Warner v. Boehringer Ingelheim Pharm., Inc.
Warner v. Boehringer Ingelheim Pharm., Inc.
2020 WL 13389902 (M.D. Fla. 2020)
August 5, 2020
Byron, Paul G., United States District Judge
Summary
The court found that Boehringer Ingelheim International GmbH (BII) had an obligation to preserve ESI related to the RE-LY clinical trial and the Reilly paper. The court also found that certain emails had not been preserved due to a transition between two different legal hold systems and a lack of electronic preservation. However, the court found that negligence was not enough to establish intent to deprive the plaintiff of evidence.
GEORGIA WARNER, Plaintiff,
v.
BOEHRINGER INGELHEIM PHARMACEUTICALS, INC., Defendant
v.
BOEHRINGER INGELHEIM PHARMACEUTICALS, INC., Defendant
Case No. 6:19-cv-1642-Orl-40EJK
United States District Court, M.D. Florida
Filed August 05, 2020
Counsel
John T. Kirtley, Pro Hac Vice, Ferrer, Poirot & Wansbrough, Dallas, TX, Russell T. Abney, Pro Hac Vice, Ferrer, Poirot, Wansbrough, Feller, Daniel, Abney, Charles Andrew Childers, Childers, Schlueter & Smith, LLC, Atlanta, GA, Stephen R. Senn, Peterson & Myers, PA, Lakeland, FL, for Plaintiff.Amanda Elizabeth Preston, Andrew R. Kruppa, Squire Patton Boggs (US) LLP, Miami, FL, Ben J. Scott, Pro Hac Vice, Eric E. Hudson, Pro Hac Vice, Butler Snow LLP, Memphis, TN, Cedric E. Evans, Pro Hac Vice, Butler Snow LLP, Austin, TX, Gregory L. Halperin, Pro Hac Vice, Paul W. Schmidt, Pro Hac Vice, Covington & Burling, LLP, New York, NY, John James DeBoy, Pro Hac Vice, Michael X. Imbroscio, Pro Hac Vice, Shankar Duraiswamy, Pro Hac Vice, Covington & Burling, LLP, Washington, DC, for Defendant.
Byron, Paul G., United States District Judge
ORDER
*1 This cause is before the Court on the following:
1. Plaintiff's Motion for Sanctions (Doc. 64);
2. Defendant's Response in Opposition (Doc. 92);
3. Plaintiff's Reply (Doc. 108);
4. Defendant's Surreply (Doc. 118);
5. Plaintiff's Motion to Strike the Declaration of Jonathan M. Redgrave filed in support of Defendant's Response in Opposition (Doc. 103); and
6. Defendant's Response in Opposition to Plaintiff's Motion to Strike. (Doc. 106).
Upon due consideration, the Court denies Plaintiff's Motion for Sanctions, and denies as moot Plaintiff's Motion to Strike the Declaration of Mr. Redgrave.
I. BACKGROUND
A. FDA Approval of Pradaxa®
The Plaintiff brings this lawsuit against Boehringer Ingelheim Pharmaceuticals, Inc. (hereafter “BI”) after allegedly suffering injuries caused by an anticoagulant drug manufactured, marketed, and sold by BI called Pradaxa®, which is the trade name for dabigatran etexilate. (Doc. 1, ¶ 2). Pradaxa® is prescribed to individuals with “non-valvular atrial fibrillation” or “Afib”. (Id.). Plaintiff avers that BI marketed Pradaxa® as “the first oral anticoagulant that did not require routine blood monitoring” and submitted its New Drug Application to the United States Food and Drug Administration (“FDA”) without instructions for monitoring or otherwise assessing the anticoagulant effects in Pradaxa® users.” (Id. at ¶ 3). The FDA approved Pradaxa® to reduce the risk of stroke and systemic embolism in patients with Afib on October 19, 2010. (Id. at ¶ 6). “The FDA approved two dosages: 75 mg and 150 mg, to be taken twice daily.” (Id.). To obtain FDA approval, Defendant conducted “The Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY)” clinical trial whereby BI studied 18,000 patients. (Id. at ¶ 9). Plasma Levels were collected on 9,000 Pradaxa® patients. (Id.).
B. Failure to Warn
Plaintiff's suit is predicated upon BI's alleged failure to adequately warn about the “possible side effect of developing severe bleeding as a result of [the use of Pradaxa®] and/or how to avoid the unnecessary risk of bleeding.” (Doc. 1, ¶ 54). The failure to warn allegations are framed in terms of strict product liability, negligence, and breach of implied warranty. (Id. at ¶¶ 51–76).[1] More specifically, Plaintiff alleges that Defendant BI aggressively marketed Pradaxa® as a “ ‘no monitoring required drug’ despite knowing Plasma Levels are closely correlated to the anticoagulant effect of Pradaxa® on an individual patient ...” (Id. at ¶ 24). Plaintiff claims Pradaxa® fails to disclose “that there is a close linear relationship between the amount of dabigatran in a patient's blood (“Plasma Level”) and the level of anticoagulation ... [and fails to] tell physicians at what point a Pradaxa® patient is over anticoagulated.” (Id. at ¶ 15).[2] Finally, Plaintiff contends that BI re-analyzed the RE-LY clinical trial data after Pradaxa® was approved by the FDA and learned that “measuring a patient's Plasma Level provides clinically useful information concerning a patient's bleed risk” and that several personal characteristics impact Plasma Levels and/or elevate risk for patents using the drug. (Id. at ¶ 25(b–f)).
