In re Mirena Iud Prods. Liab. Litig.

Decision Date08 March 2016
Docket Number14-CV–288 (CS),13-CV–6586 (CS),13-MC–2434 (CS),13-MD–2434 (CS)
Citation169 F.Supp.3d 396
Parties In re: Mirena IUD Products Liability Litigation This Document Relates To Danley v. Bayer, 13-CV-6586 Hayes v. Bayer, 14-CV-288
CourtU.S. District Court — Southern District of New York

Diogenes P. Kekatos, Seeger Weiss LLP, New York, New York, Plaintiffs' Liaison Counsel

James R. Ronca, Anapol Weiss, Philadelphia, Pennsylvania, Plaintiffs' Co-Lead Counsel

Matthew J. McCauley, Parker Waichman LLP, Port Washington, New York, Plaintiffs' Co-Lead Counsel

Fred Thompson III, Motley Rice LLC, Mt. Pleasant, South Carolina, Plaintiffs' Co-Lead Counsel

Michael K. Johnson, Kenneth W. Pearson, Rolf T. Fiebiger, Johnson Becker, PLLC, Minneapolis, Minnesota, Member of the Plaintiffs' Steering Committee

Shayna S. Cook, Brian P. O'Donoghue, Christopher J. Cook, Goldman Ismail Tomaselli Brennan & Baum LLP, Chicago, Illinois, Lead Counsel for Defendants

E. James Shepherd, Shook Hardy & Bacon LLP, Houston, Texas, Counsel for Defendants

William P. Harrington, Bleakley Platt & Schmidt LLP, White Plains, New York, Counsel for Defendants

OPINION & ORDER

Seibel, United States District Judge.

Table of Contents
III. Conclusion...488

Danley v. Bayer, 13–CV–6856, and Hayes v. Bayer, 14–CV–288, are the first two cases selected for trial in the In re Mirena IUD Products Liability Litigationmultidistrict litigation ("Mirena MDL"). Plaintiffs have sued three related companies, Bayer Healthcare Pharmaceuticals, Inc., Bayer Pharma AG and Bayer OY ("Bayer" or "Defendants"), alleging that Mirena

, an intrauterine device ("IUD") perforated Plaintiffs' uteruses and caused them injuries, and that Defendants did not adequately warn Plaintiffs about the risks of Mirena. Plaintiffs Danley and Hayes have also brought claims alleging design defect and negligence, and are seeking punitive damages.1

Before the Court is Plaintiffs' Omnibus Motion to Preclude the Expert Testimony of Defendants' Experts Steven Goldstein, M.D., Jay Goldberg, M.D., M.S.C.P., Michael Policar, M.D., M.P.H., Michelle Collins, Ph.D., C.N.M., R.N.-C.E.F.M., Vanessa Dalton, M.D., M.P.H., Geri Hewitt, M.D., and Marcia Javitt, M.D., F.A.C.R., (Doc. 2702). Plaintiffs also move to preclude Defendants' regulatory experts, Dena Hixon, M.D., (Doc. 2705), and David Feigal, Jr., M.D., M.P.H., (Doc. 2724). Also before the Court are Defendants' motions to preclude the testimony of Plaintiffs' causation experts Roger Young, M.D., Ph.D., (Doc. 2694), John Jarrell, Ph.D., P.E., (Doc. 2679), Susan Wray, Ph.D., (Doc. 2691), and Richard Strassberg, M.D., (Doc. 2688). Defendants have also moved to preclude Plaintiffs' regulatory expert Suzanne Parisian, M.D., (Doc. 2685), and Plaintiffs' epidemiological expert April Zambelli–Weiner, Ph.D., (Doc. 2697).

I. Background
A. Background Applicable to Both Cases

The following facts, which are based on the record generated by these motions and Defendants' motions for summary judgment, (Docs.2756, 2762) – including Defendants' Local Rule 56.1 Statements and Plaintiffs' responses thereto, (Docs. 2851 ("Danley 56.1 Stmt. & Resp."), 2854 ("Hayes 56.1 Stmt. & Resp.")),2 and supporting materials—are undisputed except where noted.3

In 2000 the U.S. Food and Drug Administration ("FDA") approved the Mirena, a plastic T-shaped IUD that measures 1.26 by 1.26 inches, as safe and effective for intrauterine contraception. (Danley 56.1 Stmt. & Resp. ¶¶ 1–2.) Mirena

provides contraceptive protection for up to five years, and has a cylinder in its stem that continuously releases a dose of the hormone levonorgestrel ("LNG"), (id.¶ 3), a synthetic progestin. (Declaration of Diogenes P. Kekatos in Support of Plaintiffs' Omnibus Motion ("Kekatos Omnibus Decl."), (Doc. 2704), Ex. B, General Expert Report of Jay Goldberg, M.D., M.S.C.P. ("Goldberg Report"), at 8.) It must be prescribed and inserted by a healthcare professional. (Danley Stmt. & Resp. ¶ 4.) The Mirena has removal threads that permit the user to check its placement. (Id.¶ 13.)

