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In re Testosterone Replacement Therapy Products Liability Litigation Coordinated Pretrial Proceedings

United States District Court, N.D. Illinois, Eastern Division

May 8, 2017

In re Testosterone Replacement Therapy Products Liability Litigation Coordinated Pretrial Proceedings (This document applies to all cases) MDL No. 2545

          CASE MANAGEMENT ORDER NO. 46 (RULINGS ON ABBVIE'S MOTION TO EXCLUDE EXPERT TESTIMONY ON CAUSATION AND FOR SUMMARY JUDGMENT AND PLAINTIFFS' MOTION TO LIMIT TESTIMONY OF DR. MARAIS - DKT. 1738 & 1753)

          MATTHEW F. KENNELLY, District Judge

         Plaintiffs in this multidistrict litigation (MDL) proceeding allege that they suffered either arterial cardiovascular injuries or injuries related to blood clots in the veins (venous thromboembolisms, or VTEs) as a result of taking prescription testosterone replacement therapy (TRT) drugs. Defendants AbbVie Inc., Abbott Laboratories, AbbVie Products LLC, and Unimed Pharmaceuticals, LLC (collectively, AbbVie) manufacture AndroGel, [1] one of the TRT products at issue in this litigation. Of the more than 7, 000 cases consolidated in this proceeding, seven cases in which AbbVie is a defendant have been selected for bellwether trials.[2]

         Plaintiffs in each of the seven cases-Edward Cribbs, Cecile Frost, Jeffrey Konrad, Jesse Mitchell, Arthur Myers, Robert Nolte, and Robert Rowley-allege that AndroGel caused them to suffer either a cardiovascular or a VTE injury. Following discovery, AbbVie has moved to exclude the testimony of a number of plaintiffs' proposed general and case-specific expert witnesses regarding causation under Federal Rules of Evidence 104(a), 403, 702, and 703 and Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993). AbbVie has also moved for summary judgment in each of the bellwether cases, arguing that plaintiffs lack evidence sufficient to prove that AndroGel caused their injuries. Plaintiffs, for their part, have moved to exclude the testimony of one of AbbVie's proposed expert witnesses. In this opinion, the Court addresses (1) AbbVie's motion to exclude expert testimony concerning general causation-that is, whether AndroGel is capable, in general, of causing the injuries plaintiffs allege-and specific causation-that is, whether AndroGel did indeed cause the specific injuries plaintiffs allege in their individual cases; (2) AbbVie's motion for summary judgment based on plaintiffs' purported lack of causation evidence; and (3) plaintiffs' motion to limit the testimony of Dr. M. Laurentius Marais, one of AbbVie's statistical experts. The Court grants AbbVie's motion to exclude expert testimony concerning causation in part and denies it in part. The Court also grants AbbVie's motion for summary judgment with respect to plaintiff Cribbs but otherwise denies summary judgment. In addition, the Court denies plaintiffs' motion to limit or exclude Dr. Marais' testimony.

         Background

         The Food and Drug Administration (FDA) has approved two different formulations of AbbVie's TRT drug AndroGel, AndroGel 1% and AndroGel 1.62%, for the treatment of male hypogonadism. The term "hypogonadism" refers generally to a disorder characterized by abnormally low levels of testosterone in the blood and associated symptoms such as decreased libido, reduced lean body mass, decreased energy, and depressed mood. The parties dispute whether TRT is effective, and appropriately marketed, for the treatment of all forms of hypogonadism or only for so-called "classical hypogonadism, " a disorder in which certain recognized medical conditions result in an absence of or deficiency in testosterone. Regarding plaintiffs' allegations that AbbVie inappropriately marketed AndroGel "off label, " or for purposes other than those approved by the FDA, AbbVie has filed a separate motion for summary judgment and for exclusion of expert testimony, and the Court will issue a separate opinion addressing that motion. In addition to their assertions that TRT products are ineffective and inappropriately marketed, plaintiffs allege that TRT, including use of AndroGel, increases the risk of cardiovascular and VTE injuries. Plaintiffs Cribbs, Frost, Konrad, and Mitchell assert that they suffered cardiovascular injuries as a result of taking AndroGel: Cribbs, Konrad, and Mitchell suffered myocardial infarctions (heart attacks); Frost suffered a stroke. Plaintiffs Myers, Nolte, and Rowley assert that AndroGel caused them to suffer VTE injuries: Myers and Nolte suffered pulmonary embolisms; Rowley suffered a DVT.

