Rottenstein Law Group Distressed by Further Manufacturing Gaffes of DePuy, as Detailed in FDA Warning Letter
(New York, NY, January 30, 2012) The Rottenstein Law Group, which represents clients with claims stemming from the surgical implantation of hip replacement devices manufactured and sold by DePuy Orthopaedics and other companies, has reviewed with concern, but not surprise, a recent letter sent by the U.S. Food and Drug Administration (FDA) to the embattled company.
The FDA has released a warning letter recently sent to DePuy Orthopaedics, a division of Johnson & Johnson, in which the agency identified fourteen devices and related 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). In other words, the enumerated devices have no premarket clearance or approval, or have been modified in ways that could impact their safety and effectiveness, therefore requiring separate evaluations 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 2010, DePuy announced a global recall of its ASR Hip Resurfacing System and ASR XL Acetabular System. 93,000 patients worldwide had an ASR device implanted before the recall, according to published data provided by DePuy. The company recalled its ASR devices after the National Joint Registry of England and Wales made public data showing that, within five years, about 12 percent of recipients of the hip resurfacing system and about 13 percent of recipients of the acetabular system needed amended surgery, as was reported by the 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 lawyers have a total of more than 25 years of experience fighting for the rights of clients who have suffered harm due to the negligence of powerful corporations. Affected individuals can also stay apprised of the latest developments in the DePuy situation by visiting the DePuy ASR Hip Replacement Lawsuit Information Center. The site is equipped with easy-to-use social media features which will enable users to spread the word about DePuy ASR hip replacement device failures.
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, a lawyer with over two decades of experience in compassionate representation of clients in consumer product injury, mass tort, and class action law suits. For more information, please visit their Web site, or call (888) 9-ROT-LAW.
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