Full opinion text
Memorandum and Order VOORHEES, District Judge. THIS MATTER is before the Court on the Defendant’s Motions To Exclude Or Limit The Testimony Of Plaintiffs Expert Witnesses, filed August 30, 2002; Plaintiffs Motions To Exclude Expert Testimony of Drs. Steven M. Koenig, Kenneth W. Rietor, and Marta M. Kalinski, filed August 16, 2002 and August 30, 2002; and the parties’ responsive memoranda and exhibits. The Court conducted an evidentiary hearing on December 4, 2002 and December 5, 2002, the focus of which was the parties’ cross-motions to exclude evidence of causation. On December 10, 2002, Plaintiff conducted a de bene esse deposition of Dr. Carmine Dalto, which has been transcribed and filed with the Court for purposes of supplementing the record. I. Background For purposes of the pending Daubert motions, the Court will only recite the relevant facts. Plaintiff suffers from Primary Pulmonary Hypertension (“PPH”), a rare but serious lung disease that exists when there is an elevation of the pressure in the pulmonary artery. Pulmonary hypertension can occur as a result of heart disease, liver disease, sleep apnea, blood clots in the lungs, sickle cell anemia, collagen vascular disease, and other causes. Pulmonary hypertension can occur idio-pathically or sporadically, meaning it occurs without an identifiable cause. When there is no known cause, the disease is called “primary pulmonary hypertension” or PPH. PPH occurs in the general population at the rate of 1 to 2 cases per million annually. Women between the ages of twenty (20) and fifty (50) are considered a high risk group for the disease. The landmark epidemiological study exploring the relationship between diet drugs and PPH is the International Primary Pulmonary Hypertension Study (“IPPHS”), published in the New England Journal of Medicine on August 29, 1996. IPPHS coauthors include Dr. Lucien Abenhaim of McGill University in Montreal, Canada; Dr. Francois Brenot of Antoine Beclere Hospital in Paris, France; and Dr. Stuart Rich of the Rush Heart-Lung Institute in Chicago, Illinois (Plaintiffs expert). The main objective of the IPPHS was to assess the role of several known or suspected risk factors in the development of PPH, including anorectic agents. The IPPHS, a case-controlled study, considered 95 PPH cases, along with 335 physician-based control cases from France, United Kingdom, Belgium, the Netherlands, and Switzerland. Although the exact mechanisms of action of the anorexigens in PPH have not been definitively established, the IPPHS confirmed that the use of anorexigens (or appetite suppressants) is, in fact, a risk factor for PPH. More specifically, the adjusted odds ratio for those exposed to at least one anorexigen prior to the onset of symptoms was 6.3 (95% Cl: 3.0-13.2) if all past exposures were considered and 10.1 (95% Cl: 3.4-29.9) for recent users, or those who experienced symptoms within twelve (12) months of the last exposure. For those who used anorexigens for a duration of more than 3 months, the odds ratio was 23.1 (95% CL6.9-77.7). Between 1995 and 1997, Plaintiff Rita Smith was prescribed a combination of Pondimin (name brand for fenfluramine) and Phentermine, commonly known as “Fen-Phen,” by two (2) different physicians. Plaintiff used fen-phen intermittently for a total of 8 $ months, with her last use in April 1997. According to Plaintiff, she first experienced shortness of breath (or dyspnea), a symptom of PPH, in February of 2000. She also noticed shortness of breath when exercising in November 2000. However, Plaintiff did not seek medical treatment until April 2001. On May 18, 2001, Plaintiff was diagnosed with diet-drug induced Primary Pulmonary Hypertension (“PPH”) by Dr. Dalto. At the time of her diagnosis, Plaintiff presented with systolic pulmonary pressures close to 100 mmHg and right ventricular hypertrophy. Shortly thereafter, Dr. Dalto referred Plaintiff to Duke University’s Pulmonary Hypertension Clinic. On June 19, 2001, after the referral to Duke, Dr. Tap-son confirmed Plaintiffs diagnosis. Plaintiffs treating physicians assisted in ruling out other potential causes and agree with this diagnosis. Defendant’s expert disagrees, and opines that Plaintiffs PPH is ‘sporadic,’ or that the cause is unidentifiable. II. Discussion of the Law Expert testimony is admissible under Rule 702 if it concerns (1) scientific, technical, or other specialized knowledge that (2) will aid the jury or other trier of fact to understand or resolve a fact at issue. Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 592, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993); FED. R. EVID. 702. The first prong requires an examination of whether the reasoning or methodology underlying the expert’s proffered opinion is reliable, while the second prong involves relevance. Id. at 590-92, 113 S.Ct. 2786. In assessing whether an expert’s opinion is sufficiently reliable and relevant, the Court, as gatekeeper, conducts a flexible inquiry, focusing on the principles and methodology employed by the expert rather than the conclusions reached. Id. at 594-95, 113 S.Ct. 2786. In determining reliability, the following factors, if applicable, should be considered: 1) whether the expert’s reasoning or methodology has been or could be tested; 2) whether the expert’s reasoning or methodology has been subject to peer review and publication; 3) the known or potential rate of error; 4) the level of acceptance of the expert’s reasoning or methodology by the relevant professional community. Kumho Tire Co. v. Carmichael, 526 U.S. 137, 149-50, 119 S.Ct. 1167, 143 L.Ed.2d 238 (1999); Daubert, 509 U.S. at 593-94, 113 S.Ct. 2786. According to the Fourth Circuit, the court should be conscious of two guiding, and sometimes competing, principles. On the one hand, the court should be mindful that Rule 702 was intended to liberalize the introduction of relevant expert evidence. Cavallo v. Star Enter., 100 F.3d 1150, 1158-59 (4th Cir.1996). And the court need not determine that the expert testimony a litigant seeks to offer into evidence is irrefutable or certainly correct. Id. As with all other admissible evidence, expert testimony is subject to being tested by “[vigorous cross-examination, presentation of contrary evidence, and careful instruction on the burden of proof.” Daubert, 509 U.S. at 596, 113 S.Ct. 2786. On the other hand, the court must recognize that due to the difficulty of evaluating their testimony, expert witnesses have the potential to “be both powerful and quite misleading.” Id. at 595, 113 S.Ct. 2786. And given the potential persuasiveness of expert testimony, proffered evidence that has a greater potential to mislead than to enlighten should be excluded. U.S. v. Dorsey, 45 F.3d 809, 815-16 (4th Cir.1995). Westberry v. Gislaved Gummi AB, 178 F.3d 257, 261 (4th Cir.1999)(emphasis added). An expert must account for “how and why” he or she reached the challenged opinion. General Electric Co. v. Joiner, 522 U.S. 136, 144, 118 S.Ct. 512, 139 L.Ed.2d 508 (1997). Generally, before an expert opinion on causation is allowed, the expert must be able to “take serious account of other potential causes,” and offer an explanation as to why a proffered alternative was not the sole cause. Westberry, 178 F.3d at 265. However, an opinion is not deemed unreliable simply because all other potential causes cannot be excluded. Id.; Cooper v. Smith and Nephew, Inc., 259 F.3d 194, 202 (4th