Johnson & Johnson may face a sequel to its 2010 $3 billion recall of ASR all-metal artificial hips. The company's DePuy Orthopedics unit and its Pinnacle metal-on-metal hip system currently face approximately 1,600 pending lawsuits in U.S. courts.
Flashback: Settlement of the ASR
ASR is a J&J metal-on-metal hip device that was used in over 37,000 patients in the United States. Due to a high failure rate and severe side effects in patients, J&J recalled the ASR product and set aside over $3 billion dollars for its 3,000 lawsuits. Although the final failure rate for the ASR device has not yet been reported, a recent study conducted by the British Orthopaedic Association (BOA) stated that after six years, the failure rate of the metal hip system could be up to 49%.
Continued problems with Pinnacle metal-on-metal devices
Pinnacle metal-on-metal hip implants were to replace the ASR and its severe consequences in patients. Marketed to last up to 15 years, the devices claimed to be much more durable than those made of polyethylene and ceramic. However, recent tracking studies have estimated that more than 10 percent of all Pinnacle metal-on-metal hip implants have failed to function properly in just two to three years.
Patients with the Pinnacle implants have complained of pain due to swelling, limited mobility and dislocation. More importantly, doctors have reported that the wear of the metal implants may have caused metal poisoning in patients' bloodstreams, due to high levels of cobalt and chromium. All of these problems also have been cited with ASR implants in the past.
DePuy has denied the metal poisoning accusations, claiming that there is insufficient evidence to link increased metal ions in the blood to health risks.
If the Pinnacle lawsuits hold merit, their total estimated settlement is over $5 billion covering just the revision surgeries for the 150,000 implants that were sold in the United States. An average J&J settlement is expected to be $600,000+.
Bleak future for the metal-on-metal implant industry
This case is critical for not only J&J, but also the whole metal implant manufacturing industry. More doctors have started to take notice of the metal-on-metal implants' medical consequences and refrained from using them in surgery. A survey conducted by the American Academy of Orthopaedic Surgeons in 2010 showed that the number of surgeons using metal-on-metal devices have dropped over six percent. Dr. O'Connor, an orthopedic surgeon at the Mayo Clinic in Jacksonville, Florida, stated that "autopsy studies of patients with metal-on-metal implants showed metal ions everywhere in the body--in the liver, the spleen, all over the place."
The metal-on-metal implant industry seems to have a bleak future as problems continue to rise with its devices.