Class I recalls are the most serious type of recall and are linked to situations in which there is reason to believe that use of the recalled devices can cause serious adverse health outcomes.
(PRWEB) February 22, 2013
The U.S. Food and Drug Administration announced on Feb. 22 a Class I recall of the DePuy LPS Diaphyseal Sleeve knee reconstruction device, because of risks of the device potentially fracturing and causing failure, infection and even a loss of limb.* On the heels of the recall, the Rottenstein Law Group announces it is posting information and updates about the LPS on http://www.rotlaw.com/depuy-lps/.
“Physicians and their patients trust that these devices will function properly,” said Rochelle Rottenstein, principal of the Rottenstein Law Group. “When device recipients experience potentially serious side effects, they need to know they have legal options. Class I recalls are the most serious type of recall and are linked to situations in which there is reason to believe that use of the recalled devices can cause serious adverse health outcomes. The risks can even be fatal.”
Earlier this year, DePuy issued an Urgent Medical Device Recall informing surgeons of the problems with the device and to cease use and return to Johnson & Johnson subsidiary DePuy Orthopaedics any remaining lots, according to the FDA announcement.
“DePuy is not recommending revision or additional follow up in the absence of symptoms of patients with this implanted device,” the announcement said. “However, DePuy is encouraging surgeons to communicate with patients who received these implants and discuss the risks of the implant fracture and the method for detecting implant failure if the patient begins experiencing symptoms.”
So far the FDA has received 10 reports of device malfunction (six related to fractures and four reports of loosening), according to the FDA.
The LPS Diaphyseal Sleeve was manufactured between 2008 and the middle of 2012, according to Reuters, which indicated in the same article that DePuy is currently a defendant in many lawsuits across the United States involving the recall of the ASR hip replacement device.**
Failure rates and alleged metal poisoning side-effects have been at the center of an ongoing DePuy ASR trial in Los Angeles, In re: Loren Kransky and Sheryl Kransky v. DePuy, Inc., et al. (BC456086, Los Angeles Superior Court). The ASR was recalled in August 2010. Johnson and Johnson subsidiary DePuy said at the time of the recall that the ASR hip replacement system had a 12 percent failure rate, but an Australian device registry later found that failure rate to be closer to 40 percent, according to Bloomberg.*** There are currently more than 10,000 lawsuits pending against Johnson and Johnson because of the ASR, in federal courts (MDL-2197) and state courts.
About THE ROTTENSTEIN LAW GROUP
The Rottenstein Law Group is a New York-based firm that represents clients nationwide 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. (Attorney advertising. Prior results do not guarantee a similar outcome.)
The Rottenstein Law Group, LLP
Rochelle Rottenstein, Esq.
321 W. 44th Street
New York NY 10036
(212) 933-9500 (office phone)
(212) 933-9980 (facsimile)
rochelle (at) rotlaw (dot) com