Cir.2001). Instead, the alternative causes suggested by a defendant normally affect the weight that the jury should give the expert’s testimony and not the admissibility of that testimony. Id. Speculation is not a reliable basis for expert opinion. Daubert, 509 U.S. at 590, 113 S.Ct. 2786. In addition, inferences are not allowed unless the inference is derived using scientific or other valid methods. Oglesby v. General Motors Corp., 190 F.3d 244, 250 (4th Cir.1999). Epidemiological data is admissible evidence on the issue of causation. However, the epidemiological data cannot support an inference that a suspected risk factor caused an injury unless: (i)the analysis of the data is statistically significant under scientifically accepted statistical norms; (ii) the statistical relationship is sufficiently strong to support a “more likely than not” inference; and (iii) the data being relied upon “fits” the facts of plaintiffs individual case. The proponent of expert testimony has the burden of establishing its admissibility by a preponderance of proof. Daubert, 509 U.S. at 592 n. 10, 113 S.Ct. 2786. In other words, the proponent must show that there is a reliable basis for concluding that the exposure more likely than not caused the specific harm alleged. Daubert v. Merrell Dow Pharmaceuticals, Inc., 43 F.3d 1311, 1320 (9th Cir.), cert denied, 516 U.S. 869, 116 S.Ct. 189, 133 L.Ed.2d 126 (1995)(“Daubert II”). III. Analysis 1. Defendant’s Motion 1 Plaintiff seeks to present evidence to the jury from which one can infer that Plaintiffs use of fen-phen caused her PPH. The Defendant objects, arguing that the epidemiological study establishing an association between fen-phen and PPH does not “fit” with the facts of this case. In order to find in favor of Defendant on this issue, however, the Court would have to disregard the overall, and statistically significant, finding of the IPPHS study, which establishes that use of appetite-suppressant drugs, regardless of duration of exposure and/or the onset of symptoms, results in an increased risk (630%) of PPH. For the reasons stated herein, Defendant’s motion will be granted, in part and denied in part. As Plaintiff argued during the hearing, the Court’s focus should not necessarily be on the existing epidemiological data, but rather on the process a treating physician, or a doctor in clinic, would follow. Indeed, “[u]nder Daubert, epidemiological studies are not necessarily required to prove causation, as long as the methodology employed by the expert in reaching his or her conclusion is sound.” Benedi v. McNeil-P.P.C., Inc., 66 F.3d 1378, 1384 (4th Cir.1995). “Differential diagnosis, or differential etiology, is a standard scientific technique of identifying the cause of a medical problem by eliminating the likely causes until the most probable one is isolated.” Westberry, 178 F.3d at 262. Plaintiffs evidence on causation, namely, Dr. Rich’s differential diagnosis, is admissible under Rule 702 and Daubert. Applying the reliability factors set forth within Daubert, Defendant’s concerns are addressed in turn. Dr. Rich’s reasoning and methodology, although not subject to a conclusive scientific procedure or test, is sufficiently rehable. Defendant contends that because PPH can occur idiopathieally, or without an identifiable cause, and because there is no way to distinguish an idiopathic case from a diet-drug induced case of PPH, that Plaintiffs opinion evidence is unreliable. However, as noted, supra, differential diagnosis doesn’t require plaintiff to rule out every other cause, only to offer an explanation and take account of the other potential causes. Westberry, 178 F.3d at 262. Therefore, the existence of idiopathic PPH doesn’t render Dr. Rich’s opinion inadmissible, but instead goes to the weight of the evidence. While it is true that epidemiological data is not required in order to prove causation, epidemiological data is key in this case because interpretation of the available data was considered by the parties’ experts in the differential diagnosis (or ‘algorithm’) process. As Dr. Koenig explained during his testimony, the epidemiological data comes into play because there is no way to distinguish the pulmonary arterial hypertension sporadic from diet drug-related pulmonary arterial hypertension. (12-5-02 Trans, at 13.) Consequently, the IPPHS was the primary subject of the Daubert hearing. As an initial matter, the Court is not persuaded that the IPPHS conclusively ruled out any increased risk of PPH for past users of fenfluramines. In testimony regarding the IPPHS protocol and the study’s “power,” Dr. Rich testified that the IPPHS was simply not “powered” to consider the delayed onset issue presented in this case, while Drs. Makuch and Koenig insisted that the protocol revealed the exact opposite. Defendant relies on a statement in the protocol that stratified analy-ses should be possible in order to identify potential high risk groups. (1992 IPPHS Protocol at 15.) “The power of a study expresses the probability of finding a statistically significant association of a given magnitude (if it exists) in light of the sample sizes used in the study.” Reference Manual, pg. 362. Stated differently, the term “power” refers to “the chance that a statistical test will declare an effect when there is an effect to declare” or “the probability of rejecting the null hypothesis when the alternative hypothesis is right.” Id. at 125 n. 144. In this ease, the concept of power is key because it’s helpful in evaluating whether the study’s outcome, particularly with regard to past users, is exonerative or inconclusive. Reference Manual, pg. 362. Therefore, if sufficiently powered to determine the latency issue, the failure to obtain statistically significant results with regard to past users would favor Defendant’s interpretation of the IPPHS and provide evidence that the risk of PPH does not persist more than a year after last exposure. However, the sample size for the past users category consisted of only seven (7) cases. (12-4-03 Trans, at 189-90.) More importantly, Dr. Rich, a co-author of the study, testified that the primary ‘end point’ of the IPPHS was to determine the magnitude of the association. (12-4-02 Trans, at 117, 171; Rich Affidavit, ¶ 5.) In other words, the IPPHS was designed and powered for this specific purpose even though the study also considered the temporal relationship and whether the risk diminished over time. The Court’s understanding of epidemiology ‘basics’ is consistent with Dr. Rich’s explanation in that both temporal relationship and diminishing risk are factors to be considered when assessing whether an association can support a causal relationship. In light of Dr. Rich’s testimony, as well as the sample size, the Court is persuaded that the IPPHS was not sufficiently powered to determine conclusively the risk for past users such as Plaintiff. Despite its inability to squarely address the latency issue presented in this case, the IPPHS provides reliable, scientific evidence to support Plaintiffs theory of causation. This is true despite the parties’ agreement that the specific subset analysis or study that would neatly “fit” with the facts of this case has not been done. In other words, there is no epidemiological data explaining what associated risk develops for users of fen-phen who took the diet drug for longer than 8 months and did not display symptoms within twelve (12) months of their last use. However, that