UNITED STATES OF AMERICA et al v. JOHNSON & JOHNSON et al

Filing 294

MEMORANDUM OPINION filed. Signed by Judge Zahid N. Quraishi on 1/10/2022. (jem)

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NOT FOR PUBLICATION

UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY

UNITED STATES OF AMERICA, et al., ex
rel. JESSICA PENELOW and CHRISTINE
BRANCACCIO,
Plaintiffs,
Civil Action No. 12-7758 (ZNQ) (LHG)
v.
MEMORANDUM OPINION
JANSSEN PRODUCTS, LP,
Defendant.
QURAISHI, District Judge
This matter comes before the Court upon several motions to exclude opinions and
testimony filed by Janssen Products, LP (“Janssen”), and Relators Jessica Penelow and Christine
Brancaccio (collectively, “Relators”). The parties seek to exclude expert reports and testimony
under the admissibility requirements of Federal Rule of Evidence 702 and the principles espoused
in Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993). The Court has carefully considered
the parties’ submissions and decides the matter without oral argument pursuant to Federal Rule of
Civil Procedure 78 and Local Civil Rule 78.1. For the reasons set forth below, the parties’ motions
to exclude expert testimony will be granted in part and denied in part.

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I.

BACKGROUND & PROCEDURAL HISTORY
On December 18, 2012, Relators1 filed this action on behalf of the federal government,

twenty-six states, and the District of Columbia (collectively, “Government Plaintiffs”) alleging
fifty-six counts under the Federal False Claims Act (“FCA”), the Federal Anti-Kickback Statute
(“AKS”), and the false claims acts of various states. (ECF No. 1.) The United States and certain
States declined to intervene. (ECF Nos. 46, 48, 55.) On October 3, 2016, Johnson & Johnson
(“J&J”) and Janssen filed Motions to Dismiss. (ECF Nos. 56, 57.) On May 31, 2017, the Court
granted in part and denied in part Janssen’s motion but dismissed all claims against J&J. (ECF
Nos. 86, 87.) Relators subsequently filed the Second Amended Complaint on June 30, 2017.
(“Second Am. Compl.,” ECF No. 90.) On October 14, 2020, Janssen filed a Motion for Summary
Judgment. (“Summary Judgment,” ECF No. 187.) Around the same time, Relators and Janssen
filed several motions to exclude expert testimony and opinions. (ECF Nos. 179, 181, 183, 192,
194, 196, 198, 200, 202.) Thereafter, the Court stayed the matter to afford the parties the
opportunity to attend private mediation, but the mediation was not successful. (ECF Nos. 233,
236.)
The claims in this action arise from Janssen’s purported kickback scheme and off-label
(“OL”) promotion of two HIV/AIDS drugs: Prezista and Intelence. (Second Am. Compl. at 1–2.)
With respect to Prezista, Relators allege that Janssen, through its sales representatives and
managers, delivered false and misleading messages to physicians by: (1) promoting Prezista as
“lipid neutral”; and (2) misstating Prezista’s superiority, efficacy, and potency based on the

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Between 2006 and 2013, Relator Jessica Penelow worked as a sales consultant for Tibotec Therapeutics, a subsidiary
of Johnson & Johnson that became known as Janssen in 2011. (“Second Am. Compl.” ¶ 47, ECF No. 90.) While
working for Tibotec, she marketed several HIV drugs, including Prezista and Intelence, to doctors in Manhattan. (Id.)
Similarly, in 2006, Relator Christine Brancaccio started working for Janssen as a sales representative and marketed
Prezista and Intelence to providers in Long Island and Queens. (Id. ¶ 49.)

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uniqueness of its “binding affinity.” (Id. ¶¶ 2, 105.) Relators claim Prezista presents a serious risk
of cardiovascular disease because Prezista increases lipids, such as cholesterol and triglycerides.
(Id. ¶¶ 3–4, 106–08.) They allege Janssen misrepresented that Prezista “would not affect or
increase a patient’s cholesterol or triglyceride levels, which is directly contradicted by the FDAapproved label for Prezista.” (Id. ¶¶ 3, 106.) Relators also allege Janssen misrepresented Prezista
as having superior “binding affinity,” which prevents HIV from mutating and becoming resistant.
(Id. ¶¶ 6, 126.) Furthermore, Relators contend Janssen’s representations about Prezista’s superior
binding affinity were based on a clinical study that was of limited scientific value and was not
included in the drug’s FDA-approved labeling. (Id.) Relators allege numerous instances where
Janssen sales representatives and managers misrepresented Prezista’s effect on lipids and its
superior binding affinity. (Id. ¶¶ 124–25, 137, 183.) The OL promotion concerning Prezista as a
lipid-neutral drug began in 2006 and continued through approximately 2014, and the OL
promotion concerning its superior “binding affinity” began around 2007 and continues through
present. (Id. ¶¶ 4–5, 106, 126.)
As for Intelence, Relators allege that Janssen, through its sales representatives and
managers, provided false and misleading statements to physicians by marketing the drug as safe
and effective for: (1) once-daily dosage; and (2) safe and effective for “treatment-naïve patients,”
which refers to patients who have never taken any antiretroviral medication. (Id. ¶ 9.) Relators
allege Janssen promoted Intelence for once-daily dosing, contrary to its FDA-approved label
specifying twice-daily dosing. (Id. ¶ 10.) This is significant because “if a patient does not carefully
follow the FDA-indicated dosing drug regimen, their HIV viral load can increase, potentially
weakening the drug’s ability to fight the disease.” (Id.) In addition, Relators allege that Intelence
was “only indicated for treatment-experienced patients,” not treatment-naïve patients. (Id. ¶ 11.)

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Prescribing Intelence to treatment-naive patients is harmful because it could prematurely “cause
[them] to run out of drug options as their diseases progresses.” (Id. ¶ 12.) Relators allege
numerous instances where Janssen sales representatives and managers engaged in OL promotion
concerning Intelence “from the time of its launch in 2008, continuing through September 2014.”
(Id. ¶¶ 150, 154, 159.)
Relators allege that Janssen’s OL “marketing of Prezista and Intelence was widespread.”
(Id. ¶¶ 13, 160.) According to Relators, Janssen instructed its national sales force to market the
drugs OL during pod calls, district calls, district meetings, trial meetings, and plan of action
meetings. (Id. ¶¶ 161–78.) During these calls and meetings, upper management and district
managers encouraged OL marketing, and sales representatives from different districts to share
sales strategies and tips about marketing Intelence and Prezista OL. (Id. ¶¶ 162–64.) As a result,
Janssen representatives engaged in OL marketing during sales calls with physicians, dinner
programs, and Speaker Programs. (Id. ¶¶ 13, 179–205.) In addition, Relators claim the Speaker
Programs amounted to kickbacks in violation of the AKS because Janssen paid speakers at the
dinner programs. (Id. ¶¶ 13, 71.) According to Relators, the physician-speakers were paid an
increasing honorarium based on the number of prescriptions they wrote and their market share of
the drugs, which Janssen calculated by determining the percentage of Janssen drugs a doctor
prescribed as compared to non-Janssen drugs in the same class. (Id.)
Relators allege that Janssen knowingly and misleadingly influenced physicians’ medical
judgments through its OL promotion of Prezista and Intelence. (Id. ¶ 15.) Moreover, they allege
Janssen knew the Government Plaintiffs reimbursed a substantial portion of Prezista and Intelence
prescriptions. (Id. ¶ 16.) Because a significant percentage of HIV/AIDS patients are enrolled in

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Medicaid and Medicare, Janssen allegedly caused claims tainted by the OL marketing and
kickback schemes to be submitted to the Government Plaintiffs for reimbursement. (Id.)
II.

LEGAL STANDARD
Federal Rule of Evidence 702 governs the admissibility of expert testimony and provides:
A witness who is qualified as an expert by knowledge, skill,
experience, training, or education may testify in the form of an
opinion or otherwise if:
(a) the expert’s scientific, technical, or other specialized knowledge
will help the trier of fact to understand the evidence or to determine
a fact in issue;
(b) the testimony is based on sufficient facts or data;
(c) the testimony is the product of reliable principles and methods;
and
(d) the expert has reliably applied the principles and methods to the
facts of the case.

Fed. R. Evid. 702. “Rule 702 embodies three distinct substantive restrictions on the admission of
expert testimony: qualification, reliability, and fit.” Karlo v. Pittsburgh Glass Works, LLC, 849
F.3d 61, 80 (3d Cir. 2017) (quoting Elcock v. Kmart Corp., 233 F.3d 734, 741 (3d Cir. 2000)).
The party offering the expert testimony bears the burden of establishing the existence of each
factor by a preponderance of the evidence. In re TMI Litig., 193 F.3d 613, 665 (3d Cir. 1999),
amended by 199 F.3d 158 (3d Cir. 2000).
The Third Circuit has “interpreted Rule 702’s qualification requirement liberally.” Pineda
v. Ford Motor Co., 520 F.3d 237, 244 (3d Cir. 2008) (citing Schneider ex rel. Est. of Schneider v.
Fried, 320 F.3d 396, 404 (3d Cir. 2003); In re Paoli R.R. Yard PCB Litig., 35 F.3d 717, 741 (3d
Cir. 1994)). A “broad range of knowledge, skills, and training qualify an expert as such.” Paoli,
35 F.3d at 741. Because both the “substantive” and “formal” qualifications of an expert are viewed

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liberally, the Third Circuit has “eschewed imposing overly rigorous requirements of expertise and
[has] been satisfied with more generalized qualifications.” Id. Therefore, “[i]f the expert meets
[the] liberal minimum qualifications, then the level of the expert’s expertise goes to credibility and
weight, not admissibility.” Kannankeril v. Terminix Int’l, Inc., 128 F.3d 802, 809 (3d Cir. 1997)
(citation omitted). “[I]t is an abuse of discretion to exclude testimony simply because the trial
court does not deem the proposed expert to be the best qualified or because the proposed expert
does not have specialization that the court considers most appropriate.” Pineda, 520 F.3d at 244
(alteration in original) (quoting Holbrook v. Lykes Bros. S.S. Co., 80 F.3d 777, 782 (3d Cir. 1996)).
However, while “background, education, and training may provide an expert with general
knowledge to testify about general matters, more specific knowledge is required to support more
specific opinions.” Calhoun v. Yamaha Motor Corp., U.S.A., 350 F.3d 316, 322 (3d Cir. 2003).
As for the “reliability” requirement, the Third Circuit has interpreted reliability “to mean
that an expert’s testimony is admissible so long as the process or technique the expert used in
formulating the opinion is reliable.” Pineda, 520 F.3d at 244 (internal quotations omitted) (quoting
Paoli, 35 F.3d at 742). Rule 702 imposes a “gatekeeping” obligation on the trial court to “ensure
that any and all scientific testimony or evidence admitted is not only relevant, but reliable.”
Daubert, 509 U.S. at 598; see also Kumho Tires Co., Ltd. v. Carmichael, 526 U.S. 137, 147 (1999)
(gatekeeping obligation “applies to all expert testimony”). The purported expert’s testimony “must
be based on the ‘methods and procedures of science’ rather than on ‘subjective belief or
unsupported speculation’; the expert must have ‘good grounds’ for his [or] her belief.” Schneider,
320 F.3d at 404 (citation omitted). Admissibility turns “on the expert’s methods and reasoning;
credibility decisions arise after admissibility has been determined.” Kannankeril, 128 F.3d at 806.

