United States District Court, N.D. Ohio, Eastern Division
IN RE: NATIONAL PRESCRIPTION OPIATE LITIGATION THIS DOCUMENT RELATES TO: Track One Cases
OPINION AND ORDER GRANTING IN PART AND DENYING IN
PART MOTION TO EXCLUDE KESSLER AND PERRI
AARON POLSTER, UNITED STATES DISTRICT JUDGE.
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.
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.
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).
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.
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.
reasons set forth below, the Court grants in part and denies
in part the Kessler/Perri Motion.
Credentials and Experience.
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 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.
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).
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
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.
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.
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.' 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.
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