is not to say that the IPPHS is not relevant, or does not “fit.” As explained in The Federal Judicial Center’s Reference Manual on Scientific Evidence, “In a toxic substance case in which cause in fact is disputed, an epidemiologic study of the same agent to which the plaintiff was exposed that examined the association with the same disease from which the plaintiff suffers would undoubtedly have sufficient ‘fit’ to be a part of the basis of an expert’s opinion.” Reference Manual, pg. 383 n. 134 (emphasis added). Given the above, the IPPHS is certainly relevant and provides a sufficient “fit” to serve as a basis for the proffered expert testimony. Likewise, Plaintiffs recognition that the risk of developing PPH as a result of fenfluramine use diminishes over time does not render Dr. Rich’s opinion unreliable. Dr. Rich testified that the authors of the IPPHS suspected that the risk of diet-drug induced PPH diminished over time, and that the study confirmed their suspicions. (12-4-02 Trans, at 117.) Nonetheless, the IPPHS did not conclude that there is no risk beyond twelve (12) months of the last use. The Court agrees with Plaintiff that it defies logic to contend that the -risk existed at day 364, but not at day 866. (12-4-02 Trans, at 120, 127.) As alluded to earlier, exactly how much time the increased risk persists is the unknown here. Even so, this unknown does not render the Plaintiffs proffered opinions unreliable. Instead, the Court must merely ensure that the proposed testimony is supported by “appropriate validation — i.e., ‘good grounds,’ ” based upon what is known. Benedi, 66 F.3d at 1388. The IPPHS, combined with the related medical literature, including case series reports, provides the validation needed to establish admissibility. Drs. Rich and Tapson refer to such case reports. Standing alone, case reports may or may not be a sufficient basis for expert opinion regarding causation. Nonetheless, case reports can provide supportive or corroborating data, particularly with rare-diseases such as PPH. According to the Reference Manual, Physicians also have access to .case reports or case series in the medical literature. These are reports in medical journals describing clinical events involving one individual or a few individuals. They report unusual or new disease presentations, treatments, or manifestations, or suspected associations between two diseases, effects of medication, or external causes of diseases. Case reports lack controls and thus do not provide as much information as controlled epidemiological studies do. However, case reports are often all that is available on a particular subject because they usually do not require substantial, if any, funding to accomplish, and human exposure may be rare and difficult to study. Causal attribution based on case studies must be regarded with caution. However, such studies may be carefully considered in light of other information available, including toxicological data. Reference Manual, pg. 474-75. Thus, Plaintiffs point is well taken that doctors often rely on case reports in the practice of medicine. (12-4-02 Trans, at 68-9.) Additionally, Dr. Tapson explained throughout his deposition that while experts in a particular discipline may very well disagree as to what a specific case report means, in order to glean helpful information, each case report or series should be considered and weighed individually. Defendant improperly asks the Court to weigh the evidence here. Moreover, Defendant’s conclusory argument that all case reports, including those that identify other delayed onset cases, cannot be relied upon by Plaintiffs experts lacks merit. For these reasons, the case reports may be considered in conjunction with the epidemiological data. Moreover, Dr. Rich’s approach is not unlike a method approved by the Fourth Circuit in City of Greenville v. W.R. Grace &. Co., 827 F.2d 975 (4th Cir.1987). In City of Greenville, plaintiffs expert, relying on data showing a correlation between asbestos-related diseases and high levels of exposure of asbestos, testified that even very low levels of asbestos exposure could cause serious harm. There was no epidemiological data available determining the minimum level of exposure that could support the correlation. Nor did plaintiffs expert base his testimony on identical case studies. The Fourth Circuit approved of plaintiffs expert’s methodology — extrapolating the risk of low level exposure downward from results obtained in studies involving high-level exposures — and found the expert testimony reliable. In this case, Dr. Rich agrees that the risk of PPH diminishes over time, acknowledges that the epidemiological study that would resolve the latency issue in this case has not been done, and opines that the overall results of the IPPHS can not be ignored. Just as the data on high-level exposure did not rule out harm due to low-level exposure in City of Greenville, Dr. Rich’s interpretation of the IPPHS does not mean that the risk of diet-drug induced PPH is nonexistent upwards of twelve (12) months after use. For these reasons, the Court rejects the parties’ efforts to rely solely on the subset results within the IPPHS, namely, users for duration of 3 months or more (23.1 odds ratio), and the non-statistically significant results (2.4 odds ratio) for past users. Although the entire IPPHS and all of its findings are admissible as the basis of the experts’ respective opinions, the jury will be instructed that they are only to consider the statistically significant findings within the IPPHS as substantive evidence in considering the issue of causation and may not rely solely on the past users odds ratio. Flue-Cured Tobacco Coop. v. United States EPA, 4 F.Supp.2d 435, 461-62 (M.D.N.C.1998); Wheelahan v. G.D. Searle, 814 F.2d 655, 1987 WL 267679 (4th Cir.1987)(unpublished)(“The court cannot properly draw any conclusions about the increased risk when that increased risk is not statistically significant.”) As for peer review and publication, Defendant does not seriously question that Plaintiffs expert, Dr. Rich, either authored, or otherwise contributed to, most of the publications in this discipline. Nor is there is any doubt that the IPPHS established an association between fenflu-ramines and PPH. Based on the strength of the association, the dose-response relationship, and temporal relationship, and the like, a causal relationship (i.e., general causation) can be reasonably inferred. In addition, there are numerous published ease series cited by Plaintiff documenting suspected diet-drug induced PPH cases where symptoms occurred beyond twelve (12) months of last use. Dr. Rich’s views have been adequately subjected to peer review and publication. The known or potential rate of error should also be considered when evaluating the reliability of a particular scientific technique. Because the Court is not asked to consider a particular scientific technique, and because the Court will instruct the jury that in terms of inferring causation, they should only consider the statistically significant data in the IPPHS, this factor has limited applicability here and need not be discussed. Benedi, 66 F.3d at 1384. Further, Dr. Rich’s reasoning and methodology is generally accepted in the medical field. In Westberry, the Fourth Circuit Court of Appeals held that “a reliable differential diagnosis provides a valid foundation for an expert opinion.” Westberry, 178 F.3d