City of Huntington, West Virginia v. AmerisourceBergen Drug Corporation et al
Filing
1266
MEMORANDUM OPINION AND ORDER denying without prejudice Plaintiffs' 1066 MOTION in limine for an order ruling IQVIA data admissible; granting Plaintiffs' 1204 MOTION for Leave to File a sur-reply to the motion. Signed by Senior Judge David A. Faber on 4/12/2021. (cc: counsel of record who have registered to receive an electronic NEF) (jsa)
Case 3:17-cv-01362 Document 1266 Filed 04/12/21 Page 1 of 14 PageID #: 42880
IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA
THE CITY OF HUNTINGTON,
Plaintiff,
v.
CIVIL ACTION NO. 3:17-01362
AMERISOURCEBERGEN DRUG
CORPORATION, et al.,
Defendants.
________________________________
CABELL COUNTY COMMISSION,
Plaintiff,
v.
CIVIL ACTION NO. 3:17-01665
AMERISOURCEBERGEN DRUG
CORPORATION, et al.,
Defendants.
________________________________
MEMORANDUM OPINION AND ORDER
Pending before the court is plaintiffs’ motion in limine for
an order ruling IQVIA data admissible.
See ECF No. 1066.
That
motion is fully briefed and was argued before the court on
January 6, 2021.
After the hearing, plaintiffs filed a motion
for leave to file a sur-reply, see ECF No. 1204, that defendants
opposed.
See ECF No. 1208.
The motion for leave to file a sur-
reply is GRANTED but the motion in limine is DENIED without
prejudice.
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I.
In the MDL, for the first trial (Summit and Cuyahoga
Counties) plaintiffs retained Lacey Keller, a "data mining
expert," to support their claims that the Manufacturers:
(1)
implemented inadequate suspicious order monitoring systems
("SOMS"); (2) failed to comply with the Controlled Substances Act
("CSA"), 21 U.S.C. §§ 801 et seq. and its implementing
regulations, 21 C.F.R. §§ 1301 et seq.; and (3) failed to
investigate, report, and halt orders of prescription opioids into
Summit and Cuyahoga counties which they knew, or should have
known, were suspicious.
See In re: National Prescription Opiate
Litig., MDL 2804, 2019 WL 3934470, at *1 (N.D. Ohio Aug. 20,
2019).
Plaintiffs in these cases have also retained Keller as an
expert.
In her expert report, Keller concludes:
*
Based on my analysis of IQVIA data, I conclude that
Case Defendants [ABDC, Cardinal, and McKesson] had
sufficient information to understand overall
prescribing trends in Cabell County. Had they reviewed
this data, they would have seen that dosage units of
opioids prescribed in Cabell County doubled in just
five years (1997 to 2002) and quadrupled in twelve
years (1997 to 2009). Defendants would have also seen
that MMEs – the strength of the drugs – doubled in just
three years (1997 to 2000) and increased seven-fold by
2010.
*
The over 200 million of opioid dosage units and over
three billion MMEs prescribed in Cabell County during
the IQVIA period outpaced Cabell County's approximately
95,000 residents. In the peak years, Cabell County
physicians were prescribing enough opioids to give
every man, woman, and child in Cabell County over 150
2
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dosage units per year. Had Case Defendants reviewed
IQVIA data, they would have seen that Cabell County
prescriptions were generally double the statewide
average and triple the national average dosage units
per capita. They would have also seen that Cabell
County was, at times, amongst the top 20 of the United
States' more than 3,000 counties in terms of dosage
units per capita. They also would have seen that
Cabell County exceeded the prescribing levels in West
Virginia, the leading state in the U.S. in terms of
opioid dosage unit prescriptions per capita, where
physicians prescribed over two billion opioids for its
fewer than two million residents.
*
[T]hat Case Defendants could have used IQVIA data and
dispensing data to diligently monitor the prescribing
activity of individual Cabell County prescribers. Had
Case Defendants reviewed IQVIA data, they would have
been able to identify by name prescribers exhibiting
outlier prescribing activity based upon volume, dosage,
and the composition of their prescriptions. The 1
percent of opioid prescribers – between five and nine
prescribers – wrote upwards of 43% of all opioid dosage
units and 65% of MMEs each year, totaling nearly 80
million dosage units and over 1.6 billion MMEs. In
other words, a half dozen prescribers wrote enough
opioid prescriptions to give every man, woman, and
child in the county over 60 pills per year for several
years between 2007 and 2011.
