|Johnson & Johnson's ASR all-metal hip implant--Courtesy of Johnson & Johnson|
Johnson & Johnson's ($JNJ) DePuy unit has faced plenty of pushback the past few years over its all-metal hip implants, with patients suing the company for alleged design defects causing pain and injury. Now the company is in the hot seat again, and this time, it's for manufacturing problems in the U.K. linked to the devices.
The company said that there was an "error in the measuring techniques" at a factory in Yorkshire that makes its metal-on-metal hip implants, The Telegraph reports, which could have triggered serious side effects in patients. DePuy is not saying when it uncovered the problem or how it responded to the issues.
But sources close to the company and documents show that senior employees have known about the manufacturing problems for years. In 2008, DePuy uncovered a "size" issue related to the manufacture of its Ultamet metal-on-metal hip liner and investigated the problem, according to the Telegraph story. The issue cropped up because the parts for the liner were measured when they were hot and at a different size than at room temperature, the company said.
DePuy then found that there were no safety issues and removed the "equipment causing the issue" from the manufacturing line, the company said in documents seen by The Telegraph. Still, DePuy is not saying when it removed the equipment in question. And other implants may have been affected, the newspaper points out. A senior member of the company's U.K. manufacturing team sent a spreadsheet pointing to manufacturing defects in the ASR version of the hip implant, which was pulled from the market in the U.K. in 2010.
This is not the first time DePuy has come under fire for issues tied to its all-metal hip implants. In 2011, the FDA flagged manufacturing problems for the devices and said that the products should be reviewed. In 2013, the agency rolled out more stringent regulations for metal-on-metal hip implants, which prompted J&J to stop selling its related devices.
Meanwhile, the company continues to deal with suits from patients who claim that the company's hip implants caused dislocations and pain, and in some cases, removal surgeries. Last February, J&J said it would fork over up to $420 million to resolve suits regarding its recalled hip implants, adding to a previous $2.5 billion legal stockpile to settle almost all of its existing hip-implant suits.
- read The Telegraph story