Baldwin v. Novartis Pharmaceuticals Corporation
ORDER granting, in part, and denying, in part 142 147 motions in limine. Signed on 3/8/3012 by Magistrate Judge Matt J. Whitworth. (Bode, Kay)
IN THE UNITED STATES DISTRICT COURT FOR THE
WESTERN DISTRICT OF MISSOURI
CHRISTINE WINTER, Individually,
and as Personal Representative of the
Estate of RUTH BALDWIN,
A pretrial conference was held on February 29, 2012, with counsel for all parties
participating in person. The Court heard argument on the parties’ Daubert motions and motions
The Court’s rulings on the Daubert motions were set forth on the record at the
conference, and will be finalized in a separate written order. The motions in limine were also
ruled on the record at the February 29 conference. The instant order is a written summary of the
rulings on the motions in limine.
Plaintiff Christine Winter’s Motions in Limine
I. Plaintiff’s motion seeking to exclude NPC’s Learned Intermediary Defense is denied.
Defendant has not waived the applicability of the Learned Intermediary Doctrine to the facts
before the Court. However, plaintiff asserts that the Missouri Court of Appeals for the Western
Division has just issued an opinion which may change the Court’s view of this issue.
Consequently, the Court will reserve a final ruling until the Court and parties have had an
opportunity to analyze the decision.
II. Plaintiff’s motion seeking to exclude the February 14, 2012 Supplemental Report of
Kelly Pendergrass, M.D., is granted as unduly prejudicial to the plaintiff. The detailed reasons
for this decision are set forth in the record.
III. Plaintiff’s motions seeking to exclude a multitude of evidence in subsections (a)-(j)
as not relevant are denied. However, the Court will permit objections at trial on these issues.
The Court notes, however, that subsection (f) is moot because the defendant has agreed not to ask
Dr. Marx whether he examined plaintiff.
Defendant Novartis Pharmaceuticals Corporation’s Motions in Limine
I. NPC’s motion seeking to exclude ex parte statements by Ms. Baldwin is granted.
However, if at trial these statements become relevant for purposes of cross-examination or
rebuttal, plaintiff may bring the issues to the Court’s attention for reconsideration.
II. NPC’s motion seeking to exclude evidence based on incorrect duty to warn under
Missouri law is granted. The Court will follow Missouri law on the issue of duty to warn.
Missouri law on duty to warn is admissible for purposes of determining whether the warning at
issue was adequate.
III. NPC’s motion to exclude evidence which is dated or occurred after the date of
October 21, 2004, is granted. However, plaintiff may seek reconsideration of this ruling, if she
can show that documents dated after October 21, 2004, or other evidence occurring after October
21, 2004, is relevant to what occurred prior to the date of October 21, 2004.
IV. NPC’s motion seeking to exclude evidence or argument that NPC should have
warned prior to September 2003 is denied.
V. NPC’s motion to exclude testimony concerning plaintiff’s expert witnesses’
experiences with ONJ patients is denied.
VI. NPC’s motion to exclude Adverse Drug Experience Reports is granted, in part, and
denied, in part. Any Adverse Drug Experience Reports prior to October 21, 2004, are
admissible. Any reports after October 21, 2004, are not admissible unless plaintiff’s counsel can
show why they would be relevant.
VII. NPC’s motion to exclude certain corporate documents is granted, in part, and
denied, in part, as follows:
A) January 31, 2005 email from Petraglia is not going to be offered, and therefore,
the motion to exclude is denied as moot;
B) June 15, 2005 email from Sabliska to Cook is admissible and the motion in
limine is denied;
C) January 18, 2004 letter from Klein to Dunsire is admissible and the motion in
limine is denied. However, the Court may reconsider this issue at trial if an objection is
made by NPC at the time the document is offered;
D) March 12, 2004 email from Senior Medical Information Specialist Weiss is
admissible, and the motion in limine is denied;
E) May 5, 2003 email from Fratarcangeli to Epstein is admissible and the motion
in limine is denied;
F) June 20, 2003 email from Goessl to Hei is admissible, and the motion in limine
G) July 10, 2003 email from Goessl to Hei is admissible, and the motion in limine
is denied; and
H) December 1, 2003 email from Linguri to Dunsire and attached agency is
admissible and the motion in limine is denied.
VIII. NPC’s motion to exclude statements in Ms. Baldwin’s medical records is denied.
However, at trial, the Court may reconsider as to specific entries if NPC raises an objection.
IX. The Court denies NPC’s motion to exclude evidence regarding alternative dosing.
The Court has reviewed the decisions of other courts which were submitted by the parties. While
the email of January 29, 2003, is arguably prejudicial to NPC, it may be highly relevant to the
issue of punitive damages. In addition, the email deals with a Japanese study on Zoledronic acid,
the active ingredient in Zometa. The email discusses what NPC learned from the study on dosing
regimes, and references Zometa or several different occasions. NPC can attempt to demonstrate
to the jury through cross-examination why the email is not relevant.
