Kruszka et al v. Novartis Pharmaceuticals Corporation
Filing
219
MEMORANDUM OPINION AND ORDER. Plaintiffs Motion to Exclude Expert Testimony of Dr. Carol Ann Huff 72 is GRANTED IN PART and DENIED IN PART; Plaintiffs Motion to Exclude Testimony of Dr. Dale A. Baur 81 is GRANTED to the extent he seeks to testif y on the following topics: (1) whether the benefits of bisphosphonate therapy outweigh the risks; (2) whether bisphosphonate therapy improves quality of life; and (3) whether the warnings disseminated with Novartiss bisphosphonate drugs were effecti ve, timely, or appropriate; Plaintiffs Motion to Exclude Expert Testimony Relating to Alleged FDA Compliance and/or Novartiss State of Mind 97 is GRANTED IN PART and DENIED IN PART; Defendants Motion to Exclude Expert Testimony of Dr. Suzanne Paris ian 46 is GRANTED IN PART and DENIED IN PART consistent with the Courts detailed instructions in this Memorandum Opinion; Defendants Motion to Exclude Testimony of Plaintiffs Expert Dr. Keith Skubitz 54 is DENIED AS MOOT; Defendants Motion to Exc lude Expert Testimony of Plaintiffs Expert, Prof. Wayne Ray 56 is DENIED AS MOOT; Defendants Motion to Exclude Expert Testimony of Dr. James Vogel 79 is GRANTED IN PART and DENIED IN PART; Plaintiffs Motion in Limine to Exclude Testimony of Dupli cative Defense Experts 43 is DENIED WITHOUT PREJUDICE AS MOOT; and Plaintiffs Motion to Unseal the Second Declaration of Robert G. Germany and Exhibits 1 - 182 109 is GRANTED IN PART and DENIED IN PART. (See Memorandum Opinion and Order for details.) (Written Opinion.) Signed by Judge Donovan W. Frank on 07/01/2014. (RLB)
UNITED STATES DISTRICT COURT
DISTRICT OF MINNESOTA
Candice Kruszka and Alan Kruszka,
Civil No. 07-2793 (DWF/JJK)
Plaintiffs,
v.
MEMORANDUM
OPINION AND ORDER
Novartis Pharmaceuticals Corporation,
Defendant.
_______________________________________________________________________
John A. Girardi, Esq., Molly B. Weber, Esq., and Samuel Ranchor Harris, III, 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; and John J. Beins, Esq., Beins Goldberg & Hennessey LLP,
counsel for Plaintiffs.
Donald R. McMinn, Esq., Katharine Ruth 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.
_______________________________________________________________________
INTRODUCTION
This matter is before the Court on the following motions: (1) Plaintiffs Candice
Kruszka’s (“Kruszka”) and her husband Alan Kruszka’s (“Mr. Kruszka”) (collectively,
“Plaintiffs”) Motion In Limine to Exclude Testimony of Duplicative Defense Experts
against Defendant Novartis Pharmaceuticals Corporation (“Novartis” or “Defendant”)
(Doc. No. 43); (2) Plaintiffs’ Motion to Exclude Expert Testimony of Dr. Carol Ann Huff
(Doc. No. 72); (3) Plaintiffs’ Motion to Exclude Testimony of Dr. Dale A. Baur (Doc.
No. 81); (4) Plaintiffs’ Motion to Exclude Expert Testimony Relating to Alleged FDA
Compliance and/or Novartis’s “State of Mind” (Doc. No. 97); (5) Plaintiffs’ Motion to
Unseal the Second Declaration of Robert G. Germany and Exhibits 1-182 (Doc.
No. 109); (6) Defendant’s Motion to Exclude Expert Testimony of Dr. Suzanne Parisian
(Doc. No. 46); (7) Defendant’s Motion to Exclude Testimony of Plaintiffs’ Expert
Dr. Keith Skubitz (Doc. No. 54); (8) Defendant’s Motion to Exclude Expert Testimony of
Plaintiffs’ Expert Professor Wayne Ray (Doc. No. 56); and (9) Defendant’s Motion to
Exclude Expert Testimony of Dr. James Vogel (Doc. No. 79). For the reasons set forth
below, the Court grants in part and denies in part the motions.
BACKGROUND
The facts of this case have been fully set forth in the Court’s May 19, 2014
Amended Memorandum Opinion and Order addressing summary judgment and two
Daubert motions (“May 2014 Order”). (Doc. No. 202 at 2-9.) Thus, the Court briefly
summarizes the facts of this case as follows: This case relates to claims that Kruszka
suffered osteonecrosis of the jaw (“ONJ”)—also known as dead jaw bone—as a result of
using Novartis’s product Aredia® (“Aredia”). Aredia is a bisphosphonate drug that is
used to treat multiple myeloma, a form of blood cancer from which Kruszka suffered.
Plaintiffs refer to Kruszka’s ONJ as bisphosphonate-induced osteonecrosis of the jaw
(“BIONJ”). 1
1
BONJ, BRONJ, BIONJ, and BON are similar acronyms that have all been used to
describe ONJ seen in bisphosphonate users. The Court will use BRONJ and BIONJ
interchangeably. (See Doc. No. 75 at 3 n.1.)
2
In the May 2014 Order, the Court granted in part and denied in part Defendant’s
motion for summary judgment. The Court also allowed at least some testimony from
Plaintiffs’ case-specific retained and non-retained expert witnesses Drs. Gertz, Juhlin,
and Kraut, and also from Plaintiffs’ expert Dr. Marx. Both parties now seek to exclude
the expert testimony of a number of additional potential expert witnesses under Daubert
and the relevant Federal Rules of Evidence. Plaintiffs additionally seek the unsealing of
certain exhibits and a corresponding declaration and have also moved in limine to
exclude the testimony of duplicative defense experts.
DISCUSSION
I.
Daubert Motions
A.
Legal Standard
Before accepting the testimony of an expert witness, the trial court is charged with
a “gatekeeper” function of determining whether an opinion is based on sound, reliable
theory, or whether it constitutes rank speculation. Daubert v. Merrell Dow Pharms., Inc.,
509 U.S. 579, 589-90 (1993). In Daubert, the United States Supreme Court imposed an
obligation on trial court judges to ensure that scientific testimony is not only relevant, but
also reliable under the Federal Rules of Evidence. Id. at 579.
Proposed expert testimony must meet three prerequisites to be admissible under
Federal Rule of Evidence 702. Lauzon v. Senco Prods., Inc., 270 F.3d 681, 686 (8th
Cir. 2001). “First, evidence based on scientific, technical, or other specialized knowledge
must be useful to the finder of fact in deciding the ultimate issue of fact.” Id. “[I]t is the
responsibility of the trial judge to determine whether a particular expert has sufficient
3
specialized knowledge to assist jurors in deciding the specific issues in the case.”
Wheeling Pittsburgh Steel Corp. v. Beelman River Terminals, Inc., 254 F.3d 706, 715
(8th Cir. 2001). Second, the proposed expert must be qualified. Lauzon, 270 F.3d at 686.
Third, the proposed evidence must be reliable. Id. The proponent of the expert testimony
bears the burden to prove its admissibility by a preponderance of the evidence. Daubert,
509 U.S. at 592 n.10.
In determining whether the proposed expert testimony is reliable, the Court
considers: (1) whether the theory or technique can be and has been tested; (2) whether
the theory or technique has been subjected to peer review and publication; (3) the known
rate of potential error; and (4) whether the theory has been generally accepted. Id. at
593-94. The purpose of these requirements “is to make certain that an expert, whether
basing testimony upon professional studies or personal experience, employs in the
courtroom the same level of intellectual rigor that characterizes the practice of an expert
in the relevant field.” Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137, 152 (1999).
In Kumho Tire, the Supreme Court concluded that “the trial judge must have
considerable leeway in deciding in a particular case how to go about determining whether
particular expert testimony is reliable.” Id. In other words, “a trial court should consider
the specific factors identified in Daubert where they are reasonable measures of the
reliability of expert testimony.” Id. “The objective of that requirement is to ensure the
reliability and relevance of expert testimony.” Id.
The Court’s focus should be on whether the testimony is grounded in scientifically
valid reasoning or methodology. United States v. Dico, Inc., 266 F.3d 864, 869 (8th Cir.
4
2001). “As a general rule, the factual basis of an expert opinion goes to the credibility of
the testimony, not the admissibility, and it is up to the opposing party to examine the
factual basis for the opinion in cross-examination. Only if the expert’s opinion is so
fundamentally unsupported that it can offer no assistance to the jury must such testimony
be excluded.” Bonner v. ISP Techs., Inc., 259 F.3d 924, 929-30 (8th Cir. 2001) (internal
citation omitted).
B.
