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IN RE: ONGLYZA (SAXAGLIPTIN) AND KOMBIGLYZE XR (SAXAGLIPTIN AND METFORMIN) PRODUCTS LIABILITY LITIGATION
MEMORANDUM OPINION AND ORDER
This case is the Groundhog Day of discovery disputes.1 Instead of Bill Murray's comedic shenanigans on repeat, this case has been plagued by another now-familiar, repetitive pattern: Defendants delay or refuse to disclose discovery materials resulting in Plaintiffs railing against Defendants’ assumed malicious motives. Plaintiffs then delay raising the issue before the Court until the problem is critically urgent or the deadlines have nearly passed.2 This pattern has resulted in numerous discovery disputes coming before the undersigned and Judge Caldwell extending the causation discovery deadlines five times. The current dispute is no exception to this pattern.
Plaintiffs have filed a Motion to Compel seeking disclosure of another clinical study and to extend discovery deadlines once again. [DE 573]. Defendants filed a Response [DE 587] and Plaintiffs replied [DE 590]. The Court conducted a telephonic hearing to better understand the arguments of the parties. Having reviewed the written materials as well as the arguments presented by counsel, the matter is fully ripe. For the reasons detailed below, Plaintiffs’ Motion to Compel will be denied and their Motion to Extend Deadlines will be granted.
I. RELEVANT FACTUAL AND PROCEDURAL BACKGROUND
This case is a multidistrict litigation arising from allegations that the Type 2 diabetes medication saxagliptin, sold under the brand names Onglyza and Kombliglyze XR, caused heart failure and/or increased the risk of adverse cardiac events. Judge Caldwell bifurcated this case requiring the parties to go forward initially on the sole issue of general causation. Plaintiffs propounded Requests for Production of Documents on Defendants requesting clinical trial studies (i.e., human trial studies) relating to the safety of saxagliptin, such as the “SAVOR” study. After Court intervention, Defendants produced several studies many months ago in response to the discovery requests.
Plaintiffs now move the Court to compel Defendants to produce the results and raw data from a study referred to as “MEASURE-HF”.3 In the instant Motion to Compel, Plaintiffs describe the study as follows:
AstraZeneca committed to this [MEASURE-HF] study in the aftermath of the unfavorable SAVOR data, which revealed that Saxagliptin significantly increased the risk of heart failure. MEASURE-HF and its results thus go to the heart of Plaintiffs’ case, and MEASURE-HF is particularly relevant to the parties’ expert reports on general causation.
[DE 573-1 at Page ID # 7912].
Defendants do not contest the relevancy of the MEASURE-HF study, its responsive to Plaintiffs’ prior discovery requests, or that its subject matter fits within the Court's Order dated November 5, 2019 requiring disclosure of such studies. Rather, Defendants responded that they still cannot produce the results of MEASURE-HF study because the underlying data and accompanying analysis is not complete. Specifically, the MEASURE-HF data is not yet “locked” and therefore cannot be disclosed at this time.4
Plaintiffs agree. At the hearing on October 21, 2020, Defendants projected a database lock in October 2020 “and AstraZeneca employees may begin analyzing the full data set in November 2020 with plans to complete the clinical study reports around the end of February 2021.” [DE 587-1 at Page ID # 8243 at ¶ 3]. Defendants anticipate the initial data overview will be available in early November 2020, but the full study results will not be available until sometime in December 2020 or possibly well into 2021.
In summary, Plaintiffs contend that when the MEASURE-HF study is complete, Defendants should produce the study and the fact and expert discovery should be reopened to account for the study. Plaintiffs place blame on Defendants and suggest, without any proof, that Defendants are nefariously delaying the study solely for the purposes of avoiding disclosure in this litigation. Defendants counter that Plaintiffs have waited far too long to inquire about disclosure of the MEASURE-HF study. Plaintiffs have always known about this study and pursued the litigation with that knowledge. According to Defendants, on the brink of the closure of expert disclosure and pending resolution of the causation issue, Plaintiffs now seek another bite at the apple.
