In re Mirena Ius Levonorgestrel-Related Prods. Liab. Litig. (No. II)

• Decision Date: 11 June 2019
• Docket Number: 17-MC-2767 (PAE),17-MD-2767 (PAE)
• Citation: 387 F.Supp.3d 323
• Parties: IN RE: MIRENA IUS LEVONORGESTREL-RELATED PRODUCTS LIABILITY LITIGATION (NO. II) This Document Relates to All Actions
• Court: U.S. District Court — Southern District of New York

387 F.Supp.3d 323

IN RE: MIRENA IUS LEVONORGESTREL-RELATED PRODUCTS LIABILITY LITIGATION (NO. II)

This Document Relates to All Actions

17-MD-2767 (PAE)

17-MC-2767 (PAE)

United States District Court, S.D. New York.

Signed June 11, 2019

OPINION & ORDER

PAUL A. ENGELMAYER, United States District Judge

This multi-district products liability litigation involves a contraceptive product: the Mirena intrauterine device ("IUD") developed, manufactured, and distributed by defendants Bayer HealthCare Pharmaceuticals, Inc., Bayer Pharma AG and Bayer Oy (together, "Bayer"). The Mirena IUD is implanted in the uterus and functions by releasing a synthetic steroid hormone known as levonorgestrel ("LNG"). Plaintiffs claim that the hormonal component of Mirena caused them to suffer from a disease known as idiopathic intracranial hypertension ("IIH"), also known as pseudotumor cerebri ("PTC"). IIH is an uncommon disease marked by increased cerebrospinal fluid ("CSF") pressure in the skull.

This decision resolves a defense motion for entry of summary judgment based on the limited issue of general causation. Bayer disputes that there is competent evidence to establish that the use of Mirena is a cause of IIH. And this Court, heeding the guidance of the United States Judicial Panel on Multi-District Litigation ("JPML"), prioritized discovery on that question: whether Mirena's release of LNG is capable of causing IIH. On October 24, 2018, with fact and expert discovery complete on that issue, the Court granted defense motions under Daubert v. Merrell Dow Pharmaceuticals, Inc. , 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993), to exclude plaintiffs' seven expert witnesses on general causation. Dkt. 320.¹ Each had proposed to opine that use of Mirena can cause IIH. See In re Mirena IUS Levonorgestrel-Related Products Liability Litigation (No. II), 341 F. Supp. 3d 213 (S.D.N.Y. 2018) ("Mirena IIH/Daubert "). That ruling left plaintiffs without any expert evidence as to general causation.

After the Daubert ruling, with leave of the Court, Bayer filed the present motion for summary judgment. Bayer argues that plaintiffs lack evidence sufficient to establish general causation, and that such is fatal to their claims. Bayer argues, first, as a categorical matter, that expert testimony is required to establish general causation in a products liability case involving a pharmaceutical product such as Mirena. Alternatively, Bayer argues that even if lay testimony (e.g., admissions by a product's manufacturer) could in theory establish general causation, the non-expert evidence in the record of this case is insufficient to so establish. Plaintiffs counter with a range of arguments, including that general causation is not a required element of proof, that expert evidence is not required to establish general causation, that a factfinder considering together disparate elements of non-expert evidence could reliably find general causation by Mirena of IIH, and that granting Bayer summary judgment on this element—with discovery not having been taken as to the individual cases of the approximately 920 plaintiffs comprising this MDL—would violate the Seventh Amendment and be unconstitutional.

For the reasons that follow, the Court grants Bayer's motion for summary judgment.

I. Pertinent History of This Litigation

The Court incorporates by reference its decision on the Daubert motions, which sets out the background to plaintiffs' claims, and the procedural history of this litigation, in considerable detail. See Mirena IIH/Daubert , 341 F. Supp. 3d at 218–38. The Court here supplies—including by reproducing, at points, modified excerpts of that decision's chronicle of the case history—the limited background necessary for understanding the instant motion.

A. The JPML's Centralization of Mirena/IIH Cases Before This Court

On April 6, 2017, the JPML centralized in this District pretrial proceedings in the 113 cases then pending across 17 districts nationwide in which plaintiffs had alleged IIH injuries caused by the hormonal component of the Mirena IUD. Most of these cases were at a relatively early stage of discovery or at the pleading stage, although fact and expert discovery had closed in the 10 longest pending actions. See generally Dkt. 1 at 2–3 (JPML Transfer Order). The JPML had earlier, in July 2014, denied a motion to centralize the Mirena/IIH actions, at a time when nine such actions, spanning six districts, were pending. Explaining, in 2017, its decision to centralize the pending cases, the JPML emphasized several factors that made centralized proceedings more efficient. Two are relevant here.

