United States District Court, D. Massachusetts
MEMORANDUM AND ORDER REGARDING DEFENDANT'S MOTION
TO COMPEL DISCOVERY (DKT. NO. 37)
KATHERINE A. ROBERTSON, UNITED STATES MAGISTRATE JUDGE
October 21, 2015, Defendant Margaret Luthra, M.D., was
charged in a three count indictment with violating the
Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b)(1)(B)
("AKS") (Count One), wrongfully disclosing
individually identifiable health information, in violation of
42 U.S.C. § 1320d-6(a) (Count Two), and obstructing a
criminal investigation of a health care offense, in violation
of 42 U.S.C. § 1518 (Count Three) (Dkt. No. 3).
Currently pending is Defendant's motion to compel the
government to provide information responsive to eighteen
discovery requests (Dkt. No. 37). Defendant contends that she
is entitled to this information to develop her claims of
selective and vindictive prosecution and to prepare her
defense to the charge that she violated the AKS. The
government objects to Defendant's motion with limited
exceptions (Dkt. No. 44).
consideration of the pleadings and after argument on
September 7, 2016, Defendant's motion to compel discovery
that is material to her defense is allowed in part and denied
in part, and Defendant's motion to compel discovery to
support her claims of selective and vindictive prosecution is
charges against Defendant arose from her relationship with
Warner Chilcott, a pharmaceutical company that sold Actonel
and Atelvia, which are included in a class of drugs known as
bisphosphonates that are prescribed to prevent and treat
osteoporosis (Dkt. No. 3 at ¶¶ 2, 10). The
following facts are drawn from the indictment (Dkt. No. 3).
See United States v. Ngige, 780 F.3d 497, 502 (1st
Cir. 2015) ("When a defendant seeks dismissal of an
indictment, courts take the facts alleged in the indictment
as true . . . .") (quoting United States v.
Savarese, 686 F.3d 1, 7 (1st Cir. 2012)).
was a gynecologist at the Women's Health and Education
Center in Springfield, Massachusetts (id. at ¶
1). Because Defendant "was a high volume prescriber of
bisphosphonates in western Massachusetts, " in October
2010, a Warner Chilcott sales representative ("Sales
Rep. # 1") asked Defendant to participate in Warner
Chilcott's speaker program, which was part of Warner
Chilcott's aggressive campaign to promote sales of
Actonel and Atelvia (id. at ¶¶ 3, 11).
Defendant allegedly agreed to become a speaker at medical
education ("med. ed.") events in her office
(id. at ¶ 11). The government alleges that
these med. ed. events involved Defendant speaking to Sales
Rep. # 1 for about thirty minutes while Defendant ate food
that Sales Rep. # 1 provided to Defendant and her office
staff (id. at ¶ 12). On one occasion, Sales
Rep. # 1 purportedly provided food for a barbeque that
Defendant hosted at her home (id.). Between October
2010 and November 2011, Defendant allegedly received a total
of $23, 500 from Warner Chilcott for speaker training and for
speaking at approximately thirty-one med. ed. events
(id. at ¶¶ 9, 12). In return, Defendant is
alleged to have "significantly increased" the
number of prescriptions that she wrote for Warner
Chilcott's bisphosphonate drugs (id. at ¶
13). However, the number of her prescriptions for these
Warner Chilcott pharmaceuticals dropped sharply after
December 2011 when Sales Rep. # 1 left Warner Chilcott and
Defendant stopped receiving payments (id.).
Medicare, the Federal health care program, paid for some of
Warner Chilcott's drugs that Defendant prescribed
(id. at ¶¶ 4, 9, 13).
"typically identified the drugs that they paid for on
behalf of their members [so-called 'covered drugs']
in a list called a formulary" (id. at ¶
6). If a drug was not covered on formulary, many insurers
required a prior authorization ("PA") from a
physician, explaining the medical necessity for the drug,
before the insurer would pay for it (id. at ¶
a less expensive, generic bisphosphonate was available, the
majority of insurance plans did not include Warner
Chilcott's Atelvia on their formularies and insurers
required a PA to cover it (id. at ¶ 17). When
Warner Chilcott launched Atelvia in January 2011, Defendant,
who allegedly was being paid to speak at Warner
Chilcott's med. ed. programs, began receiving
"numerous" denials from insurance companies for
Atelvia prescriptions (id. at ¶¶ 12, 19).
Defendant allegedly asked Sales Rep. # 1 to assist one of
Defendant's medical assistants in completing PAs to
obtain insurance coverage for Atelvia because their
preparation was time consuming (id. at ¶¶
18, 19). The government alleges that Defendant gave Sales
Rep. # 1 access to her patients' medical records, and
Sales Rep. #1 used them to prepare PAs for Atelvia that
Defendant signed (id. at ¶ 19). These patient
records contained "individually identifiable health
information" or "protected health information"
as defined by the Health Insurance Portability and
Accountability Act (HIPPA) (id. at ¶¶ 5,
HIPPA restricts the disclosure of this private health
information to the patient, the physician and her staff, and
the insurance company (id. at ¶¶ 5, 7).
Defendant was not authorized to disclose the information to
Sales Rep. # 1 (id. at ¶ 15).
February 10, 2014, Special Agents from the Office of the
Inspector General of the United States Department of Health
and Human Services ("HHS"), who were investigating
potential federal health care fraud, questioned Defendant
about her relationship with Warner Chilcott and Sales Rep. #
1 (id. at ¶¶ 21, 22). Defendant allegedly
told the HHS agents that Warner Chilcott paid her to read
studies and to provide her opinion, and that Sales Rep. # 1
assisted with the preparation of PAs, but did not have access
to patients' private medical information (id. at
¶ 22). The government alleges that after Defendant's
interview, she directed her medical assistant, who Sales Rep.
