Depositions Continue in DePuy Implant Lawsuit

More company executives have been deposed in the ongoing DePuy Orthopedics ASR metal-on-metal hip implant lawsuit.

Among the depositions are DePuy’s senior engineering fellow, the director of Strategic Outcomes, the vice president of Worldwide Regulatory Affairs, and the vice president of Worldwide Clinical Affairs. The depositions are scheduled to take place in February and March 2012. A deposition is the out-of-court oral testimony of a witness that is reduced to writing for later use in court or for discovery purposes. It is commonly used and almost always is conducted outside of court by the lawyers themselves (that is, the judge is not present to supervise the examination).

Sally Hunter, worldwide vice president of clinical affairs and one of the executives recently deposed, was quoted in The New York Times last March, citing declining sales as the reason the company began phasing out its ASR hip replacement implants.
The company launched a voluntary recall of the ASR devices five months later, acknowledging unusually high rates of revision surgery needed within five years of implant, rates that weren’t previously seen in post-market evaluations. By then about 83,000 people already had received the device.

In late August 2010, Johnson & Johnson’s DePuy Orthopaedics unit announced the recall of its ASR XL Acetabular System, a hip socket used in traditional replacement surgery, and the ASR Hip Resurfacing System, a partial hip replacement that involves placing a metal cap on the ball of the femur in order to preserve more bone. The company said it is recalling both products due to the number of patients who needed a second hip replacement.

About 93,000 ASR devices have been implanted in patients worldwide, according to DePuy. And while the recall may have come as a surprise to some patients, experts claim it was inevitable, saying failure rates and patient complaints doomed the device. Between 2008 and 2010, the FDA received about 400 complaints from American patients who received the implants, according to a March 2010 article in The New York Times.

Around the same time the Times article was published, the British agency that regulates medical devices issued an advisory on metal debris generated by hip implants. Devices such as the ASR products have come under fire in recent years because the metal-on-metal bearings can generate debris from wear, which can cause inflammation and tissue damage in certain patients.

In late 2009, DePuy said it was phasing out the implants because of slowing sales. Just several months later, the company warned doctors that the implants might have a high failure rate in some patients. In a letter dated March 6, 2010, DePuy told doctors that recently analyzed data from Australia suggested that the ASR had a higher-than-expected failure rate when used in traditional hip replacement on certain types of patients. The letter said the data shows that the risk is highest for patients of small stature, a group that typically includes women, and patients with weak bones.

Many hospitals that specialize in joint replacement surgery had already noticed a higher failure rate with the DePuy hip implants, Joshua J. Jacobs, M.D., chairman of orthopedic surgery at Rush University Medical Center in Chicago, told the Times. “Most major medical centers have seen issues with this device. This does not come as a surprise,” he said.