Full opinion text
MEMORANDUM OF DECISION AND ORDER SPATT, District Judge. Samuel Deutsch (“Plaintiff Deutseh”), individually and as an administrator of the estate of Helene Deutsch (collectively the “Deutsch case”), and Beth Forman (“Plaintiff Forman” and together with Plaintiff Deutsch “the Plaintiffs”), individually and as administrator of the estate of John Napolitano (collectively the “Forman case”), commenced these products liability actions against Novartis Pharmaceuticals Corporation (“Novartis” or “NPC”), alleging that the Novartis drugs Aredia and Zometa caused Mrs. Deutsch and Mr. Napolitano to develop a condition referred to as osteonecrosis of the jaw. Both Mrs. Deutsch and Mr. Napolitano passed away after filing the instant lawsuits. However, their respective spouses, Samuel Deutsch and Beth Forman, continue to pursue the claims against Novartis. Presently before the Court are nine Daubert motions by Novartis to exclude testimony by the Plaintiffs’ retained and non-retained experts (the “treating physicians”); a Daubert motion by the Plaintiffs to exclude the causation testimony of the experts retained by Novartis; and a motion by the Plaintiffs to unseal documents. The Court now rules on all of these motions. I.BACKGROUND Although familiarity with the factual background and procedural history of this case is assumed, a brief review is in order. This lawsuit involves two FDA-approved intravenous bisphosphonate (“IV BP”) drugs manufactured by Novartis, namely, Aredia (also known as pamidronate) and Zometa (also known as zoledronic acid). Both Aredia and Zometa are typically prescribed to patients with certain kinds of advanced cancer affecting bone. Mrs. Deutsch received both Aredia and Zometa as treatment for metastatic breast cancer, and Mr. Napolitano received Zometa as part of his treatment for metastatic prostate cancer. After receiving the IV BP drugs, Mrs. Deutsch and Mr. Napolitano allegedly developed osteonecrosis of the jaw (“ONJ”). The Plaintiffs’ allege that Mrs. Deutsch and Mr. Napolitano developed a form of ONJ that is caused by bisphosphonate drugs, referred to as bisphosphonate-related ONJ (“BRONJ”), bisphosphonate-induced ONJ (“BIONJ”) or bisphosphonate ONJ (“BONJ”). The American Association of Oral and Maxillofacial Surgeons (“AAOMS”) refers to ONJ that has allegedly resulted from bisphosphonate use as bisphosphonate-related osteonecrosis of the jaw and defined three requirements for its occurrence: 1. Current or previous treatment with a bisphosphonate 2. Exposed bone in the maxillofacial region that has persisted for more than 8 weeks 3. No history of radiation therapy to the jaws Salvatore Ruggiero, et al., AAOMS Position Paper on Bisphosphonate-Related Osteonecrosis of the Jaws-2009 Update, J. Oral Maxillofacial Surgery, at 3 (2009) (hereinafter “AAOMS 2009 Position Paper”). The Plaintiffs’ are primarily proceeding on strict products liability, negligence, and breach of implied warranty claims against Novartis, predicated on its alleged failure to warn of the risks associated with Aredia and Zometa. On May 24, 2006, the Plaintiffs’ cases against Novartis were consolidated with similar cases pursuant to the Multi-District Litigation Act and transferred to United States District Judge Todd J. Campbell in the Middle District of Tennessee (“the MDL court”). In the MDL court, Novartis filed two general summary judgment motions: (1) Motion for Summary Judgment Based upon a Failure of General Causation Proof under Daubert (“Causation Summary Judgment Motion”) and (2) Motion for Summary Judgment on the Adequacy of its Aredia and Zometa Warnings (‘Warnings Summary Judgment Motion”). In conjunction with the summary judgment motions, Novartis filed Daubert motions to exclude the expert testimony of Dr. Keith Skubitz, Dr. James Vogel, Professor Wayne Ray, Ph.D. (“Prof. Ray”), Dr. Talib Najjar, Dr. Robert Marx (consisting of two separate motions, one to exclude his litigation-wide testimony and one to exclude his case-specific testimony in the Forman case), Dr. Suzanne Parisian, Dr. Robert Fletcher, Dr. Paul Hanson, Dr. John Hellstein, and the Plaintiffs’ non-retained experts. The Plaintiffs’ also filed Daubert motions, including one to exclude the testimony on the causation of BONJ by Novartis’ oncologic experts. By orders dated August 13, 2009, the MDL court denied both the Causation Summary Judgment Motion, In re Aredia and Zometa Prods. Liab. Litig. (“MDL Causation Order”), No. 06-MD-1760, 2009 WL 2497536 (M.D.Tenn. Aug. 13, 2009) and the Warnings Summary Judgment Motion, In re Aredia and Zometa Prods. Liab. Litig., No. 06-MD-1760, Docket # s 2766, 2767 (“MDL Warnings Order”). In addition, the MDL court either denied or denied in part and mooted in part Novartis’ Daubert motions to exclude the expert testimony of Dr. Skubitz, Dr. Vogel, Dr. Najjar, and the litigation-wide and case specific testimony of Dr. Marx. Finally, the MDL court mooted in their entirety Novartis’ motions to exclude the expert testimony of Dr. Hanson, Dr. Hellstein, Prof. Ray, Dr. Fletcher, Dr. Parisian, as well as the Plaintiffs’ non-retained experts, and the Plaintiffs’ motions to exclude the expert testimony on the causation of BONJ by Novartis’ oncologic experts. Following the resolution of these motions, on September 25, 2009, the MDL court remanded the Deutsch case and the Forman case back to this Court for trial. On December 16, 2009, the Court held a ease management conference where it granted the parties’ request to file Daubert motions on issues not previously decided by the MDL court. Subsequently, the parties filed the motions that are the subject of this decision. Specifically, Novartis filed Daubert motions to exclude the expert testimony of (1) Dr. Skubitz, (2) Dr. Vogel, (3) Dr. Marx, (4) Prof. Ray, (5) Dr. Fletcher, (6) Dr. Parisian, (7) Plaintiffs’ non-retained experts with regard to causation, (8) Dr. Hanson, and (9) Dr. Hellstein. The Plaintiffs’ filed (10) a Daubert motion to exclude testimony on causation of BONJ by Novartis’ oncologic experts and (11) a motion to unseal documents. As an initial matter, the Plaintiffs’ have stipulated that Drs. Hanson and Hellstein will not testify at trial and therefore the Court will not address those motions. In addition, Novartis has stipulated to unseal certain documents (Calhoun Decl. Unseal Motion, Ex. 1), and to resubmit redacted versions of certain documents (Id., Ex. 3) and therefore the motion to unseal with respect to those documents is moot. With regard to the remaining documents subject to the motion to unseal that the Plaintiffs’ contend were improperly designated pursuant to the parties’ protective order, the Court denies the Plaintiffs’ request without prejudice to file the motion before United States Magistrate Judge William D. Walk II. DISCUSSION A. Legal Standard for Admissibility under Rule 702 and Daubert The present motions seek to either exclude certain experts entirely or certain lines of expert testimony for failing to satisfy the requirements of Federal Rule of Evidence 702 (“Rule 702”). Rule 702 provides that: If scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education, may testify thereto in the form of an opinion or otherwise, if (1) the testimony is based upon sufficient facts or data, (2) the testimony is the product of reliable principles and methods, and (3) the witness has applied the principles and methods reliably to the facts of the