Dr. Feldstein's latest answer to the renewed, and thus persisting, claims (by Schering's lawyers) that Feldstein has done something vaguely untoward in bringing his Qui Tam/False Claims Act action against Organon (now a Schering unit) soundly, and effectively, counter-punches the typical, overly-aggressive Schering posturing defense strategy.
Take a look at these excerpts, from his overnight filing (full PDF file):
. . . .Nevertheless, even after being provided with Dr. Feldstein’s explanation, Defendants persist in their baseless demand for sanctions pursuant to Federal Rule of Civil Procedure 11 and this Court’s inherent authority. Court-imposed sanctions are warranted only in exceptional circumstances, which are not implicated in this case. Absolutely nothing in the record gives rise to even an inference that Dr. Feldstein improperly commenced this action for the purpose of harassing the Defendants, causing delay or creating unnecessary litigation expenses. Moreover, Defendants’ assertion that Dr. Feldstein’s FCA claim is devoid of evidentiary support is absurd.
Not only has Dr. Feldstein repeatedly provided the Court with pleadings, briefs and certifications that explain both the factual and legal basis for his FCA claim, he has also submitted a copy of an internal e-mail between two senior personnel who worked on obtaining Raplon’s approval from the FDA, Dr. Jonathan Deutsch, Organon’s Director of Hospital Products, and Deborah Shapse, Organon’s Vice President of Medical Services, which unequivocally establishes that Organon and, in particular, its Head of Marketing, Michael Novinsky, sought to “downplay” and conceal critical safety information concerning Raplon from the FDA. (Amended Complaint, ¶¶ 13-17.) This is not a situation where sanctions are appropriate because a litigant has raised claims lacking any factual support or for a purpose other than having them fairly adjudicated on the merits. . . .
Organon approached Dr. Carol Hirshman, an anesthesiology professor at Columbia University, to conduct a mechanism-of-action study to determine the cause of the SAEs associated with Raplon. After she agreed, Organon paradoxically failed to authorize the study and dropped the matter. (Amended Complaint, ¶ 18.) Finally, the fact that Dr. Feldstein did not confirm the full extent of Organon’s misconduct until after his termination in no way diminishes the significance of the e-mail and other information he acquired during his employment. . . .
Ouch -- Um, try again, Lowenstein Sandler.
1 comment:
Tonnight, Judge Cavanaugh has denied Schering-Plough's motion for sanctions. He did dismiss the underlying FCA claim, as well, though, too.
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