Bartoli v. Novartis Pharmaceuticals Corporation

Filing 214

ORDER (memorandum filed previously as separate docket entry)Defendants motion to exclude the testimony of Dr. Skubitz, (Doc. 183), is GRANTED IN PART AND DENIED IN PART. Defendants motion is GRANTED as to Dr. Skubitzs observations regarding the incid ence 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)Defendants motion to exclude the testimony of Dr. Marx, (Doc. 185), is GRANTED IN PART AND DENIED IN PART. Defendants motion is GRANTED as to testimony regarding whether NPC engaged in bad faith conduct, and the adequacy of the clinical trials. Defendants 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)Defendan ts motion to exclude the testimony of Dr. Suzanne Parisian, (Doc. 187), is GRANTED IN PART AND DENIED IN PART. Defendants motion is GRANTED as to testimony of NPCs intent, pharmaceutical industry ethical standards, ghostwriting, and undisclosed compa ny funding of publications, and causation. Defendants 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)Defendants moti on to exclude the testimony of Prof. Wayne Ray, (Doc. 189), is GRANTED IN PART AND DENIED IN PART. Defendants motion is GRANTED as to the Table 6 meta-analysis and the use of the word rare in relation to the incidence rate. Defendants motion is DENIE D 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)Defendants mot ion to exclude the testimony of Dr. James Vogel, (Doc. 191), is GRANTED IN PART AND DENIED IN PART. Defendants motion is GRANTED to the extent that Dr. Vogel may not opine as to the intent or motive of NPC. Defendants 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.Signed by Honorable Malachy E Mannion on 4/17/14. (bs)

UNITED STATES DISTRICT COURT
MIDDLE DISTRICT OF PENNSYLVANIA
JOHN BARTOLI,

:

Plaintiff

:

v.

CIVIL ACTION NO. 3:13-0724

:
(JUDGE MANNION)

NOVARTIS PHARMACEUTICALS
CORPORATION,

:
:

Defendant
:
ORDER
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;

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(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.

s/ Malachy E. Mannion
MALACHY E. MANNION
United States District Judge
Date: April 17, 2014
O:\Mannion\shared\MEMORANDA - DJ\CIVIL MEMORANDA\2013 MEMORANDA\13-0724-02-order.wpd

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