Plaintiffs’ Motion to Exclude Expert Testimony of Dr. Carol Ann Huff
1.
Background
Dr. Carol Ann Huff (“Dr. Huff”) is an oncologist who is certified in internal
medicine and oncology. (Doc. No. 150 (“Huff Exs. Index”) ¶ 1, Ex. 1 (“Huff Report”).)
She is a faculty member at Johns Hopkins University where she began working in 1997
and where she has been in the Department of Oncology as an Associate Professor of
Medicine and Director of the Department’s multiple myeloma program since 2001. (Id.)
She is a member of a number of cancer-related associations and committees. (Id.)
Dr. Huff has worked with a number of multiple myeloma patients over the years. (Id.)
Dr. Huff is involved in clinic research in the multiple myeloma field and has authored or
co-authored several book chapters, as well as more than twenty peer-reviewed scientific
articles and eighteen abstracts. (Id.) Novartis proffers Dr. Huff to opine on issues
relating to myeloma and its treatment, including the effects of its treatments and
therapies. In part, Dr. Huff’s expert report opines that osteomyelitis cannot be ruled out
as a cause of Kruszka’s jaw problems, and that Kruszka benefitted from her Aredia
therapy.
5
2.
Analysis
Plaintiffs seek to exclude Dr. Huff’s specific causation testimony. Plaintiffs make
two main arguments. First, Plaintiffs argue that Dr. Huff is unqualified to render the
opinions she proffers, particularly any opinion regarding the specific cause of Kruszka’s
jaw problems, because she is an oncologist and is not an oral maxillofacial surgeon or
dentist who works with osteomyelitis or ONJ. Second, Plaintiffs argue that Dr. Huff
cannot proffer opinions on quality-of-life improvements and special benefits associated
with Aredia. Separately, Plaintiff seeks to exclude Dr. Huff’s declaration that Novartis
included as an attachment to its opposition to Plaintiffs’ Daubert motion on Dr. Huff
(“Huff Decl.”). The Court addresses each issue below.
As an initial matter, the Court concludes that Dr. Huff is qualified to opine on
myeloma treatment and therapies and their impact. A medical doctor need not have
treated the specific disease at issue to opine on medical matters relating to that condition.
Dittrich-Bigley v. Gen-Probe, Inc., Civil No. 11-17-62, 2013 WL 3974107, at *7
(D. Minn. July 31, 2013) (finding that despite not being an expert on treating
osteomyelitis specifically, a pediatrician was sufficiently qualified to opine on the cause
of an infant’s osteomyelitis). Dr. Huff is highly qualified as an oncologist and can
therefore opine on issues relating to her oncological work, including treating myeloma,
prescribing Aredia and Zometa® 2 (“Zometa”) to treat myeloma, the immunosuppressive
effect of myeloma-related treatments, and the specific effects of Aredia treatment. This
2
Zometa is also a bisphosphonate used to treat cancer patients and is manufactured
by Novartis. Kruszka did not receive Zometa.
6
also includes opining on Kruszka’s clinical course of treatment. Dr. Huff regularly treats
the cancer at issue here through a number of different methods and therapies, one of
which is by regularly prescribing Aredia and Zometa. Dr. Huff has also written on and
reviewed the key medical literature relating to complications associated with myeloma
and its therapies.
Additionally, because Dr. Huff is qualified to opine on cancer treatments,
particularly treatments with Aredia, she is similarly qualified to address issues of
improved quality of life for patients, as well as the benefits of such therapies. To the
extent that her opinions on Kruszka are grounded in her expertise with respect to
myeloma treatments and therapies, she can also opine on Kruszka specifically. Dr. Huff
need not have treated Kruszka to apply her expertise to Kruszka’s medical records.
Dr. Huff bases her opinions regarding quality of life on peer-reviewed literature that this
Court determines to be of sufficient reliability. (See Huff Report.) Her opinions are also
supported by reliable clinical trials and her own clinical practice experience. (See id.)
Dr. Huff, however, cannot opine on the diagnosis of osteomyelitis or ONJ, or
issues relating to dental training. Her expertise reaches the effects of bisphosphonate
treatments and other treatments, but this is separate from addressing the cause of
Kruszka’s jaw conditions. Thus, the Court limits Dr. Huff’s specific causation testimony
as the court did in Deutsch v. Novartis Pharm. Corp., 768 F. Supp. 2d 420 (E.D.N.Y.
2011). In that case, the court held that the specific causation expert could appropriately
address the existence of alternative risk factors, and whether those factors indicate that a
“particular opinion on causation cannot be determined,” not what caused the patient’s
7
specific jaw problems. Deutsch, 768 F. Supp. 2d at 483-84. Put another way, Dr. Huff’s
testimony can include opinions rebutting specific causation testimony so long as it is tied
to her work and expertise as an oncologist who treats and also conducts research relating
to myeloma patients. See id.
The strength and accuracy of Dr. Huff’s opinions with respect to issues arising
from and related to myeloma therapies are appropriately tested through crossexamination. The Court agrees with Novartis that Dr. Huff’s testimony is not rendered
unreliable simply because another doctor may testify to different possible causes. This is
a matter that goes to credibility and not admissibility. Loudermill v. Dow Chem. Co., 863
F.2d 566, 569 (8th Cir. 1988) (“The relative skill or knowledge of an expert goes to the
weight of that witness’s testimony, not its admissibility.”). Similarly, the bulk of
Plaintiffs’ arguments for the exclusion of Dr. Huff’s testimony, for example those
relating to whether immunosuppression is meaningful in this context, whether Aredia is
in fact beneficial, and whether the benefits are to be considered in composite rather than
independently, all go to credibility and weight.
With respect to the Huff Declaration, the Court agrees with Plaintiffs that it is not
properly before the Court. The Huff Declaration includes information not contained in
the Huff Report. Any such additional expert information must come before the Court in
the form of a supplemental or rebuttal expert report and is therefore improper and
untimely as currently filed. If the opinions Dr. Huff offers are beyond the scope of her
expert report, they are inadmissible as beyond the scope of Rule 26. The Court, however,
8
notes that the existence of the Huff Declaration does not impact its decision above as to
the admissibility of Dr. Huff’s testimony.
C.
Plaintiffs’ Motion to Exclude Testimony of Dr. Dale A. Baur
1.
Background
Dr. Dale A. Baur (“Dr. Baur”) is a licensed dentist and board-certified oral and
maxillofacial surgeon. (Doc. No. 50 (“Odette Aff. on Duplicative Experts”) ¶ 3, Ex. 1
(“Baur Report”) at 1.) Dr. Baur received his dental degree in 1980, completed his
residency in oral and maxillofacial surgery in 1997, and completed a fellowship in 2001.
(Id.) He is currently an Associate Professor and Chair of the Department of Oral and
Maxillofacial Surgery at Case Western Reserve University. (Id.) Dr. Baur is also the
Division Chief of Oral and Maxillofacial Surgery at University Hospitals/Case Medical
Center in Cleveland, Ohio. (Id.) Dr. Baur is involved in a number of dental societies and
has published approximately thirty-two peer-reviewed articles and has authored nine
book chapters. (Id.) With respect to bisphosphonates and ONJ, he has presented seven
times and has presented a case series on the topic of ONJ. (Id.) Finally, he has treated
cancer and non-cancer patients with ONJ who did not have a history of bisphosphonate
use. (Id.)
Novartis proffers Dr. Baur to opine on matters relating to his expertise as an oral
and maxillofacial surgeon.
2.
Analysis
Plaintiffs do not seek to exclude Dr. Baur’s testimony in its entirety, but instead
seek to exclude Dr. Baur’s opinions relating to: (1) whether the benefits of
9
bisphosphonate therapy outweigh the risks; (2) whether bisphosphonate therapy improves
quality of life; and (3) whether the warnings disseminated with Novartis’s
bisphosphonate drugs were effective, timely, and appropriate (including whether Kruszka
would have taken bisphosphonates if warned of its risks (proximate causation)).
Plaintiffs argue that Dr. Baur lacks sufficient qualifications to render the opinions
listed and also question the reliability of Dr. Baur’s opinions, arguing that they lack an
adequate factual and evidentiary basis. Specifically, Plaintiffs argue that because
Dr. Baur is not an oncologist and does not prescribe bisphosphonates, he cannot do a
risk-benefit analysis of bisphosphonate therapy. Additionally, Plaintiffs argue that
Dr. Baur’s background, experience, education, and training fail to establish his
qualification to opine on bisphosphonate warnings.
Dr. Baur is undoubtedly qualified to opine on ONJ as a dentist and oral and
maxillofacial surgeon with decades of experience working with patients with ONJ.
