stable dosages.
Warner-Lambert pled guilty in U.S. District Court in Baltimore, Maryland to a felony under the Food, Drug, and Cosmetic Act. Federal officials charged that the company fraudulently failed to report drug stability failures of the prescription drug Dilantin to the Food and Drug Administration (FDA).
Diantin is a widely used anti-epileptic medication. The government alleged that similar violations occurred with the prescription drugs Parsidol, an anti-Parkinsonism drug, and Euthroid and Proloid, both thyroid medications.
A grand jury in Baltimore indicted Warner-Lambert's former vice-president for quality assurance, Allan Doane, on charges of conspiracy, for having shipped adulterated Dilantin and obstructing FDA proceedings. If convicted on all charges, Doane faces a maximum sentence of 19 years imprisonment and a $1.25 million fine.
Federal officials alleged that prior to 1991, Warner-Lambert had trouble meeting FDA-approved dissolution specifications for Dilanton. By October 1991, stability test failures had occurred on two different dosages of Dilantin and company employees met to discuss the test failures. They determined that the FDA should be notified, but that decision was reversed by Warner-Lambert executives.
During several discussions with FDA about these other drugs, Warner-Lambert officials concealed the Dilantin failures. The FDA did not learn of the Dilantin stability failures until the middle of 1992, when FDA inspectors uncovered them during inspections of manufacturing facilities.
As a result of the FDA investigation, in 1993 Warner-Lambert agreed to a court-ordered injunction regulating the company's testing and reporting practices. Under terms of the injunction, Warner-Lambert continues to manufacture Dilantin. The company has discontinued production of Parsidol, Euthroid and Proloid.
Warner-Lambert spokesperson Jennifer Mann said "no consumer was injured" by the crime and the guilty plea represents Warner Lambert's first criminal conviction.