From The Wall Street Journal
About 1,000 lawsuits have been filed in federal and state courts accusing the drug and medical-device maker of knowing about problems with some of its metal-on-metal hip joints before Johnson & Johnson's DePuy Orthopaedics Inc. unit stopped making them in 2009. J&J, which later recalled the joints world-wide, denies the allegations and is fighting back.
J&J recalled its metal-on-metal hip joints last year after British data showed them wearing down or otherwise requiring replacement at unusually high rates. That was the first indication the company had of any flaws in the product, the DePuy spokeswoman said.
Some patients had to undergo risky and expensive surgery to remove and replace the recalled implant—a metal ball and socket designed to replicate a natural hip joint.
J&J estimates that about 37,000 patients in the U.S. and about 93,000 world-wide have received the recalled device. The DePuy spokeswoman said the company will cover the cost of all medical care associated with the device, including replacement surgery.
Some patients who received the recalled hip joint, the so-called articular surface replacement, or ASR, system, say in their lawsuits that medical tests showed chromium and cobalt
in their bloodstreams and allege the potentially toxic metals came from parts of the joint wearing down and leaching into their system.
Though the DePuy spokeswoman said the recalled joints contain cobalt and chromium, she said it wasn't clear whether the devices contributed to elevated levels of those metals in patients' blood or how many patients might have this problem.
In May, the FDA said particles from the metal-on-metal hip joints, such as cobalt and chromium, might wear off and make their way into a patient's blood. The agency said this could contribute to heavy concentrations of cobalt and chromium in the body but it wasn't clear if that would cause symptoms—such as trouble seeing and diseased heart muscle—that had been reported by a "small number" of those who received the joints. To better understand potential health effects, the FDA ordered J&J and other makers of the metal-on-metal joints to monitor the devices for possible health risks.