Both parties recognize that if the Court compels Defendants to produce the MEASURE-HF study results, the deadlines in this case will have to be substantially extended for the sixth time. Plaintiffs urge the Court “to extend the expert discovery deadlines to six weeks after Defendants produce the compelled documents and data to allow the parties to supplement their expert reports[.]” [DE 573-1 at Page ID # 7913]. Plaintiffs maintain that such a minor delay will not prejudice the Defendants. Defendants, however, expect that if Plaintiffs succeed on their motion,
some of the documents Plaintiff request will simply not exist until February 2021 at the earliest. Plaintiffs’ proposed extension would therefore present a significant enlargement to the current schedule. If supplemental reports and depositions occur after the production and review of these documents in late February 2020, reports would not be submitted until at least April 2021 and depositions would not be completed until mid-2021 at the earliest, followed by Daubert briefing and a hearing.
[DE 587 at Page ID # 8237 (emphasis in original)]. Unsurprisingly, Defendants argue that “[s]uch a significant delay is unreasonable” and that they will suffer prejudice if resolution of the case is delayed. [DE 587 at Page ID # 8237-38].
“The rule of law applies in multidistrict litigation under 28 U.S.C. § 1407 just as it does in any individual case. Nothing in § 1407 provides any reason to conclude otherwise․ The rules at issue here are the Federal Rules of Civil Procedure, which have the same force of law that any statute does.” In re National Prescription Opiate Litigation, 956 F.3d 838, 841 (6th Cir. 2020). Fed. R. Civ. P. 16(b) mandates that the “district judge ․ must issue a scheduling order ․ [which] must limit the time to join other parties, amend the pleadings, complete discovery, and file motions.” Fed. R. Civ. P. 16(b)(1) and (3). Once set, “[a] schedule may be modified only for good cause and with the judge's consent.” Fed. R. Civ. P. 16(b)(4). “Because a court's scheduling order is not a frivolous piece of paper, idly entered, which can be cavalierly disregarded ․ without peril, a movant must demonstrate that the reasons for the tardiness of his motion justify a departure from the rules set by the court in its scheduling order․ Scheduling orders are critical in moving cases to a just outcome in an efficient manner. In order to accomplish this end, deadlines ‘must have teeth’ and must be enforced by the courts.” Birge v. Dollar General Corp., 2006 WL 133480, at *1 (W.D. Tenn. Jan. 12, 2006) (citations and quotation marks omitted). This is no less true in the case of a multi-district litigation.
In determining whether to permit additional time for discovery, the Court must consider the following factors: “(1) when the moving party learned of the issue that is the subject of discovery; (2) how the discovery would affect the [case]; (3) the length of the discovery period; (4) whether the moving party was dilatory; and (5) whether the adverse party was responsive to prior discovery requests. The overarching inquiry in these overlapping factors is whether the moving party was diligent in pursuing discovery.” Dowling v. Cleveland Clinic Foundation, 593 F.3d 472, 478 (6th Cir. 2010) (citation omitted). The Court also considers the prejudice to the non-movant. See Leary v. Daeschner, 348 F.3d 888 (10th Cir. 2003); Korn v. Paul Revere Life Ins. Co., 382 F. App'x 443, 449 (6th Cir. 2010).
A. Dowling Analysis
1. The First Three Factors Are Not Contested.
In the Court's view, the first three factors in the Dowling analysis are not contested.
Plaintiffs do not dispute knowledge of the ongoing MEASURE-HF study for years. Specifically, Plaintiffs stated on the record during the teleconference on this motion that they were aware in 2015 that Defendants intended to undertake the MEASURE-HF study (the study did not have a name or any participants enrolled at that time). In light of the fact Plaintiffs have unquestionably known about the MEASURE-HF study since the inception of this litigation, the Court finds the first factor weighs against extending the expert discovery deadlines for the significant amount of time it will take AstraZeneca to lock its database, review the information, issue reports, produce the information to Plaintiffs in a supplemental disclosure, and then have both sides’ experts issue supplemental reports.
