Georges v. Novartis Pharms. Corp.

Full title: Adriann Georges v. Novartis Pharmaceuticals Corp., et al.

Court: UNITED STATES DISTRICT COURT CENTRAL DISTRICT OF CALIFORNIA

Date published: Nov 2, 2012

CASE NO.: CV 06-5207 SJO (VBKx) (C.D. Cal. Nov. 2, 2012)

Opinion

CASE NO.: CV 06-5207 SJO (VBKx)

11-02-2012

Adriann Georges v. Novartis Pharmaceuticals Corp., et al.

THE HONORABLE S. JAMES OTERO, UNITED STATES DISTRICT JUDGE

CIVIL MINUTES - GENERAL

PRESENT: THE HONORABLE S. JAMES OTERO, UNITED STATES DISTRICT JUDGE Victor Paul Cruz
Courtroom Clerk Not Present
Court Reporter

COUNSEL PRESENT FOR PLAINTIFF:

Not Present

COUNSEL PRESENT FOR DEFENDANT:

Not Present PROCEEDINGS (in chambers): ORDER DENYING DEFENDANT'S MOTION TO EXCLUDE CAUSATION TESTIMONY OF DR. ERIC SUNG [Docket No. 60]; ORDER GRANTING IN PART AND DENYING IN PART DEFENDANT'S MOTION TO EXCLUDE TESTIMONY OF DR. SUZANNE PARISIAN [Docket No. 58]; ORDER GRANTING IN PART AND DENYING IN PART DEFENDANT'S MOTION TO EXCLUDE TESTIMONY OF DR. ROBERT MARX [Docket No. 54] This matter comes before the Court on Defendant Novartis Pharmaceuticals Corporation's ("Defendant") three related motions: (1) Motion to Exclude Causation Testimony of Dr. Eric Sung ("Sung Motion"); (2) Motion to Exclude Testimony of Dr. Suzanne Parisian ("Parisian Motion"); and (3) Motion to Exclude Testimony of Dr. Robert Marx ("Marx Motion"). The Court found this matter suitable for disposition without oral argument and vacated the hearing set for October 9, 2012. See Fed. R. Civ. P. 78(b). For the following reasons, the Court grants in part and denies in part the various motions.

I. FACTUAL AND PROCEDURAL HISTORY

Defendant has concurrently filed a Motion for Summary Judgment (ECF No. 61), which provides a useful summary of facts. The following facts are not in material dispute. Defendant is a manufacturer of two drugs, Aredia and Zometa ("Treatment Drugs"), which are bisphosphonates used in the treatment of cancer that has metastasized to the bones. (Pl.'s Resp. to Def.'s Statement of Uncontroverted Facts and Conclusions of Law ("Defendant Facts") ¶ 1, ECF No. 95.) These drugs are prescribed to limit or prevent bone loss of various types associated with such metastases. (Def. Facts ¶ 6.) The Treatment Drugs remain on the market today, and physicians continue to prescribe them for the above treatment. (Def. Facts ¶¶ 7-8.) Osteonecrosis of the Jaw ("ONJ") is an osseous pathology leading to the deterioration of bones in the jaw. (Def. Facts ¶ 9.) In December 2002, Defendant received a report that ONJ had developed in a patient using the Treatment Drugs. (Def. Facts ¶ 10.) Following further occurrences of ONJ in patients taking the Treatment Drugs, and a review of the available literature, In September 2003 Defendant voluntarily revised the "adverse Reactions" section of its labeling for both drugs to include a warning that some people using the drugs had reported cases of ONJ. (Def. Facts ¶ 20.) No published reports demonstrated an association between the specific use of Aredia and Zometa, and onset of ONJ (Def. Facts ¶ 10), but internal Defendant emails suggest that at least a few cases of ONJ arose during clinical testing of these drugs (Def. Facts ¶ 13). Plaintiff was diagnosed with breast cancer in August 1989, and in August 1999 she was diagnosed with Stage IV metastatic breast cancer to her bones and lungs. (Pl's Statement of Uncontroverted Facts and Conclusions of Law ("Plaintiff Facts") ¶¶ 1, 2, ECF No. 96.) At the advice of her oncologist, Dr. Waisman, Plaintiff began taking Aredia, switching to Zometa in March 2002. (Pl. Facts ¶¶ 3-5.) During this time, Plaintiff also took several other drugs in the treatment regime, including medications for other related health issues. (Def. Facts ¶¶ 34-38.) Medical literature has listed several other medical treatments and conditions, including many that applied to Plaintiff concurrently with her use of the Treatment Drugs, as risk factors in the development of ONJ. (Def. Facts ¶¶ 65-70.) However, Plaintiff asserts that there is a distinction between "regular" ONJ and bisphosphonate-related ONJ ("BRONJ"), which she was diagnosed with and which has no major risk factors apart from the use of bisphosphonates. (Def. Facts ¶¶ 65-70.) In March 2000, Plaintiff's oral surgeon, Dr. Radack, noticed an exposure in Plaintiff's lower right jaw. He extracted Plaintiff's tooth #31 two months later and tooth #30 in August 2001. (Pl. Facts ¶¶ 6-9.) Dr. Radack noticed further exposure on the lower left jaw in 2003, eventually removing Plaintiff's tooth #18. (Pl. Facts ¶¶ 11-14.) Tooth #19 later fell out on its own. (Def. Facts ¶ 54.) In 2004, after learning of a possible connection between use of the Treatment Drugs and ONJ, Dr. Radack informed Plaintiff of this possibility. (Decl. of John A. Girardi in Supp. of Pl.'s Opp'n to Summ. J. ("Plaintiff Exhibits"), Ex. 6, 56-58, ECF No. 99.) Plaintiff continued treatment with Zometa until January 2005, when Dr. Waisman put Plaintiff's treatment on hold pending concerns that the Treatment Drugs were associated with ONJ. (Pl. Facts ¶¶ 5, 26-27; Pl. Ex. 16, 90:12-21.) Subsequently, Dr. Waisman referred Plaintiff to an expert at the University of California, Los Angeles ("UCLA") for further treatment specifically tailored to Plaintiff's ONJ. Plaintiff followed Dr. Radack's referral and began seeing Dr. Eric Sung for treatment in November 2006. (Def. Facts ¶ 56.) Dr. Sung diagnosed Plaintiff with ONJ in the right and left mandible and treated her accordingly, with the result that as of January 2011 Plaintiff has mostly healed, although some of her jaw remained exposed. (Def. Facts ¶¶ 56-59.) Plaintiff filed the current case against Defendant in Los Angeles County Superior Court, from which Defendant removed the case to this Court on August 18, 2006. (Notice of Removal, ECF No. 1.) On October 12, 2006, the United States District Court for the Middle District of Tennessee ("MDL Court") approved transfer of the case to that district as part of a Multidistrict Litigation ("MDL") that handled discovery and resolution of preliminary issues for multiple cases against Defendant asserting bisphosphonate-caused ONJ. (See Conditional Transfer Order, ECF No. 14.) The case was transferred back from MDL Court on July 28, 2011, for resolution of case-specific questions. (See Notice of Transfer/Remand and Reopening of Case, ECF No. 17.) Defendant filed all three of the present motions on September 11. (Marx Mot., ECF No. 54; Parisian Mot., ECF No. 58; Sung Mot., ECF No. 60) Plaintiff has filled oppositions to all three motions (Opp'n to Parisian Mot. ("Parisian Opposition"), ECF No. 92; Opp'n to Marx Mot. ("Marx Opposition"), ECF No. 97; Opp'n to Sung Mot. ("Sung Opposition"), ECF No. 102), and Defendant has replied in support of each motion (Reply in Supp. of Marx Mot. ("Marx Reply"), ECF No. 109; Reply in Supp. of Parisian Mot. ("Parisian Reply"), ECF No. 111; Reply in Supp. of Sung Mot. ("Sung Reply"), ECF No. 112).

