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In re National Prescription Opiate Litigation

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

August 26, 2019




         Before the Court is Defendants' Motion to Exclude Expert Testimony of Katherine Keyes, Anna Lembke and Jonathan Gruber re the “Gateway Hypothesis” of Causation (Doc. #: 1858). For the reasons stated below, the motion is DENIED.

         I. Introduction

         Jonathan Gruber is one of the nation's leading health economists. He received his Ph.D. in Economics from Harvard University and is the Ford Professor of Economics at the Massachusetts Institute of Technology, where he has taught for over 25 years. Gruber directs the Health Care Program at the National Bureau of Economic Research and served as President of the American Society of Health Economists from 2016-2018. He has twice won the International Health Economics Association Kenneth J. Arrow Award for the outstanding health economics paper and has served as Co-Editor for both the Journal of Public Economics and the Journal of Health Economics. Along with David Cutler, another of Plaintiffs' experts, he won the ASHEcon award for best health economist in the nation age 40 and under in 2006. Gruber has previously testified in Int'l Tobacco Partners, Ltd. v. Kline, 475 F.Supp.2d 1078, 1082 (D. Kan. 2007) (“Gruber is clearly qualified to testify as an expert in this case.”).

         Katherine Keyes is an Associate Professor of Epidemiology at Columbia University, specializing in substance use and substance use disorders epidemiology. She received her Ph.D. in Epidemiology from Columbia University. She has published 225 peer-reviewed articles and book chapters. Her work appears in leading journals such as Pediatrics, JAMA Psychiatry, Lancet Psychiatry, American Journal of Epidemiology, and International Journal of Epidemiology, and is widely cited. Keyes has published two textbooks on epidemiological methods, both with Oxford University Press. She is an elected member of the executive board of the Society for Epidemiological Research and serves as Associate Editor of the journal Drug and Alcohol Dependence. Keyes has received numerous professional awards honoring her research achievements, including early career achievement recognitions from the Research Society on Alcoholism, the American Psychopathological Association, the World Psychiatric Association-Epidemiology and Public Health Section, and the NIH Office of Disease Prevention Early-Stage Investigator award.

         Anna Lembke is an Associate Professor, Chief of the Addiction Medicine Dual Diagnosis Clinic, Medical Director of Addiction Medicine, and Program Director of the Addiction Medicine Fellowship, in the Department of Psychiatry and Behavioral Sciences at Stanford University School of Medicine. She received her M.D. from Stanford University, where she also completed a residency in psychiatry and a Fellowship in Mood Disorders, Department of Psychiatry and Behavioral Sciences. She has taught at Stanford since 2001. She teaches topics related to psychiatry, addiction, and pain. She lectures on addiction medicine as part of the Practice of Medicine series for Stanford medical students. For the last 15 years in her clinical practice, a significant proportion of her patients have taken prescription opioids for pain relief and she has treated them for misuse, dependence, and addiction. She has served on the Board of the California Society of Addiction Medicine since 2015 and has been a member of the American Society of Addiction Medicine since 2011. She has chaired the Addiction Medicine Task Force, Stanford University School of Medicine, and served as the president of the Addiction Medicine Fellowship Directors Association. Lembke has authored a book on the prescription drug epidemic: “Drug Dealer, M.D.: How Doctors Were Duped, Patients Got Hooked, and Why It's So Hard to Stop, ” published by Johns Hopkins University Press, along with over 50 peer-reviewed articles, chapters, and commentaries that have appeared in leading journals such as the New England Journal of Medicine, Journal of the American Medical Association, and Pain Medicine. The Court refers collectively to Keyes, Lembke and Gruber as “the Experts.”

         The Experts offer numerous opinions, but Defendants' Motion focuses specifically on what Defendants term the “Gateway Hypothesis.” The Experts prefer the term “Gateway Effect” and define it in various ways, but the gist of their Gateway opinion is that “there is compelling evidence of harm from the oversupply of prescription opioids, both for medical users, and to non-medical users because of diversion. These harms include opioid use disorders and overdose; these harms are greater than other pain relief drugs, and are causally related to additional harms from opioids including transition to heroin addiction.” Keyes Report at 3 (Doc. #: 1999-9). Put more simply, the Gateway Effect refers to evidence that some individuals exposed to prescription opioids tend to become addicted, and once addicted tend to later feed their addition with illicit opioids, such as heroin.

