United States District Court, N.D. Alabama, Southern Division
MEMORANDUM OPINION AND ORDER
VIRGINIA EMERSON HOPKINS, United States District Judge
case comes before the court on Defendant Novartis
Pharmaceutical Corporation (“Novartis” or
“NPC”)'s Motions To Strike Expert Testimony.
Novartis has moved to exclude the testimony of the following
• Dr. Suzanne Parisian (“Dr. Parisian”), the
“Parisian Motion” (doc. 108);
• Dr. William B. Hinshaw (“Dr. Hinshaw”),
the “Hinshaw Motion” (doc. 112);
• Dr. Wayne A. Taylor (“Dr. Taylor”), the
“Taylor Motion” (doc. 116);
• Dr. James Worthen (“Dr. Worthen”) and Dr.
Timothy Mark Ricketts (“Dr. Ricketts”),
collectively in the “Non-Retained Experts Motion”
Ernesteen Jones (“Jones”) initiated this lawsuit
against Novartis on April 4, 2013 (doc. 1), alleging that she
developed atypical femur fractures
(“AFF”) as a result of taking Novartis'
medication Reclast, which is a type of bisphosphonate
(“BP”) drug. Jones was prescribed Reclast by Dr.
Thomas Traylor, her treating physician for her osteoporosis.
(Doc. 54) at 2, ¶ 9. She was administered an annual five
milligram Reclast injection, as prescribed, on February 10,
2009, March 16, 2010, and March 17, 2011. Id. at 2,
October 26, 2011, Jones's right femur fractured,
requiring surgery. Id. at 3, ¶¶ 13-14. In
early 2012, Jones began experiencing pain in her left thigh.
Id. at 3, ¶ 16. After a bone scan revealed a
stress fraction on her left femur, she had surgery on her
left femur to prevent a complete fracture. Id. at 3,
has asserted the following claims against Novartis:
violations of the Alabama Extended Manufacturer's
Liability Doctrine (“AEMLD”) (Count 1,
id. at 6-9); failure to warn (Count II, id.
at 10); negligence and wantonness (Count III, id. at
10-12); and breach of warranty of merchantability. (Count IV,
id. at 13).
STANDARD FOR THE ADMISSIBILITY OF EXPERT TESTIMONY
A. General Requirements - Judge as
expert testimony, the Federal Rules of Evidence provide:
witness who is qualified as an expert by knowledge, skill,
experience, training, or education may testify in the form of
an opinion or otherwise if:
(a) the expert's scientific, technical, or other
specialized knowledge will help the trier of fact to
understand the evidence or to determine a fact in issue;
(b) the testimony is based on sufficient facts or data;
(c) the testimony is the product of reliable principles and
(d) the expert has reliably applied the principles and
methods to the facts of the case.
Fed. R. Evid. 702 (2011). Rule 702 must be read in
conjunction with three seminal decisions by the Supreme Court
related to expert testimony: Daubert v. Merrell Dow
Pharmaceuticals, Inc., 509 U.S. 579, 113 S.Ct. 2786, 125
L.Ed.2d 469 (1993); Gen. Elec. Co. v. Joiner, 522
U.S. 136, 118 S.Ct. 512, 139 L.Ed.2d 508 (1997); and
Kumho Tire Co. v. Carmichael, 526 U.S. 137, 119
S.Ct. 1167, 143 L.Ed.2d 238 (1999).
rulings on Daubert motions are reviewed under an
abuse of discretion standard. See, e.g., Joiner, 522
U.S. at 141, 118 S.Ct. at 517 (“All evidentiary
decisions are reviewed under an abuse-of-discretion
standard.”). “An abuse of discretion can occur
where the district court applies the wrong law, follows the
wrong procedure, bases its decision on clearly erroneous
facts, or commits a clear error in judgment.”
United States v. Estelan, 156 F. App'x 185, 196
(11th Cir. 2005) (citing United States v. Brown, 415
F.3d 1257, 1266 (11th Cir.2005)).
Daubert, the Supreme Court established that district
judges act as “gatekeepers” for expert testimony.
509 U.S. at 592-93, 113 S.Ct. at 2796. The district court
judge must assess the proffered testimony and make a
preliminary determination about the scientific validity of
the expert's reasoning and methodology. Id.
As another district court in this Circuit has stated,
Federal Rule of Evidence 702, read together with the trilogy
of Supreme Court opinions that led to the Rule's revision
in 2011, compels the district courts to perform a
“gatekeeping” function when determining the
admissibility of expert scientific and technical evidence.
See, e.g., United States v. Abreu, 406 F.3d
1304, 1306 (11th Cir. 2005) (quoting United States v.
Frazier, 387 F.3d 1244, 1260 (11th Cir. 2004)).
“This function inherently requires the trial court to
conduct an exacting analysis of the foundations of expert
opinions to ensure they meet the standards for admissibility
under Rule 702.” Id. (internal quotation
Broussard-Wadkins v. Maples, 895 F.Supp.2d 1159,
1165 (N.D. Ala. 2012), aff'd sub nom. Broussard v.
Maples, 535 F.App'x 825 (11th Cir. 2013).
burden under Rule 702 rests squarely with the proponent of
the expert witness:
The proponent of the expert testimony carries a substantial
burden under Rule 702. “The burden of laying the proper
foundation for the admission of the expert testimony is on
the party offering the expert, and admissibility must be
shown by a preponderance of the evidence.” Allison
v. McGhan Med. Corp., 184 F.3d 1300, 1306 (11th
Cir.1999) (citing Daubert, 509 U.S. at 592 n. 10,
113 S.Ct. 2786). Thus, the proponent must demonstrate that
the witness is qualified to testify competently, that his
opinions are based on sound methodology, and that his
testimony will be helpful to the trier of fact. See,
e.g., Frazier, 387 F.3d at 1260 (“The burden of
establishing qualification, reliability, and helpfulness
rests on the proponent of the expert opinion . . . .”);
McCorvey v. Baxter Healthcare Corp., 298 F.3d 1253,
1257 (11th Cir. 2002); Maiz, 253 F.3d at 664.
See Cook ex rel. Estate of Tessier v. Sheriff of Monroe
Cty., Fla., 402 F.3d 1092, 1107 (11th Cir. 2005).
The Eleventh Circuit Test for Admissibility
Eleventh Circuit has established a three-part inquiry for
district courts to follow in performing their gatekeeper
role. For evidence to be admissible under Rule 702, the
district court must find that:
(1) the expert is qualified to testify competently regarding
the matters he intends to address;
(2) the methodology by which the expert reaches his
conclusions is sufficiently reliable as determined by the
sort of inquiry mandated in Daubert; and
(3) the testimony [will] assist[ ] the trier of fact, through
the application of scientific, technical, or specialized
expertise, to understand the evidence or to determine a fact
Hendrix ex rel. G.P. v. Evenflo Co., Inc., 609 F.3d
1183, 1194 (11th Cir. 2010) (citing United States v.
