United States of America et al v. Biogen Idec Inc.

Filing 611

Judge Indira Talwani: ORDER entered. MEMORANDUM AND ORDER. Biogen's Motion to Exclude Testimony of Dr. Samuel Pleasure [Doc. No. 509 ], Motion to Exclude Testimony Dr. Richard Schwartzstein [Doc. No. 510 ], and Motion to Excl ude the Testimony of Margie Kuo [Doc. No. 512 ] are GRANTED IN PART and DENIED IN PART. Biogen's Motion to Exclude the Testimony of Dr. Joseph Ross [Doc. No. 511 ], Motion to Exclude the Testimony of Mark Scallon [Doc. No. [5 13]], and Motion to Exclude the Testimony of Janis Crum [Doc. No. 514 ] are GRANTED IN PART and DENIED IN PART and remain under advisement in part. Biogen's Motion to Exclude the Testimony of Dr. Meredith Rosenthal [Doc. No. 515 ] remains under advisement. Relator's Motion to Exclude Portions of the Report and Testimony of Nathan S. Basseen [Doc. No. 498 ] is DENIED. Relator's Motion to Exclude Portions of the Expert Report and Testimony Dr. Eric Gaier [Doc. No. 497 ], Motion to Exclude Portions of Expert Report and Testimony of Dr. Maria Houtchens [Doc. No. 499 ], Motion to Exclude Portions of Expert Report and Testimony of Katherine Norris [Doc. No. 500 ], and Motion to Exclude Portions of Expert Report and Testimony of Dennis Kowalski [Doc. No. 501 ] remain under advisement. IT IS SO ORDERED. Please see attached. (Kelly, Danielle)

UNITED STATES DISTRICT COURT
DISTRICT OF MASSACHUSETTS
UNITED STATES OF AMERICA, et al.,
ex rel. MICHAEL BAWDUNIAK,
Plaintiff-Relator,
v.
BIOGEN IDEC, INC.,
Defendant.

*
*
*
*
*
*
*
*
*
*

Civil Action No. 1:12-cv-10601-IT

MEMORANDUM & ORDER
July 8, 2022
TALWANI, D.J.
Plaintiff-Relator Michael Bawduniak’s Third Amended Complaint (“Complaint”) [Doc.
No. 132] charged Defendant Biogen Idec, Inc. (“Biogen”) with causing healthcare providers
(“HCPs”) to file fraudulent Medicare and Medicaid reimbursement claims in violation of the
False Claims Act, 31 U.S.C. § 3729, et seq., and various state laws, by paying kickbacks to
influence them to prescribe Biogen’s multiple sclerosis (“MS”) products in violation of AntiKickback Statute (“AKS”), 42 U.S.C. § 1320a-7b.
Pending before the court are Relator’s Daubert Motions [Doc. Nos. 497, 498, 499, 500,
and 501] and Biogen’s Daubert Motions [Doc. Nos. 509, 510, 511, 512, 513, 514, and 515]. In
this Memorandum and Order, the court addresses common issues raised in the Daubert motions.
The court then addresses several of Biogen’s motions individually, and will address the
remainder of the motions separately.
I.

Legal Standard
At the outset, “[t]he court must decide any preliminary question about whether a witness

is qualified, a privilege exists, or evidence is admissible.” Fed. R. Evid. 104(a). A witness

“qualified as an expert by knowledge, skill, experience, training or education” may offer expert
testimony only 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. The party proffering expert testimony must show, by a preponderance
of the evidence, that the testimony satisfies the requirements of Rule 702. See Bricklayers &
Trowel Trades Int’l Pension Fund v. Credit Suisse Secs. (USA) LLC, 752 F.3d 82, 96 (1st Cir.
2014). Courts have a “gatekeeping responsibility” to determine whether the testimony an expert
seeks to offer satisfies these criteria. Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 589
n.7, 592 n.10 (1993).
The district court has “considerable latitude” in “deciding whether expert testimony is
helpful to the jury.” United States v. Monell, 801 F.3d 34, 45 (1st Cir. 2015). Further, “trial
judges may evaluate the data offered to support an expert’s bottom-line opinions to determine if
that data provides adequate support to mark the expert’s testimony as reliable.” Ruiz-Troche v.
Pepsi Cola of P.R. Bottling Co., 161 F.3d 77, 81 (1st Cir. 1998). “Nothing in either Daubert or
the Federal Rules of Evidence requires a district court to admit opinion evidence that is
connected to existing data only by the ipse dixit of the expert. A court may conclude that there is
simply too great an analytical gap between the data and the opinion proffered.” Gen. Elec. Co. v.
Joiner, 522 U.S. 136, 146 (1997).
With respect to the reliability of the principles and methods applied, “[i]n Daubert, the
Supreme Court set forth four general guidelines for a trial judge to evaluate in considering
whether expert testimony rests on an adequate foundation: (1) whether the theory or technique

