Johnson & Johnson ($JNJ) was aware of the alarming failure rates of ASR hip implants a year before the company stopped making them and two years before they were recalled, The Wall Street Journal reports.
The disclosure comes from unsealed documents in one of J&J's 10,000 lawsuits over the all-metal hip replacements, including another internal note from 2011 revealing that the company expected about 36% of the devices to fail within 5 years--far beyond the generally accepted failure rate of 5% for hip implants--all while it was publicly downplaying concerns over the need for replacement surgeries.
A J&J spokeswoman told the Journal that the company "acted appropriately and responsibly" when it recalled the devices in 2010, and the drug and device giant has argued that its implants weren't defective and went through the FDA's 510(k) clearance process without cause for alarm.
J&J has already spent about $900 million to fight and settle suits since the recall, dealing mostly with claims that the metal-on-metal devices were prone to chafe and flake off metallic bits into the bloodstream, putting patients at risk of tissue death and toxicity. Last fall, the company said it had increased its settlement war chest by an undisclosed amount to prepare for an increase in filings.
At the same time, J&J is facing more and more litigation over Pinnacle, the company's still-on-the-market metal hip implant. That device is reported to fail at a rate of about 10%, which, while below the ASR, still exceeds what's commonly accepted by manufacturers.
All this comes as the FDA is cracking down on all-metal hips, proposing new regulations that would require devicemakers to demonstrate the safety of their commercialized implants or have them yanked from the market.
- read the WSJ story (sub. req.)