Frazier, 387 F.3d 1244, 1260 (11th Cir. 2004)). The
party offering the testimony must meet each prong by a
preponderance of the evidence. Id.
Prong One: The Expert Must Be Qualified To Testify to
the Relevant Issue
meet Prong One, a party must show that the expert has
sufficient “knowledge, skill, experience, training, or
education” to form a reliable opinion about the
relevant issue. Hendrix, 609 F.3d at 1193.
Experience in a particular field is not enough to qualify an
expert; the expert must have experience with the issue before
the court. See Id. at 1201.
Sixth Circuit, in a similar case, concluded that a district
court did not abuse its discretion in excluding the testimony
of the plaintiff's expert. See Thomas v. Novartis
Pharms. Corp., 443 F. App'x 58, 63 (6th Cir. 2011).
The expert in Thomas was “an experienced
maxillofacial surgeon who ha[d] treated several patients
suffering from osteonecrosis of the jaw.” Id.
However, the expert had not established his credentials to
“diagnose the cause of [the plaintiff's]
osteonecrosis . . . which [was] the salient issue his opinion
was offered to establish.” Id.
Prong Two: The Expert's Opinion Must Be Sufficiently
meet Prong Two, the party proffering the expert's
testimony must show that the expert's opinion is
sufficiently reliable. A district court has substantial
discretion in deciding how to test the reliability of an
expert's testimony. Rink v. Cheminova, Inc., 400
F.3d 1286, 1292 (11th Cir. 2005). “This deferential
abuse of discretion standard is applied stringently, even if
a decision on expert testimony is ‘outcome
determinative.'” Chapman v. Proctor &
Gamble Distrib., LLC, 766 F.3d 1296 (11th Cir. 2014)
(citing Joiner, 522 U.S. at 142-43, 118 S.Ct. at
to the second Daubert prong, the court should
consider the following factors: “(1) whether the
expert's methodology can be tested; (2) whether the
expert's scientific technique has been subjected to peer
review and publication; (3) whether the method has a known
rate of error; and (4) whether the technique is generally
accepted by the scientific community.” Rink,
400 F.3d at 1292 (citing Quiet Tech. DC-8, Inc. v.
Hurel-Dubois UK Ltd., 326 F.3d 1333, 1341 (11th Cir.
2003)). However, these factors are not exhaustive and a court
“should consider any additional factors that may
advance its Rule 702 analysis.” Quiet Tech,
326 F.3d at 1341.
Legal Standard for Causation Experts
Eleventh Circuit, other than in a small number of cases where
the medically community generally recognizes and agrees upon
the toxicity of the substance at issue to the injury alleged,
both general and specific causation must be established
through expert testimony if the Plaintiff's claims
require proof of causation:
For analyzing cases involving alleged toxic substances, we
have delineated two categories. McClain v. Metabolife
Int'l, Inc., 401 F.3d 1233, 1239 (11th Cir. 2005).
The first category consists of “cases in which the
medical community generally recognizes the toxicity of the
[substance] at issue” to “caus[e] the injury
plaintiff alleges.” Id.; Hendrix ex rel.
G.P. v. Evenflo Co., 609 F.3d 1183, 1196 (11th Cir.
2010). In this category are “toxins like asbestos,
which causes asbestosis and mesothelioma; silica, which
causes silicosis; and cigarette smoke, which causes
cancer.” McClain, 401 F.3d at 1239 . . . [i]n
cases where the cause and effect or resulting diagnosis has
been proved and accepted by the medical community, federal
judges “need not undertake an extensive
Daubert analysis on the general toxicity
question.” Id. at 1239.
In contrast, the second category contains cases, where the
medical community generally does not recognize the substance
in question as being toxic and having caused plaintiff's
alleged injury. Id. These cases require a two-part
Daubert analysis, comprised of (1) general
causation, “whether the [substance] can cause
the harm plaintiff alleges, ” id., and (2)
specific causation, whether experts' methodology
determines the substance “caused the plaintiff's
specific injury, ” Hendrix, 609 F.3d
at 1196 (citing McClain, 401 F.3d at 1239). For
cases in category two, a district judge “must assess
the reliability of the expert's opinion on general, as
well as specific, causation.” Id. (first
Chapman, 766 F.3d at 1303-04. This case clearly
falls into the latter category.
reliable expert testimony must establish both general and
General Causation Standard
causation refers to the “general issue of whether a
substance has the potential to cause the plaintiff's
injury.” Chapman, 766 F.3d at 1307 (citing
Guinn v. AstraZeneca Pharm. LP, 602 F.3d 1245, 1248
n.1 (11th Cir. 2010) (per curiam)); see also McClain v.
Metabolife Intern., Inc., 401 F.3d 1233, 1239 (11th Cir.
2005) (emphasis in original) (“In the second category
of toxic tort cases, the Daubert analysis covers not
only the expert's methodology for the plaintiff-specific
questions about individual causation but also the general
question of whether the drug or chemical can cause
the harm plaintiff alleges. This is called general
causation.”). General causation exists “when a
substance is capable of causing a given disease.”
Restatement (Third) of Torts: Liability for Physical and
Emotional Harm § 28 cmt. c(3) (2010)
causation refers to “the issue of whether the plaintiff
has demonstrated that the substance actually caused injury in
her particular case. Specific causation is often
distinguished from general causation, which refers to the
more general issue of whether a substance has the potential
to cause the plaintiff's injury.” Guinn,
602 F.3d at 1248 n. 1; Chapman, 766 F.3d at 1308;
see also Restatement § 28 cmt. c(3)
(“Scientists who conduct group studies do not examine
specific causation in their research. No scientific
methodology exists for assessing specific causation for an
individual based on group studies. Nevertheless, courts have
reasoned from the preponderance-of-the-evidence standard to
determine the sufficiency of scientific evidence on specific
causation when group-based studies are involved.”).
Eleventh Circuit in McClain laid out four criteria,
based on an article published by the Federal Judiciary
Center, for proving causation between exposure to a chemical
and a particular illness in an individual:
1. “[T]he toxic substance in question must have been
demonstrated to cause the type of illness or disease in
question . . . this focuses on the issue of general
2. “[T]he individual must have been exposed to a
sufficient amount of the substance in question to elicit the
health effect in question . . . this focuses on the issue of
3. “[T]he chronological relationship between exposure
and effect must be biologically plausible . . . this also
focuses on individual causation;”
4. “[T]he likelihood that the chemical caused the
disease or illness in an individual should be considered in
the context of other known causes . . . this refers to the
background risk of a specific disease.”