2

can be and has been tested; (2) whether the technique has been subject to peer review and
publication; (3) the technique’s known or potential rate of error; and (4) the level of the theory or
technique’s acceptance within the relevant discipline.” Beaudette v. Louisville Ladder, Inc., 462
F.3d 22, 26 (1st Cir. 2006) (internal quotation marks and citation omitted). “However, these
factors do not ‘constitute a definitive checklist or test,’ and the question of admissibility ‘must be
tied to the facts of a particular case.’” Id. (quoting Kumho Tire Co. v. Carmichael, 526 U.S. 137,
150 (1999)). “The object of Daubert is ‘to make certain that an expert, whether basing testimony
on professional studies or personal experience, employs in the courtroom the same level of
intellectual rigor that characterizes the practice of an expert in the relevant field.’” Milward v.
Acuity Specialty Prod. Grp., Inc., 639 F.3d 11, 15 (1st Cir. 2011) (quoting Kumho Tire, 526 U.S.
at 152).
“So long as an expert’s scientific testimony rests upon good grounds, based on what is
known, it should be tested by the adversarial process, rather than excluded for fear that jurors
will not be able to handle the scientific complexities.” Id. (internal quotation marks and citation
omitted). “Vigorous cross-examination, presentation of contrary evidence, and careful instruction
on the burden of proof are the traditional and appropriate means of attacking shaky but
admissible evidence.” Id. (quoting Daubert, 509 U.S. at 596).
In a civil case, “[a]n opinion is not objectionable just because it embraces an ultimate
issue.” Fed. R. Evid. 704. However, “the Daubert Court imposed a special relevancy
requirement.” Ruiz-Troche v. Pepsi Cola of Puerto Rico Bottling Co., 161 F.3d 77, 81 (1st Cir.
1998). “To be admissible, expert testimony must be relevant not only in the sense that all
evidence must be relevant, but also in the incremental sense that the expert’s proposed opinion, if

3

admitted, likely would assist the trier of fact to understand or determine a fact in issue.” Id.
(internal quotation marks and citations omitted).
Moreover, the court may exclude “relevant evidence if its probative value is substantially
outweighed by the danger of unfair prejudice, confusion of the issues, or misleading the jury.”
Daubert, 509 U.S. at 595. “[I]n weighing possible prejudice against probative forces under Rule
403 . . . [the court] exercises more control over experts” than lay witnesses. Id. (internal
quotation omitted).
II.

Discussion
A.

Common Issues
1. Statements Regarding Intent

Biogen moves to exclude certain portions of testimony of Dr. Samuel Pleasure1, Dr.
Richard Schwarztein2, Dr. Joseph Ross3, Margie Kuo4, Mark Scallon5, and Janis Crum6 because

1

Dr. Pleasure opines, in part, on whether speaker and consultant programs were held by Biogen
with educational or legitimate medical purpose. Pleasure Rep. [Doc. No. 516-1].
2

Dr. Schwarztein opines, in part, on the educational value of speaker programs based on certain
markers identified in his report. Schwartzstein Rep. [Doc No. 516-2].
3

Dr. Ross opines, in part, on what constitutes a modest meal with respect to speaker programs
and the temporal impact of payments on prescribing by practitioners. Ross Rep. [Doc. No. 5163]. Dr. Ross also responds to the expert rebuttal testimony of Dr. Eric Gaier, Biogen’s damages
expert. Ross Rebuttal Rep. [Doc. No. 516-4].
4

Kuo opines, in part, on whether speaker, consultant, and training programs were designed for
legitimate needs based on certain markers identified in her expert report. Kuo Rep. [Doc. No.
516-6].
5

Scallon opines, in part, on the blending methodology Biogen relied upon for its fair market
value (“FMV”) analysis with respect to the appropriateness of payments made to consultants.
Scallon Rep. [Doc. No. 516-7].
Crum opines, in part, on Biogen’s compliance programs. Crum Rep. [Doc. No. 516-8]. Crum
also responds to the expert rebuttal testimony of Katherine Norris, Biogen’s compliance expert.
Crum Rebuttal Rep. [Doc. No. 516-9].
6