The second factor—how the discovery would affect the case—requires the Court to consider the impact of production on both the schedule for the case as well as the impact on the merits. As stated above, the parties agree the production would result in a delay but contest the extent of the delay. The Court agrees with Defendants that it is more likely that it will take six months, not weeks as Plaintiffs claims, after the MEASURE-HF data results are available for the experts to review it, update their reports, and be deposed. In short, the production of one study would result in a reset of the entire expert phase of the case. As to the impact on the merits, neither the Court nor the parties have any ability to discern conclusions or details of the MEASURE-HF study. Because the study remains blinded, Plaintiffs have no idea if the study will clinch its causation case, will sound its death knell, or merely muddle the picture. Plaintiffs’ expert, Dr. Parag Goyal, opined that “[a]lthough additional data would only strengthen the case for causation, lack of additional data does not negate the cause-and-effect between saxagliptin and heart failure shown in SAVOR.” [Rebuttal Report of Dr. Goyal, DE 588 Ex. K at Page ID # 8644]. According to Dr. Goyal, additional studies such as MEASURE-HF are not necessary to prove causation. Ultimately, the Court concludes the MEASURE-HF study and its production would have a negative impact on the litigation schedule and a wholly unknown impact on the merits.5 The Court finds the second Dowling factor weighs against granting Plaintiffs’ motion.
Regarding the third factor (length of discovery), the discovery period limited to only general causation began in early 2018, nearly two years ago. At one point, in December 2018, Plaintiffs represented to the Court that they “would like to get through the general causation fact discovery by mid-June of ” and have a Daubert hearing “as early as November 2019.” [Transcript, DE 366 at Page ID # 2483]. Of course, like many complex litigations, the initial plan has gone awry. There have been nine case management orders in this case, many of which extended discovery deadlines. [See DEs 327, 412, 437, 474, 529]. The Court acknowledges that discovery, while limited to causation, has been complex and voluminous in this multi-district pharmaceutical litigation. However, the Court has been gracious with both parties working through these discovery issues and modifying the scheduling order. Outside of the eleventh hour invocation of the MEASURE-HF study, the parties had completed fact discovery, disclosed their relevant expert reports and supplemental reports, scheduled the expert depositions, and were planning the upcoming briefing and hearing schedule on the presumptive Daubert motions. The Court is hard-pressed to believe that the parties have not had ample amount of time to build their respective positions and make necessary arguments. Certainly, if Plaintiffs intended to use MEASURE-HF in this litigation, they never represented to Judge Caldwell that the schedules they repeatedly suggested were merely aspirational and contingent on obtaining the MEASURE-HF study results.6
This factor also weighs in favor denying Plaintiffs’ motion.
2. For the Fourth Factor, the Plaintiffs Have Waited Far Too Long.
The Court's analysis of fourth factor cannot be understood without recounting, at least in part, how this case unfolded over the past two years.
Since its start, the Court has constantly monitored and pressed the parties regarding the discovery schedule. In one of countless examples, the parties had the following exchange during a status conference with Judge Caldwell in April 2019:
THE COURT: Very well. So you feel like you're on track to comply with the discovery deadlines as set at this point?7
MR. CLARK [for Plaintiffs]: I believe so at this time, Your Honor. Obviously, we may have some disputes with defendants and sometimes may happen and we may need Court intervention. We'll just keep the Court aware of, you know, any – if there's any significant derailments or things where we need the Court to step in to help keep things on track, or in the event that we would need any additional time down the road. We will advise the Court as things progress.
THE COURT: All right. Well, I do want to keep this case moving forward, so if intervention is required, seek it at the earliest opportunity.
[Transcript, DE 369 at Page ID # 2506].
More relevant to the current dispute, on October 10, 2019, the undersigned conducted the first—and most comprehensive in scope—hearing on the discovery disputes in this case. [DE 374]. The hearing addressed Plaintiffs’ first Motion to Compel.8 At the hearing, the parties discussed, in depth, four categories of disputed documents: (1) non-clinical trial data (primarily animal studies); (2) clinical trial data (human studies); (3) pharmacovigilance documents; and (4) Defendants’ custodial files. To be sure, the parties spent most of their brief space and time at the hearing arguing about the clinical trial data. Although much of that dispute centered on the format the Defendants used to produce the clinical trial data, a significant discussion also ensued specifically identifying and listing which clinical trial studies were to be disclosed and which were not. For example, the Court recalls one of many such exchanges:
MR. CLARK: [․] And then if there are any clinical trials, we are willing to tailor our clinical trial request to trials that involve where heart failure occurred for -- the supporting complete trial production for those trials. It sounded like there's 18 here, even though originally they had proposed a dozen or 12 -- a dozen or 13.
THE COURT: 13.
MR. CLARK: But it sounds like, by defendants’ position, that there's 18 different studies where there's been a heart failure. I think that we would ask for those in their entirety[.]