401 F.3d at 1242-43 (citing David Eaton, Scientific
Judgment and Toxic Torts-A Primer in Toxicology for
Judges and Lawyers, 12 J.L. & POL'Y 1, 38-40
Lack of Necessity of a Daubert Hearing
a Daubert hearing is necessary is a decision within
the sound discretion of a district court. Cook, 402
F.3d at 1113. The abuse of discretion standard “applies
as much to the trial court's decisions about how to
determine reliability as to its ultimate conclusion . . .
[i]ndeed, the Rules seek to avoid unjustifiable expense and
delay as part of their search for truth and the just
determination of proceedings.” Kumho, 526 U.S.
at 139, 152-53 (internal citations omitted). There is no
requirement that a Daubert hearing always be held.
See United States v. Hansen, 262 F.3d 1217, 1234
(11th Cir. 2001); Frazier, 387 F.3d at 1264.
case, after extensively reviewing the parties' briefings
and exhibits, the court determined that a Daubert
hearing was not necessary. Furthermore, the parties agreed to
submit their Daubert-related Motions on their
respective briefs. (See Doc. 194). Accordingly, the
court made a determination as to the admissibility of
testimony by Dr. Parisian, Dr. Hinshaw, Dr. Taylor, Dr.
Worthen, and Dr. Ricketts based on the briefing submitted by
Dr. Suzanne Parisian
offers the opinions of Dr. Parisian into evidence in this
case. Dr. Parisian has offered an expert report, dated August
31, 2015. (Doc. 125-22, the “Parisian Report”).
Dr. Parisian also offered a supplemental expert report, dated
May 2, 2016. (Doc. 125-23, the “Parisian Supplemental
Report”). Dr. Parisian was deposed on June 14, 2016,
and the deposition transcript was filed into the record.
(Doc. 125-13, the “Parisian Deposition”).
August 15, 2016, Novartis filed a Motion To Strike Dr.
Parisian's expert testimony (Doc. 108). A day later,
Novartis filed a brief in support of its Motion (doc. 125-15,
the “Parisian Brief”). On September 23, 2016,
Jones filed a Response opposing Novartis' Motion To
Strike. (Doc. 166-39, the “Parisian Response”).
On October 14, 2016, Novartis filed a reply brief in support
of its Motion To Strike. (Doc. 175, the “Parisian
Dr. Parisian's Qualifications
Parisian has been offered by Jones to address
“regulatory requirements applicable to pharmaceutical
manufacturers and drug labeling.” Parisian Response,
(Doc. 166-39) at 4. She formerly served as a Medical Officer
at the Food and Drug Administration (“FDA”).
Parisian Curriculum Vitae, (Doc. 109-5) at 1. She is
board-certified in anatomic and clinical pathology and holds
a masters degree in biology. Id. at 16; Parisian
Report, (Doc. 125-22) at 2, ¶2. From 1991 to 1995, Dr.
Parisian served as Lieutenant Commander in the Unites States
Public Health Service and was assigned to the FDA.
Id. at 2, ¶4. From 1991 to 1995, she was also
employed by the FDA in several roles, including as Medical
Officer in the Office of Health Affairs, Chief Medical
Officer in the Office of Device Evaluation, and as an
instructor in the FDA's staff college. Id. at 2,
at the FDA, her responsibilities included assessing the
health hazard and health risk of products; assessing safety
alerts, reviewing adverse event reports; drafting and review
of product labeling; promotions, advertising, and corporate
records; pre-market evaluation of new product applications
and clinical trials; review of marketing applications for
safety and efficacy; and training of FDA reviewers regarding
the design and evaluation of clinical data for proposed
products. Id. at 2-3, ¶ 5.
Medical Officer in the Office of Device Evaluation
(“ODE”), Dr. Parisian participated in the review
of proposed clinical trials and pre-marketing applications.
Id. at 4, ¶9. She also trained new medical
officers and scientific reviewers in application, clinical
trial, and labeling evaluations as well as methods for health
risk assessments, health hazard evaluations, annual report
requirements, adverse event reporting, and labeling review.
Id. As an instructor in the FDA's staff college,
she had primary responsibility for review of marketing
applications and labeling and instruction on evaluation and
review of product marketing. Id. at 5, ¶ 11.
She also presided over 162 health risk assessments convened
to advise the FDA on health risk issues for the public.
Id. at 3, ¶6. Dr. Parisian advised and trained
other FDA employees regarding FDA requirements and how to
make a determination regarding the clinical impact of FDA
actions on the public. Id. at 5-6, ¶14.
leaving the FDA in 1995, Dr. Parisian has served as a
consultant on issues related to the FDA and is the owner and
founder of MD Assist, Inc. (“MD Assist”), a firm
specializing in FDA regulation of products. Id. at
1, ¶1. She is also the author of FDA Inside and
Out, a textbook on the history, rules, and regulations
of the FDA. Id. at 2, ¶3. At MD Assist, she
designs and markets new medical products; presents marketing
applications to the FDA; designs, conducts, and reviews
clinical studies, creates and evaluates marketing
applications; drafts product labeling; investigates potential
adverse events; and instructs about the requirements of the
FDA. She has provided litigation support since 1997.
Id. at 7, ¶20.
Parisian claims that she reached her opinions in this case
using the methodology that she was first trained to use at
the FDA for clinical review and health risk assessment, as
well as her own education, training, and experience.
Id. at 8, ¶21. Jones's response brief
states that her primary role is threefold: she will explain
the responsibilities of a pharmaceutical drug manufacturer in
the context of the FDA's regulatory scheme both before
and after a drug is placed on the market; she will provide
opinions on the failure of Novartis to act as a reasonable
pharmaceutical manufacturer by failing to comply with FDA
regulations; and she will explain the meaning of specialized
terminology. Parisian Response, (Doc. 166-39) at 5.
report, Dr. Parisian offers the following opinions:
(1) There is a trend in the United States for increasing
numbers of non-healing atypical femur fractures in women.
This trend is a national public health safety issue, (doc.
125-22) at 9-10;
(2) Novartis failed to adequately design, study, test,
research, or investigate whether Reclast could safely be used
by post-menopausal patients, id. at 10-33;
(3) Novartis failed to effectively use pharmacovigilance
surveillance tools to identify a signal with zoledronic
acid/Reclast, id. at 33-41;
(4) Novartis is required to submit truthful and accurate
information to the FDA. Novartis failed to adequately and
timely update the FDA with relevant safety information
regarding the risk of femur fracture, id. at 41-50;
(5) It is not the responsibility of the FDA to ensure the
adequacy of a drug label; that responsibility lies with the
drug sponsor, id. at 50-51;
(6) Novartis did not adequately warn patients of the risks of
Reclast in its patient brochure, id. at 52;
(7) As the Reclast sponsor, Novartis was required to provide
physicians with adequate warnings about its drugs. Novartis
did not adequately warn prescribing physicians regarding the
risk of femur fracture associated with Reclast, id.
