For more than nine months, Johnson & Johnson’s Ethicon division blatantly ignored direct orders from federal drug regulators to stop selling its dangerous vaginal mesh device, the Gynecare Prolift, Bloomberg News recently reported. Instead, the company put thousands of women at risk.
In August 2007, the U.S. Food and Drug Administration (FDA) demanded that Johnson & Johnson halt the sale of Prolift until the agency could decide whether the device was “substantially equivalent” to similar products on the market. Even at that time, the FDA knew the device could injure women when inserted vaginally to support and lift fallen pelvic organs. Instead of following the FDA’s orders, the company went ahead and continued the sales. It wasn’t until 2008 that the device was cleared for use. No sanctions were ever filed against the company.
“If you market the device without conforming to these requirements, you will be in violation of the Federal Food, Drug and Cosmetic Act,” FDA officials said to Johnson & Johnson in a 2007 letter, according to Bloomberg.
Blatantly Ignoring FDA Orders
Bloomberg previously reported that the Prolift device was used for more than three years before the FDA approved it. However, news that the FDA directly ordered the company to stop selling it is a new twist.
Johnson & Johnson’s deliberate disregard for the FDA’s orders shows just how little enforcement control the federal agency has and just how much muscle Big Pharma companies can flex.
“If companies can get away with selling products they aren’t supposed to sell, the FDA is a sheriff packing a water pistol,” Erik Gordon, a business professor at the University of Michigan, told the news organization.
Two Years Under the Radar
The Prolift device was introduced in March 2005 but the FDA didn’t learn about it until 2007, when Johnson & Johnson was trying to get a similar product approved. Both products were approved in 2008.
The company repeatedly argued that it was within its rights to sell the Prolift device without FDA approval because it is similar to another device already on the market. According to the FDA’s 510(k) fast-track approval process, medical devices can be fast-tracked to the market if they are substantially equal to earlier approved devices.
Earlier this year, Johnson & Johnson recalled four of its mesh products, including Prolift. However, nothing can stop the company if it decides to put the product back on the market. Apparently, not even the FDA.
In the past years, the FDA has received dozens of reports of malfunctions, serious injuries and deaths in relation to transvaginal mesh devices, including the Prolift device. Hundreds of women and their families have filed lawsuits in state court in Atlantic City, New Jersey, and federal court in Charleston, West Virginia. While a trial date has been set for another company, C.R. Bard, for its faulty transvaginal mesh device, no trial dates have been set in the Johnson & Johnson cases.