C. Motion for Sanctions (Spoliation)
1. The MDL Litigation: Dr. Lehr
*2 To understand Plaintiff's spoliation motion, one must consider the multi-district litigation (“MDL”) presided over by Chief Judge Herndon, which precedes this lawsuit.[3] Unlike the instant litigation, the MDL involved two defendants: Boehringer Ingelheim International GMBH (“BII”) and Defendant BI. (Doc. 64-1). During the pendency of the MDL, Chief Judge Herndon entered sanctions orders against BII and BI. (Id.). The Plaintiff's Steering Committee (“PSC”) in the MDL argued that Defendants failed to preserve the custodial file of Dr. Thorstein Lehr—an employee of BII, failed to identify Dr. Lehr as a custodian with potentially relevant evidence, and either failed to preserve or provided untimely disclosure of other information. (Id. at p. 2). Chief Judge Herndon found that as of June 2012, Defendants knew that nationwide Pradaxa® litigation was imminent and needed to adopt a company-wide litigation hold. (Id. at pp. 2–3, 14, 17). Chief Judge Herndon devoted ten pages of his Order summarizing the history of discovery non-compliance or abuse. (Id. at pp. 3–13). He then turned to a section of his Order titled “Potentially Sanctionable Conduct Presently in Issue.” (Id. at p. 19).
The MDL Court described Dr. Lehr as a pharmacometrician formerly employed by BII. (Id.). Dr. Lehr “was responsible for quantitative analysis relating to the interaction between Dabigatran and specific patient populations” and left the company in September 2012. (Id.; Doc. 64-5, ¶ 3).[4] The MDL Court found that the PSC learned of Dr. Lehr on September 25, 2013 during the deposition of another employee. (Doc. 64-1, p. 20). BII advised the PSC that Dr. Lehr was not subject to the litigation hold when he left the company, because he had not been identified as a custodian. (Id.). Chief Judge Herndon concluded that “with the exception of Prof. Lehr's emails, BII failed to preserve Prof. Lehr's custodial file at a time when it was under a duty to do so.” (Id. at p. 21).
The MDL Court rejected BII's assertion that it did not realize that Dr. Lehr was a custodian with potentially relevant information or, alternatively, that it had no duty to preserve his file until it received a request from the PSC. (Id.). Chief Judge Herndon cited emails describing Dr. Lehr as “our company expert for dabigatran” and articles he co-authored on Pradaxa®. (Id. at p. 22). The MDL Court also emphasized company emails exchanged between 2011 and 2012 disclosing an internal debate on whether a scientific paper drafted by Dr. Lehr should include his conclusion that plasma concentrations (therapeutic ranges) relate to the efficacy and safety of Pradaxa®. (Id. at pp. 22–25). From the email exchanges, the Court reached the following conclusion:
Dr. Lehr was a prominent scientist at BII that played a vital role in researching Pradaxa. The defendants’ management, legal team, and other top-scientists were familiar with Prof. Lehr's work and communicated with him regarding the same. The Court is stunned that Prof. Lehr was not identified by the defendants as a custodian with potentially relevant knowledge about Pradaxa. Further, given the above, it is evident that the defendants knew that Prof. Lehr's custodial file contained information relevant to this litigation in September 2012 when Prof. Lehr left his employ with BII. The emails also may lead a reasonable person to infer a motive for the defendant to abstain from placing a litigation hold on his materials, including the early versions of the exposure paper. The entire debate is relevant, or at least conceivably relevant, to this litigation and without question any documents, no matter who generated them, should have been the object of the litigation hold.
(Id. at pp. 25–26). The MDL Court dismissed as “nonsense” the notion that the duty to preserve arises only after the PSC requests the custodial file. (Id. at p. 26).[5]
*3 During oral argument on PSC's motion for sanctions, “the PSC showed the Court draft version number 5 of [Dr. Lehr's] exposure paper.” (Id.). The Defendants advised the Court “that their productions have included seven earlier distinct drafts of the exposure paper (presumably from sources other than Dr. Lehr's custodial file), dating back to January 2011. (Id. at p. 27). The Court found little comfort in this production, stating “[t]he defendants do not get to pick and choose which evidence they want to produce from which sources.” (Id.). Chief Judge Herndon framed the issued as centering on “the missing documents and material contained in Dr. Lehr's custodial file”; that is, “of the draft versions stored on Dr. Lehr's workstations, what was lost when the defendants failed to preserve Dr. Lehr's custodial file.” (Id.).