4

they, to some extent, opine on Biogen’s intent. See Mots. [Doc. Nos. 509, 510, 511, 512, 513,
514].7 Relator too moves to exclude certain portions of expert testimony of Nathan Basseen8 for
impermissibly opining on Biogen’s intent. See Mot. [Doc. No. 498].
“A party’s intent or state of mind is not the proper subject of expert testimony.”
OneBeacon Am. Ins. Co. v. Com. Union Assurance Co. of Can., 804 F. Supp. 2d 77, 85 (D.
Mass. 2011), aff’d, 684 F.3d 237 (1st Cir. 2012). For one, “an expert cannot bring any scientific,
technical, or specialized knowledge to bear on another person’s knowledge.” U.S. ex rel. Dyer v.
Raytheon Co., 2013 WL 5348571, at *13 (D. Mass. Sept. 23, 2013). Accordingly, questions
regarding a party’s intent “presents the type of judgment that jurors historically have made
without the assistance of expert testimony.” United States v. Pires, 642 F.3d 1, 12 (1st Cir.
2011). Moreover, “[b]ecause [expert] testimony can carry with it an unwarranted ‘aura of special
reliability and trustworthiness’, courts must guard against letting it intrude in areas that jurors,”
armed with “common experience, are uniquely competent to judge without the aid of experts.”
Id. (quoting United States v. Fosher, 590 F.2d 381, 383 (1st Cir. 1979)).

Biogen cites passages from each report to illustrate Relator’s experts opining on the ultimate
question of Biogen’s intent. See e.g., Pleasure Rep. 22 [Doc. No. 516-16] (“[I]t is my opinion
that Biogen’s Speaker Programs were designed in part to influence the prescribing behavior of
speaker and attendees”); Schwartzstein Rep. 15 [516-2] (“Were the intent of the sessions to
maximize learning, organizers would not…”); Ross Rpt. 6 [Doc. No. 516-3] (“[I]n my opinion,
Biogen intended that the payments it provided to speakers . . . would reward and induce
prescriptions for Biogen’s products indicated for the treatment of multiple sclerosis”); Kuo Rep
Doc. 5 [Doc. No. 503-36] (“Biogen knowingly exploited legitimate marketing tools and
concepts”); Scallon Rep. 105 [Doc. No. 516-7] (“[I]t is my professional opinion that Biogen
intentionally inflated the HCP meals caps in 2009”); Crum Rep. 43 [Doc. No. 516-8] (“[T]he
purpose of [certain consultant] meetings was to inform and persuade rather than to gather
input…”).
7

Basseen seeks to rebut Scallon’s expert testimony and opines, in part, whether the evidence
related to the FMV analysis supports finding Biogen’s intent to pressure for higher rates and
whether an industry practice of rate blending methodology exists. Basseen Rep. [Doc. No. 50211].
8

5

Relator generally contends that his experts’ testimony is admissible where the experts
merely opine about facts from which a jury might infer intent rather than on the ultimate question
of intent. To be sure, an expert may opine on industry standards and what constitutes deviations
from such standards. But an expert may not then opine on Biogen’s intent in light of any alleged
non-conformance with standards. For “[i]nferences about the intent or motive of parties or others
lie outside the bounds of expert testimony.” In re Zofran (Ondansetron) Prod. Liab. Litig., 2019
WL 5685269, at *9 (D. Mass. Nov. 1, 2019) (citing In re Solodyn (Minocycline Hydrochloride)
Antitrust Litig., 2018 WL 734655, at *2 (D. Mass. Feb. 6, 2018). As the examples above show,
the testimony of Relator’s experts goes a step too far and leaves no room for the jury to draw its
own inferences as to Biogen’s intent. While Relator’s experts may opine about standards and
alleged non-conformance with such standards from which a jury might infer intent, the experts
may not offer their opinions as to what inferences can be drawn. Such testimony is excluded.
With respect to Basseen, a portion of Basseen’s testimony at issue is offered to rebut
Scallon’s assertions. See e.g., Basseen Rep. 27 [Doc. No. 502-11] (“Mr. Scallon lacks any basis
to conclude that Biogen applied pressure on Huron or Navigant to provide higher rates”). That
issue is rendered moot where Scallon may not opine on Biogen’s intent. The remaining
testimony cited by Relator, such as that certain evidence “supports the notion that Biogen did not
pressure Huron and Navigant to increase rates or have undue influence in the rate setting
process” is not testimony as to Biogen’s intent but testimony as to alleged facts from which the
jury may infer intent.
Accordingly, Biogen’s Daubert motions are granted to the extent they seek to exclude
portions of testimony of experts opining on Biogen’s intent. Relator’s motion to exclude certain
portions of Basseen’s expert testimony is denied.

