Johnson & Johnson ($JNJ) faces new trouble concerning hundreds of lawsuits over the safety of its Gynecare Prolift vaginal mesh implant, with the revelation that it apparently sold the device for three years before gaining FDA clearance.
FDA spokeswoman Morgan Liscinsky told Bloomberg in an emailed statement that the agency disagreed with the company's "assertion" that it could begin selling the device as it did in March 2005, because it was similar to another J&J product--Gynecare Gynemesh--already on the market. The device is designed to treat weak pelvic muscles.
The FDA has a "fast-track" process that lets companies avoid human testing of a product before selling it, assuming that the FDA rules that the device is similar to something the company already sells. A J&J spokesman told Bloomberg that the company followed those guidelines, and that its actions in 2005 were "responsible, appropriate and consistent with FDA regulations" from start to finish. (J&J even heralded the product's innovation in its annual report that year, Bloomberg points out.)
But the FDA decided in 2007 that J&J was wrong, according to the article, after contacting the company's Ethicon division over its desire to use the same guidance path for approval for Prolift + M, which used the original Prolift as a predicate device. FDA regulators determined that the company should have submitted a separate 510(k) application for Prolift because it had enough product differences from Gynemesh. They asked for safety and effectiveness data and formally cleared Prolift and its successor device in May 2008, according to the story.
With this news out in the open, the Bloomberg story argues that J&J's decision to sell Gynecare Prolift for three years without formal FDA clearance might cost the company even more in its effort to resolve more than 550 lawsuits from women who say the device injured them. J&J may have a far weaker case as a result and be forced to settle for some serious cash. But the FDA's fast-track process also comes out as flawed, perhaps being too vague for companies who believe that they use it properly, only to find years after the fact that regulators view things differently.
Vaginal mesh implants also remain suspect, in light of the large number of lawsuits alleging product failure, resulting in complications and death in some cases. The FDA in January ordered manufacturers of the devices--including J&J, C.R. Bard ($BCR), Covidien ($COV), Boston Scientific ($BSX) and others--to study the rates of organ damage and other complications over three years. As of last fall, an FDA panel of experts recommended reclassifying the devices as Class III, a higher-risk designation.
- here's the Bloomberg story