Kruszka et al v. Novartis Pharmaceuticals Corporation
Filing
317
ORDER. 1. Plaintiffs' Motion to Enforce the Pretrial Scheduling Order (Doc. No. 211 ) is GRANTED IN PART AND DENIED IN PART as follows and consistent with the Court's rulings from the bench and its Memorandum Opinion and Order on summary judgment (Doc. No. 202): a. Plaintiffs motion is GRANTED to the extent Plaintiffs seek to preclude Defendant from pursuing the depositions of Mr. Osland and McKesson Corporation. Defendants may not take these depositions, however, the Court reserve s the right to order any de bene esse depositions on this matter should they become necessary over the course of trial. b. Plaintiffs' motion is DENIED to the extent that Plaintiffs are precluded from arguing the Plaintiff Candice Kruszka (Kruzs ka) received infusions of name brand Aredia after January 2002, or after such time as Aredia was no longer supplied to the Mercy Medical Center in Iowa as reflected in the Mckesson Sales Report. c. Plaintiffs' motion is DENIED to the extent tha t the Court deems admissible the McKesson Sales Report attached to the declaration of Steve Lewis as a business record under Federal Rule of Evidence 803(6). d. The Court expressly reserves the right to rule once all submissions are made by the parti es on Defendants Motion for Discovery Sanctions (Doc. No. 310 ). However, irrespective of the Courts ruling on Defendants motion for discovery sanctions pending before the Court, there are evidentiary implications relating to the complaint that was filed by Kruszka against generic pamidronate manufacturers Bedford Laboratories and APP Pharmaceuticals in 2011, In re: Pamidronate Prods. Liab. Litig., MDL No. 09-md-2120 (E.D.N.Y.) (the lawsuit against Generic Manufacturers), that will arise during the trial. (See order for additional information.)(Written Opinion). Signed by Judge Donovan W. Frank on 7/23/2014. (BJS)
UNITED STATES DISTRICT COURT
DISTRICT OF MINNESOTA
Candice Kruszka and Alan Kruszka,
Civil No. 07-2793 (DWF/JJK)
Plaintiffs,
v.
ORDER
Novartis Pharmaceuticals Corporation,
Defendant.
_______________________________________________________________________
John A. Girardi, Esq., and Molly B. Weber, Esq., Girardi & Keese; John J. Vecchione,
Esq., Valad & Vecchione PLLC; Yvonne M. Flaherty, Esq., Elizabeth R. Odette, Esq.,
and Robert K. Shelquist, Esq., Lockridge, Grindal, Nauen, PLLP, counsel for Plaintiffs.
Donald R. McMinn, Esq., Katharine R. Latimer, Esq., and Peter J. Skalaban, Jr., Esq.,
Hollingsworth LLP; Amy R. Fiterman, Esq., Christine R. M. Kain, Esq., Demoya R.
Gordon, Esq., James A. O’Neal, Esq., Joseph M. Price, Esq., Linda S. Svitak, Esq., and
M. Joseph Winebrenner, Esq., Faegre Baker Daniels LLP, counsel for Defendant.
_______________________________________________________________________
This matter came before the Court for pretrial hearing on July 16, 2014.
Consistent with, and in addition to the Court’s rulings and remarks from the bench, and
based upon the memoranda, pleadings, and arguments of counsel, and the Court having
reviewed the contents of the file in this matter and being otherwise duly advised in the
premises, the Court hereby enters the following:
ORDER
1.
Plaintiffs’ Motion to Enforce the Pretrial Scheduling Order (Doc.
No. [211]) is GRANTED IN PART AND DENIED IN PART as follows and consistent
with the Court’s rulings from the bench and its Memorandum Opinion and Order on
summary judgment (Doc. No. 202):
a.
Plaintiffs’ motion is GRANTED to the extent Plaintiffs seek
to preclude Defendant from pursuing the depositions of Mr. Osland and
McKesson Corporation. Defendants may not take these depositions,
however, the Court reserves the right to order any de bene esse depositions
on this matter should they become necessary over the course of trial.
b.
Plaintiffs’ motion is DENIED to the extent that Plaintiffs are
precluded from arguing the Plaintiff Candice Kruszka (“Kruzska”) received
infusions of name brand Aredia® after January 2002, or after such time as
Aredia® was no longer supplied to the Mercy Medical Center in Iowa as
reflected in the Mckesson Sales Report.
c.
