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. It makes me wonder if they even care about quality or the patients they service. The agreement will include those patients who have already been forced to have the device, known as the Articular Surface Replacement, or A.S.R., removed and replaced with another artificial hip.
The Price of a Hip
Under the deal, each patient would receive about $350,000 on average in compensation, though that figure will vary depending on factors like a patient’s age and medical condition. The precise value of the settlement is unclear because lawyers for patients are still trying to estimate how many of the 12,000 related lawsuits involve patients who had a replacement. Lawyers believe that number may be 7,000 to 8,000 cases. 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.
The ASR Hip
The A.S.R. hip was sold by DePuy ( a unit of Johnson and Johnson) until mid-2010, when the company recalled it amid sharply rising early failure rates. The device, which had a metal ball and a metal cup, sheds metallic debris as it wears, generating particles that have damaged tissue in some patients or caused crippling injuries. DePuy officials have long insisted that they acted appropriately in recalling the device when they did. However, internal 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. So why did they sell it? I think it was for the $$$.
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 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. Keep in mind that 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 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. Did the company do the right thing? Nope.
History of Problems
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. That is right, they blamed the doctors for not doing it right. When the FDA told the company that it was rejecting its efforts to sell the resurfacing version of the device in the United States because of concerns about “high concentration of metal ions” in the blood of patients who received it, do you think that information was passed on to other markets? No…
To make matters worse, the head of DePuy’s orthopedic unit, Andrew Ekdahl, oversaw the introduction of the hip and was warned by a company consultant in 2008 that the implant appeared to have a design flaw. It wasn’t until 2010 when they decided to recall the product and announced a program in which it offered to pay the medical costs of a replacement procedure. All-metal replacement hips like the A.S.R. were once highly popular with orthopedic surgeons who believed the devices would last longer than traditional replacement devices made of plastic and metal. But the metal devices are rarely used anymore because of their high early failure rates.
Do you think Johnson & Johnson has your best interest?