case. Fed.R.Evid. 702. As articulated by the Supreme Court in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 589, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993), Rule 702 “clearly contemplates some degree of regulation of the subjects and theories about which an expert may testify” and “assign[s] to the trial judge the task of ensuring that an expert’s testimony both rests on a reliable foundation and is relevant to the task at hand.” As the Supreme Court further explained in Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137, 152, 119 S.Ct. 1167, 143 L.Ed.2d 238 (1999), Rule 702 requires that a court fulfill this “gatekeeping” function by “mak[ing] certain that an expert, whether basing testimony upon professional studies or personal experience, employs in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field.” To determine whether expert testimony is admissible, the court must consider whether (1) the witness is qualified as an expert to testify as to a particular matter; (2) the witness has based his opinion upon reliable data and methodology; (3) the expert’s testimony on the particular subject is relevant because it will assist the trier of fact; and (4) pursuant to Rule 403 the testimony’s “probative value is substantially outweighed by the danger of unfair prejudice, confusion of the issues, or misleading the jury.” Nimely v. City of New York, 414 F.3d 381, 397 (2d Cir.2005) (quoting Fed.R.Evid. 403). To be qualified to testify as an expert under Rule 702, the Court must be satisfied that “the expert’s opinion will have a reliable basis in the knowledge and experience of his discipline.” Daubert, 509 U.S. at 592, 113 S.Ct. 2786. “If the expert has educational and experiential qualifications in a general field closely related to the subject matter in question, the court will not exclude the testimony solely on the ground that the witness lacks expertise in the specialized areas that are directly pertinent.” In re Zyprexa Prods. Liab. Litig., 489 F.Supp.2d 230, 282 (E.D.N.Y.2007) (citing Stagl v. Delta Air Lines, Inc., 117 F.3d 76, 80 (2d Cir.1997)); see also Rupolo v. Oshkosh Truck Corp., No. 05-Cv-2978, 749 F.Supp.2d 31, 37, 2010 WL 2244386, at *4 (E.D.N.Y. June 01, 2010) (“In a product liability action, an expert witness is not strictly confined to his area of practice, but may testify concerning related applications; a lack of specialization affects the weight of the opinion, not its admissibility.”) (internal quotation marks and citation omitted). When dealing with challenges to the reliability of scientific evidence, the court must focus on the methodology that the experts used to draw a conclusion and not on the conclusion itself. See Daubert, 509 U.S. at 590, 595, 113 S.Ct. 2786. In Daubert, the Supreme Court identified several non-exclusive factors that a court may consider such as: (1) whether the expert’s conclusions have been tested or are testable; (2) whether the expert’s conclusions have been published and subjected to peer review; (3) whether the scientific technique has a potential or known error rate; and (4) whether the expert’s conclusions have gained general acceptance within the scientific community. Id. at 593-94, 113 S.Ct. 2786. This list is not exhaustive. Other factors that courts have found relevant in assessing the reliability of expert testimony include: (1) whether the expert is proposing to testify about matters growing directly out of independent research he or she has conducted or whether the opinion was developed expressly for purposes of testifying; (2) whether the expert has unjustifiably extrapolated from an accepted premise to an unfounded conclusion; (3) whether the expert has adequately accounted for obvious alternative explanations; (4) whether the expert is being as careful as he would be in his regular professional work; and (5) whether the field of expertise claimed by the expert is known to reach reliable results for the type of opinion offered. In re Silicone Gel Breast Impl. Prods. Liab. Litig., 318 F.Supp.2d 879, 890 (C.D.Cal.2004) (citing Fed.R.Evid. 702 Advisory Committee’s Notes). These factors are “helpful, [but are] not definitive” and “the law grants a district court the same broad latitude when it decides how to determine reliability as it enjoys in respect to its ultimate reliability determination.” Kumho Tire Co., 526 U.S. at 151, 153, 119 S.Ct. 1167 (emphasis in original); Amorgianos v. Nat’l R.R. Passenger Corp., 303 F.3d 256, 265 (2d Cir.2002) (“[I]n analyzing the admissibility of expert evidence, the district court has broad discretion in determining what method is appropriate for evaluating reliability under the circumstances of each case.”). “[W]hen an expert opinion is based on data, a methodology, or studies that are simply inadequate to support the conclusions reached, Daubert and Rule 702 mandate the exclusion of that unreliable opinion testimony.” Id. at 266; Zyprexa, 489 F.Supp.2d at 284 (“Expert opinions based on insufficient facts or data, or on unsupported suppositions is not acceptable.”). On the other hand, “[w]here an expert otherwise reliably utilizes scientific methods to reach a conclusion, lack of textual support may “go to the weight, not the admissibility” of the expert’s testimony.” Amorgianos, 303 F.3d at 267 (citing McCulloch v. H.B. Fuller Co., 61 F.3d 1038, 1044 (2d Cir.1995)). “A minor flaw in an expert’s reasoning or a slight modification of an otherwise reliable method will not render an expert’s opinion per se inadmissible.” Id. at 267. Ultimately, when determining whether a proffered expert’s testimony is reliable, the court “must focus on the principles and methodology employed by the expert, without regard to the conclusions the expert has reached or the district court’s belief as to the correctness of those conclusions.” Id. at 266; see also Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146, 118 S.Ct. 512, 139 L.Ed.2d 508 (1997) (holding that “conclusions and methodology are not entirely distinct from one another,” and that “[a] court may conclude that there is simply too great an analytical gap between the data and the opinion proffered.”). Rule 702 codifies a liberal admissibility standard and “[vigorous cross-examination, presentation of contrary evidence, and careful instruction on the burden of proof are the traditional and appropriate means of attacking shaky but admissible evidence.” Daubert, 509 U.S. at 596, 113 S.Ct. 2786. “The final part of a trial court’s gatekeeping task is to determine whether an expert’s testimony is ‘relevant to the task at hand’; namely, whether the expert’s reasoning or methodology can be properly applied to the facts before the court.” Lidle v. Cirrus Design Corp., No. 08-CV-1253, 2010 WL 2674584, at *4 (S.D.N.Y. July 6, 2010) (quoting Daubert, 509 U.S. at 592-93, 113 S.Ct. 2786); see also Stagl v. Delta Air Lines, Inc., 117 F.3d 76, 81 (2d Cir.1997). As stated in Federal Rule of Evidence 401, evidence is relevant if it has “any tendency to make the existence of any fact that is of consequence to the determination of the action more probable or less probable than it would be without the evidence.” Fed.R.Evid. 401. In Daubert, the Court described the Rule 401 relevance consideration as one of “fit,” requiring a “valid scientific connection” between the subject matter of the expert’s testimony and the factual issues to be determined by the jury. Daubert, 509 U.S. at 591-92, 113 S.Ct. 