New Jersey Superior Court Judge Carol Higbee recently ruled that three top Johnson & Johnson executives must testify about their knowledge of the safety concerns surrounding the vaginal mesh lawsuits pending before the court.
Judge Higbee, who is presiding over more than 1,000 mesh cases in a consolidated litigation, said this month that J & J Chief Executive Officer Alex Gorsky, former J & J Vice Chairman Sheri McCoy, and Ethicon franchise leader Gary Pruden must testify at a videotaped deposition about their roles in the production of transvaginal mesh. Former Johnson & Johnson Chief Executive Officer Bill Weldon could also be called upon if documents are uncovered that link him to knowledge of the defective mesh.
Judge Higbee also ruled that electronic searches of the executives’ computers should be done before any depositions, and plaintiffs will be notified of the results. Attorneys for the defendants argued that the executives would have little knowledge of the transvaginal mesh products because of their positions in the company, but Judge Higbee disagreed.
Ethicon is a subsidiary of Johnson & Johnson and the manufacturer of multiple transvaginal mesh devices, including four that are at the center of these lawsuits — Prolift, Prolift +M, Prosima, and TVT Secur.
In January 2012 the FDA ordered 30 transvaginal mesh device manufacturers to produce 3 years of data on the safety and effectiveness of their devices and procedures. On June 4th, Ethicon announced it would stop selling (also known as a silent recall) 4 of its transvaginal mesh devices, asking the FDA for 3 months to complete the process. The recall came only only after the U.S. Food and Drug Administration (FDA) said it would need to further study the Gynecare devices to verify their safety. A spokesperson for Ethicon tried to downplay the move in a statement to The Wall Street Journal:
This is not a product recall, and we continue to have confidence in the safety and efficacy of these products. Our decision to discontinue these products is based on their commercial viability in light of changing market dynamics, and is not related to safety or efficacy.
Vaginal Mesh Lawsuits Continue
Still, the FDA has issued several public safety alerts regarding transvaginal mesh, stating that complications are not rare and such implants have not been proven more effective in treating pelvic organ prolapse (POP) than traditional surgeries. And patients are suing over serious complications, such as the erosion of the mesh into other organs in the pelvic area. Even corrective surgeries have not been able to remove some of the devices, leaving women to suffer the chronic pain and side effects, such as sexual dysfunction, for the rest of their lives.[hr]