Vaginal Mesh Lawsuit Update: Ethicon Must Disclose FDA Communications

Vaginal Mesh Lawsuit Update: Ethicon Must Disclose FDA Communications

By Andrea Gressman

A new court order will help victims of vaginal mesh implant side effects sue Johnson & Johnson and its subsidiary Ethicon over their defective vaginal mesh implants. On August 8, 2012, a New Jersey federal judge ordered the companies to hand over all communication and correspondence with the U.S. Food and Drug Administration regarding post-market studies of the safety of their Gynecare vaginal mesh implants. This disclosure requirement will allow Plaintiffs involved in vaginal mesh lawsuits to have access to the correspondence and help their pre-trial discovery process.

FDA Evaluates Safety of Vaginal Mesh Implants

In 2011, a number of complaints and post-surgery complications from patients using vaginal mesh implants caused the FDA to re-evaluate whether the material was superior to non-mesh options. As the agency took a second look at the risk factors, it issued warnings to the medical community and patients that vaginal mesh implants do not come without risk. Following up these warnings, in January 2012 the FDA ordered more than 30 vaginal mesh implant manufacturers to provide up to three years of data on the safety and effectiveness of their devices.

Between January 2012 and June 2012, Ethicon was an active seller of vaginal mesh implants. As a result, it was in regular communication with the FDA to fulfill the post-market study mandate.

On June 4, 2012, Ethicon said it was going to stop selling four of its vaginal mesh implant systems:  Gynecare TCT Secur, Gynecare Prosima, Gynecare Prolift, and Gynecare Proflift+M. The company then asked the FDA to put its post-market study orders on hold.

However, at the time Ethicon asked the FDA to halt its study orders, the company had multiple post-market studies underway. These studies covered the safety and potential complications of using its vaginal mesh implants in detail.

Prior to the August 8 ruling, both Ethicon and its parent company, Johnson & Johnson, were involved in hundreds of vaginal mesh implant lawsuits, but neither entity had submitted paperwork regarding the post-market studies to the New Jersey State Court. Their reasoning was that since Ethicon no longer sold vaginal mesh implants, the data was not relevant.

Vaginal mesh implant lawyers representing Plaintiffs in the Mass Tort requested the data be turned over to help their clients’ cases. Even though Ethicon was no longer actively involved in making or selling vaginal mesh implants, the company was the manufacturer of record for the implants in the ongoing vaginal mesh lawsuit filings.