DEPUY ASR

The ASR hip implants are metal-on-metal devices made of chromium and cobalt. The devices include a cup that is implanted into the hip with a ball joint that connects to the leg. The ASR metal-on-metal implants reconstruct human hip joints that were diseased due to conditions such as osteoarthritis, rheumatoid arthritis, avascular necrosis or fracture. Once implanted, the devices are supposed to last for an average of 15 years. 

DePuy created the ASR XL Acetabular Hip System in order to address the need for an implant device that would have a reduced dislocation risk for young, active patients. The U.S. Food and Drug Administration (“FDA”) cleared the ASR XL Acetabular Hip System, a total hip replacement version of the device, in 2005 under Section 510(k) of the Food, Drug and Cosmetic Act. Under Section 510(k), a manufacturer can obtain market approval from the FDA with very little clinical testing if the manufacturer can prove that there is a “substantially similar” product already on the market. The ASR XL Acetabular Hip System went through the FDA’s clearance process because the new metal-on-metal implants were deemed by the FDA to be “substantially equivalent” to DePuy’s previously approved plastic model. 

In 2009, DePuy endeavored to receive approval from the FDA of a resurfacing version of the ASR metal-on-metal hip implant, i.e. the ASR Hip Resurfacing Platform. DePuy eventually withdrew its application to the FDA for sale of the ASR Hip Resurfacing Platform in the United States, but some patients had already received the implants through clinical trials.

In early 2010, a study published in the British Medical Journal revealed that both the ASR Hip Resurfacing Platform and ASR XL Acetabular Hip System were potentially dangerous because they could generate large amounts of metallic debris as they wear over time. The metallic debris had been shown to cause severe inflammatory responses in some patients, causing groin pain, death of tissue in the hip joint and loss of surrounding bone, and requiring a revision surgery to replace the device. 

In August 2010, DePuy voluntarily recalled over 93,000 ASR hip implant devices worldwide, including 37,000 in the United States. In issuing the recall, DePuy claimed that more than 13% (1 out of every 8) of the ASR devices failed within five years, causing those who received the failed ASR hip implant devices to need revision surgery.

From 2008 to the device’s recall in 2010, the FDA had received in excess of 300 complaints involving patients in the United States that received the ASR hip implant devices. According to the FDA complaints, the ASR hip implant devices failed early in some patients due to component loosening, component mal-alignment, dislocation and/or fracture, all of which were attributed to the design of the devices. Further, the reports disclosed that a substantial number of patients required complicated, expensive and painful revision surgery with a prolonged recovery time.

Not long after the 2010 recall, Johnson & Johnson conducted an internal analysis in which the company estimated the metal-on-metal ASR devices would fail within five years in nearly 40% of patients who received it. Their analysis, which was disclosed in court records, also suggested that the implant was likely to fail prematurely over the next few years in thousands more patients in addition to those who already had painful and costly procedures to replace it.

Plaintiffs filed lawsuits against DePuy Orthopaedics, Inc., an Indiana corporation and subsidiary of Johnson & Johnson (“DePuy”). Plaintiffs alleged that DePuy’s ASR hip implant devices were defectively designed and/or manufactured and that the company failed to provide adequate warnings concerning the ASR medical devices.