Johnson & Johnson (JNJ) (JNJ), the biggest health-care products maker, continued to sell a vaginal mesh implant for nine months after U.S. regulators told the company to stop marketing the device, according to court records. The U.S. Food and Drug Administration told J&J in a letter on Aug. 24, 2007, to halt Gynecare Prolift sales until the agency decided whether the device was “substantially equivalent” to other products on the market. The FDA cited the “potential high risk for organ perforation” when surgeons insert the mesh vaginally to support weakened pelvic tissue. “You may not market this device until you have provided adequate information” on 16 potential deficiencies and received FDA approval, the agency told New Brunswick, New Jersey-based J&J in the letter. “If you market the device without conforming to these requirements, you will be in violation of the Federal Food, Drug and Cosmetic Act.” The FDA cleared the device in May 2008 without ordering sanctions, after nine months of negotiations with J&J’s Ethicon unit. The company faces more than 1,400 lawsuits by women who said the mesh caused organ perforation, pain, scarring and nerve damage. Lawyers for the women said the device’s approval history could increase J&J’s cost to resolve the litigation. “If a company knows the FDA tells them, ‘Don’t sell a device,’ they’re supposed to not sell it,” Adam Slater, an attorney suing on behalf of 150 women, said in a phone interview. “It’s egregious that J&J was selling the device without clearance.” Letter Unsealed The 2007 letter was part of a group of documents filed under seal in state court in Atlantic City, New Jersey, and made public in May at the request of Slater, a partner at Mazie Slater Katz & Freeman LLC in Roseland, New Jersey. Lawsuits also are pending in federal court in Charleston, West Virginia. J&J began selling (JNJ) the Prolift in 2005 without filing a new application after determining on its own that it was substantially similar to the Gynemesh, a company device already approved by the FDA, said Matthew Johnson, a J&J spokesman, in an e-mail. The device maker relied on FDA guidance for when companies must submit new applications, Johnson said. The FDA disagreed with J&J’s interpretation and required a new application that prompted questions in the August 2007 letter, Morgan Liscinsky, an agency spokeswoman, said in an e- mail. J&J faced no sanctions because the FDA determined that the company applied the guidance in good faith and it “promptly complied” when the agency required a new application, Liscinsky said. Fines, Injunctions Sanctions for selling products without approval may include fines, injunctions against a company or senior managers and the seizure of illegally marketed devices, Liscinsky said. The August 2007 letter was “only one part of an extended dialogue with FDA in 2007-08, and it is out of context,” Johnson said in the e-mail. “Throughout this process, our actions were responsible, appropriate and consistent with FDA regulations.” Henry G. Garrard III, a lawyer who represents women suing in federal court in Charleston, said the FDA’s failure to take additional steps to halt Prolift sales or to sanction J&J raises questions about the agency’s power to protect patients. “Companies know the FDA has little enforcement ability and scarce resources,” Garrard, of Blasingame, Burch, Garrard & Ashley PC in Athens, Georgia, said in a telephone interview. “Every woman in America who has been implanted with these devices absolutely should be outraged,” he said. “They should be mad at the company because the company knew they could get away with it.” ‘Water Pistol’ The Prolift negotiations point out “the industry’s ability to shrug off FDA enforcement,” said Erik Gordon, a business professor at the University of Michigan, in an e-mail. “If companies can get away with selling products they aren’t supposed to sell, the FDA is a sheriff packing a water pistol.” The U.S. Senate is to vote today on changes to the FDA’s device-review system, which has drawn scrutiny for allowing implants like vaginal mesh on the market without human testing. The bill increases funding for reviews and the FDA’s power to order safety studies after a product is cleared. It doesn’t include powers sought by consumer groups to let the FDA require clinical trials for more implants before they reach the market.
What this doesn’t say is that the Prolift was actually released in 2005 without FDA approval – and then when the FDA said they needed to get approval in 2007, J&J still didn’t take it of the market or tell any physicians