2786; Lidle, 2010 WL 2674584, at *4. B. As to Whether the MDL court Rulings are the Law of the Case As previously noted, the MDL court denied Novartis’ Causation Summary Judgment Motion and Warnings Summary Judgment Motion, and denied in part and mooted in part the Daubert motions to exclude the testimony of Drs. Vogel, Skubitz, and Marx. In the course of briefing the MDL motions, Novartis made a number of arguments against the admissibility of these experts’ opinions on general causation and failure to warn, including the contention that they lacked the requisite expertise under Daubert and employed unreliable methodologies. Rather than address the validity of each argument individually, the MDL court summarily denied the motions — with the exception of certain issues that were mooted because they were not relevant to the summary judgment motion — holding with respect to the Causation Summary Judgment Motion that: Defendant’s and Plaintiffs’ briefs convincingly demonstrate why the arguments of both sides go to the weight of the experts’ testimony, not the admissibility. The parties have presented more than unsupported speculation on both sides of this issue as to whether Aredia and Zometa can cause ONJ. Defendant’s arguments impugn the accuracy of Plaintiffs’ experts’ opinions but do not undermine the general scientific reliability under Daubert. The Court finds that Plaintiffs have satisfied their burden of establishing that their experts’ general causation opinions are admissible under Daubert and Fed.R.Evid. 702. MDL Causation Order, 2009 WL 2497536, at *2, and with regard to the Warnings Summary Judgment Motion that: Defendant’s experts say the warnings were adequate, and Plaintiffs’ experts say the warnings were false and misleading. The Court finds that the jury will have to determine which experts are credible, in whole or in part, and which side of this argument to believe. MDL Warnings Order at 3. In denying the motions as to Dr. Vogel and Dr. Skubitz, Judge Campbell, held that Dr. Vogel’s and Dr. Skubitz’s “testimony concerning general causation and the scientific and medical accuracy of warnings given by Novartis is clearly more than unsupported speculation” and that “Plaintiffs’ have carried their burden of demonstrating that [Dr. Vogel’s and Dr. Skubitz’s] testimony concerning general causation and the accuracy of warnings is admissible under Daubert.” (Vogel Order at 3; Skubitz Order at 3.) With regard to the motion to exclude the litigation-wide testimony of Dr. Marx, the MDL court held that Dr. Marx was qualified to give opinions on “(1) the causal connection between Aredia and Zometa and ONJ [and] (2) treatment of and preventative measures for ONJ” (Marx Litig.-Wide Order at 1-2), and that Dr. Marx’s testimony on these subjects were “clearly more than unsupported speculation” and that the “plaintiffs have carried their burden of demonstrating Dr. Marx’s testimony is admissible under Daubert ” (Id. at 3-4). While couching the instant motions, for the most part, in terms of objecting to specific opinions not raised to the MDL court or mooted by the MDL court, Novartis asserts a number of the same arguments with respect to the experts qualifications and the reliability of the factual basis underlying their opinions. Thus, the questions for this Court, are whether the MDL court’s summary rulings can be read to have rejected all of Novartis’ arguments, and if so, whether those rejections constitute the law of the case as to the admissibility under Daubert of opinions objected to on the same factual basis. Unsurprisingly, Novartis argues that both questions should be answered in the negative. The Court disagrees. Novartis first contends that the opinions included in its motion to the MDL, but not carved out in the MDL orders, were not “definitively and unambiguously decided.” (Def.’s Vogel Reply Br. at 3.) Essentially, because the MDL court denied the Daubert motions without specifically addressing in its orders every objection to every opinion that Novartis made in its motion papers, Novartis would have this Court review the reliability of a particular methodology or factual basis de novo. The Court rejects this argument for two reasons. First, to the extent Novartis required clarification or desired reconsideration of these issues, it could have raised them before the MDL court. That they were not raised suggests to this Court that Novartis is simply trying its hand with a different judge in hopes of changing the outcome. Second, as noted below in the section discussing the current motions to exclude certain opinions of Drs. Vogel, Skubitz, and Marx, the MDL specifically carved out the expert opinions excluded from its rulings on the ground that they were not relevant to the summary judgment motion. It would logically follow that, by carving out the non-relevant opinions, the MDL court considered all of the other opinions relevant to the summary judgment motion, and therefore subject to its Daubert determination. The second argument that Novartis puts forth is that, even if the MDL’s orders constituted the “law of the case” on the relevant opinions, the law of the case doctrine is discretionary and “does not apply if disregarding a prior ruling would not cause prejudice to the party seeking the benefit of the doctrine.” (Def.’s Vogel Br. at 3 (citing Prisco v. A & D Carting Corp., 168 F.3d 593, 607 (2d Cir.1999)).) This is a mischaracterization of the law of the case doctrine, which, as set forth below, is equally applicable, if not more so, to decisions by an MDL transferee court. It is well-established that “[ojrders issued by a federal transferee court remain binding if the case is sent back to the transferor court.” In re Zyprexa Prods. Liab, Litig., 467 F.Supp.2d 256, 273 (E.D.N.Y.2006) (citing Manual for Complex Litigation § 20.133 (4th ed.2004)). As the Supreme Court has stated, the law of the case doctrine “posits that when a court decides a rule of law, that decision should continue to govern the same issues in subsequent stages in the same case.” Arizona v. California, 460 U.S. 605, 618, 103 S.Ct. 1382, 1391, 75 L.Ed.2d 318 (1983); see also Aramony v. United Way of Am., 254 F.3d 403, 410 (2d Cir.2001). This doctrine is discretionary and a court “may depart from the law of the case for ‘cogent’ or ‘compelling’ reasons including an intervening change in law, availability of new evidence, or ‘the need to correct a clear error or prevent manifest injustice.’ ” Johnson v. Holder, 564 F.3d 95, 99-100 (2d Cir.2009) (quoting United States v. Quintieri, 306 F.3d 1217, 1230 (2d Cir.2002)). In fact, it would be impossible to reconcile the contention by Novartis that a court can feel free to disregard the law of the case as long as the party seeking the doctrine’s protection would not be prejudiced, with the Supreme Court’s caution that “as a rule courts should be loathe to [revisit prior decisions in the case] in the absence of extraordinary circumstances such as where the initial decision was clearly erroneous and would make a manifest injustice.” Christianson v. Colt Indus. Operating Corp., 486 U.S. 800, 816, 108 S.Ct. 2166, 100 L.Ed.2d 811 (1988) (citation omitted). In Prisco, the Second Circuit addressed the issue of whether a court that had a “valid reason” for reversing a previous ruling could still reverse that ruling if it would prejudice the party seeking the protection of the doctrine. Thus, whether the Plaintiffs would be prejudiced if this Court reversed the MDL court’s rulings is only a relevant consideration if there is a “valid reason” for reversal. Novartis has failed to identify any “valid reason” for reversal. Novartis does not argue that the MDL court ruling was “clearly erroneous” or that “manifest injustice” would occur if the Court did not reverse the rulings. Furthermore, any reversal of the MDL court rulings would undermine the purpose of the Multi District Litigation Act, which authorizes the coordinated and consolidated pretrial proceedings of civil actions involving one or more common issues of fact “for the convenience of parties and witnesses and [to] promote the just and efficient conduct of such actions.” 