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“The evidentiary requirement of reliability is lower than the merits standard of correctness.” Paoli,
35 F.3d at 744.
To satisfy the “fit” requirement, “the expert’s testimony must be relevant for the purposes
of the case and must assist the trier of fact.” Schneider, 320 F.3d at 404. The expert testimony
meets the “fit” requirement when it “help[s] the trier of fact to understand the evidence or to
determine a fact in issue . . . .” Fed. R. Evid. 702. “Expert testimony which does not relate to any
issue in the case is not relevant and, ergo, non-helpful.” Daubert, 509 U.S. at 591 (citation
omitted). “Rule 702’s ‘helpfulness’ standard requires a valid scientific connection to the pertinent
inquiry as a precondition to admissibility.” Id. at 591–92. The Third Circuit has also instructed
that:
A judge frequently should find an expert’s methodology helpful
even when the judge thinks that the expert’s technique has flaws
sufficient to render the conclusions inaccurate. He or she will often
still believe that hearing the expert’s testimony and assessing its
flaws was an important part of assessing what conclusion was
correct . . . .
Paoli, 35 F.3d at 744–45. See Heller v. Shaw Indus. Inc., 167 F.3d 146, 152–53 (3d Cir. 1999)
(finding the trial court should admit expert testimony “if there are ‘good grounds’ for the expert’s
conclusion” even if the court believes “there are better grounds for some alternative conclusion”).
Notably, the court also “must ensure that an expert does not testify as to the governing law
of the case.” Berckeley Inv. Grp., Ltd. v. Colkitt, 455 F.3d 195, 217 (3d Cir. 2006). In Berckeley,
the Third Circuit explained that “the line between admissible and inadmissible expert testimony
as to the customs and practices of a particular industry often becomes blurred when the testimony
concerns a party’s compliance with customs and practices that implicate legal duties.” Id. at 218.
“Although Federal Rule of Evidence 704 permits an expert witness to give expert testimony that
‘embraces an ultimate issue to be decided by the trier of fact,’ an expert witness is prohibited from
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rendering a legal opinion.” Id. at 217 (quoting United States v. Leo, 941 F.2d 181, 195–96 (3d
Cir. 1991)).
III.

DISCUSSION
Janssen moves to exclude certain opinions and testimony of the following experts: James

T. O’Reilly, George P. Sillup, Kenneth W. Schafermeyer, Aaron E. Glatt, Virginia B. Evans, Israel
Shaked, and Ian Dew. (ECF Nos. 192, 194, 196, 198, 200, 202.) Relators move to exclude certain
opinions and testimony of the following rebuttal experts: Jon Smollen, Anupam Jena, and Eric S.
Rosenberg. (ECF Nos. 179, 181, 183.) The Court addresses each expert in turn.
A. Janssen’s Motion to Exclude the Testimony of James T. O’Reilly
Janssen filed a motion to exclude the expert report and testimony of James T. O’Reilly,
(“O’Reilly Motion,” ECF No. 192), along with a brief in support of the Motion, (“O’Reilly Moving
Br.,” ECF No. 192-1). Relators opposed the Motion, (“O’Reilly Opp’n Br.,” ECF No. 282), to
which Janssen replied (“O’Reilly Reply,” ECF No. 251). Relators identified O’Reilly as an expert
in FDA law, regulatory issues under the FCA, and government reimbursement. (Chuderewicz
Decl., Ex. A, ECF No. 194-3.)
According to Janssen, the problematic nature of O’Reilly’s expected testimony becomes
evident as early as the third paragraph of his opinion, where he summarizes his conclusion:
In my opinion, based on the evidence and my education and
professional experience, Janssen misbranded Prezista and Intelence
and engaged in off[-]label marketing of the drugs that was contrary
to their FDA-approved labels, and, thus, the claims submitted to the
government healthcare programs for these drugs were false because
they were ineligible for reimbursement. Further, this conduct was
material to the government’s payment decision for reimbursement
of claims for Prezista and Intelence.
(Chuderewicz Decl., Ex. A, “O’Reilly Report” ¶ 3, ECF No. 263.) Janssen counts three legal
conclusions in that statement alone. (O’Reilly Moving Brief at 1, 4.) Beyond these concerns as
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to potentially improper legal advocacy, Janssen challenges O’Reilly’s opinions on the grounds that
they believe “he is not qualified to offer any non-legal opinions about the marketing of Intelence
and Prezista or about government reimbursement for Intelence and Prezista prescriptions,” and
Janssen contends “he does not tie any non-legal opinions to reliable principles or methods.”
(O’Reilly Moving Br. at 2–10.)
In opposition, Relators maintain that O’Reilly does possess the necessary qualifications
and that his opinions are reliable. (O’Reilly Opp’n Br. at 2.) Relators argue that O’Reilly’s
opinions “are grounded in well-supported citations to relevant authority.” (Id. at 11.) His “report
meets [the good grounds] standard and contains detailed citations to the relevant statutes,
regulations, guidelines, policy documents, etc. relevant to his opinions regarding the government
regulatory scheme at issue in this case.” (Id.) They note that O’Reilly has the educational,
academic, and industry background to explain FDA and Centers for Medicare & Medicaid
Services (“CMS”) regulatory issues. (Id. at 10.) In addition, with respect to Janssen’s argument
that O’Reilly provided a legal opinion, Relators fault Janssen for focusing on O’Reilly’s
conclusion while ignoring the rest of his opinion that explains the complex regulatory environment
at issue in this case. (Id. at 12.) They cite instances where other courts have allowed experts to
opine about the complex Medicare regulatory scheme. (Id. at 13.) Relators have their own view
of what constitutes inadmissible legal conclusions: they insist that O’Reilly’s opinions are proper
because “they do not go to the ultimate issue to be decided by the jury in the case,” i.e., whether
Janssen is liable. (Id. at 15.) Relators temper their position by proposing that the Court defer
assessing the admissibility of O’Reilly’s potentially legal testimony until trial when there is more
context and after hearing Janssen’s objections. (Id. at 15 n.1.)

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In its reply, Janssen focuses on O’Reilly’s testimony regarding intent, stating that it is
inadmissible legal advocacy. (Id. at 4.) Janssen emphasizes that “O’Reilly intends to instruct the
jury on what the law requires and to tell the jury that Janssen violated the law.” (O’Reilly Reply
at 1.) It argues that “[i]nstructing the jury on what the law requires is exclusively within the
province of this Court.” (Id. at 3.) Furthermore, Janssen argues that O’Reilly is not qualified to
reliably opine on matters because his experience is unrelated to the opinion he intends to offer.
(Id. at 6–7.)
The Court has reviewed O’Reilly’s qualifications. He has advised on over-the-counter
drug, pharmaceutical, and medical device issues, taught an FDA course as an adjunct law professor
for twenty-five years, and currently chairs the FDA committee of the American Bar Association
(“ABA”). (O’Reilly Report ¶ 7.) He teaches medical and public health for graduate students at
the University of Cincinnati, College of Medicine, and he has authored over 50 textbooks and 220
articles. (Id. ¶ 5; see also Id. ¶¶ 4–9.) He has also authored the drugs chapter of the special
textbook on AIDS for the ABA’s Coordinating Committee on AIDS. (Id. ¶ 8.) O’Reilly can be
reasonably characterized as a lawyer with a specialization in healthcare public policy. (Id. at 41–
49.) Thus, based on his education and experience, the Court finds that O’Reilly satisfies the liberal
minimum qualifications required for expert testimony admissibility. Paoli, 35 F.3d at 741. He is,
therefore, qualified to speak on general topics concerning FDA regulations and reimbursement.
Likewise, his experience is sufficient to render his testimony “reliable.” Pineda, 520 F.3d at 244
Notwithstanding his qualifications, the question of “fit” remains.

The Court must

determine whether O’Reilly’s testimony will help the trier of fact. Berckeley, 455 F.3d at 217.
This determination necessarily includes ensuring that he will not provide improper legal opinions
that will intrude on the Court’s role in explaining the law to the jury. Berckeley, 455 F.3d at 218.

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Although experts can testify about business customs and background information that they have
developed through their personal experience and expertise, they cannot give opinions “as to what
was required under the law, or whether the defendant complied with the [law].” Id. (quoting Leo,
941 F.2d at 196–97); see also Casper v. SMG, 389 F. Supp. 2d 618, 621 (D.N.J. 2005)). In
Berckeley, the Third Circuit confirmed that an expert, a former SEC lawyer with experience in the
crucial matter in the case, could testify about customs and business practices in the securities
industry at the time the parties entered into their contested agreement. 455 F.3d at 218. However,
the Third Circuit reversed the district court’s decision to permit the expert to testify regarding the
defendant’s compliance with legal duties that arose under the federal securities laws because such
testimony represented improper legal opinions. Id.
As a first matter, and consistent with Berckeley, the Court rejects Relators’ proposed
“ultimate issue” test for the admissibility of the portions of O’Reilly’s testimony that verge on
legal opinion. 455 F.3d at 217. “Ultimate issue” is inconsistent with the rules of evidence. Rule
704 expressly states that “[a]n opinion is not objectionable just because it embraces an ultimate
issue.” The correct question in this context is whether, and to what extent, O’Reilly’s opinion
attempts to introduce improper legal testimony.
The Court has reviewed O’Reilly’s report and finds acceptable those portions that provide
background information regarding the drug approval process, misbranding in general, and the
mechanism by which the government reimburses for prescriptions. Such background information
could be helpful to the jury. Likewise, O’Reilly’s observations regarding Janssen’s compliance
efforts could also prove helpful. Unfortunately, however, his report quickly devolves into his
opinion as to legal issues. These include but are not limited to: how Janssen’s activities constituted
OL promotion and therefore misbranding, (O’Reilly Rep. ¶¶ 29–34, 47–49); Janssen’s purportedly

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purposeful manipulation of Medical Information Requests, (id. ¶¶ 40, 42); how Janssen’s OL
promotion can form the basis for a violation of the FCA, (id. ¶¶ 61–62, 70); and the legal test for
materiality and its application, (id. ¶¶ 71, 73, 84–85). Because these portions of the O’Reilly
report, and others like them, risk usurping the Court’s primary role in articulating the law to the
jury, the Court will exclude them. Under the circumstances, Relators’ proposal that the Court
defer its decision as to admissibility until trial is unsatisfactory. There are likely to be close cases
requiring an admissibility determination at trial, but permitting O’Reilly to testify, in the first
instance, as to what are clearly legal opinions would be prejudicial to Janssen. For these reasons,
Janssen’s motion to exclude the testimony of James T. O’Reilly will be granted in part and denied
in part.
B. Janssen’s Motion to Exclude Certain Opinions of George P. Sillup
Janssen filed a motion to exclude the testimony of George P. Sillup, (“Sillup Motion,” ECF
No. 194), along with a brief in support of the Motion, (“Sillup Moving Br.,” ECF No. 194-1).
Relators opposed the Motion, (“Sillup Opp’n Br.,” ECF No. 284), to which Janssen replied,
(“Reply,” ECF No. 249). Relators identified Sillup as an expert in pharmaceutical marketing
issues relating to Janssen’s marketing of Prezista and Intelence, and its Speaker Programs.
(Chuderewicz Decl., Ex. A, ECF No. 194-3; Sillup Opp’n Br. at 4.) Sillup’s report provides the
following summary of the opinion he intends to offer at trial:
In my professional opinion and based on my understanding of the
impact of pharmaceutical marketing and my review of the
evidentiary record, I believe that Janssen’s widespread and topdown campaign of off-label marketing for Prezista and Intelence
was a substantial factor in driving the volume of OL prescribing for
Prezista and Intelence.
(Chuderewicz Decl., Ex. B, “Sillup Report” at 8, ECF No. 264.) Sillup organized his report in two
sections: (1) Janssen’s management took multiple actions to facilitate or encourage OL marketing
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(“Marketing Opinion”), and (2) the increased numbers of OL scripts were the foreseeable and
intended result of Janssen’s OL marketing (“Causation Opinion”). (Id. ¶¶ 36–134).
Janssen argues that Sillup’s Marketing and Causation Opinions are inadmissible because
he does not tie the opinions to any reliable principles and methods. (Sillup Moving Br. at 2, 7.)
Janssen also contends that Sillup’s Causation Opinion is inadmissible because “he is not qualified
to offer it” and the opinion “is an impermissible legal opinion.” (Id. at 4–7.)
In opposition, Relators argue that “Sillup is qualified to offer all of his opinions, and his
opinions are reliable.” (Sillup Opp’n Br. at 8.) Relators explain that, in analyzing and evaluating
Janssen’s marketing conduct, Sillup “reviewed extensive evidence in the case and broke down his
conclusions into multiple prongs that a jury can readily follow and assess.” (Id. at 12.) He
analyzed highly technical documents, such as the FDA-approved labels for Prezista and Intelence,
the eligible patient population, and Janssen’s sales forecasts. (Id. at 12.) Relators also argue that
Sillup’s opinion concerning causation “is both within [his] expertise and reliably based on his
experience in pharmaceutical marketing, from both the academic and industry perspectives.” (Id.
at 20.) They note that Sillup has the educational, academic, and industry background to explain
the marketing surveys Janssen commissioned. (Id. at 22.) In addition, with respect to Janssen’s
argument that Sillup provided a legal opinion, Relators argue that courts have allowed
pharmaceutical marketing experts to opine about OL marketing campaigns as a “significant
contributing factor” to OL sales. (Id. at 22–23.) In the alternative, Relators contend the phrase
“substantial factor,” the term Sillup used in his report, is a common phrase such that “its use does
not take [his] expert opinions into the realm of legal conclusions.” (Id. at 23.)
In its reply, Janssen reiterates that Sillup’s Marketing Opinion “usurps the role of the jury
and is untethered from reliable principles and methods.” (Sillup Reply at 2–4.) Janssen likewise

