Judge Graham Mullen ruled on Novartis’s Daubert motion in a Zometa case, excluding large portions of the opinions of Dr. Suzanne Parisian.  Lemons v. Novartis Pharm. Corp., No. 3:08-cv-00361 (W.D.N.C. Order March 21, 2012).  Dr. Parisian is a perennial plaintiff’s expert in virtually all drug or device litigations. The opinion followed an evidentiary Daubert hearing at which Dr. Parisian testified and was cross-examined.

The court disallowed any testimony from Dr. Parisian regarding Novartis’s conduct regarding FDA approvals and post-approval interactions about New Drug Applications because “Dr. Parisian does not possess the requisite experience or expertise, as an employee or insider of a pharmaceutical drug sponsor, to opine on the conduct of Novartis.”  For the same reason, the court barred Dr. Parisian from commenting on Novartis’s communication of the risks at issue in the litigation to health care providers. Furthermore, the court found that Dr. Parisian was not qualified to testify regarding Novartis’s pharmacovigilance efforts or its internal investigation of the alleged association of its drug with the adverse event.  Dr. Parisian was further barred from offering testimony on Novartis’s intent, its monitoring of its clinical trials, or causation. Her testimony was thus limited to generic discussion of the role of the FDA and the responsibilities of pharmaceutical companies, and to commenting on Novartis’s interactions with the FDA on the subject of labeling.