FDA Says DePuy Sold Medical Implants Without Approval

The FDA last month accused Johnson & Johnson subsidiary DePuy Orthopaedics, Inc. of selling 14 different types of medical devices without necessary FDA approval. The medical devices failing to receive FDA approval included artificial knee and artificial hip systems. The FDA also said DePuy's quality control system did not comply with FDA requirements.

This latest FDA action only adds scrutiny to DePuy following DePuy's artificial hip recall that included tens of thousands ASR XL Acetabular Hip Replacement Systems.

In addition to DePuy's failure to receive FDA approval for the devices, the agency was also concerned that DePuy did not have adequate procedures to ensure the devices met user's needs; DePuy could not adequately review customer complaints; and had no employee charged with remedying non-conformance issues.

In December 2011, the New York Times confirmed that the high failure rate for DePuy's metal-on-metal hips – including the recalled Acetabular Hip Replacement Systems – resulted in a high cost to patients, hospitals, insurers, employers, and tax payers totaling in the billions of dollars in the coming years. NBC called metal-on-metal hips one of the largest failures ever.

While DePuy did receive FDA approval for its recalled metal-on-metal hips systems, the abbreviated FDA approval process that DePuy used has been questioned. The 510(k) approval process rests on the notion that if one device has been cleared by the FDA, then similar devices need little or no testing on actual patients. If a new medical device is "substantially equivalent" to an already-marketed device, then clinical testing is not required. This allowed for DePuy's metal-on-metal hips to be approved without any patent testing at all.

The FDA's 510(k) program has been under attack from many fronts, including by the New England Journal of Medicine. The NEJM agreed with the Institute of Medicine that the 510(k) approval process was "unfixable". An editorial in the NEJM recommended that the FDA immediately stop using the 510(k) program for Class III devices — which are considered to pose the highest threat to patients. The NEJM editorial specifically discussed the ongoing problems with metal-on-metal hip implants, including Johnson & Johnson's DePuy ASR Acetabular System and DePuy ASR Hip Resurfacing System.

As a report by Bloomberg noted, this safety debate has presented a conundrum for medical device makers. These manufactures have avoided testing and clinical scrutiny by claiming the devices are similar to previous versions, yet are marketing the devices to doctors and patients as having advanced far beyond original versions.

[More on the DePuy Hip Recall]

Read More:

• FDA says Johnson & Johnson subsidiary DePuy sold orthopaedic devices without approval [Michael L. Diamond at Asbury Park Press]
• FDA Warns J&J's DePuy Orthopaedics Unit On Custom Devices [Dow Jones Newswire via WSJ]

(c) Copyright 2011 Brett A. Emison

Follow @BrettEmison on Twitter.