Insight: As lawsuits climb, J&J may have new hip trauma
By Debra Sherman
CHICAGO (Reuters) - Johnson & Johnson faces a potentially more damaging and costly sequel to the $3 billion recall of its ASR all-metal artificial hips two years ago, one of the most expensive medical device failures in U.S. history.
A successor to ASR, the Pinnacle metal-on-metal hip system has nearly 1,600 lawsuits pending in U.S. courts. Doctors who are tracking large groups of patients with both products estimate that more than 10 percent of the Pinnacle all-metal hips will have failed in the next two to three years.
Metal-on-metal hip implants were sold on being more durable than those made of other materials, such as polyethylene or ceramic. They are meant to last up to 15 years, but as controversy over all metal-on-metal implants heats up, fewer surgeons are using them.
A survey taken by the American Academy of Orthopaedic Surgeons in 2010 showed 16 percent of surgeons were using metal-on-metal implants before the U.S. Food and Drug Administration warned of potential problems. That number dropped to 10 percent since the FDA warning, and doctors say the number probably has dwindled further.
Many patients with the Pinnacle metal-on-metal device are experiencing the same problems as those who got the ASR product, including pain and swelling, limited mobility, and dislocation. Perhaps most concerning, some doctors say, is the high levels of cobalt and chromium in the bloodstream resulting from wear of the all-metal implants. Metallosis, as it is known, can lead to cardiovascular, neurological, renal and thyroid problems, in addition to destroying soft tissue, muscle and bone.
"We're simply seeing the tip of the iceberg with metal-on-metal failures," Dr Mary O'Connor, an orthopedic surgeon at the Mayo Clinic in Jacksonville, Florida, said of the entire class of metal-on-metal devices. O'Connor said she does not use metal-on-metal hip implants because she has been concerned about metal poisoning for years.
The new round of complaints represents a significant threat for J&J's DePuy Orthopedics unit, whose Pinnacle line includes non-metal models and covers a much wider range of products than ASR. The diversified healthcare giant, under new Chief Executive Alex Gorsky, has also just raised its bet on orthopedic products with the $20 billion purchase of device maker Synthes.
"Litigation is what it is, but the ASR is a very different system and has a very different design and has very different clinical performance" than the Pinnacle, said Mindy Tinsley, a spokeswoman for DePuy. "We recalled it because it was not performing as it should." Continued...