Plaintiffs’ motion is DENIED to the extent that the Court
deems admissible the McKesson Sales Report attached to the declaration of
Steve Lewis as a business record under Federal Rule of Evidence 803(6).
d.
The Court expressly reserves the right to rule once all
submissions are made by the parties on Defendant’s Motion for Discovery
Sanctions (Doc. No. [310]). However, irrespective of the Court’s ruling on
Defendant’s motion for discovery sanctions pending before the Court, there
are evidentiary implications relating to the complaint that was filed by
Kruszka against generic pamidronate manufacturers Bedford Laboratories
and APP Pharmaceuticals in 2011, In re: Pamidronate Prods. Liab. Litig.,
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MDL No. 09-md-2120 (E.D.N.Y.) (the “lawsuit against Generic
Manufacturers”), that will arise during the trial.
2.
Defendant’s Motion in Limine to Exclude Evidence of 2006 Mayo Clinic
Consensus Statement (Doc. No. [220]) is GRANTED IN PART AND DENIED IN
PART as follows:
a.
The Court concludes that to the extent Plaintiffs seek to
introduce the 2006 Mayo Consensus Statement to show what physicians
would have done at the time of Kruszka’s treatment, or that the guidelines
themselves would have been released earlier, the evidence is presumptively
inadmissible pursuant to the Court’s Article 4 and Article 7 analysis.
b.
However, assuming that proper foundation is established
pursuant to Rule 104 of the Federal Rules of Evidence establishing notice
to or knowledge on the part of Novartis and other entities and individuals
within the medical pharmaceutical community, and if offered for issues
other than those outlined in Section (a), above, examination of Plaintiffs’
and Defendant’s witnesses as it relates to the 2006 Mayo Clinic Consensus
Statement shall be permitted, subject to whatever objections respective
counsel make as each witness is questioned. The Court expressly reserves
ruling on any Rule 803(18), Rule 403, or Rule 703 issues.
c.
Absent further ruling by the Court, there shall be no reference
to the 2006 Mayo Consensus Statement in the opening statements of either
Plaintiffs or Defendant.
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3.
Defendant’s Motion in Limine to Exclude Certain Documents Containing
Hearsay Statements (Doc. No. [226]) is GRANTED IN PART AND DENIED IN
PART as follows:
a.
Subject to foundation being established, the statements made
in reference to the drafting process of the “White Paper” from Dr. Schubert
and Dr. Huff shall be presumptively admissible on one or both of the
following grounds:
i.
In the event the statements are introduced for
the truth of the matter asserted, they shall be received as a
business record pursuant to Rule 803(6).
ii.
In the event the statements are received as non-
hearsay, in other words regardless of the truth or falsity, for
the purpose of showing what Novartis was told, and what, if
any, reaction Novartis had to these statements, regardless of
whether they were true or false.
iii.
In the event the statements are received, they
will not be received as pattern or habit evidence pursuant to
Rule 404(b) or as admissions of a party opponent.
b.
Counsel for the Plaintiffs stated at the pretrial hearing on
July 16, 2014, that Plaintiffs will not be offering the September 2005
statement by Dr. Gultcher at an AAOMS Annual Meeting.
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c.
However, absent further ruling by the Court, there shall be no
reference to the edits to or comments regarding the so-called “White Paper”
in the opening statements of either Plaintiffs or Defendant.
d.
The Court reserves the right to make additional rulings on
issues related to the “White Paper” and edits and comments to the “White
Paper” at trial.
4.
Defendant’s Motion in Limine to Exclude Speculative Testimony
Regarding Other Treater’s Knowledge and State of Mind (Doc. No. [233]) is GRANTED
IN PART AND DENIED IN PART as follows:
a.
The motion is DENIED to the extent Defendant seeks to
exclude the testimony of Dr. Kraut.
b.
Subject to foundation being established, testimony by Dr.
Kraut relating to the general understanding of the dental profession as it
related to ONJ at the time of Kruszka’s treatment is presumptively
admissible.
c.
The Court reserves the right to limit the scope of Dr. Kraut’s
testimony at trial, if necessary.
d.
However, any state of mind testimony by Dr. Kraut relating
to what other doctors did or would have done is presumptively
inadmissible.
