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Jones v. Novartis Pharmaceuticals Corp.

United States District Court, N.D. Alabama, Southern Division

January 26, 2017

ERNESTEEN JONES, Plaintiff,
v.
NOVARTIS PHARMACEUTICALS CORPORATION, Defendant.

          MEMORANDUM OPINION AND ORDER

          VIRGINIA EMERSON HOPKINS, United States District Judge

          I. INTRODUCTION

         This 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 experts:

• Dr. Suzanne Parisian (“Dr. Parisian”), the “Parisian Motion” (doc. 108);[1]
• 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” (doc. 118).

         II. PROCEDURAL HISTORY

         Plaintiff Ernesteen Jones (“Jones”) initiated this lawsuit against Novartis on April 4, 2013 (doc. 1), alleging that she developed atypical femur fractures (“AFF”)[2] 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.[3] 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, ¶ 8.

         On 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, ¶¶ 17-18.

         Jones 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).

         III. STANDARD FOR THE ADMISSIBILITY OF EXPERT TESTIMONY

          A. General Requirements - Judge as Gatekeeper

         Regarding expert testimony, the Federal Rules of Evidence provide:

         A 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 methods; 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).

         All 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)).

         In 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 omitted).

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).

         The 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).

         B. The Eleventh Circuit Test for Admissibility

         The 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 in issue.

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.

         1. Prong One: The Expert Must Be Qualified To Testify to the Relevant Issue

          To 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.

         The 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.

         2. Prong Two: The Expert's Opinion Must Be Sufficiently Reliable

          To 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 517).

         Pursuant 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.

         C. Legal Standard for Causation Experts

         In the 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 emphasis added).

Chapman, 766 F.3d at 1303-04. This case clearly falls into the latter category.

         Accordingly, reliable expert testimony must establish both general and specific causation.

         1. General Causation Standard

         General 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) (“Restatement”).

         2.Specific Causation Standard

         Specific 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.”).

         The 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 causation;”
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 individual causation;”
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 (2003)).

         D. Lack of Necessity of a Daubert Hearing

         Whether 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.

         In this 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 the parties.

         IV. ANALYSIS

         A. Dr. Suzanne Parisian

         Jones 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”).

         On 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 Reply”).

         1. Dr. Parisian's Qualifications

         Dr. 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, ¶5.

         While 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.

         As a 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.

         Since 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.

         Dr. 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.

         2.Dr. Parisian's Opinions

         In her 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. at 52-58;
(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. at 66-71;
(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.

         Dr. Parisians's supplemental report offers the following opinions:

(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.

         3. 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.

         The 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 drug manufacturers.

         She has 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.

         Further, 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 fact.”).[4]

         Novartis 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.[5] 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.

         Novartis 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.

         To 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 inappropriate.”).

         As 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 conclusions.

         a. Causation and “Causal Association”

         Novartis 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.

         Jones 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.

         Dr. 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.[6] 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 Reclast.

         Despite 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).

         In her 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.

         As 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 n.76.

         Jones 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.

         Dr. 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.

         b. Labeling

         Novartis 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.

         Several 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.”).

         Novartis 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.[7] 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) at 50-51.

         This 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.

         c.Notice” to Novartis, including Study 2202

          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.

         Second, 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.

         However, 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 that issue).

         In 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).

         Though 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.

         d. Advertising and Marketing

         Novartis 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.

         Dr. 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.

         Dr. 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 regulations”).

         However, 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.

         Novartis' 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).

         Jones 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.

         Therefore, 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.

         e. Novartis' 2008 and 2015 Reports to the FDA

          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.

         Generally 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.

         Jones 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).

         Novartis 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.

         However, 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.

         Therefore, 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.

         f. Intent and State of Mind

         Jones 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.

         However, 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.

         Novartis, 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).

         Regardless 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 Novartis' possession.

         g. References to Osteonecrosis of the Jaw (“ONJ”)

         Novartis 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. Id.

         As the 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.

         Therefore, Dr. Parisian is prohibited from testifying regarding ONJ, BRONJ, and Novartis' drug Zometa.

         4. Conclusion as to the Admissibility of Dr. Parisian's Testimony

         Based 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.

         Dr. 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.

         Dr. 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.

         B. Dr. William B. Hinshaw

         Jones 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”).

         On 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”).

         1. Dr. Hinshaw's Qualifications

         Dr. 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.

         Since 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).

         In 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).

         Jones 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 ...


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