Johnson & Johnson executives decided to phase out a replacement hip joint and sell its remaining inventory to be surgically implanted in patients just weeks after the company got a letter from the Food and Drug Administration about serious safety concerns with the devices.
The Times cites documents it attained under the Freedom of Information Act.
A report in the New York Times says that after receiving the letter, company executives waited a year to take the DePuy hip implants off the market via a recall. Thousands of patients now claim they’ve suffered debilitating injuries as a result.
The report deals with two related models of hip implant. DePuy Orthopaedics, a division of Johnson & Johnson, marketed one of the models in other countries despite the fact that the FDA refused to approve it in the United States because of its high early failure rate. The other model – approved in the U.S. under an FDA loophole despite the fact that it was never safety tested in humans – proved to have an even higher failure rate in subsequent years than the one the FDA rejected, the New York Times reports.
In an eight-year period, about 93,000 patients worldwide received the implants, with about 30,000 in America. Not only is there a high rate of premature failure, but also numerous reports that metallic particles break off from the DePuy implants as the metal-on-metal components wear, and cause crippling side effects and injuries.
Contact Lopez McHugh for a free case evaluation if you received a DePuy Orthopaedics hip implant and experienced complications.
See the article here: https://www.nytimes.com/2012/03/23/business/fda-asked-depuy-for-safety-data-just-before-hip-implants-phaseout.html