5.
Defendant’s Motion in Limine to Exclude Evidence Related Only to
Zometa® (Doc. No. [246]) is DENIED as follows:
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a.
The motion is DENIED to the extent Defendant seeks to
exclude any and all documents and testimony relating only to Zometa®.
b.
The Court reserves the right to examine Zometa®-only
documents on a case-by-case basis at trial.
c.
The Court notes the parties have agreed to not offer the
“Zometa Turnaround Plan” which the Court otherwise deems inadmissible
pursuant to Article 4.
6.
Defendant’s Motion in Limine to Exclude May 5, 2003 Email from Stefano
Fratarcangeli to David Epstein (Doc. No. [252]) is DENIED as follows:
a.
Subject to foundation being established, the email shall be
presumptively admissible. The Court makes this decision pursuant to Rule
104 and Rule 403, finding that the issue of notice and knowledge of
Novartis regarding bisphosphonate-related ONJ is relevant and not unduly
prejudicial.
b.
However, there will be no reference to the email in Plaintiffs’
opening statement.
7.
Defendant’s Motion in Limine to Exclude Labeling and Dosing Issues
Controlled by FDA (Doc. No. [258]) is DENIED as follows:
a.
The Court declines to preclude Plaintiffs from offering
evidence that Defendant should have changed the FDA-approved label by
recommending a different dosing regimen, consistent with the analysis of
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the court in Dopson-Troutt v. Novartis Pharms. Corp., 975 F. Supp. 2d
1209, 1217-18 (M.D. Fla. 2013).
b.
The Court reserves the right to exclude this evidence and
testimony at trial, on a case-by-case basis.
8.
Defendant’s Motion in Limine to Exclude Evidence Post-Dating Plaintiff’s
Last Dose of NPC’s Product, Brand-Name Aredia® (Doc. No. [264]) is GRANTED IN
PART AND DENIED IN PART as follows:
a.
The motion is DENIED as premature.
b.
The Court declines to draw an absolute time boundary for all
evidence post-dating Kruszka’s last dose of name-brand Aredia®. Certain
documents after January 2002 could bear on relevant issues. For example,
certain documents could have been developed before, but published after,
Kruzska’s last dose. Certain documents may also tie to Aredia® insofar as
questions of half-life are at issue.
c.
The Court reserves the right to exclude this evidence and
testimony at trial on a case-by-case basis.
9.
Plaintiffs’ Omnibus Motion in Limine to Exclude Certain Subjects of
Evidence at Trial (Doc. No. [280]) is GRANTED IN PART AND DENIED IN PART
as follows:
a.
Plaintiffs’ Motion with respect to Category 1 (all evidence,
argument, comment, references, or eliciting any testimony which expands
the use or efficacy of Aredia® or Zometa® beyond the FDA approved
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indications at the time Mrs. Kruszka received the drugs as specified within
the “four corners” of the package insert/label, including but not limited to
statements calling Aredia® a “cancer drug,” a “wonder drug,” a “miracle
drug,” that Aredia® “prolongs life,” “extends life,” is “a pain reliever,”
“cures cancer,” “fights cancer,” or any statement that Mrs. Kruszka’s life
has been extended by Aredia®) is GRANTED IN PART AND DENIED
IN PART as follows:
i.
Defendant is not limited to the “four corners”
of the package insert/label with respect to testimony or
evidence of the efficacy or benefits of Aredia®, but the Court
reserves the right to exclude this evidence and testimony at
trial on a case-by-case basis.
ii.
However, Defendant is precluded from using
the following phrases as they relate to Aredia®: “wonder
drug,” “miracle drug,” “prolongs life,” “extends life,” and
“cures cancer,” which are presumptively inadmissible under
Article 4.
iii.
Subject to foundation being established, the
Court concludes that the statements “improves quality of
life,” “decreases potential skeletal related events,” and “fights
cancer” are presumptively admissible.
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iv.
The admissibility of this category of testimony
will relate in substantial part to the treating physicians’
testimony and evidence presented via medical records.
b.
Plaintiffs’ Motion with respect to Category 2 (any evidence,
argument, comment, or testimony suggesting that Plaintiffs’ damages may
be offset by the benefits of Aredia®) is GRANTED IN PART AND
DENIED IN PART as follows:
i.