         All of the plaintiffs allege injuries that can result from, or are exacerbated by, some form of a clot (thrombus) in the blood. The cardiovascular injures alleged in this case are the result of atherosclerosis, the accumulation of plaque and debris within one or more arteries. Plaque build-up on the arterial walls can result in narrowing of the arteries, limiting blood flow. In addition, in certain circumstances, platelets and red blood cells can adhere to and clump around the plaque, ultimately forming a clot. If the clot interrupts blood flow through the artery to the heart, a heart attack occurs. If the clot interrupts blood flow to the brain, an ischemic stroke occurs. It is well established and undisputed that certain factors increase one's risk of a heart attack or ischemic stroke, including increased age, smoking, obesity, elevated blood cholesterol level, and high blood pressure.

         Like the cardiovascular injures alleged in this litigation, VTE injuries also result from clotting, but in veins rather than arteries. The relevant medical literature recognizes three factors, sometimes referred to as "Virchow's triad, " that cause or contribute to the formation of problematic clotting in the veins: (1) slowing or stasis of blood flow in the veins, (2) damage to the blood vessel walls, and (3) hypercoagulability, or abnormal predisposition of the blood to form clots. A deep vein thrombosis (DVT) occurs when blood clots form in a deep vein, usually in the legs, causing pain and swelling. A clot that breaks off and travels to a new part of the body is called an embolus. A pulmonary embolism occurs when an embolus travels to and lodges in a pulmonary blood vessel, blocking blood flow to the lungs. As in the case of the alleged cardiovascular injuries, it is undisputed that there are number of well-established risk factors for VTEs. Established genetic risk factors include a so-called Factor V Leiden mutation, a prothrombin gene mutation, protein C and protein S deficiencies, and antithrombin III deficiency. Established acquired risk factors include prolonged immobilization, previous thromboembolism, recent major surgery, trauma, pregnancy, and polycythemia (elevated volume of red blood cells).

         Plaintiffs' experts posit a number of potential mechanisms by which AndroGel and other TRT drugs might increase the risk of cardiovascular and VTE injuries. Specifically, plaintiffs' experts suggest TRT is pro-thrombotic-that is, it increases the risk of blood clots-because of its tendencies to increase (1) estradiol, a metabolite of testosterone and a form of estrogen, which has been connected to increased risk of clot formation; (2) thromboxane A2 receptors, which can promote abnormal platelet function and increased risk of clotting; and (3) hematocrit (the ratio of the volume of red blood cells to the total volume of blood), which can increase blood viscosity, leading to a higher incidence of clotting.[3] Plaintiffs have retained a number of expert witnesses to testify about these potential biological mechanisms, as well as the medical and scientific literature concerning the possible association between TRT and cardiovascular or VTE injuries. Two cardiologists, Dr. Hossein Ardehali and Dr. Phillip Cuculich, and an epidemiologist, Dr. Burt Gerstman, have prepared expert reports in support of their opinions that TRT increases the risk of heart attacks and strokes. Dr. Henry Rinder, an internal medicine doctor specializing in hematology, has provided expert reports in support of his opinion that TRT increases the risk of VTE injuries. Dr. Perry Halushka, a doctor of internal medicine specializing in pharmacology, offers an opinion primarily regarding the effects of TRT on thromboxane A2 receptor activation, and he concludes that TRT's tendency to increase density of thromboxane A2 receptors can increase the risk of both cardiovascular and VTE injuries. Though each of the aforementioned experts discusses studies regarding the potential association between TRT and the alleged injuries, plaintiffs have also retained a biostatistician, Dr. Martin T. Wells, to offer testimony assessing the statistical power of studies concerning the connection between TRT and cardiovascular risk. AbbVie offers the testimony of its own expert in statistics, Dr. M. Laurentius Marais, who provides an analysis of the studies relied upon by plaintiffs' experts. (AbbVie has also retained other experts on various issues, but plaintiffs have not challenged the admissibility of their testimony.)

