Get used to the name "Pinnacle." Johnson & Johnson ($JNJ) has a metal-on-metal hip system with the name poised to cause an onslaught of legal problems for the company. Even more, as Reuters reports, observers believe the growing controversy could surpass J&J legal and financial costs in the wake of its massive recall of a predecessor product two years ago.
The company's DePuy division recalled some 100,000 ASR implants in 2010. J&J set aside $3 billion to settle some 3,000 lawsuits relating to the product's safety, after 37,000 patients in the U.S. received the ASR implant, according to the story. Right now, out of 150,000 patients in the U.S. who received the Pinnacle all-metal hip implant, nearly 1,600 lawsuits are pending. As with the ASR implant, plaintiffs claim the implants have caused post implant fractures, pain, swelling and high levels of cobalt and chromium in the blood. But plaintiff attorneys quoted in the Reuters article say the Pinnacle lawsuits, if found to have merit, could cost J&J nearly $5 billion to cover just the revision surgeries, or new surgeries required to replace problem implants.
The thing is, unlike with the ASR implant, J&J/DePuy is fighting hard to challenge the Pinnacle implants. DePuy spokeswoman Mindy Tinsley told Reuters that DePuy is monitoring the Pinnacle metal-on-metal implant's performance very closely, but the company remains "very confident" in it and will defend itself against the lawsuits.
"The ASR is a very different system and has a very different design and has a very different clinical performance" than the Pinnacle product, Tinsley is quoted in the Reuters piece as saying. "We recalled it because it was not performing as it should." (Experts believe the company is rolling the dice to determine how the first few lawsuits will play out.)
Reuters says more than 10% of Pinnacle all-metal hips will have failed within the next two or three years, doctors tracking the implants have concluded. That's higher than the 4% to 4.5% failure rate within 5 years of implantation accepted with implant manufacturers. By contrast, the British Orthopaedic Association and British Hip Society estimated that the ASR implant failed at a rate of up to 49% after 6 years, Reuters reports, almost four times higher than the rate DePuy itself cited during the 2010 recall. Solid numbers are hard to find, according to the story, because in the U.S., nothing exists to track how well the hips (or other devices) perform once they are implanted.
As concerns about all-metal hip implant safety mushroom, their use is declining. Reuters notes, for example, that only 10% of surgeons use metal-on-metal hip implants. That number was at 16% in 2010, before the FDA warned that the devices could cause health problems. The FDA asked metal-on-metal hip manufacturers for new product safety studies. Late last month, regulators also convened an expert panel to explore the issue. Panelists recommended that doctors avoid the implants because of the risk.
- read the Reuters article