at 263; Benedi, 66 F.3d at 1384 (“We will not declare such methodologies invalid and unreliable in light of the medical community’s daily use of the same methodologies in diagnosing patients.”) A differential diagnosis, like other expert testimony, is deemed reliable when supported by scientific, technical, or other specialized knowledge, or inferences derived from scientific or other valid methods. Cooper, 259 F.3d at 200 (citing Oglesby v. General Motors Corp., 190 F.3d at 250). In addition, it was not necessary for Dr. Rich to have examined Plaintiff personally in order for him to render a reliable differential diagnosis. Cooper, 259 F.3d at 203. In sum, differential diagnosis methodology “has widespread acceptance in the medical community, has been subject to peer review, and does not frequently lead to incorrect results.” Westberry, 178 F.3d at 262. Despite the disagreement between the parties’ experts on the latency issue, there is no indication that Dr. Rich’s testimony is not reliable or trustworthy. In fact, the number of Plaintiffs treating physicians (four) that arrived at the same conclusion, and rendered the identical diagnosis, supports Plaintiffs position. Finally, Defendant appears to argue that Plaintiffs evidence is insufficient as a matter of law. However, Rule 702 and Daubert do not support such a contention. Rather the Court is to consider whether Plaintiffs proffered expert testimony is admissible under the standards recited herein. See generally, Ambrosini v. Labarraque, 101 F.3d 129 (D.C.Cir.1996)(“dispositive question under Daubert, is whether testimony will ‘assist the trier of fact to understand the evidence or to determine a fact in issue,’ not whether the testimony satisfies the plaintiffs burden on the ultimate issue at trial.”) 2. Defendant’s Motion 2 Defendant Wyeth further seeks to preclude Plaintiffs treating physicians from rendering expert opinions regarding Plaintiffs diagnosis, prognosis, the causes or risk factors for PPH, and the most likely cause of Plaintiffs PPH. Plaintiff disagrees, arguing that her treating physicians are at least as qualified to provide opinion testimony on causation as Defendant’s expert, Dr. Koenig. Plaintiff further argues that it is premature for the Court to consider whether Plaintiffs treating physicians’ testimony is cumulative pri- or to hearing any evidence. With one exception, the Court agrees with Defendant that Plaintiffs treating physicians are not qualified to provide opinion testimony on the causes of PPH or its relationship to anorexigens. As Defendant points out, any expert, including physicians, must have the specialized knowledge or skill in the specific area in which the testimony is proffered. Thus, Defendant seeks a ruling that limits the treating physicians’ testimony to factual testimony and / or analysis of any tests performed ruling out other causes of Plaintiffs PPH. Plaintiffs treating physicians are surely experts in their specialty areas. However, with the exception of Dr. Dalto, they lack the specialized knowledge or experience in PPH, PH, or the relationship between diet drugs and PPH necessary to assist the jury in understanding the etiology of Plaintiffs PPH. The rationale behind Rule 702 and Daubert is to “make certain that an expert ... employs in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field.” Kumho Tire, 526 U.S. at 152, 119 S.Ct. 1167. Plaintiff contends that if Plaintiffs physicians are qualified to treat her, they are certainly qualified to assist the trier of fact in understanding Plaintiffs medical condition. With this proposition, the Court fully agrees. However, in terms of actually treating Plaintiff for PPH, even Dr. Dalto referred Plaintiff to another physician for additional treatment, undercutting Plaintiffs argument to some degree. Even so, diagnosis and prognosis, within the limits identified herein, are within the province of Plaintiffs treating physicians. Therefore, Drs. McMillan, Pasquini, Boka, and Dalto will be allowed to provide factual testimony regarding examination, observations, in addition to Plaintiffs PPH diagnosis and prognosis. With the exception of Dr. Dalto, Plaintiffs treating physicians will not, however, be allowed to specify that they believe or agree that Plaintiffs PPH was induced by her exposure to fen-phen. Dr. Dalto is distinguishable from the other treating physicians in that he is a board-certified pulmonologist, has treated numerous cases of pulmonary hypertension, has diagnosed and treated a number of PPH patients, and has reviewed a substantial portion of the relevant medical literature. In addition, Dr. Dalto’s opinion, documented over three (3) years ago and prior to the commencement of litigation, is in that respect, more reliable than the opinions to be offered by the retained experts in this case. For this reason, Dr. Dalto will be allowed to provide expert testimony on the etiology of Plaintiffs PPH. Further, because the Court will allow Drs. Rich, Tapson, and Dalto to provide expert opinion testimony on the issue of causation, a case can be made for excluding needlessly cumulative evidence by treating physicians. However, given Plaintiffs response, the undersigned is satisfied that Plaintiff does not seek to present mere cumulative evidence via her medical witnesses (Plaintiffs Response to Motion 2 at 17.) 3. Defendant’s Motion 3 Defendant contends that Drs. Dalto and Boka should not be allowed to provide expert testimony regarding the onset of Plaintiffs PPH. Plaintiff disagrees and contends that in addition to their clinical experience, Drs. Dalto and Boka rely primarily upon their understanding of “basic physiology” in concluding that Plaintiffs condition was chronic by the time she was diagnosed with PPH. Plaintiff asks the Court to recognize the biological variability that exists between individual PPH cases, as is the case with many other diseases. According to Plaintiff, Drs. Dalto and Boka will explain objective medical findings supporting the theory that Plaintiff suffered from PPH for a period of time before noticing symptoms. The first of these findings involves Plaintiffs right ventricular hypertrophy or “RVH.” The second finding is Plaintiffs elevated systolic pulmonary artery pressures. Relying in part on these findings, Drs. Dalto and Boka opine that examination of Plaintiff at the time of the PPH diagnosis revealed “chronicity.” Thus, they believe Plaintiffs PPH developed approximately twelve (12) to eighteen (18) months earlier than Plaintiffs first reported onset of symptoms. Dr. Dalto explains that his opinion on this point is based on “a cumulative block of knowledge about the physiology” and is derived from different sources including work with pulmonary embolism, historical animal experiments, and his understanding of how muscle responds to a pressure stress in various conditions. (Plaintiffs Tab A/Dalto Deposition at 120-22.) The same analysis applies to Dr. Boka and his observations. Although Dr. Boka is not a board-certified pulmonologist, any objective medical observations regarding Plaintiffs condition based upon examination are proper areas of testimony. Consistent with the Court’s ruling on Motion 2, Drs. Dalto and Boka will both be able to provide factual testimony regarding Plaintiffs condition. As noted, in light of his vast clinical experience and his certification in pulmonology, Dr. Dalto’s testimony will be more expansive, including a broader range of opinion testimony — i.e., etiology. More specifically, testimony regarding Plaintiffs systolic pulmonary pressures, the condition of her right ventrical, Plaintiffs medical history, and any conclusions drawn, or actions taken as a result, are all proper areas of testimony. As is true for Drs. Rich and Tapson, Dr. Dalto will also be allowed to provide testimony that the onset of PPH is typically insidious, and that patients are often asymptomatic in the early stages of pulmonary hypertension. In terms of what these facts ultimately reveal regarding Plaintiffs actual onset date will, of course, be a fact for the jury to decide. Defendant’s third motion will be denied. 