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United States v. Berkeley Heartlab, Inc.
United States District Court, D. South Carolina, Beaufort Division
December 1, 2017
United States of America, et al., Plaintiffs,
Berkeley Heartlab, Inc., et al, Defendants. ex rel. Scarlett Lutz, et al., Plaintiffs-Relators,
ORDER AND OPINION
RICHARD MARK GERGEL UNITED STATES DISTRICT COURT JUDGE
matter is before the Court on the BlueWave Defendants'
Motion for Clarification (Dkt. No. 763) of this Court's
prior Order on the Government's Motions in Limine (Dkt.
No. 736). The Court has reconsidered and clarified its prior
Order as set forth below.
Motion in Limine, the Government asked the Court to exclude
testimony from physician witnesses not disclosed as expert
witnesses about the medical necessity of laboratory tests.
(Dkt. No. 588.) The Court ruled as follows on that issue:
Under Rule 26(a)(2)B) of the Federal Rules of Civil Procedure
and this Court's Scheduling Order, Defendants were
required to identify and disclose all experts by February 6,
2017, including the subject matter on which the expert was
expected to testify and a summary of the expert's
opinions. The BlueWave Defendants have disclosed and provided
an expert report from Dr. Robert Fishberg on the issue of
medical necessity of laboratory tests. The Government did not
move to exclude Dr. Fishberg. Defendants disclosed no other
experts to testify on the issue of medical necessity. Later,
in their pre-trial disclosures, Defendants identified several
physicians they intend to call at trial, including Dr. Joseph
McConnell, Dr. Tauqueer Alam, Dr. Joe Hollins, Dr. Rex
Butler, Dr. John Eberly, Dr. Samual Fillingane, and Dr.
Szilard Voros. (Dkt. Nos. 563 at 3-4; 583 at 4.) The BlueWave
Defendants also stated that they intended to present the
deposition testimony of Dr. Tara Dall, HDL's former Chief
Medical Officer. Defendants claim that these physicians may
testify as lay witnesses because they are treating
To the extent that these physicians would testify about the
medical necessity of laboratory tests either in routine
clinical practice or for a particular patient, that testimony
is based on "scientific, technical, or other specialized
knowledge" so falls in the category of expert testimony.
FRE 701, 702. The testimony of treating physicians that
involves "diagnosis, prognosis, and future medical care
is opinion testimony that falls under Rule 26(a)(2)(A)'s
expert disclosure requirement." See, e.g., Stogsdill
v. S.C. Dep't of Health & Human Servs., Civ. A.
No. 3:12-0007-JFA, 2017 WL 3142497, *15 (D.S.C. July 25,
2017) (appeal pending); Ingram v. ABC Supply Co.,
Civ. A. No. 3:08-1748-JFA, 2010 WL 233859, *2 (D.S.C. Jan.
14, 2010). If it is true, as Defendants claim, that the
physicians' testimony is "a far cry from utilizing
medical training and expertise to evaluate an individual
patient's symptoms, course of treatment, and medical
history, offer a diagnosis or prognosis..." (Dkt. No.
642 at 15), then the physicians' testimony is not
probative of any material issue in this case.
For these reasons, any probative testimony these physicians
would provide falls under the disclosure requirements of Rule
26. Defendants did not comply with Rule 26, and their
argument that their failure to do so is justified or harmless
fails. Defendants have offered no justification for their
failure to identify these physicians as expert witnesses
earlier, and the Government would be prejudiced by the
introduction of expert testimony for which it had no
opportunity to procure a rebuttal report. While the
Government did have the opportunity to depose some of these
physician witnesses, it did not at the time of those
depositions have notice of the facts and opinions those
physicians would introduce at trial if they testified as
expert witnesses. Because Defendants failed to comply with
Rule 26 and their failure was neither justified nor harmless,
they may not introduce the testimony of these physician
witnesses about the medical necessity of laboratory tests.
Defendants will have the opportunity to introduce the expert
testimony of their [expert] Robert Fishberg about the medical
necessity of laboratory tests, so the Court is not concerned
that its decision to exclude certain testimony from these
physicians is unfairly prejudicial. For the reasons set forth
above, the Government's motion to exclude the physician
testimony discussed in the parties' briefs is granted.
(Dkt. No. 736 at 14-16.)
have asked the Court to clarify or reconsider this portion of
its prior Order to allow them to introduce testimony from
treating physicians regarding their personal knowledge of
essential facts in this case and their reasons for making
diagnosis and treatment decisions for particular patients.
Defendants anticipate that the physicians' testimony
would cover the following issues:
(1) background information on their medical practices,
patient populations and their reasons for ordering lab tests;
(2) Blue Wave's sales and marketing practices; (3)
process and handling (P&H) agreements between the
physicians and labs HDL and/or Singulex; (4) P&H fees
paid to the physicians; (5) waiver of copayments and
deductibles for TRICARE beneficiaries; (6) testing services
and test panels of the labs; (7) the process and handling
work involved to prepare blood samples for shipment; (8)
relationships and communications with the Defendants,
entities owned or controlled by any defendant and sales
representatives; (9) their intent to file, or cause or
conspire with any Defendant to file, fraudulent claims to
Medicare or TRICARE; (10) the impact, if any, of the
Defendants' conduct on the medical judgment of the
physician; (11) topics which the witnesses have information
relevant to the allegations in the United States'
Complaint in Intervention and defendants' Answers
thereto; and, (12) topics which may be brought out in the
Government's case-in-chief of which the witnesses have
(Dkt. No. 763 at 2-3.)
Court has reconsidered its prior Order, specifically its
finding about risk of prejudice to the Government that could
result from allowing Defendants to call these physicians as
trial witnesses. Although the Government had the opportunity
to depose several of these treating physicians, the Court
indicated in its prior Order that the Government would still
be prejudiced because it did not have the opportunity to
review an expert report and procure a rebuttal report.
However, treating physicians are not necessarily required to
provide an expert report under Rule 26 of the Federal Rules
of Civil Procedure:
The requirement of a written report in paragraph (2)(B),
however, applies only to those experts who are retained or
specially employed to provide such testimony in the case or
whose duties as an employee of a party regularly involve the
giving of such testimony. A treating physician, for example,
can be deposed or called to testify at trial without any
requirement for a written report. By local rule, order, or
written stipulation, the requirement of a written report ...