II. DISCUSSION

The test for admissibility of expert witness testimony as laid out in Rule 702 allows a proposed expert witness to testify 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." Red. R. Evid. 702. The Supreme Court formed the basis for this standard in Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579 (1993), noting particularly that would-be expert witnesses must demonstrate a "reliable basis in the knowledge and experience of [their] discipline," id. at 592, where "'knowledge' 'connotes more than subjective belief or unsupported speculation,'" id. at 599. The courts in general have a "gatekeeping responsibility" to ensure that these standards are met. Id. at 600. And parties wishing to introduce expert witnesses bear the burden of proof that such testimony is admissible. Lust By & Through Lust v. Merrell Dow Pharms., Inc., 89 F.3d 594 (9th Cir. 1996). To be admissible, expert testimony, like all other forms of evidence, must be relevant. Fed. R. Evid. 401. The danger of unfair prejudice, confusion of the issues, misleading the jury, undue delay, waste of time, or needless presentation of cumulative evidence must not substantially outweigh the testimony's probative value. See Fed. R. Evid. 402; 403.

A. Defendant's Motion to Exclude Dr. Sung's Testimony One of Plaintiff's primary expert witnesses is Dr. Sung, who is designated to testify, among other things, that the Treatment Drugs specifically caused Plaintiff's ONJ. (Sung Mot. 1.) Defendant moves to exclude Dr. Sung's testimony as to specific causation on the basis that (1) Dr. Sung is unqualified to address the question of ONJ causation; and (2) Dr. Sung fails to utilize a reliable methodology to form his opinions. (Sung Mot. 1.) Defendant does not contest that Dr. Sung's testimony is based on sufficient facts or data (see generally Sung Mot.), and so the Court does not address the second factor in the Rule 702 test. Defendant also does not contest that Dr. Sung may testify regarding his diagnosis and treatment of Plaintiff.

1. Dr. Sung's Qualifications Defendant first alleges that Dr. Sung simply does not have the requisite experience and knowledge to testify as to the causation of Plaintiff's ONJ. Defendant characterizes Dr. Sung's experience as limited to having treated approximately 25 individuals with ONJ and co-authored two studies involving ONJ-like lesions in rats. (Sung Mot. 9.) Defendant challenges the sufficiency of Dr. Sung's experience on the basis that (1) diagnosis and treatment of medical conditions does not qualify someone to determine the cause of such conditions; (2) causation research in rats does not equate to causation research in humans; and (3) Dr. Sung admits that he is not an expert in oncology, or in the functionality of any bisphosphonate drug, which makes him unqualified to testify as to their effect. (Sung Mot. 9-10.) Defendant further observes that "Dr. Sung is not a medical doctor, and he is not an oral/maxillofacial surgeon, pathologist, or specialist. He is a dentist." (Sung Reply 3.) Defendant then directs the Court to several cases excluding dentists from testifying as to causation. (Sung Reply 3-4.) Plaintiff responds by emphasizing Dr. Sung's experience in the field. As she demonstrates, Dr. Sung has focused on cancer in his dental work, treating and performing studies on head and neck cancer patients. (Sung Opp'n 8-10; Decl. of John A Girardi in Supp. of Sung Opp'n ("Plaintiff Sung Exhibits"), Ex. 5, Sung CV at 1-3, ECF No. 101.) Dr. Sung has also authored publications on cancer-related ONJ topics, including the incidence of ONJ as a complication of chemotherapy, certain risk factors for BRONJ, and managing BRONJ in patients; he has given numerous presentations on these topics as well as on the diagnosis and treatment of BRONJ. (Sung Opp'n 9-10; Sung CV 8-11.) And finally, he has consulted with oncologists specifically regarding dental treatment of cancer patients. (Pl. Sung Ex. 5.) On the facts above, Dr. Sung is clearly qualified to testify. The Court is aware of no requirement that an expert testifying as to medical causation must have obtained a Doctorate of Medicine ("M.D."). Certainly a certified doctor is more likely to qualify as an appropriate expert, but Daubert requires only that an expert demonstrate a "reliable basis" in the relevant discipline, 509 U.S. at 592, and Dr. Sung in this circumstance has clearly demonstrated a broad-based knowledge of ONJ and its causes. Defendant's citation to caselaw disqualifying dentists from testifying as to specific causation is not helpful: in each of those cases, the court disqualified the dentists in question because plaintiffs had provided no indication that these dentists were experts on ONJ risk factors. See generally In re Aredia & Zometa Prods. Liab. Litig. (Kyle/Mahaney), No. 06-495, slip op. (M.D. Tenn. Dec. 7, 2010); In re Aredia & Zometa Prods. Liab. Litig. (Baldwin/Winter), No. 06-496, slip op. (M.D. Tenn. Dec. 7, 2010); In Re Aredia & Zometa Prods. Liab. Litig. (Anderson), No. 08-1157, slip op. (M.D. Tenn. Aug. 13, 2009) ("Dr. Liang not only testified that he had no expertise in diagnosing [ONJ] . . . but he also testified that he had no opinion as the cause of . . . ONJ.").¹ Defendant's other objections are similarly inapposite. Defendant is correct that diagnosis of medical conditions does not qualify someone to testify as to the causes of these conditions, but in this case Plaintiff has provided significant evidence suggesting independently that Dr. Sung is so qualified. And while causation in rats is certainly distinct from that in humans, Dr. Sung's involvement in studies examining risk factors for ONJ suggests at least that he is well versed in that area of medical research. Defendant's own citation to supplemental authorities within the MDL only strengthens this conclusion. One such case suggests that an expert can be approved to testify based on the strength of "his education and his experience treating [15 BRONJ] patients," even where the expert has not engaged in any significant academic work examining BRONJ risk factors. Luttrell v. Novartis Pharm. Corp., No. 07-CV-3015-TOR, 2012 WL 4513109, at *9 (E.D. Wash. Oct. 1, 2012). Dr. Sung has significantly more academic experience in the field of ONJ, and has treated 25 patients with ONJ, 10 more than the expert in Luttrell. Another case suggests that an expert's modesty as to his or her own expertise does not disqualify them as a witness. Harvey v. Novartis Pharm. Corp., 2:06-CV-1140-VEH, 2012 WL 4713097, at *4 (N.D. Ala. Oct. 4, 2012) ("Just as an individual cannot simply declare himself to be an expert, a person cannot simply declare himself not to be an expert."). Thus, Dr Sung's assertions that he is not an expert in oncology, and is just a dentist, need not disqualify him from testifying as an expert.

1 These cases might appropriately be used to exclude the causation testimony of Dr. Radack, but Plaintiff does not attempt here to qualify Dr. Radack as an expert witness on the question of specific causation. Dr. Sung was brought in specifically as an ONJ specialist to treat Plaintiff's injuries at the request of Plaintiff's oncologist, Dr. Waisman. This recognition from peers in the medical/dental community provides yet more evidence that Dr. Sung is qualified to discuss ONJ-related issues.