6

2. Narrative Summaries of the Evidence
Courts generally do not permit experts to narrate the record by characterizing and
summarizing documents and the testimony of other witnesses. “[A] narrative summary of [a
company’s] documents” should “be presented directly to a factfinder” through a fact witness, not
an expert. In re Zofran, 2019 WL 5685269, at *9. Narrative testimony by expert witnesses usurps
the role of fact witnesses. See Raytheon Co., 2013 WL 5348571 at *12. Such testimony also
usurps the role of the jury to weigh the evidence and to draw credibility assessments and ultimate
conclusions. Specifically, “[c]redibility determinations, the weighing of the evidence, and the
drawing of legitimate inferences from the facts are jury functions.” Hunt v. Cromartie, 526 U.S.
541, 552 (1999).
Biogen moves to exclude certain portions of testimony of Dr. Pleasure, Dr. Ross, Scallon
and Crum that Biogen contends are narrative summaries of the record evidence and their
interpretations. See Mots. [Doc. Nos. 509, 511, 513, 514]. In the case of Dr. Pleasure, Biogen
further contends that Dr. Pleasure improperly makes credibility determinations. See Mot. [Doc.
No. 509]; see also Pleasure Rep. 48 [Doc. No. 516-1] (“Witnesses attempted to explain such
troubling documents, but I found the witnesses explanations of their own documents and emails
non-credible”).
In response, Relator makes three general arguments: (i) there is no need to make any
ruling at this time as the information cited by experts is likely to be in evidence prior to the
expert testifying, removing the need for the expert to reprise it; (ii) the experts set forth the full
basis of their opinions in their report as required, citing to “particularly relevant passages” of
evidence, and (iii) expert testimony about record evidence is appropriate when it involves

7

inferences that would not be apparent without the benefit of experience or specialized
knowledge, or when it involves complex frameworks.
Biogen is correct that experts may not assume the role of counsel in making narrative
arguments or cherry-picking documents, and the court will ensure that documents in the record
relied upon by the experts will be presented directly through fact witnesses. Similarly, the court
may exclude expert testimony if the court determines it is unhelpful to the jury when the issue
arises. Specifically, expert testimony that either characterizes the evidence or makes credibility
determinations will be excluded. See e.g., Pleasure Rep. 40 [Doc. No. 516-1] (“A Biogen witness
rationalized HCP Speakers subsequently attending a Speaker Program on the same subject on
which they had presented…”). However, to the extent that Biogen’s objections constitute
disagreement with expert opinions after an expert’s review of the record, such disagreement is
more appropriate for cross-examination at trial. For instance, Scallon identified a specific piece
of evidence, a note between Biogen and its third-party consultant, Huron, as part of the basis for
his conclusions that Biogen was involved in calculating FMV rates in 2011 in a manner
inconsistent with industry practice. Scallon Rep. 54 [Doc. No. 516-7]. Scallon may rely on his
expertise to explain the inferences he made from such document to arrive at his conclusion.
Accordingly, Biogen’s Daubert motions are granted to the extent they seek to exclude
narrative summaries of the record evidence and credibility determinations. Biogen’s Daubert
motions are denied to the extent they seek to exclude expert testimony explaining why the expert
found certain evidence meaningful for his or her conclusion.
3. Opinions on Legal Issues
Although “there is no blanket prohibition on expert testimony concerning the law,”
Adams v. New England Scaffolding, Inc., 2015 WL 9412518, at *5 (D. Mass. Dec. 22, 2015), a

8

“district court has broad discretion to exclude expert opinion evidence about the law that would
impinge on the roles of the judge and the jury.” Pelletier v. Main St. Textiles, LP, 470 F.3d 48,
54 (1st Cir. 2006). However, “[t]he line between testimony regarding what the law requires and
testimony describing how an industry practice typically operates is not always clear.” Ji v. Bose
Corp., 538 F. Supp. 2d 354, 358 (D. Mass. 2008). Testimony from an expert that describes
industry practices may incorporate the expert’s “understanding of the law,” but “the expert
cannot testify as to what the law requires.” Bacchi v. Massachusetts Mut. Life Ins. Co., 2016
WL 1170958, at *3 (D. Mass. Mar. 23, 2016).
Biogen contends that Kuo offers an opinion concerning a legal question where she opines
on whether conduct violated AKS or falls within a safe harbor provision. See e.g., Kuo Rep. 69
[Doc. No. 516-6] (Kuo opines that nine markers “were known in the industry to be indicia of
violations of the Anti-Kickback Statute”). Relator contends that pharmaceutical marketers
operate in a highly regulated setting and Kuo should be able to talk about marketers’ perceptions
of such industry practices, including standards pharmaceutical marketers respected to avoid
violations of AKS.
The court finds that Kuo’s testimony is admissible to the extent she opines on industry
standards used to avoid AKS violations, but she cannot opine as to what does or does not
constitute an AKS violation.
B.