         II. Discussion

         Each of the Experts is well-qualified to testify, and Defendants do not challenge their qualifications. But Defendants do ask the Court to exclude testimony of the Experts concerning the Gateway Hypothesis, which Defendants characterize (or mischaracterize) as positing that “the entire problem of illicit heroin and fentanyl use today was somehow ‘caused' by the last quarter century of trained healthcare providers prescribing legal opioid medicines.” Motion at 2 (Doc. #: 1858) (emphasis added). Defendants also specifically ask the Court to bar the Experts from opining “that there is a correlation between non-medical prescription opioid use and heroin abuse.” Motion at 16 (Doc. #:1858).

         Defendants offer three reasons in support of their motion. First, they assert “there is no scientific evidence that even purports to look at - let along [sic] find a causal link between - properly prescribed pain patients and today's heroin and fentanyl problems.” Motion at 6 (Doc. #: 1858). Second, the studies the Experts rely on, which Defendants insist examine only a population of “non-medical” opioid users, [1] “do not claim that heroin or fentanyl use is ‘caused' by such prior non-medical use or abuse of prescription opioids in this population.” Id. Third, Defendants argue the Gateway Hypothesis lacks relevance to Plaintiffs' case, or, in the parlance of Daubert, lacks fit, and is thus apt to mislead the jury.

         Defendants' first two arguments differ subtly, and that distinction rests entirely on the classification of two populations studied by Lembke and Keyes, as well as by the epidemiologists whose work they cite: (1) “medical users” of prescription opioids and (2) “non-medical users” of prescription opioids. The term “medical users” of prescription opioids refers to individuals who used prescription opioids entirely in accord with a prescription they received, themselves. In contrast, by “non-medical users, ” Defendants refer to individuals who used prescription opioids, but either (a) did so despite not having a prescription written for them (e.g., used Grandma's prescription opioids), or (b) received a valid prescription, but then used their opioids not in conformity with prescribed usage, dosage, or duration (e.g., consumed their opioids in greater amounts or more often or longer than directed). Defendants' first argument essentially contends that none of the literature the Experts cite studied medical users of opioids, and thus it affords no basis to conclude that medical use of prescription opioids caused widespread heroin use. Defendants' second argument contends that the literature stops short of concluding that even non-medical use of prescription opioids caused the harms associated with heroin and illicit fentanyl.

         A. The Gateway Experts Appropriately Relied on Epidemiological Literature.

         Defendants argue the Experts lack any valid basis for their opinions on the Gateway hypothesis. Defendants assert that none of the Experts “has offered a single study that even tests - let alone supports - the hypothesis that medical use of prescription opioids causes the abuse of illicit street drugs, and their belief otherwise is speculation.” Motion at 10 (Doc. #: 1858). Defendants also assert that “[n]one of the [16 epidemiological articles Keyes reviewed] reports on a controlled clinical trial designed to answer the hypothesis (or any hypothesis) the Experts put forth.” Motion at 9 (Doc. #: 1858); see also Reply at 5 (Doc. #: 2446). Defendants ask, therefore, that the Court exclude “the Experts' ‘gateway' opinion” as unreliable. Motion at 11 (Doc. #: 1858).

         In response, Plaintiffs initially observe that a “review of scientific literature is a sound methodology.” Opp. at 5-6 (Doc. #: 2197); see In re Heparin Prods. Liab. Litig., 803 F.Supp.2d 712, 738 (N.D. Ohio 2011) (“Courts have admitted expert testimony as reliable where experts extrapolate their opinions from their knowledge and experience combined with a review of the relevant scientific literature.”). Plaintiffs next lay out in detail numerous published studies analyzing heroin users' prior nonmedical prescription opioid use, which the Experts relied upon in their reports. Opp. at 5-16 (Doc. #: 2197). Plaintiffs maintain that Defendants' insistence on a sharp division between medical and non-medical use is both untenable and beside the point. Opp. at 11, 24, n. 68 (Doc. #: 2197). Plaintiffs cite studies showing that “the majority of [non-medical use by addicts] involved a history of medical use.”[2] Plaintiffs assert that “the medical users of prescribed opioids become the nonmedical users of those same addictive drugs, who then become part of the population of heroin users described in the Compton article. This is the Gateway Effect, in no uncertain terms.”[3] Opp. at 11 (Doc. #: 2197). In other words: a ...

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