Opinion
MASTER FILE NO. 5:18-MD-2809-KKC MDL DOCKET NO. 2809
2021-01-22
IN RE: ONGLYA (SAXAGLIPTIN) AND KOMBIGLYZE XR (SAXAGLIPTIN AND METFORMIN) PRODUCTS LIABILITY LITIGATION
MEMORANDUM OPINION AND ORDER
"There is no way that this winter is ever going to end as long as this groundhog keeps seeing his shadow. I don't see any other way out. He's got to be stopped. And I have to stop him." Bill Murray in GROUNDHOG DAY (Sony Pictures Home Entertainment 1993). On November 9, 2020, this Court entered a Memorandum Opinion and Order ("Opinion") describing this case as "the Groundhog Day of discovery disputes. 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." [DE 594 at Page ID # 8684 (footnote omitted)].
Plaintiffs are back before the Court seeking compulsion of many of the same documents the Court barred them from obtaining in the Opinion. Undaunted, Plaintiffs complain Defendants are wrongly withholding these documents with, at the time of filing, a mere week left in expert discovery. In other words, the groundhog has once again seen his shadow on the eve of spring. Six more weeks of winter. But unlike Bill Murray, this Court has an obvious mechanism by which to end this proverbial "winter": the discovery deadlines in this case. For the reasons stated below and previously set forth in the Opinion, Plaintiffs’ Motion to Compel will be denied.
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 multiple Court intervention, Defendants produced several studies over a year ago in response to the discovery requests. The parties proceeded to complete fact discovery and moved forward with expert discovery.
In late October 2020, with only weeks left in expert discovery, Plaintiffs moved the Court to compel Defendants to produce the results and raw data from a study the parties call "MEASURE-HF." At the time of that motion, the results of the MEASURE-HF study were unavailable because the underlying data was not "locked" and the analysis was not complete. At the hearing on October 21, 2020, Defendants projected a database lock later that month "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]. Plaintiffs contended the study should be produced upon completion and fact and expert discovery should be reopened.
As the Court previously cited, "[t]he 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].
As detailed in the Opinion, the Court rejected Plaintiffs’ arguments. [DE 594]. In so doing, the Court considered the factors for permitting additional discovery time as set forth in Dowling v. Cleveland Clinic Foundation : "(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." 593 F.3d 472, 478 (6th Cir. 2010) (citation omitted). The Court also considered the prejudice to Defendants. See Leary v. Daeschner , 349 F.3d 888 (6th Cir. 2003). All five Dowling factors weighed against Plaintiffs’ position. In short, Plaintiffs’ dilatory actions in failing to raise the MEASURE-HF study with the Court until October 2020—despite calling it "key evidence," despite two years of fact discovery, despite nearly one year of expert discovery, despite knowing about the study for years, despite numerous times before the Court where the study could have been raised—revealed that the evidence is either not as critical as Plaintiffs claim, or Plaintiffs were utterly negligent in failing to pursue it. Plaintiffs delayed making that request until just days before the expert depositions were to occur, forcing the Court to extend the expert discovery deadlines once again. Plaintiffs chose not to appeal the Court's adverse ruling to Judge Caldwell.
In the instant Motion to Compel, Plaintiffs limited their request from the six broad categories of study results and underlying data previously requested to three specific categories of documents concerning the MEASURE-HF study: "(1) the MEASURE-HF Core Team's presentation on its original conclusions regarding the study and the conclusions as modified by the Development Review Committee ("DRC") and any relevant communications; (2) the case report forms ["CFRs"] or electronic case report forms; and (3) the cardiac magnetic resonance imaging (MRIs) for each patient in the study." [DE 609 at Page ID # 8829]. The Court cannot determine with certainty whether these three categories were included in the documents Plaintiffs sought in October 2020, but there appears to be significant overlap.
II. ANALYSIS
Plaintiffs’ current motion is nothing more than a second attempt convince the Court to compel Defendants to produce the MEASURE-HF study. The Court denied this request in the Opinion because of the delay in Plaintiffs’ pursuit and the delay it would cause in this case. Now, reviewing Plaintiffs’ slightly reshaped request, the Court finds its prior logic still holds. The Court is aware that there will always be more studies and additional data points to consider relevant to this dispute. Yet, as the Kentucky Supreme Court once famously said, "[t]he curtain must fall at some time upon the right of a litigant." Neal v. Welker , 426 S.W.2d 476 (Ky. 1968). Three years of discovery on causation is enough. This case must proceed forward.