4. Defendant’s Motion 4 Defendant seeks to limit the testimony of Dr. Lemuel A. Moye to the area of biostatistics. Explained in more detail, Defendant argues that Dr. Moye should only be allowed to provide testimony regarding the statistical interpretation of medical data and the manner in which medical studies should be designed as opposed to the standard of care, obesity, pharmacology, moral views, or FDA law. Defendant also argues that Dr. Moye is not a factual witness and, therefore, should not be allowed to provide factual or “intent” testimony. Dr. Moye is offered by Plaintiff as a “generic” expert witness. His proposed expert testimony is offered in the following areas: 1) a discussion of general epidemiology, including how epidemiologists determine if exposure to a particular medication is associated with a disease process; 2) the risks associated with exposure to fenfluramine and dexfenfluramine, including PPH and Valvular Heart Disease (“VHD”); 3) the risks of exposure versus the benefits of using diet drugs; 4) notice of the risks of PPH and VHD to Defendant from adverse drug event reporting, including a discussion of the relevant federal regulatory reporting and labeling requirements; and 5) discussion of Wyeth’s conduct related to its notice of the risks of PPH and VHD associated with fenflura-mine and dexfenfluramine, and its reporting of adverse drug events to the FDA. Dr. Moye is an associate professor of biostatistics at the University of Texas School of Public Health with a Ph.D. in Community Health Science — Biometry. Dr. Moye holds an M.D. degree as well, and is licensed to practice medicine in Texas and Indiana. From 1995 to 1999, he was a member of “The Cardio-Renal Advisory Committee” to the FDA, which advised the FDA regarding approvals of drugs used in the treatment of cardiovascular and renal conditions. Dr. Moye has also participated in clinical trials of drugs evaluated by the FDA and repeatedly served as a clinical trial consultant in both the public and private sector. Dr. Moye has numerous peer-reviewed publications. He has also testified in other diet-drug cases. Dr. Moye’s “fact” and “corporate intent” testimony is inadmissible. Indeed, the MDL Court, Judge Bechtle, has already ruled that testimony regarding corporate intent is inadmissible. (PTO 1332 at 21-22; PTO 1685 at 6.) The Court agrees with 'the MDL Court’s rationale — that is, the jury should hear and / or see first-hand any relevant evidence pertaining to the Defendant’s intent. Then the jury, not the witnesses, should consider the facts and make its own determination regarding Defendant’s intent. As for risk / benefit analysis, Defendant concedes that Dr. Moye’s consideration of the IPPHS is within his area of expertise. Notwithstanding this, Defendant argues that Dr. Moye is not qualified to testify about the risk / benefit analysis in this case due to his lack of specialized knowledge on the use of diet drugs to treat obesity. According to Defendant, the risk / benefit evaluation should be done on a case-by-case basis due to the risks associated with obesity in general, the seriousness of a patient’s obesity, consideration of any other complications, how a patient has responded to other therapies, and how the prescribing physician’s other patients have responded to drug therapy. Defendant seems to be describing the requisite area of expertise too narrowly. In addition, all of these factors, if relevant, can just as easily be explored thoroughly on cross-examination. Moreover, Defendant’s criticism of Dr. Moye’s preparation is curious. Dr. Moye has reviewed testimony from the FDA Advisory Committee hearings for Redux as well as the majority of the relevant medical literature in forming his opinion. The Court takes judicial notice that this process is not unusual, but rather is precisely how many experts go about developing an opinion within their disciplines. Given Dr. Moye’s educational background, as well as his experience as a clinical trial investigator and consultant, his qualifications in this area are beyond question. Dr. Moye can provide testimony that will be helpful to the jury. Plaintiff also seeks to use Dr. Moye’s testimony to establish Defendant’s knowledge of the risks associated with Pondimin and Redux. According to Plaintiff, Dr. Moye is able to provide expert testimony regarding adverse drug events, FDA reporting and labeling requirements, and the link between Aminorex and Pondimin. In support of its proffered expert witness, Plaintiff cites Dr. Moye’s experience as a member of the FDA CardioRenal Advisory Committee, which required members to weigh the advantages and disadvantages of medications presented to the Advisory Committee for FDA approval, and Dr. Moye’s experience supervising the collection of adverse event reports to drug companies and to the FDA resulting from his involvement in clinical trials for manufacturers of pharmaceutical products. Defendant challenges Dr. Moye’s proposed testimony in all of these areas. In terms of reporting adverse drug events (or “ADEs”), Defendant questions Dr. Moye’s knowledge of the applicable standard for reporting adverse drug events, claiming that Dr. Moye lacks knowledge about the pharmaceutical industry’s standard as opposed to the FDA regulations and has no knowledge of the requirements for postmarketing adverse drug events that a manufacturer like Wyeth would be required to report. Plaintiff asserts that the pharmaceutical industry standards are essentially the same as that required by the FDA. Plaintiff also reiterates that Dr. Moye has direct experience working with pharmaceutical companies as well as with the FDA. In terms of regulations applicable to post-marketing adverse drug events, the regulations speak for themselves. It is the application of the regulations to the facts of this case that gives rise to Defendant’s motion. While Defendant makes much of the fact that there are differences in the premarketing and postmarketing regulations for reporting ADEs, Dr. Moye recognized this but explained that the intent of all of the reporting requirements is essentially the same. (Moye 3/23/00 Deposition, at 56-58.) In fact, Dr. Moye explains in his deposition that the FDA standards constitute the ‘minimum’ reporting requirements and that pharmaceutical eom-panies may exceed what the FDA requires. (Moye 3/28/00 Deposition, at 78-81.) For this reason, Dr. Moye’s experience with the FDA is sufficient to support opinion testimony regarding the applicable standard of care for reporting adverse drug events. Regarding FDA labeling requirements, Defendant asserts that Dr. Moye should not be allowed to provide opinion testimony about Wyeth’s compliance, or alleged lack thereof. The Court agrees since to allow such testimony would infringe upon