         The existing medical literature contains at least thirty peer-reviewed epidemiological studies that assess the potential association between TRT and either cardiovascular events or VTEs. Experts on both sides of this litigation provide extensive analysis of four studies that reported a statistically significant association between TRT and increased cardiovascular events, studies which prompted a petition to the FDA from a public advocacy group and a subsequent investigation of the four studies and the potential risks of TRT. See Shehzad Basaria et al., Adverse Events Associated with Testosterone Administration, 363 New Eng. J. of Med. 109 (2010) (the Basaria study); Lin Xu et al., Testosterone Therapy and Cardiovascular Events among Men: A Systematic Review and Meta-Analysis of Placebo-Controlled Randomized Trials, 11 BMC Med. 108 (2013) (the Xu meta-analysis); Rebecca Vigen et al., Association of Testosterone Therapy with Mortality, Myocardial Infarction, and Stroke in Men with Low Testosterone Levels, 310 JAMA 1829 (2013) (the Vigen study); William D. Finkle et al., Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men, 9 PLOS ONE e85805 (2014) (the Finkle study). Plaintiffs' experts point to these and other studies as evidence that TRT increases users' cardiovascular risks. AbbVie argues that the studies on which plaintiffs' experts rely are flawed and that the majority of the published epidemiology supports AbbVie's position that TRT is not associated with increased cardiovascular risks.

         With regard to the connection between TRT and increased risk of VTEs, AbbVie emphasizes four retrospective database studies that have addressed the question, most of which reported no association between TRT and increased VTE risk, and none of which found a statistically significant association between VTE and TRT when considering all groups of TRT users. See Jacques Baillargeon et al., Risk of Venous Thromboembolism in Men Receiving Testosterone Therapy, 90 Mayo Clinic Proc. 1038 (2015) (the Baillargeon study); Rishi Sharma et al., Association Between Testosterone Replacement Therapy and the Incidence of DVT and Pulmonary Embolism: A Retrospective Cohort Study of the Veterans Administration Database, 150 Chest 563 (2016) (the Sharma study); Hu Li et al., Association between Use of Exogenous Testosterone Therapy and Risk of Venous Thrombotic Events among Exogenous Testosterone Treated and Untreated Men with Hypogonadism, 195 J. Urology 1065 (2016) (the Li study); Carlos Martinez et al., Testosterone Treatment and Risk of Venous Thromboembolism: Population Based Case-Control Study, 355 BMJ i5968 (2016) (the Martinez study). Despite the findings of these studies, plaintiffs and their expert Dr. Rinder maintain that TRT and VTEs are associated. Dr. Rinder contends that the retrospective database studies regarding TRT and VTEs are seriously flawed, and he places greater emphasis on case series and other clinical data in forming his opinion in this case.

         AbbVie disputes the contention of plaintiffs and their experts that the medical and scientific literature supports an association between TRT and plaintiffs' alleged injuries. According to AbbVie, not only does the relevant scientific literature fail to show that TRT increases the risk of cardiovascular or VTE injuries, but the most recent observational study suggests that TRT has a protective effect against cardiovascular injury. See T. Craig Cheetham et al., Association of Testosterone Replacement with Cardiovascular Outcomes among Men with Androgen Deficiency, 177 JAMA Intern. Med. 491 (2017) (the Cheetham study). AbbVie contends that plaintiffs' experts lack a scientific basis, in the published literature or elsewhere, for their opinions that TRT is capable of causing the alleged injuries and argues that their opinions are therefore unreliable and must be excluded. Plaintiffs, for their part, have moved to exclude or limit the testimony of Dr. Marais, largely on the basis that his lack of expertise in medicine and biology renders him unqualified to opine on epidemiology and biostatistics.

         In arguing that the scientific literature does not support a finding that TRT is associated with the alleged injuries, AbbVie emphasize the importance of considering the statistical significance of study results. Though experts for both AbbVie and plaintiffs agree that statistical significance is a widely accepted concept in the field of statistics and that there is a conventional method for determining the statistical significance of a study's findings, the parties and their experts disagree about the conclusions one may permissibly draw from a study result that is deemed to possess or lack statistical significance according to conventional methods of making that determination.

         Statisticians test for statistical significance to determine the likelihood that a study's findings are due to chance. Take, for example, a study examining whether smoking cigarettes increases one's risk for developing a particular disease. Statisticians often express the result of such a study in terms of an odds ratio (sometimes expressed as "relative risk" where the outcome measured is rare and the odds ratio provides a reasonable approximation of the relative risk). If the incidence of developing the disease is the same for both smokers (the treatment group) and non-smokers (the control group), the ratio will be 1.0. A positive ratio, such as 1.5, would indicate a higher incidence of the disease among smokers. According to conventional statistical practice, such a result-that is, a finding of a positive association between smoking and development of the disease-would be considered statistically significant if there is a 95% probability, also expressed as a "p-value" of <0.05, that the observed association is not the product of chance. If, however, the p-value were greater than 0.05, the observed association would not be regarded as statistically significant, according to prevailing conventions, because there is a greater than 5% probability that the association observed was the result of chance.