The Court found BII's failure to apply the litigation hold to Dr. Lehr to be in “bad faith.” (Id. at p. 44). And Chief Judge Herndon held that the Defendants “failed to ensure that the auto delete feature of their employee cell phones ... was disengaged for the purpose of preserving text messages and, as such, this allowed countless records to be destroyed.” (Id. at pp. 44–45). The Court found “this action to be violation of the case management orders to produce relevant material by a date certain and in bad faith.” (Id. at p. 45). Chief Judge Herndon directed “BII to produce all complete ‘files’ of Professor Lehr within 7 days.” (Id.). If the files have been destroyed, the Court ruled that “a further order will issue, allowing more time with possible conditions, or an order assessing sanctions pursuant to Rule 37 or the Court's inherent authority, if appropriate.” (Id. at p. 46).
2. Declaration of Dr. Lehr
Dr. Lehr prepared a declaration on November 26, 2013, in which he states that upon his departure from the company his desktop remained in his former office and he returned his laptop and Blackberry. (Doc. 64-5, ¶ 4). Dr. Lehr described the practices he followed regarding the storage of electronic data and hard copy documents, as follows:
6. Regarding my desktop and laptop use, my general policy was to store and archive my files on the company network. I did not store or archive any documents on my desktop. I would only save files on my laptop when travelling if I needed offline access. However, upon my return, I would upload any files that I worked on to the company network in IDEA for Sub and Global Pharmacokinetic Network System (GPNS).
7. I never stored or archived any files in my user share drive, which was the company network space assigned to each user. In my department, it was our policy to store and archive files on the network so that they would be accessible to other team members.
8. Regarding hard copy documents, I would occasionally print reports or investigator brochures for ease of offline reading. It was not my practice to make marks or notes on the print outs, although I may have placed a post-it note on pages for ease of reference. In addition, I did not maintain any notebooks, journals or ledger books for any of my Pradaxa work. While I may have occasionally taken notes or stored other paper documents related to Pradaxa, I would periodically clean up my office three to four times a year and discard any papers that I no longer needed. By August 10, 2012, I had cleaned out my office and discarded any Pradaxa related paper that I had, and left behind some non-Pradaxa related paper for my supervisor. At that time, I estimate that I had 2–3 binders of report printouts related to Pradaxa, which were hard copy versions of electronic files stored on the company network.
9 As a general practice I maintained my calendar electronically in Outlook. I did have a print calendar hanging on my office wall showing six months at a time, in which I marked my upcoming travel dates. I discarded the calendar after each year. However, I have located my 2012 calendar and provided it to the company on November 22, 2013. I estimate that all of the work related information from my print calendar was also in Outlook.
*4 10. While employed at Pharma KG, I had a company issued Blackberry phone. I did not use my Blackberry to send text messages regarding Pradaxa.
11. I never had a company issued tablet, such as an iPad.
(Doc. 64-5, ¶¶ 6–11). Plaintiff avers in her reply brief that Dr. Lehr's assertion that he archived his files on the network drive is inaccurate.[6] (Doc. 108). In support of this contention, Plaintiff cites the deposition of Dr. Hugo Maas. (Id.). Plaintiff argues that in early 2014, Dr. Maas could not find the exposure-response model created by Dr. Lehr on BI's server, so Dr. Lehr emailed five (5) program files used to perform the exposure-response analysis. (Id. at p. 2). Dr. Maas needed access to additional programming files to run the analysis, and Dr. Lehr emailed files with the following path: C:\Users\ThorstenLehr\Googledrive\Manuscript_preparation\2012\Exposure_ Response. (Id.). Plaintiff maintains that the Google Drive portion of the path proves that Dr. Lehr did not archive all his files on BI's server. (Id.).
Dr. Maas’ deposition testimony is not as simple—or arguably damning—as Plaintiff's summary suggests. Dr. Maas was asked whether the files contained in the zip file relate to the RE-LY clinical trial, and he replied: “I think that's perfectly plausible.” (Doc. 108-1; 413:10–414:1).[7] Plaintiff asked if the files emailed by Dr. Lehr “include his [Lehr's] script files for the exposure–response analysis for the RE-LY clinical trial,” and Dr. Maas answered, “As far as I can ascertain based on the text, that could indeed by the case.” (Id. at p. 414:13–18). Plaintiff also asked Dr. Maas if he had the script files available to him would he have requested them from Dr. Lehr? (Id. at p. 415:1–3). Dr. Maas replied “if I had been able to find them and had access to them ... perhaps, it would have been unnecessary [to request them]; but, as I said, I am not sure what the background was to this possible request.” (Id. at p. 415:5–9). Dr. Maas further testified that “[i]f I needed the data and was unable to find them, I might have sent him a request to send me those data.” (Id. at p. 417:8–10). He qualified his answer by adding, “From what I read here, I seem to be asking for sources of a figure that I was unable to find at that moment.” (Id. at p. 417:24–418:1).[8] Accordingly, Dr. Maas’ testimony indicates, at best, that the files emailed by Dr. Lehr may have related to the RE–LY clinical trials or the Reilly paper and that he might have requested the files because he could not locate them “at that moment.”
