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In re National Prescription Opiate Litigation

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

August 28, 2019




         Before the Court is Defendants' Motion to Exclude the Marketing Causation Opinions of Mark Schumacher, Anna Lembke, and Katherine Keyes (Doc. #: 1868). For the reasons and to the extent stated below, the Motion is GRANTED IN PART.

         * * * * *

         Schumacher and Lembke are medical doctors, with expertise in pain medicine and addiction, who offer opinions about, inter alia, misleading and inaccurate information contained in Defendants' marketing and promotional materials. As part of these opinions, Schumacher and Lembke conclude this alleged misinformation influenced the prescribing practices of physicians, thereby resulting in increased prescriptions of opioids. Keyes, on the other hand, is an epidemiologist who specializes in opioid-related harm. She offers opinions about harms in the population related to increased opioid supply and misuse, including that increases in the supply of prescription opioids resulted in an exponential increase in prescription opioid overdose. As part of this opinion, Keyes states that inaccurate marketing information contributed to the increase in the supply of prescription opioids.

         Defendants assert all three witnesses lack the necessary qualifications to testify as an expert on pharmaceutical marketing and its alleged causation of opioid overdose and related harms. In addition, Defendants assert these opinions are unreliable and would mislead, confuse, and unfairly prejudice the jury.

         The Court agrees that, although Schumacher and Lembke are distinguished experts in the medical fields of pain and addiction, they lack the specialized training or experience necessary to testify as experts about pharmaceutical marketing causation. Also, as to Keyes, the Court finds that, although she is highly qualified as an expert in epidemiology, Plaintiffs have not shown this expertise extends to her opinions on marketing causation in this case. Accordingly, as to these three witnesses, the Court will exclude the limited portions of their opinions that purport to find causation with respect to the effect that Defendants' marketing efforts had on increased sales and/or increased prescriptions of opioids. As discussed below, this ruling applies narrowly ‒ that is, it excludes only to these witnesses' opinions regarding marketing causation and does not impact their remaining opinions in any way. The Court's reasoning is set forth below.[1]

         I. Schumacher.

         A. Credentials and Experience.

         Schumacher received an M.D. and Ph.D. degrees in Physiology and Pharmacology from the University of California, San Diego. See Defs. Mtn. to Excl. Mktg. Causation Ops., Ex. 6 at 1 (“Schumacher CV”) (Doc. #: 1868-9). He is currently a Professor and Chief of the Division of Pain Medicine in the Department of Anesthesia and Preoperative Care at the University of California, San Francisco. Over the past 24 years, Schumacher has devoted his academic career to advance pain medicine, through clinical care and research. See Id. at 2; Defs. Mtn. to Excl. Mktg. Causation Ops., Ex. 5 at 7 (“Schumacher Rpt.”) (Doc. #: 1868-8).

         Schumacher served as one of 18 members on the National Academies of Sciences, Engineering, and Medicine (“NASEM”) Committee on Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse, which published a Consensus Report in July of 2017. See Schumacher Rpt. at 7, 27 (Doc. #: 1868-8); Pls. Opp., Ex. 1 (“Consensus Report”) (Doc. #: 2166-1). The Committee described its task as: “to review and assess approaches and actions that the Federal Drug Administration (“FDA”) and others have taken, and could take, to resolve the [opioid epidemic] and prevent such problems from arising in the future.” Consensus Report at 40 (Doc. #: 2166-1).

         B. Opinions.

         Schumacher offers the following opinions:

(1) the medical standard of care for treating chronic and acute pain changed as a result of Defendants' widespread promotion and marketing of opioids that trivialized the risk of addiction and exaggerated the benefits of long-term opioid use;
(2) through direct physician marketing, medical education, and industry-sponsored and industry-funded Key Opinion Leaders (“KOLs”), Defendants influenced physicians to prescribe long-term opioids based on misinformation about the risks and benefits of chronic opioid use;
(3) for the vast majority of chronic pain patients, the risks of prescription opioids significantly outweigh any benefits; and
(4) even in situations where opioids are effective in treating pain, the risks are so significant that non-opioid alternatives should be used whenever possible.

See Schumacher Rpt. at 6-7 (Doc. #: 1868-8).

         Part of Schumacher's second opinion involves “marketing causation.” As to this opinion, Schumacher reviewed discovery materials in this case and identified dozens of marketing efforts by Purdue and other Defendants, finding they contained false and/or misleading messages about prescription opioids that minimized the risks of addiction and misrepresented and/or exaggerated the benefits, including statements that more potent and long-acting formulations of opioids (such as OxyContin) were safe and effective in the treatment of chronic, non-cancer pain. See Id. at 30-41. Schumacher opines that, to increase the sales of prescription opioids, Purdue and other Defendants delivered these messages through: (i) direct marketing to physicians and consumers; (ii) funding of research, pain-related medical societies, and continuing medical education; (iii) lobbying medical boards and agencies responsible for pain-related treatment guidelines; and (iv) lobbying state and local governments to remove barriers to broader use of opioids for the treatment of pain. See Id. at 28-29. Schumacher states these efforts influenced physicians to replace a cautious and conservative approach to the use of opioids with much more liberal prescribing practices, thereby causing a significant increase in the number of opioid prescriptions. See Id. at 21, 28-30.