Challenges to Experience, Reliability and Relevance

“Rule 702 has been interpreted liberally in favor of the admission of expert testimony.”
Levin v. Dalva Bros., Inc., 459 F.3d 68, 78 (1st Cir. 2006). “As such, expert witnesses need not
have overly specialized knowledge to offer opinions.” Id. Further, expert testimony supported by
relevant experience and third-party authorities is permitted under the Federal Rules of Evidence.

9

See Fed. R. Evid. 702 advisory committee notes, 2000 amend. (“Nothing in this amendment is
intended to suggest that experience alone— or experience in conjunction with other knowledge,
skill, training or education—may not provide a sufficient foundation for expert testimony”). “If a
witness relies primarily on experience, she 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.’” U.S. ex rel. Jones v. Brigham & Women's Hosp.,
678 F.3d 72, 94 (1st Cir. 2012) (quoting Fed. R. Evid. 702 advisory committee note).
“[E]xpert testimony must be predicated on facts legally sufficient to provide a basis for
the expert’s opinion.” Damon v. Sun Co., 87 F.3d 1467, 1474 (1st Cir. 1996) (internal citations
and quotations omitted). While “an expert should not be permitted to give an opinion that is
based on conjecture or speculation from an insufficient evidentiary foundation,” id., “Rule 702
does not demand that experts rely on all data that could be deemed relevant. It does not even
require the expert to seek out the best possible source of relevant information.” Lawes v. CSA
Architects & Engineers LLP, 963 F.3d 72, 101 (1st Cir. 2020).
Furthermore, “[n]otwithstanding the deep dive that courts often take to adequately assess
the reliability of expert methodology . . . they must stop short of weighing the evidence,
evaluating credibility, or unnecessarily picking sides in a battle between experts. Id. at 98. “In
carrying out this responsibility [of determining whether to admit or exclude relevant expert
testimony], the trial court must bear in mind that an expert with appropriate credentials and an
appropriate foundation for the opinion at issue must be permitted to present testimony as long as
the testimony has a ‘tendency to make the existence of any fact that is of consequence to the
determination of the action more probable or less probable than it would be without the
evidence.’” Pages-Ramirez v. Ramirez-Gonzalez, 605 F.3d 109, 115 (1st Cir. 2010) (quoting

10

Fed. R. Evid. 401). “An unduly restrictive review of the relevant expertise of a[n] [expert] is
incompatible with what we have characterized as a liberal standard of relevance.” Id.
Further, “mindful of the wide variety of matters on which expert testimony may be
useful, Federal Rule of Evidence 702 demands that the inquiry into an expert’s methodology
must be tailored to fit the circumstances of each particular case.” United States v. Encarnacion,
26 F.4th 490, 505 (1st Cir. 2022). “Especially outside of scientific fields, factors bearing on the
reliability of an expert’s methodology will vary.” Id; see also Fed. R. Evid. 702 advisory
committee notes (“[S]ome types of expert testimony will not rely on anything like a scientific
method, and so will have to be evaluated by reference to other standard principles attendant to
the particular area of expertise”).
1.

Dr. Pleasure

In his expert report, Dr. Pleasure identified ten characteristics of activities that lack
medical educational purpose or educational value. Pleasure Rep. 7-8 [Doc. No. 516-1]. In
addition to challenging Dr. Pleasure’s opinions regarding Biogen’s intent as discussed above,
Biogen moves to exclude Dr. Pleasure’s expert testimony regarding the markers he uses to
identify speaker programs that purportedly lack educational value. Specifically, Biogen contends
that Dr. Pleasure’s opinions are not supported by any external guidance or standard and Dr.
Pleasure cannot rely on his professional experience where he has no experience in the private
sector and has not attended a Biogen speaker program.
As already noted, Federal Rule of Evidence 702 does not preclude expert opinions based
on the expert’s experience alone. Relator contends that in assessing the educational value of
speaker programs, Dr. Pleasure applied his experience as a neurologist treating patients with MS,
including prescribing the Biogen drugs at issue, as well as decades of experience designing