Plaintiffs do not dispute this. Dr. Baur is further qualified to opine on questions of
causation with respect to bisphosphonates and ONJ based on the presentations he has
made on that topic, his case series, and his review and knowledge of relevant scientific
literature and other relevant materials. (See Baur Report.)
This, however, does not qualify Dr. Baur to opine on bisphosphonates as an
independent topic. Dr. Baur presents no evidence that he has any degree of expertise on
bisphosphonates outside of their interaction with ONJ—he does not prescribe them, is not
an oncologist, and has not spoken on, researched, or written about bisphosphonates
specifically. The sole basis of Dr. Baur’s knowledge with respect to the risks and
10
benefits and quality-of-life impact of bisphosphonate therapy, and bisphosphonate
labeling 3 appears to be scientific literature. In fact, Novartis admits that Dr. Baur’s
opinions on these issues are largely based on his review of relevant scientific literature
(Doc. No. 155 at 7-9, 12) (“Dr. Baur has considered extensive relevant literature
published in the oral and maxillofacial surgery field . . .” and “Dr. Baur considered this
abundant medical and dental literature supporting his opinion.”) “[N]othing in either
Daubert or the Federal Rules of Evidence requires a district court to admit opinion
evidence that is connected to existing data only by the ipse dixit of the expert. A court
may conclude that there is simply too great an analytical gap between the data and the
opinion proffered.” Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997). Here, the
analytical gap is too great. Id. The mere reading of others’ articles on a treatment that is
outside of his expertise, though it may loosely connect to his work, is not enough to
qualify Dr. Baur on these subjects. In fact, Dr. Baur’s main expertise when it comes to
bisphosphonates is arguably patients who have jaw problems, but do not use
bisphosphonates. (See Baur Report.) Thus, Dr. Baur’s expertise is related to dental and
jaw conditions, not cancer therapies.
Accordingly, Plaintiffs’ motion to exclude the limited testimony of Dr. Baur is
granted only as it relates to the following opinions: (1) whether the benefits of
bisphosphonate therapy outweigh the risks; (2) whether bisphosphonate therapy improves
3
This extends to testimony relating to whether Kruszka would have taken
bisphosphonates even if warned of their risks (proximate causation). Dr. Baur was
neither her, nor anyone’s, prescribing or myeloma-treating physician.
11
quality of life; and (3) whether the warnings disseminated with Novartis’s
bisphosphonate drugs were effective, timely, or appropriate.
D.
Plaintiffs’ Motion to Exclude Expert Testimony Relating to Alleged
FDA Compliance and/or Novartis’s “State of Mind”
1.
Background
Dr. Janet B. Arrowsmith-Lowe (“Dr. Arrowsmith”) is the president of
Arrowsmith-Lowe Consulting, Inc. which is a drug, biologic, and device consulting firm.
(Doc. No. 50 (“Odette Aff. on Duplicative Experts”) ¶ 5, Ex. 3 (“Arrowsmith Report”) at
¶ I.) Dr. Arrowsmith received her M.D. in 1972 and completed her residency in 1982.
(Id.) She is board certified and licensed in internal medicine and is a member of a
number of associations and societies. (Id.) Dr. Arrowsmith worked at the National
Centers for Disease Control and Prevention (the “CDC”) from 1984 to 1986 and was
assigned to the Food and Drug Administration (the “FDA”). (Id.) In this role she worked
with the CDC and the FDA on epidemiologic investigations of reported adverse drug
events, among other things. (Id.) As a staff epidemiologist she monitored
post-marketing safety of marketed drugs. (Id.) As a medical review officer at the FDA,
Dr. Arrowsmith reviewed Investigational New Drug (“IND”) or Biological
Investigational New Drug (“BIND”) submissions and New Drug Applications (“NDAs”).
(Id.) Dr. Arrowsmith has published a number of peer-reviewed medical articles and has
co-authored book chapters addressing the FDA’s regulations and practices, with a focus
on pharmaceutical product safety. (Id.)
12
Dr. David W. Feigal (“Dr. Feigal”) is board certified in internal medicine and also
has a master’s degree in public health relating to epidemiology and biostatistics. (Odette
Aff. on Duplicative Experts ¶ 8, Ex. 6 (“Feigal Report”) at ¶ I.) Between 1992 and 1994,
Dr. Feigal held a number of senior positions at the FDA, including positions at the Center
for Drug Evaluation and Research, which is responsible for the review and approval of all
new drugs and the ongoing assessment of the quality, safety and effectiveness of
marketed drugs. (Id.) Dr. Feigal has also served on a number of FDA advisory
committees. (Id. at 2.) Additionally, Dr. Feigal has held senior positions at various
pharmaceutical companies. (Id. at 3.)
Novartis generally proffers Drs. Arrowsmith and Feigal to opine on the regulatory
framework within which pharmaceutical companies work when bringing new drugs to
market, the continued FDA monitoring of those drugs once approved, and the FDA’s
approval and post-market safety monitoring of Aredia and Zometa.
2.
Analysis
Plaintiffs seek to exclude the testimony of certain experts who proffer testimony
relating to the FDA regulation of the drugs Aredia and Zometa, and relating to NDAs and
clinical trials for Zometa. Plaintiffs have detailed the testimony of these experts as
follows:
Arrowsmith:
IND applications with FDA; NDAs with FDA;
FDA regulation of Aredia and Zometa; FDA safety
surveillance of Aredia and Zometa; timeliness and
adequacy of Zometa label changes and warnings;
post-marketing experience with ONJ; rebuttal of
Dr. Parisian (Plaintiffs’ FDA expert).
13
Feigal:
The New Drug Approval Process; INDs; NDA
Review; Post-marketing surveillance; Product
labeling; development of Aredia and Zometa;
post- marketing experience with ONJ and
development of a signal; label changes; rebuttal of
Dr. Parisian.
(Doc. No. 99 (citing Arrowsmith Report; Feigal Report).) Plaintiffs argue that
Drs. Arrowsmith and Feigal’s opinions amount to inadmissible opinions about the FDA
and Novartis’s state of mind. (Doc. No. 99 at 2.) 4
Novartis argues that their experts’ opinions are not intent or “state of mind”
opinions and are therefore admissible. Novartis also argues that their experts’ opinions
are distinguishable from the “state of mind” testimony presented by Plaintiffs’ expert
Dr. Parisian (see Section E, below).
The Court finds that testimony about the FDA and Novartis’s state of mind is not
appropriate as expert testimony. Expert testimony on “the intent, motives, or states of
mind of corporations, regulatory agencies and others have no basis in any relevant body
of knowledge or expertise.” Deutsch, 768 F. Supp. 2d at 442 (citing In re Rezulin Prods.
Liab. Litig., 309 F. Supp. 2d 531, 546 (S.D.N.Y. 2004)). Thus, Drs. Arrowsmith and
Feigal may not proffer an opinion relating to what individuals at Novartis or with the
FDA thought with respect to certain documents or about their motivations.
However, the Court agrees with Novartis that not all of Dr. Arrowsmith’s and
Dr. Feigal’s testimony relating to the FDA seeks to opine on “the intent, motives, or
4
Plaintiffs initially sought to exclude four experts in this Motion, however, two
have been withdrawn (Drs. Bunn and Bukowski). Therefore the Court only addresses
Drs. Arrowsmith and Feigal.
14
states of mind” of Novartis and the FDA. Dr. Feigal has knowledge of the FDA’s
regulation of prescription drugs and corresponding labeling and also has knowledge
about pharmaceutical company post-marketing surveillance programs. Dr. Arrowsmith
also has knowledge relating to FDA regulatory issues from her work at the FDA and her
consulting work regarding the FDA. Thus, both Drs. Arrowsmith and Feigal have the
expertise and experience to allow them to opine on the reasonableness of Novartis’s
interaction with the FDA and compliance with FDA regulations, including with respect to
labeling and warnings, and such testimony would be helpful to the trier of fact from a
regulatory perspective. See, e.g., Deutsch, 768 F. Supp. 2d at 465-66.
Testimony about the reasonableness of Novartis’s actions is different from
testimony including opinions about whether Novartis acted as a “good company,” which
the Court will not allow. In re Baycol Prods. Litig., 532 F. Supp. 2d 1029, 1069
(D. Minn. 2007) (“The question of corporate intent is one for the jury, not for an
expert.”). For example, should Dr. Arrowsmith seek to testify that Novartis acted
“thoroughly and diligently” when it investigated reports or acted “on its own initiative,”
such testimony is improper state of mind testimony—Drs. Arrowsmith and Feigal cannot
know whether or not this was the case from either the perspective of Novartis or the
FDA. In re Rezulin, 309 F. Supp. 2d at 547 (“Inferences about the intent or motives of
parties or others lie outside the bounds of expert testimony.”). Conversely, testimony that
Novartis acted in accordance with regulations or established procedure which reflects
diligence; or fact-based testimony that the FDA “found no fault with the company
conduct”; or testimony that opines on what the FDA or Novartis actually did, rather than
15
thought, are properly within the scope of admissible testimony. Remaining issues such as
Plaintiffs’ claim that the FDA never made a finding on adequacy are disputed issues of
fact that go to weight and not admissibility and are to be challenged on
cross-examination.
