June 26, 2012 ~ Johnson & Johnson, the global healthcare company, has once again found itself in the spotlight for failing to follow the rules.
J & J was ordered to stop selling a controversial vaginal mesh product, the Gynecare Prolift, but kept selling it even after being warned by the U.S. Food and Drug Administration in an August 24, 2007 letter. The letter said that the Prolift mesh had the “potential high risk for organ perforation” when it was inserted vaginally to support prolapsed tissues and organs in women.
The letter was recently released among a number of documents that had been under seal in Atlantic City, NJ state court and made public by attorney, Adam Slater, who is representing about 150 vaginal mesh victims, reports Bloomberg.
“You may not market this device until you have provided adequate information” on 16 potential deficiencies and received FDA approval, the agency told the New Jersey-based company. “If you market the device without conforming to these requirements, you will be in violation of the Federal Food, Drug and Cosmetic Act.”
What happened? Nothing. All was forgiven in May 2008 when the FDA failed to apply any sanctions and approved the Prolift for market.
You’ll recall the Prolift was put on the market by J & J’s Ethicon division in 2005 without undergoing any FDA scrutiny. In its defense when the lapse was discovered, the company claimed the Prolift was the substantial equivalent of the Gynemesh, already on the market. The FDA had ordered Prolift sales stop in the August 2007 letter while it determined whether Prolift was the same as Gynemesh.
However an FDA spokeswoman recently told Bloomberg that there could yet be sanctions for selling an unapproved product which could include a fine, an injunction against a company or its managers and/or the seizure of the illegally marketed device.
A lead attorney in the mesh lawsuits, Henry G. Garrard III told Bloomberg that the inability or unwillingness of the FDA to follow its own rules and impose sanctions raises questions about the agency’s credibility and its power to protect Americans.
“Companies know the FDA has little enforcement ability and scarce resources,” Garrard, of Blasingame, Burch, Garrard & Ashley PC of Athens, Georgia told Bloomberg 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.”
No recall has been issued on the Prolift. Instead on June 5, J & J announced it would stop selling four vaginal meshes, the Prolift among them. Refraining from the word “recall” the company’s Ethicon division says it has plans to “discontinue” the product over the next three to nine months.
“Our decision to discontinue these products is based on their commercial viability in light of changing market dynamics,” said spokesman Matthew Johnson to Bloomberg.
Mass Device reports J & J is calling the news about unsealed FDA letters misleading and says that it acted in good faith.
“Ethicon remains committed to vigorously defending all product liability lawsuits concerning the use of our pelvic mesh products,” Johnson told us. “Numerous clinical studies suggest that when combined with proper surgical technique, surgical mesh can improve patient outcomes, and Ethicon’s devices are among the most studied devices on the market for this condition.”
J & J is facing more than 1,000 lawsuits in Atlantic City state court and in a federal multidistrict litigation in District Court in Charleston West Virginia where women allege the defective vaginal mesh, used to correct incontinence and prolapse, instead caused traumatic and life-altering injuries. #
Bloomberg, June 26, J&J Sold Vaginal Mesh Implant After Sales Halt Ordered
Mass Device, June 26, J&J says unsealed FDA letters on vaginal mesh sales taken “out of context”
MDND, June 5, Four J & J Vaginal Meshes Named, Will be Removed from the Market