Missouri judge slashes 86 plaintiffs from Essure suit against Bayer

A federal judge in Missouri cut 86 of the 94 plaintiffs from a group of consolidated lawsuits filed against Bayer (ETR:BAYN) over its Essure female sterilization device. Essure is a small metal coil that’s placed in the fallopian tubes via catheter. The FDA said in 2015 that it received 5,093 complaints in the 13 years since Essure’s approval, including for pain or menstrual irregularities after using the device and complaints of the device breaking. In addition to five fetal deaths, there were four reports of adult deaths for reasons such as infection and uterine perforation, the FDA said. In November 2016, the federal safety watchdog released new labeling requirements for Essure other permanent hysteroscopically-placed tubal sterilization implants. The updated guidelines madated a patient checklist to avoid possible adverse events and a boxed warning as labeling for the devices. The FDA last year mandated a new study and new labeling of Essure. In August 2016, the agnecy said it completed a review of a trade complaint which alleged that Bayer  was engaged in clinical trial misconduct and altering data, finding no signs of manipulation. A group of 94 plaintiffs from 25 states sued Bayer in January, alleging that Essure caused their injuries. In a July 14 ruling, Judge Carol Jackson of the U.S. District Court for Eastern Missouri tossed all but eight defendants, seven from Missouri and one from Illinois whose implantation occurred in The Show Me State. Ba...
Source: Mass Device - Category: Medical Devices Authors: Tags: Legal News Product Liability Women's Health Bayer Source Type: news