United States District Court, S.D. West Virginia, Huntington Division
CLAUDE R. KNIGHT and CLAUDIA STEVENS, individually and as Personal Representatives of the Estate of Betty Erelene Knight, deceased, Plaintiffs,
BOEHRINGER INGELHEIM PHARMACEUTICALS, INC. Defendant.
MEMORANDUM OPINION AND ORDER
C. CHAMBERS UNITED STATES DISTRICT JUDGE
Memorandum Opinion and Order issued on May 31, 2018, this
Court dispensed with a majority of the pending motions in
this matter, including the parties' cross-motions for
summary judgment and related motions in limine.
Mem. Op. and Order, ECF No. 118. However, five
motions still remain unresolved: (1) Defendant's Omnibus
Motion to Exclude the Opinions of Plaintiff's General
Experts (“Defendant's Omnibus Motion”) (ECF
No. 47); (2) Defendant's Motion in Limine No. 2
to Exclude Evidence, Testimony, and Argument on Financial
Metrics (“Financial Metrics Motion”) (ECF No.
64); (3) Plaintiffs' Omnibus Motion in Limine
(“Plaintiffs' Omnibus Motion”) (ECF No. 73);
(4) Defendant's Motion in Limine No. 1 to
Exclude Evidence, Testimony, and Argument Regarding Alleged
Spoliation Issues, MDL Discovery Sanctions, and other
Litigation (“Motion to Exclude Spoliation”) (ECF
No. 63); and (5) Plaintiffs' Motion for Spoliation
Finding and Adverse Inference Charge (“Motion for
Sanctions”) (ECF No. 71). After holding a hearing on
June 5, 2018, during which parties offered argument regarding
each of those five remaining motions, the Court is prepared
and as explained below, the Court GRANTS, IN
PART and DENIES, IN
PART, Defendant's Omnibus Motion (ECF No. 47),
DENIES Defendant's Financial Metrics
Motion, GRANTS, IN PART and
DENIES, IN PART,
Plaintiffs' Omnibus Motion (ECF No. 73),
GRANTS, IN PART and
DENIES, IN PART,
Defendant's Motion to Exclude Spoliation (ECF No. 63),
and DENIES Plaintiffs' Motion for
Sanctions (ECF No. 71).
factual background of this matter, refer to the Court's
Memorandum Opinion and Order that was issued on May 31, 2018.
See Knight v. Boehringer Ingelheim Pharms., Inc.,
No. 3:15-cv-6424, 2018 WL 2470990, at *1-6 (S.D. W.Va. May
31, 2018) (Chambers, J.). Due to that lengthy recitation of
this case's facts, the Court will not repeat that
STANDARD OF REVIEW
702 of the Federal Rules of Evidence governs the
admissibility of expert witness testimony. A qualified
expert's testimony is admissible if it “rests on a
reliable foundation and is relevant[.]” Daubert v.
Merrell Dow Pharm. Inc., 509 U.S. 579, 597
(1993). There is no mechanistic test for determining if an
expert's proffered relevant testimony also is reliable.
Rather, “‘the test of reliability is
flexible' and ‘the law grants a district court the
same broad latitude when it decides how to determine
reliability as it enjoys in respect to its ultimate
reliability determination.'” United States v.
Wilson, 484 F.3d 267, 274 (4th Cir. 2007) (quoting
Kumho Tire Co. v. Carmichael, 526 U.S. 137, 141-42
(1999) (italics original in Kumho)).
fulfill its gatekeeping responsibility, the court must
determine whether: (1) “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;” (2) “the testimony is based on sufficient
facts or data;” (3) “the testimony is the product
of reliable principles and methods;” and (4) “the
expert has reliably applied the principles and methods to the
facts of the case.” Fed.R.Evid. 702(a)-(d). “This
entails a preliminary assessment of whether the reasoning or
methodology underlying the testimony is scientifically valid
and of whether that reasoning or methodology properly can be
applied to the facts in issue.” Daubert, 509
U.S. at 592-93.
considering reliability, the Court must ensure that the
expert opinions are “‘based on scientific,
technical, or other specialized knowledge and not on
belief or speculation, and inferences must be derived using
scientific or other valid methods.'” Nease v.
Ford Motor Co., 848 F.3d 219, 229 (4th Cir. 2017)
(italics original) (quoting Oglesby v. Gen. Motors
Corp., 190 F.3d 244, 250 (4th Cir. 1999)). While using
reliable or valid methods, the expert must also rely upon the
facts and data of the type that “experts in the
particular field would reasonably rely” upon.