11

educational programming. Further, Dr. Pleasure has previous experience evaluating the
educational value of speaker programs materials by way of his expert testimony in another trial.
Relator contends that Dr. Pleasure relied on that experience, and his experience as a researcher
and scientist designing and implementing medical studies, in his opinion on the legitimacy of
consulting programs. For his opinion on consultant programs, Dr. Pleasure also reviewed
medical literature regarding MS and purported “regional differences.”
The court finds that Dr. Pleasure’s professional career in an academic setting is sufficient
to allow him to opine regarding markers to identify speaker programs that purportedly lack
educational value.
Biogen further moves to exclude as unreliable portions of Dr. Pleasure’s testimony that
speaker programs with certain markers lacked educational value for attendees. Specifically,
Biogen argues that Dr. Pleasure (i) relies on arbitrary thresholds unrelated to the educational
value of speaker programs and (ii) forms opinions not based on his expertise.
Relator contends that Dr. Pleasure’s opinion is not arbitrary where he relies on objective
criteria or industry standards. For instance, in setting a 6-month temporal threshold for when
repeat attendance becomes educationally unjustified, Dr. Pleasure explained that guidelines
surrounding MS treatment usually change no more than once a year, HCPs typically retain
information effectively, and decks that do not present new scientific information are redundant.
Pleasure Rep. 36-39 [Doc. No. 516-1]. The fact that Dr. Pleasure set each threshold using what
he contends is a conservative measure (less than a year) is not a basis for excluding his
testimony. Having found that Dr. Pleasure has sufficient experience to form the bases for his
opinion with respect to educational value of speaker programs, all else that is required of Dr.
Pleasure is that he explain how he applied his experience to the facts to reach his conclusions.

12

The court finds that Dr. Pleasure has done so sufficiently here to allow his testimony.
Accordingly, Biogen’s motion is denied to the extent it seeks to exclude Dr. Pleasure’s testimony
on the basis that his markers are arbitrary or not based on his expertise. Biogen’s concerns are
best suited for cross-examination.
Biogen argues further that Dr. Pleasure (i) offers generalized opinions about the
educational value of thousands of Biogen programs and (ii) forms opinions based on speculation
with respect to what occurred at speaker meetings. Relator counters that the fact that Dr. Pleasure
has not attended a Biogen speaker program does not preclude him from applying relevant
educational principles to Biogen’s programming where he explains in detail the speaker related
materials he reviewed and how he formed their conclusions. Where Dr. Pleasure’s expertise is
generalized and not based on direct observation of Biogen’s programs, he may testify based on
his expertise as to the standards he would apply to such programs, and how the programs
compare with those indicia, leaving the jury to determine for itself the purpose of Biogen’s
speaker programs.
2.

Dr. Schwartzstein

Dr. Schwartzstein’s expert report opines on (i) standards and best practices for medical
education based on cognitive theory and relevant literature and (ii) whether specific activities
have educational value and benefits based on application of principles of adult learning and
education. Schwartzstein Rpt. 3 [Doc. No. 516-2]. Specifically, Dr. Schwartzstein opines that the
following six activities lack educational value: (1) an HCP attends two or more events on the
same slide deck within 6 months; (2) an HCP speaks and then attends an event on the same
subject within 12 months; (3) a speaker program that fails to present a slide deck or presentation
to attendees; (4) speaker programs held at immodest restaurants, resorts, or other lavish venues;

13

(5) speaker programs where the only audience member is a Biogen employee; (6) speaker
programs where an educationally inappropriate deck is presented to an inappropriate attendee. Id.
at 9.
As a threshold issue, Biogen moves to exclude the entirety of Dr. Schwartzstein’s
testimony as irrelevant to the jury’s evaluation of Biogen’s speaker programs. Biogen contends
that his opinions regarding cognitive theory and best practices impose inapplicable educational
standards to pharmaceutical companies’ speaker programs that are both promotional and
educational in nature. Biogen further contends that Dr. Schwartzstein’s testimony is irrelevant as
he opines on whether Biogen’s speaker programs were optimally educational rather than whether
they lacked educational value altogether. Regardless of whether Biogen’s speaker programs had
a dual purpose, one purpose proffered by Biogen was to educate. Dr. Schwartzstein’s expert
testimony is relevant to inform the jury of educational principles that it may then rely upon in
determining whether Biogen intended for the program to be educational. However, Dr.
Schwartzstein’s testimony that Biogen’s speaker programs were designed for optimal education
is not only irrelevant, and thus inadmissible for that reason, but also unhelpful to the jury where
the jury can make such determinations based on expert testimony put forth regarding educational
principles.
Second, Biogen moves to exclude portions of Dr. Schwartzstein’s expert opinion for
reasons similar to the challenge to Dr. Pleasure’s testimony: that Dr. Schwartzstein (i) relies on
arbitrary thresholds unrelated to the educational value of speaker programs and (ii) forms
opinions not based on his expertise.
Relator largely refutes Biogen’s motion in a similar manner as he did for Dr. Pleasure’s
testimony regarding educational markers. Dr. Schwartzstein is a Harvard Medical School