Plaintiffs previously requested that the Court should delay the expert discovery deadline until Defendants produced the MEASURE-HF "underlying data." [DE 573-1 at Page ID # 7926]. Because the Court rejected that motion and rebuked Plaintiffs for their tardy action, Plaintiffs have now refashioned their request for the MEASURE-HF study results as a motion to compel Rule 26 supplementation. The current motion to compel, filed on December 23, 2020, eight days before expert discovery deadline, did not make a request to extend the deadlines. Instead, Plaintiffs requested the Court expedite their motion to obtain a decision within the expert discovery timeframe. This was a transparent attempt to renew the request for the MEASURE-HF study results but avoid the Dowling analysis detailed in the Opinion. The Court will not be gulled by this tomfoolery.
This is the fifth request for the Court to take extremely expedited action in this case since mid-September 2020. [DE 559, 564, 572, 604, and 610].
Plaintiffs hang their entire motion on footnote 10 of the Opinion where the Court reminded Defendants of their obligation that "[t]o 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." [DE 594 at Page ID # 8698, n. 10]. Plaintiffs use this footnote to argue that large swaths of the underlying data from the MEASURE-HF study should be produced.
However, Defendants have produced volumes of MEASURE-HF information. The parties described Defendants’ productions of MEASURE-HF documents in response to footnote 10:
• "the November 6, 2020 CVRM DRC Meeting Minutes" [DE 609-1 at Page ID # 8835].
• "eCTD module 5 FDC submissions, including materials related to MEASURE-HF" [DE 617 at Page ID # 9308].
• "materials related to MEASURE-HF from the custodial files of Dr. Nayyar Iqbal" [DE 617 at Page ID # 9308].
• " ‘high-level results’ — 87 pages of charts and statistical analyses setting forth a broad set of the study findings" [DE 617 at Page ID # 9309] ("high-level results" are "based on the participants’ MRIs" [DE 609-1 Page ID # 8838]).
• "the complete underlying statistical data used to calculate those results" [DE 617 at Page ID # 9309]; ("raw data from the MEASURE-HF study" [DE 615-1 at Page ID # 9203, ¶ 12]).
• "a template MEASURE-HF Case Report Form" [DE 617 at Page ID # 9309].
• "October 13, 2020 LSPC Meeting Overview & Memos" [DE 609-1 at Page ID # 8837].
• "the study's Statistical Analysis Plan" [DE 615-1 Page ID # 9201, ¶ 12].
The Court holds that Defendants have satisfied their Rule 26 obligations with these productions relevant to the MEASURE-HF study. "A party is required to supplement in a ‘timely’ fashion once it ‘learns’ a prior response is no longer complete or accurate." U.S., ex rel. Natural Resources Defense Council v. Lockheed Martin Corp. , 2014 WL 6909652, at *3 (W.D. Ky. 2014). Based on Defendant's projections about the progress of MEASURE-HF, it appears they timely disclosed the MEASURE-HF documents in a judicious fashion as they became available. The lengthy list of disclosures above appears to be the "additional responsive documents" that were in Defendants’ possession at the time of the Court's Opinion and many additional documents that became available thereafter.
Undaunted, Plaintiffs filed the current motion seeking drafts of the conclusions of the still ongoing MEASURE-HF study as well as primary evidence supporting the underlying data from the still ongoing MEASURE-HF study. The key word is ongoing. The Court's prior Opinion did not require Defendants to produce the full MEASURE-HF study results and underlying data because, inter alia , the study was incomplete. "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." [DE 594 at PageID# 8698]. At that point, the parties agreed that production of the MEASURE-HF study should not occur prior to its completion. [Id. at PAGE ID# 8686]. The Court's position has not changed. The Court will not require Defendants to produce the MEASURE-HF study, including the primary evidence of the MEASURE-HF study itself (the CFRs and MRIs), prior to the study's completion. Not only will this serve as a complete subterfuge of the Court's prior Opinion, but the Court's prior logic still holds true—raw, incomplete, and partial data is prejudicial to all. As Defendants note, even "the items being sought are interim drafts and analyses, still subject to scientific discussion within the company" undercutting any reliability of such documents at this stage. [DE 615 at PageID# 9192]. The Court finds that the prejudice to Defendants is far too great by producing additional data, drafts, and communications from a study that is yet to be finished. See Leary v. Daeschner , 349 F.3d 888 (6th Cir. 2003) ; Korn v. Paul Revere Life Ins. Co. , 382 F. App'x 443 (6th Cir. 2010).
While the prior request addressed in the Opinion concerned the underlying data or secondary evidence captured for the MEASURE-HF study, the current request seeking the CFRs and MRIs is the primary evidence. In short, using the primary evidence, Plaintiffs could make an effort to construct the underlying data to which the Court previously denied.