THE COURT: [․] Let me turn to the defendants for a second and address, you know, there was 13 studies and 11. Now there's 18 I asked you a question earlier about. But how do I have assurances, if the world is everything that -- I think all the parties agree that if a clinical study was directly about a cardiovascular issue, that's relevant to be produced. I don't think anybody has a problem with that. [․] Again, I don't know what shape, form, or fashion, but you've referenced that there are some more outside of the original 13 or 11 that you're willing to produce. How do I define that world? How do I know -- how can I give assurances to the plaintiff that this 18 is it?
MS. ULLMAN [for the defendants]: Sure. Well, first, sort of just to back up a little bit, Your Honor, when we originally identified 13 and then 11, what we used as our criteria was if either heart failure was an endpoint or something related to cardiac issues was an endpoint, so something that the study was designed to analyze.
THE COURT: Right.
MS. ULLMAN: The 18 includes the last -- is defined by the last group. The 13 are the first two buckets that you just said. They overlap somewhat, but not entirely. So in total, it would be about 22.
THE COURT: Okay. That's what I'm looking for. The total, final, comprehensive number is 22.
MS. ULLMAN: Yeah. And I can do the addition there, but I think it's -- it's less than 18 plus 13, Your Honor.
THE COURT: Mr. Clark, would you suggest alternative terms by which to trigger, you think, a study would involve a cardiovascular issue, or do you think that is satisfactory? Again, I understand your other concerns. I'm trying to figure out what this definition would even look like and if we can get the parties to agree as to what that would look like.
MR. CLARK: I think that with crystal clear assurances and definitions of we know what this production would entail as far as that, as Your Honor's teasing out, and exactly what studies, and then if we were able to have some form of certification from defendants that we understand that this is it, this is the universe, I think that's something that we would be willing to agree to to reduce the scope, as long as that we could then -- you know, format and things like that that is, I know, on the side at the moment. But I think that is absolutely something plaintiffs would be willing to agree to.
[Transcript of Motion to Compel Hearing, October 10, 2019, DE 438 at Page ID # 2930-31; 2937-38; and 2939-40]. During the extensive briefing or exhaustive arguments, Plaintiffs never raised nor so much as mentioned the concept of the MEASURE-HF study despite the parties identifying each and every clinical study at issue.
The Court resolved that first Motion to Compel in its Memorandum Opinion and Order dated November 5, 2019, stating:
Plaintiffs clarified their position at the hearing, requesting that Defendants be compelled to produce eCTD data for all clinical trials submitted to the FDA and additional, supporting data for those trials which had either a cardiac endpoint or a cardiac event, regardless of the endpoint of the study. Defendants state there are approximately 150 clinical trials submitted to the FDA in eCTD format, but only 22 of those clinical trials had a cardiac endpoint, echocardiogram, or a cardiac event. Defendants object to producing all 150 clinical trials as overbroad and not relevant to this litigation. Plaintiffs were willing to compromise as to the clinical trials produced along the lines suggested by Defendants, but the fight then moved to the format in which the documents should be produced.
The Court agrees with Plaintiffs that all of the clinical trial data submitted to the FDA is routinely produced in pharmaceutical products liability cases like this one and is necessary for the Plaintiffs and their experts to evaluate general causation even where the trial does not discuss cardiac events.
[Memorandum Opinion and Order, DE 399 at Page ID # 2777-78]. The Court did not, as Plaintiffs suggest, order Defendants to produce the “MEASURE-HF and other post-SAVOR study information that are at issue in this Motion” in its Memorandum Opinion and Order at DE 399. The Court's Order did not nor could not require Defendants to produce data from a still incomplete, unpublished, and, until a couple weeks ago, unidentified study.
Since this first hearing and over the past year, the undersigned has held other hearings to resolve discovery disputes between the parties. Like the hearing in November 2019, these later hearings focused on the studies previously identified and produced and how the parties were progressing in the litigation. [See DEs 374, 461, 563]. The Court addressed issues concerning productions of additional studies, application of international privacy law to these studies, the propriety of redactions from these studies, alleged trade secrets included in the studies, procedures for expert depositions about these studies during a global pandemic, etc. [See DEs 399, 490, 547]. Again, despite knowing about the potential of the MEASURE-HF study since 2015, never once did Plaintiffs advance the specter of the MEASURE-HF study. Never once did Plaintiffs suggest more time will or even might be necessary because of this study.