2. Dr. Sung's Methodology The larger part of Defendant's argument challenges the methodology Dr. Sung uses to draw his conclusion that the Treatment Drugs caused Plaintiff's ONJ. Specifically, Defendant argues that Dr. Sung's process for determining causation is insufficient because Dr. Sung did not employ "differential diagnosis." Differential diagnosis is defined as "the determination of which of two or more diseases with similar symptoms is the one from which the patient is suffering, by a systematic comparison and contrasting of the clinical findings." Stedman's Medical Dictionary 474 (28th Ed. 2006). In the context of the court system, this meaning has been amended slightly: "courts have used the term in a more general sense to describe the process by which causes of the patient's condition are identified. Clausen v. M/V NEW CARISSA, 339 F.3d 1049, 1057 n.4 (9th Cir. 2003). Defendant provides significant evidence in support of its assertion that Dr. Sung did not conduct differential diagnosis. Most notably, Dr. Sung has testified explicitly that he did not conduct differential diagnosis with respect to Plaintiff's condition:

Q. Did you perform any type of differential diagnosis with regards to Ms. Georges' osteonecrosis of the jaw?
A. No.
Q. Did you consider any other risk factor for ONJ that Ms. Georges has other than bisphosphonate use?
A. No.
Q. And it's your opinion that Ms. Georges has osteonecrosis of the jaw from - due to her Aredia and/or Zometa use. Correct?
A. Correct.

(Sung Mot. 13-14; Def. Ex. 76 ("Sung Dep."), 172-73.) Defendant further observes that Dr. Sung "did not look at the history" of Plaintiff's condition, instead focusing on "what we do from here" (Sung Dep. 175), and that he has admitted to not considering the possibility that Plaintiff's metastatic cancer spread to her jaw, causing her ONJ (Sung Dep. 70, 185-86). Plaintiff argues in return that there is a clear scientific basis for Dr. Sung's conclusions. She cites first to Dr. Sung's expert report, prepared for this litigation, in which he declares the following:

At the time of my initial examination of the patient in which her history was obtained from her and her husband in detail, and my subsequent research, it was my opinion the patient has osteonecrosis of the jaw (ONJ) resulting from the infusion of Aredia and Zometa medications, and not resulting from metastatic cancer, or in other words, the ONJ was not a manifestation of spreading breast cancer . . . . All these opinions are based upon my personal observations and the results of a multiplicity of laboratory studies at UCLA as well as those secured by [prior] health providers.

(Pl. Ex. 6, at 2.) Plaintiff further argues, contrary to Defendant, that Dr. Sung did in fact perform differential diagnosis here. Most notably, when asked about performing differential diagnosis, Dr. Sung testified that Plaintiff's ONJ "was obviously ONJ secondary to bisphosphonate, and given such, the other differential diagnosis may have been around my head. I think they were fairly quickly dismissed, given what I saw." (Sung Dep. 233.) In short, Plaintiff argues that Dr. Sung "considered the usual array of alleged causes based on his clinical experience and reading of the literature, and ruled them out." (Sung Opp'n 13.) Both parties agree that if Dr. Sung's analysis is underpinned by differential diagnosis, it should be admitted, and the Court concurs. The Ninth Circuit has explicitly held that differential diagnosis is a "reliable methodology" for determining causation. Clausen, 339 F.3d at 1058. It has also declined to overturn district courts' holdings that certain expert testimony is inadmissible where the expert failed to conduct a proper differential diagnosis. Morin v. United States, 244 F. App'x 142, 143 (9th Cir. 2007); Whisnant v. United States, 274 F. App'x 536, 537 (9th Cir. 2008). In short, differential diagnosis is a significant factor to consider in evaluating the sufficiency of an expert's process—and at the least, expert testimony based in part on a properly conducted differential diagnosis is likely to be admissible. In this case, Dr. Sung did not conduct an explicit, formal differential diagnosis of Plaintiff's condition when he first saw her. In addition to having testified to that fact, Dr. Sung admits that he did not initially consider the possibility that Plaintiff's ONJ might have resulted from her metastatic cancer, because "in his mind" it was clearly bisphosphonate-related ONJ. Defendant's citation to cases within this MDL provide a basis to exclude Dr. Sung's testimony. See Luttrell, 2012 WL 4513109, at *10-11 (excluding testimony from an expert testifier because he did not provide evidence that he had assessed and dismissed other risk factors); Harvey, 2012 WL 4713097 at *6 ("[Expert's] failure to give a reasonable explanation for concluding that bisphosphonate drug use rather than osteomyelitis caused [plaintiff's] injury renders his differential diagnosis not sufficiently reliable."). As in the experts in Luttrell and Harvey, Dr. Sung here does not provide significant testimony in support of his differential diagnosis, and has admitted to having not conducted a formal differential diagnosis with respect to Plaintiff's ONJ. This does not complete the Court's analysis, however: the question mandated to this Court by Daubert is not whether Dr. Sung conducted a formal differential diagnosis, but whether his procedures were, taken as a whole, fundamentally flawed in some way. The Ninth Circuit, per above, puts great value in a properly conducted differential diagnosis, but it "has never explicitly rejected or validated expert causation testimony based on a [formal] differential diagnosis . . . [while recognizing] its use as a reliable methodology." Clausen, 339 F.3d at 1058 (emphasis added). There is no indication that differential diagnosis should replace the Daubert standard in the context of medical causation testimony, and this Court declines to change this standard here. Further, the Court does not agree with Defendant that Dr. Sung failed entirely to conduct any sort of differential diagnosis. The definition as acknowledged by the Ninth Circuit contemplates a more holistic set of activities:

A reliable differential diagnosis typically, though not invariably, is performed after physical examinations, the taking of medical histories, and the review of clinical tests, including laboratory tests, and generally is accomplished by determining the possible causes for the patient's symptoms and then eliminating each of these potential causes until reaching one that cannot be ruled out or determining which of those that cannot be excluded is the most likely.

Clausen, 339 F.3d at 1057 (quoting Westberry v. Gislaved Gummi AB, 178 F.3d 257, 262 (4th Cir. 1999) (citation and internal quotation omitted). Here, although Dr. Sung admits that he did not conduct a formal differential diagnosis at the start, there is strong indication that he conducted an informal differential diagnosis, and later confirmed his initial suspicions through his clinical work and other tests. As Dr. Sung has testified, when Plaintiff first came in for treatment he considered some non-bisphosphonate risk factors, but dismissed them "fairly quickly" based on what he saw of Plaintiff's condition. (Sung Dep. 233.) This alone suggests that Dr. Sung made at least some consideration of causation. More tellingly, Dr. Sung's expert report indicates that his diagnosis, which included a finding as to causation, was based on Plaintiff's medical history, a physical examination, laboratory tests, and his knowledge of ONJ and BRONJ. This squares quite well with the process anticipated in Clausen, and particularly so when considering that the process anticipated in Clausen does not require that an expert eliminate all other possible causes of BRONJ so long as he can determine which cause is the most likely. Thus, even were differential diagnosis required, Dr. Sung has demonstrated conformity with the requirements laid out by the Ninth Circuit. Based on the sum total of the evidence, and considered in a light favorable to Plaintiff, the Court finds Dr. Sung's testimony to be admissible. The Ninth Circuit has allowed district courts, in their discretion, to exclude expert testimony where the experts "failed to account for possible alternate causes," see Whisnant, 274 Fed. App'x at 537, but it has not held that district courts must exclude helpful expert testimony merely for failing to conduct a formal differential diagnosis. Defendant has provided substantial evidence that Dr. Sung's process may have been incomplete in different ways, and it is free to challenge Dr. Sung's conclusions on the stand accordingly; but challenges to the reliability of an expert's conclusions, as opposed to their underlying methodology, are best left to a jury.

