STORY FROM: Drugs & Medical Devices
Neb. Federal Judge Orders IUD Makers to Produce Breakage Information
May 9, 2018
OMAHA — A Nebraska federal judge has ordered the makers of an intrauterine contraceptive device to produce all breakage and embedment documents dated before the plaintiff’s insertion date, holding they are relevant to whether defendants received information warranting a labeling update.
However, in the May 6 order, Magistrate Judge Cheryl R. Zwart held that documents dated after the insertion date are not relevant to the case because “defendants’ knowledge and conduct are not evaluated from the perspective of hindsight.”
Stephanie Ideus underwent implantation of Teva’s ParaGard T-380 device. During removal of the device in 2014, a piece broke off and ...
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