The Mirena

label has undergone four changes to its warning regarding the risk of perforation since the FDA's initial approval in 2000.4 (Id.¶ 6.) The 2009 label, which was in effect at the time both Ms. Hayes' and Ms. Danley's Mirenas

were inserted, included a "Highlights" section on the first page that stated: "Perforation may occur during insertion. Risk is increased in women with fixed retroverted uteri, during lactation, and postpartum." (Id.¶¶ 8–9; Hayes 56.1 Stmt. & Resp. ¶¶ 8–9.) The 2009 label also included a Warnings section that stated, "Perforation or penetration of the uterine wall or cervix may occur during insertion although the perforation may not be detected until some time later ... Delayed detection of perforation may result in migration outside the uterine cavity, adhesions, peritonitis, intestinal obstruction, abscesses and erosion of adjacent viscera." (Danley 56.1 Stmt. & Resp. ¶ 10.) It further warned that surgical removal might be required if perforation occurred. (Id.) The label also instructed healthcare providers to teach patients that they should check the Mirena threads every month, and that a patient should contact her doctor if unable to feel the threads. (Id.¶ 13.) The label additionally instructed healthcare providers to, prior to insertion, give each patient a copy of the "Patient Information Booklet" that is included with every Mirena, and to discuss potential side effects and how to feel the Mirena threads. (Id.¶ 14.) The Patient Information Booklet states that "Mirena can cause serious side effects," including embedment and perforation, without reference to the timing of these potential events. (Id.¶ 15.) Beginning in 2005, the warning label for ParaGard, another IUD, included the sentence: "Spontaneous migration has also been reported." (Id.¶ 53.)

The parties agree that Defendants warned against the possibility of uterine perforation during insertion. (Id.¶ 9.) They also agree that Defendants did not warn against the possibility that perforation could occur after and unrelated to insertion, which Plaintiffs call "secondary perforation" or "spontaneous migration."5 Whether such a possibility exists is at the heart of their dispute. Plaintiffs and their experts maintain that a properly placed Mirena

, with no perforation related to insertion, is capable of later perforating the uterus and migrating out of it. (Id.¶ 56; Declaration of Christopher J. Cook in Support of Defendants' Motion to Exclude the Testimony of Roger C. Young, M.D., Ph.D. ("Cook Young Decl."), (Doc. 2696), Ex. B, General Causation Expert Report of Roger C. Young, M.D., Ph.D. ("Young Report"), at 6; Declaration of Christopher J. Cook in Support of Defendants' Motion to Exclude the Testimony of Susan Wray, Ph.D. ("Cook Wray Decl."), (Doc. 2693), Ex. B, General Expert Report of Dr. Susan Wray, Ph.D. ("Wray Report"), at 22.) Defendants and their experts assert that Plaintiffs' theory of secondary perforation has not been proven, and that perforation of the uterus can only occur upon insertion of a Mirena, although detection of perforation or migration can occur later. (Danley 56.1 Stmt. & Resp. ¶ 56; Kekatos Omnibus Decl. Ex. A, General Expert Report of Steven Goldstein, M.D. ("Goldstein Report"), at 23; Kekatos Omnibus Decl. Ex. F, General Expert Report of Geri D. Hewitt, M.D. ("Hewitt Report"), at 24.) The expert reports and proposed expert testimony discussed below deal primarily with these issues.

The parties also dispute the significance and validity of the European Active Surveillance Study on Intrauterine Devices ("EURAS") study. EURAS was a study of 61,448 women using Mirena or copper

IUDs in six European countries who were followed between 2006 and 2013 to "identify and compare the incidence of uterine perforation and other medically adverse events associated with levonorgestrel-releasing intrauterine systems ... and copper intrauterine devices (IUDs) under routine conditions of use in a study population representative of typical users." (Declaration of Christopher J. Cook in Support of Defendants' Motion to Exclude the Testimony of April Zambelli–Weiner, Ph.D. ("Cook Zambelli–Weiner Decl."), (Doc. 2699), Ex. E, Klaas Heinemann et al., Risk of Uterine Perforation with Levonorgestrel–Releasing and Copper Intrauterine Devices in the European Active Surveillance Study on Intrauterine Devices,91 Contraception 274, 274 (2015) (hereinafter "Heinemann 2015").) The study concluded that uterine perforation was rare, and that there were no clinically significant differences in perforation rates between IUDs containing LNG and copper IUDs. (Id.at 274, 278–79.) EURAS was funded by Bayer, (Cook Zambelli–Weiner Decl. Ex. D, at 1), but overseen by an independent Safety Monitoring and Advisory Council consisting of "internationally acknowledged experts in the field," which made "recommendations and final decisions in all scientific matters" and which approved all study materials, (id.at 26).

The parties also dispute the capacity of two-dimensional ("2D") versus three-dimensional ("3D") ultrasound in detecting proper...

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