3. Basis for Dr. Sung's Diagnosis Defendant raises an additional line of argument in its Reply,² that Dr. Sung's testimony is inadmissible because it is based on a flawed assumption that Plaintiff had dental extractions prior to developing ONJ. The basis for this argument is testimony from Dr. Sung suggesting that he might believe that dental extractions caused Plaintiff's ONJ: as Dr. Sung noted, Plaintiff "has a history of bisphosphonate use. There was [sic] dental procedures done on it. Again, I don't recall the dental procedure, but it predated me. And given such, she ended up with exposed bone." (Sung Dep. 233.) Defendant argues this is important because Dr. Sung has testified that ONJ will develop in a patient after undergoing a dental surgery with "almost a certainty" when on Zometa, and "[g]reater than 50 percent" when on Aredia. (Sung Dep. 75-76.) Conversely, Dr. Sung testified that spontaneous development of ONJ is "[p]robably 1 percent" when on Zometa, and "[p]robably 1 percent or less" when on Aredia. (Sung Dep. 136.) Defendant raises a valid question as to the basis of Dr. Sung's diagnosis; it is at least possible that Dr. Sung's testimony may indicate that his diagnosis was based on a mistaken belief. However, this single quote does not establish that Dr. Sung's understanding of the causation is incorrect; Dr. Sung went on to testify that, in a patient with a history of dental procedures, chemotherapy, and bisphosphonate use, he would estimate that bisphosphonate "predominantly" led to ONJ. (Sung Dep. 234). Further, Dr. Sung has not testified that Plaintiff's first lesion was ONJ, and the undisputed facts state only that Plaintiff developed a lesion preceding extraction of tooth #31; not that this legion definitively resulted from Plaintiff's ONJ. Had Defendant raised these arguments in its original motion, Plaintiff could have responded and Defendant could have countered any of these arguments; however, the Court will not accept Defendant's argument here without it having demonstrated an absence of factual question that Dr. Sung's analysis is based entirely on a flawed assumption. Moreover, the fact that Dr. Sung believes there is about a one percent chance of ONJ developing spontaneously following years of bisphosphonate use does not equate to a belief that there is a one percent chance that spontaneous ONJ was caused by bisphosphonate use. In fact, Dr. Sung's estimate that about one in every one hundred people using the Treatment Drugs could develop spontaneous ONJ is extremely high, as compared with the actual incidence of ONJ in the general population. Defendant does not provide evidence suggesting that spontaneous ONJ is significantly less likely to have been caused by the Treatment Drugs; to the contrary, in its examination of Dr. Sung Defendant acknowledged that the American Association of Oral and Maxillofacial Surgeons's (AAOMS) definition of BRONJ "simply requires prior history of bisphosphonate use or current history of bisphosphonate use, exposed bone in the maxillofacial region persistent for more than eight weeks, and no history of radiation to the jaws." (Sung Dep. 235.) The Court therefore finds no basis for excluding Dr. Sung's testimony based on Dr. Sung's testimony regarding causation. Given this, the Court DENIES Defendant's Sung Motion to exclude certain testimony.

2 The Court notes that this argument should properly have been raised in Defendant's original motion, which would have given Plaintiff an opportunity to respond.

B. Defendant's Motion to Exclude Dr. Parisian's Testimony Another important Plaintiff witness in the case is Dr. Suzanne Parisian, who is designated as Plaintiff's regulatory expert. Dr. Parisian is expected to testify as to the sufficiency of Defendant's clinical research process and labeling, including whether its actions conformed with industry practice and regulatory requirements. (Parisian Mot. 1.) The Parisian Motion can be broken into eight distinct requests. Defendant asks the Court to exclude the following anticipated testimony from Dr. Parisian: (1) that Defendant did not comply with the FDA's regulatory requirements; (2) that the Treatment Drugs should have been deemed to cause ONJ; (3) that Defendant's labeling of the Treatment Drugs after 2003 constituted an insufficient warning; (4) any testimony relating to Defendant's "state of mind"; (5) that Defendant's actions were "unreasonable" or otherwise out of compliance with industry standards; (6) that Defendant improperly conducted its clinical trials; (7) any irrelevant or unfair testimony, including that relating to any drugs other than the Treatment Drugs in this case as well as general critique of the pharmaceutical industry; and (8) that Defendant attempted to improperly influence the academic literature by "ghostwriting" articles questioning any association between the Treatment Drugs and ONJ. (See generally Parisian Mot.) Defendant's arguments in support of these motions vary, but they center on three main allegations: (1) that Dr. Parisian acts as a "superlawyer" who offers legal conclusions instead of expert testimony; (2) that she testifies on subjects about which she lacks sufficient qualifications to testify; and (3) that her testimony is more prejudicial than it is probative. (Parisian Mot. 2.) In doing so, Defendant argues, she usurps the jury's function impartially deciding the facts and the Court's function stating the law, thereby confusing and misleading the jury. (Parisian Mot. 1.) Defendant also requests that the Court schedule a Daubert hearing. (Parisian Mot. 1.) Given the extensive briefing by the parties and the large amount of opinions and orders available from other courts discussing the admissibility of Dr. Parisian's expert testimony, the Court does not find it necessary to hold a Daubert hearing. See Winter v. Novartis Pharms. Corp., No. 06-CV-4049, 2012 WL 827305, at *4 (W.D. Mo. March 8, 2012) ("There is an extensive amount of material available to the Court concerning Dr. Parisian and the Court does not believe a Daubert hearing at this late stage would be helpful or is necessary in order to rule.").