(8) Novartis, through its sales force, including Kelly Pyron,
helped delay providing health care providers with adequate
and truthful information about the long-term risks of
Reclast. Novartis' drug advertising and communications
with health care providers were not fair and balanced,
id. at 58-66;
(9) Novartis' conduct regarding acknowledging a risk of
femur fractures is similar to its conduct regarding
bisphosphonate-related osteonecrosis of the jaw, id.
(10) Ernesteen Jones fit the profile for Novartis'
marketing strategy, id. at 71-74;
(11) The report on Ms. Jones's adverse events is
indicative of Novartis' failure to conduct meaningful
pharmacovigilance, id. at 74-75;
(12) Novartis' actions regarding Reclast do not support
that patient safety was its highest priority. Its actions
were misleading and directly impacted the quality of life of
patients, including Ernesteen Jones, id. at 75.
Parisians's supplemental report offers the following
(1) Novartis submitted a 2008 report to the FDA that was
inaccurate and misleading and downplayed the risk of AFF with
Reclast, (doc. 125-23) at 6-8;
(2) Novartis in 2015 submitted inaccurate and misleading
information to the FDA in its Errata Document regarding AFF,
id. at 8-25;
(3) Opinions on the Expert Report of Dr. David Feigal,
id. at 26-43.
Novartis' Motion To Exclude Dr. Parisian's Testimony
Is Granted in Part and Otherwise Is Denied
Novartis first argues that all of Dr. Parisian's
testimony should be fully excluded because she lacks adequate
expertise, she does not employ a reliable methodology, and
her opinions would not assist the jury.
court finds that Dr. Parisian is qualified, based on her
experience at the FDA as a Medical Officer, to offer
testimony about regulatory requirements for the testing,
marketing, and development of prescription drugs. Even though
her time at the FDA was primarily spent on medical devices,
Dr. Parisian has extensive experience with the regulation of
drugs. Her report further demonstrates that she has
particularized knowledge of the FDA standards that apply to
also followed an appropriate methodology. Experts are
permitted to draw conclusions from a set of observations that
are based on their extensive and specialized experience.
Kumho Tire, 526 U.S. at 156, 119 S.Ct. at 1178. Dr.
Parisian is a regulatory expert who has drawn conclusions
based on her review of regulatory filings and company
documents in light of FDA regulations and her experience at
the FDA. She claims she used the methodology she was trained
to use at the FDA “for clinical review and health risk
assessment, as well as her scientific and medical education,
professional training, and experience.” Parisian
Report, (Doc. 125-22) at 7-8, ¶¶ 20-21. However,
the court's general acceptance of her methodology does
not mean that all aspects of her testimony will be admitted.
to the extent that her opinions are admissible, her
assessment would be helpful to the jury to understand the
complex, technical topic of FDA regulations. See In re
Mirena IUD Products Liability Litigation, 169 F.Supp.3d
396, 474 (E.D.N.Y. 2016) (“Expert testimony from a
regulatory expert on complicated schemes like the FDA's
statutory framework, as well as opinions on the adequacy of a
drug's label and the reasonableness of a pharmaceutical
company's conduct, are useful in assisting the trier of
relies on Hogan v. Novartis Pharms. Corp., No.
06-CV-260, 2011 WL 1533467 (E.D.N.Y. Apr. 24, 2011), which is
one of the few cases where the court fully excluded all
testimony by Dr. Parisian. However, Hogan differs from
the current litigation because, in that case, the plaintiff
brought common law claims that were unrelated to FDA
regulations, so testimony from a regulatory expert was not
needed. Id. at *2. Here, Jones argues that FDA
regulations impact her claims, so Dr. Parisian's
testimony and her expertise would be helpful to a jury.
Parisian Response, (Doc. 166-39) at 15.
also relies on In re Prempro Prod. Liab. Litig., 554
F.Supp.2d 871 (E.D. Ark. 2008), aff'd in part,
rev'd in part, 586 F.3d 547 (8th Cir. 2009), to
demonstrate that Dr. Parisian's testimony should be
excluded. The district court in In re Prempro
initially allowed her to testify in both the compensatory and
punitive damages phases of the trial. However, the district
court struck her punitive damages testimony post-trial
because Dr. Parisian had mainly read from documents and
provided unhelpful narrative testimony. 586 F.3d at 570. The
Eighth Circuit held that the district court's error in
admitting Dr. Parisian's testimony in the punitive
damages phase was prejudicial error that warranted a new
trial on punitive damages. Id. at 573. While In
re Prempro guides the court to scrutinize Dr.
Parisian's testimony closely for narrative testimony or
other impermissible statements, it does not suggest that Dr.
Parisian's testimony should be excluded in full.
support her claim that Dr. Parisian's testimony is
credible, Jones cites to several cases where Dr.
Parisian's testimony was permitted in part and excluded
in part. See, e.g., Kruska v. Novartis Pharms.
Corp., 28 F.Supp.3d 920, 934 (D. Minn. 2014) (denying
motion to fully exclude Dr. Parisian's testimony);
Lemons v. Novartis Pharms. Corp., 849 F.Supp.2d 608,
613 (W.D. N.C. 2012) (“Exclusion of [Dr.
Parisian's] testimony in the entirety would be
explained below, Dr. Parisian is qualified and will be
permitted to testify about the FDA regulatory process.
However, her testimony will be limited and excluded in part.
Jones agrees that Dr. Parisian will not testify as to
Novartis' intent or state of mind, so any testimony on
these issues is not admissible. Parisian Report, (Doc.
125-22) at 9, ¶ 23. Additionally, Dr. Parisian is not
qualified and will not be permitted to testify regarding
causation or “causal association”; whether and
when Novartis was put on “notice”; whether any
advertising or marketing changes might have impacted the
opinion of a physician; studies conducted on other BP drugs;
pharmaceutical industry standards; correlations between AFF
and osteonecrosis of the jaw; and other improper legal
Causation and “Causal
argues that Dr. Parisian lacks the expertise to testify on
either causation or “causal association.” In her
deposition, Dr. Parisian agreed that she is not a causation
expert and does not intend to offer a medical opinion about
causation. Parisian Deposition, (Doc. 125-13) at
13(46:9-47:2) (“For Mrs. Jones - in terms of one
patient, I'm not the causation person. It has to be the
surgeon who's taking care of her.”). As a
regulatory expert rather than a medical expert, Dr. Parisian
does not have the expertise or qualifications to testify as
to general or specific causation.
argues, however, that Dr. Parisian should be able to testify
relating to “causal association, ” as the term is
used in FDA regulations. See 21 C.F.R.
201.57(c)(6)(i) (providing that a drug's “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 definitively established.”). In her
Response brief, Jones attempts to distinguish Dr.