         Statistical significance can also be expressed equivalently in terms of a confidence interval. A confidence interval consists of a range of values. For a 95% confidence interval, one would expect future studies sampling the same population to produce values within the range 95% of the time. So if the confidence interval ranged from 1.2 to 3.0, the association would be considered statistically significant, because one would expect, with 95% confidence, that future studies would report a ratio above 1.0-indeed, above 1.2. If, however, the confidence interval range includes values below 1.0-for example, from 0.5 to 3.0-the observed association would not be statistically significant, because one could not say with confidence that the association would be observed in a future study.

         According to AbbVie, to establish that AndroGel is capable of causing plaintiffs' alleged injuries, plaintiffs' experts must point to literature establishing a statistically significant association between TRT and the alleged injuries-that is, with odds ratios above one and with p-values below 0.05 (or 95% confidence intervals that do not include 1.0 within their range). Plaintiffs and their experts argue that AbbVie overemphasizes the importance of conventional determinations of statistical significance. They contend that a study reporting a confidence interval ranging from 0.9 to 3.5, for example, should certainly not be understood as evidence that there is no association and may actually be understood as evidence in favor of an association, when considered in light of other evidence. Thus, according to plaintiffs' experts, even studies that do not show a statistically significant association between TRT and the alleged injuries may plausibly bolster their opinions that TRT is capable of causing such injuries.

         Plaintiffs also intend to offer expert testimony regarding specific causation-that is, whether AndroGel was the cause of each plaintiff's alleged injury. In addition to their opinions regarding general causation, Drs. Ardehali and Cuculich opine, respectively, that AndroGel use was the cause of the heart attacks suffered by Mitchell and Konrad. Dr. John Setaro, a cardiologist, incorporates the general causation opinions of Drs. Ardehali and Rinder in reaching his conclusion that AndroGel use was the cause of Cribbs's heart attack. Dr. Ronald Ziman, a doctor in internal medicine specializing in vascular neurology, also incorporates the general causation opinions of Drs. Ardehali and Rinder in forming his expert opinion that AndroGel was the cause of Frost's stroke. Dr. Rinder provides specific-causation expert reports for Myers, Nolte, and Rowley, opining that AndroGel use was the cause of their VTE injuries. Each of plaintiffs' specific-causation experts purports to employ a "differential diagnosis" or "differential etiology" to reach his conclusion. When using that methodology, an expert "rules in all the potential causes of a patient's ailment and then by systematically ruling out causes that would not apply to the patient, the physician arrives at what is the likely cause of the ailment." Myers v. Ill. Cent. R.R. Co., 629 F.3d 639, 644 (7th Cir. 2010). Although "[t]here is nothing controversial about that methodology, " id., AbbVie argues that none of plaintiffs' experts appropriately apply the method, rendering their opinions unreliable and inadmissible.

         Because causation is a required element of all of plaintiffs' claims, AbbVie argues, the lack of admissible expert testimony regarding general and specific causation requires the Court to grant summary judgment in each bellwether case. Plaintiffs maintain that their proposed experts have provided reliable, scientific bases for their opinions, such that their testimony should be allowed and AbbVie's motion for summary judgment denied. The Court addresses the parties' arguments below, first considering plaintiffs' challenge to Dr. Marais' testimony before analyzing the opinions of plaintiffs' experts regarding general and specific causation.

         Discussion

         A. Legal standards for testimony by an expert witness

         Federal Rule of Evidence 702 governs the admissibility of expert testimony. It provides:

A witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise if:
(a) the expert's scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue;
(b) the testimony is based on sufficient facts or data;
(c) the testimony is the product of reliable principles and methods; and
(d) the expert has reliably applied the principles and methods to the facts of the case.

Fed. R. Evid. 702. Under Daubert, the district court plays the role of gatekeeper in determining whether proposed expert testimony meets the standards of Rule 702. Daubert, 509 U.S. at 597. The Seventh Circuit[4] has described the district court's gatekeeping role as having three steps: determining (1) whether the witness is qualified, (2) whether the expert's applied methodology is scientifically reliable, and (3) whether the testimony will assist the trier of fact to understand the evidence or determine a fact in issue. Myers, 629 F.3d at 644.

