DePuy Cited By The FDA For Illegally Manufacturing Hip Implants Without Prior Approval
We have an active DePuy Orthopaedics defective hip recall law practice here at The Beasley Firm, and so we closely follow all of the developments relating to those systems. On December 8, 2011, the Food and Drug Administration served DePuy Orthopaedics, a division of Johnson & Johnson, with a warning letter citing the company for manufacturing and distributing multiple medical implants - ranging from ankle prosthesis to hip cups, femoral heads, and hip arthroplasty systems - without any sort of a pre-market approval whatsoever from the FDA.
DePuy argued that they did not need any sort of pre-market approval ("PMA") for these devices, which can only be implanted through invasive surgery, because the devices were each "custom made" for individual patients. The FDA rejected that argument, and pointed out that the implants were by and large all the exact same design, with only minor modifications for each patient.
Ironically, the FDA requirements in place for pre-market approval of medical implants like the DePuy ASR acetabular cup system are not particularly stringent. The FDA's 510(k) loophole allows medical device manufacturers like DePuy Orthopaedics to sell implants that have not undergone any sort of safety testing whatsoever so long as the company can make an argument that the implants are similar to other medical devices which have been approved.
To ensure patient safety, we oppose this dangerous loophole, and we're not alone: the Institute of Medicine has previously recommended to Congress that the loophole be closed. Nonetheless, it is telling that, even under minimal federal requirements, Johnson & Johnson and DePuy Orthopaedics feel emboldened to skirt safety regulations, despite the recall of nearly 100,000 ASR and Pinnacle hip implant systems. This revelation comes not too long after a federal court ordered DePuy to stop damaging or altering implants lawsuits removed from patients as part of its defense to the lawsuits.
The Beasley Firm's hip implant defect lawyers have devoted decades to successfully representing the rights of injured patients against some of the world's largest businesses and corporations, resulting in over $2 billion in verdicts and settlements. The minimal assistance Broadspire offers DePuy patients only covers, at most, the medical bills, but our experienced lawyers can ensure your legal right to compensation for future health risks, lost wages, pain, and reduced quality of life is enforced. If you or a loved one has a DePuy hip replacement implant and has started to experience symptoms like pain, or if your physician has recommended your undergo a replacement surgery, contact our DePuy hip recall lawyers, nurses, and doctors for a confidential and free consultation.