Johnson & Johnson is being sued for $1.7 billion over complications linked to the company’s Prolift vaginal mesh device implant. One of the claims made by the plaintiff is that the drug giant sold the mesh before it was FDA approved.
This lawsuit was filed in the District Court in Lod, Israel, with a request that the case be turned into a class action that will represent women in Israel who have suffered from vaginal mesh-related injuries. The suit is asking for NIS 6 billion — or about $1.7 billion — on behalf of about 60,000 women in Israel who allegedly experienced similar injuries tied to the Prolift mesh, according to Jewish Business News.
The female plaintiff alleges that in August 2006, she underwent a surgical procedure to relieve vaginal pain and was implanted with the Prolift mesh. The lawsuit claims that marketing of the Prolift vaginal mesh has been going since March 2005 in Israel even though the device had not yet received FDA approval. The claim also points out that the FDA made a statement that agrees with that fact. The lawsuit goes on to state that after six years of marketing the device, it was finally recalled and discontinued once constant reports of the dangers linked to it were made public. These complications caused thousands of women to file lawsuits over the device’s erosion. So many lawsuits have been filed that settlement negotiations have been reached in multiple cases, and more are expected from J&J as well as other manufacturers of similar devices.
For its part, J&J officials argue that they were allowed to market their vaginal mesh products without FDA approval under the 510(k) guidelines (which state that as long as a device is significantly similar to another approved device, it can be sold prior to gaining FDA approval). The Prolift device is very similar to the Gynecare Gynemesh vaginal mesh device and, therefore, J&J believe the guidelines apply.