"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." [DE 594 at Page ID # 8694].
In addition, the expert testimony offered Plaintiffs no favors. For example, Plaintiffs imply they need the requested documents because defense expert Dr. Eric Adler "testified that the MEASURE-HF high-level results supported his conclusion that there is no mechanism to explain the relationship between Saxagliptin and heart failure" which somehow necessitates Plaintiffs accessing the underlying study data. [DE 609-1 at Page ID # 8837]. But the quoted testimony in Plaintiffs’ brief (and his deposition transcript) does not support their argument—quite the opposite. Dr. Adler expressly said that even if the MRIs were available, he would not review them; instead he intended to rely on the study team's interpretation of MEASURE-HF data—the same high-level results Plaintiffs already had in hand when they deposed Dr. Adler. [DE 609-1 at Page ID # 8836; DE 617-3 at Page ID # 9350-51]. And if that was not enough, the testimony and opinions of Plaintiffs’ sole causation expert, Dr. Parag Goyal, thoroughly vitiates Plaintiffs’ arguments that additional data is necessary. As the Court noted in its prior Opinion on this topic, Dr. 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]. Dr. Goyal had the MEASURE-HF production Defendants made in December 2020 available to him in advance of his December 30, 2020, deposition. And for all of Plaintiffs’ blustering of the importance of that information, Dr. Goyal did not believe the information was necessary for his opinion. Dr. Goyal repeatedly answered "[n]ot sure" in response to questions about the MEASURE-HF document production and stated that he had not reviewed the MEASURE-HF study results that Defendants had produced. [DE 617-2 at Page ID # 9332, 9336, and 9339]. To the extent Plaintiffs argue that it is necessary for Dr. Goyal to have the requested documents to form his opinion and supplement his report, Dr. Goyal's own testimony and report completely blunts their claim.
Defendants produced the high-level results on December 10, 2020 [DE 615-6 and 615-7]; Plaintiffs deposed Dr. Adler on December 18, 2020 [DE 617-3].
Alas, even if the Court were to grant Plaintiffs’ requested relief, the Court is at a complete loss how the parties would practically sort through the result and comply with the Court's schedule. By Plaintiffs’ own proposed briefing schedule, the matter would have become ripe only two days prior to the close of expert discovery. Assuming the Court issued its ruling the moment the matter became ripe, Defendants would surely need days or weeks to produce the documents and Plaintiffs the same to review. The parties have already produced their expert reports and deposed those experts. The documents, arriving after the close of expert discovery, would serve no purpose in this case unless the Court postponed the end of the discovery period once more. "But deadlines are important things. And when the Court establishes deadlines, the parties are obliged to follow them." Century Indem. Co. v. Begley Co. , 323 F.R.D. 237, 239 (E.D. Ky. 2018). "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).
Plaintiffs originally filed their Motion on Thursday, December 23, 2020, and proposed that Defendants should respond by Monday, December 27, 2020. [DE 610]. Plaintiffs were to reply by Wednesday, December 29, 2020, with the Court presumably making a ruling on and ordering complete effectuation of that order in the remaining two days of expert discovery. [Id. ].
Granting Plaintiffs’ motion would not only delay the close of discovery, but almost inevitably give rise to additional discovery disputes that have plagued this case, which would ultimately—once again—delay the Daubert hearing. The potential for such continued disregard of the Court's schedule brings to mind Bill Murray's exclamation: "Well, what if there is no tomorrow? There wasn't one today!" Groundhog Day (Sony Pictures Home Entertainment 1993).
If Plaintiffs were displeased with the Court's Opinion, they should have appealed that issue to Judge Caldwell as instructed in the last paragraph of that Opinion. [DE 594 at Page ID # 8700]. The current motion is an attempt to circumvent that appeal process as well as the Court's schedule. After six deadline extensions, there can be no more Groundhog Days.
III. CONCLUSION
"[N]either § 1407 nor Rule 1 remotely suggests that, whereas the Rules are law in individual cases, they are merely hortatory in MDL ones." In re National Prescription Opiate Litigation , 956 F.3d 838, 844 (6th Cir. 2020). Discovery in this case could, theoretically, continue indefinitely as long as AstraZeneca and others are studying saxagliptin. The civil rules do not contemplate that the duty to supplement requires interminable rolling productions, preposterously postponing the close of the discovery period and Daubert hearing until a study comes along that mirror Plaintiffs’ theory of causation.
Accordingly, for the reasons stated herein and the Court being sufficiently advised, IT IS ORDERED that Plaintiffs’ Motion to Compel is DENIED.
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).