New York, NY (PRWEB) February 24, 2012
On Tuesday, the New York Times reported on an August 21, 2009, internal email sent by DePuy Orthopaedics vice president for worldwide clinical affairs Pamela Plouhar to three company executives, including then-president David Floyd, regarding a communication from the U.S. Food and Drug Administration concerning the company’s now-embattled ASR device. The Times has drawn the conclusion that the content of the internal DePuy email “contrast[s] with statements made in recent years by the company, which continued to market the device in Europe (and a related model in the United States) before announcing a recall in 2010.”
DePuy issued a statement on Tuesday (printed in full in the Times piece). “The ASR Hip Resurfacing System was not ‘rejected’ by the U.S. Food and Drug Administration (FDA), nor did the company inappropriately sell it in other countries.” The thrust of the statement is that DePuy’s decision not to pursue further the ability to market in the U.S. its ASR Resurfacing System was based not on the FDA’s nonapproval of the device, but rather on “the declining demand for hip resurfacing.
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—both of which had been approved under the FDA’s less stringent 510(k) process. 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. The ASR devices fail at higher-than-normal rates because the metal components grind together, eroding the implants and poisoning the surrounding tissues and blood stream with cobalt and chromium ions.
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 DePuy Lawsuit Settlement Information Center at http://www.depuysettlement.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.
1259 Veeder Drive
Hewlett NY 11557
(212) 933-9500 (office phone)
(212) 933-9980 (facsimile)