1. Defendant's Compliance with the FDA Defendant's arguments seeking to exclude testimony relating to FDA compliance center on their contention that Dr. Parisian acts here as a "superlawyer," asserting legal conclusions without substantive evidentiary analysis. (Parisian Mot. 5.) Defendant cites to the decisions of several other courts that have excluded similar testimony from Dr. Parisian in whole or in part to support its assertion that such testimony should be excluded here. See Hogan v. Novartis Pharms. Corp., No. 06-CV-0260, 2011 WL 1533467, at *1-4 (E.D.N.Y. April 24, 2011); In re Trasylol Prods. Liab. Litig., 709 F. Supp. 2d 1323, 1351 (S.D. Fla. 2010); Miller v. Stryker Instruments, CV 09-813-PHX-SRB, 2012 WL 1718825 (D. Ariz. Mar. 29, 2012); In re Trasylol Prods. Liab. Litig., 709 F. Supp. 2d 1323, 1346, 1349 (S.D. Fla. 2010); Parisian Daubert Hr'g at 126-27, 127, Deutsch v. Novartis Pharms. Corp., No. 09-CV-4677 (E.D.N.Y. Apr. 11, 2011 and May 2, 2011) ("Deutsch Daubert Hr'g"). Not all of Defendant's case citations are instructive or on point to the case at hand. In Hogan, the parties agreed that the FDA was mostly irrelevant to the action and all testimony on FDA compliance was excluded. 2011 WL 1533467, at *2. In Trasylol, Dr. Parisian's testimony was excluded after a Daubert hearing, but that case did not involve the Treatment Drugs or the same report at issue here. 709 F. Supp. 2d 1323. However, several courts have expressed concern that Dr. Parisian's expert reports offer impermissible legal conclusions and opinions. See Stryker, 2012 WL 1718825; In re Trasylol, 709 F. Supp. at 1346, 1349; Deutsch Daubert Hr'g. The Court agrees with Defendant and other courts that it is not the role of an expert witness to offer legal conclusions. See Fed. R. Evid. 702, 104, 403. Dr. Parisian is not permitted to offer legal conclusions on any topic, including whether Defendant was in regulatory compliance with the FDA. The Court also notes though that many courts from the Treatment Drugs multi-district litigation have permitted Dr. Parisian to testify generally regarding FDA regulatory requirements. See Lemons v. Novartis Pharms. Corp., 08-CV-00361, 2012 WL 965977, at *6 (W.D.N.C. Mar. 21, 2012) (holding that, "Dr. Parisian may offer testimony only on the following issues: (1) the role, process, and function of FDA and the responsibilities of pharmaceutical drug sponsors; (2) Novartis' interactions with the FDA on the subject of labeling"); Order on Def.'s Daubert Mots ("Brodie Order"), Brodie v. Novartis Pharms. Corp., No. 4:10-CV-0138 (E.D. Mo. Jan. 20, 2012) (permitting Dr. Parisian to testify on, among other topics, (1) the complex regulatory framework governing the approval, labeling, advertising, and marketing of pharmaceutical and medical products, and (2) manufacturer responsibility and compliance with FDA regulations and guidelines); Order on Def.'s Daubert Mots. ("Mahaney Order"), Mahaney v. Novartis Pharms. Corp., No. 1:06-CV-0035 (W.D. Ky. Sept. 12, 2011) (holding a Daubert hearing because of concerns over Dr. Parisian's Report but permitting Dr. Parisian to offer general testimony on the FDA and its drug labeling process);³ Deutsch, 2011 WL 790702, at *43-44 (also holding a Daubert hearing because of concerns over Dr. Parisian's Report, but permitting her to testify on the general and regulatory requirements of prescription drugs by the FDA). Although not bound by the decisions of these other courts, this Court finds their decisions instructive given the similarity in facts between those cases and the case at hand. The Court determines that Dr. Parisian may testify generally regarding pharmaceutical drugs within the context of the FDA. Such testimony will be helpful to members of the jury who are likely not familiar with the intricacies of FDA pharmaceutical drug approval and regulation. Thus, the Court GRANTS IN PART and DENIES IN PART Defendant's motion to exclude Dr. Parisian's testimony on FDA compliance.

3 Plaintiff cites primarily to six prior court opinions within the current MDL that she believes may be instructive here. Stevens v. Novartis Pharms. Corp., 247 P.3d 244 (Mont. 2010); Bessemer v. Novartis Pharms. Corp., No. MID-L-1835-08-MT (N.J. Sup. Ct. Law Div. Oct. 2010); Fussman v. Novartis Pharm. Corp., No. 1:06-cv-0149, 2011 WL 5836928 (M.D.N.C. Nov. 21, 2011); Brodie Order; Winter v. Novartis Pharms. Corp., No. 3:06-CV-4049, 2012 WL 3156768 (W.D. Mo. Aug. 3, 2012). The Court subsequently refers to these cases as a group, as "Plaintiff's MDL Citations."

2. Causation and Diagnosis of ONJ Defendant next seeks to exclude Dr. Parisian's testimony on causation or diagnosis of ONJ. As Defendant argues here, Dr. Parisian is not, and has never claimed to be, an expert on medical causation of ONJ. As such, Defendant urges this court to exclude all causation testimony from Dr. Parisian. (Parisian Mot. 8-9.) Plaintiff agrees that Dr. Parisian is not qualified to testify as to medical causation, but responds that Dr. Parisian is not being called to testify about "medical causation," but rather will testify on regulatory "causal association." (Parisian Opp'n 15.) The distinction that Plaintiff would have this Court draw is between medical causation, which "is the result of causally randomized clinical trials," and regulatory causation, which is "not the standard of medical causation . . . [but] what would trigger a manufacturer to have to change their warnings" due to causal association. Parisian Daubert Hr'g ("Talley Daubert Hr'g"), Talley v. Novartis Pharms. Corp., No. 3:08-CV-0361 (W.D.N.C. June 20, 2011. The Court is not convinced by Plaintiff's arguments distinguishing medical causation from causal association. Dr. Parisian's attempt to draw this distinction is confusing at best and would almost certainly confuse or mislead the jury. Other courts have agreed. See Brown v. Novartis Pharms. Corp., No. 7:08-CV-00130, at 12, Magistrate Memorandum and Recommendation (finding "Plaintiffs' attempt to distinguish causal association from medical causation to be confusing and generally ineffective") (Index of Unpublished Cases and Court Orders for Def.'s Parisian Mot., No. 1.); Deutsch v. Novartis Pharms. Corp., 768 F. Supp. 2d 420, 468-69 ("Dr. Parisian is not qualified to diagnose ONJ and cannot opine on the propriety of Novartis' actions based on her own diagnosis. Accordingly, the Court grants Novartis' motion to exclude any testimony by Dr. Parisian that involves her own assessment of diagnosis or causation."). Dr. Parisian's expertise lies in issues relating to the FDA, and not in issues relating to the diagnosis or treatment of disease. As such, she is not qualified to offer any testimony relating to the cause or diagnosis of Plaintiff's or any other patient's ONJ. Further, allowing her to testify as to causal association would confuse the issue of causation and impermissibly allow the jury to rely on Dr. Parisian's opinion regarding the cause of Plaintiff's ONJ. The danger of unfair prejudice outweighs the probative value of this testimony.

The Court GRANTS Defendant's motion to exclude Dr. Parisian's testimony on causation.

3. Adequacy of Labeling Defendant next asks the Court to exclude Dr. Parisian's testimony that the Treatment Drugs' labeling failed to timely and adequately warn doctors who prescribed these medicines. (Mot. 10.) It argues that Dr. Parisian is not qualified because she is not an expert on these drugs or an oncologist who prescribes these medicines, and is therefore unqualified to testify about how oncologists might respond to different warnings. (Parisian Mot. 10.) Defendant further argues that Dr. Parisian's testimony would be unreliable because she has not drafted any proposed alternative labeling for the Treatment Drugs. (Parisian Mot. 10-11.) Plaintiff counters that Dr. Parisian is well qualified to testify about labeling and warnings. (Opp'n to Parisian Mot. 17.) In support of this contention, Plaintiff argues that Dr. Parisian "was involved in both drafting and reviewing product labeling while at FDA." (Parisian Opp'n 17.) Plaintiff further contends that her MDL Citations largely followed this trend, with only one case within the MDL declining to allow Dr. Parisian's testimony here. (Opp'n to Parisian Mot. 17 (referring to Hogan v. Novartis Pharms. Corp., No. 06-CV-0260, 2011 WL 1533467 (E.D.N.Y. Apr. 24, 2011)).) Plaintiff also argues that although Dr. Parisian is not required to and did not provide draft labeling for the Treatment Drugs, she did state that she preferred the FDA's original drafting of the labeling. (Parisian Opp'n 17.) The Court has already stated that Dr. Parisian's testimony as it relates to FDA requirements is admissible, and that holding applies here as well to testimony relating to FDA labeling requirements. In so holding, the Court agrees with the decisions of many other courts in this MDL that have permitted Dr. Parisian to testify on the labeling and warning of the Treatment Drugs. For example, one court observed:

[T]he issue of adequacy of warning and labeling must be viewed, in part, in the context of the FDA's role in the approval and marketing of pharmaceuticals. Dr. Parisian's testimony on the role of the FDA and the pharmaceutical industry in general and regarding new drug approvals is relevant to establish a context in which to analyze the reasonableness of NPC's actions regarding Zometa.

