January 19, 2012 – The beleaguered Johnson & Johnson subsidiary DePuy Orthopaedics manufactured and marketed more than a dozen different prosthetic hip and knee replacement devices without getting approval from federal regulators, the FDA said in a press release issued this week. According to the administration, DePuy made 14 types of devices that failed to earn pre-market clearance or FDA approval. DePuy has also recently been under fire over its controversial ASR XL Acetabular Hip Replacement System, which was recalled after it had been found to fail in 13% of patients.
DePuy Hip Update 1/23/13: Newly disclosed court documents have revealed that a 2011 internal investigation conducted by Johnson & Johnson on its much-troubled DePuy ASR hip implant estimated that the device would fail within five years in nearly 40% of recipients. For reasons still unclear, the company failed to make this information public while simultaneously downplaying the potential health complications associated with its metal-on-metal hip. Click here to learn more.
Free DePuy Lawsuit Evaluation: If you or a loved one has been injured by a DePuy hip or knee replacement device, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against DePuy and we can help.
What’s the problem?
The FDA press release, which was issued by Steven D. Silverman, director of the office of compliance, was sent on December 8th as the result of an inspection conducted by the administration between May 10th and June 7th, 2011.
In its defense, DePuy claimed that the devices were custom-made, requested by surgeons to match patients’ individual anatomies, thereby being exempt from the approval process. A company spokesperson said that custom medical devices have been exempt from the standard approval process since 1976, and that DePuy firmly believes it has complied with all legal requirements to date.
But the FDA denied the claim, saying the devices failed to meet appropriate criteria, mainly because once the products were completed they could have been made available to other doctors and patients.
“The fact that the final specifications are tailored to match a patient’s anatomy does not preclude a clinical study or submission of a marketing application for the devices,” Silverman wrote.
In addition to the problems plaguing DePuy, New Brunswick-based Johnson & Johnson has seen a number of its other subsidiaries become the target of federal health regulators in recent years.
J&J’s McNeil Consumer Healthcare company shut down one of its Tylenol manufacturing plants in Fort Washington, PA, last year after it recalled millions of bottles of tainted pain relievers. The plant will not be allowed to reopen until FDA officials are convinced the products manufactured there are safe and effective.
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The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in DePuy lawsuits. We are handling individual litigation nationwide and currently accepting new DePuy knee and hip injury cases in all 50 states.
Free DePuy Lawsuit Evaluation: If you or a loved one has been injured by a DePuy knee or hip replacement device, you should contact our law firm immediately. You may be entitled to compensation by filing a DePuy injury suit and we can help.