October 15, 2012 ~ It could become the largest class action product liability lawsuit in Australian history.
Julie Davis is the plaintiff who heads the class action lawsuit filed against Johnson & Johnson (J&J), in the third class action against the company in Australia in as many years.
She like other women had what they thought was a simple procedure, a polypropylene mesh sling was implanted to reinforce the pelvic floor and hold pelvic organs in place.
Australian Broadcasting Corporation (ABC) aired a news story (here) that introduces Davis and her husband. When Davis had a traumatic forceps birth ten years ago, her bladder prolapsed or fell. The mesh implant had left her in pain, unable to walk, and depressed with symptoms that felt like a cheese grater inside her vagina.
Australian urogynecologist, Dr. Richard Reid has since removed the mesh.
Unlike the July 2011 warning from the FDA that vaginal mesh offers risk with no evidence of a greater clinical benefit, the Australia government has not issued such a warning.
It’s estimated 20,000 women could eventually become part of the class.
ABC television reports that the mesh in question has been removed from the market. Johnson & Johnson issued a statement:
“The decision to discontinue these products was based on their commercial viability in light of changing market dynamics and is not related to safety or efficacy. This is not a product recall and based on this notification, it is not necessary for women who have received one if these products to take any action.”
Johnson & Johnson announced it was removing four vaginal meshes from the U.S. market in June (back story here) however it has left the Gynecare Gynemesh on the market with changes to its label that restricts its use.
The Therapeutics Goods Administration (TGA), the Australian regulator, is being blamed for the third regulatory failure in 12 months following the defective breast implant and metal hip scandals. None of those medical devices had undergone clinical trials to prove they were safe before being introduced into the marketplace.
In the U.S. the majority of medical devices also do not have to prove safety before being used on patients.
Instead of a class action, there are more than 10,000 lawsuits filed in the U.S. in state courts and in federal court in multidistrict litigation.
Class actions in Australia were launched over two other Johnson & Johnson products – its DePuy hip replacement device which left hundreds of patients disabled, and in 2010, a J &J knee implant was the subject of litigation.
U.S. mesh makers sold about $175 million worldwide of prolapse mesh and $295 million of incontinence mesh in 2010, reported Bloomberg.