In re Mirena Iud Prods. Liab. Litig.

• Decision Date: 28 July 2016
• Docket Number: 13-MD-2434 (CS), 13-MC-2434 (CS)
• Citation: 202 F.Supp.3d 304
• Parties: IN RE: MIRENA IUD PRODUCTS LIABILITY LITIGATION This Document Relates To All Actions
• Court: U.S. District Court — Southern District of New York

202 F.Supp.3d 304

IN RE: MIRENA IUD PRODUCTS LIABILITY LITIGATION

This Document Relates To All Actions

13-MD-2434 (CS), 13-MC-2434 (CS)

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

Signed July 28, 2016

OPINION & ORDER

Seibel, District Judge

Hundreds of plaintiffs have sued three related companies—Bayer Healthcare Pharmaceuticals, Inc., Bayer Pharma AG and Bayer OY ("Bayer" or "Defendants")—alleging that they were injured when Mirena

, an intrauterine contraceptive device manufactured by Defendants, perforated, became embedded in or migrated from their uteruses. These diversity cases have been consolidated before this Court as part of a multi-district litigation ("MDL"). (Case Management Order No. 1, (13–MD–2434 Doc. 8).)¹ Plaintiffs have brought claims alleging negligence, strict liability, manufacturing defect, design defect, failure to warn, breach of warranty (implied and express), negligent misrepresentation, fraud, and various state-specific statutory violations, (see, e.g. , Shayna S. Cook Decl. Ex. 8),² all arising from alleged "secondary perforation" of Mirena. Before the Court is Defendants' Omnibus Motion for Summary Judgment. (13–MD–2434 Doc. 3172; 13–MC–2434 Doc. 215.) For the reasons stated below, Defendants' Motion is GRANTED.

I. Background

A. Factual Background

The following facts, which are based on Defendants' Local Rule 56.1 statement and Plaintiffs' responses thereto ("56.1 Stmt. & Resp."), (Doc. 3228), Plaintiffs' Opposition 56.1 statement and Defendants' responses thereto ("Opp. 56.1 Stmt. & Resp."), (Doc. 3246), supporting materials, and the record in this case, are undisputed except where noted.³

Mirena

is a plastic, intrauterine device ("IUD")⁴ that delivers the hormone levonorgestrel ("LNG") into the uterus and is designed to prevent pregnancy for up to five years. (Opp. 56.1 Stmt. & Resp. ¶¶ 8-9; Kekatos Decl. Ex. 3, at 4.)⁵ Mirena is inserted by a trained health care provider using an inserter provided by Bayer. (Kekatos Decl. Ex. 2, at 2-3.) Mirena has been sold in the United States since December 2000 when it was approved by the Food and Drug Administration ("FDA"). (Opp. 56.1 Stmt. & Resp. ¶ 10.) A risk associated with Mirena is uterine perforation, which may include the IUD penetrating into, passing through or becoming embedded in the uterine wall or cervix. (Kekatos Decl. Ex. 2, at 13.)

The meaning of perforation is important to this litigation but somewhat confounding. According to defense expert Jay Goldberg, M.D., M.S.C.P.:

To perforate means to create a hole in the wall of a structure, usually iatrogenically [inadvertently]. Perforation can be categorized as total (or complete) perforation and partial (or incomplete) perforation. A total uterine perforation signifies an injury completely through the uterine wall, whereas a partial uterine perforation goes only partially through the myometrium [the middle layer of the uterine wall]. (Sometimes the term partial perforation is used to describe an IUD that has breached completely through the myometrium and serosa [the outer layer of the uterine wall], but is at least partially still within the uterine cavity.) When a partially perforated IUD becomes fixed within the myometrium of the uterus, it is often referred to as being embedded.... [M]igration is a term sometimes used to describe the movement of an IUD from inside the uterine cavity through a complete perforation and out into the abdominal cavity. As such, migration is a consequence of complete perforation, rather than a distinct phenomenon (just as embedment is a consequence of partial perforation).

(Kekatos Daubert Decl. Ex. B, at 12-13.)⁶ One of Plaintiffs' experts, Dr. Susan Wray, Ph.D., whose testimony has been excluded but whose definition of perforation is instructive for purposes of understanding the alleged phenomenon of secondary perforation, described uterine perforation as "puncturing" or "penetration" of IUDs and migration as the "movement" of "IUDs within the body." (Declaration of Christopher J. Cook in Support of Defendants' Motion to Exclude the Testimony of Susan Wray, Ph.D., (Doc. 2693), Ex. B, at 21.) The difficulty arises from the fact that the term "perforation," it seems, may refer to both the injury to the uterine wall (which may be a puncture partly or all the way through that wall) and to the penetration of part or all of the IUD device itself either into or through the uterine wall. At issue in this litigation is the timing of such perforations, and whether Mirena

's label adequately warned of all risks associated with perforation.