28 U.S.C. § 1407(a). As stated in the initial order consolidating and transferring the Aredia and Zometa cases, “[centralization under Section 1407 is necessary in order to eliminate duplicative discovery; prevent inconsistent pretrial rulings; and conserve the resources of the parties, their counsel and the judiciary.” In re Aredia and Zometa Prods. Liab. Litig., 429 F.Supp.2d 1371, 1372 (Jud.Pan.Mult.Lit.2006). To prevent inconsistent pretrial rulings on the admissibility of expert testimony, it is only in “exceptional cases, [that] the federal or state court to which an MDL case is transferred or remanded may revisit a transferee court’s decision.” Zyprexa, 467 F.Supp.2d at 274 (E.D.N.Y.2006) (citing Manual for Complex Litigation § 20.133 (“Although the transferor judge has the power to vacate or modify rulings made by the transferee judge, subject to comity and ‘law of the case’ considerations, doing so in the absence of a significant change of circumstances would frustrate the purposes of centralized pretrial proceedings.”)). Reversing or otherwise undermining the decisions by the MDL court could lead to the type of inconsistent pretrial rulings that Congress sought to avoid, and therefore frustrate the very purpose of consolidation. Accordingly, the Court will not decide any issues previously presented to and denied by the MDL court. However, in an abundance of caution, the Court will address one of Novartis’ main arguments against the admissibility of certain expert opinions, namely whether an opinion based on a non-controlled trial or study is reliable. C. Reliability of Epidemiologic Studies A common objection that Novartis makes throughout the various motions is that an expert’s opinion is unreliable because it is not based on the results of a randomized controlled clinical trial or study. These same objections were made in the MDL court motions, and in most instances with regard to the same studies and articles challenged in the instant motions. (See, e.g., Def.’s Vogel MDL Br. at 13 (“To the extent Dr. Vogel relies on any larger studies, those studies have no control group and fail to control for confounding. Without controlled human data, it is not possible to know whether the occurrences of ONJ are more common in patients taking Aredia and/or Zometa than in the general population.”); Def.’s Skubitz MDL Br. at 13 (seeking two exclude Dr. Skubitz’s causation opinions based on three retrospective non-eontrolled studies, Hoff, Dimopoulos, and Cairo, that are also challenged as unreliable in the present motions).) As previously stated, the Court finds the MDL rulings on the admissibility of opinions premised on these studies constitutes the law of the case. However, assuming the MDL court ruling cannot be read so broadly, the Court still finds that the early stage of research on BRONJ, the difficulty in performing a randomized controlled clinical trial or study, and the dispute among the various experts with regard to the importance of controlling for certain factors, support the admissibility under Daubert of the challenged opinions. This does mean the Court has not considered Novartis’ other objections as they relate to the reliability of these articles — e.g., failure to define ONJ or expert opinions that are inconsistent with a study’s conclusions. However, to the extent Novartis’ argues that an opinion is inadmissible because it relies on a retrospective non-controlled study, the Court finds that these arguments go to the weight and not the admissibility of the opinions. To study the relationship between bisphosphonate drugs and ONJ, researchers rely primarily on epidemiologic studies. “Epidemiology is the field of public health and medicine that studies the incidence, distribution, and etiology of disease in human populations.” Michael D. Green et al., Reference Guide on Epidemiology, in Reference Manual on Scientific Evidence 333, 335) (Fed.Jud.Ctr.2d ed.2000) (hereinafter “Reference Manual ”). The medical field that performs epidemiologic studies as they relate to “the study of the utilization and effects of drugs in large numbers of people” is referred to as pharmacoepidemiology. See International Society for Pharmacoepidemiology, About Pharmacoepidemiology, http://www.pharmacoepi.org/ about/index.efm (last visited March 7, 2011. Expert opinions in medical-related eases typically involve results from clinical trials, epidemiologic studies, and case studies. The clinical trial is the “gold standard” of medical research. In re Rezulin Prods. Liab. Litig., No. MDL 1348, 369 F.Supp.2d 398, 406 (S.D.N.Y.2005) (citing Reference Manual at 335). To date, there have been a limited number of clinical trials that have produced meaningful data. In the initial Aredia and Zometa clinical trials, there was no common definition for BRONJ and researchers were not necessarily looking for BRONJ. As such, a disputed issue in this litigation is how many instances of ONJ actually occurred in those clinical trials. See infra Section D.8.b. Dr. Salvatore Ruggiero, one of the original BRONJ researchers, who is also one of Plaintiff Deutsch’s non-retained experts, has explained that, putting together the type of randomized controlled study to get definitive data on causation is particularly difficult in this case, because drugs such as Zometa and Aredia are considered a standard form of care for many patients with breast cancer or multiple myeloma. (Ruggiero Dep. 77-78.) In In re Fosamax Products Liability Litigation, 645 F.Supp.2d 164 (S.D.N.Y.2009), the court faced similar issues with the lack of controlled studies on the association between an oral bisphosphonate drug and the development of ONJ. There, the court held that Considering the early state of the research, the lack of evidence from controlled epidemiological studies is not fatal. Under Daubert, an expert need not base his or her opinion on the best possible evidence, regardless of availability, but upon “good grounds, based on what is known.” Id. at 178 (quoting Daubert, 509 U.S. at 590, 113 S.Ct. 2786). Accordingly, the fact that a particular opinion is not based on a randomized controlled clinical trial, while certainly an area for cross-examination, will not affect its admissibility. Where, as here, there is limited research from clinical trials, and what is available is heavily disputed, observational epidemiologic studies are often used to assess an association between a drug and disease and in turn general causation. Reference Manual at 406 & nn. 55-57. Although epidemiology does not directly address the question of causation, the results of epidemiologic studies can be “highly probative on the issue of causation.” DeLuca by DeLuca v. Merrell Dow Pharm., Inc., 