City of Huntington, West Virginia v. AmerisourceBergen Drug Corporation et al

Filing 1284

MEMORANDUM OPINION AND ORDER denying without prejudice Defendants' 1052 MOTION to Exclude the opinions of James E. Rafalski and denying Defendants' 1140 MOTION to Strike the errata sheet of James Rafalski. Signed by Senior Judge David A. Faber on 4/23/2021. (cc: counsel of record who have registered to receive an electronic NEF) (jsa)

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.
v.

Civil Action No. 3:17-01665

CABELL COUNTY COMMISSION,
Plaintiff,
v.

AMERISOURCEBERGEN DRUG
CORPORATION, et al.,
Defendants.
MEMORANDUM OPINION AND ORDER
Pending before the court are defendants’ motion to exclude
the opinions of James E. Rafalski (ECF No. 1052) and defendants’
motion to strike the errata sheet of James Rafalski (ECF No.
1140).
I.

For the reasons that follow, the motions are DENIED.

Background
James Rafalski (“Rafalski”) worked as an investigator for

the Drug Enforcement Agency (“DEA”) for thirteen years.

When he

joined the DEA, he brought with him twenty-six years of law

enforcement experience.

Judge Polster has described Rafalski’s

role at the DEA as follows:
Diversion Investigators are responsible for conducting
regulatory, state, civil, administrative, and criminal
investigations. From 2011 to 2017, Rafalski was
primarily responsible for conducting administrative,
civil, and regulatory investigations of DEA
registrants. In this capacity, he investigated the
criminal conduct of individual physicians regarding
improper opioid prescriptions and conducted regulatory
investigations involving, inter alia, Distributors’
compliance with DEA requirements regarding suspicious
order monitoring systems (“SOMS”).
For example, in 2006, Rafalski conducted an
accountability audit, record-keeping review, and
security investigation of a Walgreens in Ohio to
ensure compliance with controlled substances
regulations and record keeping. This investigation
resulted in the DEA issuing a letter of admonition for
the maintenance of an inadequate SOMS.
From 2010 to 2013, Rafalski conducted an
administrative investigation of The Harvard Drug Group
to identify unusual patterns of distribution of
oxycodone to Florida pain clinics. His work included
the review of company records and policies, as well as
the DEA’s ARCOS data. This investigation resulted in
the DEA issuing an order to show cause for, inter
alia, developing a work-around to avoid triggering the
company’s SOMS.
Also, from 2010 to 2013, Rafalski conducted an
administrative investigation of Masters
Pharmaceutical, reviewing company files regarding
customer due diligence, including questionnaires, onsite investigation reports, and SOMS information.
This investigation resulted in the DEA revoking the
company’s registration to manufacture and/or
distribute controlled substances.
From 2010 to 2017, Rafalski conducted an
administrative investigation of Mallinckrodt in which
he reviewed chargeback data that revealed some
pharmacies and/or practitioners were utilizing
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multiple Distributors to purchase the same product in
large quantities. As a result of this investigation,
the DEA and Mallinckrodt entered into a three-year
Memorandum of Agreement.
In re Nat’l Prescription Opiate Litig., No. 1:17-MD-2804, 2019
WL 3934490, at *1–2 (N.D. Ohio Aug. 20, 2019) (citations
omitted).
II.

Legal Standards
a.

Rule 702

The court incorporates by reference the legal standard set
forth in its memorandum opinion of April 22, 2021 (ECF No.
1282).
b.

Errata Sheet

On request by
deposition is
30 days after
transcript or

the deponent or a party before the
completed, the deponent must be allowed
being notified by the officer that the
recording is available in which:

(A)

to review the transcript or recording; and

(B)

if there are changes in form or substance, to
sign a statement listing the changes and the
reasons for making them.

Fed. R. Civ. P. 30(e)(1).
III. Discussion
a.

Rule 702

While a bench trial does not eliminate the need to decide
whether proffered expert opinions meet the requirements of Rule
702, it does allow the court to defer such a determination until
after presentation of the opinions.
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The court has already

determined that it will exercise its discretion to allow other
challenged experts to testify and to admit their testimony
conditionally.

See ECF No. 1282.

The court incorporates its

previous order here and determines that Rafalski should be
allowed to present his opinions subject to the court’s ability
to exclude them, should it turn out that they do not pass muster
under Rule 702.
b.