Parisian's use of causal association terminology from
medical causation. Parisian Response, (Doc. 166-39) at 27-31;
see Parisian Deposition, (Doc. 125-13) at
78-79(309:13-310:1)(“[I]n terms of the way the FDA is
talking about causal association, it's not that high of a
bar. It's not causation.”)). Novartis counters that
Dr. Parisian is engaging in “verbal semantics”
and is attempting to create a back-door method of testifying
to medical causation without violating her stipulation.
Parisian Reply Brief, (Doc. 175) at 7.
Parisian's attempts to distinguish her opinion as a
“causal association” opinion rather than a
causation opinion fall short of the mark. First, Dr. Parisian
has failed to sufficiently define causal association, as
found in 21 C.F.R. 201.57(c)(6)(i), or distinguish it from
medical causation. She states in her deposition that in order
to make a label change pursuant to FDA regulations, you must
have “reasonable evidence of a causal
association.” Parisian Deposition, (Doc. 125-13) at
78(309:22-310:1). Dr. Parisian will be permitted to tell the
jury what FDA regulations require in terms of label changes,
including what action is required if a drug manufacturer has
“reasonable evidence” of a causal association
between a drug and an injury. However, she will not be
permitted to testify whether Novartis had reasonable evidence
or whether Novartis should have changed its label for
her assertions to the contrary, Dr. Parisian has implicitly
provided her own causation opinion in both her report and her
deposition. See Parisian Supplemental Report, (Doc.
125-23) at 38-39, ¶ 93 (“[bisphosphonates] may not
be the only cause of AFF, but it is one drug class that has
been linked to AFF.”); Id. at 38, ¶92
(“it is my opinion that . . . there is
‘reasonable evidence of a causal
association' sufficient to trigger Novartis'
duty to update its Reclast label to provide adequate risk
information.”) (emphasis in original).
Supplemental Expert Report, Dr. Parisian states that she has
based her causation association opinion on “the
evidence of [bisphosphonates] and zoledronic acid”; the
“occurrence of femur fractures in Study 2301"; the
“lack of adequate pharmacovigilance practices to work
up femoral fractures”; and the
“literature.” Parisian Supplemental Report, (Doc.
125-23) at 38, ¶ 92. However, Dr. Parisian cites to no
specific medical literature establishing a causal
association, and she neither specifies why Study 2301
demonstrated a causal association nor explains why Novartis
should be responsible for the lack of adequate
pharmacovigilance practices. Id. Dr. Parisian is not
an endocrinologist and does not otherwise have the expertise
to review medical literature on femoral fractures and opine
on whether a correlation between a disease and an alleged
injury amounts to a causal association.
another district court recently determined, Dr. Parisian is
not qualified to opine “either that the risk was
clinically significant or that there was reasonable evidence
of causal association”; she could “testify as to
what Defendants should have done in terms of investigation
based on the post-marketing information available to them,
but may not opine that that information amounted to evidence
of causal association sufficient to warrant a label
change.” In re Mirena, 169 F.Supp.3d at 476
cites to Hill v. Novartis Pharms. Corp., No.
06-CV-939, 2012 WL 5451809 (E.D. Cal. Nov. 7, 2012) to
support her argument that Dr. Parisian is qualified to opine
as to whether a pharmaceutical company should be responsible
for failing to warn of a causal association. However, the
court in Hill merely denied the defendant's
motion to exclude Dr. Parisian's testimony on causal
association as a “causation opinion in disguise”
without providing any explanation to help guide this
court's analysis. Therefore, this court will not rely on
Hill as persuasive authority.
Parisian's expertise lies in FDA regulations and in
corporate compliance with FDA regulations. Her expertise does
not lie in reviewing medical literature or determining
whether causal associations exist between products and
clinically significant hazards. Therefore, she has the
expertise to explain the technical terminology of 21 C.F.R.
201.57(c)(6)(i) to a jury, but she does not have the
expertise to assess whether a causal association existed that
would impact Novartis' alleged failure to warn.
Therefore, none of Dr. Parisian's testimony as to the
existence of either causation or causal association will be
permitted in front of a trier of fact in this case.
also argues that Dr. Parisian does not have sufficient
experience to discuss labeling and product warnings. However,
this argument overlooks Dr. Parisian's extensive
experience with reviewing proposed labeling and providing
comments for patient brochures. For example, Dr.
Parisian's report states that while she was at the
FDA's Office for Device Evaluation, she trained medical
officers on labeling review, among other types of
assessments. Parisian Report, (Doc. 125-22) at 4, ¶9.
Further, during her time at the FDA, she helped design an FDA
epidemiologic study that was created to capture risk to the
public and “trigger the appropriate label changes for
both the involved drugs and devices in order to protect the
public.” Id. at 4, ¶8.
other courts that have scrutinized Dr. Parisian's
qualifications and only allowed her testimony in part have
allowed Dr. Parisian to testify about communications between
the FDA and Novartis regarding Novartis' labeling.
See Lemons v. Novartis Pharms. Corp., 849 F.Supp.2d
608, 614 (W.D. N.C. 2012) (“Dr. Parisian's
experience and expertise with the FDA and its regulatory
scheme does render her fit to offer testimony on the issue of
Novartis' interactions with the FDA on the subject of
labeling.”); Rowland v. Novartis Pharms.
Corp., 9 F.Supp.3d 553, 561 (W.D. Pa. 2014) (allowing
Dr. Parisian to testify about the FDA”s requirements
for labeling and the adequacy of the product warnings and
labels due to her FDA experience and expertise). The court in
Rowland, however, found Dr. Parisian's testimony
regarding alternative actions physicians might have
taken had they received different warnings required an
“impermissible degree of speculation from Dr. Parisian,
as she is not an oncologist.” Id. at 562;
see also Stambolian v. Novartis Pharms. Corp., No.
12-CV-4378, 2013 LEXIS 173016 at *29 (C.D. Cal. Dec. 6, 2013)
(“Dr. Parisian is not qualified to offer testimony as
to what decisions prescribing doctors would have made had
they been given different labeling information . . . Dr.
Parisian is not an oncologist. Therefore, such testimony
would be outside the scope of her expert knowledge.”).
cites to this court's decision in Thomas v. Evenflo
Co., No. 2:02-CV-2001, 2005 WL 6133409, at *14 (N.D.