911 F.2d 941, 958 (3d Cir.1990). The two main types of observational epidemiologic studies are case-control studies and cohort studies. Reference Manual at 339. One of the Plaintiffs’ experts, Prof. Wayne Ray, explained in his expert report how causation can be determined from observational studies as follows: The term observational comes from the fact that, unlike randomized clinical trials, patients in observational studies are not assigned to the study groups. Rather, clinical investigators observe differences between patients who either use or do not use a particular medication. Because the patients in observational studies are not randomly assigned to the study groups, the findings from epidemiologic studies are sometimes referred to as associations. This simply implies that the disease of interest occurs more frequently in patients with the factor under study than in other patients.... Epidemiologists thus have developed procedures for determining whether or not an observed association is likely to be causal. (Ray Rev. Report at 9.) A cohort study “usually work[s] by classifying a population into those who have exposure to the drug (the exposed group) and those who do not (the control group.)” (Id. at 12.) The researcher then follows both groups for a specified length of time and then compares the propositions of individuals in each group who develop the disease. Reference Manual at 340. The observed result is referred to as the “association” between the drug and the disease. The strength of an association between exposure and the disease can be statistically stated in a measurement of association that examines the degree to which the risk of the disease increases when individuals are exposed to an agent. Reference Manual 348. For example, the association can be calculated in terms of “relative risk” and “attributable risk.” The relative risk is the ratio of the incidence rate of disease in exposed individuals to the incidence rate of unexposed individuals. Id. at 348. The relative risk is “the standard measure clinical researchers use to describe the magnitude of occurrence of health effects associated with medications or other exposures.” (Ray Rev. Report at 13.) “The threshold for concluding that an agent was more likely than not the cause of an individual’s disease is a relative risk greater than 2.0.” Reference Manual at 384. The attributable risk, which can be calculated using the relative risk, is the proportion of disease eases that are attributable to the exposure. (Ray Rev. Report at 14.) By contrast, a case-control study measures and compares the “frequency of exposure in the group with the disease (the “cases”) and the group without the disease (the “controls”)”. Reference Manual at 340. The groups are then compared in terms of past exposure, and if a certain exposure is associated with or caused the disease, then “a higher proportion of past exposure among the cases than among the controls would be expected.” Id. at 342. When assessing the reliability of a epidemiologic study, a court must consider whether the study adequately accounted for “confounding factors.” A confounding factor involves a situation where “both a risk factor for the disease and a factor associated with the exposure of interest” are present in the same study, and the study does not separate the effects of the two processes. Id. at 389. The distortion created by confounding factors can lead to an erroneous result. Id. As a result, there are a number of ways to control for known confounding factors. However, failure to control for an unknown confounding factor does not necessarily render the results unreliable. In the instant case, Novartis objects to the reliability of the observational studies because many of them fail to control for alleged confounding factors such as cancer type, or other known risk factors associated with BRONJ, such as other cancer therapies and tooth extractions. In order to be considered a “confounding factor” the risk of an IV BP user developing ONJ with the risk factor must be substantially different than the risk of developing ONJ without the risk factor. See id. at 373. The Plaintiffs’ experts do not assert with any degree of certainty that such risk factors are not confounding factors. Indeed, as the AAOMS 2009 Position Paper indicates, further research is needed to develop valid BRONJ risk assessment tools. AAOMS 2009 Position Paper at 10. As the MDL court noted, one of the myriad of factual issues that the jury will need to decide is “whether there are, in fact other ‘risk factors’ for ONJ and what those are.” MDL Warnings Order at 3. As the testimony of the Plaintiffs’ experts and the relevant medical literature suggest, it is at least plausible that a study that does not control for a certain factor is still a reliable basis for an opinion. For example, as reviewed in greater detail within the discussion of Novartis’ Daubert motion to exclude the testimony of Prof. Ray, he performed a type of analysis that required a review of a number of cohort studies, many of which are relied upon separately by other experts in this litigation. Novartis argued that because the various cohort studies did not control for all of the confounding factors, and that Prof. Ray’s analysis did not control for such factors, the results were inherently unreliable. However, Prof. Ray concluded that it was not necessary to control for these factors in order to determine the relative risk of bisphosphonate therapy because there is no evidence that these conditions cause ONJ absent bisphosphonate use. For example, Prof. Ray stated in his report that “if cancer were strongly associated with this rare condition, there should have been equal numbers of cases occurring prior to 2001-2002.” (Ray Report at 32.) Prof. Ray also noted that the presence of other cancer therapies also “fails to explain the dramatic increase in cases that occurred following 2001” (Id. at 33). Novartis disputes the accuracy of Prof. Ray’s opinions because they are based on case-reports, but “mere weaknesses in the factual basis of an expert witness’ opinion ... bear on the weight of the evidence rather than on its admissibility.” McLean v. 988011 Ontario, Ltd., 224 F.3d 797, 801 (6th Cir.2000) (internal quotation marks and citation omitted). In addition, another one of the Plaintiffs’ experts, Dr. Keith Skubitz, testified that it was not necessary to control for cancer type because, based on his conclusion, IV BPs “could cause ONJ whether or not one had cancer” because “the type of cancer presumably is not the mechanism of the ONJ, so it wouldn’t matter the type of cancer.” (2/16/09 Skubitz Dep. 319:9-320:2.) Highlighting the disputed nature of this position, Novartis’ counsel responded to Dr. Skubitz by stating: “I understand you presume it’s not the mechanism of ONJ. Other people might differ with you on that.” (Id. at 320:3-5.) Furthermore, the position that cancer type or certain risks may not be strongly associated with the development of BRONJ or that the ability to make such a determination remains unknown is also supported in the relevant medical literature. See, e.g., AAOMS 2009 Position Paper at 5 (“[A] few current studies have noted an increased risk of BRONJ among patients exposed to chemotherapeutic agents.... Others, however, have failed to confirm the association between chemotherapeutic agents and BRONJ risk.”); Sundeep Khosla, et al., Bisphosphonate-Associated