         A considerable body of case law since Daubert provides guidance regarding how a district court should exercise its gatekeeping role. To determine whether an expert is sufficiently qualified, a court should consider the expert's "full range of practical experience as well as academic or technical training." Smith v. Ford Motor Co., 215 F.3d 713, 718 (7th Cir. 2000) (hereinafter "Ford Motor Co."). Regarding an expert's qualifications, the question "is not whether an expert witness is qualified in general, but whether his qualifications provide a foundation for him to answer [the] specific question" he purports to answer. Gayton v. McCoy, 593 F.3d 610, 617 (7th Cir. 2010). In determining the reliability of an expert's opinion, "[t]he focus . . . must be solely on principles and methodology, not on the conclusions that they generate." Daubert, 509 U.S. at 595. "The soundness of the factual underpinnings of the expert's analysis and the correctness of the expert's conclusions based on that analysis are factual matters to be determined by the [jury]." Ford Motor Co., 215 F.3d at 718. An expert, however, must provide some reliable basis for the conclusions he reaches. A court may properly exclude "opinion evidence that is connected to existing data only by the ipse dixit of the expert." Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997). To offer a reliable opinion, an expert must "employ[] in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field." Kumho Tire Co. v. Carmichael, 526 U.S. 137, 152 (1999). Relevant factors for assessing the reliability of an expert's methods include "(1) whether the scientific theory or technique can be (and has been) tested; (2) whether the theory or technique has been subjected to peer review and publication; (3) whether a particular technique has a known potential rate of error; and (4) whether the theory or technique is generally accepted in the relevant scientific community." Schultz v. Akzo Nobel Paints, LLC, 721 F.3d 426, 431 (7th Cir. 2013). But "[i]mportantly, this list is neither exhaustive nor mandatory." C.W. ex rel. Wood v. Textron, Inc., 807 F.3d 827, 835 (7th Cir. 2015). A court should ultimately determine reliability on a case-by-case basis. Id. Finally, in addition to being reliable, the expert's testimony must assist the trier of fact. In other words, it must "fit" the facts of the case and have "a valid scientific connection to the pertinent inquiry." Daubert, 509 U.S. at 591-92.

         The proponent of expert testimony bears the burden of establishing, by a preponderance of the evidence, that the testimony satisfies Daubert's standards and is otherwise admissible under the Rules of Evidence. Lewis v. CITGO Petroleum Corp., 561 F.3d 698, 705 (7th Cir. 2009). When determining whether the proponent of expert testimony has met that burden, however, a court must be mindful that "[a] Daubert inquiry is not designed to have the district judge take the place of the jury to decide ultimate issues of credibility and accuracy." Lapsley v. Xtek, Inc., 689 F.3d 802, 805 (7th Cir. 2012). If the credibility or accuracy of an expert opinion is in question, the proper remedy is not exclusion of the testimony, but rather testing the opinion before the jury using the traditional tools of "[v]igorous cross-examination, presentation of contrary evidence, and careful instruction on the burden of proof." Daubert, 509 U.S. at 596.

         B. Dr. Marais' testimony

         Plaintiffs' motion to limit Dr. Marais' testimony is based almost entirely on their contention that Dr. Marais is unqualified to offer many of the opinions expressed in his expert report.[5] Dr. Marais is vice president of a consulting firm that specializes in applied mathematical and statistical analyses. He holds a Ph.D. in business administration and mathematics, as well as master's degrees in statistics and mathematics, all from Stanford University. He has taught and conducted research while on the faculties of the University of Chicago and Stanford, and he is a member of a number of professional societies related to mathematics and statistics.

         Given Dr. Marais' background, plaintiffs do not dispute that Dr. Marais is qualified in general to offer expert opinions on statistical and mathematical matters. They do argue, however, that the statistical analysis at issue in this case, and the statistical opinions Dr. Marais intends to offer, concern specific sub-fields of statistics- biostatistics and epidemiology-in which he lacks expertise. According to plaintiffs, proper statistical analysis of biological or medical studies involves the exercise of medical and scientific judgment based on training and experience in medicine, biology, or a related field. Because Dr. Marais has no experience and training in such a field, plaintiffs argue, he is unqualified to offer many of his proposed opinions in this case.

         The Court agrees with plaintiffs in general that the practice of biostatistics and epidemiology often requires medical or other specific scientific expertise. But the Court is not persuaded that Dr. Marais lacks the necessary expertise to render the particular opinions he intends to offer in this case. As the Seventh Circuit has made clear, the inquiry into an expert's qualifications is not a generalized one: rather, a court "must look at each of the conclusions [the expert] draws individually to see if he has the adequate education, skill, and training to reach them." Gayton, 593 F.3d at 617. In support of their motion to limit his testimony, plaintiffs do address Dr. Marais' conclusions individually, explaining why they believe he is unqualified to offer them, but each conclusion plaintiffs challenge lies within the scope of his expertise as a statistician.