14

(“HMS”) professor specializing in medical education in university settings. He serves as the Vice
President for Education at Beth Israel Deaconess Medical Center (“BIDMC”) and Executive
Director of the Carl J. Shapiro Institute for Education and Research at BIDMC and HMS. Within
these roles, Dr. Schwartzstein designs curricula and educational activities for HCPs and medical
students, studies the effectiveness of educational activities, and works to broaden and strengthen
scholarship and innovation in medical education. As with Dr. Pleasure, the court finds that Dr.
Schwartzstein has sufficient experience to opine on the educational value of speaker programs.
Relator further contends that in forming his opinions regarding the educational value of
the speaker programs based on certain thresholds, Dr. Schwartzstein relied on his experience
designing educational programming and educational standards. For instance, Dr. Schwartzstein
stated that, “in [his] experience, when educating HCPs on drugs or therapies, the most engaging
programming includes information on new medical breakthroughs, clinical trials, or the latest
safety information.” Schwartzstein Rep. ¶ 22 [Doc. No. 516-2]. Dr. Schwartzstein explained that
he found “attending two or more events on the same slide deck within six months serves no
educational purpose and provides no educational benefit to the attendees” id. at ¶ 25, especially
where “board-certified neurologists, nurses, and physician assistants, treat MS patients with
some regularity and would already have experience with the MS drugs at issue, id. at 26. Relator
has sufficiently demonstrated that Dr. Schwartzstein properly applied his experience and
explained how he reached his conclusions such that he should be allowed to testify. Biogen’s
contentions that Dr. Schwartzstein’s markers are arbitrary are best suited for cross-examination.
Biogen also objects to Dr. Schwartzstein’s testimony where he has not attended a Biogen
speaker program. As with Dr. Pleasure, the court finds that not attending such programs does not
prevent him from applying relevant educational principles to Biogen’s programming where he

15

explains in detail the speaker related materials he reviewed and how he formed his conclusions.
Biogen’s argument that the data Dr. Schwartzstein reviewed was “cherry-picked” is unavailing
where Biogen does not provide additional detail as to why such a characterization is appropriate.
To be sure, “[i]f an expert ‘cherry picks’ favorable data . . . ignor[ing] a significant quantity of
other important facts, the trial court would be justified in concluding that the expert's testimony
is not based on sufficient facts or data.” 29 Charles Alan Wright & Arthur R. Miller, Federal
Practice and Procedure § 6268 (2d ed. 2017). But Biogen does not claim that the sample Dr.
Schwartzstein or any of the other experts reviewed is not representative of the speaker programs,
and thus the allegation that his opinion is based on a skewed perspective of speaker program
materials is unsupported.
Accordingly, the court finds that expert testimony is admissible, and does not constitute
speculation, where the expert reviews representative materials (or lack thereof) related to speaker
programs and opines on whether the materials could facilitate an educational experience for
attendees. To the extent that Biogen argues that the markers identified by the expert are arbitrary
or illogical, such objections are better suited for cross-examination. Again, however, the court
will limit Dr. Schwartzstein’s testimony based on his expertise to indicia that programs lack
educational value and assessment of how Biogen programs compare with those indicia, leaving
the jury to determine for itself the purpose of Biogen’s speaker programs.
3.