Osteonecrosis of the Jaw: Report of a Task Force of the American Society for Bone and Mineral Research, J. of Bone and Mineral Research, at 1483 (Nov. 10, 2007) (“Table 6 summarizes risk factors currently felt to predispose to bisphosphonate-associated ONJ; however, the task force recognized that the evidence on risk factors predisposing to ONJ was weak.”); Aristotle Bamias, et al., Osteonecrosis of the Jaw in Cancer After Treatment with Bisphosphonates: Incidence and Risk Factors, J. of Clinical Oncology, at 8585 (Dec. 31, 2005) (“The difference in incidence between myeloma and breast cancer in our series is not significant and is most probably due to the different time of exposure between these groups.”); Id. at 8586 (“Because of the diversity of the chemotherapy regimens and the timing of administration, it was impossible to perform an analysis addressing the contribution of this factor in the development of ONJ.”); Thacharot Boonyapakorn, et al., Bisphosphonate-induced Osteonecrosis of the Jaws: Prospective Study of 80 Patients with Multiple Myeloma and other Malignancies, Oral Oncology, at 865 (2008) (identifying certain risk factors that had no significant association with ONJ such as age, sex, conventional chemotherapy, corticosteroids, thalidomide and time of exposure, and identifying a strong association with the history of extraction or surgical tooth removal during bisphosphonate therapy); but see Calhoun Deck in Support of Novartis’ Daubert Motion to Exclude the Testimony of Wayne Ray, Ph.D., Exs. 2(a)-2(k) (examples of articles regarding ONJ occurring absent bisphosphonate therapy). The plausibility that an observational study is reliable despite not controlling for cancer type or other potential risk factors has been sufficiently established through the testimony of expert witnesses and the peer-reviewed medical literature. “That the research is accepted for publication in a reputable scientific journal after being subjected to the usual rigors of peer review is a significant indication that it is taken seriously by other scientists, i.e., that it meets at least the minimal criteria of good science.” Daubert v. Merrell Dow Pharm., Inc. (“Daubert II”), 43 F.3d 1311, 1318 (9th Cir.1995). Therefore, Novartis’ objections to expert opinions on the grounds that they are unreliable because they rely on non-controlled epidemiologic studies or extrapolate opinions from articles based on different cancer types than those of Mrs. Deutsch and Mr. Napolitano will not affect the admissibility of such opinions. The weight of a conclusion derived from these studies involves the resolution of a factual dispute and therefore is a classic question for the jury. See Quiet Tech. v. Hurel-Dubois UK Ltd., 326 F.3d 1333, 1340-41 (11th Cir.2003) (“[I]t is not the role of the district court to make ultimate conclusions as to the persuasiveness of the proffered evidence.... By attempting to evaluate the credibility of opposing experts and the persuasiveness of competing scientific studies, the district court conflated the questions of admissibility of expert testimony and the weight appropriately to be accorded such testimony by a fact finder.”) (internal citations and quotations omitted). D. Novartis’ Daubert Motions to Exclude Portions of the Expert Testimony of Drs. Vogel, Skubitz, and Marx As previously stated, the MDL court denied in part and mooted in part Novartis’ Daubert motions to exclude the expert testimony of Drs. Vogel, Skubitz, and Marx. Specifically, the MDL court carved out from its decision the following issues that Judge Campbell deemed were not relevant to the summary judgment motion: • “Dr. Vogel’s opinions concerning the alleged corporate behavior of Novartis, his statement that the delay and failure in transmission of certain information impacted a large number of patients, or his testimony concerning the benefit of pretreatment dental screening” (Vogel Order at 3.) • “Dr. Skubitz’s opinions about extending the dosing interval for patients treated with Zometa or recommending that patients treated with Aredia and/or Zometa receive pre-treatment preventative dentistry to reduce the incidence of ONJ.” (Skubitz Order at 3.) • “... Dr. Marx’s opinions concerning the alleged “bad faith” misconduct of Novartis or his opinions concerning the clinical trials.” (Marx Litig.-Wide Order at 4.) The arguments in the motions to exclude Drs. Vogel, Skubitz, and Marx’s expert opinions before this Court fall into three categories. The first are objections that were raised in Novartis’ submissions to the MDL court and which were subject to the MDL court’s rulings. As previously stated, the Court considers the MDL court decisions the law of the case and will not revisit these issues. The second type of objection involves new arguments for excluding specific opinions in general areas of testimony subject to the MDL court’s orders. Although the Plaintiffs’ assert that these types of objections were implicitly decided by the MDL court, the Court will address the sufficiency of the arguments to the extent that doing so will not undermine the MDL court’s decision. The final type of objection is to an issue that was either carved out by the MDL court, or not otherwise raised before the MDL court. The Court will address these objections the Court de novo to the extent that doing so is not inconsistent with the MDL court’s other rulings. 1. The Experts and the Present Motions a. Dr. Vogel Dr. James M. Vogel has been a practicing physician in the field of hematology and medical oncology for the last 35 years. In addition, Dr. Vogel is presently an Associate Professor at the Mount Sinai School of Medicine in the Department of Medicine, Division of Hematology/Medical Oncology. In his practice, Dr. Vogel primarily sees patients with “solid tumors,” predominantly breast and lung etiologies, and also sees patients with hematologic malignancies involving multiple myeloma, lymphomas and leukemias. At trial, the Plaintiffs’ seek to offer Dr. Vogel to testify on a number of subjects including: (1) Dr. Vogel’s personal experience in prescribing bisphosphonate drugs and the clinical course of his patients that developed ONJ; (2) Dr. Vogel’s experience with cancer patients who were not taking a bisphosphonate drug and whether they developed ONJ; (3) Dr. Vogel’s opinion as to whether bisphosphonate drugs cause ONJ; (4) his opinion on whether Novartis adequately warned hematologists and medical oncologists of the risk of ONJ in patients who were prescribed intravenous bisphosphonate drugs, and whether Novartis possessed any information about this risk that should have been provided to the medical professionals; (5) whether the risk of ONJ could be reduced without reducing the efficacy of the drugs by using pamidronate rather than zoledronic acid, reducing the amount of drug exposures based on the dosing schedule, or reducing the frequency of drug usage; and (6) whether and which dental care strategies could be used to prevent or minimize ONJ in patients treated with intravenous bisphosphonates. (Vogel Report ¶ 8.) Presently before this Court is Novartis’ Daubert motion to exclude Dr. Vogel’s opinions on five areas that Novartis contends were not addressed by the MDL court: (1) Novartis’ corporate conduct in connection with the development and labeling of Aredia and Zometa, and publications regarding ONJ and Aredia and Zometa; (2) benefits of an individual receiving