Mirena MDL v. Bayer HealthCare Pharmaceuticals Inc.

713 F. App'x 11
CourtCourt of Appeals for the Second Circuit
DecidedOctober 24, 2017
Docket16-2890-cv(L); 16-3012-cv(CON)
StatusPublished
Cited by16 cases

This text of 713 F. App'x 11 (Mirena MDL v. Bayer HealthCare Pharmaceuticals Inc.) is published on Counsel Stack Legal Research, covering Court of Appeals for the Second Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Mirena MDL v. Bayer HealthCare Pharmaceuticals Inc., 713 F. App'x 11 (2d Cir. 2017).

Opinion

SUMMARY ORDER

Plaintiffs-appellants, women who were injured When the intrauterine device (“IUD”) Mirena injured their uteruses (“Plaintiffs”), appeal the July 29, 2016 judgment of the District Court. On appeal, Plaintiffs argue that the District Court .improperly excluded their expert witnesses on general causation in a March 8, 2016 Opinion and Order, and improperly granted summary judgment for defendant-ap-pellee Bayer Pharmaceuticals Inc. (“Bayer”) in a July 28, 2016 Opinion and Order, thereby terminating the multi-district litigation (“MDL”). We assume the parties’ familiarity with the underlying facts, the procedural history of the case, and the issues on appeal.

Mirena is a plastic, T-shaped, 1.26 by 1.26 inch IUD that delivers the hormone levonorgestrel (“LNG”) into the uterus to prevent pregnancy. Plaintiffs are women from across the country who were injured when Mirena perforated, became embedded in, and/or migrated from their uter-uses. Plaintiffs sued the manufacturer of Mirena, Bayer, 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. In 2013, the nearly 1,300 cases were certified as part of this MDL. Several were chosen to be part of an Initial Disposition Pool and went through full discovery.

At bottom, the MDL is about when Mirena perforated Plaintiffs’ uteruses. Both parties agree—and Bayer has always warned—that Mirena can injure a woman’s uterus during insertion and afterward migrate outside the uterus (what is called “primary perforation”). But the parties disagree about whether, in the absence of an injury at the time of insertion, Mirena can later perforate and migrate from a uterus (what is called “secondary perforation”). Bayer did not warn about the possibility of post-insertion, secondary perforation, and thus is exposed to liability if secondary perforation in fact occurred.

The instant appeal concerns the evidence Plaintiffs proffered to establish general causation of secondary perforation by Mirena. General causation concerns whether the type of injury at issue can be caused by the product. Plaintiffs principally proffered three categories of evidence for general causation of secondary perforation: 1) statements from Bayer employees, including short excerpts from a handful of Bayer employee emails, a PowerPoint presentation slide, and a sentence in a deposition all appearing to say that secondary perforation can occur; 2) the 2014 change Bayer made to tlie Minera warning label; and 3) expert witnesses.

On March 8, 2016, the District Court issued an Opinion and Order excluding all of Plaintiffs’ experts on general causation because, it found, their testimony was not reliable and thus not helpful to the trier of fact. The District Court emphasized that the expert opinions all assumed the existence of the very fact in dispute—the possibility of secondary perforation—and then “worked backwards to hypothesize a mechanism by which it might occur.” Joint App’x at 349. The District Court also applied the Daubert factors to each witness, finding that none of their tests had known error rates, none was subject to peer review, none was generally accepted in the scientific community, all had been developed for the purpose of litigation, and most used tests that are not easily replicable.

Bayer then filed an omnibus motion for summary judgment in the MDL docket, arguing that expert witnesses were necessary to prove general causation and thus Plaintiffs, lacking any such witnesses, could not prove general causation. Plaintiffs responded that summary judgment was inappropriate because a reasonable jury could find general causation on the basis of the admissible evidence, in particular the employee statements and the 2014 label change.

On July 28, 2016, the District Court granted summary judgment to Bayer and terminated the entire MDL. The District Court found, first, that in all fifty states expert witness testimony is typically required to prove causation in complex medical device cases. Second, assuming arguen-do that Federal Rule of Evidence 801(d)(2) admissions could substitute for expert testimony in some jurisdictions, the District Court found that the “admissions” here were too ambiguous to do so.

Judgment was entered on July 29, 2016. This appeal followed.

STANDARD OF REVIEW

This Court “review[s] the district court’s decision to admit or exclude expert testimony under a highly deferential abuse of discretion standard.” Zuchowicz v. United States, 140 F.3d 381, 386 (2d Cir. 1998). Accordingly, a district court Rule 702 ruling “will be reversed only for manifest error.” United States v. Tin Yat Chin, 371 F.3d 31, 40 (2d Cir. 2004). “That standard applies as much to the trial court’s decisions about how to determine reliability as to its ultimate conclusion.” Kumho Tire Co. v. Carmichael, 526 U.S. 137, 152, 119 S.Ct. 1167, 143 L.Ed.2d 238 (1999).

This Court reviews a district court’s award of summary judgment de novo, “constru[ing] the evidence in the light most favorable to the [losing party]” and “drawing all reasonable inferences and resolving all ambiguities in [its] favor.” Darnell v. Pineiro, 849 F.3d 17, 22 (2d Cir. 2017) (internal quotation marks omitted). This Court “will affirm only when ‘there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.’ ” In re 650 Fifth Ave. & Related Props., 830 F.3d 66, 86 (2d Cir. 2016) (quoting Fed. R. Civ. P. 56(a)).

DISCUSSION

I. The District Court Properly Excluded Plaintiffs’ Expert Witnesses on General Causation under Daubert

We first consider whether, in its March 8, 2016 Opinion and Order, the District Court properly excluded three of Plaintiffs’ expert witnesses on general causation: Dr. Young, Dr. Jarrell, and Dr. Wray. Upon review, we conclude that it did.

In Daubert, the Supreme Court provided a non-exhaustive list of factors for a district court to consider when determining whether an expert’s specialized knowledge will assist the trier of fact. Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993). The Daubert factors include: “[1] the theory’s testability, [2] the extent to which it has been subjected to peer review and publication, [3] the extent to which a technique is subject to standards controlling the technique’s operation, [4] the known or potential rate of error, and [5] the degree of acceptance within the relevant scientific community.” United States v. Romano, 794 F.3d 317, 330 (2d Cir. 2015) (internal quotation marks omitted).

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713 F. App'x 11, Counsel Stack Legal Research, https://law.counselstack.com/opinion/mirena-mdl-v-bayer-healthcare-pharmaceuticals-inc-ca2-2017.