Order on Mot. to Exclude Test. of Pl.'s Expert Dr. Suzanne Parisian ("Stevens Order"), Stevens v. Novartis Pharms. Corp., No. DV-08-100, at 3 (Mont. 4th Jud. Dist. Ct. Oct. 14, 2009); see also Fussman v. Novartis Pharms. Corp., No. 1:06CV149, 2011 WL 5836928, at *3 (M.D.N.C. Nov. 21, 2011) (permitting Dr. Parisian to testify "as to what Novartis knew or should have known regarding the risks of ONJ and the corresponding failure of Novartis to provide an adequate warning of those risks"); Lemons v. Novartis Pharms. Corp., 849 F. Supp. 2d 608, 615 (W.D.N.C. 2012) (permitting Dr. Parisian to testify on the issue of Novartis' interactions with the FDA on the subject of labeling). Although Defendant cites to several cases that excluded Dr. Parisian's testimony about the adequacy of warnings and labels (see Parisian Mot. 10 n.12 (citing Oakberg v. Zimmer, Inc., No. CV-03-472004, WL 5503779, at *2 (D. Mont. Nov. 23, 2004), Reece v. Astrazeneca Pharms., LP, 500 F. Supp. 2d 736, 745, and Barnes Order, at 1)), those decisions involved medical devices or drugs that are different from those at issue in this case. This limits their persuasive value, and the Court treats them accordingly. Plaintiff may testify as to the adequacy of warnings and labels. The Court is not convinced that Dr. Parisian has the expertise to testify how treating physicians might react to different labeling, however, particularly in light of Defendant's caselaw citations. (Parisian Mot. 10 n. 13.) Several cases have excluded speculative expert testimony relating to what decisions the experts thought prescribing doctors would have made if the drugs had different labels. In re Diet Drugs Prods. Liab. Litig. MDL No. 1203, 2001 WL 454586, at *18 (E.D. Pa. Feb. 1, 2001); In re Rezulin Prods. Liab. Litig., 309 F. Supp. 2d 531, 557 (S.D.N.Y. 2004)). Another case excluded Dr. Parisian's testimony "on matters of which she has no knowledge, such as actions of [the treating oncologist] and other doctors' understanding of the Zometa label". Stevens Order 3. The Court agrees with this line of cases that such testimony is speculative and goes beyond Dr. Parisian's knowledge. Dr. Parisian may not offer testimony as to what decisions prescribing doctors would have made had they been given different labeling. Finally, the Court addresses the question whether Dr. Parisian is required to draft an alternative labeling for the Treatment Drugs. Neither party has cited binding authority delineating whether an expert witness is required to provide alternative labeling. The Court in Brown v. Novartis Pharmaceuticals Corp. addressed the same issue in its Memorandum and Recommendation and denied Defendant's request to exclude Dr. Parisian's testimony on labeling. (Index of Unpublished Cases and Court Orders for Defendant's Parisian Mot. Ex. 3. ("Brown Order"), at 12). Brown cites to two other cases, upon which Defendant also relies, that require expert witnesses to draft an alternative warning label. See Bourelle v. Crown Equip. Corp., 220 F.3d 532, 539 (7th Cir. 2000); Jaurequi v. Carter Mfg. Co., 173 F.3d 1076, 1084 (8th Cir. 1999). This Court agrees with the court in Brown, which distinguished Dr. Parisian from the experts in those cases who talked "off the cuff" or suffered from a "level of disconnectedness" (Brown Order at 14.) Defendant also cites Oswalt v. Resolute Industries, Inc., No. 08-CV-1600, 2010 WL 519736 (W.D. Wash. Feb. 4, 2010), rev'd on other grounds, 642 F.3d 856 (9th Cir. 2011), where the court granted summary judgment on an inadequate warning claim when plaintiff's expert failed to provide an "alternate hypothetical warning that would have been effective." Oswalt, 2010 WL 519736, at *3. However, the court in Oswalt took issue with the fact that the plaintiff's expert had not considered any alternative language, not with his failure to draft his own language. Here, Dr. Parisian has not only considered alternative warnings, she has even cited to an alternative (the FDA-proposed text) that she says would have been sufficient. Thus, there is no basis for excluding her testimony on this ground. Based on the above, the Court GRANTS IN PART and DENIES IN PART Defendant's Motion to exclude Dr. Parisian's testimony on labeling and warnings of the Treatment Drugs.

4. State of Mind Defendant seeks to exclude Dr. Parisian's opinions about Defendant, the FDA and any person's state of mind. (Parisian Mot. 11.) Plaintiff states that Dr. Parisian will not be asked any questions regarding any party's state of mind and will not offer opinions about any party's state of mind. (Parisian Opp'n 19.) Plaintiff appears to concede this point, and so Dr. Parisian is not permitted to testify at trial on issues related to intent or state of mind.

The Court GRANTS Defendant's motion to exclude Dr. Parisian's state of mind testimony.

5. Reasonableness of Defendant's Conduct and Whether it Followed Industry Standards Defendant next asks the Court to exclude testimony by Dr. Parisian that Defendant failed to act reasonably or follow unspecified industry standards, arguing that she is unqualified to discuss pharmaceutical companies' operating procedures and standards. (Parisian Mot. 11.) Plaintiff argues that Dr. Parisian should be permitted to testify as to the reasonableness of Defendant's actions in the context of FDA regulations, but provides no justification for this argument other than her MDL Citations. (Opp'n to Parisian Mot. 19.) The court in Deutsch addressed the same issue in its opinion and excluded Dr. Parisian's opinions on the ethical standards in the pharmaceutical industry and on the obligations of Defendant in addition to those required by the FDA. It stated that:

Although Dr. Parisian may be qualified to opine on the actions of a pharmaceutical company as it relates to its interactions with the FDA, Dr. Parisian is not qualified to opine on the ethical standards in the pharmaceutical industry, nor is she qualified to testify as to any obligations Novartis may have had to the medical community in addition to the FDA requirements.

The Court has determined above that Dr. Parisian is allowed to testify on Defendant's conduct in the context of the FDA. Plaintiff has not provided any justification for allowing Dr. Parisian to testify as to Defendant's conduct outside the context of the FDA, however. To the extent Dr. Parisian's Report refers to industry standards that are separate or different from those of the FDA, the Court determines that Dr. Parisian is not qualified to testify as to whether Defendant complied with those standards. Deutsch v. Novartis Pharms. Corp., 768 F. Supp. 2d 420, 468 (E.D.N.Y. 2011). Thus, the Court GRANTS Defendant's motion to exclude Dr. Parisian's testimony on whether Defendant followed non-FDA industry standards.

6. Clinical Trials Defendant seeks to exclude Dr. Parisian's opinion testimony that Defendant failed to adequately monitor clinical trial safety. (Parisian Mot. 12.) Plaintiff also does not contest this section of the Parisian Motion. Instead, she claims that Dr. Parisian has never before been asked any questions about Defendant's failure to adequately monitor its clinical trials during cases within this MDL, restricting her testimony to opinions on their conduct and reporting of results. (Parisian Opp'n 19.) As such, Dr. Parisian is not permitted to testify at trial on the issue whether Defendant adequately monitored its clinical trials.

