Rosen v. Exact Sciences Corporation et al

Filing 101

ORDER denying without prejudice 85 Motion to Compel. Signed by Magistrate Judge Amanda Arnold Sansone on 2/2/2023. (SFC)

Case 8:19-cv-01526-MSS-AAS Document 101 Filed 02/02/23 Page 1 of 5 PageID 1706

UNITED STATES DISTRICT COURT
MIDDLE DISTRICT OF FLORIDA
TAMPA DIVISION
UNITED STATES OF AMERICA
ex rel. NILES ROSEN, M.D.,
v.

Plaintiff,

Case No. 8:19-cv-1526-MSS-AAS

EXACT SCIENCES CORPORATION
and EXACT SCIENCES
LABORATORIES, LLC,
Defendant.
______________________________________/
ORDER
Plaintiff United States of America ex rel. Niles Rosen, M.D. (collectively,
the plaintiffs) move to compel documents and testimony from Defendants
Exact

Sciences

Corporation

and

Exact

Sciences

Laboratories,

LLC

(collectively, Exact Sciences). (Doc. 85). Exact Sciences responds in opposition.
(Doc. 87).
I.

BACKGROUND
The plaintiffs initiated this qui tam action on June 29, 2019, alleging

Exact Sciences violated the False Claims Act (FCA) through its violation of the
Anti-Kickback Statute (AKS), 42 U.S.C. § 1320. (Doc. 1). The plaintiffs allege
Exact Sciences offered illegal kickbacks through their Patient Compliance
Program (PCP), wherein Exact Sciences offered $75 Visa gift cards to patients

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in exchange for their use of Cologuard, a colon cancer screening exam. (Id. at
¶ 48–65).
On September 26, 2022, the court denied Exact Sciences’ motion to
dismiss. (Doc. 78). Exact Sciences filed its answer on October 24, 2022. (Doc.
80). The plaintiffs now move to compel Exact Sciences to “produce all evidence
relevant to the subject matter of Exact Sciences’ alleged ‘good faith belief’ that
their actions with respect to offering and paying incentives to induce patients
to order their product were lawful,” or in the alternative “[prohibit] Exact
Sciences, their witnesses, and current or former employees from contending
they had a good faith belief the program was legal.” (Doc. 95, Ex. 1, pp. 20–21).
II.

LEGAL STANDARD
A party may obtain discovery about any nonprivileged matter relevant

to any party’s claim or defense and proportional to the needs of the case. Fed.
R. Civ. P. 26(b)(1). Discovery helps parties ascertain facts that bear on issues.
ACLU of Fla., Inc. v. City of Sarasota, 859 F.3d 1337, 1340 (11th Cir. 2017)
(citations omitted).
A party may move for an order compelling discovery from the opposing
party. Fed. R. Civ. P. 37(a). The party moving to compel discovery has the
initial burden of proving the requested discovery is relevant and proportional.
Douglas v. Kohl’s Dept. Stores, Inc., No. 6:15-CV-1185-Orl-22TBS, 2016 WL
1637277, at *2 (M.D. Fla. Apr. 25, 2016) (quotation and citation omitted). The
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responding party must then specifically show how the requested discovery is
unreasonable or unduly burdensome. Panola Land Buyers Ass’n v. Shuman,
762 F.2d 1550, 1559–60 (11th Cir. 1985).
III.

ANALYSIS
In Exact Sciences’ motion to dismiss (Doc. 38), Exact Sciences argued at

length that the plaintiffs could not meet their burden of showing Exact
Sciences acted with the proper intent in violating the AKS: that is, that Exact
Sciences’ “violation ‘was committed voluntarily and purposely, with the specific
intent to do something the law forbids, that is with a bad purpose, either to
disobey or disregard the law.’” (Doc. 38, p. 14) (citing United States v. Vernon,
723 F.3d 1234, 1256 (11th Cir. 2013)). Exact Sciences specifically argues it had
a “good faith belief” that its operation of the PCP was lawful. (Doc. 38, pp. 15–
21).
On the basis of this argument from Exact Sciences’ motion to dismiss, a
handful of similar quotes from Exact Sciences executives, and a request for an
advisory opinion by the Health and Human Services’ Department’s Office of
the Inspector General, the plaintiffs request a court order finding a blanket
waiver of Exact Sciences’ attorney-client privilege objections. See (Doc. 95, Ex.
1, p. 20) (requesting the court’s order “encompass, but not be limited to, those
documents identified in Exhibit L” and “extend to witness testimony, both
previously taken as well as future testimony”). The plaintiffs argue that by
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raising the issue of their good faith belief in the legality of their actions, Exact
Sciences raised the issue of “its belief in the lawfulness of its conduct” such
that “any attorney-client privilege claims shielding relevant evidence” have
been duly waived. (Doc. 95, Ex. 1, p. 14).
As a general rule, a party “waives the [attorney-client] privilege if it
injects into the case an issue that in fairness requires an examination of
otherwise protected communications.” Cox v. Administrator, U.S. Steel &
Carnegie, 17 F.3d 1386, 1419 (11th Cir. 1994). “Injecting” an issue into
litigation in this context means “when a litigant ‘place[s] information protected
by it in issue through some affirmative act for his own benefit, and to allow the
privilege to protect against disclosure of such information would be manifestly
unfair to the opposing party.’” Conkling v. Turner, 883 F.2d 431, 434–435 (5th
Cir. 1989) (citing Hearn v. Rhay, 68 F.R.D. 574, 581 (E.D. Wash. 1975)).
Exact Sciences argues it has not injected the issue of its good-faith belief
in the legality of the PCP, and instead “merely den[ied] an element relating to
[its] mental state.” (Doc. 87). Exact Sciences is correct insofar as its answer
(Doc. 80) does not specifically plead good faith as an affirmative defense and
that denials of intent “without more . . . do not amount to a waiver of the
[attorney-client privilege] protections.” Centennial Bank v. ServisFirst Bank,
Inc., No. 8:16-cv-88-T-36CPT, 2020 WL 1061450, at *2 (M.D. Fla. Mar. 4, 2020).
However, as previously noted, Exact Sciences devotes six pages and two
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subsections of its motion to dismiss on the exact contention that “Exact
Sciences had a Good Faith Belief that its [PCP] Complied with the Law.” (Doc.
38, pp. 15, 18). In denying Exact Sciences’ motion to dismiss, the court
acknowledged Exact Sciences “argue[d] it had a good faith belief that its [PCP]
complied with the law and thus lacked the requisite intent for a violation of
the AKS.” (Doc. 78, p. 11).
Thus, Exact Sciences has certainly raised the issue of its good-faith belief
in the legality of its conduct. Despite this, because Exact Sciences answer and
affirmative defenses do not further allege Exact Sciences had a good-faith
belief in the legality of their conduct, the undersigned concludes compelling a
blanket waiver of attorney-client privilege would be manifestly unfair at this
time.
The plaintiffs’ Motion to Compel (Doc. 85) is thus DENIED without
prejudice.
ORDERED in Tampa, Florida on February 2, 2023.

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