*5 In their surreply, Defendant points out that four (4) of the five (5) SAS files referenced in Dr. Lehr's January 24, 2014 email bear date stamps showing that they were created after Dr. Lehr left the company. (Doc. 118, p. 1).[9] Defendant notes that Dr. Lehr continued to work on Pradaxa® after he left BI to become a professor. (Id. at p. 2). Accordingly, these files were never part of his custodial files and were not lost. As for the two SAS files with date stamps from 2011, referenced in Exhibit B to Plaintiff's reply, they were both produced in native format on December 16, 2013. (Docs. 118-1–118-5). The three (3) other SAS files with date stamps from 2013 were also produced at the same time. (Doc. 118-6).
Defendant next addresses Exhibit C to Plaintiff's Reply which Plaintiff argues proves Dr. Lehr used Google Drive while at BI and did not back up all his work on the company network. (Doc. 118, p. 3). Defendant cites the full file path for these files to demonstrate they were created in April 2013, after Dr. Lehr left BII. (Id.). The Plaintiff citation of the file path stops too soon, creating the appearance that the files were created in 2012. (Id.).[10]
3. Miscellaneous Allegations of Spoliation
In two short paragraphs, the Plaintiff alleges that BI failed to preserve, “even after the litigation hold was in place,” the emails of Dr. Martina Brueckmann who is described as having “authored the protocol for a pediatric trial where the very issues concerning therapeutic range, plasma concentration, and dose adjustment that Prof. Lehr had worked on were put into practice.” (Doc. 64, p. 10). The dosage protocol prepared by Dr. Brueckmann is attached to Plaintiff's motion. (Doc. 64-16). Similarly, Plaintiff notes that BI failed to preserve emails of Dr. Jorge Cari and Ms. Ingrid Schulz, without offering an explanation as to who these people are, or the relevance of their emails to this case. (Doc. 64, p. 10). Plaintiff also asserts that BI failed to preserve “records of sales representatives, clinical science consultants and medical science liaison officers” without identifying the potential relevance of these records. (Id.).
4. Declaration of Eric E. Hudson
Mr. Hudson is counsel for Boehringer Ingelheim Pharmaceuticals, Inc. and Boehringer Ingelheim International GmbH in several cases in the Connecticut Consolidated Pradaxa Litigation. (Doc. 92-6, ¶ 1). After summarizing the discovery provided to Plaintiff in the In re Paradax MDL and additional discovery, Mr. Hudson states that in November and December 2016, he informed Plaintiff that emails for three BII custodians—Dr. Brueckmann, Ms. Schultz, and Dr. Caria—were inadvertently not subject to the legal hold for varying time periods. (Id. at ¶¶ 3–6). While some emails were not captured in the legal hold, a separate two–year retention rule was in place. Accordingly, for Dr. Brueckmann emails from August 6, 2013 to July 2, 2016, were released from the legal hold, but emails are stored in her two-year retention folder for the period of July 2, 2014 through July 2, 2016. (Id. at ¶ 7). Similarly, for Ms. Schultz emails from January 30, 2014 until July 2, 2016, were released from the hold, but emails from July 2, 2014 to July 2, 2016, are in the two–year retention. (Id. at ¶ 8). And for Dr. Caria emails from October 8, 2013 until October 13, 2016, were not subject to the legal hold, but email from October 13, 2014, were retained under the retention policy. (Id. at ¶ 10).
*6 All three custodians informed Mr. Hudson that emails regarding Pradaxa would have included others within the Company [cc or bcc], meaning the emails produced for these other individuals would have captured the relevant emails from Drs. Brueckmann and Caria and Ms. Schultz, which predate and were not preserved under the two–year retention policy. (Id. at ¶¶ 12–16). Moreover, Defendant BI provided Plaintiff with the names and current employment status of thirteen sales representatives that had contact with Plaintiff's prescribing physician, Dr. Fierstein. (Id. at ¶¶ 18–19). BI also produced four Professional Information Request Response Letters which contain information in response to specific questions from Dr. Fierstein. (Id. at ¶ 20).
5. MDL Findings
Plaintiff suggests that this Court “might ... exercise its discretion to collaterally estop BI from contesting ... [the] conclusions” reached by Chief Judge Herndon. (Doc. 64, p. 9).[11] Plaintiff argues that “[t]hese findings should allow judgment in whole or in part against BI, or a presumption that the destroyed data was harmful to BI, and an award of attorneys’ fees and costs.” (Id. at p. 10).
