A Los Angeles jury found in favor of Plaintiff Loren “Bill” Kransky, ordering Johnson & Johnson to pay the man $8.3 million in compensatory damages for debilitating injuries he suffered as a result of a faulty hip implant. This was the first of many cases pending in ongoing litigation against J&J and its subsidiary, DePuy orthopedics, involving the ASR XL metal-on-metal hip implant.
Court documents unsealed before the trial started showed that DePuy executives knew in 2008 that the ASR hip implants were failing early at unusually high rates, but the company continued to make the devices for several more months before finally recalling them in August 2010. The recall, which included the DePuy ASR XL Acetabular and Hip Resurfacing Systems, affected about 93,000 patients worldwide, including around 40,000 Americans.
Testimony provided during the trial by a DePuy biostatistician confirmed the company was told the design of the device was flawed, and estimated 36 percent of the ASR devices would fail within four and a half to five years. The average lifespan of most artificial hips is 20 years or more, with a failure rate of around 12-14 percent.
Traditional hip implants are made from plastic or ceramic parts. The ASR was among a new breed of hip implants made of all metal parts, with a metal ball fitting into a metal socket, or cup. The intention was to make the hip implant more durable. However, as the metal parts rub against each other, tiny metal particles can be released into the joint space. This can lead to tissue damage, and result in loosening, fracturing and dislocation around the device.
In some cases, patients experienced a type of blood poisoning known as metallosis, when metal ions from the device leeched into the bloodstream. This may result in extreme pain, tumors and muscle wear.
The U.S. Food & Drug Administration (FDA) required all makers of metal-on-metal hip implants to review the safety and efficacy of the devices. In January, the FDA proposed new regulatory rules that would require orthopedic device manufacturers to test all-metal hip replacement systems prior to approval.
Current FDA regulations do not require thorough clinical testing of class III medical devices, like hip implants. They instead allow certain devices to be approved on a “fast track” through its 510(K) system as long as they seem to be similar enough to already approved devices.