         First, plaintiffs argue that Dr. Marais is unqualified to offer an opinion about the effect of excluding certain cardiovascular adverse events from the Basaria study. Dr. Marais lacks the medical expertise, plaintiffs argue, to determine the appropriateness of excluding those events from the study. But Dr. Marais explained during his deposition that it was Dr. William J. French, another of AbbVie's experts, who suggested that Dr. Marais focus on major adverse cardiac events as opposed to all of the adverse cardiovascular events included in the Basaria study. It is undisputed that Dr. French, a cardiologist, is qualified to make a judgment about which cardiovascular events are most relevant to this case, and thus it was appropriate for Dr. Marais to follow his suggestion. And Dr. Marais is qualified to assess the statistical effect of removing such events from the Basaria study's underlying data.

         Second, plaintiffs object to Dr. Marais' critique of the Xu meta-analysis. Dr. Marais performed a statistical "sensitivity analysis" to determine the extent to which the results of the Basaria study drove the results of the Xu meta-analysis. Plaintiffs argue that Dr. Marais' critique of the Xu meta-analysis is inadmissible because it rests on his purportedly inadmissible analysis of the Basaria study. As just discussed, Dr. Marais is qualified to analyze the Basaria study in the way he did, and thus his analysis of the Xu meta-analysis is also appropriate. In addition, the "sensitivity analysis" that Dr. Marais conducted involves the application of a statistical method that is well within the scope of his statistical expertise and does not require any biological or medical background.

         Third, plaintiffs argue that Dr. Marais is unqualified to criticize the Vigen study for using a novel statistical method. As a statistical expert, however, Dr. Marais is obviously qualified to assess the appropriateness of the statistical method used in a study. Plaintiffs note that one of AbbVie's own experts in epidemiology refrained from opining on the Vigen study during his deposition because he is not a biostatistician, but a review of that expert's deposition makes clear that it was his lack of statistical expertise that kept him from commenting on the study, not his lack of other scientific knowledge. Dr. Marais possesses the requisite statistical expertise to opine about the statistical methods used in the Vigen study.

         Fourth, plaintiffs maintain that Dr. Marais is unqualified to criticize the Finkle study for lacking a control group and for failing to control for potential biases. But the importance of a control group and the need to control for bias are central statistical concepts about which Dr. Marais is certainly qualified to testify, and plaintiffs have failed to suggest how Dr. Marais' discussion of these concepts ventures into territory outside his expertise.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Plaintiffs challenge Dr. Marais&#39; qualifications to offer opinions on a number of other subjects. They contend that he is unqualified to opine about the findings of various government investigations into the risks of TRT, but in offering that opinion, Dr. Marais states carefully that he only agrees with the findings of those investigations to the extent their conclusions rest on statistical matters. Such statistical matters are, of course, within his expertise as a statistician. In addition, plaintiffs take issue with Dr. Marais&#39; criticism of certain data adjustments plaintiffs&#39; expert Dr. Gerstman made in conducting his own meta-analysis[6] of studies. But a review of this section of Dr. Marais' export report makes clear that Dr. Marais' criticisms of Dr. Gerstman's methods are statistical in nature and do not rest on biological or medical judgment. Plaintiffs also object to Dr. Marais' opinion that their theory of elevation of cardiovascular risk for transdermal TRT lacks coherence, because, according to plaintiffs, "coherence" is an epidemiological term, an assessment of which requires expertise in epidemiology. Dr. Marais testified, however, that he was not using the word "coherence" as an epidemiological term of art. Rather, he was commenting on the opinion of plaintiffs' expert, Dr. Wells, who reported that there was a greater association between major cardiovascular events for transdermal formulations of TRT as compared to injectable formulations of TRT. According to Dr. Marais, this opinion appears to be inconsistent with (that is, lacking "coherence" with) plaintiffs' position that higher levels of testosterone in the blood (and thus higher levels of estradiol and hematocrit) increases the risk of cardiovascular injuries, because intramuscular TRT has been associated with higher levels of testosterone, estradiol, and hematocrit in the blood than transdermal formulations. Though this opinion of Dr. Marais' arguably requires ...


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