This summer, DePuy hip implant devices—the ASR Hip Resurfacing System and the ASR XL Acetabular System—were recalled following numerous complaints from both patients and doctors over pain, discomfort, flexibility issues, and ambulation problems. The defective devices were manufactured by DePuy Orthopaedics, a unit of beleaguered pharmaceutical giant, Johnson & Johnson.

DePuy has been making headlines for its devices' higher-than-normal failure rates that have forced patients to undergo both removal of the defective implant and reimplantation with a different device—so called revision surgery. Most recently, DePuy was reported as being one of five implantable medical device makers reaching a $310 million agreement to settle charges it paid kickbacks to physicians in exchange for using its products.

A design flaw in the metal hip cup is responsible for some of DePuy's problems, but another growing problem includes that some physicians have noted that the metal-on-metal implants disburse metal shards that have left patients with masses in their body's tissues and increased blood cobalt levels.

Recent news also includes reports of negligent record-keeping, which has left nearly half of all DePuy implant patients unaware that the devices have been recalled. Also, it seems that representatives of the device maker have allegedly been attending revision surgeries to remove defective hip implant devices from surgical rooms. The implications of removing medical devices from surgical rooms points to an attempt to prevent some evidence being used in legal proceedings.

Now, Drug Watch reports that amid the growing DePuy debacle, the U.S. Food and Drug Administration (FDA)—the agency responsible for oversight of medical devices and drugs—has passed on a proposal meant to enhance and ensure medical device safety and to put in place stronger mandates on medical device makers.

If you have been implanted with one of these defective devices, you should immediately seek advice from a lawyer that is knowledgeable about the DePuy hip implant recall and the injuries associated with these hip implants. For a free consultation with such an attorney, complete the form to the right or call 212-566-1000.  Based in New York City, Sullivan & Brill, LLP represents clients throughout the United States.