Does the FDA Really Protect Patients from Defective Medical Devices?
Written By: Rheingold, Valet, Rheingold, Ruffo & Giuffra LLP
While the U.S. Food and Drug Administration (FDA) sets stringent requirements for approval of pharmaceuticals, it allows many medical devices to go to market without any clinical testing. As one would expect, untested medical products (some implanted inside patients' bodies) sometimes prove to be unsafe and must be recalled. The problem is getting worse, as the number of medical device recalls increased 160 percent the first quarter of 2012.
Nevertheless, defective medical devices are not a new problem. Take, for example, DePuy Orthopaedics metal hip replacements. DePuy, a division of medical giant Johnson & Johnson, recalled two hip-implant products in 2010 after 93,000 of them had been implanted worldwide. Recipients had been complaining for two years of product failure requiring expensive and painful replacement surgeries.
The problem was the metal-on-metal bearings, which created metallic debris that caused inflammation and even tissue damage in some recipients. DePuy estimated a 12 to 13 percent failure rate for its artificial hip devices within five years of initial implant, but many U.S. medical centers found the rate to be higher. The recalled devices were not subject to clinical trials before being sold and implanted in patients.
Whose Fault Is It?
It is easy to place blame squarely on DePuy and Johnson & Johnson, the device manufacturers, for failing to do clinical trials before releasing the products. However, the company complied with all federal regulations. The problem may be the FDA's 510(k) program, which allows medical device manufacturers to avoid lengthy and costly clinical testing if the product is "substantially" equivalent to an approved product already on the market.
The 510(k) process has allowed many defective products (such as heart valve rings, surgical mesh and defibrillator leads) to enter the market, harming and even killing many unsuspecting patients. It is alarming that instead of protecting consumers, the FDA appears to be turning a blind eye to destructive products put into the stream of commerce through seemingly lax regulations.
The program has come under such scrutiny recently that the Institute of Medicine recommended the FDA abolish the program completely. Massachusetts Rep. Ed Markey has recently introduced legislation to close the loophole on the 510(k) approval process.
If you or a loved one has been injured or killed by a faulty medical device, contact an experienced medical device attorney to discuss your situation and your options.