the jury’s role in determining an ultimate issue in the case. However, as Plaintiff points out, Judge Bechtle found that testimony from physicians, who were admittedly not experts in the regulatory field, were, in fact, qualified to opine on ‘the medical facts and science regarding the risks and benefits of the diet drugs in question and to compare that knowledge with what was provided in the text of labeling and warnings on the diet drugs in question. In other words, [the physicians] are qualified to render an opinion as to the labels’ completeness, accuracy, and ... the extent to which any inaccuracies or omissions could either deprive a reader or mislead a reader of what the risks and benefits of the diet drugs in issue are or were at the time the labeling was published.” (PTO 1332 at 27-28.) The Court intends to follow the MDL Court’s ruling. Defendant finally seeks to prohibit Dr. Moye from testifying about an alleged link between the side effects of Pondimin and Aminorex. While this issue is discussed fully in conjunction with Defendant’s Motion 5, the parties agree at least to some extent that any expert testimony regarding alleged chemical similarities in the two (2) diet drugs would have to be offered by a pharmacologist. Dr. Moye is clearly not a pharmacologist and, therefore, is not qualified. For this reason, he will be precluded from testifying about the alleged chemical similarities between the two (2) drugs. 5. Defendant’s Motion 5 Defendant seeks a ruling from the Court excluding evidence about Amino-rex. Defendant challenges any such testimony on the grounds that it lacks any reliable scientific basis in that Plaintiffs “chemically similar” theory based upon the presence of a phenylethylamine (“PEA”) structure is flawed. In support, Defendant proffers the affidavit of Dr. Nancy Balter, pharmacologist, averring that there is no validity to the proposition that drugs with overlapping chemical structures are generally likely to have the same or similar therapeutic effects or side effects. Defendant also makes the argument that evidence of Aminorex would require a “mini-trial,” would necessarily confuse and mislead the jury, and may result in unfair prejudice, warranting exclusion pursuant to Fed. R. Evid. 403. According to Plaintiff, the side effects of Aminorex should have placed Defendant on notice that Pondimin would also increase the risk of PPH since the two (2) drugs have chemical similarities and are in the same drug ‘class.’ Plaintiff elaborates on its intentions, stating that it does not intend to present testimony about Amino-rex as direct evidence that fenfluramine causes PPH because it is chemically similar to Aminorex. Plaintiff hopes to present testimony that the published medical literature regarding what Plaintiff describes as ‘the Aminorex epidemic’ should have put Wyeth on notice that the entire class of diet drugs might cause PPH. Pointing to references to the similarities as far back as 1981, Plaintiff contends that the medical literature should have spurred Defendant into action upon learning of the first PPH case reports associated with fen-fluramine, and eventually prompted Defendant to change its product labeling. Plaintiff fails to mention that the medical literature exploring the relationships between Aminorex, Pondimin, and PPH was not published until after the first PPH cases associated with fenfluramines occurred. For this reason, Defendant contends that it properly acted as others in the scientific community did in waiting for the IPPHS results before making changes to the Pondimin label. The MDL Court considered Aminorex evidence during its consolidated pretrial proceedings, yet deferred to the trial courts. (PTO 1332 at 23-25.) Judge Bechtle noted the pharmacological differences between Aminorex and Pondimin and stated that there “appears to be good ground to exclude an opinion” that fenflu-ramine causes PPH because of its similarities to Aminorex, Id. Judge Bechtle compared Plaintiffs’ stated purpose for the evidence, namely, to show that the scientific community was on notice that anorexi-gens have long been associated with PPH. Id. He then predicted the trial court’s dilemma in applying Rule 403 given that “Notice could very well be an issue with a negligence claim ...” Id. Indeed, because Plaintiffs Complaint involves numerous allegations of negligence, evidence of Amino-rex, another anorectic agent identified by the World Health Organization as a definite risk factor for PPH, is relevant in determining what Defendant knew or should have known about potential harms of fenfluramines such as PPH. FED. R. EVID. 401. The more difficult issue is whether its probative value substantially outweighs the risk of unfair prejudice to the Defendant. FED. R. EVID. 403. However, the purpose for which Plaintiff offers this evidence, to establish notice rather than causation, tends to lessen the concerns described by Dr. Balter. In other words, aside from the common classification as anorexigens, the jury need not ascertain the chemical similarities between the two (2) drugs, in order to find the Aminorex related PPH incidents are probative on the notice issue. Thus, testimony from a pharmacologist is not necessary. In Benedi v. McNeil-P.P.C., Inc., the Fourth Circuit examined a similar eviden-tiary issue. Considering a negligent failure to warn claim, the Fourth Circuit upheld the admissibility of dissimilar case reports known as Drug Experience Reports (“DERs”) for the purpose of proving notice, finding that they were “highly probative” despite various differences. Benedi, 66 F.3d at 1385-87. Although Benedi considered case reports involving the same drug, the appellate court’s reasoning is instructive on this issue. The Fourth Circuit explained that the dissimilarities between plaintiffs situation and those reported in the DERs did not affect admissibility of the evidence, but rather went to the weight that the jury should give the evidence. Id. The Fourth Circuit further stated that when prior incidents are admitted to prove notice, the required similarity of the prior incidents to the case at hand is more relaxed than when prior incidents are admitted to prove negligence. Id. at 1386. Therefore, the incidents need only be sufficiently similar to make defendant aware of the potential danger. Id. Because Aminorex and fenfluramines are both anorectic agents, the jury should be able to consider whether Defendant should be considered to have been placed on notice that PPH was likewise a potential risk for fenfluramine users. In addition, the fact that some of the medical literature on PPH was prompted by the Aminorex related PPH cases is a historical fact, or a piece of the puzzle so to speak. The extent that Defendant was aware of the Aminorex related PPH cases, if at all, its lack of involvement with Ami-norex, and the fact that Aminorex was never marketed or distributed in the United States, can be brought out on cross-examination. The Court can also provide a limiting instruction warning the jury to limit their consideration of this evidence to whether or not Defendant knew, or should have known, of the alleged risks of its product. For these reasons, the Court cannot find that the probative value is substantially outweighed by the danger of unfair prejudice to Defendant. 