Moreover, the parties repeatedly had status conferences with Judge Caldwell to address scheduling concerns and the overall status of the case. [See DEs 163, 189, 248, 313, 348, 415, 418]. Again, never once did Plaintiffs advance the specter of the MEASURE-HF study. And again, never once did Plaintiffs suggest more time will or even might be necessary because of this study. Plaintiffs, by any measure, were dilatory.
Rather, according to the record before the Court, the MEASURE-HF study was not formally raised between the parties until July 2020. Only then, well after the close of fact discovery, after expert reports were disclosed, and just days before their expert report was due, Plaintiffs’ expert asked counsel about the outcome of the MEASURE-HF study. In turn, Plaintiffs’ counsel asked Defendants’ counsel “for an update on the status of the MEASURE-HF study and to identify the study results in the Defendants’ production.” [DE 573-1 at Page ID # 7915]. Defendants responded that “[t]he MEASURE-HF study is still ongoing, and database lock is presently set to occur in mid-September.” [DE 573-1 at Page ID # 7915]. Plaintiffs did not raise the issue with the Court. [DE 563 (hearing to discuss, among other issues, the upcoming expert discovery deadline and expert depositions)]. Plaintiffs still took no action with the Court based upon this exchange.
Plaintiffs inquired of Defendants again on September 25, 2020. [DE 573-1 at Page ID # 7915]. Defendants then projected a database lock in October 2020 “and AZ employees may begin analyzing the full data set in November 2020 with plans to complete the clinical study reports around the end of February 2021.” [DE 587-1 at Page ID # 8243 at ¶ 3].
Finally, on October 7, 2020, Plaintiffs filed the current motion for the first time raising the issue with the Court. There, Plaintiffs ignore their own delay and boldly argue that the delay in the MEASURE-HF study was all part of litigation tactics by Defendants to frustrate Plaintiffs’ ability to prove causation. [DE 573-1 at Page ID # 7916]. Defendants submitted affidavits explaining the delay in the MEASURE-HF study was due to inconsistent MRI readings in the data as well as complications due to COVID-19. [DE 587]. Plaintiffs, undaunted and still without any proof, persisted that Defendants’ motives seemed questionable. [DE 590].
The history of this litigation, like most multidistrict litigations, is long and fraught. Yet, the history is critical to understand whether Plaintiffs were dilatory in pursuing the issue of the MEASURE-HF study, a study that Plaintiffs admit they have known about since 2015. The Court will not entertain a ruling based upon Plaintiffs’ worst theories and fears about Defendants, but based only upon the record. And here, the record establishes that Plaintiffs’ inability to raise the MEASURE-HF study with the Court prior to October 2020 is inexcusable. More specifically, the record is devoid of any conceivable justification from Plaintiffs as to why they failed to raise the MEASURE-HF study during the numerous hearings with the undersigned or Judge Caldwell on June 25, 2019, September 17, 2019, October 10, 2019, December 17, 2019, January 22, 2020, April 22, 2020, or September 17, 2020. Nor did Plaintiffs raise this issue in any motion or status report prior to this Motion to Compel [DE 573], despite having filed prior motions to compel on September 19, 2019 [DE 349] and May 18, 2020 [DE 479]. The history of the case demonstrates a willingness to bring any and all discovery issues before the Court, many of which have worked in Plaintiffs’ favor. All of these hearings, conferences, and motions afforded Plaintiffs abundant opportunities to advise the Court that they expected the results of the MEASURE-HF study in the near future and would need the deadlines set far enough out to account for time to receive and analyze those results. If the MEASURE-HF study is, as Plaintiffs represent, “key evidence” in this case, it is unfathomable that they would wait so late in the litigation to raise this issue with Defendants or the Court. The Court cannot reach any conclusion but that Plaintiffs were dilatory in pursuing production of the MEASURE-HF study.
Accordingly, the fourth factor weighs heavily against granting Plaintiffs’ motion.
