The number of women who claim they are being injured by transvaginal mesh devices, and the severity of their injuries, has many victims and their families wondering how such potentially dangerous medical products were approved for use. Were the devices properly evaluated before they hit the market? Is the U.S. Food and Drug Administration (FDA) doing its job to protect consumers from potentially dangerous drugs and medical devices?
Consumer and safety experts have strongly criticized the FDA’s 510k approval process, which has allowed transvaginal mesh devices and many other medical products to glide through the agency’s approval procedures with little or no clinical testing, as long as the products are significantly similar to already-approved products.
This fast-track process has led to record numbers of recalls in recent years, creating what Consumer Reports has described as a “nightmare scenario” for public safety. As hundreds of medical devices like transvaginal mesh are sped to market, thousands of patients are ultimately left in their wake suffering from sometimes permanent and debilitating injuries.
But as troublesome as the FDA’s flawed approval process is, it isn’t the only problem causing increasing numbers of people to be injured by inadequately tested medical devices. Recent news about a transvaginal mesh device made and sold by Johnson & Johnson unit Ethicon without FDA approval demonstrates that the agency simply doesn’t have the muscle to adequately protect consumers.
On August 24, 2007, the FDA sent a letter to Johnson & Johnson, the world’s largest health care products manufacturer, telling it to stop sales of its Gynecare Prolift transvaginal mesh. The agency warned Johnson & Johnson, “You may not market this device until you have provided adequate information” on 16 possible deficiencies identified by the FDA. The letter also stated that the Gynecare Prolift device could not be sold without FDA approval.
“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 letter further warned.
Johnson & Johnson sold it anyway. The company had been selling the product for three years without FDA approval and continued to sell it for another nine months after receiving the FDA’s order to stop. Meanwhile, it continued to reap huge profits from the sale of the potentially dangerous device, which has been implicated in more than 1,400 personal-injury lawsuits.
Plaintiffs allegedly injured by the devices blame them for organ perforation, infection, pain, nerve damage, and other serious complications. In some cases, the injuries are so extensive, they have resulted in an inability to work, failed marriages and relationships, depression, and suicidal thoughts.
Johnson & Johnson’s refusal to follow FDA orders demonstrates the sheer power and resources of company to essentially write its own rules when there is a significant financial benefit to do so. Giant pharmaceutical companies know the FDA has relatively scant resources and little ability to enforce rules.
The worst that can happen to Johnson & Johnson is a civil fine for its illegal practices, but federally imposed fines always amount to a small percent of the profits made from making and selling a potentially dangerous product. In other words, there is no incentive to obey the law.
In this scenario, the court of law is possibly the last hope consumers have in preventing Big Pharma from flooding the marketplace with potentially dangerous drugs and devices. If those harmed by such products are justly compensated and punitive damages are levied against their manufacturers, maybe then companies like Johnson & Johnson will be less inclined to rush their products to market and profit off of the pain and suffering of others.