Products Liability Law Daily Failure to prove causation ends Mirena® IUD litigation against Bayer
Tuesday, October 24, 2017

Failure to prove causation ends Mirena® IUD litigation against Bayer

By Susan Engstrom

Patients in a multi-district litigation alleging injuries from the Mirena® intrauterine device (IUD) failed to establish general causation, the U.S. Court of Appeals for the Second Circuit ruled in a summary order, affirming the district court’s termination of the MDL against the IUD’s manufacturers. The lower court properly excluded the plaintiffs’ expert testimony on general causation under the Daubertstandard and properly granted summary judgment in favor of the manufacturers after finding that purported admissions by the defendants regarding "secondary perforation" could not substitute for the required expert testimony (In re: Mirena IUD Products Liability Litigation (Mirena MDL Plaintiffs v. Bayer HealthCare Pharmaceuticals Inc.), October 24, 2017, per curiam).

The Mirena is an intrauterine contraceptive device manufactured by Bayer Healthcare Pharmaceuticals, Inc., Bayer Pharma AG, and Bayer OY (Bayer). The patients in this case alleged that they were injured when the device perforated, became embedded in, or migrated from their uteruses. They 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, all arising from alleged "secondary perforation" of Mirena. The parties did not dispute that all iterations of the Mirena label warned that perforation could occur at the time of, or related to, the insertion procedure. They disagreed, however, on the existence of a "secondary perforation," defined as a perforation that occurred subsequent and unrelated to the insertion of a Mirena.

District court rulings. In March 2016, the district court excluded the testimony of the plaintiffs' general causation experts under Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993), finding it to be unreliable and, thus, unhelpful to the trier of fact. In July 2016, the district court granted summary judgment to the manufacturers and terminated the entire MDL.

Expert testimony. The Second Circuit agreed with the district court’s reasons for excluding the patients’ experts. First, the experts’ theories regarding secondary perforation were not accepted in the wider obstetrics and gynecological scientific community. Second, the experts lacked pre-litigation expertise in the phenomenon of secondary perforation and developed their theories for the purposes of this litigation. Third, having found no direct support in the literature for secondary perforation and having conducted no prior research on the subject, the experts all assumed the existence of the very phenomenon in dispute and then hypothesized how it could occur. Thus, the district court’s exclusion of the experts was appropriate.

Summary judgment. In addition, the district court properly granted summary judgment to Bayer. The patients asserted that they could meet their burden of introducing sufficient evidence to create a genuine issue of material fact on the issue of general causation through documents and testimony that they argued amounted to admissions by the defendants that secondary perforation existed. As the district court concluded, however, no reasonable juror could find general causation more likely than not based on the patients’ admissible evidence.

For example, excerpts from emails authored by Bayer employees that purportedly admitted that secondary perforation can occur were from emails in which the employees reported, without necessarily endorsing, adverse event reports. The reports were anecdotal and, thus, were of very limited probative value. In addition, a sentence from a Bayer PowerPoint presentation, which stated that "Migration into the abdomen (spontaneous perforation unrelated to insertion) can occur," could not be a substitute for expert testimony because it did not supply the jury with knowledge of the causes of secondary perforation, and the appellate court did not know the context in which the slide was presented, let alone what was said at the meeting. Furthermore, an acknowledgment by a Bayer expert of the possibility of causation did not establish that causation was more likely than not.

Finally, the patients argued that the changes Bayer had made to the Mirena label in 2014 constituted proof of general causation. The revised label 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." However, the grammatical structure of this label was cryptic at best, and at most suggested the hypothetical possibility of secondary perforation. It could not substitute for expert testimony. Accordingly, the district court’s judgment was affirmed.

The case is No. 16-2890-cv(L).

Attorneys: Jay L.T. Breakstone (Parker Waichmari Alonso LLP) for Mirena MDL Plaintiffs. Lisa S. Blatt (Arnold & Porter Kaye Scholer LLP) for Bayer Healthcare Pharmaceuticals Inc.

Companies: Bayer Healthcare Pharmaceuticals Inc.

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