# 1 had assisted in preparing the PAs, to tell the HHS agents
that Sales Rep. #1 did not have access to patients'
records (id. at ¶ 23). Defendant purportedly
repeated this instruction to the medical assistant the next
day and said that "there is a HIPPA law and there would
be hefty fines for them both" if the investigators
learned that they shared medical records with an unauthorized
person (id. at ¶ 24). The HHS investigators
interviewed Defendant again on March 7, 2014 when she
allegedly told them that Warner Chilcott paid her $3, 250 in
2010 for speaker training and $19, 500 in 2011 for reading
abstracts of clinical trials and writing a research paper
(id. at ¶ 25). The government alleges that
Defendant's representations to the investigators were
in criminal cases is left to the trial court's
discretion. See United States v. Lewis, 517 F.3d 20,
23 (1st Cir. 2008). The government has produced automatic
discovery in accordance with Fed. R. Crim. P. 16 and LR
116.1(C) and 116.2. Defendant seeks eighteen categories of
additional discovery to support her claims of selective and
vindictive prosecution and to defend the charge that she
violated the AKS. See Brady v. Maryland, 373 U.S.
83, 86 (1963) (Brady); Fed. R. Crim. P. 16(a)(1)(E).
Each category will be discussed in turn.
alleges that she has been singled out for prosecution
"based on an amalgam" of race, religion, national
origin, and gender -- she is "non-Caucasian, "
Hindu, "of Indian origin, " and female -- and seeks
discovery to support a future motion to dismiss the
indictment for selective prosecution (Dkt. No. 38-1 at 5-6
¶¶ 13, 14, 15). Lewis, 517 F.3d at 26. The
government responds that Defendant is not entitled to
discovery on this basis because she cannot satisfy her
evidentiary burden to demonstrate both the discriminatory
effect of the prosecution and the prosecutor's
discriminatory intent, which are essential to a successful
discovery request. See United States v. Armstrong,
517 U.S. 456, 465 (1996). The government's position is
more persuasive: Defendant fails to make the requisite
showing that entitles her to discovery to support a selective
selective prosecution claim asks the [c]ourt to exercise
judicial power over a core Executive function - the
enforcement of criminal laws." United States v.
Khanu, 664 F.Supp.2d 28, 31 (D.D.C. 2009). "In an
ordinary case, 'so long as the prosecutor has probable
cause to believe that the accused committed an offense
defined by statute, the decision whether or not to prosecute,
and what charge to file or bring before a grand jury,
generally rests entirely in [her] discretion.'"
United States v. Mathur, No. 2:11-cr-00312-MMD-PAL,
2012 WL 3135532, at *3 (D. Nev. Aug. 1, 2012) (quoting
Bordenkircher v. Hayes, 434 U.S. 357, 364 (1978)).
"A prosecutor's discretion is, however, subject to
constitutional limits such as the equal protection component
of the Fifth Amendment's Due Process Clause, which
prohibits a prosecutor from making decisions based on race,
religion, or other arbitrary classifications."
Khanu, 664 F.Supp.2d at 31 (citing
Armstrong, 517 U.S. at 464). See also Wayte v.
United States, 470 U.S. 598, 608 (1985).
order to dispel the presumption that a prosecutor has not
violated equal protection, a criminal defendant must present
'clear evidence to the contrary.'"
Armstrong, 517 U.S. at 465 (quoting United
States v. Chem. Found., Inc., 272 U.S. 1, 14-15 (1926)).
"Carrying this burden entails a binary showing: the
defendant must adduce clear evidence of both  the
discriminatory effect of the prosecution and  the
prosecutor's discriminatory intent." Lewis,
517 F.3d at 25 (citing Armstrong, 517 U.S. at 465).
See also Khanu, 664 F.Supp.2d at 31 ("The
defendant must show both (1) that he was singled out for
prosecution from others similarly situated and (2) that his
prosecution was motivated by a discriminatory purpose.")
(citing United States v. Palfrey, 499
F.Supp.2d 34, 39 (D.D.C. 2007)). "[T]he standard is a
demanding one." Armstrong, 517 U.S. at 463.
For this purpose, the evidence in support of the asserted
discriminatory effect must comprise a credible showing that
similarly situated individuals who do not share the protected
characteristic were not prosecuted. Similarly, the evidence
in support of the asserted discriminatory intent must consist
of a credible showing that the government chose to prosecute
"at least in part because of, not merely in spite of,
" the defendant's protected characteristic.
Lewis, 517 F.3d at 25 (internal citations omitted).
obtain discovery to support a selective prosecution claim,
the defendant must present "'some evidence'
tending to show both discriminating effect and discriminatory
intent." Lewis, 517 F.3d at 25 (quoting
Armstrong, 517 U.S. at 468). See also Attorney
Gen. v. Irish People,Inc.,684 F.2d 928, 932
(D.C. Cir. 1982) (holding that defendant must make a
colorable showing of both selectivity and improper motivation
to obtain discovery). "Just as the standard for
ultimately proving a selective prosecution claim is a
rigorous one, so too is the evidentiary threshold for
obtaining discovery from the government to support such a
claim." United States v. Olvis, 97 F.3d 739,
743 (4th Cir. 1996) (citing Armstrong, 517 U.S. at
468). "A significant barrier to discovery is necessary
because discovery 'imposes many of the costs present when
the Government must respond to a prima facie case of
selective prosecution'; it diverts governmental resources
and discloses prosecutorial strategies." Id.
(quoting Armstrong, 517 U.S. at 468). "It