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reiterates that “Sillup’s Causation Opinion is inadmissible because it impinges on the role of the
jury, . . . he is unqualified to opine on what caused doctors to prescribe HIV medications for HIV
patients, . . . [and] he fails to apply reliable causation methodology.” (Id. at 5–8.)
Sillup is a Professor in the Pharmaceutical & Healthcare Marketing Department at St.
Joseph’s University and served as chair of the Department from 2010 through 2017. (Sillup Report
¶¶ 4, 5; Sillup Report at 79.) Sillup holds an M.S. in Human Behavior and Development and a
Ph.D. in Human and Organizational Structures. (Sillup Report ¶ 6; Sillup Report at 78.) He
teaches courses on pharmaceutical marketing, publishes on the topic, and provides marketing
consulting for pharmaceutical companies. (Sillup Report ¶ 5.) His research focuses on strategic
planning, forecasting, market practices of pharmaceutical companies, and the effects of those
practices on prescription medications. (Id.) Notably, he “transitioned to academia full time in
2004 after working 28 years in the pharmaceutical, diagnostic and medical device industry.” (Id.
¶ 4.) While working in the pharmaceutical industry, he held positions from salesman to Chief
Operating Officer and “guided numerous product launches for drugs and devices, which included
developing product forecasts, marketing materials and sales training program to support products”
across the United States and global market. (Id.) The Court finds that Sillup’s qualifications are
substantial.
According to Sillup, Relators retained him to opine on the following issues: (1) how
pharmaceutical manufacturers promote the sale and use of drugs, especially when there are
competing drugs in the market; (2) whether Janssen’s management facilitated or encouraged the
OL marketing done by its sales force and the paid speakers; and (3) whether Janssen’s OL
promotion and conduct a significant contributing factor in causing physicians to prescribe Prezista
and Intelence for OL uses. (Id. ¶¶ 8–9.) In reaching his Marketing and Causation Opinions, Sillup

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assessed Janssen’s strategic corporate documents, financial records, testimony, and relevant
academic research. (Id. at ¶¶ 5; Sillup Report, at 94–102.)
As to whether Sillup used reliable principles and methods to reach opinions, the Court finds
Smith v. Pfizer, 714 F. Supp. 2d 845 (M.D. Tenn. 2010), persuasive. In that case, the court denied
the defendants’ motion to exclude testimony of a marketing expert who also concluded that the
defendants’ OL marketing campaign led to an increase in OL prescriptions. Id. at 855. The
defendants argued that he employed no ascertainable methodology. Id. However, the court found
his testimony reliable because he “relie[d] on and frequently cite[d] scholarly articles and studies,”
applied his “understanding of the drug marketplace and how marketing campaigns generally
influence doctors,” and examined sales and data. Id. at 857. See also Fed. R. Evid. 702 Advisory
Committee Notes to 2000 Amendments (explaining that when an expert witness relies primarily
on experience rather than a scientific study, the expert must “explain how that experience leads to
the conclusion reached, why that experience is a sufficient basis for the opinion, and how that
experience is reliably applied to the facts”); United States v. Ford, 481 F.3d 215, 219 (3d Cir.
2007) (reliability may turn on the proposed expert’s “personal knowledge or experience”).
Here, like the expert in Smith, Sillup reviewed extensive evidence and broke down his
conclusions into multiple prongs. (Sillup Report ¶¶ 5, 18–49; Sillup Report, Ex. A, at 94–102.)
In his report, Sillup explained that Janssen’s management took the following actions to facilitate
or encourage OL marketing: (1) developed unrealistic sales forecasts before it launched Prezista
and Intelence; (2) instructed and trained its national sales force to promote Prezista and Intelence
for OL uses; (3) encouraged physicians to write OL scripts through the Speaker Programs where
OL promotion took place; (4) set compensation policies for sales staff that was based on an
expectation of OL marketing; (5) encouraged sales staff to use unapproved studies when promoting

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Prezista and Intelence; and (6) failed to discipline its sales staff or managers for OL marketing.
(Sillup Report ¶¶ 18–49.) Indeed, Sillup reached these conclusions by analyzing the FDAapproved labels for Prezista and Intelence, the eligible patient population, and Janssen’s sales
forecasts. (Id. ¶ 12.) His report explained the highly technical process of creating sales forecasts
for pharmaceutical products, and he relied on this same process to determine that Janssen created
unrealistic sales forecasts for Prezista and Intelence. (Id. ¶¶ 18–28.) Sillup also analyzed
documents tracking Prezista and Intelence sales to show that a significant proportion of sales were
OL. (Id. ¶¶ 32–34.) Throughout his report, he referenced documents and testimony to show that
Janssen’s training of its sales force, its bonus incentive, and corporate culture all encouraged OL
marketing. (Id. ¶¶ 34–49.) To the extent Janssen disagrees with the evidence and testimony Sillup
relies upon to render his expert opinions, disagreement about his assumptions “go[] to the weight
given to his testimony, rather than [its] admissibility.” Leonard v. Stemtech Int’l Inc., 834 F.3d
376, 391 (3d Cir. 2016). See also Breidor v. Sears, Roebuck & Co., 722 F.2d 1134, 1138–139 (3d
Cir. 1983) (“Where there is a logical basis for an expert’s opinion testimony, the credibility and
weight of that testimony is to be determined by the jury, not the trial judge.”); Fed. R. Evid. 702
Advisory Committee Notes to 2000 Amendments. Similarly, for the reasons stated above, this
Court finds that Sillup used reliable principles and methods to reach his Marketing Opinion.
In the causation portion of his report, Sillup concludes that the increased numbers of OL
scripts of Prezista and Intelence were the foreseeable and intended result of Janssen’s OL
marketing. (Sillup Report ¶ 45.) First, the Court finds that Sillup is qualified to offer his opinion
based on the specialized knowledge he has acquired through his many years of training, education,
and experience. Calhoun, 350 F.3d at 322. Not only is he a professor in pharmaceutical marketing,
but he worked in the pharmaceutical industry for nearly three decades and developed product sales

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forecasts, marketing materials, and sales training programs for new drugs. (Sillup Report ¶ 6.) In
addition, his research focuses on strategic planning, sales forecasting, market practices of
pharmaceutical companies, and the impact of those practices on prescription medications. (Id.)
Second, as to the reliability of Sillup’s Causation Opinion, the Court notes that he relied
on the following: (1) guidance from courts, federal agencies, and the Office of the Inspector
General that recognize OL marketing can cause physicians to write OL scripts; (2) academic and
marketing literature that shows OL marketing influences prescribers; and (3) Janssen’s internal
and external marketing surveys showing that its OL marketing was causing physicians to write OL
scripts. (Id. ¶¶ 49–66.) The Court, therefore, finds that Sillup’s opinion concerning causation is
tied to reliable methods and principles. See Smith, 714 F. Supp. 2d at 857.
Third, courts have allowed experts to opine as to the causal link between pharmaceutical
OL marketing efforts and doctors’ prescribing decisions. See, e.g., Smith, 714 F. Supp. 2d at 856;
United States ex rel. Brown v. Celgene Corp., 226 F. Supp. 3d 1032, 1039–40 (C.D. Cal. 2016);
Hanrahan v. Wyeth, Inc., Civ. No. 04-1255, 2012 WL 2395986, at *5 (E.D. Mo. June 25, 2012).
Accordingly, the Court will deny Janssen’s motion to exclude the expert report and testimony of
George P. Sillup.
C. Janssen’s Motion to Exclude Certain Opinions of Kenneth W. Schafermeyer
Janssen filed a motion to limit the testimony of Kenneth W. Schafermeyer, (“Schafermeyer
Motion,” ECF No. 196), along with a brief in support of the Schafermeyer Motion, (“Schafermeyer
Moving Br.,” ECF No. 196-1). Relators opposed the Motion, (“Schafermeyer Opp’n Br.,” ECF
No. 282), to which Janssen replied (“Schafermeyer Reply,” ECF No. 247). Relators identified
Schafermeyer as a rebuttal expert to Janssen’s expert, Dr. Babette Edgar, who intends to testify

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about the statutory and regulatory framework for Medicare Part D (“Part D”). (Chuderewicz
Decl., Ex. A, “Schafermeyer Report” ¶ 3, ECF No. 265.)
Schafermeyer’s report provides the following summary of the opinion he intends to offer
at trial: “It is my opinion that CMS does maintain a ‘medically necessary and reasonable’
requirement for services under Part D and, based on Dr. Glatt’s opinion, that prescriptions relying
on Janssen’s false and misleading marketing do not meet this standard and should not be covered.”
(Schafermeyer Report ¶ 59.) Schafermeyer organized his report in two sections: (1) issues
pertaining to Part D, including administration of the drug benefit, funding sources, drug coverage,
and utilization management tools; and (2) the financial implications of Janssen’s alleged behavior
on Part D for promoting Prezista and Intelence for OL and/or medically unnecessary use (the
“Coverage and Reimbursement Opinions”). (Id. ¶¶ 6–58.)
Janssen contends that Schafermeyer’s Coverage and Reimbursement Opinions are
inadmissible because he “does not have [the] relevant expertise to offer these Opinions.”
(Schafermeyer Moving Br. at 3.) Although “Schafermeyer’s experience may be sufficient for him
to walk the jury through the Medicare Part D statutory framework, he has no expertise to opine on
how CMS makes coverage and reimbursement decisions for antiretroviral medications under
Medicare Part D.” (Id. at 1.) Janssen notes that Schafermeyer has not worked or consulted for
CMS or a Part D sponsor, has not specifically taught about such topics, and has reimbursement
knowledge that is not at issue here. (Id. at 2–4.) Janssen argues that Schafermeyer’s Coverage
and Reimbursement Opinions are based solely on his understanding of the regulatory framework
and of CMS’ factors in making coverage and reimbursement decisions. (Id. at 4.) Janssen
concludes that Schafermeyer’s education and experience do not “qualify him to testify on the more

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specific subject of how CMS makes coverage and reimbursement decisions under Medicare Part
D for antiretroviral medications such as Prezista and Intelence.” (Id. at 4.)
In opposition, Relators argue that Janssen overstated the qualification requirement for
expert testimony admission. (Schafermeyer Opp’n Br. at 3, 11.) Noting that precedents show that
“rejection of expert testimony is the exception rather than the rule,” Relators state that “the liberal
standards for admissibility have supported acceptance of expert[s’] opinions outside their narrow
area of expertise in many different settings, including with regard to regulatory schemes.” (Id. at
3–5.)