dental screenings prior to an individual’s commencing Aredia or Zometa therapy; (3) the incidence of ONJ in persons exposed to bisphosphonates; (4) the information Novartis should disseminate regarding alternate dosing and the duration of treatment; and (5) the impact that the dosing mechanism of bisphosphonates has on bones. The Plaintiffs’ contend that all of these opinions, with the exception of Dr. Vogel’s opinions on Novartis’ corporate conduct and the benefits of pretreatment dental screening were already decided by the MDL court. The Court will now address below whether it considers itself bound by the MDL court as to a particular objection within its discussion of each objection. b. Dr. Skubitz Dr. Skubitz is a Professor of Medicine at the University of Minnesota Medical School and conducts research on basic biological aspects of cancer and clinical cancer therapy in addition to treating patients in the oncology clinic. Dr. Skubitz also has extensive experience as a peer-reviewer and author of medical publications and has been involved in a multi-center trial using an antibody that inhibits osteoclast development to treat a rare bone tumor known as giant cell tumor of bone, or osteoclastoma. At trial, the Plaintiffs seek to offer Dr. Skubitz to testify on a number of subjects including: (1) his experience prescribing bisphosphonate drugs and the occurrence of ONJ in his patients; (2) his experience with regard to ONJ in patients who were not taking a bisphosphonate drug; (3) his opinion on whether there is a generally accepted understanding within the oncology community as to whether IV BP drugs cause ONJ in certain patients; (4) his opinion on whether the company had certain information about Zometa and Aredia that it did not disclose to the medical community and that would have been important to oncologists in making decisions about how to advise and treat their patients; and (5) his opinion on whether Novartis completely and accurately informed the medical community about the risk of ONJ in patients taking IV BP drugs and about ways to avoid or minimize that risk. (Skubitz Report ¶ 5.) Presently before this Court is Novartis’ Daubert motion to exclude Dr. Skubitz’s opinions on the following areas that Novartis contends were not addressed by the MDL court: (1) opinions on the drafting and approval of the Zometa and Aredia labels; (2) opinions not stated in Dr. Skubitz’s expert report or deposition testimony; (3) opinions on alternative dosing; and (4) the benefits of pretreatment dental screening. The Plaintiffs’ contend that all of these opinions, with the exception of certain of Dr. Skubitz’s opinions on dosing, the benefit of pretreatment dental screening, and the admissibility of opinions not in Dr. Skubitz’s report were already decided by the MDL court. The Court will address below whether it considers itself bound by the MDL court as to a particular objection within its discussion of each objection. c. Dr. Marx Dr. Robert Marx is a board certified oral and maxillofacial surgeon and the active Professor of Surgery and Chief of the Division of Oral and Maxillofacial Surgery at the University Of Miami Miller School Of Medicine. In his clinical practice at the University of Miami, Dr. Marx spends one day a week consulting with patients, and four days a week performing surgeries, including removal of benign and malignant tumors, reconstructive surgery, and treatment and removal of diseased or dead jawbone. Dr. Marx has published extensively on all aspects of the diagnosis and surgical treatment of maxillofacial diseases and disorders and is considered an authority on bone science and diseases of bone. Indeed, BRONJ was first identified and described in the medical literature in a textbook that Dr. Marx co-authored in 2002 called Oral and Maxillofacial Pathology: A Rationale for Diagnosis and Treatment (Quintessence Publishing Co.). Dr. Marx contacted Novartis in July 2003 to discuss 36 cases of unexplained ONJ between late 1999 and July 2003 that he believed were attributable to bisphosphonates, particularly Aredia and Zometa. Subsequently, Dr. Marx submitted these findings to the Journal of Oral and Maxillofacial Surgery as a medical alert to notify the dental profession of BIONJ, which were published in the September 2003 edition. Although Novartis disputed Dr. Marx’s findings, they continued to work with Dr. Marx to determine whether a causal connection existed. During this time Dr. Marx continued to extensively research the relationship between bisphosphonate therapy and BIONJ. Dr. Marx’s relationship with Novartis terminated when he declined to include his name in an article on the subject because it failed to identify bisphosphonates as the cause of ONJ or recommended any serious prevention and treatment protocols. At the trial, the Plaintiffs’ seek to offer Dr. Marx to testify on a number of litigation-wide subjects including: (1) his clinical experience that made him aware of a causal relationship between bisphosphonates and ONJ and which led to his finding BIONJ is a discrete pathology; (2) the reasons that he has concluded that bisphosphonates are the sole cause BIONJ; and (3) steps that can be taken to prevent and treat BIONJ in individuals receiving bisphosphonate therapy. (Marx Report ¶ 14.) Presently before this Court is Novartis’ Daubert motion to exclude Dr. Marx’s opinions on six areas that Novartis contends were not addressed by the MDL court: (1) that dental treatment measures are effective in preventing BIONJ; (2) that Novartis engaged in “bad faith” conduct;- (3) certain patients in the clinical trials had BIONJ; (4) criticizing the clinical trials; (5) presenting general causation testimony based on adverse event reports that Dr. Marx has not reviewed; and (6) the biological mechanism by which bisphosphonate drugs cause ONJ. The Plaintiffs’ contend all of these opinions, with the exception of Dr. Marx’s opinion that Novartis engaged in “bad faith” conduct or his opinions relating to the clinical trials were already decided by the MDL court. The Court will address below whether it considers itself bound by the MDL court as to a particular objection within its discussion of each objection. 2. Novartis’ Motions to Exclude Opinions by Drs. Vogel, Skubitz, and Marx on the Benefits of Preventative Measures and specifically Pretreatment Dental Screening Novartis seeks to exclude Drs. Vogel, Skubitz and Marx from testifying about the benefits of warnings or preventative measures such as pretreatment dental screening in reducing the risk of ONJ. Novartis mainly objects to their opinions on the benefits of preventative measures because the theory is speculative and based on unreliable non-controlled studies. As an initial matter, Novartis contends that because Dr. Vogel is not a dentist or oral surgeon and is not otherwise an expert on bisphosphonates or ONJ, Dr. Vogel is not qualified to opine on the effects of pretreatment dental screening on the incidence of ONJ in persons exposed to bisphosphonates. However, “[ujnlike an ordinary witness ... an expert is permitted wide latitude to offer opinions, including those that are not based on firsthand knowledge or observation.” Daubert, 509 U.S. at 592, 113 S.Ct. 2786; see also Major League Baseball Props., Inc. v. Salvino, Inc., 542 F.3d 290 (2d Cir.2008). To be qualified to testify on such a subject the Court must be satisfied that “the expert’s opinion will have