US District Judge Cathy Seibel’s decision has affected more than 1,200 lawsuits in the multidistrict litigation, which consolidated the lawsuits in 2013. In the two years leading up to the MDL Mirena claims increased, leading to a consolidation because of the similar issues of “the alleged risks of uterine perforation and migration associated with Mirena and the adequacy of the product’s warning label.”
Plaintiffs’ experienced a setback in March - when Seibel excluded four plaintiffs’ experts - paved the way for last month’s ruling in Bayer’s favor. Seibel decided that, without expert testimony, no jury would have a sound basis to find in favor of plaintiffs. “The court reaches this conclusion reluctantly, knowing that it will doom hundreds of cases, but in the court's view it is compelled by the law,” Seibel said (Case 7:13-mc-02434-CS-LMS D).
Why did Seibel disallow their experts’ testimonies to show that Mirena could cause uterine perforation after insertion, or “secondary perforation”? In March she said the testimony would have been biased, finding that “their opinions were not supported by scientific literature and had been developed for the purpose of the litigation”.
It Ain’t Over til it’s Over
In June, plaintiffs told Seibel that they can prove their case without experts. They had to demonstrate that the Mirena starts to move through tissue after insertion, and when the insertion procedure produced no injury. And that the Mirena labels - when they were prescribed the product (the wording had changed somewhat) - inadequately warned of that risk. Bayer stated that there is no "secondary perforation" and that perforations always start with some injury during insertion.
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Instead, the court reasoned that "an analysis of the anatomy and physiology of the uterus, the strength of its muscles, the types of injuries that could be caused by the Mirena insertion procedure, and whether and how such injuries can be detected with existing technology" would be "well beyond the common understanding of lay jurors," according to druganddevicelawblog.com, meaning that plaintiffs did need expert testimony.
More than 1,200 Mirena claimants in the MDL are likely hopeful that it ain’t over till the appeal is over…