Reporters from Bloomberg Businessweek and the New York Times have stated that Johnson & Johnson has tentatively agreed to pay $4 billion to settle lawsuits over recalled metal on metal hip implant devices manufactured by its DePuy unit. More than 7,500 lawsuits have been filed in federal and state courts by patients who claim the hip implant devices were defective. Injuries such as bone infection, necrosis, nerve and tissue damage, and increased metal ion levels in the blood have been mentioned in these claims.

According to the Bloomberg article this agreement, if approved, would be the largest settlement of U.S. legal claims for a medical device. It would also be the second multibillion-dollar agreement for Johnson & Johnson this month. In August 2010, DePuy voluntarily recalled the metal on metal implant product line—ASR Xl Acetabular System. This recall came after data indicated that the 5 year failure rate of DePuy’s hip replacement product was approximately 13%, or 1 in 8 patients (typically, hip replacements last 15 years). The recall means that patients who have already undergone one surgical procedure to replace a hip will have to undergo a second surgery to replace the defective device. But even if the defective device is replaced, it can leave behind dangerous, possibly deadly fragments and tiny particles of cobalt and chromium that might not be discovered for years. It is expected that the settlement will be announced within the next week.