Thus, as with Dr. Marx (see Doc. No. 202 at 17-180) and Dr. Parisian (below), the
Court will not allow Drs. Arrowsmith and Feigal to testify to the state of mind, intent or
motives of Novartis or the FDA. To the extent that certain phrases used by Novartis’s
experts move their opinions into impermissible “state of mind” or other “intent or
motive” testimony, the Court shall address specific objections at trial, if necessary.
Plaintiff’s motion on Novartis’s “state of mind” experts is therefore granted in part and
denied in part.
E.
Defendant’s Motion to Exclude Expert Testimony of Dr. Suzanne
Parisian
1.
Background
Dr. Susanne Parisian, M.D. (“Dr. Parisian”) is a Board Certified Anatomic and
Clinical Pathologist who also holds a master’s degree in biology. (Doc. No. 48-2 (“Def.
Parisian Index”) ¶ 8, Ex. 8 (“Parisian Report”) ¶ 1.) She is the founder of MD Assist,
Inc., a regulatory and medical consulting firm specializing in matters involving the
regulation of products by the FDA. (Id.) She was a Medical Officer in the Office of
Health Affairs at the FDA. (Id. at ¶ 3.) While working for the FDA, Dr. Parisian was an
instructor at the FDA’s Staff College and was “sent by the FDA to provide guidance on
the FDA’s interpretation of Food and Drug laws as they pertain to medical products . . . .”
16
(Id. at ¶ 6, 8.) Since leaving the FDA, Dr. Parisian has written a text about the FDA and
participated in a panel of experts the FDA convened to comment on proposed changes to
requirements for medical device labeling. (Id. at ¶ 1, 12.) In this case and a number of
related cases, Dr. Parisian seeks to provide (or has provided) her expert opinion with
respect to the regulatory framework and processes of the FDA and Novartis’s compliance
with both.
2.
Analysis
Novartis moves to exclude the testimony of Dr. Parisian in its entirety. Novartis
moves to exclude Dr. Parisian’s testimony on the basis of Federal Rules of Evidence
401-403, 702, and Daubert. Novartis questions Dr. Parisian’s expertise in general, and
also contends that Dr. Parisian is not qualified to offer opinions regarding Novartis’s
regulatory compliance or regarding Aredia labels because she is not an expert on the
drug. (Doc. No. 48 at 12, 18.)
A number of courts have examined the admissibility of Dr. Parisian’s expert
opinions. The MDL Court declined to examine the admissibly of Dr. Parisian’s
testimony because the court found it unnecessary to rely upon her testimony for purposes
of summary judgment. (Def. Parisian Index ¶ 1, Ex. 1 (In re Aredia & Zometa Prods.
Liab. Litig., Civ. No. 06-MD-1760 (M.D. Tenn. Aug. 13, 2009)).) As a result, each
transferee court has independently examined the admissibility of Dr. Parisian’s
testimony.
Novartis first asks the Court to rely on Hogan v. Novartis Pharm. Corp., Civ.
No. 06-260, 2011 WL 1533467 (E.D.N.Y. Apr. 24, 2011), where the court excluded
17
Dr. Parisian’s testimony in its entirety. In that case, Plaintiff brought common law claims
that were unrelated to FDA regulations, and therefore the court excluded all testimony
and evidence discussing the FDA, including Dr. Parisian’s testimony. Id. at *2. The
court, however, did not examine her qualifications. See id. Here, FDA regulations are
related to Plaintiffs’ claims, and, as a result, Dr. Parisian’s testimony will not be excluded
as irrelevant.
Novartis next argues that Dr. Parisian fails to demonstrate expertise when called at
trial. In previous Aredia and Zometa cases, courts have regularly found Dr. Parisian’s
testimony to be relevant and reliable under Daubert as a general matter. See, e.g.,
Lemons v. Novartis Pharm. Corp., 849 F. Supp. 2d 608, 613 (W.D.N.C. 2012) (finding
Dr. Parisian qualified to testify generally due to her significant experience with the FDA
and extensive education); Forman v. Novartis Pharm. Corp., 794 F. Supp. 2d 382, 384
(E.D.N.Y. 2011) (“Dr. Parisian testified . . . by taking this information and applying the
relevant FDA regulations and procedures. [T]his is the same methodology that she
applied while working at the FDA.”).
Specifically, a number of courts have determined that Dr. Parisian is qualified to
testify as an expert on issues of the FDA regulatory process. See, e.g., Guenther v.
Novartis Pharm. Co., Civ. No. 08-456, 2013 WL 1278089, at *2-3 (M.D. Fla. Mar. 28,
2013) (finding Dr. Parisian generally qualified to testify regarding the FDA regulatory
process due to her experience in the field); Deutsch, 768 F. Supp. 2d at 464 (“Dr. Parisian
is qualified to testify with regard to the FDA . . . [including] regulatory requirements
relating to the development, testing, marketing, and post-market surveillance of
18
prescription drugs.”) Beyond this, Dr. Parisian has also frequently been permitted to
testify to the extent she explains the FDA regulatory standards themselves. See, e.g.,
Lemons, 849 F. Supp. 2d at 614 (“Dr. Parisian’s testimony will assist the trier of fact in
understanding the complexity of the FDA’s regulatory scheme . . .”); Deutsch,
768 F. Supp. 2d at 465 (“[T]he FDA and others in the industry have continued to rely on
her for guidance on FDA regulations . . . .”)
Dr. Parisian has also been tested and deemed qualified with respect to issues of
Novartis’s compliance with FDA regulations. 5 For example, the Court in Forman found
that, “Dr. Parisian’s methodology is reliable and [she] is permitted to render opinions on
the reasonableness of Novartis’ conduct in its interactions with the FDA and compliance
with FDA regulations, including Novartis’ interactions with the FDA with respect to
labels and warnings, and FDA regulations and interactions with companies regarding
clinical trials.” Forman, 794 F. Supp. 2d at 384 (internal citations and quotations
omitted). This is distinguishable, however, from any testimony from the perspective of
Novartis or the pharmaceuticals industry as Dr. Parisian has not had experience and does
not have expertise from this point of view. See Deutsch, 768 F. Supp. 2d at 468
(excluding Dr. Parisian's testimony regarding what a “reasonable manufacturer would
do” and “industry standards” because she “has never worked at a pharmaceutical
company or with a pharmaceutical company outside of her interactions with companies
involved in FDA processes.”).
5
Novartis argues that Dr. Parisian has stated that Novartis never deviated from any
regulations she cites in her reports. (Doc. No. 48 at 7.) This goes to the weight of
Dr. Parisian’s testimony on this issue, not its admissibility.
19
The Court agrees with the findings of the courts detailed above, and it too finds
that Dr. Parisian is qualified with respect to FDA regulations, processes, and Novartis’s
actions as they relate to those subjects. As a general matter, Dr. Parisian is a credible and
reliable expert in her particular field. Dr. Parisian has extensive knowledge of the FDA’s
processes through her work with the FDA, supported by her appointment as an instructor.
She has continued to supplement her knowledge since leaving the FDA through her work
with MD Assist and with the expert panel. Novartis’s argument that because Dr. Parisian
has not worked with live patients for more than twenty years, and worked at the FDA for
only 4 years, she is therefore unqualified to opine on matters of FDA regulations, does
not alter the Court’s conclusion. Such testimony goes to the weight of her testimony, not
the admissibility.
As such, the Court concludes that Dr. Parisian is qualified to testify on matters
related to FDA regulation outlined above and her testimony is sufficiently based on
specialized knowledge which will be helpful for the jury to understand the complex topic
of FDA regulation. (See Def. Parisian Index ¶ 28, Ex. 28 (Stevens v. Novartis Pharm.
Corp., Civil No. DV-08-100, at 5 (Mont. 4th Jud. Dist. Ct., Oct. 14, 2009)).) Of course,
attempts by Dr. Parisian to offer an opinion as to whether Novartis violated the law with
respect to the FDA constitute a legal conclusion and are not admissible. Thus, in sum,
Novartis’s motion to exclude the entirety of Dr. Parisian’s testimony is denied, and
Dr. Parisian is permitted to testify on the FDA regulatory process and regulations and on
Novartis’s compliance. Also, Dr. Parisian will be permitted to testify regarding
20
Novartis’s conduct in its interactions with the FDA regarding labels and warnings on
prescription drugs, but only from the perspective of her knowledge about the FDA.
