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In re Mirena IUS Levonorgestrel-Related Prods. Liab. Litig.

United States District Court for the Southern District of New York

October 24, 2018, Decided; October 24, 2018, Filed

17-MD-2767 (PAE); 17-MC-2767 (PAE)


 [*217]  OPINION & ORDER

PAUL A. ENGELMAYER, District Judge:

This multi-district litigation involves products liability claims regarding a contraceptive product: the Mirena intrauterine device developed, manufactured, and distributed by defendants Bayer HealthCare Pharmaceuticals, Inc., Bayer Pharma AG, and Bayer Oy (together, "Bayer"). The Mirena IUD 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. If untreated, IIH can cause headaches and vision problems, including, in extreme cases, blindness.

Currently before the Court are motions by each side, pursuant to Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 113 S. Ct. 2786, 125 L. Ed. 2d 469 (1993), to exclude the other's expert testimony with respect to the issue of general causation—that is, whether Mirena's release of its hormonal component, LNG, is capable of causing IIH. In overseeing this MDL, this Court, heeding the guidance of the United States Judicial Panel on Multi-District Litigation [**63]  ("JPML"), prioritized discovery and Daubert motions and briefing with respect to this issue.

Plaintiffs have put forward seven expert witnesses on general causation. Each opines that use of Mirena can cause IIH. These are: two obstetrician-gynecologists ("OB/GYNs"), an ophthalmologist, a neuroscientist, a pediatric neurologist, an epidemiologist, and a pharmacologist-toxicologist. In response, Bayer has put forward 12 expert witnesses. Each opines that the available scientific evidence does not reliably permit the conclusion that using Mirena can cause IIH. These are: three epidemiologists, a pharmaco-kineticist, five neuroophthalmologists, and three OB/GYNs.


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341 F. Supp. 3d 213 *; 2018 U.S. Dist. LEXIS 182420 **; 2018 WL 5276431


Prior History: In re Mirena Ius Levonorgestrel-Related Prods. Liab. Litig. No. II, 2017 U.S. Dist. LEXIS 221643 (S.D.N.Y., July 28, 2017)


studies, androgen, patients, contraceptives, causation, causes, factors, methodology, obese, epidemiological, hormone, biological, cases, symptoms, reliable, deposition, disease, intracranial, choroid, hypertension, plexus, progestin, analogy, weight gain, confounding, plaintiffs', users, receptors, effects, levels

Evidence, Admissibility, Expert Witnesses, Daubert Standard, Helpfulness, Testimony, Qualifications, Scientific Evidence, Standards for Admissibility, Civil Procedure, Trials, Jury Trials, Province of Court & Jury