The Mirena

label has undergone several changes. In 2000, when Mirena was approved, the label stated: "An IUD may perforate the uterus or cervix, most often during insertion although the perforation may not be detected until some time later." (Christopher J. Cook Decl. Ex. 1, at MIR_INDNDA_00010729.)⁷ The perforation portion of the label changed in 2008, 2009, 2013 and 2014. (Id. Exs. 2, 25, 27; Kekatos Decl. Ex. 19.) The first three of these labels contained the same sentence regarding the timing of any risk of perforation: "Perforation or penetration of the uterine wall or cervix may occur during insertion although the perforation may not be detected until some time later." (Christopher J. Cook Decl. Ex. 2, at MIR_INDNDA_00039752; id. Ex. 25, at MIR_FCR_2046; id. Ex. 27, at MIR_INDNDA_00319917.) The 2014 label reflected a change. It stated: "Perforation (total or partial, including penetration/embedment of Mirena in the uterine wall or cervix) may occur most often during insertion, although the perforation may not be detected until sometime later." (Kekatos Decl. Ex. 19, at 13.) The current label, approved in 2015, contains the same sentence. (Id. Ex. 2, at 13.)

The parties do not dispute that all iterations of the Mirena

label have warned that perforation can occur at the time of, or related to, the insertion procedure. They disagree, however, on the existence of what has been called "secondary perforation," "spontaneous perforation," or "spontaneous migration" throughout this litigation. A secondary perforation is defined as a perforation that occurs subsequent and unrelated to the insertion of a Mirena. (56.1 Stmt. & Resp. ¶ 1.) Bayer argues that the consensus in the scientific community is that secondary perforation cannot occur, and that any injury to the uterine wall occurs only at the time of insertion, even if detection of the injury or movement of the IUD itself occurs later.

(Ds' Mem. at 4, 16.)⁸ Such an injury may be caused during insertion by the sound (a device used to measure the uterus before insertion), by the inserter or by the IUD itself. (Kekatos Daubert Decl. Ex. B, at 13.) Plaintiffs contend that secondary perforation can occur, which means that Mirena

can spontaneously perforate or migrate without any injury at the time of or related to the insertion procedure. (Ps' Mem. at 1-3.)⁹ Such a possibility, they argue, was not mentioned in the label warning used from 2008 through 2014, the time frame of Plaintiffs' injuries. (Id. at 3.)¹⁰

B. Procedural Posture

On April 8, 2013, pursuant to 28 U.S.C. § 1407, the Judicial Panel on Multidistrict Litigation consolidated cases in which Plaintiffs alleged that Mirena

"migrate[d] away from its original position, perforate[d] the uterus, and/or cause[d] related injuries," and found there were "common" issues "concerning the alleged risk of perforation and migration." (Shayna S. Cook Decl. Ex. 2, at 1.) Almost 1,300 cases are currently pending before this Court. During the course of the MDL, several cases were selected to be part of an Initial Disposition Pool ("IDP") and went through full discovery. (Docs. 883, 1524.) After a series of strikes by both sides, as well as voluntary dismissals, two cases were left and set to go to trial as early as the spring of 2016. (Docs. 2660, 2951.) In connection with the IDP cases, the parties submitted a number of motions to exclude several of each other's experts pursuant to Daubert v. Merrell Dow Pharmaceuticals, Inc. , 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993). (See Docs. 2679, 2682, 2685, 2688, 2691, 2694, 2697, 2702, 2705, 2724.) On March 8, 2016, the Court excluded all of Plaintiffs' experts who had offered opinions on general causation—in other words, that Mirena is capable of causing secondary perforation. See

Mirena , 2016 WL 890251, at *61. Familiarity with that decision, which is incorporated herein by reference, is presumed.

Following the Daubert rulings, Plaintiffs voluntarily dismissed the two cases that were being prepared for trial. (Docs. 3148, 3149.) Defendants filed the instant omnibus motion on May 4, 2016, (Doc. 3172), requesting that the Court grant summary judgment in all pending cases in this MDL because Plaintiffs are left without any experts to show that Mirena is capable of causing secondary perforation. Plaintiffs opposed on June 8, 2016, (Doc. 3227); Defendants filed reply papers on June 22, 2016, (Doc. 3245); and Plaintiffs filed a sur-reply on July 6, 2016, (Doc. 3262), which I permitted because of the importance of the issue, (Doc. 3249).

The parties agree that proof of general causation—"whether the type of injury at issue can be caused or exacerbated by the defendant's product," Ruggiero v. Warner–Lambert Co. , 424 F.3d 249, 251 n.1 (2d Cir.2005) (emphasis in original)—is necessary in a products liability case such as this.¹¹ The "type of injury at issue" is perforation, embedment or migration absent injury to the uterus

upon insertion—the concept Plaintiffs call secondary perforation or spontaneous migration. The parties do not dispute that the Mirena label has always warned of the potential risk of perforation upon or related to insertion. Plaintiffs, however, argue that the label is inadequate because it did not warn of perforation unrelated to insertion, which they must show exists as a phenomenon in order to prove general causation and prevail. Thus, "in the context of these cases, evidence...