However, as have numerous other courts in related cases, the Court also limits
Dr. Parisian’s testimony. A number of courts have found that Dr. Parisian is not qualified
to testify regarding causation, monitoring clinical trials, corporate state of mind,
ghostwriting, industry standards outside FDA regulations, or to make legal conclusions.
See, e.g., Guenther, 2013 WL 1278089, at *2-3; see also Chiles v. Novartis Pharm.
Corp., 923 F. Supp. 2d 1330, 1333 (M.D. Fla. 2013).
Here, Plaintiffs agree that Dr. Parisian will not testify regarding medical causation,
corporate state of mind, industry standards, monitoring clinical trials, and ghostwriting. 6
(See Doc. No. 142 at 8.) Any testimony on these issues is not admissible. However,
though Plaintiffs have agreed they will not present any testimony on these issues, the
Court briefly outlines certain specific limits on any such testimony as follows.
First, with respect to questions of medical causation that address the direct causal
link between bisphosphonates and ONJ, the Court finds that Dr. Parisian is neither an
expert on ONJ nor on bisphosphonate medications and may not offer testimony on either
issue. (See Def. Parisian Index ¶ 11, Ex. 11 at 11.) For example, Dr. Parisian states in
her report that “causation is clear,” meaning that bisphosphonates clearly cause ONJ.
6
Dr. Parisian may refer to the Gotcher and Jee article relating to the “rice rat”
study. Novartis argues that Dr. Parisian uses this to offer “backdoor causation” opinions.
(Doc. No. 142 at 15.) However, the Court has concluded that Dr. Parisian cannot opine
on causation, thus the admissibility of this article will depend on the way the evidence is
introduced and whether the proper foundation is laid. The Court will address these issues
in accordance with Federal Rule of Evidence 104 and Article 7, including specifically
Rule 703.
21
Any testimony of this nature will not be permitted. (Parisian Report at ¶ 15.) Further,
Dr. Parisian will also not be permitted to opine that Novartis should have conducted
safety evaluations sooner, or that Novartis should have noticed the link between
bisphosphonates and ONJ sooner. Id.
Second, as Novartis asserts, regulatory causation or “causal association” is also
outside Dr. Parisian’s expertise and should be excluded. Under 21 C.F.R.
§ 201.57(c)(6)(i), which relates to labeling requirements for prescription drugs, “labeling
must be revised to include a warning about a clinically significant hazard as soon as there
is reasonable evidence of a causal association with a drug; a causal relationship need not
have been definitely established . . . .” Plaintiffs’ counsel fails to meaningfully
distinguish the causal association outlined in § 201.57(c)(6)(i) from medical causation,
and as such, testimony on this issue must be excluded. See Dopson-Troutt v. Novartis
Pharm. Corp., Civ. No. 06-1708, 2013 WL 1344755, at *3 (M.D. Fla. Apr. 2, 2013);
Taylor v. Novartis Pharm. Co., Civ. No. 06-61337, 2013 WL 5118945, at *9 (S.D. Fla.
Apr. 22, 2013). Dr. Parisian’s discussion of regulatory causation would not be beneficial
to the jury’s decision-making process, and is thus not permissible. (See, e.g., Def.
Parisian Index ¶ 3, Ex. 3 (Georges v. Novartis Pharm. Corp., Civ. No. 06-5207, at 20
(C.D. Cal. Nov. 2, 2012)) (“Dr. Parisian’s attempt to draw this distinction is confusing at
best and would almost certainly confuse or mislead the jury.”).
Third, to the extent Dr. Parisian attempts to opine on whether Novartis acted
according to the regular practices of pharmaceutical companies outside of FDA
regulations, Dr. Parisian is not qualified and any such testimony would be unreliable.
22
Dr. Parisian is an expert on the FDA, not on the industry practices of pharmaceutical
companies, and as such she is prohibited from testifying as to whether Novartis complied
with industry standards. (See Def. Parisian Index ¶ 3, Ex. 3 (Georges, Civ. No. 06-5207,
at 20 (C.D. Cal. Nov. 2, 2012)).) This does not include testimony as outlined above that
strictly pertains to the FDA. For example, Dr. Parisian may discuss Novartis’s
compliance with 21 C.F.R. § 314.80 as it pertains to Aredia risk information, as that is
her field of expertise, but she cannot go outside those boundaries.
Finally, Dr. Parisian’s opinions that Novartis convinced doctors to write
publications favoring Aredia and Zometa under the guise of independent reporting, or
“ghostwriting,” are outside the realm of Dr. Parisian’s expertise, and, as a result, this
category of testimony will not be permitted. (See Parisian Report at ¶ 232.) Further,
Dr. Parisian may not testify regarding any type of implied coercion of doctors by
Novartis to prescribe Novartis drugs as she does in her report. (Id. at ¶ 241.) Dr. Parisian
may testify as to whether Novartis’s marketing complied with FDA regulations, as that is
within her area of expertise, but she will not be permitted to expand the discussion
beyond those bounds as she has in the past.
In sum, the Court finds that Dr. Parisian is qualified and reliable as an expert on
issues relating to FDA processes and regulations and Novartis’s compliance therewith.
However, Dr. Parisian is precluded from opining on those issues the parties themselves
identified as excluded. Also, given the more-than-sufficient pleadings before the Court
and the number of cases that have already examined the admissibility of Dr. Parisian’s
opinions, the Court declines to order a Daubert hearing on Dr. Parisian. As a result, the
23
Court grants in part and denies in part Novartis’s motion relating to Dr. Parisian
consistent with its analysis above.
F.
Defendant’s Motion to Exclude Testimony of Plaintiffs’ Expert
Dr. Keith Skubitz and of Plaintiffs’ Expert Professor Wayne Ray
Plaintiff has withdrawn Dr. Keith Skubitz and Professor Wayne Ray as experts.
(6/10/14 Hearing Tr. at 98.) Accordingly, the Court dismisses these motions as moot.
G.
Defendant’s Motion to Exclude Expert Testimony of Dr. James Vogel
1.
Background
Dr. James Vogel (“Dr. Vogel”) is an oncologist and a hematologist. (Doc.
No. 85-2 (“Def. Ex. Index”) ¶ 6, Ex. 6 (“Vogel Report”) at ¶ 1.) He has been practicing
in that field for 35 years. (Id.) Dr. Vogel is currently an associate professor at Mount
Sinai School of Medicine in the Division of Hematology/Medical Oncology. (Vogel
Report at ¶ 12.) Dr. Vogel testified that he has observed ONJ in two patients, though he
has treated hundreds with Aredia and Zometa. (Vogel Report at ¶ 16; Def. Ex. Index ¶ 3,
Ex. 3 (“Vogel Dep. I”) at 126; Def. Ex. Index ¶ 7, Ex. 7 (“Vogel Dep. II”) at 17-18.)
Dr. Vogel prescribes bisphosphonates in his practice. (Vogel Report at ¶ 15.)
2.
Analysis
Novartis seeks to exclude Dr. Vogel’s opinions relating to the following:
(1) Novartis’s corporate conduct; (2) pre-bisphosphonate-treatment dental screening;
(3) ONJ incidence; (4) an alternative bisphosphonate dosing-duration regimen that has
not been approved by the FDA; and (5) the biological mechanism by which
bisphosphonates allegedly affect jaw bones. Novartis is not challenging Dr. Vogel’s
24
general causation opinion that Aredia can cause ONJ. Novartis is also not challenging
Dr. Vogel’s opinion relating to risk factors for ONJ included on Aredia labeling.
Novartis, however, seeks to distinguish this labeling-related testimony from other
labeling-related testimony that Aredia labels should or should not have included certain
information or regarding drafting and approval of labeling.
In addressing Novartis’s Daubert motions, the MDL court primarily denied
Novartis’s motion to exclude Dr. Vogel’s testimony. With respect to Plaintiffs’ general
causation experts, including Dr. Vogel, the MDL court held that the parties’ arguments
“go to the weight of the experts’ testimony not the admissibility.” In re Aredia & Zometa
Prods. Liab. Litig., Civ. No. 06-MD-1760, 2009 WL 2497536, at *2 (M.D. Tenn.
Aug. 13, 2009). The MDL court further held that “the parties have presented more than
unsupported speculation . . . as to whether Aredia and Zometa can cause ONJ . . .