Ala. August 11, 2005), aff'd 205 F. App'x
768 (11th Cir. 2006), where the plaintiff was not permitted
to testify on labeling because he did not follow accepted
methodology in determining warnings were defective and did
not provide alternative warning language. However, unlike the
expert in Thomas, this court finds that Dr. Parisian
has the expertise to discuss the adequacy of warnings and
labels based on her contributions to the FDA study that
discussed label changes and the associated risks to the
public. Dr. Parisian substantiates her methodology
by stating that she employed the same approach while at the
FDA, and her opinion on Novartis' label cites frequently
to applicable FDA regulations. Parisian Report, (Doc. 125-22)
court finds persuasive the distinction other courts have
drawn between allowing Dr. Parisian to discuss FDA label
compliance and adequacy of labeling versus allowing her to
speculate about the potential impact of a label change on
prescribing physicians. Therefore, Dr. Parisian will be
permitted to testify to communications between Novartis and
the FDA regarding Reclast label changes and the adequacy of
the Reclast label, but she will not be permitted to testify
to the potential impact a Reclast label change would have had
on treating physicians if the labeling change had occurred.
“Notice” to Novartis, including Study
Novartis seeks to prevent Dr. Parisian from testifying that
certain events should have put Novartis on notice that
Reclast could cause harm. First, for the purposes of this
litigation, Dr. Parisian will not be permitted to testify to
any studies, reports, or trials that were published after
September 2011, when Jones alleges that she first developed
symptoms of thigh pain, as they could not have put Novartis -
or Jones's treating physicians - on notice.
Dr. Parisian was involved in clinical trials as a medical
officer in the FDA's Office of Device Evaluation.
See Parisian Report, (Doc. 125-22) at 4, ¶9
(“I participated in the review of proposed clinical
trials, the review of pre-marketing applications . . . and
training new medical officers” in clinical trial
evaluation). Therefore, she is qualified to testify about the
operations of clinical trials and the FDA review process for
proposed clinical trials.
Dr. Parisian will not be permitted to testify to
“notice” as a method of circumventing the
court's ruling preventing her from discussing causation,
and Jones's assertion that Dr. Parisian should be
permitted to testify about all notice to Novartis is
overbroad. See Parisian Response, (Doc. 166-39) at
32. Dr. Parisian is a regulatory expert, yet in her report
she opines that certain drug potencies, a study on match
factory workers in the 19th century, and causal associations
between other BP drugs and femur fractures should
all have put Novartis on “notice.” See
Parisian Report, (Doc. 125-22) at 10-13, ¶¶ 30-36.
Dr. Parisian is not an expert on bisphosphonate medications,
a toxicologist, or a pharmacologist, and she will not be
permitted to opine that Novartis should have conducted safety
evaluations more quickly or should have noticed a link
between bisphosphonates and femur fractures earlier. See
Kruska v. Novartis Pharms. Corp., 28 F.Supp.3d 920, 934
(D. Minn. 2014)(finding that Dr. Parisian is not an expert on
bisphosphonate medications and may not offer testimony on
particular, Novartis objects to Dr. Parisian's reliance
on Study 2202 to demonstrate that Novartis was put on notice.
Study 2202 was a clinical trial where children with a severe
genetic disorder called osteogenesis imperfecta
(“OI”) were injected with zoledronic acid either
once or twice a year. Parisian Report, (Doc. 125-22) at 19,
¶58. While Study 2202 was conducted on pediatric
patients with OI, Reclast is a drug designed for
postmenopausal women with osteoporosis. See Parisian
Reply Brief, (Doc. 175) at 14. As the Eleventh Circuit has
stated, “even minor deviations in chemical structure
can radically change a particular substance's properties
and propensities.” Rider v. Sandoz Pharm.
Corp., 295 F.3d 1194, 1201 (11th Cir. 2002) (internal
quotation and citation omitted).
Dr. Parisian is qualified to testify generally to the review
process for Study 2202, as well as the results, she does not
have the expertise to opine that Study 2202 put Novartis on
“notice” or to compare the chemical structures of
the drug used in Study 2202 with Reclast.
Advertising and Marketing
argues that Dr. Parisian is not qualified to discuss a
pharmaceutical company's marketing or advertising to
physicians. It also argues that her opinion is not reliable
because she has formed improper conclusions about the extent
to which Reclast advertising and marketing was communicated
to one of Jones's prescribing physicians. (Doc. 125-15)
at 22. Jones counters that her experience at the FDA fully
qualifies her to render her opinion on advertising and
marketing. (Doc. 166-39) at 33.
Parisian is qualified to give her opinion on whether
Novartis' marketing and advertising complied with FDA
regulations. While at the FDA, Dr. Parisian helped draft FDA
guidance documents that outlined “the requirements for
obtaining FDA's marketing approval and the FDA Safety
Alerts directed to healthcare providers and their
patients.” Parisian Report, (Doc. 125-22) at 5, ¶
13. Further, while serving as an instructor in the FDA's
Staff College for training FDA reviewers, she was responsible
for reviewing marketing applications and “teach[ing]
medical officers the process for evaluation and review
required by FDCA directed to product marketing.”
Id. at 4-5, ¶10. Therefore, Dr. Parisian has
the expertise to opine on whether Novartis' marketing
complied with FDA regulations.
Parisian's report cites to 21 C.F.R. § 202.1, which
sets out the requirements for prescription drug
advertisements, as well as 21 C.F.R. §§ 201, 202,
314, and 352. See Id. at 61, ¶200; 66,
¶213. Her report also cites to 21 C.F.R. § 314.80,
which outlines the requirements of post-marketing reporting
of adverse drug experiences. Id. at 61, ¶200
(“It is also required as part of pharmacovigilance (21
C.F.R. 314.80) to have investigated and obtained accurate
post-market safety information about the risks of
Reclast.”). In some areas of her report, she properly
ties her analysis of Novartis' marketing and sales
practices to pertinent FDA regulations. See Id.
(concluding that a directive to the Novartis sales team was
“not permitted by the FD&C Act or implementing
other areas of her report impermissibly extend beyond
compliance with FDA advertising and marketing and into the
“intent” or “state of mind” of
Novartis. See Id. at 58, ¶190 (“Novartis
chose not to accurately update its sales force or prescribers
about the growing risk of association.”). Her report
also speculates about whether Jones's prescribing
physician, Dr. Traylor, was actually provided with certain
sales and marketing information before prescribing Reclast.
Id. at 58-59, ¶191. Allowing Dr. Parisian to
testify as to the actions prescribing doctors would have
taken with adequate labeling amounts to impermissible
speculation by her. In these speculative statements, Dr.
Parisian does not outline a sufficiently sound methodology
for assessing the adequacy of advertising or marketing and
does not apply the language of any FDA regulation to an
allegedly improper marketing mechanism.
briefing cites to other courts which have found that Dr.
Parisian does not possess the qualifications to assess
whether Novartis' communication of risks to health care
providers, through drug sponsors or members of the sales
team, was appropriate. See Lemons v. Novartis Pharms.