II. LEGAL STANDARD
A. Spoliation
Spoliation is “defined as the destruction of evidence or the significant and meaningful alteration of a document or instrument.” Tesoriero v. Carnival Corp., No. 18-11638, 2020 WL 3969265, at *9 (11th Cir. July 14, 2020) (quoting Green Leaf Nursery v. E.I. DuPont De Nemours & Co., 341 F.3d 1292, 1308 (11th Cir. 2003)) (no spoliation claim under Florida law without a “significant impairment in the ability to prove the lawsuit.”); (See also, Walter v. Carnival Corp., No. 09-20962-CIV, 2010 WL 2927962, at *2 (S.D. Fla. July 23, 2010) (evidence must be “crucial to the movant being able to prove its prima facie case or defense” to establish spoliation). “[A]nticipation of litigation is not the standard for spoliation sanctions—bad faith is.”[12]Tesoriero, 2020 WL 3969265, at *9. Even if bad faith is shown, however, the court may decline to impose sanctions for spoliation if “the practical importance of the evidence” was minimal. Id. (quoting Flury v. Daimler Chrysler Corp., 427 F.3d 939, 945 (11th Cir. 2005)). Sanctions for spoliation may include “(1) dismissal of the case; (2) exclusion of expert testimony; or (3) a jury instruction on spoliation of evidence which rises a presumption against the spoliator.” Flury, 427 F.3d at 945.
Before sanctions for spoliation may be imposed, the Court must consider the following factors: “(1) whether the partying seeking sanctions was prejudiced as a result of the destruction of evidence and whether any prejudice could be cured, (2) the practical importance of the evidence, (3) whether the spoliating party acted in bad faith, and (4) the potential for abuse if sanctions are not imposed.” Tesoriero, 2020 WL 3969265, at *9 (citations omitted). Bad faith “in the context of spoliation, generally means destruction for the purpose of hiding adverse evidence.” Id. (citation omitted). “However, ‘[i]n spoliation cases, courts must not hold the prejudiced party to too strict a standard of proof regarding the likely contents of the destroyed evidence because doing so allows the spoliators to profit from the destruction of evidence.” Alabama Aircraft Indus., Inc. v. Boeing Co., 319 F.R.D. 730, 742 (N.D. Ala. 2017) (quoting, Southeastern Mechanical Services, Inc. v. Brody, 657 F.Supp.2d 1293, 1300 (M.D. Fla. 2009).
*7 Added to this analysis is the amendment to Federal Rule of Civil Procedure 37(e), effective December 1, 2015, which addresses electronically stored information (“ESI”). Rule 37(e) provides:
Failure to Preserve Electronically Stored Information. 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.
In the Eleventh Circuit the test used to determine when the duty to preserve ESI arises is “whether litigation was ‘pending or reasonably foreseeable’ when the spoliation occurred.” Alabama Aircraft Indus., 319 F.R.D. at 740; see also Oil Equip. Co. Inc. v. Modern Welding Co. Inc., 661 Fed. App'x. 646, 652 (11th Cir. 2016). The “duty to preserve evidence extends to those employees likely to have relevant information—the key players in the case, and applies to unique, relevant evidence that might be useful to the adversary.” Id. at 741 (citation omitted). The “intent to deprive” standard in amended Rule 37(e)(2) “may very well be harmonious with the “bad faith” standard previously established by the Eleventh Circuit.” Alabama Aircraft Indus., 319 F.R.D. at 746 (citations omitted).
B. Collateral Estoppel
Collateral estoppel applies where: (1) the issue at stake is identical to the one involved in the earlier proceeding; (2) the issue was actually litigated in the earlier proceeding; (3) the determination of the issue was a critical and necessary part of the earlier judgment; and (4) the party against whom collateral estoppel is asserted had a full and fair opportunity to litigate the issue. Tampa Bay Water v. HDR Eng'g., Inc., 731 F.3d 1171, 1180 (11th Cir. 2013).
III. DISCUSSION
A. Collateral Estoppel is Inapplicable
To begin, the Court rejects the invitation to adopt the findings of Chief Judge Herndon by applying the doctrine of collateral estoppel. The MDL Court never reached the ultimate issue of whether Defendants are responsible for spoliation or what sanctions, if any, were appropriate. The portion of Chief Judge Herndon's Order that addresses Dr. Lehr's custodial file is captioned “IV. Potentially Sanctionable Conduct Presently in Issue.” (Doc. 64-1, p. 19). The MDL Court specifically reserved judgement on whether sanctions may be appropriate. (Id. at pp. 45–46). Moreover, under the heading “VI. FINDINGS AND CONCLUSIONS,” Chief Judge Herndon found “that BII has specifically not applied the hold to Dr. Lehr and now failed to produce certain of his ‘files.’ To fail to do so was in violation of the Court's case management orders and in bad faith.” (Id. at p. 44).
*8 Absent from Plaintiff's instant motion is an analysis of why the “bad faith” actions of BII–Dr. Lehr's employer–should be attributable to BI–the lone defendant in this action. Defendant BI and Defendant BII are separate corporate entities, and the subject of Chief Judge Herndon's ire is BII, who Plaintiff elected not to sue in this.[13] Additionally, the issue of potential spoliation by BII was not fully litigated before the MDL Court, nor was there any determination on the merits. This was all left for another day, and the parties settled before that day could come. Clearly, collateral estoppel does not apply.