First, the JPML noted the heightened difficulty coordinating discovery and other pretrial proceedings given the increased number and dispersal of pending actions and of participating law firms. Id. at 2. "The record," the JPML stated, "demonstrates that centralization is necessary to facilitate the efficient conduct of common discovery." Id. at 3.

Second, general causation had emerged as an important issue common to all proceedings. "[T]he records in the many actions filed since [2014] demonstrate that discovery and pretrial motions concerning the issue of general causation have been, or will be, at the center of all actions—that is, whether the hormonal component in Mirena is capable of causing intracranial hypertension." Dkt. 1 at 3; see also id. at 4 ("Issues concerning general causation [and] the background science ... will be common to all actions.").

B. Organization of This MDL

In overseeing this action, this Court has given priority to the matters that led the JPML to centralize the Mirena/IIH actions.

Specifically, on June 21, 2017, after appointing plaintiffs' leadership team and reviewing written submissions and eliciting counsel's input at an initial conference, see generally Dkt. 51 (transcript of June 13, 2017 hearing), the Court issued an order stating that priority would be given to: (1) "the process of providing common fact discovery to plaintiffs from Bayer," and (2) "resolving whether plaintiffs have admissible evidence sufficient to establish general causation" by Mirena of IIH. Dkt. 40 at 1 (June 21, 2017 Order). The Court has done so as follows.

Outgoing discovery from Bayer : On July 27, 2017, after receiving submissions delineating the 14 discovery disputes identified by the parties and inquiring about them at a hearing, the Court resolved these disputes in a series of bench rulings. See generally Dkt. 51 at 10–59 (transcript of July 27, 2017 hearing). The Court ordered that Bayer broadly produce written discovery on all common issues, including electronic records from more than 50 Bayer custodians, and including broad production from Bayer's adverse-events database. Both as to custodians and as to search parameters, the common discovery ordered from Bayer extended well beyond the parameters then used in the individual cases comprising the MDL. It also substantially exceeded the discovery that Bayer had produced in an immediately prior MDL also relating to the Mirena IUD. See MDL No. 2434 (the "Perforation MDL"). In that case, overseen by the Hon. Cathy Seibel of this District, the plaintiffs had alleged different injuries: that the hormone-release feature of Mirena had caused the IUD to migrate within the uterus after its insertion, leading to uterine perforation and related migration injuries.

General causation : The Court directed that the issue of general causation be litigated in the MDL as a threshold issue. To facilitate that issue's prompt resolution, the Court ordered that all fact discovery relating to general causation—including all document and deposition discovery—be completed by December 8, 2017. Dkt. 62. Alerted by counsel that each side expected to make Daubert challenges to the admissibility of each other's experts on general causation, the Court set deadlines spanning late December 2017 through late March 2018 for the submission of all expert reports on general causation, depositions of general causation experts, and reciprocal Daubert briefing. The Court set for the week of April 9, 2018 a "Science Day" tutorial for the Court on the background scientific issues in the case, followed by a Daubert hearing as to expert testimony on general causation. Id.

In prioritizing general causation, the Court was informed by, in addition to the guidance of the JPML, the representations of counsel in this case that the issue of general causation would be common and identical to all potential Mirena/IIH plaintiffs so as to make it an appropriate issue for this transferee court to resolve at the threshold. See, e.g. , Dkt. 51 at 29. The Court was also informed by the experience of the Perforation MDL. There, Judge Seibel held that plaintiffs' proposed expert testimony as to the general causation proposition at issue—that the Mirena IUD's release of the hormone LNG was capable of causing the Mirena IUD to migrate after insertion and cause uterine perforation—was not reliable under Daubert . See In re Mirena IUD Prods. Liab. Litig. , 169 F. Supp. 3d 396, 427–61 (S.D.N.Y. 2016) ("Mirena Perforation/Daubert "). Based on that ruling, Judge Seibel later granted summary judgment for Bayer on all claims, holding that, without any admissible expert testimony, the remaining evidence was insufficient to establish general causation. See In re Mirena IUD Products Liab. Litig. , 202 F. Supp. 3d 304, 310–28 (S.D.N.Y. 2016) (" Mirena Perforation/SJ "). The Second Circuit affirmed. See generally 713 F. App'x. 11 (2d Cir. 2017). The possibility of a similar outcome here, this Court determined, counseled deferring other time- and cost-intensive phases of this litigation pending resolution of the anticipated Daubert motions.

C. The Daubert Motions as to General Causation Experts

Plaintiffs proposed to call seven expert witnesses as to general causation. Each opined that using the Mirena IUD can cause a woman to develop IIH. The seven experts were: (1) Dr....