         Schumacher notes “there are a number of reasons” why the opioid epidemic was able to take root in the United States, including: (i) a lack of medical education on the treatment of pain and (ii) market forces that reduced the availability of multidisciplinary pain treatment. See Id. at 26-27. However, Schumacher also states: “there is no real question that the epidemic has been driven by an unwarranted increase in prescription opioids orchestrated by the pharmaceutical industry.” Id. at 27. More specifically, he opines:

the driving force of this national catastrophe has been the introduction and marketing of long-acting formulations of high potency opioids such as OxyContin in 1996. Physicians were misled through Defendants' marketing and sales detailing intended to persuade doctors to accept that more potent and long-acting formulations of opioids (such as OxyContin) were safe and effective . . . and even at high doses.

Id. at 28. It is this “marketing causation” opinion that Defendants seek to exclude.

         C. Analysis.

         Defendants assert Schumacher is not qualified to testify as an expert on marketing causation because he has no specialized expertise or experience in this field. See Defs. Mem. at 4 (Doc. #: 1862-2). Plaintiffs respond that Schumacher's “most relevant and significant credential” regarding marketing causation is his participation on the NASEM Committee on Pain Management, which they contend “reached a consensus that Defendants' marketing contributed causally to the opioid epidemic.” Pls. Opp. at 2 (Doc. #2166). But the Committee specifically stated it was not directed to investigate the cause of the opioid epidemic and “did not aim to assign responsibility” in this regard. Consensus Report at 40 (Doc. #: 2166-1). Plaintiffs point to statements by the Committee that “certain hypotheses” about causation are “inescapable” and that certain data makes a “prima facie case” that Manufacturers' marketing and increased prescribing by physicians were “key contributors” to the increase in opioid use.[2] Pls. Opp. at 2-3 (Doc. #2166) (quoting Consensus Report at 40-41 (Doc. #: 2166-1). On their face, these statements do not indicate that the Committee made causation findings. See, e.g. Merriam-Webster Online ( (“hypothesis” means “a tentative assumption made in order to draw out and test its logical or empirical consequences”); ( (“prima facie” means “true, valid, or sufficient at first impression”). Moreover, even if the Committee made causation findings (which it apparently did not), Plaintiffs have not shown the extent of Schumacher's involvement therein.

         To qualify as an expert under Rule 702, a witness must establish his expertise through “knowledge, skill, experience, training, or education, ” Fed.R.Evid. 702, and the expert's training and qualifications must “relate to the subject matter of his proposed testimony.” Rose v. Truck Ctrs., Inc., 611 F.Supp.2d 745, 749 (N.D. Ohio 2009) (citation omitted). Here, the record demonstrates that Schumacher is highly distinguished as an expert in the scientific disciplines of physiology, pharmacology, and pain medicine. He is, therefore, “fully qualified” to opine on matters involving medical facts and science that fall within these subject areas. In re Diet Drugs Prods. Liab. Litig., 2000 WL 876900, at *11 (E.D. Pa. June 20, 2000). Plaintiffs have not shown, however, that Schumacher has specialized training, knowledge, or experience in the field of pharmaceutical marketing. See Defs. Mtn. to Excl. Mktg. Causation Ops., Ex. 9 at 30:9 to 31:5 (“Schumacher Depo.”) (Doc. #: 1868-12) (“I have not stated I've ever been an expert in marketing.”); see also Diet Drugs, 2000 WL 876900, at *9-11 (concluding medical doctors did not have specialized knowledge or experience in the way the pharmaceutical marketplace reacts, behaves, or thinks).

         On this record, the Court finds Schumacher may not testify regarding the effect of Defendants' marketing efforts on doctors' prescribing practices.[3] See, e.g., Pfizer Inc. v. Teva Pharm. USA, Inc., 461 F.Supp.2d 271, 277 (D.N.J. 2006) (medical doctor may not opine regarding the effect that marketing materials had on doctors' prescribing practices); Bartlett v. Mut. Pharm. Co., 742 F.Supp.2d 182, 195 (D.N.H. 2010) (most courts have prohibited doctors from testifying as experts “about what all doctors generally think in making prescription decisions”) (quoting Diet Drugs, 2000 WL 876900, at *11-12). This ruling applies narrowly, only to the small portion of Schumacher's second opinion (listed above) that purports to find that Defendants' marketing efforts resulted in increased sales and/or increased prescriptions of opioids. The Court's ruling does not in any way impact Schumacher's remaining opinions, including the remainder of his second opinion regarding the inaccuracy of statements and representations made in marketing materials and other promotional and/or educational efforts.[4] See, e.g., In re Gadolinium-Based Contrast Agents Prod. Liab. Litig., MDL No. 1909, 2010 WL 1796334, at *19 (N.D. Ohio May 4, 2010) (nephrologist may offer opinions on whether labeling and marketing information contained inaccuracies or omissions that could deprive or mislead physicians, like himself, who treated renally impaired patients); Pfizer, 461 F.Supp.2d at 277 (doctor may render an opinion on the accuracy of defendant's marketing materials).

         II. Lembke.

         A. Credentials ...

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