B. The Miscellaneous Claims of Spoliation
As previously discussed, Plaintiff dedicates two paragraphs of the Motion to her claim that sanctions should be imposed against Defendant BI, because BII failed to preserve some of the emails generated by Dr. Brueckmann, Ms. Schultz and Dr. Caria. (Doc. 64, p. 10). Plaintiff incorrectly attributes the alleged loss of a portion of their emails to Defendant BI, when the correspondence submitted in support of her Motion makes clear that BII's change in legal hold systems resulted in a subset of emails being lost.[14] On the issue of prejudice, the Court notes that Plaintiff has access to all emails preserved in the two-year retention folder for these three individuals, and the balance of the emails should be identifiable from recipient accounts. Yet, she fails to cite any of the existing emails in support of her implicit argument that the sub-set of emails lost during the transition have relevance to any issue in dispute.
In fact, Plaintiff limits her discussion of relevance to one sentence: “Dr. Brueckmann authored the protocol for a pediatric trial where the very issues concerning therapeutic range, plasma concentration, and dose adjustment that Prof. Lehr had worked on were put into practice.” (Doc. 64, p. 10). Plaintiff attaches the 103-page Clinical Trial Protocol to the motion for sanctions, but she fails to tie the protocol into the emails, the work of Dr. Lehr, or the FDA approval process. (Doc. 64-16). Furthermore, Plaintiff does not even attempt to fashion an argument for why the lost sub–set of emails for Dr. Caria and Ms. Schulz may be relevant.
Even assuming Defendant BI had a duty preserve these emails, the record before the Court fails to establish bad faith or intent to deprive. At best, non–party BII inadvertently lost a sub–set of emails for three individuals that can be mined from other recipients. The record similarly fails to support a finding of prejudice to Plaintiff. The Court is mindful of the admonition that “courts must not hold the prejudiced party to too strict a standard of proof regarding the likely contents of the destroyed evidence, because doing so allows the spoliators to profit from the destruction of evidence.” Alabama Aircraft Indus., Inc., 319 F.R.D. at 742. However, here Plaintiff has access to two-years of emails from these three BII employees and a lengthy Clinical Trial Protocol, and she still fails to advance any argument to support her claim of prejudice. Mere speculation is not enough to warrant sanctions. Accordingly, Plaintiff's Motion for Sanctions for the loss of a sub-set of emails for Dr. Brueckmann, Dr. Caria and Ms. Schulz is due to be denied.
*9 Next, Plaintiff submits that BI failed to preserve unspecified records of sales representatives, clinical science consultants, and medical science liaison officers. (Doc. 64, p. 10). Plaintiff offers no explanation for why the failure to preserve text messages and other records of this group of individuals results in prejudice, or why the Court should find that BI acted with the intent to deprive Plaintiff of the information. Instead, Plaintiff relied on Chief Judge Herndon's determination that the failure to preserve was in bad faith. (Doc. 64, p. 10). While Chief Judge Herndon does provide context in his order for the work performed by clinical science consultants, he largely cites the PSC's initial motion for sanctions in so doing. (Doc. 64-1, p. 28, n.5). The same is true for the medical science liaison officers. (Id. at p. 30). Even if Plaintiff had cited to this portion of Chief Judge Herndon's Order to provide some context and background, this Court is unpersuaded that mere citation to another court's non–binding order, which in turn relies heavily upon the PSC's motion for sanctions, is an adequate evidentiary basis to support a finding of bad faith or prejudice. Accordingly, Plaintiff's Motion for Sanctions as it relates to the alleged failure to preserve unspecified records of sales representatives, clinical science consultants, and medical science liaison officers is due to be denied.
C. Dr. Lehr
In seeking the imposition of sanctions for spoliation, Plaintiff again relies heavily upon the order entered by Chief Judge Herndon, while concurrently asserting that they have submitted “substantial record evidence for this Court to independently reach the same findings as made by the MDL court.” (Doc. 64, p. 9). The record evidence consists of 22 exhibits to Plaintiff's Motion for Sanctions. The exhibits include an email that identifies Dr. Lehr as the company's expert for dabigatran. (Doc. 64–2). Several additional exhibits are email communications revealing internal discussion over whether and how to disclose the correlation between dabigatran plasma concentrations and safety/efficacy when considering the marketing strategy for the sale of Pradaxa®. (Docs. 64–4, 7–12, 17–20). None of these exhibits, standing alone, demonstrate how the Plaintiff has been prejudiced by the purported loss of electronically stored information.
Plaintiff describes the issue of prejudice as follows:
If Ms. Warner's physician had been informed that there was a therapeutic range that should not be exceeded and that there is a test for dabigatran levels which would allow him to monitor dabigatran levels in Ms. Warner's blood, he could have done so, or prescribe a different drug. Given his areas of research, Dr. Lehr's missing information may also shed more light on risk factors for patients, like Ms. Warner, who are elderly, who have a history of gastroesophageal reflux, and who take blood pressure medicine.
(Doc. 64, pp. 19–20). Further, Plaintiff argues that the “destroyed evidence” would have been relevant to defeat BI's primary defense of preemption, because BI has the burden of showing the absence of new information that might have prompted label improvements. (Id. at p. 20).