ECF No. 1066-2 at 59.
In formulating her opinions, Keller relied on data compiled
by, and available for purchase from, healthcare company IQVIA
("IQVIA Data").
See id. at 5, 60.
IQVIA Data is submitted from
pharmacies, mail order services, and long term care facilities
and provides information about physicians and the drugs they
prescribed.
IQVIA Data is used to measure market and product
demand and to track product demand over time.
3
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Plaintiffs’ motion in limine seeks to have the court rule
two datasets owned and maintained by IQVIA are admissible in this
trial.
The two datasets--IQVIA's XPONENT and XPONENT
PLANKTRAK--are part of the National Prescription Audit ("NPA")
and are referred to as "the industry standard for measuring the
retail outflow of prescriptions through the front door into the
hands of consumers."
ECF No. 1066-2 at 5.
According to
plaintiffs, these datasets are relevant to the issues of (1)
defendants' notice or constructive knowledge of physicians'
opioid prescribing patterns in Cabell County and Huntington, and
(2) these opioid prescribing patterns themselves.
Although defendants argue in opposition that the IQVIA
datasets are inadmissible hearsay, plaintiffs contend they are
not for two reasons.
First, plaintiffs argue that the datasets
are not hearsay to the extent plaintiffs may use them to show
that defendants had notice or constructive knowledge of opioid
prescribing patterns in Cabell County and Huntington.
Second,
even if the datasets otherwise are hearsay, plaintiffs maintain
they are admissible under the hearsay exception for "[m]arket
quotations, lists, directories, or other compilations that are
generally relied on by the public or by persons in particular
occupations."
Fed. R. Evid. 803(17).
4
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II.
A.
Notice
Evidence that is offered to show notice rather than to seek
to prove the truth of the matter asserted is admissible as
non-hearsay.
See United States v. Cone, 714 F.3d 197, 219 (4th
Cir. 2013) (allowing emails to be admitted “for the non-hearsay
purpose of showing that [the defendants] were on notice as to the
counterfeit nature of the goods they sold”).
“‘Hearsay’ is a statement, other than one made by the
declarant while testifying at the trial or hearing,
offered in evidence to prove the truth of the matter
asserted.” Fed. R. Evid. 801(c). Thus, an essential
element of whether a statement is hearsay at all is
determining for what purpose(s) the statement is
offered. If not offered for the truth of the matter it
asserts, it is not hearsay. Significantly, “‘evidence
is not hearsay when it is used only to prove that a
prior statement was made and not to prove the truth of
the statement.’” United States v. Ayala, 601 F.3d 256,
272 (4th Cir. 2010) (quoting Anderson v. United States,
417 U.S. 211, 220 n.8 (1974)). Thus, a statement is
not hearsay when the statement is offered to show that
the County was on notice of the statement. See Green
v. Adm'rs of the Tulane Educ. Fund, 284 F.3d 642, 660
(5th Cir. 2002) (holding that testimony as to three
other complaints of sexual harassment was not hearsay
because it was offered to prove that the employer was
on notice of the complaint rather than for the truth of
the matter asserted), abrogation on other grounds
recognized by McCoy v. City of Shreveport, 492 F.3d
551, 559 (5th Cir. 2007); see also Southerland v.
Sycamore Cmty Sch. Dist. Bd. of Educ., 125 F. App'x 14,
22 (6th Cir. 2004) (holding that rumor testimony and
notes were admissible as non-hearsay because they were
not offered to prove the truth of the matters they
asserted, but instead were used to show that government
officials had knowledge of the problem); Dixon v. Int'l
Fed'n of Accountants, No. 09cv2839, 2010 WL 1424007, at
*2 n.4 (S.D.N.Y. Apr. 9, 2010) (holding that evidence
of complaints by other employees against the plaintiff
5
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was non-hearsay because it was not offered for the
truth of the matter asserted—that the plaintiff
actually did the things complained of—but offered to
show that plaintiff's employer was on notice of the
complaints). A statement is also not hearsay if it is
offered to prove knowledge or show the effect on the
listener or listeners' state of mind. United States v.