Fed.R.Evid. 703. For instance, an expert may rely upon the
work of other individuals in his or her field, as well as the
testimony of a lay witness. See Gopalratnam v.
Hewlett-Packard Co., 877 F.3d 771, 789 (7th Cir. 2017)
(“Of course, as a general matter, there is nothing
objectionable about an expert relying upon the work of a
colleague.”); U.S. v. Mann, 712 F.2d 941, 942
(4th Cir. 1983) (rejecting a challenge to the admissibility
of an expert's opinion where the expert relied upon
another witness's testimony). However, as Rule 703
reflects, the determination regarding what constitutes
acceptable information to rely upon is context-dependent, and
specific to the field of the expert. Fed.R.Evid. 703 advisory
committee's note (noting that, for example, a physician
can rely upon a “considerable variety” of
information from “numerous sources”).
witnesses have the potential to be both powerful and quite
misleading[.]” PBM Prods., LLC v. Mead Johnson
& Co., 639 F.3d 111, 123 (4th Cir. 2011) (internal
quotation marks and citations omitted). Therefore, the
Court's gatekeeping role with respect to experts is
critical. When experts formulate opinions from existing data,
“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[-translation: “he himself said
it”-]of the expert.” Gen. Elec. Co. v.
Joiner, 522 U.S. 136, 146 (1997). When an expert's
opinion is based upon mere ispe dixit, “[a]
court may conclude that there is simply too great an
analytical gap between the data and the opinion
proffered.” Id. (citation omitted).
Adverse Instruction Standard Under Rule 37(e)
to the integrity of the judicial process, our adversarial
system relies upon the presentation of evidence to separate
the wheat from the chaff, and to reveal the truth of the
matter. See Silvestri v. General Motors Corp., 271
F.3d 583, 590 (4th Cir. 2001). Tampering with the
completeness of the necessary evidence may require court
action to ensure judicial integrity. See Id.
Spoliation refers to this inference with evidentiary
soundness, defined as “the destruction or material
alteration of evidence or [ ] the failure to preserve
property for another's use as evidence in pending or
reasonably foreseeable litigation.” Id.
(citing West v. Goodyear Tire & Rubber Co., 167
F.3d 776, 779 (2d Cir. 1999)). A federal court's power to
impose sanctions for spoliation arises both from “(1)
[Federal Rule of Civil Procedure] 37(e), and (2) its inherent
power . . . to redress conduct which abuses the judicial
process.” Steves & Sons, Inc. v. JELD-WEN,
Inc., No. 3:16-cv-545, 2018 WL 2023128, at *3 (E.D. Va.
May 1, 2018) (internal quotation marks omitted) (quoting
Silvestri, 271 F.3d at 590). Courts have broad
discretion when determining whether or not to impose
sanctions regardless of the source of the court's power
to do so. Id. (citing Turner v. United
States, 736 F.3d 274, 281 (4th Cir. 2013)).
37(e) governs a court's spoliation analysis concerning
electronically stored information (“ESI”).
Amended effective December 1, 2015, the relatively new
formulation of the rule provides in whole:
If electronically stored information that should have been
preserved in the anticipation or conduct of litigation is
lost because a party failed to take reasonable steps to
preserve it, and it cannot be restored or replaced through
additional discovery, the court:
(1) upon finding prejudice to another party from loss of the
information, may order measures no greater than necessary to
cure the prejudice; or
(2) only upon finding that the party acted with the intent to
deprive another party of the information's use in the
(A) presume that the lost information was unfavorable to the
(B) instruct the jury that it may or must presume the
information was unfavorable to the party; or
(C) dismiss the action or enter a default judgment.
Fed. R. Civ. P. 37(e). As laid out by the rule, a movant must
establish four threshold elements before a court may consider
the appropriateness of sanctions. Those four elements are:
“(1) the information should have been preserved, (2)
the information was lost, (3) the loss occurred because a
party failed to take reasonable steps to preserve it, and (4)
the information cannot be restored or recovered through
additional discovery.” In re Ethicon, Inc.,
No. 2:12-cv-497, 2016 WL 5869448, at *3 (S.D. W.Va. Oct. 6,
2016) (Goodwin, J.).
establishing the four-part threshold, a court must then
consider whether the movant has established one of two
options that would permit imposing sanctions. The first,
under Rule 37(e)(1), the Court may impose a proportional
sanction upon the finding of prejudice. Id. Rule
37(e)(2), the second option, requires a finding that a
“party acted with the intent to deprive the opposing
party of relevant information.” Fed.R.Civ.P. 37(e)(2).
