J&J Cleared In Philly Pelvic Mesh Trial
Product liability cases alleging manufacturers of pelvic mesh are responsible for patient injuries continued even as the US FDA is halting sales of the product. In the most recent verdict, a Philadelphia jury said Johnson & Johnson was not responsible for adverse events experienced by a Pennsylvania woman.
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Two separate Philadelphia juries have ruled against Johnson & Johnson subsidiary Ethicon in cases brought by women who say they were injured by the company’s pelvic mesh products, awarding damages totaling $200m.
FDA Yanks Transvaginal Mesh From US Market; Boston Sci 'Surprised'; Firms Have 10 Days To Submit Withdraw Plan
Transvaginal mesh products made by Boston Scientific and Coloplast were ordered pulled from US shelves by the agency on Aug. 16. Under the rare FDA order, the two firms must immediately stop selling the mesh and have 10 days to submit plans to the agency outlining how they will recall their unimplanted devices.
News We’re Watching – LivaNova And Medtronic Recalls; Approvals For Abbott And Guardant; Pediatric Device Grants
Recalls on a life-support device used during heart surgery and dialysis tubing were announced this week, as were approvals for a breast cancer companion diagnostic and two cardiac ablation catheters. Additionally, the US FDA has grants available for groups that assist in pediatric device development.