Corp., 849 F.Supp.2d 608, 615 (W.D. N.C. 2012)
(“Dr. Parisian does not possess the requisite
experience or expertise, as an employee or insider of a
pharmaceutical drug sponsor, to opine on the conduct of
Novartis.”); Kruska v. Novartis Pharms. Corp.,
28 F.Supp.3d 920, 935 (D. Minn. 2014) (“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 as she has in the past.”);
see also Deutsch v. Novartis Pharms. Corp., 768
F.Supp.2d 420, 468 (E.D.N.Y. 2011) (“Dr. Parisian is
not qualified to opine on the ethical standards in the
pharmaceutical industry, not is she qualified to testify as
to any obligations Novartis may have had to the medical
community in addition to the FDA
requirements.”) (emphasis added).
cites to Earp v. Novartis Pharms. Corp., No.
5:11-CV-680, 2013 WL 4854488 (E.D. N.C. Sept. 11, 2013) for
the proposition that Dr. Parisian should be allowed to
provide all of the advertising and marketing opinions in her
report and deposition. However, the court in Earp
merely summarily states that her expertise at the FDA
qualified her to testify to the approval, advertising, and
marketing of drugs without any further specificity or helpful
parameters. Id. at *4. Jones also cites to
Stambolian, 2013 LEXIS 173016 at *29, where the
court found that Dr. Parisian was qualified to speak to the
FDA's requirements for labeling and marketing. However,
the court in Stambolian also excluded Dr.
Parisian's testimony on the actions physicians might have
taken with adequate labeling or marketing and other matters
outside the scope of her knowledge. Id. at *28.
like with the court's “labeling” analysis,
the court finds that Dr. Parisian is qualified to opine
whether Novartis complied with FDA advertising and marketing
regulations. However, Dr. Parisian will not be permitted to
extend her testimony beyond that scope.
Novartis' 2008 and 2015 Reports to the
Novartis argues that Dr. Parisian should not be permitted to
testify regarding the adequacy of Novartis' 2008 and 2015
reports to the FDA because her opinions do not properly cite
to FDA regulations and her opinion would be both unreliable
and unhelpful to a jury. Parisian Brief, (Doc. 122-15) at
24-25. Jones counters that Dr. Parisian has the expertise to
testify that Novartis' communications in its 2008 and
2015 reports to the FDA were misleading and inaccurate.
Parisian Response, (Doc. 166-39) at 33-36. Novartis also
argues that any omission it may have made in its reports was
a product of “inadvertent human error, ” so Dr.
Parisian's opinions on the adequacy of Novartis'
reporting are irrelevant. Parisian Reply, (Doc. 175) at 13.
speaking, an assessment of the reasonableness of a
pharmaceutical company's conduct in conforming with FDA
regulations and in communicating with the FDA would be
helpful to a jury. Further, it is well within Dr.
Parisian's area of expertise to discuss a company's
compliance with FDA regulations.
cites to In re Mirena, 169 F.Supp.3d at 481, where
the court allowed Dr. Parisian to testify as to the
reasonableness of another pharmaceutical company's
conduct so long as Dr. Parisian did not attempt to offer
narrative testimony or merely regurgitate statements from
company documents with little analysis. Jones also cites to
Deutsch v. Novartis Pharms. Corp., 768 F.Supp.2d 420
(E.D.N.Y. 2011), where the court found that Dr. Parisian had
the expertise to discuss the “reasonableness of
Novartis' conduct in its interactions with the
FDA.” Id. at 468 (emphasis added).
argues that Dr. Parisian should not be allowed to opine on
communications between the FDA and Novartis regarding the
2008 and 2015 reports because she does not cite to specific
FDA standards that were purportedly violated. To support its
claim, Novartis cites to In re Trasylol Prods. Liab.
Litig., where the court barred Dr. Parisian's
testimony in full because she did not back up her opinions
that the company behaved inappropriately with a citation to
any FDA standard that was violated. 709 F.Supp.2d 1323, 1350
(S.D. Fla. 2010). Novartis also cites to this court's
opinion in Thomas, 2015 WL 6133409 at *15, where
this court excluded the expert's opinion as nothing more
than a “bare assertion” without any citations to
the record to support his opinions.
Novartis does not dispute that Dr. Parisian is qualified to
testify to the communications between the FDA and a
pharmaceutical company, particularly regarding requests made
by the FDA. Further, Dr. Parisian's Supplemental Report,
which criticizes Novartis' 2008 and 2015 reports as
inaccurate and misleading, specifically references FDA
regulations and applies those regulations to Novartis'
conduct. See Supplemental Report, (Doc. 125-23) at
¶¶ 65, 75, 83, 94. She also discusses in detail FDA
terminology and processes, including the process of
conducting a safety labeling change notification.
Id. at 35, ¶83.
Dr. Parisian has demonstrated that she applied appropriate
methodology in formulating her opinions on Novartis' 2008
and 2015 reports to the FDA. She will be permitted to testify
regarding the adequacy of these communications, and Novartis
will be able to critique her methodology on cross-exam.
Intent and State of Mind
agrees that Dr. Parisian will not testify as to Novartis'
intent or state of mind. Parisian Brief, (Doc. 125-15) at 22;
see also Parisian Report, (Doc. 125-22) at 9, ¶
23 (“There are no unsupported opinions intended to be
offered regarding the ‘state of mind' or
‘intent' of Novartis.”). Accordingly, any
testimony on these issues will be excluded.
Jones argues that Dr. Parisian should still be able to
express opinions on what Novartis was “aware” of
or “knew” based on the information that was in
its possession. She cites to Block v. Woo Young Med.
Co., 937 F.Supp.2d 1028, 1045 (D. Minn. 2013), where the
court excluded testimony on corporate motive or intent but
allowed Dr. Parisian to testify to “the state of the
medical literature, the state of FDA approval, and other
information about which [the company] should have been
aware.” Jones also cites to In re Mirena, 169
F.Supp.3d at 479, where the court allowed Dr. Parisian to
testify to what the company “knew, ” in the sense
of what information was in its possession. The court also
allowed Dr. Parisian to testify to what the FDA “would
have done in a typical situation when presented with a set of
facts” and to what the FDA or the company's intent
was, only to the extent that it was clear from public
documents. Id. at 479-80.
in comparison, relies on Jenkins v. Novartis Pharms.
Corp, 2012 WL 6213494 at *6 (E.D. Tenn. Dec. 13, 2012),
where the court allowed Dr. Parisian to testify about when
certain materials were submitted to the FDA but excluded
testimony on what Novartis “knew” because
knowledge is an issue properly reserved for the jury. See
Id. (“Dr. Parisian has no specialized knowledge or
scientific/medical expertise that provides her with a
superior ability to judge Novartis's knowledge, and there
is no basis for finding that the jury needs her assistance in
evaluating Novartis's knowledge.”); see also In
re Trasylol, 709 F.Supp.2d at 1338 (excluding Dr.
Parisian from addressing Novartis' intent, motive, or bad
faith); Bartoli v. Novartis Pharms. Corp., No.