6. Defendant’s Motion 6 Defendant seeks to exclude testimony concerning the possible biological mechanisms of action by which Pondimin may cause PPH. The gist of Defendant’s argument is that because the biological mechanisms of Pondimin are unknown, a matter that is not disputed, Plaintiffs speculative theories do not satisfy Daubert. As an initial matter, Plaintiff does not object to Defendant’s motion to the extent it seeks to exclude opinions about the exact biological mechanism by which fenflura-mines may cause PPH. However, Plaintiff seeks to introduce testimony regarding biological plausibility. According to Plaintiff, biological plausibility is relevant in light of Defendant’s latency argument. Thus, Plaintiff contends that she is entitled to elicit testimony about the process of pulmonary arteriopathy and right ventricular hypertrophy, both of which take some time to develop according to Plaintiffs experts, in order to demonstrate that fenfluramine could continue to pose a risk years after exposure has ceased, or that this occurrence is consistent with existing knowledge. Although Defendant contends that opinions regarding biological plausibility are not relevant unless there is evidence suggesting that a relationship exists, and could not be supported by scientific evidence, the Court disagrees for the reasons discussed generally in relation to the admissibility of case reports. (See “III, 1”) Further, Defendant’s reliance on the Reference Manual is misplaced in that the weight that evidence of biological plausibility has in a given case is discussed — not admissibility of the evidence. Reference Manual, at 378. Defendant also seeks to exclude testimony comparing the biological mechanisms of Pondimin with the way other substances affect the body. The undersigned agrees with Plaintiff that to grant this request would be somewhat unrealistic, and tantamount to foreclosing Plaintiffs experts from using medical analogies to help explain their testimony. There is nothing within FED. R. CIV. P. 26 that requires Plaintiffs experts to disclose their testimony verbatim to Defendant prior to trial. Any specific objection to the use of an analogy during testimony can be addressed contemporaneously with the objection. Defendant’s Motion 6 will be denied in part and granted in part. 7. Defendant’s Motion 7 . Defendant requests, as an alternative to its first motion, that the testimony of Drs. Tapson and Dr. Rich should be restricted. Specifically, the areas of testimony Defendant seeks to preclude are: 1) the minimum period of exposure to Pondimin that is safe; 2) precipitation of secondary PH by Pondimin; 3) the adequacy of the Pon-dimin warning label; 4) outdated survival rates for PPH patients; 5) other physicians’ opinions; and 6) the withdrawal of Pondimin from the market preventing a PPH epidemic. A review of Defendant’s arguments, as well as Plaintiffs response, confirms that these issues do not arise in the context of Daubert, but are instead motions in limine essentially involving questions of relevancy. The Court will not decide these issues prematurely. The Court does note, however, that the MDL Court has already determined that Dr. Rich is not qualified to provide expert testimony in the area of FDA regulatory standards. (PTO 1685) Accordingly, Dr. Rich will not be allowed to testify about whether the Pondimin label actually complied with regulatory standards. Defendant’s motion will be granted to that extent. However, also consistent with Judge Bechtle’s directives, Dr. Rich is likely qualified to testify about the relevant medical facts and science and compare that knowledge with what was provided in the labeling and warning. It will be the jury’s role to determine whether the labeling and warning was adequate. The Court will defer ruling on the remainder of Defendant’s Motion 7 until trial. 8. Defendant’s Motion 8 Defendant’s final motion requests that the Court exclude all evidence regarding side effects of Pondimin other than PPH, namely, valvular heart disease or “VHD In support, Defendant notes that Plaintiff does not have VHD, and doesn’t allege so in her Complaint. Moreover, prior to initiation of this lawsuit, Plaintiff settled any claims she had against Defendant in a class action suit with the exception of injuries related to PPH. (Defendant’s Exhibit 96) Plaintiff opposes Defendant’s motion, contending that evidence of VHD is directly relevant for purposes of her failure to warn claim and inadequate drug label claim. According to Plaintiff, evidence related to the VHD cases demonstrate Defendant’s knowledge of risks associated with the use of fenfluramines, the risk / benefit analysis, and proximate cause or cause-in-fact. Additionally, Plaintiff points out that the VHD occurrences are what led to the withdrawal of fenfluramines from the market at the FDA’s request and that it is an integral part of the background of this case. Defendant misstates the issue. The issue presented regarding VHD evidence, not unlike the question of Aminorex evidence, is in actuality, a motion in li-mine pursuant to FED. R. EVID. 403 rather than a Daubert challenge. However, the Court will enter a ruling now in anticipation of trial. The Court generally agrees that any injuries Plaintiff suffers from other than PPH, with the exception of those physical observations that may be related to Plaintiffs PPH (such as right ventricular hypertrophy), are not relevant. The Court also agrees that pursuant to the Settlement, Plaintiff is prohibited from ‘prosecuting’ claims against Defendant that she has already agreed to release. However, the Settlement does not preclude Plaintiff from admitting facts into evidence that are relevant to the claims asserted here. Evidence regarding instances of VHD associated with fenfluramines as used to treat obesity is, in fact, relevant to demonstrate the knowledge of Defendant. Under North Carolina law, a products liability action based upon negligence requires the plaintiff to prove the following essential elements: 1) duty; 2) breach; 8) causation; and 4) damages. Bryant v. Adams, 116 N.C.App. 448, 465, 448 S.E.2d 832 (1994). A duty to warn arises when the supplier of a product knows or has reason to know that the product is, or can be, dangerous for the use for which it is supplied. Stegall v. Catawba Oil Co., 260 N.C. 459, 133 S.E.2d 138 (1963). In order to prove causation, a products liability plaintiff asserting a failure to warn claim must show that the injury was caused by the defendant’s failure to warn. N.C. Gen. Stat. § 99B-5. Defendant’s knowledge, or lack thereof, regarding the potential dangers of its product are indeed relevant to the issues of duty and causation. When considering a negligence claim based upon failure to warn, and specifically the element of causation, it is the decision process of Plaintiff, as opposed to the specific injury, that must be considered. Haroutounian v. American Home Products, et al., LASC Case No. VC025742 (California Superior Court for the County of Los Angeles, Feb. 8, 2000) (Plaintiffs Response / Tab 13)(evidence of PPH relevant to plaintiffs negligence claims based upon failure to warn of VHD • associated with Pondimin use); Bryant, 116 N.C.App. at 466-67, 448 S.E.2d 832 (where plaintiff claims that he would have used product differently had he been adequately warned by defendant, jury question existed on proximate cause issue). Defendant’s contention to the contrary is rejected. In this case, Plaintiff alleges that had she known of the risk of VHD associated with fenfluramine use, she would never have requested a prescription, or taken fen-phen. Similarly, Plaintiff presents an affidavit from Dr. Fisher, who was first to prescribe fen-phen for Plaintiffs obesity, in which Dr. Fisher avers that he would not have prescribed fen-phen had he been aware of the risks of VHD. (Fisher Affidavit, ¶ 6) Moreover, Plaintiff does not allege that she suffers from VHD and the jury can be instructed on this at the outset of the trial. Further, when this evidence is presented, Defendant’s concerns regarding confusion of the issues can be addressed with a special cautionary instruction. In light of its probative value on the issue of notice to Defendant, duty to warn, and causation, the probative value of VHD evidence is not substantially outweighed by the risk of unfair prejudice to Defendant. FED. R. EVID. 403. Defendant’s final motion will be denied. 