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Executive Summary

THEOCRON/THEO-DUR: SCHERING LEGAL TACTICS "MISREPRESENTED" the public health risks of substituting Forest's 100 mg and 200 mg doses of theophylline for equivalent doses of Theo-Dur, New Jersey Federal Court Judge Maryanne Trump Barry said in a March 10 decision imposing a $ 100,000 fine against Schering. The judge found that Schering's request for a recall of Vitarine's Theocron, based on its assertion that substitution endangered public health, "was a misrepresentation because it was false and misleading" and caused the court and defendants to prepare for a "preliminary injunction on an expedited basis at great expense to defendants." Schering had sought a preliminary injunction last fall in its suit against Vitarine, and its Major Group subsidiary. Schering asked for the "recall from distribution channels" of all Theocron products disseminated under advertisements by Major's subsidiary Murray Drug "indicating bioequivalence" to Theo-Dur, the opinion notes. Although Theocron was AB rated to Theo-Dur in the 300 mg dose, the 100 mg and 200 mg doses did not receive an AB rating until January 25. The Murray comparative ad claims for bioequivalence apparently did not distinguish between the different dosages. After arguing that a prompt hearing and expedited discovery period were essential to protect the public from the generic theophylline sold under the Murray claim, Schering withdrew its preliminary injunction application Oct. 26, one day before the expedited hearings were to be completed. Ruling on the Vitarine/Major Group follow-up motion for sanctions against Schering after the early withdrawal, Judge Barry awarded Vitarine/Major Group $ 100,000 to be recovered from Schering and the company's attorneys. The judge pointed out that the sanctions were imposed because of the legal tactics employed to expedite discovery, and not due to the argument against substitutability. "Absent allegations of serious health risks," the decision points out, "plaintiffs could nonetheless have sought a preliminary injunction which might not have been found wholly frivolous." Vitarine/Major Group had filed a motion for sanctions against Schering and its attorneys on the grounds that the drug firm had "no factual or legal basis for claiming that a public health risk was posed by defendants' product," and that Schering's counsel "engaged in abusive litigation tactics." However, the judge notes that "the voluntary dismissal [of the preliminary injunction] will still preclude any determination of the merits of the underlying action, and will still permit the refiling of the action." Schering Plough is represented in the suit by the firm of Hellring, Lindeman, Goldstein, Siegal, Stern & Greenberg, Newark, N.J. and the New York City firm, Milgrin, Thomajan & Lee. Attorneys for Vitarine/Major Group are Budd Larner Gross Picillo Rosenbaum Greenberg & Sade, Short Hills, N.J. and Lord, Day & Lord, Barrett Smith, New York, N.Y.

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