Margie Kuo

Margie Kuo is the founder and principal of MK Insights LLC, a strategic healthcare
marketing consultancy specializing in product launches and repositionings. Her clients include or
have included large pharmaceutical companies such as Pfizer, Boehringer Ingelheim and
AbbVie, as well as a number of smaller biotech companies. She is also a curricula designer and

16

an adjunct instructor at New York University School of Professional Studies Division of
Programs in Business. Since 2014, she has taught the first and last required courses, Campaign
Strategy and Execution and the Business Planning Capstone, in the University’s Master of
Science, Integrated Marketing Communications program. More recently, she designed and
developed New York University’s Certificate in Healthcare Marketing and Communications, and
its Executive Master of Science in Strategic Marketing and Communications.
Kuo is offering expert testimony to provide background on the standards for evaluating
HCP consultants, speaker trainings and speaker programs in the United States, how to translate
those standards into evaluative criteria, and how those standards are applied in practice. Kuo
Rep. 7 [Doc. No. 516-6]. Kuo identifies characteristics and other indicia that suggest that an
HCP engagement does not meet the standards for legitimate need and/or reasonable necessity to
achieve a commercially reasonable business purpose.
In addition to moving to exclude portions of Kuo’s testimony that Biogen argues opine
on Biogen’s intent and on questions of law, Biogen moves to exclude Kuo’s expert testimony
regarding three markers based on speaker program attendance thresholds that Biogen contends
are arbitrary, and without any external support or reliance on Kuo’s experience. To be clear,
Biogen does not challenge Kuo’s opinions that the underlying conduct is inappropriate, but
contests where she drew the line as to those practices.
In response, Relator cites to testimony from Kuo that provides her basis for the
attendance-based markers. For instance, Kuo testified that based on her experience there is little
educational value for an HCP to see the same program within a short period of time, particularly
in the case of a drug with which the HCP is already familiar with and which (like Tysabri and
Avonex) had been on the market for a long time. Kuo testified that she did have experience with

17

the issue of repeat attendance at Pfizer, where such a practice was discouraged and policies on
the point were covered in their handbook, and at Adamis, where a one seating policy was
employed. Kup Dep., Tr. at 155:1-5, 162:6-9 [Doc. No. 533-3]. The fact that Kuo could not
readily distinguish the commercial reasonableness of allowing an HCP to attend the same
presentation at six, seven or eight months is of no importance where in her opinion there would
likely be no reasonable business purpose to invite an HCP to view the same program at any of
those intervals. Again, that Kuo selected the threshold conservatively is not a basis for excluding
her testimony. Relying on her relevant experience, Kuo provided her reasoning as to the other
two attendance-based markers that Biogen seeks to challenge. See e.g., Kup Rep. 60 [Doc. No.
516-6] (“Events should not occur where fifty percent or more of the attendees are employees or
office colleagues of the speaker. In these cases, the speaker’s own employees, staff and
colleagues padded the attendance of a program and made it appear that there was sufficient
demand for the program, justifying the payment made to the speaker”).
Even if Kuo arrives at her attendance-based markers based on relevant professional
experience rather than peer-reviewed studies, “[v]igorous cross examination, presentation of
contrary evidence, and careful instruction on the burden of proof are the traditional and
appropriate means of attacking shaky but admissible evidence.” Lawes, 963 F.3d at 99.
Accordingly, Biogen’s motion to exclude Kuo’s testimony based on the disputed markers is
denied.
III.

Conclusion
For the foregoing reasons, Biogen’s Motion to Exclude Testimony of Dr. Samuel

Pleasure [Doc. No. 509], Motion to Exclude Testimony Dr. Richard Schwartzstein [Doc. No.
510], and Motion to Exclude the Testimony of Margie Kuo [Doc. No. 512] are GRANTED IN

18

PART and DENIED IN PART. Biogen’s Motion to Exclude the Testimony of Dr. Joseph Ross
[Doc. No. 511], Motion to Exclude the Testimony of Mark Scallon [Doc. No. 513], and Motion
to Exclude the Testimony of Janis Crum [Doc. No. 514] are GRANTED IN PART and DENIED
IN PART and remain under advisement in part. Biogen’s Motion to Exclude the Testimony of
Dr. Meredith Rosenthal [Doc. No. 515] remains under advisement. Relator’s Motion to Exclude
Portions of the Report and Testimony of Nathan S. Basseen [Doc. No. 498] is DENIED.
Relator’s Motion to Exclude Portions of the Expert Report and Testimony Dr. Eric Gaier [Doc.
No. 497], Motion to Exclude Portions of Expert Report and Testimony of Dr. Maria Houtchens
[Doc. No. 499], Motion to Exclude Portions of Expert Report and Testimony of Katherine Norris
[Doc. No. 500], and Motion to Exclude Portions of Expert Report and Testimony of Dennis
Kowalski [Doc. No. 501] remain under advisement.

IT IS SO ORDERED.
July 8, 2022

/s/ Indira Talwani
United States District Judge

19