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In re National Prescription Opiate Litigation

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

September 3, 2019




         Before the Court is Defendants' Motion to Exclude the Testimony of David A. Kessler, M.D. and Mathew Perri, III BS Pharm, Ph.D., RPh. (“Kessler/Perri Motion”) (Doc. #: 1927). The Court has carefully considered the Kessler/Perri Motion, Plaintiffs' Response (Doc. #: 2195), and Defendants' Reply (Doc. #: 2536) and GRANTS IN PART AND DENIES IN PART the Kessler/Perri Motion.

         I. Legal Standards.

         The Court incorporates the general legal standards set forth in the Court's Opinion and Order regarding Defendants' motion to exclude the opinion and testimony of Prof. Meredith Rosenthal. See Doc. #: 2495.

         II. Introduction.

         Plaintiffs intend to call Kessler to testify about the United States Food and Drug Administration's (“FDA”) regulatory scheme, FDA practice and procedure, the FDA's relationship with pharmaceutical companies, the standard of care applicable to the pharmaceutical industry based on Kessler's training and experience, the Manufacturers' compliance with FDA regulations and industry standards, and the impact of the Manufacturers' compliance or lack thereof. See Plaintiffs' Memorandum in Opposition to Defendants' Motion to Exclude the Testimony of David Kessler, M.D. and Matthew Perri (“Pls. Opp. Resp. re Kessler & Perri”) at 23 (Doc. #: 2195).

         Perri was retained by Plaintiffs to explain pharmaceutical marketing, how it differs from other marketing, and the marketing standards prescription opioid marketers should follow. See Id. at 3. Perri opines about Defendants' prescription opioid marketing strategies and messages, how these strategies were implemented and messages disseminated, and the effectiveness of both. Id.

         Defendants seek to exclude both experts' testimony to the extent it constitutes a narrative or presents opinions about Manufacturer knowledge, intent, or state of mind. Defendants further seek to exclude Perri's testimony, in its entirety, arguing his methodology is not reliable and his opinions are not relevant. Defendants also move to exclude Kessler's opinions on the additional grounds that they contain legal conclusions and, as to Noramco and Tasmanian Alkaloids, are untimely.

         For the reasons set forth below, the Court grants in part and denies in part the Kessler/Perri Motion.

         III. Kessler.

         A. Credentials and Experience.

         Kessler received his J.D. from the University of Chicago in 1978 and his M.D. from Harvard University in 1979. See Expert Report of David Kessler, M.D. (“Kessler Report”) at 10 (Doc. #: 1927-3). In 1990, Kessler was appointed as Commissioner of the FDA, where he served until 1997. Id. In his role as FDA Commissioner, Kessler was responsible for implementing and enforcing the United States Food, Drug, and Cosmetic Act. Among his responsibilities, Kessler oversaw the Center for Drug Evaluation and Research, Center for Devices and Radiological Health, and Center for Biologics[1] Evaluation and Research. Id. He created the Office of Criminal Investigations and was responsible for the FDA's Division of Drug Marketing, Advertising, and Communications. Id. at 11. Kessler also served as Dean of the Yale University School of Medicine and Dean of the School of Medicine at the University of California, San Francisco. Id. at App'x. 1 at 1.

         During his career, Kessler has been awarded numerous honors, has served on several boards of directors, and has published articles in legal, medical, and scientific journals on a variety of topics, including the federal regulation of food, drugs, and medical devices, drug promotion and marketing practices, and addiction. See Pls. Opp. Resp. re Kessler & Perri at 2 (Doc. #: 2195).

         B. Opinions.

         Plaintiffs retained Kessler to offer opinions concerning: the Food Drug & Cosmetics Act, 21 U.S.C. § 301, et seq. (“FDCA”); legal standards, regulation, guidance, and industry practice pertaining to the sponsors of prescription opioids; and whether documents produced in discovery establish that the Manufacturers “departed from accepted regulatory standards” and, if so, how. Kessler Report at 13 (Doc. #: 1927-3). In addition, Kessler offers marketing causation opinions, ultimately concluding that:

the manufacturers' departures from FDA standards would be expected to (and likely did) have an affect on how healthcare providers prescribed opioids, contributing to a shift in the practice of medicine with regards to the use of opioids in the treatment of pain. This change in the practice of medicine led to an increase in opioid prescriptions, an increase of opioids in interstate commerce, and an increase in inappropriate use of opioids, all of which in turn increased the risk of opioid abuse and contributed to a public health crisis.

Id. at 320.

         Kessler's report first addresses the responsibilities of manufacturers pursuant to the FDCA. See Id. at 14-25. He then offers specific opinions about how the marketing and promotional activities of various Manufacturers deviated from their FDA responsibilities which, in turn, increased the risk of opioid abuse and endangered patient safety. Id. at 31-291. Kessler also opines that the Manufacturers' support for, and involvement with, pain advocacy groups, professional medical groups, and trade groups worked to expand opioid use and increased the risk of opioid abuse. Id. at 295-313.

         Kessler offers dozens of specific opinions concerning what he alleges to be the Manufacturers' false and misleading marketing statements about prescription opioids, including that they minimized the risks of addiction and abuse and exaggerated the benefits of use. Kessler is particularly critical of the Manufacturers' promotional efforts to increase dosing and to advance the theory of ‘pseudoaddiction.'[2] Kessler also proposes corrective measures involving promotion, advertising, and professional education directed to the individuals who received the allegedly false and misleading messaging from the Manufacturers in the first place. See id. at 314-320. And, Kessler creates charts and spreadsheets summarizing the information he reviewed, including voluminous sales representative call notes, labeling information, and FDA documentation. See id. at Schedules 1-12.

         C. Analysis.

         Defendants assert Kessler should be excluded from testifying about three general areas and one specific area. They first argue Kessler's report amounts to nothing more than a lengthy factual narrative, including hundreds of pages of one-sided selective quotes from the Manufacturers' documents, followed by his opinions about each Manufacturer. Motion at 10 ((Doc. #: 1927-1). According to Defendants, this type of narrative summary of the evidence usurps the role of lawyers and the jury. Id. at 11. Plaintiffs address these criticisms by urging it is common, and acceptable, to allow experts to discuss documents on which they rely in formulating their opinions-particularly when the documents are generated by a party. See Opp. at 4-6 (Doc. #: 2195). Plaintiffs emphasize that, as long as the expert is summarizing voluminous records and material or explaining a complicated issue to the jury, and not simply ...

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