To disprove Janssen’s argument that Schafermeyer’s Coverage and Reimbursement

Opinions are based solely on his understanding, Relators point to Schafermeyer’s basis for
understanding the topic, including materials that Dr. Babette Edgar (Janssen’s own expert) uses in
her report.

(Id. at 8–10.)

Relators further argue that Janssen’s arguments regarding

Schafermeyer’s lack of experience working or consulting for CMS go to the weight of his
testimony, not its admissibility. (Id. at 11–12.)
In its reply, Janssen emphasizes four points to prove that “none of [Schafermeyer’s]
experience is relevant to his Coverage and Reimbursement Opinions.” (Reply at 1.) According
to Janssen, Schafermeyer does not explain which courses involved teaching Part D, how his
teaching history relates to his Coverage and Reimbursement Opinions, or whether his courses
taught Part D policy issues in great depth. (Id. at 3–4.) Janssen notes that Schafermeyer has neither
advised agencies nor private companies on Part D nor consulted for a pharmaceutical company on
managed care or reimbursement since 1995, over a decade before Part D existed. (Id. at 5.)
Janssen then argues that Schafermeyer’s previous expert testimony centered on over-inflated drug
prices instead of coverage and reimbursement of HIV medications. (Id. at 6.) Finally, Janssen
argues that Relators attempt to buttress Schafermeyer’s credentials by pointing to alleged errors,

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which is an inappropriate factor to consider when determining the qualification of an expert. (Id.
at 7–8.)2
As mentioned above, the qualification requirement of Rule 702 is interpreted liberally with
a “broad range of knowledge, skills, and training qualify[ing] an expert.” Pineda, 520 F.3d at 244
(quoting Paoli, 35 F.3d at 741). The qualification prong of Rule 702 requires “that the witness
possess specialized expertise.” Id. (quoting Schneider, 320 F.3d at 404). “Unlike an ordinary
witness, . . . an expert is permitted wide latitude to offer opinions, including those that are not
based on first[-]hand knowledge or observation.” Daubert, 509 U.S. at 592.
Schafermeyer earned an M.S. and Ph.D. in Pharmacy Administration, is a licensed
pharmacist, has earned credits in business, economics, and marketing, and is currently a Professor
of Pharmacy Administration at St. Louis College of Pharmacy. (Schafermeyer Report, Ex. A, at
23.) In a previous role, he “served as the Director of Graduate Studies and headed a Master’s
degree program in Managed Care Pharmacy.” (Id. ¶ 1.) Since 1976, Schafermeyer has worked
with, taught about, and analyzed the operations of pharmacies, their financial performance, their
costs of dispensing, and their reimbursement by private and public prescription programs,
including government-supported health care programs such as Medicare, Medicaid, TRICARE,
and the Federal Employees Health Benefits Program. (Id.) He has also worked with and taught
about the operations of managed care organizations and pharmacy benefit managers (“PBMs”).
(Id.) Furthermore, Schafermeyer has testified in four cases since 2015, but Janssen alleges they

In its reply, Janssen appears to raise the issue of reliability for the first time. (Reply at 3–6.) “An issue is waived
unless a party raises it in its opening brief, and for those purposes ‘a passing reference to an issue . . . will not suffice
to bring that issue before this court.’” Laborers’ Int’l Union of N. Am., AFL-CIO v. Foster Wheeler Energy Corp., 26
F.3d 375, 398 (3d Cir. 1994). In addition, although both parties argue these points, the Court does not have a sufficient
basis to rule whether Schafermeyer’s testimony is reliable because the argument was, at best, unclear in the moving
brief. This finding is supported by the fact that neither party has effectively argued for or against the factors for the
reliability of Schafermeyer’s testimony. See In re Paoli R.R. Yard PCB Litig., 916 F.2d 829, 854 (3d Cir. 1990) (“The
adversarial process upon which our legal system is based assumes that a fact finder will give the parties an adequate
opportunity to be heard; if it does not, it cannot find facts reliably.”).
2

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were related to over-inflated drug prices and not the issues in this current matter.

(Id.;

Schafermeyer Reply at 6.) According to Janssen, he has not taught such a course since 2005,
around when Part D was enacted. (Schafermeyer Moving Br. at 2–4; Reply at 5.)
Schafermeyer has been involved in pharmacy administration for approximately forty-five
years. (Schafermeyer Report ¶ 1.) He has taught classes in pharmacy administration, which
included reimbursement by private and public prescription programs. (Id.) Moreover, he has
consulted on matters related to reimbursement. (Id.) Even if Janssen’s concerns are taken as true,
Schafermeyer’s long and storied career in pharmacy administration gives him the specialized
knowledge required to qualify as an expert under Rule 702. See Paoli, 35 F.3d at 741 (“We have
eschewed imposing overly rigorous requirements of expertise and have been satisfied with more
generalized qualifications.”). Although the time since Schafermeyer taught or worked in the field
may be pertinent, the Court finds that these concerns go to the credibility and weight of his
testimony, a function better left to trial before a jury. Daubert, 509 U.S. at 596 (“Vigorous crossexamination, presentation of contrary evidence, and careful instruction on the burden of proof are
the traditional and appropriate means of attacking shaky but admissible evidence.”). With the
policy of liberal admissibility in mind, the Court finds that Schafermeyer is qualified to testify
about his Coverage and Reimbursement Opinions.
The Court finds that Janssen’s argument regarding Schafermeyer’s qualifications is
unpersuasive and primarily goes to the weight and credibility of Schafermeyer’s testimony. As
such, the Court will deny Janssen’s motion to limit the expert testimony of Kenneth W.
Schafermeyer.

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D. Janssen’s Motion to Exclude Certain Opinions of Aaron E. Glatt
Janssen filed a motion to limit certain testimony of Aaron E. Glatt, (“Glatt Motion,” ECF
No. 198), along with a brief in support of the Motion, (“Glatt Moving Br.,” ECF No. 198-1).
Relators opposed the Motion, (“Glatt Opp’n Br.,” ECF No. 285), to which Janssen replied (“Glatt
Reply,” ECF No. 246). Relators identified Glatt as an expert in the approved labels of Prezista
and Intelence, Janssen’s marketing of Prezista and Intelence, and the Speaker Programs.
(Chuderewicz Decl., Ex. A, ECF No. 194-3.) Glatt’s report provides the following summary of
the opinion he intends to offer at trial:
I conclude, with a reasonable degree of medical certainty, that none
of these types of promotional messaging were clinically appropriate
given the limited FDA approval, available recommendations and
guidelines by respected professional and regulatory agencies, and
the standard of care for treatment of HIV/AIDS patients in the
infectious disease and broader medical community . . . .
(Chuderewicz Decl., Ex. A, “Glatt Report” ¶ 9, ECF No. 266.) Glatt’s report also contains the
following opinion: “There was considerable significance of Janssen’s marketing in terms of likely
impact on physician’s prescribing decisions, potential patient harm, and expansion of the potential
market for Prezista and Intelence.” (Id. ¶ 11.) Janssen argues that “Glatt opines repeatedly in his
report that those practices likely caused physicians to write Intelence and Prezista prescriptions
that they would not otherwise have written” (“Causation Opinion”). (Glatt Moving Br. at 1.)
Janssen argues that Glatt’s Causation Opinion should be excluded from his report, and he should
not be permitted to testify about his Causation Opinion at trial. (Id. at 2.) Janssen contends Glatt’s
Causation Opinion is inadmissible because: (1) “he is not qualified to offer it” and (2) it “is not
reliable.” (Id. at 2, 4.)
In opposition, Relators argue that the challenged testimony is “both within Dr. Glatt’s
expertise and reliable based on Dr. Glatt’s broad experience in the field of drug treatment for HIV22

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AIDS patients . . . .” (Glatt Opp’n Br. at 7–8.) Relators explain that Glatt’s experience is further
evidenced by his “years of teaching and consultation with other physicians and students, including
specifically about the appropriate selection of drug therapies for HIV/AIDS patients” and “career
on hospital committees,” which dealt with the potential impacts of pharmaceutical marketing on
physicians and other prescribers. (Id. at 8.) Relators explain that Glatt draws on his previous
experience but also “carefully describes how the substance or content of Janssen’s messaging
could mislead physicians and influence their selection and use of Janssen’s drugs.” (Id. at 10–11.)
In addition, with respect to Janssen’s argument that Glatt’s opinion is not reliable, Relators argue
that he meets the standard applied to expert witnesses relying on experience because he explains
how his experience helped shape his conclusions, why his experience is a sufficient basis, and how
his experience is “reliably applied to the facts.” (Id. at 16.)
In its reply, Janssen argues that “Glatt’s Causation Opinion extends beyond the factors that
physicians generally consider when making prescribing decisions and impermissibly speculates
how all physicians weigh and interpret marketing information when prescribing Prezista and
Intelence to HIV patients.” (Glatt Reply at 2.) Janssen emphasizes that Glatt does not have
experience in pharmaceutical marketing to support his opinion. (Id. at 3.) Further, Janssen focuses
on Glatt’s methodology, stating “Glatt does not identify any methodology that he used to reach his
Causation Opinion.” (Id. at 5.)
Glatt is a Clinical Professor of Medicine at Icahn School of Medicine at Mount Sinai.
(Glatt Report ¶ 1.) Glatt is the Chairman of the Department of Medicine and Chief of Infectious
Diseases and Hospital Epidemiologist at South Nassau Communities Hospital. (Id.) He is a fellow
of the Infectious Disease Society of America, the American College of Physicians, and the Society
of Healthcare Epidemiologists of America. (Id.) He has practiced in the infectious disease field

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for over thirty-three years with a “significant focus on treating patients with HIV/AIDS.” (Id. ¶
2.) He has authored numerous articles related to HIV/AIDS drugs and treatment. (Id. at 74–81.)
Glatt has been the spokesperson for the Infectious Diseases Society of America since 2002 and is
a member of several Infectious Disease and HIV committees. (Id. at 71–73.)
According to Glatt, Relators retained him to opine on the following issues: (1) the drug
treatment for patients with HIV/AIDS during the “Relevant Time Period3”; (2) the clinical issues
related to the HIV/AIDS drug regimen that are particularly important to patients and physicians;
(3) the FDA-approved labels and marketing indications for Prezista and Intelence; and (4) the
education value of the Speaker programs. (Id. ¶¶ 5–7.) In reaching his opinion, Glatt used his
professional experience and educational background to assess the FDA label, “the weight of
medically accepted standards and the significance of Janssen’s messaging, including the likely
impact of physician’s prescribing decisions,” and the “potential patient harm and likely expansion
of the market for the drugs.” (Id. ¶ 6.)
As mentioned above, an expert’s testimony is admissible when the expert is qualified, the
testimony is reliable, and the testimony fits the facts of the case. When an expert relies primarily
on experience rather than a scientific study, the expert must “explain how that experience leads to
the conclusion reached, why that experience is a sufficient basis for the opinion, and how that
experience is reliably applied to the facts.” Fed. R. Evid. 702 Advisory Committee Notes to 2000
Amendments. See also Ford, 481 F.3d at 219 (reliability may turn on the proposed expert’s
“personal knowledge or experience”). However, the party seeking admission for expert testimony
must prove (and a court must find) that the expert has sufficient bases to make specific conclusions.
See Pfizer Inc. v. Teva Pharm. USA, Inc., 461 F. Supp. 2d 271, 275 (D.N.J. 2006).