The Court GRANTS Defendant's motion to exclude Dr. Parisian's testimony regarding clinical trials.

7. Other Drugs and Post-injury Actions Defendant further argues that Dr. Parisian should not be permitted to testify on events occurring after Plaintiff's exposure to the Treatment Drugs, and on events regarding other drugs. (Parisian Mot. 12.) Specifically, it seeks to exclude testimony on (1) Dr. Parisian's criticism of the FDA and the pharmaceutical industry that does not relate to the Treatment Drugs; (2) drugs other than the Treatment Drugs that have caused ONJ; (3) injuries other than ONJ that have resulted from the Treatment Drugs; and (4) events that occurred after Plaintiff stopped taking Zometa in March 2005. (Parisian Mot. 12.) Defendant argues such testimony would be irrelevant, unfairly prejudicial, and confusing. (Parisian Mot. 12.) Plaintiff has not addressed Defendant's arguments in her Opposition. The Court agrees with Defendant that the probative value of testimony on drugs other than the Treatment Drugs and injuries other than ONJ is outweighed by the danger of unfair prejudice, because it could contribute to a negative overall view of Defendant's drug manufacturing activities. To the extent events that occurred after Plaintiff stopped taking Zometa in March 2005 are unrelated to her use of Zometa, this testimony is also excluded because the danger of unfair prejudice outweighs its probative value. The Court GRANTS Defendant's motion to exclude Dr. Parisian's testimony regarding drugs other than the Treatment Drugs, and on events after Plaintiff stopped taking Zometa.

8. Ghostwriting Finally, Defendant asks the Court to exclude Dr. Parisian's testimony regarding ghostwriting and company funding of publications. (Parisian Mot. 12.) Again, Plaintiff does not object to this section of the Parisian Motion. (Parisian Opp'n 20.) As such, Dr. Parisian is not permitted to testify at trial on the topic of ghostwriting.

The Court GRANTS Defendant's motion to exclude Dr. Parisian's testimony regarding ghostwriting.

C. Defendant's Motions to Exclude Dr. Marx's Testimony Defendant next asks the Court to exclude certain testimony from Dr. Robert Marx, who Plaintiff has designated as her expert on general causation issues, as well as on Defendant's conduct in conducting its clinical trials and determining the safety of the Treatment Drugs. Defendant seeks to exclude the following testimony by Dr. Marx: (1) whether dental evaluation and treatment measures are effective in preventing BRONJ; (2) Defendant's alleged "bad faith" conduct; (3) criticism of Defendant's clinical trials; (4) whether certain patients in clinical trials had BRONJ; (5) general causation testimony based on adverse events reports; and (6) the biological mechanism by which BP drugs allegedly cause ONJ. (See generally Marx Mot.) Defendant provides different reasons for each of these requests. It does not challenge the admissibility of Dr. Marx's testimony on general causation. /// ///

1. Preventing BRONJ Through Dental Evaluation and Treatment Defendant first asks the Court to preclude Dr. Marx's opinion that obtaining a dental examination before starting BP therapy and avoiding oral surgery (including tooth extractions) while on BP drugs can prevent BRONJ. (Marx Mot. 3.) Defendant argues that Dr. Marx has no basis for his testimony, and that therefore any opinions he has on the preventative value of dental treatment measures are "speculative belief," not admissible as expert testimony. (Marx Mot. 4.) Defendant does not cite any case from the multi-district litigation involving the Treatment Drugs that excluded Dr. Marx's testimony on this topic. To the contrary, this Court found multiple decisions from other courts within the MDL addressing the substantially similar issue of the admissibility of Dr. Marx's testimony on preventative measures of BRONJ, and declining to exclude this evidence. In In re Aredia & Zometa Products. Liability Litigation, the Middle District of Tennessee found that Dr. Marx's testimony was admissible under Daubert relating to (1) the causal connection between the Treatment Drugs and ONJ, and (2) treatment and preventative measures for ONJ. No. 3:06-MD-1760, Order of Def.'s Mot to Exclude Litigation-Wide Test. of Pl.'s Expert Dr. Robert Marx, D.D.S. (M.D. Tenn. Aug. 13, 2009) (mentioned in Girardi Decl. Ex. 1). Similarly, in Bessemer, like in this case, Novartis sought to prevent Dr. Marx's testimony that certain dental treatment measures are effective in preventing BRONJ. The court found that:

Dr. Marx's opinion is based on scientific literature and his own clinical experience treating patients with BRONJ. To the extent that there is conflicting evidence regarding the effectiveness of dental treatment measures in preventing BRONJ, Defendant will be able to cross-examine this witness. As such, the court will not exclude Dr. Marx's testimony.

Bessemer v. Novartis Pharms. Corp., No. MID-L-1835-08 (N.J. Sup. Ct. Law Div. Oct. 2010) (Girardi Decl. Ex. 3, at 3). In Hogan v. Novartis Pharmaceuticals Corp., the court noted that the "MDL Court has already found Dr. Marx qualified to opine on general and specific causation as well as on treatment and preventive measures for ONJ." (No. 06-CV-0260, 2011 WL 1533467, at *4 (E.D.N.Y. Apr. 24, 2011); see also Mahaney Order 28-29) (permitting testimony on preventive dental treatment for BRONJ and stating that Dr. Marx's testimony "may be thoroughly vetted on cross examination" by Defendant); Deutsch v. Novartis Pharms. Corp., 768 F. Supp. 2d 420, 438 ("The theory that preventative measures, including pretreatment dental screening, may decrease the risk of [BRONJ] is admissible and it is well within . . . [Dr. Marx's] field of expertise"). Although not binding on this Court, the decisions of other courts who have addressed the admissibility of substantially the same evidence at issue in this case are persuasive and well-reasoned. Defendant is free to provide contrary evidence and attack Dr. Marx's testimony on cross examination, but has not demonstrated any basis for exclusion of Dr. Marx's testimony here. Based on the above, the Court DENIES Defendant's motion to exclude Dr. Marx's testimony on the prevention of BRONJ through dental evaluation and treatment.

2. Defendant's Alleged "Bad Faith" Conduct Defendant next asks the Court to exclude Dr. Marx's testimony on any alleged "bad faith" conduct of Defendant or opinions on Defendant's intent or motives. (Marx Mot. 4-6.) In support of this, Defendant points to Dr. Marx's testimony about one article where he notes that his testimony alleging bad faith by Defendants is his "own personal opinion." (Marx Mot. 5.) Plaintiff responds by citing to substantial caselaw (see generally Marx Opp'n), although Plaintiff also notes that Defendant's challenge to the "bad faith" comments is not frivolous; she argues that this testimony falls "within the purview of the jury" (Marx Opp'n 9). Other courts in the MDL have routinely excluded such testimony on "bad faith" and state of mind, because such statements fall outside of Dr. Marx's expertise and qualify instead as personal opinion testimony. See Hogan, 2011 WL 1533467, at *4; Bessemer (Girardi Decl. Ex. 3, at 3-4); Brodie Order 4; Mahaney Order 26-33; Winter, 2012 WL 827305, at *5-*9; and Deutsch, 768 F. Supp. 2d at 448. This Court agrees with this general consensus, and will not allow Dr. Marx to testify on his personal opinions. Thus, the Court GRANTS Defendant's motion to exclude Dr. Marx's testimony on Defendant's alleged "bad faith" conduct, intent, or motives.