Plaintiffs have satisfied their burden of establishing that their experts’ general causation
opinions are admissible under Daubert and Fed. R. Evid. 702.” Id. With respect to
Dr. Vogel specifically, the court further held that Dr. Vogel’s “testimony concerning
general causation and the scientific and medical accuracy of warnings given by Novartis
is clearly more than unsupported speculation . . . [and] Plaintiffs have carried their burden
of demonstrating that Dr. Vogel’s testimony concerning general causation and the
accuracy of warnings is admissible under Daubert.” (Doc. No. 148 (“Vogel Odette
Aff.”) ¶ 3, Ex. 1 (In re Aredia & Zometa Prods. Liab. Litig. (M.D. Ten.. Aug. 13, 2009)
(Doc. No. 2811)).) However, the MDL court explicitly did not consider “Dr. Vogel’s
opinions concerning the alleged corporate behavior of Novartis, his statement that the
25
delay and failure in transmission of certain information impacted a large number of
patients, or his testimony concerning the benefit of pretreatment dental screening.” Id.
First, the Court maintains its view articulated in the May 2014 Order with respect
to the law of the case doctrine. (Doc. No. 202 at 12-13.) In sum, the Court concluded
that while the law of the case doctrine is not automatic, the Court should not and will not
disturb MDL court rulings in “the absence of a significant change of circumstances.”
(Id.) Here, there is no significant change of circumstances, and thus the MDL court’s
finding that Dr. Vogel’s testimony concerning general causation and the scientific
medical accuracy of warnings given by Novartis applies. This means that the MDL’s
determination that Dr. Vogel is qualified to opine on a number of issues based on his
experience as an oncologist and hematologist with substantial experience treating patients
with bone metastases, and is qualified to opine with respect to bisphosphonates, stands.
a.
Novartis’s corporate conduct
With respect to Novartis’s corporate conduct, Novartis seeks to exclude
Dr. Vogel’s criticism of Novartis’s response to ONJ reports and Novartis’s labeling at
that time. Specifically, Novartis seeks to exclude Dr. Vogel’s testimony that Novartis:
(1) misrepresented causation evidence; (2) referenced corticosteroid therapy as a potential
risk factor for ONJ in the warnings on its label to misdirect medical attention from the
jaw area; (3) minimized the incidence rate of ONJ; (4) knew and failed to communicate
that ONJ occurs in a patient after fewer infusions of Zometa than Aredia; and (5) knew
and failed to communicate that a decrease in the duration, dose and/or frequency of
therapy decreases the incidence of ONJ. (Doc. No. 85 at 8 (citing Vogel Report at ¶ 62).)
26
Plaintiffs agree that they will not present Dr. Vogel’s testimony regarding “state of
mind, intent, or motives” of Novartis or of the FDA. (Doc. No. 147 at 4 n.4.) Even so,
much of Novartis’s memorandum outlines the myriad of reasons this Court should
exclude the very testimony Plaintiff has agreed to not present. To the extent that this is
the case, Novartis’s motion to exclude Dr. Vogel’s testimony on Novartis’s corporate
conduct is largely moot. Nonetheless, the Court will briefly outline the parameters of
permissible testimony by Dr. Vogel on this subject.
The Court agrees with the parties that Dr. Vogel may not proffer an opinion
relating to what individuals at Novartis thought about information found in certain
internal documents or about their motivations regarding those documents. Expert
testimony on “the intent, motives, or state of mind of corporations, regulatory agencies
and others have no basis in any relevant body of knowledge or expertise.” Deutsch, 768
F. Supp. 2d at 442 (citing In re Rezulin, 309 F. Supp. 2d at 546).
This does not mean, however, that Dr. Vogel is precluded from referencing or
relying on Novartis documents in any way. Novartis argues that Dr. Vogel’s testimony,
as it relates to Novartis documents, only presents speculative advocacy on Novartis’s
corporate conduct. The Court disagrees and declines to wholly exclude what Novartis
has characterized as “corporate conduct” testimony. As the court concluded in Deutsch,
testimony on Novartis’s state of mind, intent, or motive is “distinct from whether
Dr. Vogel can opine on his interpretation of whether certain information contained in the
Novartis internal documents indicated certain risks and whether such information would
have been useful to doctors.” Deutsch, 768 F. Supp. 2d at 443. The latter type of
27
testimony is properly within Dr. Vogel’s qualifications and expertise and “may be helpful
[to a jury] in defining complex or specialized terminology, or drawing inferences that
may not be apparent without the benefit or experience or specialized knowledge.” Id.
Specifically, it may be helpful to a jury to learn “what type of information a doctor
expects to receive from the company advertising a drug and what information they are
expected to and are able to ascertain on their own,” and, “why including some risk factors
and not others are misleading to a prescribing doctor.” Id. In sum,
Dr. Vogel can opine on the medicine and science that was available at the
time regarding the risks and benefits of Aredia and Zometa, and can
compare that information to what was disclosed on the label or in other
materials Novartis presented to the medical community. To the extent the
information on the known risks is derived from internal Novartis
documents, Dr. Vogel’s scientific expertise is helpful to the trier of fact in
understanding those documents.
Id. To the extent Novartis is concerned about Dr. Vogel making “uniformed, erroneous
assumptions,” Novartis’s concerns are properly addressed on cross-examination and do
not go to the admissibility of Dr. Vogel’s testimony. If, for example, Dr. Vogel failed to
consider that Novartis does not manufacture corticosteroid medications, then Novartis
may cross-examine Dr. Vogel on this issue. Thus, Novartis’s motion on Novartis’s
“corporate conduct” is granted in part and denied in part.
b.
Pre-bisphosphonate Treatment Dental Screening
Dr. Vogel opines that preventative dental measures prior to Aredia or Zometa
treatment reduce the incidence of ONJ. Novartis argues that Plaintiffs cannot lay the
appropriate foundation to support Dr. Vogel’s testimony on this issue. Specifically,
Novartis argues that Dr. Vogel is not qualified to present such testimony and that the
28
methodology he uses is not scientifically reliable as it is based on a single, inconclusive
article.
Other courts have held that Dr. Vogel is qualified and has a reliable basis with
respect to pretreatment dental screening by his “extensive experience as an oncologist
and hematologist including treating patients with bisphosphonate therapy . . . .” Deutsch,
768 F. Supp. 2d. at 437. As the court reasoned in Bowles & Sheffer, “there is significant
medical literature pointing to the benefits of pretreatment screening,” including from
Novartis itself. Mathews v. Novartis Pharm. Corp., Civ. No. 12-314, 2013 WL 5780415,
at *22 (S.D. Ohio October 25, 2013) (citing to the same court’s September 20, 2013
decision in two related cases Bowles (Civ. No. 12-145) and Sheffer (Civ. No. 12-238),
which is attached to its decision as Exhibit 1 and is incorporated by reference) (“Bowles
& Sheffer”). The Court agrees. Thus, Dr. Vogel’s opinion is based on sufficient, reliable
facts or data.
However, the Court also agrees with the court’s determination in Brodie, which
deemed admissible Dr. Vogel’s pre-treatment dental screening, “assuming a sufficient
foundation can be established, of which the Court is dubious.” (Vogel Odette Aff. ¶ 3,
Ex. 5 (Brodie v. Novartis Pharm. Corp., Civ. No. 10-138 at 3 (E.D. Mo. Jan. 20, 2012)).)
The Court therefore reserves the right to exclude testimony on this matter should
Plaintiffs fail to establish sufficient foundation. Certainly, Dr. Marx is better positioned
29
to testify to this issue, and the Court has already admitted his testimony in this regard.
(See Doc. No. 202 at 13-14.) 7
c.
ONJ incidence
Dr. Vogel opines that the incidence rate of ONJ in patients taking bisphosphonates
is “generally five percent or above.” (Vogel Report at ¶ 47.) Novartis argues that this
testimony should be excluded because: (1) it is a corporate conduct opinion; (2) it does
not “fit” the facts of the case because it relates to Zometa and not Aredia; (3) it is based
on insufficient facts or data; and (4) the methodology is flawed. In sum, Novartis argues
that Dr. Vogel’s opinion is unreliable. The Court disagrees.
A number of courts have allowed Dr. Vogel to testify to ONJ incidence rate.
(Vogel Odette Aff. ¶ 3, Ex. 4 (Mahaney v. Novartis Pharm. Corp., Civ. No. 06-35
(W.D. Ky. Sept. 9, 2011)) (“Vogel’s statements on the incidence rate of ONJ are
admissible.”); Deutsch, 768 F. Supp. 2d at 441 (allowing opinion testimony that the
incidence rate of ONJ was generally five percent or above); Davids v. Novartis Pharm
Corp., 857 F. Supp. 2d 267, 275-76 (E.D.N.Y. 2012) (adopting Deutsch for a number of
experts, including Dr. Vogel, and explaining that Novartis’s attempts to differentiate
Davids from Deutsch fail); Earp v. Novartis Pharm. Corp., Civ. No. 11-680, 2013 WL
48544488, at *4 (E.D.N.C. Sept. 11, 2013) (finding Dr. Vogel qualified to testify on
incidence rate of ONJ); Bowles & Sheffer, 2013 WL 5780415 at *22-23 (allowing
Dr. Vogel to testify on the five percent incidence rate and holding that Novartis’s
7
Novartis also contests “fit” in this case. However, this is a question of fact for the
jury, and Plaintiffs have presented evidence that Kruszka would have benefitted from
additional pretreatment dental screening.