As used by the parties and their experts, “Relevant Time Period” (as well as “Review Period” or “relevant periods”)
refers to the period of 2006 to 2014, when Janssen’s alleged misconduct occurred. (Glatt Report ¶ 2.)
3

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In Pfizer Inc. v. Teva Pharmaceuticals USA, Inc., Pfizer filed a motion to exclude a
rheumatologist’s testimony regarding a medicine’s therapeutic properties, the absence of
therapeutic advantages over other non-steroidal anti-inflammatory drugs (“NSAID”), and
physician prescribing practices, specifically the role of marketing materials in influencing
physicians to prescribe the drug. 461 F. Supp. 2d at 275. Plaintiff argued that the rheumatologist’s
testimony should have been excluded in its entirety because it was speculative and not based on a
reliable methodology. Id. at 275–76. The defendant argued that the rheumatologist should have
been permitted to testify because his opinions were “based on his 20 years [of] practicing
rheumatology and prescribing NSAID therapies for the treatment of chronic pain.” Id. at 276.
In Pfizer, the court granted narrow exclusions where the rheumatologist did not have a
reliable basis for his testimony. Id. at 275–78. The court found that the expert’s “20 years
practicing rheumatology and prescribing NSAID therapies for the treatment of chronic pain” was
“not a sufficiently reliable basis for his broad opinions on the prescribing practices and general
understanding of all physicians.” Id. at 277. Moreover, the court found that the rheumatologist
could “render an opinion on the accuracy of Celebrex’s marketing materials” but “not opine as to
physicians’ . . . understanding of these materials or the effect that these materials had on their
prescription choices” because the latter opinions “are speculative and not based on a reliable
methodology.” Id. Finally, the court found that the rheumatologist did not have a sufficiently
reliable basis for his opinions that “prescriptions were heavily influenced by advertising and
promotion” because his personal knowledge and experience did not persuade the court that he
could “form[] a sufficient basis for his broad conclusions concerning the impact of sales and
marketing efforts on . . . prescriptions.” Id. at 277–78. Ultimately, the court drew a distinction
between reliable and unreliable expert testimony from physicians. Id. at 275. Because of a

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physician’s training and expertise, they can opine on prescribing medication, label accuracies,
marketing accuracies, comparisons between various medications, and how they would act in a
certain situation. Id. at 275–77. However, physicians cannot go beyond their expertise to opine
about the effect of marketing materials or put forth broad opinions about prescribing practices and
the general understanding of all physicians without more expertise. Id. at 277.
The Court has considered Glatt’s qualifications and the opinion he intends to offer. The
Court finds that Glatt has extensive personal knowledge and expertise in the field of HIV/AIDS
drugs and their labels. Glatt is a practicing physician, has practiced medicine for almost forty
years, has been involved with infectious disease departments for much of his practice, and has
been in several teaching and head positions over the course of his career. (Glatt Report ¶ 1.) He
also sat as chair on various hospital committees that dealt “with the potential impact of
pharmaceutical advertising on appropriate usage of medications both in the hospital and in the
community.” (Id. ¶ 5.)
Glatt has personal knowledge of pharmaceutical marketing and advertising throughout his
career, including “setting up policies and practices that the hospital should engage in in terms of
allowing, not allowing pharmaceutical industry representatives to come into the hospital” to
prevent undue influence on physicians. (Id. ¶¶ 7, 27.) In his current position, Glatt continues to
consult with other physicians about recommended drug treatments for patients, and he has seen on
numerous occasions the increased usage of a drug for no medical indication after pharmaceutical
representatives have visited. (Id. ¶¶ 25–30.) Contrary to Janssen’s argument, Glatt’s personal
knowledge and expertise are far greater in comparison to the physician in Pfizer on the testimony
involved. The Court finds that Glatt’s personal knowledge and expertise indicate that he is
generally qualified to offer his opinion with respect to HIV, its drugs, its labels, and its marketing.

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However, the Court finds inadmissible Glatt’s opinions about the effects of Janssen’s OL
promotions on physicians’ prescribing decisions. Although Glatt has some experience with
pharmaceutical marketing in hospitals and has firsthand knowledge of many concerns regarding
HIV/AIDS due to his career in infectious diseases, he does not have the same qualifications as
Sillup, for example, to opine on the effects of OL promotion and marketing. (Glatt Report ¶¶ 1–
5; Glatt Report at 91–97.) Relying on the court’s guidance in Pfizer, this Court will bar Glatt from
opining on how Janssen’s OL promotion and marketing impacted the physicians’ prescribing
decisions. 461 F. Supp. 2d at 277–78. Accordingly, the Court grants Janssen’s motion to limit the
testimony of Aaron E. Glatt.
E. Janssen’s Motion to Exclude the Testimony of Virginia B. Evans
Janssen filed a motion to exclude the expert report and testimony of Virginia B. Evans
(“Evans Motion,” ECF No. 200), along with a brief in support of the Motion, (“Evans Moving
Br.,” ECF No. 200-1). Relators opposed the Motion, (“Evans Opp’n Br.,” ECF No. 281), to which
Janssen replied, (“Evans Reply,” ECF No. 244). Relators identified Evans as “an expert in the
field of health care compliance.” (Evans Opp’n Br. at 9.) Evans’ report provides the following
summary of the opinion he intends to offer at trial:
[I]t is my opinion that Janssen’s Prezista and Intelence Speaker
Programs did not comply with applicable government and industry
standards, and that Janssen did not have an effective compliance
program to prevent and detect Speaker Program misconduct. Based
on my review and analysis, I conclude that Janssen used its Speaker
Programs to pay doctors to induce them to prescribe Prezista and
Intelence, and/ or to reward them for doing so. I further conclude
that Janssen paid its Speaker physicians to promote the off-label use
of these drugs to other prescribing physicians.
(Chuderewicz Decl., Ex. A, “Evans Report” ¶¶ 5–6, ECF No. 267.) According to her expert report,
Relators asked Evans to opine on whether the Speaker Programs were conducted in compliance

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with the laws, regulations, and guidance in the pharmaceutical industry, and whether Janssen’s
compliance program was “effective” as that term is understood in the healthcare and
pharmaceutical industries. (Id. ¶ 5.)
Janssen argues that Evans intends to “offer[] legal advocacy, rather than specialized
knowledge, that would not help the trier of fact to understand the evidence or to determine a fact
in issue.” (Evans Moving Br. at 2–7.) Aside from the legal conclusions, Janssen also argues that
Evans’ “opinion that Janssen’s compliance program was ‘ineffective’ is inadmissible because she
fails to tie her opinions to reliable methods or principles.” (Id. at 7–14.)
In opposition, Relators argue that Evans did not provide legal conclusions.
(Evans Opp’n Br. at 11.) They contend Evans “analyzed the evidence in the record under
applicable government and industry standards, offered her expert opinion in a written expert report,
and provided testimony.” (Id. at 11–12.) They argue that Evans’ report does not improperly
summarize evidence and usurp the role of the jury. (Id. at 20–23.) Moreover, Relators contend
Evans used reliable methods to form her opinions. (Id. at 23–35.)
In its reply, Janssen emphasizes that Evans offers legal advocacy that would usurp the role
of the jury and the Court. (Evans Reply at 2.) Also, Janssen reiterates that Evans failed to apply
reliable methodology to render her non-legal opinions admissible. (Id. at 6.)
The Court has reviewed Evans’ qualifications because her specialized knowledge and
experience in health care compliance is relevant to understanding how she formed her opinions
and deciding the issue of reliability. Evans graduated from New York University School of Law
and is admitted as a member of the bar in several states. (Evans Report ¶ 7; id. at 78.) She worked
as a federal prosecutor for over twenty-five years but transitioned into private practice in 2005 and
started providing health care consulting services. (Id. ¶¶ 5–6.) When she first transitioned into

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private practice, she “managed several Independent Review Organization engagements for health
care clients under Corporate Integrity Agreements, conducted compliance risk assessments and
internal investigations, and worked with Audit Committees and Internal Audit Departments of
large health care providers including hospitals, insurers, a national retail pharmacy chain, and an
international pharmaceutical company.” (Id. ¶ 6.) In 2010, she became partner at a large firm’s
Health Law practice where she represented health care providers in civil and criminal
investigations. (Id. ¶¶ 6–7.) During that time, she also became a compliance resource for
pharmaceutical companies, drug manufacturers, and physician practices. (Id. ¶ 6.) She wrote and
reviewed compliance policies for many clients and negotiated settlements with state and federal
health care agencies in cases involving the FCA, FDA, and other health care matters. (Id.) At one
point, Evans served as a Vice President, Compliance Officer, and General Counsel for a hospital
system.

(Id. ¶ 7.)

Evans also has experience working as a Senior Legal Editor for

ThomsonReuters’ Health Care & Life Science legal journal, and she is certified in Health Care
Research Compliance. (Id.)
In her report, Evans used specialized knowledge as a health care compliance expert to
determine whether Janssen maintained an effective compliance program by reviewing its
compliance policies. Evans noted that she reviewed numerous documents before reaching her
conclusions, including but not limited to Janssens’ compliance policies on the Speaker Programs,
documents concerning its Speaker Programs (e.g., procedures, promotional policies, management
guide, and internal emails and communications), summary reports of investigations, honoraria
reports, return on investment reports, data collection efforts, transcripts of depositions of
witnesses, and Janssen’s responses to discovery request. (Id. ¶ 8; id. at 81–84.) More specifically,
Evans reviewed Janssen’s Speaker Programs to determine if they complied with the standards set

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forth in the Compliance Program Guidance for Pharmaceutical Manufacturers (“OIG Guidance”)
written by the Office of Inspector General (“OIG”) of the Department of Health and Human
Services. (Id. ¶¶ 8–9.) She sought to determine whether Janssen implemented “controls,” as
recommended by OIG guidance, to prevent its Speaker Programs from being used to improperly
influence physicians’ prescribing behavior. (Id. ¶ 9.) Evans also reviewed Janssen’s compliance
program and other internal documents to determine whether Janssen complied with its own
policies. (Id.) In addition to the OIG Guidance, Evans also relied on other materials about industry
standards and practices that help manufacturers implement and maintain effective compliance
programs. (Id. ¶¶ 9–10.)
After reviewing Evans’ approach, the Court rejects Janssen’s argument that Evans’
methodology was “unreliable and litigation-driven.” (Evans Moving Br. at 9.) To the extent
Janssen takes issue with the evidence Evans relies upon to render her non-legal opinions, Janssen
may cross-examine her and present evidence to the contrary at trial. Krys v. Aaron, 112 F. Supp
3d 181, 192 (D.N.J. 2015) (quoting Daubert, 509 U.S. at 595). See also MicroStrategy Inc. v.
Business Objects, S.A., 429 F.3d 1344, 1355–356 (Fed. Cir. 2005) (explaining that an expert “must
consider enough factors to make his or her opinion sufficiently reliable in the eyes of the court
. . . [but the] expert need not consider every possible factor to render a ‘reliable’ opinion”). The
Court is not required to preclude Evans’ expert testimony simply because Janssen believes she
“could have performed . . . her analysis in a better manner.” Pfizer, 461 F. Supp 2d at 274. For
the reasons stated above, the Court finds that Evans used “reliable principles and methods” to reach
her conclusion concerning the effectiveness of Janssen’s compliance program, and her opinion is
supported by “sufficient facts and data.” See Fed R. Evid. 702(b), (c).

