Johnson & Johnson is now preparing for additional metal-on-metal hip litigation, litigation potentially more costly than its recent $3 billion, to date, ASR metal hip recall. The successor to the ASR is the company’s Pinnacle metal-on-metal hip system and it faces mounting lawsuits across the country, some 1,600 at last count. Experts tracking the product say that more than 10 percent of the Pinnacle metal-on-metal hips will fail in the next two to three years.
Metal-on-metal hip implants were originally created as more durable alternatives to plastic or ceramic hip systems. The all-metal variety were meant to last up to 15 years, surgeons are starting to turn their backs on the devices as problems mount. A survey taken by the American Academy of Orthopaedic Surgeons in 2010 showed 16 percent of surgeons were using metal-on-metal hip implants while a survey in 2011, following the FDA warning of potential problems, showed a drop to 10 percent. Many expect that number to have fallen even further since the last survey.
Patients with the Pinnacle metal hip implant are experiencing much the same problems as those with the ASR device. These issues include pain and swelling, limited mobility, and dislocation. Even more worrisome are the high levels of cobalt and chromium found in the bloodstream of patients with the devices, the trace metals resulting from wear and tear on the implants. This condition, known as metallosis, can lead to cardiovascular, neurological, renal and thyroid problems. There are also concerns that high ion levels cause cancer, though that science is still being developed.
A total of 500,000 patients in the United States have received metal-on-metal hips, according to government data. Of those patients, an estimated 150,000 received the Pinnacle device, compared to the approximately 37,000 who received the ASR implant.
Legal experts say Johnson & Johnson is taking a firm approach to defending itself against Pinnacle metal-on-metal claims, hiring a top product liability defense firm and refusing to recognize patient complaints or pay for replacing the hip devices. The company argues the device performs better than other all-metal hip implants. Many believe Johnson & Johnson is using a strategy of taking its chances to see how the first few lawsuits play out before admitting to any problems. Should the Pinnacle lawsuits be found to have merit, Johnson & Johnson could end up paying nearly $5 billion to cover revision surgeries alone.
The final failure rate for the ASR device recalled a few years ago has not yet been established, but a study released recently by the British Orthopaedic Association and the British Hip Society indicated a failure rate of up to 49 percent after six years - nearly four times the rate cited by DePuy when it first recalled the device. The failure rate for the Pinnacle line of products remains unknown as the process of collecting for damage done is only just beginning.