a reliable basis in the knowledge and experience of his discipline.” Daubert, 509 U.S. at 592, 113 S.Ct. 2786. Dr. Vogel’s extensive experience as an oncologist and hematologist including treating patients with bisphosphonate therapy provides a reliable basis for his opinions on the benefits of preventative measures such as pretreatment dental screening. With regard to the speculative nature of the theory, Novartis cites testimony from Dr. Marx’s deposition where he stated “whether any particular patient would have developed ONJ, but then didn’t develop ONJ because of some sort of prebisphosphonate treatment dental exam, that’s an unknowable situation at this point” and that “the jury is still out in terms of controlled data on this issue.” (5/26/09 Marx Dep. at 1367-68.) According to Novartis, any opinions expressed by Drs. Vogel, Skubitz, or Marx as to the potential benefit of preventative measures that contradict Dr. Marx’s statement are inadmissible. However, Daubert does not require absolute certainty before an expert can proffer an opinion and allows for the admissibility of new theories provided they are based on a reliable methodology. See In re Baycol Prods. Litig., 532 F.Supp.2d 1029, 1066 (D.Minn.2007) (“Other courts have recognized that science is constantly evolving, and the fact that a theory is new or in the process of becoming generally accepted does not prevent its admission in court.”) (citing Ruiz-Troche v. Pepsi Cola Puerto Rico Bottling Co., 161 F.3d 77, 85 (1st Cir.1998)). Indeed, none of the experts claim that it is a scientific certainty that preventative measures, such as pretreatment dental screening, reduce the risk or incidence of ONJ. Rather, they all opine that the relationship is supported in the literature, and in Dr. Marx’s case, by his own experience. The fact that an expert witness speaks in probabilities, rather than certainties, does not by itself make the testimony unreliable. See Pension Comm. of Univ. of Montreal Pension Plan v. Banc of America Secs., LLC, 691 F.Supp.2d 448 (S.D.N.Y.2010). Consistent with the Court’s earlier ruling, arguments as to the reliability of non-controlled studies go to the weight, not the admissibility of these experts’ opinions on preventative measures. Furthermore, these experts’ opinions are not wholly unsubstantiated observations, but rather this theory has been deemed plausible and credible in the relevant medical literature and through Dr. Marx’s own published study. See, e.g., AAOMS 2009 Position Paper at 6 (“These findings suggest that, although BRONJ is not eliminated, dental evaluations, and treatment before initiating IV bisphosphonate therapy among cancer patients reduces ONJ risk.”). The theory that preventative measures, including pretreatment dental screening, may decrease the risk of BRONJ is admissible and it is well within all of the experts field of expertise to opine on this subject. Accordingly, Drs. Marx, Skubitz, and Vogel’s testimony satisfies the Daubert standard and Novartis’ motions to preclude their opinions on the benefits of preventative pretreatment dental care are denied. 3. Novartis’ Motions to Exclude the Opinions of Drs. Vogel and Marx on the Biological Mechanism for How IV BP Drugs Cause ONJ As part of their causation opinions, Drs. Vogel and Marx opined on possible mechanisms by which bisphosphonates can cause ONJ. Notably, the experts discussed this theory in terms of its plausibility, not as a factual conclusion. “That the mechanism remains unknown does not mean that the one proposed by the [plaintiffs’ experts] is not widely accepted as plausible.” Fosamax, 645 F.Supp.2d at 183 (citing In re Neurontin Mktg. Sales Practices and Prods. Liab. Litig., 612 F.Supp.2d 116, 149 (D.Mass.2009) (finding that biologic plausibility supported opinion on causation despite the fact that there was “robust debate in the scientific community” on the proposed mechanism); In re PPA Prods. Liab. Litig., 289 F.Supp.2d 1230, 1247 (W.D.Wash.2003) (“The fact that the mechanism remains unclear does not call the reliability of the opinion into question.”)). As such, the Court agrees with the court in the Fosamax litigation that “any testimony about the mechanism is admissible only if qualified in substance with a statement that it remains a theory that, subject to testing, may be proved or disproved.” Fosamax, 645 F.Supp.2d at 198. Novartis challenges the qualifications of Drs. Vogel and Marx, who are not bone experts, to reliably opine specifically on the theory that ONJ is caused by bisphosphonates targeting bone by disabling osteoclasts and inhibiting resorption in the jaw. The Plaintiffs’ respond that, not only are Drs. Marx and Vogel qualified, but that these objections have already been raised to and rejected by the MDL court. The Court finds that the MDL court ruled on Dr. Marx’s qualification but not those of Dr. Vogel. However, in either event, both are qualified. a. Dr. Marx In its motion to exclude Dr. Marx’s litigation-wide testimony, Novartis argued that Dr. Marx was not qualified to provide an opinion relating to the bone resorption mechanism. Insofar as this was not among the topics explicitly excluded from the MDL court’s opinion, the admissibility of Dr. Marx’s opinion on this subject is the law of the case. However, even if the MDL court’s decision was not binding, the Court would still find that Dr. Marx is more -than qualified to testify with regard to this theory. Dr. Marx has conducted research, published peer-reviewed articles, and essentially served as an authority on the relationship between bisphosphonates and ONJ. The Court has no doubt that his academic involvement and extensive background in identifying, treating, and studying patients with ONJ qualifies him to render opinions on this subject. See Fosamax, 645 F.Supp.2d at 198 (denying a motion to exclude Dr. Marx’s opinion on the mechanism that Fosamax was “toxic to bone because it kills or impairs osteoclasts”). b. Dr. Vogel With regard to Dr. Vogel’s qualifications, Novartis asserts that this Court should exclude Dr. Vogel’s opinions on the mechanism theory that BRONJ is caused by bisphosphonates targeting bone by disabling osteoclasts and inhibiting resorption in the jaw because Dr. Vogel admitted that “he cannot explain the mechanism by which bisphosphonates allegedly cause ONJ” and because Dr. Vogel is not a bone pathologist or bone biologist. In the Novartis Daubert motion to exclude Dr. Vogel’s opinions to the MDL court, Novartis argued that Dr. Vogel’s opinions were unreliable because he admitted that “he cannot explain the mechanism by which bisphosphonates allegedly cause ONJ” and because “both of the publications cited by Dr. Vogel to suggest possible mechanisms as to how bisphosphonates may cause ONJ cast doubt on his causation opinion.” (Def.’s MDL Vogel Br. at 12.) Accordingly, while the MDL court did find that Dr. Vogel’s inability to explain the mechanism did not render his opinions unreliable as to the biological mechanism generally, the MDL court did not directly address whether Dr. Vogel is qualified to offer an opinion on the particular hypothesis about bisphosphonates targeting the bone. Nevertheless, the Court finds that Dr. Vogel’s lack of expertise as a bone biologist or bone pathologist does not disqualify him from opining on a plausible causation mechanism involving how bisphosphonates target bone to cause BRONJ. Dr. Vogel does not purport to rely on su