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Moreover, Evans’ testimony about the industry compliance standards and her opinion that
Janssen did not have an effective compliance program is admissible because it would help “the
trier of fact to understand the evidence [and] to determine a fact in issue . . . .” Fed. R. Evid.
702(a). Evans’ opinion would help the jury determine whether Janssen’s “conduct or actions meet
the underlying bases for an ultimate issue” to be decided in this case. Krys, 112 F. Supp. 3d at
193. However, Evans’ opinion that “Janssen used its Speaker Programs to pay doctors to induce
them to prescribe Prezista and Intelence” is inadmissible because it is a legal conclusion.
Berckeley, 455 F.3d at 217. Whether Janssen used its Speaker Programs to induce doctors to
prescribe Prezista and Intelence is an issue for the jury because it decides an element of the AKS
claims. See 42 U.S.C. § 1320a-7b(b)(2)(B). Although Federal Rule of Evidence 704(a) allows an
expert to proffer testimony that “embraces an ultimate issue to be decided by the trier of fact,” the
ultimate issue rule does not enable an expert to tell the jury what result to reach. Krys, 112 F.
Supp. 3d at 192. The Court agrees with Janssen that this is a question of intent for the jury, and
Evans cannot provide testimony concerning state of mind or culpability. Id. at 203.
The Court, therefore, will grant in part and deny in part Janssen’s motion to exclude the
expert testimony of Virginia Evans.
F. Janssen’s Motion to Exclude the Testimony of Israel Shaked and Ian Dew
Janssen filed a motion to exclude the testimonies of Israel Shaked and Ian Dew, (“Shaked
Motion,” ECF No. 202), along with a brief in support of the Motion, (“Shaked Moving Br.,” ECF
No. 202-1). Relators opposed the Motion, (“Shaked Opp’n Br.,” ECF No. 280), to which Janssen
replied, (“Shaked Reply,” ECF No. 248). Relators retained “Shaked to perform statistical analyses
of the prescription claims data and to opine on issues of causation and damages.” (Shaked Opp’n
Br. at 1.) Shaked’s expert report provides many opinions he intends to offer at trial, including: the

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positive relationship between compensation paid to physicians and subsequent prescriptions
written for Prezista and Intelence; the opinion that Janssen’s conduct “influenced” OL
prescriptions that were then reimbursed by the government for the relevant periods; and the total
damages related to Janssen’s alleged violation of the FCA and AKS. (Chuderewicz Decl., Ex. A,
“Shaked Report” ¶¶ 13–145, ECF No. 268.) Shaked performed twelve different analyses in which
he calculated various metrics to explain the relationships between payments to speakers, effects of
payments on prescribing physicians, and the relationship between speakers and non-speakers. (Id.
at 35–63.) In reaching his conclusions, Shaked relied on Ian Dew for analytical support.4 (Id. ¶
14; Chuderewicz Decl., Ex. D, “Dew Rebuttal Report” at 3, ECF No. 268-2.)
Janssen challenges the reliability of Shaked’s opinions and, by proxy, of Dew’s opinions.
(Shaked Moving Br. at 4.) Janssen also seems to challenge Shaked’s qualification by claiming
that he does not have the requisite experience to opine on medical claims because his work centers
on financial analyses.5 (Id. at 4.) First, Janssen argues that “Shaked’s general causation opinions
relating to [OL] promotion and speaker payments should be excluded because they are based on
an unreliable methodology for assessing causation.” (Id. at 10–20.) It contends that Shaked’s
“[c]correlation analyses are not generally accepted methods for assessing causation” and fails to
consider “confounding factors that may affect physicians’ prescribing decisions.” (Id. at 11, 15.)
Second, Janssen argues that “Shaked’s general causation opinions relating to [OL] promotion also
should be excluded because the two variables being measured in his correlation analyses are based
on unsupported assumptions that do not fit the facts of this case and result in an unreliable

4

Ian Dew is a partner at Steck Consulting and has over twenty years of experience in data analysis. (Id. ¶ 17, n.6)
Shaked utilized Dew to query databases of ADAP, Medicaid, and Medicare. (Id.) Shaked describes the data he
requested from Dew throughout his report. (Id.)
5
Janssen also asks the Court to exclude Dew because of his alleged lack of qualifications. (Shaked Moving Br. at 9–
10.) The Court declines to address this argument because Dew supports Shaked’s opinion, has no independent
opinion, and Janssen has asked this Court to posit Dew’s exclusion on Shaked’s exclusion.

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methodology.” (Id. at 20–27.) Janssen contends that Shaked’s definition of an “influenced”
prescriber and his attribution of a patient’s lifelong prescriptions to the first prescriber are both
variables based on unsupported assumptions. (Id. at 20, 24.) Third, Janssen argues that “Shaked’s
specific causation opinions identifying false claims and estimating damages resulting from
Janssen’s alleged improper promotion should be excluded because they are based on unsupported
assumptions and errors that do not fit the facts of this case and result in an unreliable
methodology.” (Id. at 27–30.)
In opposition, Relators argue that “Shaked has excellent support for his analyses and
opinions here, and his opinions easily satisfy the applicable standards of reliability and
admissibility.” (Shaked Opp’n Br. at 3.) They argue that Shaked accounted for confounding
variables, has a basis for assumptions and definitions for his damages and causation analyses, and
can prove causation under the FCA through a general causation analysis rather than a “but for”
analysis. (Id. at 3–6.) In addition, Relators explain that Shaked is an expert in statistics and uses
“common and well-established methods to perform his analyses,” applying the methods to
comparable groups. (Id. at 2.) They note that Shaked has the educational, academic, and industry
background necessary to qualify as an expert. (Id.)
In its reply, Janssen reiterates that Shaked’s general causation opinions are inadmissible
because they fail to satisfy the reliability requirement of Federal Rule of Evidence 702. (Shaked
Reply at 2.) Janssen argues that Shaked cannot prove any existence of a causal relationship
because his assumption that all of Janssen’s contacts “influenced” physicians has no reliable basis
in the facts. (Id. at 4; see id. at 11, n.8.) Emphasizing its point that two-variable correlation
analyses are not a generally accepted method for assessing causation, Janssen argues that the lack

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of a randomized control experiment and the lack of multiple regression analyses cause his general
causation opinion to be unreliable. (Id. at 5–11.)
The parties’ disagreement centers on whether Shaked’s analyses have “good grounds” for
his conclusions. The “good grounds” analysis implicates the reliability prong; once determined,
the fit of the testimony to the facts of the should be adjudged. See Daubert, 509 U.S. at 598. “The
evidentiary requirement of reliability is lower than the merits standard of correctness.” Paoli, 35
F.3d at 744. “An expert is . . . permitted to base his opinion on a particular version of disputed
facts and the weight to be accorded to that opinion is for the jury.” Walker v. Gordon, 46 Fed.
App’x 691, 695–96 (3d Cir. 2002). An expert’s report and testimony are reliable if the expert has
“good grounds” for his or her opinions. Paoli, 35 F.3d at 744. When evaluating whether a
particular scientific methodology is reliable, the Third Circuit has instructed district courts to
consider the following non-exhaustive factors: (a) whether a method consists of a testable
hypothesis; (b) whether the method has been subject to peer review and publication; (c) the known
or potential rate of error; (d) the existence and maintenance of standards controlling the technique’s
operation; (e) whether the method is generally accepted; (f) the relationship of the technique to
methods which have been established to be reliable; (g) the qualifications of the expert witness
testifying based on the methodology; and (h) the non-judicial uses to which the method has been
put. Id. at 742, n.8 (citation omitted). See also Pineda, 520 F.3d at 247–48.
The Court reviewed Shaked’s report to determine whether he used methods with good
grounds to reach his general causation opinions. The Difference of Two Population Means Test
(the two-factor correlation analysis Janssen references) determines whether there is a statistically
significant difference between two independent population means. (Shaked Report at 73.) If the
z-score is higher than the critical value, then there is a statistically significant difference between

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the two populations. (Id. at 73.) Here, Shaked clearly explains his rationale for setting up tests,
tests each of his hypotheses (e.g., whether payments “influenced” physicians) against the negative
hypotheses (e.g., whether payments did not “influence” physicians), and used z-scores to
determine whether the results were statistically significant. (Shaked Report ¶¶ 76, 96, 105, 131,
140.) Moreover, Shaked calculated the Spearman Rank Correlation values for dollar amounts paid
to speakers and their dollar amount of prescriptions. (Id. at 36.) As understood by the Court and
expressed by Shaked, the Spearman Correlation Test measures the positive relationship between
two variables; a value of “-1” implies a weak association, a value of “0” implies no association,
and a value of “1” implies a positive association. (Shaked Report at 73–74.) The Spearman Rank
Correlation Significance Test analyzes the strength of the correlation test and the possibility that
the correlation is by chance. (Id. at 74.) Furthermore, contrary to Janssen’s argument that Shaked
did not run regressions, Shaked ran multiple regressions on the data when challenged by Anupam
Jena; however, Shaked chose not to include it in the supplemental report because he believed that
the identical results did not need to be included in his report. (Chuderewicz Decl., Ex B., “Shaked
Dep.” 291:10–25, ECF No. 202-4.) With positive values, high z-scores, and high t-values, the
values are statistically significant (i.e., cannot be rejected) under accepted statistical checks.6
(Shaked Report at 74.) As such, the Court finds that Shaked’s report has “good grounds” and is,
therefore, reliable. Since Shaked uses data pertinent to the facts of the case, the Court finds that
his analysis is also relevant to the case at hand.

6

When applying the Rank Correlation Significance Test, Shaked calculated a correlation of 0.235 and a t-value of
4.212 for the correlation between a change in total compensation and average annual prescription; he also calculated
a correlation of 0.406 and a t-value of 31.944 for the correlation between a change in marketing contacts and OL
prescriptions. (Shaked Report ¶¶ 89, 119.) According to the t-score table found, the t-values for 99.995% confidence
in the result is 3.97 for a data set of 200 values and 3.92 for a data set of 500 values.
https://faculty.washington.edu/heagerty/Books/Biostatistics/TABLES/t-Tables/. As such, the Court finds that the
values calculated are reliable.

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The Reference Manual on Scientific Evidence does note that randomized controlled
experiments generally are a better measure of causation than observational studies. Federal
Judicial Center, 220 (3d ed. 2011). Although the Court does not doubt that Shaked has the capacity
to make such a decision, it would be prudent to probe the reason for his choice. Shaked collected
the data for his analyses from a variety of sources, including state databases, and explains that his
analysis is a controlled experiment due to the nature of the data. (Reply at 9; Shaked Dep. 290:79.) Each of Shaked’s checks for significance imply that the values are not insignificant. (Shaked
Report ¶¶ 76, 89, 96, 105, 119, 131, 140.) Furthermore, Shaked ran multiple checks on his analyses
to determine whether the conclusions were sound. (Shaked Dep. 291:18-25.) Holding that the
lack of complete control over all aspects of a study is sufficient to defeat the reliability of the study
would mitigate the use of studies in many cases heard in this Court. See, e.g., In re Johnson &
Johnson Talcum Powder Products Mktg., 509 F. Supp. 3d 116, 166–67 (3d Cir. 2020) (“The Court
cannot deem Plaintiffs’ experts’ opinions unreliable simply because they determined that the casecontrol studies were entitled to greater weight than the cohort studies, particularly since the
experts’ explanations of their methods were supported by scientific reasons.”).
Considering that Shaked has proven that the variables are strongly correlated through a
reliable methodology, the question becomes whether Shaked has a strong basis for asserting that
the kickbacks resulted in physicians writing more prescriptions for Prezista and Intelence. That is
a question of weight, not of reliability. See In re Johnson & Johnson, 509 F. Supp. 3d at 167
(“Defendants may disagree with the experts’ interpretations of those studies and their usefulness,
but such issues go to the weight of the experts’ testimony, and not their reliability.”). Many of
Janssen’s arguments attack Shaked’s assumptions and question his choice of methodology: the
proper venue for such arguments is at trial during cross-examinations. See Daubert, 509 U.S. at

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596. The Court’s role at this point is to determine whether the methodology is reliable. Id. As it
has, the Motion to exclude Shaked’s and Dew’s report and testimony is denied.
G. Relators’ Motion to Exclude the Testimony of Jon Smollen
Relators filed a motion to exclude the expert report and testimony of Jon Smollen
(“Smollen Motion,” ECF No. 179), along with a brief in support of the Motion, (“Smollen Moving
Br.,” ECF No. 276). Janssen opposed the Smollen Motion, (“Smollen Opp’n Br.,” ECF No. 210),
to which Relators replied, (“Smollen Reply,” ECF No. 254). Janssen identified Smollen as a
rebuttal expert to Relators’ compliance expert, Virginia Evans, and as an individual who has
“specialized knowledge” and analysis regarding “Janssen’s efforts to comply with the AKS.”
(Smollen Opp’n Br. at 1.) Smollen’s report provides the following summary of the opinion he
intends to offer at trial:
Based on my professional experience and expertise, it is my opinion
that throughout the Review Period, Janssen proactively identified
compliance risks arising from its Speaker Programs, designed and
implemented compliance policies and controls to mitigate those
risks, and effectively operationalized its policies.
(Ellerbe Decl., Ex. 1, “Smollen Report” at 4, ECF No. 279.) Smollen opined on (1) whether
Janssen had effective compliance policies in place to minimize the risk that its Speaker Program
violated the AKS (“Effective Compliance Opinion”), and (2) whether Janssen had effective
compliance policies in place overall (“Overall Compliance Opinion”). (Smollen Motion at 4.)
After considering OIG and PhRMA (“Pharmaceutical Research and Manufacturers of America”)
Code guidance, the testimony and evidence provided by Janssen, and his own professional
judgment, Smollen concluded the following: (1) Janssen had effective compliance policies to
prevent violation of the AKS; and (2) Janssen had effective compliance policies in place overall.
(Id. at 4.)