3. Defendants are Not Dilatory in Producing What Does Not Yet Exist.
Lastly, as to the fifth factor, Defendants have not always been adequately responsive to discovery requests, sometimes requiring Court intervention. [See DEs 399, 547 (granting in part Plaintiffs’ prior motions to compel)]. There is no evidence in this instance, however, that Defendants failed to produced evidence related to the MEASURE-HF study results because those results do not yet exist.9
Plaintiffs list six categories (and many sub-categories) of MEASURE-HF documents responsive to their Requests for Production of Documents in their memorandum in support of their motion. [DE 573-1 at Page ID # 7922-24]. Defendants do not dispute the responsiveness of these documents; instead, they respond that many of these documents—1,900 pages’ worth that do currently exist—have already been produced.10
The bulk and most important part of the remaining information to be produced related to the MEASURE-HF study, of course, is the underlying data itself. Plaintiffs are seeking an extension of the expert discovery deadlines until this data can be produced. Plaintiffs’ primary argument for extending the discovery deadlines, however, is not that Defendants have withheld documents, but that the date of the MEASURE-HF data lock and “study results seemed to keep getting pushed beyond the expert deadlines in this case[.]” [DE 573-1 at Page ID # 7916]. Plaintiffs suggest, without any proof, that Defendants have purposefully delayed locking the MEASURE-HF data so that it could not be produced in this litigation.
Nevertheless, Defendants are not dilatory in producing something that does not yet exist. The Court will not delay this litigation for months after Plaintiffs’ repeated failures to pursue this discovery based solely on their “hunch” that Defendants are delaying the study results for malicious purposes.
B. Prejudice to the Defendants
When the Court considers the prejudice to Defendants, it is evident that Defendants will suffer tremendous prejudice by being forced essentially to re-open fact discovery and wait six months or more to close expert discovery. Defendants have participated in this litigation for two years with numerous deadline extensions. They now deserve their “day in court.” Leary v. Daeschner, 349 F.3d 888, 909 (6th Cir. 2003) (“Thus, in addition to Rule 16’s explicit ‘good cause’ requirement, we hold that a determination of the potential prejudice to the nonmovant also is required when a district court decides whether or not to amend a scheduling order.”).
C. Other non-clinical and clinical trials
Plaintiffs claim Defendants have not produced information about six additional clinical and non-clinical studies. [DE 573-1 at Page ID 7919]. Defendants state these studies were either proposed and not carried out or carried out by an entity other than Defendants. [DE 587 at Page ID # 8240]. Thus, Defendants state they have no further information to produce to Plaintiffs.
Plaintiffs, then, requested the “that Defendants be required to provide a declaration that to the best of Defendants’ knowledge, these two studies were never conducted.” [DE 590 at Page ID # 8659]. Plaintiffs chose not to serve interrogatories in this case. The Court is not aware of any procedural mechanism to force Defendants to provide such a declaration and Plaintiffs have not cited any Rule or case that would support the Court taking this action. In conclusion, this request is denied.
D. Extension of Deadlines
Although the Court denies Plaintiffs’ Motion to Compel, the filing of that motion on October 7, 2020, delayed expert discovery (which the parties had extended for a few days by agreement) and made the October 24, 2020, deadline to file Daubert motions impossible to sustain. Accordingly, the Court has no choice but to grant the motion to extend the expert discovery and Daubert motion deadlines in this matter. The extension will be as brief as practicable to minimize the prejudice to Defendants and keep this litigation moving towards a resolution on the issue of general causation.
“MDLs are not some kind of judicial border country, where the rules are few and the law rarely makes an appearance.” In re National Prescription Opiate Litigation, 956 F.3d 838, 844 (6th Cir. 2020). Plaintiffs have not shown good cause for extending the deadlines at this late date for the length of time required to obtain, analyze, and depose experts on the MEASURE-HF results. If Plaintiffs believed this “key evidence” had to be included in its discovery, Plaintiffs should have raised this issue with the Court at any number of opportunities they had when discussing scheduling and discovery disputes. Plaintiffs have not shown “good cause” as Rule 16(b) requires for extending the Court's scheduling order. All five factors of the Dowling test weigh against granting Plaintiffs’ motion. Dowling v. Cleveland Clinic Foundation, 593 F.3d 472, 478 (6th Cir. 2010) (citation omitted). “The Sixth Circuit has determined that a moving party's diligence in pursuing discovery is the ‘overarching inquiry’ in the five, overlapping Dowling factors.” Moonbeam Capital Investments, LLC v. Integrated Construction Solutions, Inc., 2020 WL 1429498, at *4 (E.D. Mich. March 24, 2020).