3. Criticism of Defendant's Clinical Trials Defendant also asks the Court to exclude Dr. Marx's criticism of its clinical trials of the Treatment Drugs. (Marx Mot. 6-7.) Other courts in the Treatment Drugs cases have routinely excluded this testimony and this Court does so for the same reasons. See Hogan, 2011 WL 1533467, at *6 (Dr. Marx could not give testimony criticizing the design of the clinical trials); Brodie Order 4) (Dr. Marx was not permitted to give conclusory criticism of the clinical trials); Bessemer (Girard Decl. Ex. 3, at 3-4) (excluding testimony on Dr. Marx's criticism of the clinical trials, but permitting him to give factual statements about them); Mahaney Order 32 (Dr. Marx was not permitted to give criticism of the clinical trials); Winter, 2012 WL 827305, at *8 (Dr. Marx was not permitted to testify as to his opinion on the design of the clinical trials); and Deutsch, 768 F. Supp. 2d at 450 (excluding Dr. Marx's opinions on the design and conduct of the clinical trials). Thus, the Court GRANTS Defendant's motion to exclude Dr. Marx's testimony criticizing Defendant's clinical trials of the Treatment Drugs.

4. Diagnosis of BRONJ in Clinical Trials Patients Defendant next asks the Court to exclude Dr. Marx's testimony about whether certain patients in the Treatment Drugs clinical trials had BRONJ. (Marx Mot. 7-9.) It argues this testimony is speculative and not based on a reliable methodology because Dr. Marx abandoned the methodology he normally uses when he concluded that these patients had BRONJ. (Marx Mot. 7-9.) Plaintiff again responds with a litany of caselaw, although it argues specifically that Dr. Marx's testimony will be limited to diagnosis rates and will avoid testimony concerning the sufficiency of Defendant's process. (Marx Opp'n 9.) Defendant made substantially the same argument in Hogan. 2011 WL 1533467, at *5. The court there rejected Defendant's argument that Dr. Marx's conclusions were speculative and stated that "Dr. Marx's opinion on whether participants in defendant's clinical trial had BRONJ . . . is both relevant and reliable." Id.; see also Deutsch, 768 F. Supp. 2d at 450 (denying Defendant's motion to exclude Dr. Marx's testimony on whether the individuals in the clinical trials had BRONJ and stating that "[w]hile the Court finds that Dr. Marx may be overstating the results by concluding that these patients had 'likely ONJ,' Novartis is certainly free to cross-examine him on the strength of that statement and the accuracy of his results"). Thus, the Court DENIES Defendant's motion to exclude Dr. Marx's testimony diagnosing BRONJ in certain patients from the clinical trials of the Treatment Drugs.

5. General Causation Testimony Based on Adverse Events Reports Defendant asks the Court to exclude Dr. Marx's general causation testimony that is based on Adverse Event Reports ("AER") submitted to the FDA or Defendant, because Dr. Marx did not review these reports, and because AERs do not constitute scientifically reliable causation proof. (Marx Mot. 9.) Plaintiff does not reply specifically to these arguments. Defendant's arguments here are unavailing. Although Dr. Marx may not have reviewed any of the AERs, his testimony makes clear that he discussed these AERs with the FDA and relied upon their results. (Def. Ex. 15, Dep. of Robert Marx ("Marx Dep."), at 859-860.) Dr. Marx's testimony notes further that it is standard practice, because it is often difficult to obtain the original AERs. (Marx Dep. 859-60.) Turning to the sufficiency of AERs as scientific proof, Defendant cites to McClain v. Metabolife Intern. Inc., 401 F.3d 1233 (11th Cir. 2005), to support its contention that such reports are inadmissible. But even if its decision were binding, the court in McClain considered the expert's reliance on AERs as but one factor in a many-factor test to determine whether the expert's testimony was admissible under Daubert. McClain, 401 F.3d at 1250. This is a far cry from ruling that testimony based on AERs is inadmissible per se. Other courts in the Drug Treatment cases have also permitted this testimony and, as above, Defendant has not cited any cases that have excluded it. See Mahaney 835 F. Supp. 2d 299, 311-12; Deutsch, 768 F. Supp. 2d at 450-51. Additionally, the court in Bessemer characterized Defendant's substantially similar challenge in that case as "overly broad and vague" and stated that it would await the trial testimony to determine whether Dr. Marx relied on adverse event reports in forming his opinion. (Girardi Decl. Ex. 3, at 4). For all of these reasons, the Court DENIES Defendant's motion to exclude Dr. Marx's general causation testimony based on adverse events reports.

6. Biological Mechanism by Which BP Drugs Allegedly Cause ONJ Finally, Defendant seeks to exclude Dr. Marx from testifying on the biological mechanism by which BP drugs allegedly cause ONJ. (Marx Mot. 10.) Once again, the Court finds the decisions of other courts involved in the Drug Treatment cases persuasive and agrees with their findings admitting this testimony. See Bessemer (Girardi Decl. Ex. 3, at 4) ("Dr. Marx has offered sufficient expertise and reliability to offer his opinion" on this topic); Deutsch, 768 F. Supp. 2d at 438 ("The Court has no doubt that [Dr. Marx's] academic involvement and extensive background in identifying, treating, and studying patients with ONJ qualifies him to render opinions on this subject."). Defendant has provided no meritorious argument to exclude this testimony that would run counter to the general caselaw on this point.⁴ Based on the above, the Court DENIES Defendant's motion to exclude Dr. Marx's testimony on the biological mechanism by which BP drugs allegedly cause ONJ.

4 The Court is similarly unconvinced by Defendant's argument that studies on mice cells are irrelevant to knowledge of how human cells work, which line of argument Defendant also attempted in its Sung Motion. If mouse cell activity were irrelevant to greater understanding of human cell activity, no one would study mouse cells. Defendants may argue in their cross examination that the study is an indirect indicator of human cell activity, but these arguments go to the strength of Dr. Marx's testimony, not to its admissibility. --------

III. RULING

For the foregoing reasons, the Court DENIES DEFENDANT'S SUNG MOTION; GRANTS IN PART AND DENIES IN PART DEFENDANT'S PARISIAN MOTION; and GRANTS IN PART AND DENIES IN PART DEFENDANT'S MARX MOTION. Dr. Sung may testify as designated by Plaintiff in full. Dr. Parisian may testify as to FDA regulatory compliance and the adequacy of Defendant's labels and warnings. Dr. Parisian may not testify as to (1) causation, regulatory or otherwise; (2) how prescribing doctors would have responded to different labeling; (3) Defendant's or any other party's "state of mind"; (4) the reasonableness of Defendant's actions, or whether they complied with industry standards; (5) the propriety of Defendant's clinical trials; (6) any drugs other than the Treatment Drugs or any actions occurring after Plaintiff stopped treatment; or (7) Defendant's alleged "ghostwriting" of articles. Dr. Marx may testify as to (1) the effectiveness of dental treatment; (2) the diagnoses from Defendant's clinical trials; (3) the findings of Adverse Event Reports; and (4) the biological mechanism by which BP drugs cause ONJ. Dr. Marx may not testify as to Defendant's "bad faith" conduct, or the propriety of Defendant's clinical trials. IT IS SO ORDERED.