New York Federal Judge Dismisses Mirena IUD Product Liability Litigation For Lack Of Expert Evidence That Secondary Perforation Could Occur
Hundreds of plaintiffs filed product liability actions against defendants Bayer Healthcare Pharmaceuticals, Inc., Bayer Pharma AG, and Bayer OY, claiming that they sustained injuries when Mirena, an intrauterine contraceptive device manufactured by defendants, perforated, became embedded in, or migrated from their uteruses. The cases were consolidated on April 8, 2013, in the United States District Court for the Southern District of New York as part of a multi-district litigation. Plaintiffs asserted claims of 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. Plaintiffs claimed that although Mirena labels warned that perforation could occur at the time of insertion and not be detected until later, the labels from 2008-2014 failed to warn that secondary perforation could occur without any injury at the time of or related to the insertion procedure. Defendants argued that there was no scientific evidence of perforation or injury to the uterine wall occurring at any time other than insertion.
On March 8, 2016, Judge Cathy Seibel granted defendants' motion to exclude all of plaintiffs' experts who had opined that Mirena was capable of causing secondary perforation. Defendants filed a motion for summary judgment on May 4, 2016, on the ground that there was no expert testimony to show that Mirena was capable of causing secondary perforation. Judge Seibel granted defendants' motion on July 28, 2016. The court's judgment resulted in dismissal of approximately 1,300 related cases.
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