Defendant is precluded from arguing that
damages may be offset by the benefits of Aredia®. The
Court concludes that the benefits sought by Defendant are not
the type contemplated by the Restatement (Second) of Torts
§ 902 justifying equitable relief. Even if the benefits at issue
were of the kind contemplated by the Restatement (Second)
of Torts § 902, on the record before the Court they would be
entirely speculative.
ii.
However, this ruling is to be consistent with the
Court’s decision above (Section 9.a.) as it relates to Plaintiffs’
Motion with respect to Category 1 and the admissibility of
testimony and evidence relating to efficacy and benefits of
Aredia® generally.
c.
Plaintiffs’ Motion with respect to Category 3 (any evidence,
whether direct or indirect, that Plaintiffs are covered by some form of
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insurance for the incident in question) is DENIED AS MOOT and in
accordance with the agreement of the parties.
d.
Plaintiffs’ Motion with respect to Category 4 (any evidence of
irrelevant prior personal history, specifically that they filed for
reorganization in Bankruptcy Court) is GRANTED as follows:
i.
Testimony and all other evidence relating to
Kruszka’s personal bankruptcy filings are presumptively
inadmissible pursuant to Rule 104 and Article 4, particularly
pursuant to Rule 403.
ii.
The Court also declines to assert the doctrine of
judicial estoppel with respect to Plaintiffs’ bankruptcy
proceedings as Defendant has failed to adequately meet the
factors or other considerations outlined in Stallings v.
Hussmann Corp., 447 F.3d 1041, 1047 (8th Cir. 2006).
10.
Defendant’s Objections to Plaintiffs’ Designation of Prior Sworn
Testimony for Dr. Marx, Dr. Salvatore Ruggerio, and Ray Watkins (Doc. No. [302]) is
GRANTED IN PART AND DENIED IN PART as follows:
a.
Plaintiffs shall present any testimony from Dr. Marx live.
Dr. Marx is one of Plaintiffs’ key witnesses. This cases deviates from most
cases where the Court receives early requests to accommodate witnesses
when there is concern over their availability, particularly for key witnesses.
Here, the Court notes that Plaintiffs made no request for a continuance of
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the trial or for different trial dates based on the unavailability of any
witnesses. The decision of the court is also made pursuant to Rule 102 of
the Federal Rules of Evidence and Rules 1 and 43 of the Federal Rules of
Civil Procedure.
b.
Plaintiffs may present testimony by Dr. Ruggerio, but it shall
be limited to his testimony relating to his interactions and conversations
with Novartis and its reactions, subject to other evidentiary determinations
by the Court. The Court notes that evidence on this issue may or may not
necessitate the use of Dr. Ruggerio’s deposition testimony.
c.
Plaintiffs may not present the testimony of Mr. Watkins. The
decision of the court is also made pursuant to Rule 102 and Article 4 of the
Federal Rules of Evidence and Rules 1 and 43 of the Federal Rules of Civil
Procedure.
d.
Defendant’s request to submit a reply memorandum (Doc.
No. [309]) is denied as moot in light of the Court’s decision above.
11.
Plaintiffs’ Request for the Court to Take Judicial Notice of Voluntary
Dismissal of Lawsuit Against Generic Manufacturers Signed by Counsel for Defendant
(Doc. No. [305]) is GRANTED IN PART AND DENIED IN PART as follows:
a.
Subject to foundation being established, the Court concludes
that the testimony regarding the fact of and information relating to the filing
of the lawsuit against Generic Manufacturers will be presumptively
admissible.
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The fact of a dismissal is of little probative value in a civil jury trial
without an explanation as to what a dismissal represents, including but not
limited to the factual and legal reasons for dismissal, all of which raise
Rule 403 issues.
b.
Absent further ruling by the Court, there shall be no reference
to the lawsuit against Generic Manufacturers in the opening statements of
either Plaintiffs or Defendant.
c.
The Court reserves the right to limit the scope of testimony at
trial, if necessary. The Court expects parties to make a Rule 104 offer of
proof prior to referencing the lawsuit.
Opening Statements
12.
Plaintiffs and Defendant shall each be allotted 45 minutes for opening
statements.
Dated: July 23, 2014
s/Donovan W. Frank
DONOVAN W. FRANK
United States District Judge
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