If, and only if, a court makes that required finding of
intent to deprive, then a court may impose one of the three
more severe sanctions, which includes an adverse instruction.
In re Ethicon, Inc., 2016 WL 5869448, at *3.
Rule 37(e) clearly announces the required showings, that of
prejudice or intent to deprive, determining whether a
scenario meets those standards lacks certitude. Generally,
courts find prejudice when spoliation compromises a
party's ability to present its case. See Victor
Stanley, Inc. v. Creative Pipe, Inc., 269 F.R.D. 497,
532 (D. Md. 2010) (citing Silvestri, 271 F.3d at
593-94). Phased differently, prejudice arises when a party
“cannot present evidence essential to its underlying
claim.” Id. (internal quotation marks omitted)
(quoting Krumwiede v. Brighton Assocs., L.L.C., No.
05 C 3003, 2006 WL 1308629, at *10 (N.D. Ill. May 8, 2006)).
But lacking a rigid definition, prejudice “range[s]
along a continuum from an inability to prove claims or
defenses to little or no impact on the presentation of
proof.” Id. (internal quotation marks omitted)
(quoting Rimkus Consulting Gp., Inc. v. Cammarata,
688 F.Supp.2d 598, 613 (S.D. Tex. 2010)). Regardless of the
malleable standard for prejudice, determining whether
prejudice exists given a set of facts “necessarily
[requires] an evaluation of the information's importance
in the litigation.” Fed.R.Civ.P. 37, Comm. Notes on
finding of an intent to deprive, the Fourth Circuit has not
provided guidance regarding the level of intent required.
Steves & Sons, Inc., 2018 WL 2023128, at *10
(citing Jenkins, 2017 WL 362475, at *17). However,
the Rule 37(e) “intent” is a stringent
requirement that “does not parallel to other discovery
standards.” Jenkins, 2017 WL 362475, at *17
(citing Buckley v. Mukasey, 538 F.3d 306, 323 (4th
Cir. 2008) and Trigon Ins. Co. v. United States, 204
F.R.D. 277, 287 (E.D. Va. 2001)).
assuming that a movant satisfies the burden, and a court
makes one of the two prerequisite findings, a court is not
required to impose sanctions. BMG Rights Mgmt. (US) LLC
v. Cox Commc'ns, Inc., 199 F.Supp.3d 958, 986 (E.D.
Va. 2016), rev'd, in part, on different grounds,
881 F.3d 293 (4th Cir. 2018). Consistent with the purpose and
goal for their imposition, sanctions reside in the broad
discretion of the Court. See Turner v. United
States, 736 F.3d 274, 281-82 (4th Cir. 2013).
that the pending motions touch upon differing topics, the
Court will address each separately, with the exception of
Defendant's Motion to Exclude Spoliation and
Plaintiffs' Motion for Sanctions. The Court will address
those two motions concerning spoliation and sanctions
together because they intersect and largely overlap.
Defendant's Omnibus Motion
Omnibus Motion, Defendant moves to preclude certain opinions
from several of Plaintiffs' experts. The opinions that
Defendant seeks to exclude generally fall into three broad
categories: (1) opinions regarding monitoring; (2) opinions
regarding labeling sufficiency; and (3) opinions based upon
Boehringer Ingelheim's (“BI”) internal
documents. Def.'s Mem. in Supp. of Omnibus Mot.,
ECF No. 48, at 1. As detailed below, the Court disagrees with
Defendant's argument for preclusion for each category,
with one relatively minor exception. Therefore, the Court
GRANTS, IN PART, and DENIES, IN
PART Defendant's Omnibus Motion.
have multiple experts who have opined regarding the relative
need or appropriateness of recommending a monitoring regime
for patients taking Pradaxa who have a heightened risk of
experiencing a major bleed. Pls.' Resp. to Def.'s
Omnibus Mot., ECF No. 52, at 11-15. Plaintiffs have
three experts that opine generally regarding monitoring, Drs.
Baruch, Plunkett, and Chertow. Def.'s Mem. in Supp.
of Omnibus Mot., at 3. In Dr. Baruch's opinion, he
“explains how the decreasing stroke-prevention benefit
at high Pradaxa levels means that there exists a level of
Pradaxa beyond which there is no clinical benefit.”
