In 2010, Johnson & Johnson recalled an all-metal hip implant device because of a high failure rate and because the grinding of its components released tiny bits of metal that damaged tissue and bone. The company conducted an internal review of the device in 2011 that showed the implant would fail within five years in about 4 in 10 patients.
Only now, as reported by the New York Times, is that information coming to light.
J&J’s report is among hundreds of internal company documents, says The Times, expected to become public as the first of more than 10,000 lawsuits by patients who got the implant, the Articular Surface Replacement (ASR), went to trial yesterday.
Hip implants made of metal and plastic instead of the metal-on-metal design of the ASR often last for 15 years before they wear out, according to The Times. They can fail prematurely for a variety of reasons, but not at the rate of the recalled device. A premature replacement rate would be about 1 in 100 after a year, and 5 in 100 after five years.
J&J never released the dismal five-year failure results for the ASR. “But at the same time that the medical products giant was performing that analysis,” says The Times, “it was publicly playing down similar findings from a British implant registry about the device’s early failure rate.”
We’ve written about the problematic history of metal-on-metal hip implants, and the new disclosure about hidden company documents once again puts Johnson & Johnson’s DePuy Orthopaedics division in the hot seat: What did company officials know about the device’s problem before its recall? What actions did they take or fail to take?
How many more failures of this shoddy device are about to occur? How many more patients who had the surgery are facing more painful and expensive surgeries to replace it?
As The Times reports, last year J&J took a $3 billion charge so that money could be reserved for patients and lawyers involved in the upcoming product liability lawsuits. DePuy, The Times says, has offered to cover the cost for patients to correct the problems.
That’s nice, but, really, if the company knew of the high potential for such problems and did nothing to address them before they harmed thousands of people, is that really much consolation?
The discovery last week of the internal report is only a tiny bit of what will become public knowledge if the company doesn’t settle, and the lawsuit proceeds to trial. Plaintiffs’ lawyers have been preparing for two years, and who knows what other ugly secrets J&J was protecting.
Approximately 93,000 people around the world have received an ASR; more than 31,000 of them live in the U.S. Some 7,000 separate ASR lawsuits have been consolidated in a federal court in Ohio, and another 2,000, says The Times, have been consolidated in a California state court.
The California case that brought the internal report to light involved a cancer patient who might not live much longer. The paper said DePuy has settled some ASR cases before trial, and it may do so in his.
Cold comfort, indeed. But a testimonial, at least, to the power of lawsuits to unlodge secrets of corporate wrongdoing.