Johnson & Johnson has entered into an agreement to pay more than $2 billion to cover claims over a faulty hip replacement device. At issue is an all-metal replacement hip, marketed by the company’s DePuy Orthopaedics unit, that caused tissue damage and, in some cases, crippling injuries.
One of the largest product liability payouts in medical history
The device, called the Articular Surface Replacement (A.S.R.), was sold by DePuy until mid-2010, when the company recalled the product due to high failure rates. The device was creating metallic debris in the body over time, which caused damage.
The settlement will be one of the largest payouts for product liability claims involving a medical device and will resolve thousands of lawsuits. It’s expected to cover about 7,000 to 8,000 patients who needed to undergo a second procedure to have the device removed and replaced with another artificial hip.
What did the company know, and when did they know it?
The company claims it issued the recall in a timely manner. However, documents at one trial revealed DePuy had been aware the hip was flawed and had a tendency for early failure before the recall.
Many artificial hips can be expected to last about 15 years or longer before they need to be replaced. In the case of DePuy’s A.S.R. device, data in 2008 showed a high rate of failure in only a few years (resulting in a failure rate about eight times higher than other hip replacement devices).
When issues about the device first surfaced, the company claimed the problems were due to the faulty work of surgeons implanting the device. In 2008, a company consultant warned that the product apparently had a design flaw.
The New York Times reports that DePuy company executives decided in 2009 to phase out the device, but not before continuing to sell existing inventory – even after the FDA raised warnings about its safety.
It is estimated that about 93,000 patients worldwide received an A.S.R., with about 30,000 of those patients living in the U.S. Orthopedic surgeons first welcomed an all-metal device, in the hopes that it would be superior to traditional devices used. Today, after evidence of early failure rates, the metal devices are now rarely used.