According to the New York Times, Johnson & Johnson has tentatively agreed to a settlement that could reach up to $4 billion to resolve thousands of lawsuits filed by patients injured by a flawed all-metal replacement hip implant.
The tentative plan, which must win court approval, represents one of the largest payouts for product liability claims involving a medical device. A spokeswoman for the company's DePuy Orthopaedics unit declined to comment on the possibility of a settlement.
The agreement will apparently include patients who have been forced to have the device, known as the Articular Surface Replacement, or A.S.R., removed and replaced with another artificial hip.
Under the deal, each patient could possibly receive about $350,000 in compensation. This figure will vary depending on factors like a patient's age and medical condition.
The final cost of the deal to Johnson & Johnson could rise, depending on how many claimants who received the device undergo replacement operations in the future. Under the proposed plan, patients who have not had a replacement would not receive compensation, the lawyers said.
DePuy officials have long insisted that they acted appropriately in recalling the device. However, company documents disclosed during the trial of a patient lawsuit this year showed that DePuy officials were long aware that the hip had a flawed design and was failing prematurely at a high rate.
Many artificial hips last 15 years or more before they wear out and need to be replaced. But by 2008, data from orthopedic databases outside the United States also showed that the A.S.R. was failing at high rates in patients after just a few years.
Internal DePuy projections estimate that it will fail in 40 percent of those patients in five years, a rate eight times higher than for many other hip devices.
The hip was first sold by DePuy in 2003 outside the United States for use in an alternative hip replacement procedure called resurfacing. Two years later, DePuy started selling another version for use here in standard hip replacements that used the same cup component as the resurfacing device. Only the standard version was sold in the United States; both were sold outside the country.
About 93,000 patients received an A.S.R., about one-third of them in the United States.
Problems with the design first came to light in Australia and England just a few years after its marketing began. But DePuy officials insisted for years to surgeons who complained about that device that patient problems reflected their surgical technique rather than the implant's design.
While the settlement, if approved, would resolve much of the litigation against DePuy involving that device, it continues to face thousands of lawsuits involving another all-metal hip that it no longer sells called the Pinnacle.
If you or someone you know have been injured by a defective product or medical device, contact the attorneys at Abraham, Watkins, Nichols, Sorrels, Agosto & Friend by calling 713-222-7211 or 1-800-870-9584.