New York (PRWEB) January 30, 2012
The U.S. Food and Drug Administration (FDA) has released a warning letter recently sent to DePuy Orthopaedics, in which the federal agency identified fourteen devices and device components being manufactured at the company’s Warsaw, Indiana location as “adulterated” under applicable regulations because DePuy does not have approved applications for premarket approval (PMA) in effect or approved applications for investigational device exemptions (IDE). That is, the enumerated devices have no premarket clearance or approval, or have been modified in ways that could impact the safety and effectiveness of the devices, therefore requiring separate evaluation before they may be sold.
“Your firm should take prompt action to correct the violations addressed in this letter,” the FDA warns. “Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the awarding of contracts.”
The FDA letter can be viewed here.
In August of 2010, DePuy, a subsidiary of Johnson & Johnson, announced a global recall of its ASR Hip Resurfacing System and ASR XL Acetabular System. 93,000 persons worldwide had an ASR device implanted before the recall, according to data published by DePuy itself. DePuy recalled its ASR devices after the National Joint Registry of England and Wales made public data showing that, within five years, about 12% of recipients of the hip resurfacing system and about 13% of recipients of the acetabular system needed corrective surgery, as reported by the New York Times.
Rochelle Rottenstein, principal of the Rottenstein Law Group, says, “We implore anyone with a friend or relative who has received a hip replacement device since 2003 to reach out to that person and recommend that he or she consult a physician immediately and then speak to a qualified personal injury lawyer.”
The Rottenstein Law Group maintains a Hip Replacement Recall Information Center at http://www.hiprecalllaw.com. The site has features that allow for easy sharing, including links for automatic posting on Facebook and Twitter, specifically to enable visitors to spread the word about the DePuy ASR recall.
About THE ROTTENSTEIN LAW GROUP
The Rottenstein Law Group is a New York-based law firm that represents clients in mass tort actions. The firm was founded by Rochelle Rottenstein, who has more than two decades of experience as a lawyer, to represent clients hurt by defective medical devices. http://www.rotlaw.com
The Rottenstein Law Group LLP
Rochelle Rottenstein, Esq.
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