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Knight v. Boehringer Ingelheim Pharmaceuticals, Inc.

United States District Court, S.D. West Virginia, Huntington Division

June 19, 2018

CLAUDE R. KNIGHT and CLAUDIA STEVENS, individually and as Personal Representatives of the Estate of Betty Erelene Knight, deceased, Plaintiffs,



         In a 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 to rule.

         Accordingly, 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).

         For the 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 information here.


         A. Daubert Standard

         Rule 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)).

         To 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.

         In 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”).

         “[E]xpert 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).

         B. Adverse Instruction Standard Under Rule 37(e)

         Central 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)).

         Rule 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 litigation may:
(A) presume that the lost information was unfavorable to the party;
(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)[1]. 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.).

         After 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.

         Although 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 Rules-2015 Amendment.

         For the 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)).

         Even 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).


         Given 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.

         A. Defendant's Omnibus Motion

         In its 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.

         a. Monitoring Opinions

         Plaintiffs 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.

         Defendant 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.

         Taking 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.

         As this 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 relationship.

         However, 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 specific case.

         In 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 ...

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