X. NPC’s omnibus motion in limine is granted, in part, and denied, in part.
A) To the extent some of these documents are the same as those set forth in
Section VII, this Court rules consistent with those prior rulings. Further, only those
portions of the “White Paper” underlined by Dr. Tarassoff, and then sent on with
comments to the rest of the group are admissible as admissions by a party opponent. All
of the remaining out-of-court comments made by the panel of physicians and oral
surgeons regarding NPC’s draft “White Paper” on ONJ are excluded as hearsay.
B) NPC’s motion to exclude testimony as to Dr. Noopur Raje is granted. Plaintiff
may seek reconsideration at trial if necessary, but must ensure that issues are brought to
the Court’s attention first.
C) After withdrawal of the offer of evidence, NPC’s motion seeking to exclude
“Recommendations from the Osteonecrosis of the Jaw Advisory Panel” is denied as
D) NPC’s motion seeking to exclude a statement made by Dr. Jack Gotcher at the
Annual AAOMS meeting in September 2005 is granted. If plaintiff seeks to offer this
evidence for impeachment purposes at trial, she must first bring it to the Court’s
E) NPC’s motion to exclude sales and marketing materials is denied. Plaintiff
must lay the proper foundation, and the materials must be those from October 21, 2004,
F) NPC’s motion to exclude testimony or evidence that NPC misled, deceived, or
defrauded FDA about Zometa is denied. However, Dr. Parisian cannot testify as to the
subjective state of mind of anyone at NPC. Dr. Parisian will be allowed to testify
consistent with the Court’s ruling on the Daubert motion..
1. Motion to exclude evidence that articles concerning bisphosphonates in
medical journals were actually “ghostwritten” by companies, including NPC, is
granted consistent with prior rulings. Plaintiff further indicated at pretrial
conference she had no intention of offering such evidence at trial.
2. NPC’s motion to exclude evidence concerning foreign regulatory
actions or materials is granted. However, the Court reserves ruling on whether the
Australian email is admissible. The January 29, 2003 Epstein email with regard
to the Japanese study is admissible as set forth above.
3. NPC’s motion to exclude discovery disputes is granted. If there are any
discovery disputes that parties want to raise in the presence of the jury, the parties
are to discuss the issue with the Court first, out of the hearing of the jury.
4. NPC’s motion seeking to exclude characterization of NPC counsel in a
manner that could prejudice NPC is moot. Plaintiff has assured the Court she has
no intention of characterizing defense counsel in this manner.
5. NPC’s motion seeking to exclude reference to drug companies as
having an incestuous relationship with the FDA is granted. Plaintiff assures the
Court she has no intention of using the term “incestuous relationship” at trial.
Nevertheless, the Court specifically directs Dr. Parisian not to make this specific
statement. However, Dr. Parisian may discuss the type of relationship that exists
between the FDA and drug companies.
6. NPC’s motion seeking to exclude reference to Dr. Parisian as the
“former Chief Medical Officer” is granted, in part. Plaintiff may not assert that
Dr. Parisian was “the” former Chief Medical Officer of the FDA, but may assert
she was “a” former Chief Medical Officer of the FDA.
7. NPC’s motion seeking to exclude reference to dental pain that jurors
may have experienced and the treatment they received is denied. Plaintiff is
advised not to go too far with this type of reference. The Court will entertain an
objection if appropriate at trial.
8. NPC’s motion seeking to exclude expert opinions which may be
offered in an attempt to allege “moral obligations” or “legal conclusions” is
granted. This ruling is granted subject to relevant prior rulings on this issue,
including the testimony of Dr. Parisian.
9. NPC’s motion seeking to exclude evidence or argument regarding
regulatory enforcement or interactions between FDA and NPC concerning drugs
other than Aredia or Zometa is denied.
10. NPC’s motion seeking to exclude references to Dr. Marx’s lack of
compensation for his testimony is denied.
11. NPC’s motion seeking to exclude reference to NPC’s corporate
structure or the fact that NPC is based in Switzerland is granted, in part, and
denied, in part. Plaintiff cannot make inappropriate argument referencing that this
is a Swiss company and that “they are not one of us”; however, there is no basis
for the parties to redact or alter any testimony relating to the fact that NPC is a
corporation based in Switzerland for this purpose.
12. NPC’s motion seeking to exclude reference to other litigation
involving bisphosphonates is granted, in part, and denied, in part. The parties
should avoid undue reference to other litigation. However, it may be necessary to
reference sworn testimony from other litigation during trial, particularly during
cross-examination. The parties should proceed consistent with the direction
provided by the Court during the pretrial conference.
IT IS SO ORDERED. [142, 147]
Dated this 8th day of March, 2012, at Jefferson City, Missouri.
Matt J. Whitworth
MATT J. WHITWORTH
United States Magistrate Judge
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