Pls.' Resp. to Def.'s Omnibus Mot., at 12.
And based upon that, Dr. Baruch opines that BI should have
instructed doctors to monitor Pradaxa levels. Id. at
13. Similarly, Dr. Plunkett opines that BI should have
provided doctors with information regarding both a target
range for Pradaxa levels, and a monitoring regime for
ensuring that a patient's levels reside within that
range. Id. at 13; Def.'s Mem. in Supp. of
Omnibus Mot., at 9. Finally, Dr. Chertow explains both
“kidney function generally and . . . how kidney
function affects the absorption of [Pradaxa], plasma
concentrations of the anticoagulant[, ] and the corresponding
effects on patients.” Ex. 18 to Pls.' Resp. to
Def.'s Omnibus Mot., ECF No. 52-18, at 3. Like the
other two doctors, Dr. Chertow ultimately opines that based
upon his knowledge and experience, BI should have established
a therapeutic range, and it should have recommended that
doctors monitor. Def.'s Mem. in Supp. of Omnibus
Mot., at 11; Pls.' Resp. to Def.'s Omnibus
Mot., at 15-16.
poses two types of challenges to the monitoring opinions.
First, as a broad objection, Defendant argues that the
monitoring opinions, as a whole, do not “fit the facts
of this case.” Def.'s Mem. in Supp. of Omnibus
Mot., at 3. Second, Defendant challenges the opinions of
each of those doctors, for slightly different reasons, but
all of the challenges revolve around the
“unreliability” of the doctors' opinions.
first the issue of fit, it is axiomatic that “expert
testimony which does not relate to any issue in the case is
not relevant [and] non-helpful.” Edwards v.
Ethicon, Inc., 2014 WL 3361923, at *2 (S.D. W.Va. July
8, 2014) (quoting Daubert, 509 U.S. at 591-92).
Defendant claims that the opinions of Drs. Baruch, Plunkett,
and Chertow “are not relevant to this case because
there is no evidence that a monitoring instruction would have
impacted Ms. Knight's treatment.” Def.'s
Mem. in Supp. of Omnibus Mot., at 3. Without this
evidence, Defendant lacks a “case specific
connection.” Id. at 4. In essence then,
Defendant appears to argue that because the monitoring
opinions of the three doctors do not address Ms. Knight's
scenario specifically, their opinions are irrelevant. But
Defendant misapprehends both Plaintiffs' evidentiary
production to this point, and Plaintiffs' ability to
retain multiple experts to connect broader topics to the
specifics of Ms. Knight's case.
Court as already determined in its previously issued
Memorandum Opinion and Order, Plaintiffs have sufficiently
adduced evidence demonstrating a causative link between the
lack of a warning to monitor and Ms. Knight's ultimate
injuries to establish a question of fact. See
Knight, 2018 WL 2470990, at *14, *16-17. That judicial
finding reflects the necessary showing of a causal
during argument, when confronted with this Court's
previous finding, counsel for Defendant attempted to downplay
its importance. Without legal citation, Defendant's
counsel contended that the standard necessary to satisfy
case-specific causation for the purposes of summary judgment
differs from the connection required to make an expert
opinion relevant under Daubert. Oddly, despite this
contention during the hearing, in its brief, Defendant cites
Meade v. Parsley, No. 2:09-cv-00388, 2010 WL 4909435
(S.D. W.Va. Nov. 24, 2010), to support its argument that the
doctors' monitoring opinions are irrelevant.
Def.'s Mem. in Supp. of Omnibus Mot.,
at 3-4 (citing Meade, 2010 WL 4909435, at *5, 9). In
Meade, Judge Copenhaver had before him a motion for
summary judgment on various product liability claims. Indeed,
Judge Copenhaver's causation analysis, on which Defendant
relies in arguing for the preclusion of the three
doctors' opinions, was in the context of summary
judgment. Therefore, Defendant's leaky pail of argument
holds no water. The Court's earlier finding establishes
the relevance of the monitoring opinions to this case, as
well as the connection between them and Ms. Knight's
addition to challenging the connection between the monitoring
opinions and the facts of this case, Defendant also advocates
for a requirement that the opinions of Plaintiffs'
experts must address every aspect of the case. In other
words, Defendant seems to argue that each doctor must provide
not only information regarding a general connection between