Accordingly, for the reasons stated herein and the Court being sufficiently advised, IT IS ORDERED that Plaintiffs’ Motion to Compel is DENIED and Plaintiffs’ Motion for Extension of Time is GRANTED.
1. Depositions of expert witnesses on the issue of general causation must be completed by December 31, 2020;
2. Any Daubert motions challenging expert witness testimony on the issue of general causation must be filed by January 22, 2021. Any responses to such motions must be filed by February 19, 2021. Any replies must be filed by March 10, 2021; and
3. Judge Caldwell will reschedule the hearings on any Daubert motions by separate order.
The undersigned enters this Memorandum Opinion pursuant to 28 U.S.C. § 636(b)(1)(A). Within fourteen (14) days after being served with a copy of this Memorandum Opinion, either party may appeal this decision to Judge Caldwell pursuant § 636(b)(1)(A) and Fed. R. Civ. P. 72(a).
1. Groundhog Day is a 1993 movie starring Bill Murray in which his character, Phil, becomes trapped in a perpetual loop of waking up in a small town to repeat everything—most of which is unpleasant—that happened on February 2nd. Phil is unable to break the loop until he learns a valuable lesson about how he should comport himself in the future. “Groundhog Day” has become a short-hand term in modern American vernacular for repeating the same troublesome scenario endlessly with little hope of breaking the cycle. GROUNDHOG DAY (Sony Pictures Home Entertainment 1993).
2. In the past two months alone, the parties have requested the Court address three disputes on an extremely expedited basis because of the looming deadlines. [DEs 560, 564, and 576].
3. “The MEASURE-HF study is a 24-week, multicenter, randomized, double-blind, parallel group, placebo-controlled study to investigate the effects of saxagliptin and sitagliptin in patients with Type 2 diabetes mellitus (“T2DM”) and heart failure (“HF”). The primary objective of the MEASURE-HF study is to exclude an increase in left ventricular end diastolic volume (LVEDV) index of greater than 10% of the overall baseline value in patients with T2DM and HF treated with saxagliptin for 24 weeks, compared to placebo.” [Declaration of Dr. Barry Reicher, DE 587-1 ¶ 3 at Page ID # 8243].
4. The MEASURE-HF database is double-blinded until it is locked. Until the data lock occurs, data may be added, removed, or edited. Defendants explained on the record the purpose of a datalock is to preserve the integrity of the double-blind nature of the study; if the researchers or analysts were to alter the data after unblinding, it would permit possible bias to be introduced into the study. It is impossible for Defendants to produce any usable information to Plaintiffs without unblinding the data; therefore, no production can be made until the data is locked. Plaintiffs did not dispute the veracity of any of this information.
5. Because the results of the MEASURE-HF are unknown (and unknowable) at the time the Court makes this decision, the Court analyzes the second Dowling factor based only on the information before it, including Dr. Goyal's report.
6. Plaintiffs’ representations to the Court in December 2018 and April 2019 regarding the expected conclusion of fact and expert discovery in 2019, when considered with Plaintiffs’ own statements about when they believed the MEASURE-HF study would be complete, make the Court skeptical about whether Plaintiffs ever intended to use the MEASURE-HF study in this litigation. Either Plaintiffs never intended to use MEASURE-HF and now that they realize they may be able to slip its results in at the eleventh hour to bolster (hopefully) their case; or Plaintiffs were utterly negligent in failing to raise this issue until now. The Court is not sure which of these narratives is more concerning.
7. At the time of this April 25, 2019, status conference, the expert reports from Plaintiffs were due on July 25, 2019, and from Defendants on August 8, 2019.
8. The parties have represented to the Court that Plaintiffs have not served any Interrogatories or Requests for Admissions in this case.
9. Plaintiffs urge the Court to consider that other courts have required parties to produce unpublished study results. [DE 573-1 at Page ID # 7926]. Results that are simply unpublished are not the same as results that do not yet exist, as in the MEASURE-HF study, because the data has not been unblinded at this time.
10. To the extent there are any additional responsive documents related to MEASURE-HF that can be produced at this time (i.e., documents other than the blinded study results), Defendants should supplement their production to produce those documents.
Matthew A. Stinnett, United states Magistrate Judge
Response sent, thank you
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Docket No: MASTER FILE NO. 5:18-MD-2809-KKC
Decided: November 09, 2020
Court: United States District Court, E.D. Kentucky,
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