A news report in Australia’s ABC News on 16th October 2012 tells how Johnson & Johnson is facing a massive class action which could make legal history in Australia. The case was filed in the Federal Court on 15th October 2012 and relates to a transvaginal mesh implant for pelvic organ prolapse.
The news article describes the case of Julie Davis who had the implant to treat a prolapsed bladder but then suffered terrible complications with disabling pain and erosion of the synthetic material into the vagina following the surgery. Urogynaecologist Richard Reid, who treated Ms Davis, describes the mesh inside Ms Davis’ body as acting like a cheese grater. She has undergone five surgeries in four years related to the mesh.
Rebecca Jancauskas, who is representing Ms Davis as the lead plaintiff in the prolapse class action, suggests it could be the biggest product class action Australia has ever seen. Class actions have already been initiated in the United States and Canada.
The case brings the Australian system of device approval into the spotlight because the mesh was introduced for sale without any pre-market testing. Some are angry at the Australian regulator, the Therapeutic Goods Administration (TGA) and have accused it of failing in its duties.