1. Plaintiff’s Motion 1 Plaintiff seeks to exclude expert testimony of Dr. Steven Koenig, a pulmonologist identified as Defendant’s expert on causation. Dr. Koenig is from the University of Virginia and specializes in the area of “obesity-related pulmonary disorders.” Dr. Koenig contends that the IPPHS fails to establish an increased risk of PPH more than 1 year after exposure, a different interpretation than that offered by Dr. Rich. Based upon this, Dr. Koenig opines that Plaintiffs PPH could not have been caused by Pondimin use because her symptoms developed more than one year after exposure. (12-5-02 Trans, at 16; Koenig Affidavit, ¶ 7) Plaintiff challenges Dr. Koenig’s testimony, stating that his focus on latency between exposure and onset of PPH is error. . More specifically, Plaintiff contends that: 1) Dr. Koenig is not qualified to give expert testimony on PPH causation; 2) that he cannot provide reliable support for his opinion regarding causation; 3) that his opinion lacks the requisite intellectual rigor that a practicing physician would apply; 4) that his opinion has not been subject to peer review; 5) that his opinion is not based on the treatment of Plaintiff, but rather in. preparation for litigation; and 6) that his opinion cannot assist the jury and would be misleading. For the reasons set forth in response to Defendant’s Motion 1, Dr. Koenig’s opinion is admissible. Briefly, the Court will address Plaintiffs concerns with the reliability of Dr. Koenig’s opinion. While Dr. Koenig is not the leading expert in this area, he is qualified to provide expert opinion testimony regarding causation. Dr. Koenig is a licensed physi-can and surgeon in Virginia and Illinois, and a board-certified pulmonologist specializing in obesity-related pulmonary disorders. (Koenig Affidavit, ¶ 1) Dr. Koenig is currently an Associate Professor at the University of Virginia School of Medicine, where his responsibilities include teaching medical students at all levels. (12-5-02 Trans, at 6.) The University of Virginia Medical Center where Dr. Koenig teaches is a referral facility for pulmonary hypertension and primary pulmonary hypertension, exposing Dr. Koenig to volumes of PH and PPH patients. (12-5-02 Trans, at 4.) Dr. Koenig testified that he teaches his students, fellows, and residents how to diagnose PPH as well as how to treat it. (12-5-02 Trans, at 6.) Dr. Koenig admitted that he has not participated in scientific research or clinical trials concerning pulmonary hypertension or PPH and has not published in this discipline. (12-5-02 Trans, at 31-32.) Through his clinical practice, which consists of 70-75% of his time, Dr. Koenig has diagnosed and treated patients with both pulmonary hypertension and PPH. (Koenig Affidavit, ¶ 3)(12-5-02 Trans, at 5-6, 14-15.) Thus, the Court cannot find that Dr. Koenig’s opinion lacks the requisite intellectual rigor that a practicing physician would apply. Indeed, Dr. Koenig is at least as qualified as Dr. Dalto to testify regarding causation. As was true with Dr. Rich, Dr. Koenig’s opinion is derived using the methodology of differential diagnosis, or what Dr. Koe-nig describes as a diagnostic “algorithm.” Pursuant to Dr. Koenig’s analysis, once all other secondary causes of Plaintiffs PPH are ruled out, the IPPHS does not support Plaintiffs theory that her PPH is diet-drug induced. As discussed regarding Dr. Rich’s differential diagnosis methodology, the Court will not exclude Dr. Koenig’s testimony because it cannot be subjected to a conclusive scientific procedure or test. (See Section “HI, 1”) Likewise, there is no need to reiterate the acceptance of differential diagnosis methodology by the medical community and the Fourth Circuit or discuss potential error. Id. The Court will, however, scrutinize Dr. Koenig’s application of the relevant principles and methods to the facts of this case in an effort to ensure it can assist the trier of fact. FED. R. EVID. 702. During the evidentiary hearing, Dr. Koenig clarified that in forming his opinion, he did not rely exclusively on the past users odds ratio, which is not statistically significant, and that he does not interpret the IPPHS as conclusively finding that fenfluramine does not cause latent PPH. (12-5-02 Trans, at 7-8.) Even so, during cross-examination, Dr. Koenig was less than convincing. Dr. Koenig claimed that the overall 6.3 odds ratio was not the best odds ratio to apply in this case because it assessed the overall risk for the entire group and while the most proper odds ratio to apply to the general population, it did not take into consideration Plaintiffs specific characteristics. (12-5-02 Trans, at 49-50.) According to Dr. Koenig, it would be “unscientific” to apply the overall odds ratio to a particular individual. (12-5-02 Trans, at 48.) Considering Plaintiffs specific characteristics, namely, the additional facts regarding duration of use and timing of use, Dr. Koenig also found the 23.1 odds ratio for those users of at least three (3) months relevant, stating that because Plaintiff used fen-phen for at least three (3) months, she was clearly at an increased risk for PPH. (12— 5-02 Trans, at 50.) Dr. Koenig fully agreed that the users for more than three (3) months category included patients like Plaintiff, whose first symptoms began more than a year after their exposure ceased. (12-5-02 Trans, at 51.) Minutes later, when asked to explain why the 23.1 odds ratio led him to believe that the risk doesn’t persist more than a year after exposure, Dr. Koenig merely referred to the timing of use categories — which also do not consider a factor he admits is pertinent to Ms. Smith’s diagnosis — her duration of use and subsequent increased risk. (12-5-02 Trans, at 51.) The Court finds Dr. Koenig’s application somewhat contradictory in that he seeks to apply all of the relevant IPPHS data to the individual Plaintiff, but does not appear to do so. Even Dr. Makuch, who sought to ‘synthesize’ the applicable IPPHS subgroup results, testified that the 2.4% odds ratio for past users did not adequately describe Plaintiffs risk because both the duration of use and the onset of symptoms must be considered. (12-4-02 Trans, at 84-85.) Immediately following, Dr. Makuch failed miserably in his attempt to explain why, in light of this concession, he determined that the past users odds ratio was the ‘best possible match’ to the facts of this case. Therefore, the Court agrees that to the extent Dr. Koenig solely relies on the odds ratio for past users, his opinion is misleading and, therefore, unreliable. Reference Manual, pg. 359-60. In support of Dr. Koenig’s conclusio