Safari, 849 F.2d 891, 894 (4th Cir. 1988). Thus, when
used to show notice, knowledge, or effect on the
listener, Mohler's statement is not hearsay. . . .
Bland v. Fairfax Cnty., Va., No. 1:10cv1030 (JCC/JFA), 2011 WL
2490995, at *4 (E.D. Va. June 20, 2011).
The notice argument is a nonstarter.
First, it is clear
that plaintiffs want to offer the evidence for the truth of the
matter asserted, i.e., physicians’ opioid prescribing patterns in
Cabell County and Huntington.
See ECF No. 1152 at 4-5.
Furthermore, although there is evidence that defendants had
purchased some products from IQVIA, there is no evidence that
defendants had purchased the two datasets at issue here.
According to plaintiffs, they do not need to show defendants
had actual knowledge of the data.
They argue that the IQVIA
datasets are admissible because defendants should have known of
them, whether or not they actually did.
Plaintiffs maintain that
Keller's testimony shows that defendants should be charged with
constructive knowledge of physicians' opioid prescribing patterns
in Cabell County and Huntington.
In so arguing, plaintiffs rely
on Keller's deposition testimony that "IQVIA was widely available
for purchase by the pharmaceutical industry.
.
.
.
And what
we're trying to demonstrate here is the information that could
6
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have been gleaned from distributors, had they accessed the IQVIA
Xponent data or some other similar dataset."
ECF No. 1124-2 at
12; see also id. ("We're saying based off what we have seen in
the IQVIA data, there was -- you could understand the prescribing
trends in Cabell County.").
“[B]efore [a] plaintiff can argue non-hearsay notice she
must show that the defendant was at least inferentially put on
notice by the report.”
(2d Cir. 1990).
George v. Celotex Corp., 914 F.2d 26, 30
Keller's statements are insufficient to
establish that defendants should have been on notice.
In
determining whether to admit newspaper articles to prove a
criminal defendant's notice, one court stated that it must
consider "the specific content of the articles and the
connection, if any, between the articles and the defendant."
United States v. Buck, No. 13 Cr. 282, 2017 WL 5201447, at *3
(S.D.N.Y. Oct. 30, 2017).
The court noted that a decision to
admit such evidence would depend “upon the relevance of the
specific articles and the likelihood the defendant would have
read them.”
Id. (emphasis added).
Thus, showing a connection
between the IQVIA data and defendants is important.
See Austin
v. Hill, Civil Action No. 11-2847, 2014 WL 3797284, at *2 (E.D.
Pa. Aug. 1, 2014) (admitting document “for the limited purpose of
demonstrating what effect, if any, it had on the defendants
provided that plaintiff establishes defendants were aware of this
7
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document and that it was sufficient to put them on notice. . .
.”) (emphasis added); R.K. v. Kanaskie, CASE NO. 02-61534-CIVMORENO/SIMONTON, 2006 WL 8450679, at *11 (S.D. Fl. Apr. 28, 2006)
(“[T]his document is [n]ot hearsay, not offered for the truth of
the matter asserted. . . .
Therefore, it is not hearsay, and may
be used to establish notice, assuming that there is evidence that
the document was received or reviewed by a defendant.”) (emphasis
added) (internal citation and quotation omitted).
And the cases cited by plaintiffs do not really help their
position.
In those cases, the link between the evidence to be
admitted and the party opposing admission is either far less
tenuous or the evidence was not admitted because of an inability
to show that it was reasonable to put the party on notice.
See,
e.g., Gardner v. Q.H.S., Inc., 448 F.2d 238, 244-45 (4th Cir.
2017) ("[The witness] should have been permitted to be
cross-examined as to the article in Consumers Report provided
that the article had been published and was read by him before
the time of the fire in this case.
If the president had not read
the article, the jury should be cautioned that the question of
counsel on cross- examination did not constitute evidence, and
whether he admitted reading it or not, the jury should be
cautioned that they might not rely upon the article for the truth
of the legal or factual conclusions it contained."); Franchina v.
