Medical devices, such has hip, knee and joint replacement devices, require FDA approval prior to marketing and surgical implantation. Apparently Johnson & Johnson’s DePuy Orthopedics unit didn’t totally comprehend the approval requirement and they failed to place more than a dozen of the devices in the FDA approval process prior to marketing them.
The U.S. Food and Drug Administration (FDA) sent a letter to Johnson & Johnson/DePuy warning them that several of their hip, knee and joint replacement devices were "improperly marketed" which has caused Johnson & Johnson/DePuy to refrain from marketing some of these devices.
A January 18, 2012, article in the The Asbury Park Press, by Michael Diamond, says FDA’s director of the office of compliance, Steven D. Silverman, sent a December 8 warning letter to Johnson & Johnson/DePuy noting that DePuy made 14 types of devices which did not receive pre-market clearance or approval by the FDA. The information provided in the letter resulted from inspection(s) which occurred from May 10 to June 7, 2011. The company had indicated "it believed the devices were custom-made, requested by surgeons to match an individual patient’s anatomy and exempt from the approval process." A DePuy spokesperson, Lorie Gawreluk, said "Custom medical devices have been exempt from pre-market review since 1976." It appears the FDA’s position is just because devices are tailored to an individual’s anatomy doesn’t make the device unavailable to other doctors, nor does it preclude the FDA approval process.
In the warning letter, the FDA also cited inadequate product non-conformance and complaint review processes by DePuy and quality problems with some of the devices. Gawreluk said DePuy has responded to the FDA and addressed the concerns from the inspection and the warning letter.
This is yet one more major problem and headache for DePuy and Johnson & Johnson as the companies have suffered from poor quality concerns and numerous recalls, including the DePuy ASR metal on metal hips which are failing and causing affected patients to have high metal concentrations in their blood (chromium and cobalt), pain and swelling, and revision surgeries to remove and replace the defective ASR hip implants.
Additionally, the DePuy Pinnacle metal on metal hip implants may also be similarly defective, but Johnson & Johnson and DePuy have not recalled those hips, arguing those hip implants are not defective; one line of thought on the Pinnacle metal on metal hip implants is that DePuy may be lumping in the ceramic and polyethylene (plastic) bearing/surface implant data with the metal on metal data, thereby diluting the failure rates of its Pinnacle line of hip implants. The failure rates for the Pinnacle implants, however, may be trending upward nonetheless. There are thousands of DePuy ASR and Pinnacle cases in litigation now, both models being subject to individual state court actions and federal multi-district litigation.
It appears as if it may get worse for these companies before it gets better, unless they can get a handle on their various problems.