Defendant concedes that “the company made specific but limited errors in a massive preservation and collection process during the long–closed MDL proceeding.” (Doc. 92, p. 2). Defendant argues that Plaintiff fails to “point to any document or category of documents created by Dr. Lehr that are missing and would otherwise be relevant to her specific claims.” (Id.). BII is the entity that employed Dr. Lehr, and they produced voluminous materials generated by him, including the files he stored on the network servers and “scores of emails where Dr. Lehr shared his Pradaxa work.” (Id.).
The record indicates that Dr. Lehr followed company policy and stored his files on the BII network. Nonetheless, Plaintiff fails to cite a single existing email or document indicating that Dr. Lehr's earlier work on the exposure–response paper varies from the conclusions he reached in later drafts. During oral argument before Chief Judge Herndon, it became clear that the PSC had in its possession 8 drafts of Dr. Lehr's exposure-response paper.[15] While Chief Judge Herndon rightly concluded that the defense does not get to select which documents it will produce, Plaintiff has access—via the MDL discovery collection—to these drafts and could presumably use the drafts to support their claim of prejudice. Moreover, if Dr. Lehr's earlier work on the exposure–response differed from the conclusion reached by Dr. Reilly, following the RE–LY trials, one would assume that point would be made. Finally, contrary to Plaintiff's assertion, nothing stopped Plaintiff from deposing Dr. Lehr, both prior to leaving his fulltime post with BII and since entering academia, to discuss his research and to explore whether relevant data has indeed been lost. Plaintiff elected not to avail herself of the Hague Convention and now askes this Court to assume the worst.
*10 As observed by Judge Robert Chambers in Knight v. Boehringer Ingelheim Parma., Inc., 323 F.Supp.3d 837, 859 (S.D. W. Va. 2018), “the Court is troubled by the fact that the potentially sanctionable activity did not occur subject to this Court's direction... The Court has serious reservations about imposing one of the most serous sanctions, and adverse jury instruction, when the actions giving rise to that potential sanction were not within this Court's purview.” This Court agrees with Judge Chambers and is similarly hesitant to impose sanctions when it has not observed firsthand the course of conduct that is complained of by Plaintiff. Id.
Applying Rule 37(e) to the facts, the Court finds that Dr. Lehr occupied a prominent position within BII such that BII should have preserved his electronically stored information in anticipation of litigation. Having said that, the Court notes that in the case at bar the Defendant is BI and not BII. Plaintiff cites no authority for the proposition that Defendant BI is responsible for ensuring that BII preserved ESI or that BI can be sanctioned, assuming a failure by BII. To the contrary, the unambiguous language of Rule 37(e) teaches that the duty to preserve ESI is limited to “a party.” Next, Dr. Lehr attests that he archived all relevant Pradaxa® files to the network. Thus, BII took reasonable steps to preserve Dr. Lehr's ESI.[16] While the Court need not reach the issue of prejudice, Plaintiff has failed to demonstrate—even applying the liberal standard announced in Alabama Aircraft Indus., Inc.—that evidence crucial to the movant being able to prove its prima facie case has been lost or destroyed. This is true whether the Court considers Plaintiff's burden of proving her case–in–chief or the defense of preemption. Accordingly, Plaintiff's motion for sanctions is denied.
D. Motion to Strike Declaration of Jonathan M. Redgrave
Plaintiff next moves to strike the declaration of Mr. Redgrave on the basis that it constitutes improper expert opinion testimony on issues of law and state of mind and provides additional argument in support of BI's response in opposition thus exceeding the page limitation for briefing. (Doc. 103, p. 1).[17] The Court need not address the merits of the Plaintiff's motion to strike, because the Court has not relied upon Mr. Redgrave's opinions or his analysis in resolving Plaintiff's Motion for Sanctions. Accordingly, the motion to strike is denied as moot.
IV. CONCLUSION
*11 For these reasons it is ORDERED AND ADJUDGED as follows:
1. Plaintiff's Motion for Sanctions (Doc. 64) is DENIED; and
2. Plaintiff's Motion to Strike the Declaration of Mr. Redgrave (Doc. 103) is DENIED AS MOOT.
DONE AND ORDERED in Orlando, Florida on August 5, 2020.
Footnotes
On May 20, 2019, before the instant suit was filed, the Supreme Court decided in Merck Sharp & Dohme v. Albrecht, —U.S.—, 139 S. Ct. 1668, 1679, 203 L.Ed.2d 822 (2109), that federal preemption in a failure-to-warn case involving a regulated pharmaceutical is a question of law for the judge to decide.
Plaintiff asserts other specific deficiencies in the product's label, including that the “aPTT (activated partial thromboplastin) test” which approximates Pradaxa's anticoagulant activity is not approved by the FDA to monitor the anticoagulant effect of Pradaxa®, and that aPTT values were bases on a specific aPTT “reagent/test that is sensitive to dabigatran” not used in the United States. (Doc. 1, ¶¶ 15–16).
See 3:12-md-02385-DRH-SCW, In re Pradaxa (Dabigatran Etexilate).