Errata Sheet

Rafalski submitted an errata sheet that makes several
corrections to his deposition testimony.

Defendants argue that

Federal Rule of Civil Procedure 30(e) does not allow these
changes, characterize the changes (particularly two of them) as
“gamesmanship” (ECF No. 1142, at 9), and ask the court to strike
the errata sheet.
The parties acknowledge that there is no binding precedent
on whether substantive changes are permitted in an errata sheet.
In the context of summary judgment, the Third Circuit has
adopted a case-by-case approach to this question.

See EBC, Inc.

v. Clark Bldg. Sys., Inc., 618 F.3d 253, 268 (3d Cir. 2010).
Until the Fourth Circuit holds differently, this approach is a
sound one.

See Preston v. Grimes, No. 7:19-CV-00243, 2021 WL

150168, at *2 (W.D. Va. Jan. 15, 2021) (“The court is still
persuaded that the case-by-case approach is best.”).

“Although

some authority questions the scope of substantive changes
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permitted under Rule 30(e), the rule itself clearly recognizes
that a deponent may make any ‘changes in form or substance’
which the witness desires.”

Holland v. Cedar Creek Mining,

Inc., 198 F.R.D. 651, 653 (S.D.W. Va. 2001).

In other words,

substantive changes are generally allowed, but the court may
reject them when appropriate.
Rejection of the errata sheet is not called for here.

This

is not a case where “[p]reservation of the original testimony
for impeachment at trial [would] serve[] as cold comfort” to
defendants.

See EBC, 618 F.3d at 268.

The court disagrees that

defendants face the kind of prejudice that would warrant
striking the errata sheet.

Defendants assert that allowing the

errata sheet will “undermine[] [their] ability to examine Mr.
Rafalski” on inconsistencies in his analysis.
9.)

(ECF No. 1173, at

It is not clear how this is so, as “[t]he witness who

changes his testimony on a material matter between the giving of
his deposition and his appearance at trial may be impeached by
his former answers.”

Holland, 198 F.R.D. at 653.

Defendants

can point out the changes, and the trier of fact is free to
accept or reject them. 1
See Creech v. Nguyen, 153 F.3d 719 (4th Cir. 1998) (“The jury
also had before it an errata sheet to Dr. Nguyen's deposition,
which in substance changed his deposition testimony regarding
the presence of the elastic bands on January 11, 1991 from
“still on” to “no” longer still on. Dr. Nguyen told the jury
that he changed his testimony because, upon his subsequent
1

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Defendants also assert that allowing the errata is
prejudicial to their Daubert motion seeking to exclude Rafalski
from testifying at trial.

Again, if both versions of his

answers are available, Rafalski’s alleged misunderstanding
should be apparent.

If Rafalski’s methods are in fact reliable,

his opinions should be admitted regardless of whether he
misspoke in his deposition.
IV.

Conclusion
Defendants find fault with the reliability of Rafalski’s

opinions.

For the reasons expressed above, defendants’ motion

to exclude his opinions (ECF No. 1052) is DENIED without
prejudice.
Defendants also find fault in Rafalski’s errata sheet.

But

if Rafalski had not submitted an errata sheet, and had attempted
to clarify his answers at trial, defendants likely would have
faulted him on that basis.

(See ECF No. 1005-1, at 12 (stating

that another witness had an opportunity to change her testimony
through an errata sheet).)

Certainly, there are cases where

deponents may abuse Rule 30(e).

But because the court is

review of Creech’s medical chart and “certain documents prepared
by Mr. Creech in November of 1990,” he believed his deposition
testimony that the elastic bands were still on as of January 11,
1991 to be inaccurate. Once again, the jury, in weighing the
credibility of the evidence, was entitled to accept or reject
Dr. Nguyen’s explanation for changing his deposition
testimony.”) (citations to record omitted).
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unconvinced that this is one of them, defendants’ motion to
strike the errata sheet (ECF No. 1140) is DENIED.
The Clerk is directed to send a copy of this Memorandum
Opinion and Order to those counsel of record who have registered
to receive an electronic NEF.
IT IS SO ORDERED this 23rd day of April, 2021.
ENTER:
David A. Faber
Senior United States District Judge

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