3:13-CV-0724, 2014 WL 1515870 at *5 (M.D. Pa. April 7, 2014)
(same); Lopez v. I-Flow, Inc., 2011 WL 1897548 at
*11 (E.D. N.C. Jan. 9, 2012) (excluding Dr. Parisian from
testifying to the knowledge, state of mind, or motivations of
either the pharmaceutical company or the FDA itself).
of Jones's reassurances, any testimony on Novartis'
state of mind or intent is excluded as a question for the
jury rather than for Dr. Parisian. Dr. Parisian may, however,
testify regarding what information was or should have been,
pursuant to specific FDA regulations, in
References to Osteonecrosis of the Jaw
argues that Dr. Parisian should be excluded from opining on
bisphosphonate-related osteonecrosis of the jaw
(“BRONJ”) or osteonecrosis of the jaw generally
(“ONJ”), as she does in both her report and
supplemental report. Jones counters that because Zometa,
another Novartis drug that was associated with BRONJ, and
Reclast, the subject of this litigation, are
“chemically identical, ” it is proper for Dr.
Parisian to discuss the entire class of drugs. Parisian
Response, (Doc. 166-39) at 38. However, arguments of counsel
are not evidence. Moreover, even if the two drugs are
“chemically identical, ” even Jones admits the
dosages are different, as are the alleged injuries.
Eleventh Circuit has explained, even “minor deviations
in chemical structure can radically change a particular
substance's properties and propensities.” Rider
v. Sandoz Pharm. Corp., 295 F.3d 1194, 1201 (11th Cir.
2002) (internal quotation and citation omitted) (excluding an
expert witness from testifying that, because other drugs in
the same class cause a certain effect, a drug from that class
must cause the same effect as well). Jones has not cited any
case law to support her claim that a regulatory expert should
be able to opine on a different type of injury, associated
with a different drug, than the injury that is the subject of
the current litigation. Further, Jones has not established
why any discussion of chemical analogies would help, rather
than confuse, a jury.
Dr. Parisian is prohibited from testifying regarding ONJ,
BRONJ, and Novartis' drug Zometa.
Conclusion as to the Admissibility of Dr.
on the foregoing, Novartis' Motion To Strike Dr.
Parisian's testimony (doc. 108) is due to be DENIED to
the extent that it seeks to exclude Dr. Parisian's
testimony in its entirety. However, Novartis' Motion is
due to be GRANTED IN PART and DENIED IN PART as to the
particular areas of Dr. Parisian's testimony that it
seeks to exclude.
Parisian may testify on the following issues: (1)
Novartis' interactions with the FDA on the subject of
labeling; (2) compliance and/or noncompliance with FDA
regulations on advertising and marketing; (3) Novartis'
conduct in communicating with the FDA, including the 2008 and
2015 reports; and (4) what information Novartis should have
had, based on specific FDA regulations.
Parisian may not testify on the following issues: (1)
causation, including “causal association”; (2)
how a change in labeling might have impacted the decision of
a prescribing physician; (3) whether or not Novartis was put
on “notice, ” including by Study 2202; (4) how a
change in advertising and marketing might have impacted the
decision of a prescribing physician; (5) Novartis' state
of mind, intent, or motive, including what Novartis
“knew”; and (6) comparisons between ONJ, BRONJ,
or the drug Zometa.
Dr. William B. Hinshaw
also offers the opinions of Dr. Hinshaw into evidence. Dr.
Hinshaw has offered both an expert report (doc. 125-26, the
“Hinshaw Report”) and a supplemental expert
report (doc. 125-25, the “Hinshaw Supplemental
Report”). Dr. Hinshaw was deposed on June 1, 2016, and
the deposition transcript was filed into the record (doc.
125-21, the “Hinshaw Deposition”).
August 15, 2016, Novartis filed a Motion To Strike Dr.
Hinshaw's expert testimony (Doc. 112) and a brief in
support of its Motion (doc. 125-20, the “Hinshaw
Brief”). On September 19, 2016, Jones filed a Response
opposing Novartis' Motion To Strike. (Doc. 166-41, the
“Hinshaw Response”). On October 14, 2016,
Novartis filed a reply brief in support of its Motion To
Strike. (Doc. 180, the “Hinshaw Reply”).
Dr. Hinshaw's Qualifications
Hinshaw is Jones's designated scientific expert and
offers opinions on both general and specific causation.
Hinshaw Response, (Doc. 166-41) at 4. Dr. Hinshaw is a
bioorganic chemist and a practicing gynecologist,
specializing in menopause and clinical management of bone
fragility. Hinshaw Report, (Doc. 125-26) at 2. He received a
B.S. degree in Chemistry in 1963 from Duke University and a
Ph.D. in Biomimetic Organic Chemistry in 1967 from Stanford
University. Id. He received a medical degree from
Albany Medical College in 1978. Id. Subsequently, he
completed a four-year residency in Obstetrics and Gynecology
at Albany Medical Center Hospital, serving as the chief
senior resident. Id.
1983, Dr. Hinshaw has worked as a board-certified
gynecologist. Hinshaw Curriculum Vitae, (Doc. 125-26) at
21-23. Approximately ninety percent of his current
gynecological practice is devoted to “hormonal
aberrations of menopause which are associated with problems
of bone fragility.” Hinshaw Response, (Doc. 166-41) at
7. Dr. Hinshaw served as an assistant investigator during a
clinical trial involving a non-Reclast BP drug around 1997.
Hinshaw Deposition, (Doc. 125-21) at 7 (18:14-19:23).
2012, Dr. Hinshaw authored a peer-reviewed article titled
“Using Medical Chemistry to Solve an Old Medical
Mystery” that discussed unusual femur fractures
suffered by match factory workers in the nineteenth century.
Hinshaw CV, (Doc. 125-26) at 24. In total, Dr. Hinshaw has
published twenty-one peer-reviewed articles, five of which
pertained to phosphorous chemistry, bone fragility, and
fractures. See Id. In 2012, he co-authored an
article titled “Atypical Femur Fractures: 81 Individual
Personal Histories, ” that was published in the Journal
of Clinical Endocrinology and Metabolism. Id. In
fall 2016, Dr. Hinshaw co-authored an article, titled An
Evaluative History of Bisphosphonate Drugs: Dual Physiologic
Effects of Pyrophosphate as Inspiration for a Novel
Pharmaceutical Class, that was accepted by the Journal
of Osteoporosis for publication. See (Doc. 169).
claims that Dr. Hinshaw has reviewed scientific literature on
the chemistry and kinetics of BPs on bone and has studied
early scientific literature of the effect of pyrophosphates
on bone. Hinshaw Response, (Doc. 166-41) at 9. Jones states
that Dr. Hinshaw has primarily been offered “to explain
to the jury the science of bone self-repair and Reclast's