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Relators argue that Smollen’s Effective Compliance Opinion is unreliable because his
opinions regarding Janssen’s effective compliance “is based on a skewed and unreliable
consideration of very limited select evidence in the case and simply ignores a wealth of evidence
that contradicts his opinions.” (Smollen Moving Br. at 7.) Relators also argue that Smollen’s
Overall Compliance Opinion is irrelevant, unreliable, and likely to confuse the jury because “it is
not relevant to any issues in this case[,] fails to even consider the issue of [OL] marketing at all[,]
. . . fails to consider the overwhelming evidence regarding Janssen’s [OL] marketing scheme[,]
and is likely to confuse the jury.” (Id.) Relators point to examples of “Smollen providing
superficial opinions without ever delving into the underlying facts in the record.” (Id. at 24.)
In opposition, Janssen argues that Smollen’s testimony “would help the jury ‘understand
the evidence’ and ‘determine a fact in issue’ (that is, whether Janssen intended to violate the
AKS).” (Smollen Opp’n Br. at 1.) Janssen argues that Smollen’s reluctance to adopt Relators’
view of the case for his Effective Compliance Opinion is not a basis for reliability. (Id. at 3.) He
“reviewed Relators’ witnesses’ testimony, the testimony from other witnesses, and hundreds of
documents, including Relators’ witnesses’ emails, compliance monitoring and investigation logs,
compliance trainings, compliance communications, compliance risk assessments, and compliance
policies.” (Id. at 4–5.) Janssen states that “Smollen did not ignore key deposition testimony” and
gave “thoughtful consideration” to all the evidence. (Id. at 7, 9.) With respect to Smollen’s Overall
Compliance Opinion, Janssen argues that Smollen’s opinion is relevant and that he opined on the
same relevant topics as Evans. (Id. at 10.) According to Janssen, Smollen “considered how
Janssen operationalized compliance across the company and across all risk,” which was also
considered in Evans’ expert report. (Id. at 12.)

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In its reply, Relators reiterated that Smollen “ignored substantial deposition testimony”
from Mark Wilhelm and Sara Strand7 and, when asked about this testimony, Smollen “admitted
that Janssen’s practices violated its own written policies, applicable industry standards, and the
law.” (Smollen Reply at 1–2.) Relators also allege that Smollen made credibility determinations
among witnesses, which was inappropriate for experts to do. (Id. at 5–8.)
The Court first considers Smollen’s qualifications before addressing the reliability of his
opinions. Smollen is qualified to opine on compliance issues due to his education and experience.
He held leadership and advisory positions in several pharmaceutical companies, assisted in
establishing and enhancing U.S. and global compliance programs, and currently teaches
compliance and ethics at Temple Law School. (Smollen Report at 10–12.) In reaching his
opinions, he thoroughly walks through Janssen’s regulatory procedure, applies the PhRMA Code
and OIG recommendations, compares Janssen’s policies to the industry standard, and applies the
same framework—like Relators’ expert, Evans—to come to a different conclusion. (Id. at 67.) In
this instance, Smollen’s report is relevant because it discusses a pertinent issue of the case
(compliance), rebuts Relators’ experts, and provides helpful information to the jury. As the Court
previously mentioned, “the line between admissible and inadmissible expert testimony as to the
customs and practices of a particular industry often becomes blurred when the testimony concerns
a party’s compliance with customs and practices that implicate legal duties.” Berckeley, 455 F.3d
at 217. Here, the Court finds that the Overall Compliance Opinion and Effective Compliance
Opinion are reliable because Smollen applied his professional judgment and expertise in a reliable
manner.

Mark Wilhelm was a Key Account Director for Janssen’s Western Division from 2007 and 2009. Sara Strand was
a Regional Business Director for the Eastern Division from 2006 to 2011. Relators included them as witnesses with
first-hand knowledge of Janssen’s practices. (Smollen Reply at 1–2.)
7

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Relators argue that Smollen should have taken note of Wilhelm’s and Strand’s testimony
in his expert opinion. As a reminder, “[a]n expert is . . . permitted to base his opinion on a particular
version of disputed facts and the weight to be accorded to that opinion is for the jury.” Walker, 46
Fed. App’x at 695–96. See In re Johnson & Johnson, 509 F. Supp. 3d at 167 (“Defendants may
disagree with the experts’ interpretations of those studies and their usefulness, but such issues go
to the weight of the experts’ testimony, and not their reliability.”). Although he did not mention
Wilhelm, Smollen took note of Strand’s testimony.8 (Smollen Report at 56.) Smollen’s failure or
unwillingness to respond to testimony from certain witnesses is an issue for cross-examination.
Moreover, to the extent Relators assert that Smollen agreed Janssen violated its policies, a quick
look at Smollen’s deposition reveals that Smollen only agreed that certain facts, if proven true,
could hypothetically constitute violations of written policies and statutes. (Ellerbe Decl., Ex. 2,
“Smollen Dep.” 77:10-80:21, 82:15-89:21, 93:3-95:23, 97:8-101:23, ECF No. 279-1.)
Relators raise other arguments that attack assumptions and do not go to the reliability of
Smollen’s report; as mentioned above, the proper venue for such arguments is trial, not a Daubert
motion. Daubert, 509 U.S. at 596. Accordingly, Relators’ motion to exclude Smollen’s report
and testimony is denied.
H. Relators’ Motion to Exclude Certain Opinions of Anupam Jena
Relators filed a motion to limit the opinions of Anupam Jena, (“Jena Motion,” ECF No.
181), along with a brief in support of the Motion, (“Jena Moving Br.,” ECF No. 277). Janssen
opposed the Motion, (“Jena Opp’n Br.,” ECF No. 215), to which Relators replied (“Jena Reply,”
ECF No. 253). Janssen identified Jena to opine on issues of causation and damages, and to respond

Evans focuses on Strand’s testimony that she would occasionally send OL Intelence studies to the sales force.
However, Evans ignored that Strand testified that she sent OL studies with a directive to her team that the studies were
for background only and could not be used on sales calls with HCPs.
8

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to Shaked’s opinions and analyses on those same topics. (Chuderewicz Decl., Ex. A, ECF No.
194-3.)
Jena organized his report into three main sections: (1) HIV treatment background; (2)
assessing causation with respect to Janssen’s alleged improper promotion in the current case; and
(3) assessing causation with respect to Janssen’s speaker payments in the current case. (Ellerbe
Decl., Ex. 25, “Jena Report” ¶¶ 16–63, ECF Nos. 279-6.) Jena organized his rebuttal report in two
main sections: (1) a discussion of Shaked and Dew’s causation conclusions (“Causation Opinion”),
and (2) a discussion of Shaked’s damages estimates (“Damages Opinion”). (Ellerbe Decl., Ex. 24
“Jena Rebuttal Report” ¶ 3, ECF. No. 279-5.) In sum, Jena’s reports conclude: (1) Shaked’s
analysis with respect to causation is flawed because he did not use the appropriate data, methods,
and accounting for external factors to correctly conclude that Janssen caused false claims to be
written through speaker payments and OL marketing; and (2) the correct damages calculation for
Relators’ claims is approximately $0 once the analyses accounts for the purported issues. (Jena
Report ¶¶ 10–15, Jena Rebuttal Report ¶¶ 12, 14, 63, 122–125.)
Relators seek to strike portions of Jena’s reports and testimony that “are based on erroneous
legal principles or which implicate such principles.”9 (Jena Moving Br. at 4.) Relators contend
that certain parts of Jena’s report are inadmissible because: (1) he “applies a standard that is
contrary to the law”; (2) he “ignored substantial evidence in the record”; and (3) his opinions on
damages “have no basis in the law and do not support reducing damages to zero.” (Id. at 8, 17,
19.) Relators argue that Jena’s requirement of a “direct causal link” is “directly contrary” to the
law regarding liability and causation under the FCA. (Id. at 12.) Thus, Relators argue that Jena’s

Relators have asked this Court to exclude the following paragraphs of Jena’s Expert Report: ¶¶ 11, 25, 27–29, 33–
34, 54, 57–58, 60, 62, and 64. (Jena Moving Br. at 4–5.) Relators have also asked to exclude the following paragraphs
of Jena’s Expert Rebuttal Report: ¶¶ 3, 5-8, 11 (bullets 3–5), 12–17, 20, 37–40, 43–45, 52–54, 63–65, 84, 86–87, 91,
93–97, 99, 100–15, and 118–25. (Id. at 5.)
9

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opinions are unreliable, irrelevant, and confusing to a jury. (Id. at 14.) Relators also argue that
Jena failed to review evidence and reviewed only five of the eighteen depositions taken in this
case. (Id. at 17.) Relators contend that these purported issues cause Jena’s Damages Opinion to
be unsupported and thus inadmissible. (Id. at 20.)
In opposition, Janssen argues that “Jena appropriately evaluated the issues of causation and
claimed damages from a scientific perspective using his broad experience in the fields of
economics, statistics, and medicine.” (Jena Opp’n Br. at 1.) According to Janssen, Jena opines on
whether Shaked’s correlation analyses are sufficient to show a causal relationship between
promotion and prescription numbers or payment and prescription numbers, not whether there is a
direct causal relationship between each respectively. (Id. at 3–4.) As such, Janssen argues that
Jena’s opinion is consistent with the generally accepted standards in economics and medicine, as
well as the relevant legal standards under the FCA and admission of scientific evidence. (Id. at 9.)
Janssen further argues that Jena’s opinions are based on a sufficient factual foundation, consisting
of what he considered to be pertinent court documents and publicly available materials. Finally,
Janssen argues Jena’s removal of and reductions to Shaked’s damages estimates are appropriate
under FCA law. (Id. at 22–27.)
In its reply, Relators emphasize that Jena applies a direct “but for” test rather than the
“substantial factor” test. (Jena Reply at 1–2; Ellerbe Decl., Ex. 23, “Jena Dep.” 59:4-60:4, ECF
No. 279-5.) Relators argue that Jena’s opinions are premised on the application of a “but for”
causation; to this point, Relators argue that Jena admitted to using “but for” causation analysis in
his deposition. (Jena Reply at 2–3; see Jena Dep. 59:4-60:4.) Furthermore, Relators take issue
with Jena’s position that “prescriptions written 6 months after Janssen’s unlawful conduct should
not be included in the case for purposes of causation or damages[,]” arguing that the FCA and

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AKS do not impose strict temporal cutoffs for false claims. (Jena Reply at 9–10.) Relators also
argue that Jena should have considered Wilhelm’s and Strand’s testimony when considering
causation and damages. (Id. At 11–13.) Finally, Relators argue that certain of Jena’s Damages
Opinion is contrary to applicable law because legal precedents do not support his damages
calculations. (Id. at 13–15.)
Jena is appropriately qualified to opine on the matters in his report. Though Jena does not
hold any degrees in statistics, he holds a Ph.D. in Economics and has extensive experience studying
and analyzing physician behavior in the microeconomic context. (Jena Report at 35, 41–42, 44–
60.) Jena uses the same data as Shaked, “corrects” Shaked’s data, methodology, and conclusions
(an appropriate subject for a rebuttal expert and an important point of view for the jury), and puts
forth calculations based on Jena’s expertise and Janssen’s defense. (Id. at ¶¶ 60–63; Jena Rebuttal
Report ¶¶ 22–45, 66–125.) Thus, Jena reliably applies his expertise to his Causation Opinion and
Damages Opinions, raising criticisms and concerns about Shaked’s methodologies.

