202 F. Supp. 3d 304
S.D.N.Y.2016Background
- MDL: ~1,300 plaintiffs sued Bayer over Mirena IUDs alleging "secondary perforation" (perforation/migration occurring after and unrelated to insertion); cases consolidated in SDNY MDL.
- Mirena label historically warned perforation may occur during insertion and "may not be detected until sometime later;" 2014/2015 label added language about "perforation (total or partial, including penetration/embedment) may occur most often during insertion, although the perforation may not be detected until sometime later."
- Plaintiffs’ theory (general causation): Mirena can spontaneously perforate or migrate after an uneventful insertion (secondary perforation); they need proof general causation to survive.
- Court previously excluded all of Plaintiffs’ experts on general causation (Daubert), leaving Plaintiffs with documentary and company-statement evidence only.
- Defendants moved for omnibus summary judgment arguing Plaintiffs cannot prove general causation without expert testimony; Plaintiffs contend certain Bayer statements/labels/emails amount to admissions sufficient to create a factual dispute.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether general causation (secondary perforation) can be proved without expert testimony | Admissions/statements (labels, internal emails, letters) by Bayer suffice to create a triable issue on general causation | Medical-device causation is a complex scientific question outside jurors’ common experience and, under all relevant jurisdictions, requires expert proof; contested documents are ambiguous | Court: Expert testimony is required; plaintiffs’ proffered admissions are too ambiguous and unreliable to substitute for expert proof; summary judgment granted |
| Whether corporate statements/labels constitute admissible admissions of causation that could replace experts | Labels, DHCP letters, internal emails and presentations plainly admit Mirena can cause secondary perforation | The statements are ambiguous, context-dependent, and do not unambiguously concede causation absent insertion injury | Court: Even if admissible, the statements are not clear, concrete, or reliable enough to establish general causation without experts |
| Whether manufacturer adoptive-admission (e.g., Progestasert label) binds Bayer as admitting secondary perforation exists | FDA suggested Mirena warnings mirror other IUDs (e.g., Progestasert); Bayer’s silence or use of similar language constitutes adoption/admission | Bayer did not adopt Progestasert language; similarity of risk language across IUDs does not admit secondary perforation | Court: No adoption shown; Progestasert language is ambiguous and not an admission of spontaneous perforation |
| Whether public-health/policy considerations permit using internal adverse-event discussion as admissions | Plaintiffs: internal safety discussions and case reports reveal Bayer conceded post-insertion perforation risk | Defendants: allowing such use would chill internal safety communications and these items are anecdotal and unreliable for causation | Court: Policy and reliability concerns support requiring expert proof; internal documents/case reports cannot substitute for expert causation opinions |
Key Cases Cited
- Daubert v. Merrell Dow Pharm., 509 U.S. 579 (expert admissibility framework) (trial court gatekeeping on scientific expert testimony)
- Anderson v. Liberty Lobby, 477 U.S. 242 (summary judgment standard) (reasonable jury/ genuine dispute test)
- Celotex Corp. v. Catrett, 477 U.S. 317 (summary judgment burdens) (movant’s initial showing and nonmovant burden)
- Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574 (summary judgment) (nonmovant must show more than metaphysical doubt)
- Amorgianos v. Nat’l R.R. Passenger Corp., 303 F.3d 256 (2d Cir.) (products-liability: need admissible expert testimony for general and specific causation)
- Meridia Prods. Liab. Litig. v. Abbott Labs., 447 F.3d 861 (6th Cir.) (labels can sometimes be strong evidence; district court treated an express label statement as creating a material fact on causation in context)
- C.W. ex rel. Wood v. Textron, 807 F.3d 827 (7th Cir.) (summary judgment proper where plaintiffs lack experts to prove causation in toxic-tort/medical cases)