San Diego, CA (PRWEB) May 05, 2013
Resource4thePeople announced today that its national team of attorneys is now reviewing lawsuits on behalf of consumers who allegedly suffered serious health problems as a result of the use of a DePuy knee sleeve.
The announcement comes after the U.S. Food and Drug Administration issued a Class 1 Recall of the DePuy Orthopaedics LPS Diaphyseal Knee Sleeve with a warning* that the failure of the device could have life-threatening consequences.
The FDA used strong language in announcing its “Reason for Recall,” including a warning that health complications as drastic as death could occur if this device malfunctions, said Resource4thePeople.
“The LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients,” the FDA said in its warning.
“This may result in fracture of the sleeve at the taper joint which may also lead to loss of function or loss of limb, infection, compromised soft tissue or death.”
The FDA issued the warning on Feb. 22, 2013.
“Our experienced, aggressive lawyers are now investigating claims from families who may have been affected by this product, which, according to the FDA, can have life-threatening side effects when it fails,” said Resource4thePeople.
“This is the most serious type of recall by FDA regulators and patients who may have suffered these dangerous side effects should also be aware that they may have legal rights to seek compensation in this situation.”
Resource4thePeople said its national network of lawyers are now offering free consultations to consumers who may have been affected by alleged DePuy knee sleeve side effects.
The consultations may provide consumers with information about the legal options they may be entitled to in seeking compensation for medical costs, pain and suffering, loss of wages and other costs that may have been incurred.
The DePuy Orthopaedics LPS Diaphyseal Knee Sleeve is described by the manufacturer as an end-stage revision knee device that has been used in numerous operations by surgeons who are reconstructing severe soft tissue and bony defects. The diaphyseal sleeve is intended to enhance the fit and fill of the diaphyseal femoral canal with femoral and tibial replacements.
In an urgent notification to health care professionals and consumers, the FDA issued the Class 1 Recall of the DePuy Orthopaedics LPS Diaphyseal Knee Sleeve.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
The FDA said in its announcement that the LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients.
The FDA said it acted after receiving 10 reports (6 fractures and 4 reports of loosening that may or may not be attributed to the same device design issue) of incidents in which the device has malfunctioned.
DePuy has informed the FDA that the affected devices were manufactured from 2008 to July 20, 2012 and that it has recommended that hospitals and surgeons immediately stop distributing or using the recalled lots.
Resource4thePeople attorneys are investigating the following side effects that DePuy has identified as adverse events in connection with the use of the DePuy knee sleeve with the DePuy Limb Preservation System:**
"Some of the most common adverse events associated with the device include a change in the position of the components, loosening, bending, cracking, fracture, deformation or wear of components, fatigue fractions, infection, tissue reaction to wear debris, pain, dislocation, decreased range of motion and loss of limb."
“Patients and health care professionals place their trust in the integrity of medical devices but on some occasions these devices can malfunction,” said Resource4thePeople.
“In such cases consumers or loved ones who may have been injured as a result of a failed or recalled device should know that there are legal options available to them to seek compensation and we will actively update them about their legal rights and future developments affecting this product.”
Resource4thePeople also notes that the DePuy knee sleeves are not the first medical products manufactured by DePuy Orthopaedics that have been the subject of massive recalls and numerous lawsuits on behalf of patients injured by those products.
DePuy recalled** thousands of its metal-on-metal hip implant systems in 2010 and thousands of DePuy metal-on-metal hip implant lawsuits have been filed by patients alleging injuries in a federal court system multi-district litigation.****
Bloomberg News, in a Jan. 18, 2013 analysis***** of the litigation, said that DePuy’s parent company, Johnson & Johnson is defending itself against more than 10,000 lawsuits over the recalled hip implants and may face over $2 billion in legal costs.
“In 2010, J&J recalled 93,000 all-metal hips worldwide, including 37,000 in the U.S., saying more than 12 percent failed within five years,” said Bloomberg. “Patients who sued contend they suffer pain and are immobilized by joint dislocations, infections and bone fractures. They alleged metal debris from the hips causes tissue death around the joints.”
*http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm340708.htm Feb. 22, 2013
**** DePuy Orthopaedics Multidistrict Litigation # MDL 2197 U.S. District Court, Northern District of Ohio