(Id.)

Although Relators may critique Jena’s assumptions, the Court finds that Jena’s Causation Opinion
and Damages Opinions are reliable because they stem from Jena’s analytical modeling expertise
and arise from the same set of data Shaked utilized. Furthermore, the Court finds that Jena’s
opinions are relevant because they provide Janssen’s views of causation and damages based on
Janssen’s view of the facts.
Relators’ motion and reply focus heavily on Jena’s supposed improper application of a
legal standard to the facts of the case. (Jena Reply at 5–6.) Relators argue that the application of
an improper legal standard causes Jena’s opinion to not fit the facts of the case. (Id. at 1–3.) If
this were true, it would be a cause for concern. The Court does not find support for Relators’
argument that Jena is applying the incorrect legal standard to reach his conclusion. In his report,

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Jena points to other factors that doctors may consider, which are supported by his own study of
doctors’ behavior and his own practice of medicine. (Jena Report at 35, 41–42, 44–60.) He
discusses his rationale for excluding certain calculations and how his method differs from
Shaked’s. (See, e.g., Jena Rebuttal Report at ¶¶ 114–24.)
Where Relators point to Jena’s testimony as bases for exclusion, the testimony does not
support what Relators argue. As one of their primary bases for exclusion, Relators argue that Jena
agreed that he applied direct (“but for”) causation principles during his deposition. (Jena Dep.
59:19-60:4.) Jena admitted several times that he is testifying as a doctor and economist, not as a
lawyer. (Jena Dep. 61:6-12.) As such, his testimony’s reliability and relevance should be
considered with respect to his expertise in these fields. The Court does not find it surprising that
Janssen’s expert, opining in support of Janssen’s defense with respect to causation, discusses at
length the absence of direct evidence in the record as to causation. However, to the extent that
Relators believe that Jena applies the incorrect legal test with respect to causation, that issue can
be adequately tested by cross-examination. Ultimately, the Court will articulate the proper legal
standard for causation to the jury.
Relators criticize Jena’s damage reductions as contrary to law. (Jena Reply 13–15.) In
part, Relators point to ZF Meritor as proof that Jena’s report and testimony should be excluded
because it apparently shows that an expert cannot form a reliable opinion through a selective
review of the evidence. (Jena Moving Br. at 17–18.) ZF Meritor supports the notion that existence
of conflicting evidence is not a basis on which to exclude an expert’s testimony. 696 F.3d 254,
290 (3d Cir. 2012). “The respective credibility of Plaintiffs’ and [Defendant]’s experts [is] a
question for the jury to decide.” Id. at 290. The damages expert in ZF Meritor was excluded
because he could not reliably estimate damages from speculative assumptions and the facts on the

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record. Id. at 294. Here, the facts are bare insofar; as noted in this Court’s recent decision denying
Summary Judgment, most of the material facts in this case are in dispute. Additionally, the
assumptions arise from each party’s view of the case; because no facts have been proven at this
point, it is difficult for the Court to determine whether Jena’s (or Shaked’s) assumptions are indeed
speculative.
“[E]xclusion of critical evidence is an ‘extreme’ sanction . . . .” Konstantopoulos v.
Westvaco Corp., 112 F.3d 710 (3d Cir. 1997). Although Relators may disagree, Jena’s opinions
are informed by Janssen’s version of events, which is not a basis to exclude an otherwise reliable
and relevant opinion. Accordingly, the Court will deny Janssen’s motion to exclude the expert
testimony of Anupam B. Jena.
I. Relators’ Motion to Limit the Testimony of Eric S. Rosenberg
Relators filed a motion to limit the testimony of Eric S. Rosenberg, (“Rosenberg Motion,”
ECF No. 183), along with a brief in support of the Motion, (“Rosenberg Moving Br.,” ECF No.
278). Janssen opposed the Motion, (“Rosenberg Opp’n Br.,” ECF No. 209), to which Relators
replied (“Rosenberg Reply,” ECF No. 255). Janssen identified Rosenberg as an expert in
infectious diseases, HIV therapies, and strategies surrounding the management of HIV-infected
individuals. (Ellerbe Decl., ECF No. 187-3 at 3–4; Rosenberg Reply at 1.)
Rosenberg is Janssen’s HIV expert and the opposing expert to Relators’ HIV expert, Dr.
Aaron Glatt.

(Ellerbe Decl., Ex 28, “Rosenberg Rebuttal Report” ¶ 3, ECF No. 279-8.)

Rosenberg’s report provides an overview of a general practitioner’s choices when treating a patient
with HIV/AIDS, goals of treatment, materials doctors may use to reach their goals of treating
patients with HIV/AIDS, and Rosenberg’s experience treating patients with HIV/AIDS. (Ellerbe
Decl., Ex. 29, “Rosenberg Report” ¶¶ 9–13, ECF No. 279-9.) Rosenberg’s rebuttal report provides

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additional context on the treatment of HIV/AIDS patients with OL uses of medications, comments
on Glatt’s report, and provides Rosenberg’s personal experience with treating such patients.
(Rosenberg Report ¶¶ 34, 42–46; Rosenberg Rebuttal Report ¶¶ 3, 7, 13, 14–16, 19.)
Relators have asked the Court to preclude Rosenberg from testifying beyond clinical or
medical background about HIV/AIDs and the types of drugs used in its treatment. (Rosenberg
Moving Br. at 5.) Relators assert Rosenberg’s report and testimony is inadmissible because: (1)
Rosenberg’s personal approach to prescribing drugs and utilizing multiple sources of information
is irrelevant, and unreliable with no fit to the issues of the case; and (2) testimony about appropriate
OL use of drugs is irrelevant to drug marketing practices at issue in the case and is likely to mislead
the jury. (Id. at 13–14.) Relators do not challenge the use of Rosenberg’s testimony for “providing
medical background and explanations about HIV/AIDS and the drugs used to treat it,” but they do
request that this Court limit Rosenberg’s testimony when he goes beyond this function.
(Rosenberg Reply at 4.)
In opposition, Janssen argues that Rosenberg’s testimony is reliable due to his experience
and his testimony is relevant because it is a key component of Janssen’s causation defense.
(Rosenberg Opp’n Br. at 1.) Janssen contends Rosenberg’s testimony is reliable because it comes
from his experience as a physician specializing in HIV/AIDS. (Id. at 4.) Furthermore, Janssen
claims that Rosenberg does not opine on inadmissible topics, such as testimony “concerning what
all doctors generally consider.” (Id. at 5.) Finally, Janssen claims that Rosenberg’s testimony is
relevant because it would help the jury understand Janssen’s causation defense. (Id. at 7–8.)
Relators argue there are three “fatal problems” with Janssen’s argument. (Rosenberg Reply
at 6.) First, Janssen attempts to use Rosenberg to opine as to the effects of OL marketing even
though Rosenberg himself readily admits he does “not feel qualified to offer an expert opinion

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regarding the effects of promotional marketing.” (Id. at 5.) Second, Janssen improperly attempts
to misconstrue Rosenberg’s testimony as applicable to other doctors. (Id. at 7.) Relators contend
Rosenberg did not offer his opinion to speculate on how other HIV experts treat HIV patients;
instead, Rosenberg’s report explains what sources of information he relies on when deciding which
medication to prescribe. (Id.) Third, the court should reject the general concept that doctors glean
knowledge from various sources because it is well within an average layperson’s understanding.
(Id. at 7–8.) For these points, Relators ask the Court to exclude all aspects of Rosenberg’s opinions
beyond the clinical or medical background he provides about HIV/AIDS and the types of drugs
used to treat it. 10 (Id. at 15.)
The Court has reviewed Rosenberg’s qualifications. He has a plethora of experience
diagnosing and treating patients with HIV/AIDS and has many journal articles on treating
HIV/AIDS. (Rosenberg Report at 24–26, 30–40.) The Court finds that Rosenberg is qualified to
opine on treating and prescribing HIV/AIDS patients. As such, the Court finds that Rosenberg’s
professional opinions on HIV/AIDS are very reliable. Rosenberg’s personal opinions about
prescribing drugs, using multiple sources of information, and the appropriate OL use of drugs are
relevant to Janssen’s causation defense. Accordingly, the Court finds that Rosenberg’s opinions
also fit the facts of the case.
The Court agrees with Relators that any attempt to move beyond the purviews of explaining
how Rosenberg reaches his prescription decision would be inadmissible. However, Rosenberg has
not. He clearly delineates what his testimony and report opine on (his methods for prescribing

Relators have asked this Court to exclude “Dr. Rosenberg’s testimony to the extent that it ventures beyond
explanations of the disease state and the drugs themselves.” (Rosenberg Reply at 4.) Among other examples, Relators
point to several examples that Rosenberg may move beyond his medical and professional expertise to opine on
inadmissible points. (Rosenberg Report, ¶¶ 34, 42-46; Rosenberg Rebuttal Report, ¶¶ 7, 16; Ellerbe Decl., Ex. 27,
“Rosenberg Dep.” 12:22-25, 22:5-7, 25:19-25, 29:8-20, 41:18-42:14, 90:23-92:8, 93:2-14, 134:24-135:5, ECF No.
279-7.)
10

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HIV/AIDS medications to patients) and what it does not (marketing, what the average doctor
should do). (Rosenberg Report ¶¶ 34, 42–46; Rosenberg Rebuttal Report ¶¶ 3, 7, 13, 14–16, 19.)
As the Court found above, Rosenberg is qualified to opine on the subject through his credentials
and experience, has good grounds to discuss such topics due to his extensive experience as an
HIV/AIDS specialist, and it fits a point that Janssen is raising as a defense (that a doctor considers
a variety of factors in prescribing medicine). The Court finds that these concerns can be raised at
trial if they are salient. See Daubert, 509 U.S. at 596. Therefore, the Court will deny Relators’
Motion to limit certain opinions of Eric S. Rosenberg.
IV.

CONCLUSION
For the foregoing, the Court rules as follows:
1. Janssen’s Motion to Exclude the Testimony of O’Reilly is GRANTED in part and DENIED
in part. Specifically, O’Reilly’s testimony is limited to background information regarding
the drug approval process, misbranding in general, the mechanism by which the
government reimburses for prescriptions, and his observations regarding Janssen’s
compliance efforts. As discussed, O’Reilly is not permitted to provide legal conclusions.
2. Janssen’s Motion to Exclude the Testimony of Sillup is DENIED.
3. Janssen’s Motion to Exclude Certain Opinions of Schafermeyer is DENIED.
4. Janssen’s Motion to Exclude Certain Opinions of Glatt is GRANTED. Glatt will not be
permitted to opine on how Janssen’s OL promotion and marketing impacted physicians’
prescribing decisions.
5. Janssen’s Motion to Exclude the Testimony of Evans is GRANTED in part and DENIED
in part. Evans will not be permitted to testify that Janssen used its Speaker Programs to
induce doctors to prescribe Prezista and Intelence.

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6. Janssen’s Motion to Exclude the Testimony of Shaked and Dew is DENIED.
7. Relators’ Motion to Exclude the Testimony of Smollen is DENIED.
8. Relators’ Motion to Exclude Certain Opinions of Jena is DENIED.
9. Relators’ Motion to Exclude Certain Opinions of Rosenberg is DENIED.
An appropriate order follows.

Dated: January 10, 2022
s/ Zahid N. Quraishi
ZAHID N. QURAISHI
UNITED STATES DISTRICT JUDGE

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