Dr. Lehr's declaration begins on page 14 of docket entry 64-5. However, his declaration will be cited as Doc. 64-5 and the paragraph number. Dr. Lehr completed his work by August 10, 2012. (Doc. 64-5, ¶ 8).
The MDL Court's Case Management Order (PSC's Second Motion for Sanctions) addresses various discovery deficiencies and not just Dr. Lehr's custodial file, including “[m]aterials ... being turned over months and moths late—often on the even of a deposition.” (Doc. 64-1, p. 44).
Plaintiff claims she has been “unable to depose Dr. Lehr on these claims” because he “is a German citizen and no longer employed by BI.” (Doc. 108, pp. 1–2). This assertion is incorrect for two reasons. First, Dr. Lehr was employed by BII—not BI, and, secondly, Fed. R. Civ. P. 28(b) provides for the use of depositions taken in a foreign country. Germany is a party to The Hague Convention on the Taking of Evidence Abroad in Civil and Commercial Matters, enacted 18 March 1970. Thus, Plaintiff had the ability to depose Dr. Lehr if she wanted to do so.
Dr. Maas reiterated this position later in the deposition when he is asked if “[t]hese emails are referring to the Reilly article.” He replies: “That is possible. I am not entirely sure of that, but as said (sic), it is a possibility.” (Doc. 108-1, p. 418:10–14).
After Dr. Lehr sent Dr. Maas five (5) files in the zip file, Dr. Mass asked Dr. Lehr to send him the two files that contain Google Drive in their path. (Doc. 108-3). That is, Dr. Maas specifically identified the path, as opposed to the path being disclosed by Dr. Lehr. Dr. Maas was not asked at deposition how he knew to request data on a Google Drive. Google Drive is the equivalent of a hard drive that lives on Google's servers, as well as on one's PC or laptop. (http://googledrive.in30minutes.com/what-is-google-drive/#:~:text=Google%20Drive%20is%20an%20online%2...)
For example, 1160_0026_Exposure_Bleeding_20130424.sas was created on April 24, 2013.
The Court will give Plaintiff the benefit of the doubt that the voluminous discovery produced by the Defendant and BII in the MDL afterwards caused Plaintiff to misconstrue the evidence.
Plaintiff does not enumerate the findings made by the MDL Court for which she seeks a ruling of collateral estoppel or claim preclusion, but the Court assumes the findings include the following: (1) Dr. Lehr should have been identified as a custodian; (2) his custodial files should have been subject to the litigation hold; and (3) the failure to preserve the custodial file was undertaken in bad faith.
Anticipation of litigation is relevant, however, to the duty to preserve ESI.
While the parties at times conflate BI and BII, the separate nature of these legal entities is driven home by Chief Judge Herndon when he finds that BI's “preservation obligation was triggered in February of 2012 ... and, at the latest, April 2012 (as to BII).” In re Pradaxa Prods. Liab. Litig., 2013 WL 6486921, at *1 (S.D. Ill. Dec. 9, 2013); (Doc. 64-1, p. 17).
Plaintiff cites a letter dated November 2, 2016, where Defense Counsel writes: “I want to bring to your attention the fact that, within the past several months, Boehringer Ingelheim International GmbH (“BII”) completed a transition between two different legal hold systems. During that transition certain emails for Dr. Martina Brueckmann and Ingrid Schulz that were preserved by the prior legal hold system inadvertently did not become subject to preservation by the new hold system.” (Doc. 64-15, p. 3). As for Dr. Caria, Counsel wrote that “BII recently discovered that the hold was not implemented electronically for his materials. As a result, emails that were not stored in two year folders would not have been automatically preserved.” (Id. at p. 4).
Chief Judge Herndon assumes the seven earlier drafts produced by the defense came “from sources other than Dr. Lehr's custodial files,” but the Court does not articulate the basis of this assumption. (Doc. 64-1, p. 27).
First, and in fairness, both BI and BII were before Chief Judge Herndon, and they were collectively identified as BI. When Chief Judge Herndon said that BI acted in bad faith, it is unclear if he was assessing the conduct of BI or BII. Secondly, this Court agrees that Dr. Lehr should have been identified early in the MDL as a custodian and that his files should have been part of the preservation order. The mere fact that some of his files may be missing, however, is not enough for this Court to find intent to deprive or bad faith. The data collection and production were monumental, and it is not inconceivable that some ESI will be unaccounted for. See, e.g., Wooden v. Barringer, No. 3:16cv-446-MCR-GRJ, 2017 WL 5140518, at *10 (N.D. Fla. Nov. 6, 2017) (negligence is not enough to establish Defendant acted with intent to deprive Plaintiff of evidence).
It is unclear when Mr. Redgrave was first disclosed to Plaintiff as an expert. Mr. Redgrave's declaration is dated May 3, 2018, (Doc. 64-5), but it first appears on the docket on July 2, 2020. (Doc. 64). The Case Management Scheduling Order establishes May 14, 2020 as the deadline for expert disclosures. (Doc. 46).