City of Providence, 881 F.3d 32, 50 (1st Cir. 2018) ("The
8
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transcript, then, was admissible as non-hearsay if, as Franchina
argues, it was offered for the purpose of establishing that the
City was, or should have been, on notice of Franchina's alleged
workplace harassment."); George v. Celotex Corp., 914 F.2d 26, 30
(2d Cir. 1990) ("Philip Carey could not have been put on notice
by the Hemeon Report because there was no proof at trial .
.
.
that it reasonably should have seen it as part of the published
literature in the industry.").
B.
Rule 803(17) hearsay exception
Federal Rule of Evidence 803(17) provides a hearsay
exception for “[m]arket quotations, lists, directories or other
compilations that are generally relied on by the public or
persons in particular occupations.”
The United States Court of
Appeals for the Fourth Circuit has made clear that the rule is
intended to cover “established factual information.”
In re C.R.
Bard, Inc., 810 F.3d 913, 923 (4th Cir. 2016) (holding that
document did not fall under 803(17) because it bore “no
resemblance to the factual list-type documents enumerated in Rule
803(17)”).
Therefore, Rule 803(17) applies to “objective
compilations of easily ascertainable facts,” not reports
containing “conclusions reached by analysis by a specialized
marketing company.”
JPC Management, Inc. v. Incredible Pizza
Co., No. CV 08-04310 MMM (PLAx), 2009 WL 8591607, at *24 (C.D.
Cal. July 14, 2009).
9
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Rule 803(17) is a narrow exception to the hearsay
rule, which applies by its terms to “[m]arket
quotations, lists, directories, or other compilations
that are generally relied on by the public or by
persons in particular occupations.” That enumeration
suggests that the exception is designed to include
compilations of information such as reports of stock
market prices, telephone directories, and sales
information for products. The advisory committee's
note supports that interpretation, explaining that the
exception applies to matters such as “newspaper market
reports, telephone directories, and city directories.”
The note adds that the “basis of trustworthiness is
general reliance by the public or by a particular
segment of it, and the motivation of the complier to
foster reliance by being accurate.”
The courts have generally taken a similarly narrow
view of the scope of Rule 803(17), applying it to
compilations of data, not to narrative and potentially
subjective assessments in either general or specialized
publications. See United States v. Woods, 32 F.3d 361,
363–64 (3d Cir. 2003) (database showing location of
manufacture of automobiles within exception); United
States v. Masferrer, 514 F.3d 1158, 1162 (11th Cir.
2008) (Bloomberg market price quotes for various
markets admissible); Conoco, Inc. v. Dep't of Energy,
99 F.3d 387, 393 (Fed.Cir. 1996) (characterizing Rule
803(17) as reaching "market reports, telephone
directories, weather reports, mortality tables, or like
documents"); United States v. Cassiere, 4 F.3d 1006,
1018–19 (1st Cir. 1993) (real estate listing of
properties sold, sale prices, and dates sales closed
admissible); United States v. Goudy, 792 F.2d 664, 675
(7th Cir. 1986) (bank directory showing bank routing
numbers admissible); United States v. Grossman, 614
F.2d 295, 297 (1st Cir. 1980) (catalogue of a
particular company's products admissible).
Bianco v. Globus Med., Inc., Case No. 2:12-CV-00147-WCB, 2014 WL
119285, at *1 (E.D. Tex. Jan. 12, 2014).
According to Keller:
The IQVIA Xponent® data is one of many datasets
owned and maintained by IQVIA, a healthcare information
company formerly known as IMS Health and Quintiles.
10
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The data is part of the National Prescription Audit
("NPA") and "is the industry standard for measuring the
retail outflow of prescriptions through the ‘front
door’ into the hands of consumers." The data is said
to "integrate real-world data" to provide a "timely,
accurate picture of [. . .] competitive performance and
demand," as well as a "deep understanding of [. . .]
key drug dispensing channels." IQVIA data is
considered by some pharmaceutical companies as the
"gold standard in terms of understanding prescription
trends."