30
objections go to weight and not admissibility of his opinions); Georges v. Novartis
Pharm. Corp., Civ. No. 06-5207, 2013 WL 5217198, at *15 (C.D. Cal. Apr. 4, 2013)
(denying Novartis’s Daubert motion on Dr. Vogel with respect to incidence of ONJ
testimony); Taylor, 2013 WL 5118945, at *4 (allowing Dr. Vogel’s testimony on the
incidence rate of ONJ, except to the extent he would opine on whether Novartis sought to
minimize the incidence rate, which addresses motive or intent).
The Court agrees with these cases and finds that Dr. Vogel may opine that the
incidence rate of ONJ was five percent or greater, and that he has an adequate and
reliable basis for this opinion based on his background, experience, and his analysis of a
number of publications. Novartis’s generalized issues relating to the reliability and
methodology of Dr. Vogel’s opinion on ONJ incidence do not affect the admissibility of
his opinion. (See Vogel Odette Aff. ¶ 3, Ex. 4 (Mahaney, Civ. No. 06-35 (W.D. Ky.
Sept. 9, 2011).) Therefore, Dr. Vogel’s opinions will not be excluded on these grounds.
Novartis seeks to differentiate this case from those that have allowed Dr. Vogel’s
incidence testimony based on the fact that his opinions involve Zometa, and Kruszka only
took Aredia. This does not render Dr. Vogel’s testimony inadmissible. Portions of
Dr. Vogel’s expert report address both Aredia and Zometa, including testimony about
labeling which is similar for both drugs. On the simplest level, both drugs are
Novartis-manufactured bisphosphonates used in the treatment of myeloma. To the extent
that there are chemical, labeling, or other differences, those issues too are best addressed
through cross-examination and do not go to admissibility. Thus, the Court also declines
to exclude Dr. Vogel’s opinions on this basis.
31
Accordingly, Dr. Vogel can opine that the incidence rate of ONJ was generally
five percent or above in accordance with the limitations detailed above, and Novartis’s
motion on this issue is denied.
d.
Alternative Dosing-Duration regimens
Dr. Vogel opines on the efficacy of a reduced dosing schedule and that additional
information on dosing should have been provided to patients. Novartis argues this is not
supported by FDA recommendations and that the sole study (“Corso Study” 8) Dr. Vogel
cites is scientifically unreliable. Also, Novartis relies on the decision in Brodie, wherein
the court excluded the same testimony because the topic was outside Dr. Vogel’s area of
expertise and was not based on scientifically reliable sources. (Vogel Odette Aff. ¶ 3,
Ex. 5 (Brodie, Civ. No. 10-138 (E.D. Mo. Jan. 20, 2012)).)
Here, Dr. Vogel’s reliance on the Corso Study provides some scientific basis for
his opinion, and Dr. Vogel is qualified to opine on the results of the study based on his
expertise as an oncologist and hematologist, including treating patients with
bisphosphonate therapy. As the court stated in Deutsch,
[T]he MDL court stated that Dr. Vogel was qualified to opine on whether
the information provided to the medical community, including information
on dosing, was false or misleading. Furthermore, the MDL court has also
ruled on the admissibility of Dr. Vogel’s opinions that are based on the
relevant medical literature. . . . Accordingly, the MDL court implicitly
found Dr. Vogel qualified to interpret [observational] studies . . . .
Deutsch, 768 F. Supp. 2d at 444. Also, “[w]hether the results of the Corso study are
sufficiently verified or whether subsequent studies have reached different results goes to
8
A. Corso, et al., A Different Schedule of Zoledronic Acid Can Reduce the Risk of
Osteonecrosis of the Jaw in Patients with Multiple Myeloma, 21 Leukemia 1545 (2007).
32
the weight rather than the admissibility of the testimony and may be explored on cross
examination.” Taylor, 2013 WL 5118945, at *5 (citing Deutsch, 768 F. Supp. 2d at 437).
The Court agrees with this conclusion. Accordingly, the Court denies Novartis’s motion
as to dosing and duration for Dr. Vogel.
e.
Biological Mechanisms
Dr. Vogel opines that bisphosphonates are more likely to accumulate in the jaw
than other bones. Novartis seeks to exclude this opinion on the basis that Dr. Vogel lacks
the requisite expertise to address the issue because he has admitted he is not a bone
biologist or pathologist. Novartis appears to rest its argument on the fact that the Brodie
court excluded Dr. Vogel’s testimony on this issue. (See Vogel Odette Aff. ¶ 3, Ex. 5
(Brodie, Civ. No. 10-138 (E.D. Mo. Jan. 20, 2012)).)
In Brodie, the court held, without further explanation, that, “Dr. Vogel has
admitted that he is not an expert on bone biology and, therefore, he is unqualified to
opine on how bisphosphonates affect bone. As such, he is precluded from opining on
[this area].” (Id. at 3.). However, other courts have admitted the same testimony. For
example, in Deutsch the court found that “Dr. Vogel’s lack of expertise as a bone
biologist or bone pathologist does not disqualify him from opining on a plausible
causation mechanism involving how bisphosphonates target bone to cause BRONJ.”
Deutsch, 768 F. Supp. 2d at 439. The court found that his educational and experiential
qualifications were closely related and that he has substantial experience treating patients
with bone metastases. Id. Finally, the court noted that Dr. Vogel “is not proffering this
opinion as the definitive mechanism, but rather for the proposition that it is a plausible
33
mechanism that has been identified based on his professional understanding of the
relevant literature.” Id.
Here, the Court finds that there are no material legal or factual differences between
the motion that was before the court in Deutsch and the motion now before this Court
with respect to this topic. Therefore, the Court finds the thorough reasoning of Deutsch
persuasive and adopts it here. See id. at 439-40; see also Georges, 2013 WL 5217198, at
*15 (adopting Deutsch and denying Novartis’s request to exclude testimony on biological
mechanisms); Davids, 857 F. Supp. 2d at 273, 276 (same); Bowles & Sheffer, 2013 WL
5780415, at *23 (“In admitting Dr. Vogel’s testimony concerning general causation . . .
the MDL Court has already impliedly held that Dr. Vogel is qualified to testify on this
topic [of biological mechanisms.”) Accordingly, Novartis’s motion as to this area of
testimony is denied.
II.
Plaintiffs’ Motion in Limine to Exclude Testimony of Duplicative Defense
Experts
Plaintiffs seek to preclude Novartis from submitting cumulative testimony from
multiple experts. At the time of filing this motion, Novartis had offered fourteen experts.
(Doc. No. 208 (6/10/14 Hearing Tr.) at 16.) At the time of this Court’s hearing on the
motion, the parties had agreed to withdraw the following experts: (1) Dr. Ronald
Bukowski; (2) Dr. Paul Bunn; (3) Dr. Serge Ferrari; (4) Dr. Thomas Flynn; (5) Dr. Peter
Krakowiak; and (5) Dr. Socrates Papapoulos. (Id. at 16.)
Plaintiffs still seeks to limit Novartis’s experts. (Tr. at 17.) However, the parties
have agreed to continue to work together to determine which experts will be offered at
34
trial. (Tr. at 18-26.) The Court has agreed to address this issue at the July 16, 2014 pretrial, should the parties be unable to agree to an acceptable number of Novartis’s experts,
and thus issues regarding the number of experts remain. (Tr. at 25-26.) Accordingly, the
Court dismisses this motion without prejudice as moot and reserves the right to address
issues relating to the cumulative and duplicative nature of Novartis’s expert testimony
should it need to do so.
III.
Plaintiffs’ Motion to Unseal the Second Declaration of Robert Germany and
Exhibits 1-182
Plaintiffs seek the unsealing of the Declaration of Robert Germany (“Germany
Declaration”) and the attached 182 exhibits (“Germany Exhibits”) which include articles,
Novartis corporate documents, and certain information sent to the public. The Germany
Declaration and Germany Exhibits are under seal on the basis of the Protective and
Confidentiality Order (“Confidentiality Order”) the MDL court put into place on
August 15, 2006. (Doc. No. 136 (“Ex. Index”) ¶ 1, Ex. 1.) The Confidentiality Order
was entered in all MDL cases. The Confidentiality Order allows the parties to designate
certain documents “confidential” to be filed under seal and kept protected. The
Confidentiality Order includes a time line for contesting confidentiality designations.
