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Bartoli v. Novartis Pharmaceuticals Corporation

United States District Court, M.D. Pennsylvania

April 17, 2014

JOHN BARTOLI, Plaintiff
v.
NOVARTIS PHARMACEUTICALS CORPORATION, Defendant

ORDER

MALACHY E. MANNION, District Judge.

In light of the memorandum issued this same day, IT IS HEREBY ORDERED THAT:

(1) Defendant's motion to exclude the testimony of Dr. Skubitz, (Doc. 183), is GRANTED IN PART AND DENIED IN PART. Defendant's motion is GRANTED as to Dr. Skubitz's observations regarding the incidence of ONJ in his own patients after he implemented a reduced dosing regimen, and DENIED as to testimony regarding the benefits of alternative dosing, the benefits of pre-therapy dental screening, and incidence of ONJ;
(2) Defendant's motion to exclude the testimony of Dr. Marx, (Doc. 185), is GRANTED IN PART AND DENIED IN PART. Defendant's motion is GRANTED as to testimony regarding whether NPC engaged in "bad faith" conduct, and the adequacy of the clinical trials. Defendant's motion is DENIED as to opinions on preventative dental screenings, the opinion that some of the clinical trial patients had ONJ, general causation opinions based on adverse event reports, and opinion of the biological mechanism by which BPs allegedly cause ONJ;
(3) Defendant's motion to exclude the testimony of Dr. Suzanne Parisian, (Doc. 187), is GRANTED IN PART AND DENIED IN PART. Defendant's motion is GRANTED as to testimony of NPC's intent, pharmaceutical industry ethical standards, ghostwriting, and undisclosed company funding of publications, and causation. Defendant's motion is DENIED as to opinions regarding regulatory compliance and the reasonableness of NPC's conduct in its interactions with the FDA and compliance with FDA regulations;
(4) Defendant's motion to exclude the testimony of Prof. Wayne Ray, (Doc. 189), is GRANTED IN PART AND DENIED IN PART. Defendant's motion is GRANTED as to the Table 6 meta-analysis and the use of the word "rare" in relation to the incidence rate. Defendant's motion is DENIED as to the Table 5 meta-analysis, the biological plausibility that BPs cause ONJ, the opinion that a causation determination could have been reached in 2003, and an opinion that the incidence rate of ONJ in BP users is 5%, and;
(5) Defendant's motion to exclude the testimony of Dr. James Vogel, (Doc. 191), is GRANTED IN PART AND DENIED IN PART. Defendant's motion is GRANTED to the extent that Dr. Vogel may not opine as to the intent or motive of NPC. Defendant's motion is DENIED as to testimony regarding pre-dental screenings, incidence rate of ONJ in patients, alternative BP dosing regimens, and the biological mechanism by which BPs affect the jaw bone.

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