IQVIA describes the key prescription information
offerings of Xponent data as: "A suite of sub-national
reporting providing granular prescription performance
perfectly aligned to help manage customer operations,
sales targeting, and representative incentive
compensation." IQVIA is not reported through a
government agency but is proprietary and purchased by
financial and pharmaceutical companies. . . . Given
that IQVIA reflects the prescribing history of
physicians, the dataset could allow anyone who
purchases it to determine how frequently a physician
prescribed particular drugs, as well as what
formulations and in what dosages, and how prescribers
ranked among other prescribers. The data also allows
for the identification of opioid prescribing patterns
of individual physicians compared to their cohorts
based on specialty, geography (e.g., city, county, zip
code, state), and time period.
ECF No. 1066-2 at 5.
Keller's description of the IQVIA data as
“the industry standard” is taken from IQVIA's own information.
Defendants argue that the IQVIA datasets do not recite
established factual information because IQVIA itself asserted at
the time it produced these datasets in the MDL that the data
therein represents "an estimate" and a "reasonable approximation"
and is the product of "independent judgment, expertise and
opinion of IQVIA representatives."
11
ECF 1124-2 at 31 (quoting
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Defendants' Ltr. from IQVIA dated July 25, 2018).
According to IQVIA:
Although there is an inclination to view numerical
data as fact, the IQVIA Information represents an
estimate of measured activity and should be treated
accordingly. As more fully described in our Published
Specifications for Information Services (“Published
Specifications”), IQVIA Information reflects
projections, estimates, forecasts that are the result
of a combination of confidential and proprietary
technologies, statistical methodologies and a
significant number of sources. These estimates reflect
the independent judgment, expertise, and opinion of
IQVIA representatives to arrive at a reasonable
approximation of market activity. The IQVIA
Information is intended to support sales, marketing and
research applications, and it is highly reliable for
those purposes. The IQVIA Information, although
appropriate for its intended purpose of supporting
business and marketing analyses in industries such as
the pharmaceutical industry, contains data that is
susceptible to error or variance, and is not intended
to be used as direct evidence or to establish any fact.
Accordingly, IQVIA offers no assurances that the IQVIA
Information will be suitable for use as evidence in any
litigation.
Id.
Given IQVIA’s disclaimer, it is impossible for the court to
conclude that the datasets are merely a compilation of objective
facts as contemplated by Rule 803(17).
See In re Dual--Deck
Video Cassette Recorder Antitrust Litig., No. CIV 87-987-PHX RCB,
1990 WL 126500, at *4 (D. Ariz. July 25, 1990) (“The type of
publications contemplated by Rule 803(17) are those which deal
with compilations of objective facts not requiring for their
statement, a subjective analysis of other facts.”); White Indus.,
Inc. v. Cessna Aircraft Co., 611 F. Supp. 1049, 1069 (W.D. Mo.
1985) (“[T]he kinds of publications contemplated by the rule are
those which deal with compilations of relatively straightforward
12
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objective facts not requiring, for their statement, a subjective
analysis of other facts.”) (emphasis in original).
Furthermore, on the basis of the record as it now stands, it
is difficult to conclude that the datasets are “generally relied
on by . . . persons in particular occupations.”
See, e.g. Allen
v. Hylands Inc., CV 12-1150-DMG (MANx), 2015 WL 12720304, at *13
(C.D. Cal. Aug 20, 2015) (“Plaintiffs state that the compilation
is intended to inform ‘the public, consumers in the market for
homeopathic OTC drugs, and persons in the medical and drug
manufacturing occupations,’ but asserting a compilation’s
intended audience is different from demonstrated that it is
generally relied on by that audience.”).
At this juncture, the court cannot conclude that the IQVIA
datasets fall within 803(17).
III.
The motion in limine is DENIED without prejudice.
Plaintiffs are free to seek admission of the datasets at trial if
Keller and/or another witness can lay an appropriate foundation
for admission under Fed. R. Evid. 803(17), see BMG Rights Mgmt.
v. Cox Commc’ns, Inc., 881 F.3d 293, 314 (4th Cir. 2018) (no
abuse of discretion in admission of two studies under Rule
803(17) where expert testified that studies “were widely cited in
the industry” and were “the most substantial published publicly
available studies” on the issue), or some other rule.
13
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The Clerk is directed to send copies of this Memorandum
Opinion and Order to counsel of record who have registered to
receive an electronic NEF.
IT IS SO ORDERED this 12th day of April, 2021.
ENTER:
David A. Faber
Senior United States District Judge
14
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