Novartis does not dispute that documents that have been published at prior trials
are no longer confidential. Specifically, Novartis agrees that all but sixty-seven of the
182 Germany Exhibits are no longer confidential. (Ex. Index ¶ 2, Ex. 2.) Thus, the Court
agrees that those Germany Exhibits which have been published at previous trials, and
which do not include those sixty-seven Germany Exhibits listed by Novartis, are no
35
longer confidential under the Confidentiality Order and can be filed publicly. 9 The Court
also concludes that any additional exhibits that have been admitted at any trial, even if
not published, but which were not identified by Novartis as no longer confidential, are
also no longer confidential and can be filed publicly. 10
For the remaining Germany Exhibits never admitted at any trial and for which the
confidentiality status is disputed, there is a common-law right of access to judicial
records. See Webster Groves Sch. Dist. v. Pulitzer Publ’g Co., 898 F.2d 1371, 1376 (8th
Cir. 1990). However, the Eighth Circuit does not recognize the strong presumption
favoring access adopted by some circuits and thus the Court must “weigh the competing
interests” of the parties in determining whether to unseal court records. Id. n.4. The
interest in protecting a company’s internal information can warrant sealing of records. In
re Guidant Corp. Implantable Defibrillators Prods. Liab. Litig., 245 F.R.D. 632, 636
(D. Minn. 2007).
Plaintiffs argue that the remaining sixty documents are all at least seven years old
and thus any potentially competitive information has expired. Plaintiffs further argue that
keeping the materials under seal stretches the Confidentiality Order beyond the intended
9
Those exhibits which Novartis admits have been published at prior trials and are
no longer confidential include the following exhibits: 1-7, 9-19, 21-25, 27, 29-37, 39-53,
56, 59, 61-65, 67, 72-74, 76-79, 84-87, 90, 92, 93, 95-97, 100, 101, 103-105, 107, 110,
111, 113-118, 120, 121, 124, 125, 127, 129, 131, 133, 135, 137, 139, 140, 144, 145, 147,
149, 151, 153, 156-58, 164, 165, 170, 171, 173, 174, and 182.
10
For example, Plaintiffs indicate that Exhibit 71 (an e-mail from Spet to Hei) was
admitted at a number of previous trials. That exhibit should not remain under seal. (Doc.
No. 178 (“Odette Aff.”) ¶ 3, Ex. A.)
36
scope and frustrates the public interest of keeping information in the public domain. As a
result, Plaintiffs contend that these documents should be made public.
Novartis argues that the weighing of competing interests favors non-disclosure
because the pharmaceuticals industry is highly competitive, and, as such, any internal
documents holding competitive information must remain sealed. Novartis further points
to the untimeliness of Plaintiffs’ motion and the fact that a number of courts have
declined to wholesale unseal all of the Germany Exhibits.
At oral argument, the parties represented to the Court that the unsealing of the
approximately sixty documents will have little practical effect on the trial. Novartis
explained that the documents in dispute have not been used in previous trials, and likely
will not be used at this trial, thereby making the review of the confidentiality status of
any of those documents practicable for the Court on a case-by-case basis. The Court
agrees.
The MDL Confidentiality Order is controlling here for those documents not
already made public, and Plaintiff provides no persuasive reason to deviate from it at this
juncture. While the Court recognizes the interest of having the documents at issue here
public, when weighing competing interests the Court concludes that ongoing protection is
merited. First, Plaintiffs have had a number of opportunities—with the MDL court, in
other cases, and in this case—to dispute the designations of the documents at issue but
have failed to do so. Second, without a document-by-document analysis, the Court
cannot determine whether documents, even those dating from 2007, contain confidential
competitive information. The Court need not engage in that analysis here based on a
37
number of factors: (1) the parties have represented that the documents will not likely be
introduced at trial; (2) to date, the parties have always agreed on the designation of
documents for trial amongst themselves; and (3) if the documents are introduced at trial,
the Court can adequately examine their confidentiality status at that time. Therefore, the
Court declines to undo the Confidentiality Order at this late phase in the proceedings and
will examine the remaining disputed exhibits on an as-needed basis. The Court notes that
should such a situation arise at trial, Novartis will have to justify the sealing of the
documents at issue.
Plaintiffs’ specifically request that the expert reports of Dr. Arrowsmith and
Dr. Feigal be unsealed because they have already been made public. The Court agrees.
Dr. Arrowsmith’s and Dr. Feigal’s reports may be unsealed in a manner consistent with
the above ruling.
In sum, those documents already made public through admission at prior trials will
be unsealed per the agreement of the parties, and all documents not yet public will remain
sealed. The Court will address any remaining exhibits on a document-by-document basis
during the trial, as needed, but declines to unseal all of them at this stage.
ORDER
Based on the foregoing, and all the files, records, and proceedings here, IT IS
HEREBY ORDERED that:
1.
Plaintiffs’ Motion to Exclude Expert Testimony of Dr. Carol Ann Huff
(Doc. No. [72]) is GRANTED IN PART and DENIED IN PART as follows:
38
a.
Dr. Huff’s testimony relating to treating myeloma,
prescribing Aredia and Zometa to treat myeloma, the immunosuppressive
effect of myeloma-related treatments, the specific effects of Aredia
treatment, and also Kruszka’s clinical course of treatment are admissible to
the extent they are consistent with this Memorandum Opinion;
b.
Dr. Huff’s specific causation testimony is limited in a manner
consistent with this Memorandum Opinion; and
c.
Dr. Huff will not be permitted to testify to information
contained in the Huff Declaration, but not contained in the Huff Report.
2.
Plaintiffs’ Motion to Exclude Testimony of Dr. Dale A. Baur (Doc.
No. [81]) is GRANTED to the extent he seeks to testify on the following topics:
(1) whether the benefits of bisphosphonate therapy outweigh the risks; (2) whether
bisphosphonate therapy improves quality of life; and (3) whether the warnings
disseminated with Novartis’s bisphosphonate drugs were effective, timely, or appropriate.
3.
Plaintiffs’ Motion to Exclude Expert Testimony Relating to Alleged FDA
Compliance and/or Novartis’s “State of Mind” (Doc. No. [97]) is GRANTED IN PART
and DENIED IN PART as follows:
a.
Drs. Arrowsmith and Feigal are precluded from testifying to
the state of mind, intent or motives of Novartis or the FDA; but
b.
Drs. Arrowsmith and Feigal testimony relating to the
reasonableness of Novartis’s interaction with the FDA and compliance with
39
FDA regulations, including with respect to labeling and warnings is
admissible.
4.
Defendant’s Motion to Exclude Expert Testimony of Dr. Suzanne Parisian
(Doc. No. [46]) is GRANTED IN PART and DENIED IN PART consistent with the
Court’s detailed instructions in this Memorandum Opinion;
5.
Defendant’s Motion to Exclude Testimony of Plaintiffs’ Expert Dr. Keith
Skubitz (Doc. No. [54]) is DENIED AS MOOT;
6.
Defendant’s Motion to Exclude Expert Testimony of Plaintiffs’ Expert,
Prof. Wayne Ray (Doc. No. [56]) is DENIED AS MOOT;
7.
Defendant’s Motion to Exclude Expert Testimony of Dr. James Vogel
(Doc. No. [79]) is GRANTED IN PART and DENIED IN PART as follows:
a.
Dr. Vogel’s testimony relating to the state of mind, intent or
motives of Novartis is inadmissible, but Dr. Vogel’s testimony relating to
his interpretation of whether certain information contained in Novartis’s
internal documents indicated certain risks and whether such information
would have been useful doctors is admissible, subject to the limitations
outlined in detail in this Memorandum Opinion;
b.
Dr. Vogel’s pre-treatment dental screening testimony is
admissible;
c.
Dr. Vogel can opine that the incidence rate of ONJ was
generally five percent or above in accordance with the limitations detailed
in this Memorandum Opinion;
40
d.
Dr. Vogel can opine on dosing and duration in accordance
with the limitations detailed in this Memorandum Opinion;
e.
Dr. Vogel can opine on biological mechanisms in accordance
with the limitations detailed in this Memorandum Opinion;
8.
Plaintiffs’ Motion in Limine to Exclude Testimony of Duplicative Defense
Experts (Doc. No. [43]) is DENIED WITHOUT PREJUDICE AS MOOT; and
9.
Plaintiffs’ Motion to Unseal the Second Declaration of Robert G. Germany
and Exhibits 1 - 182 (Doc. No. [109]) is GRANTED IN PART and DENIED IN PART
as follows:
a.
Those documents admitted in any previous trials are public
and are unsealed; and
b.
Those documents not previously admitted will remain under
seal and will be addressed by this Court at trial on a case-by-case basis.
Dated: July 1, 2014
s/Donovan W. Frank
DONOVAN W. FRANK
United States District Judge
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