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Executive Summary

SMITHKLINE BEECHAM SEEKING MONETARY DAMAGES FROM BOLAR, SCHEIN, VITARINE for marketing fraudulent generic versions of Dyazide. In a complaint filed June 12 in Philadelphia federal court. SmithKline Beecham names as defendants Bolar, its founder and former President Robert Shulman, Bolar's triamterene/hydrochlorothiazide comarketer Schein, and Vitarine, which independently marketed another fraudulent version of Dyazide. The complaint charges the defendants with civil violations of the Racketeer-Influenced and Corrupt Organizations Act in connection with the marketing of generic versions of Dyazide, which were approved on the basis of false data submitted to FDA. The suit also alleges violations of federal trademark laws. SmithKline would not specify the damages it is seeking. However, the company's U.S. sales of Dyazide, which were $320 mil. in 1987 before generic versions hit the market, dipped to$153 mil. in 1988 following the introduction of the generics, and recovered to $186 mil. in 1989 as the generic drug scandal began to unfold. The RICO statute allows for recovery of treble damages. The complaint states that SmithKline was injured by the "defendants' fraudulent schemes and false representations [which] enabled defendants to obtain FDA approval to market their generic versions of Dyazide and to sell their generic versions of Dyazide to persons who otherwise would have bought Dyazide from plaintiff."

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