San Diego, CA (PRWEB) November 22, 2013
Resource4thePeople today announced a clarification of the services being offered involving recent developments in litigation involving allegations of defective products manufactured by DePuy Orthopaedics that have both been the subject of Class 1 Recalls by the U.S. Food and Drug Administration.
“There have been recent media reports* involving a $4 billion settlement by Johnson & Johnson of thousands of lawsuits against its subsidiary, DePuy Orthopaedics, involving metal-on-metal hip implants that has caused confusion among the consumer inquiries we have been receiving,” said Resource4thePeople.
“To provide complete clarification, this proposed settlement does not in any way affect any consumer claim involving allegations over the DePuy Orthopaedics knee sleeve, which is a completely different product.
“Our lawyers are still offering free consultations to any consumer who is seeking information about what legal options may be available to seek compensation for medical costs, pain and suffering and other expenses caused by allegations of a defective DePuy knee sleeve.”
The proposed $4 billion settlement involves over 8,000 lawsuits** grouped together in a multidistrict litigation being overseen by a U.S. District Court judge in the Northern District of Ohio over claims that the DePuy ASR metal hip system was defectively designed.
The DePuy ASR metal hip implant system was the subject of an Aug. 24, 2010 Class 1 Recall*** by the FDA and the DePuy LPS Diaphyseal Sleeve was the subject of a Feb. 15, 2013 Class 1 Recall**** by the FDA.
“Some of the consumer confusion may have occurred because both DePuy products were the subject of similar Class 1 Recalls, which are the most serious issued by the FDA,” said Resource4thePeople.
“Any consumer affected by the concerns raised in these recalls is welcome to contact us for a free consultation in which the specifics of the allegations involving two different products will be explained.”
The FDA provided the following details in its recall notice involving the DePuy knee sleeve:
"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. 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."
Resource4thePeople notes that the FDA describes Class I recalls such as those issued for the DePuy knee sleeve as 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.
"We urge any consumers who have suffered any of the following medical conditions allegedly as a result of an operation involving a DePuy knee sleeve to take advantage of our complimentary consultations," said Resource4thePeople.
Here is a partial list of the conditions being investigated:
Possible loss of limb
Decreased range of motion
Lengthening or shortening of leg
Shifts in the positioning of the device
Loosening, bending, cracking, fracture, deformation or wear of one or more of the components
Resource4thePeople also has updated its consumer information resource center in which details of the FDA recall and other important information about allegations involving the DePuy LPS Diaphyseal Knee Sleeve are now posted.
These details also include types of knee sleeve failures, symptoms and other important information for consumers who may have been affected by the concerns raised in the FDA recall, said Resource4thePeople.
"We also are encouraging all consumers considering a knee operation or those who have had a DePuy knee sleeve implanted to completely familiarize themselves with what the FDA considers life-threatening concerns."
In the recall notice the FDA said it had notified health care professionals of the Class I Recall of the LPS Diaphyseal Sleeve.
The FDA said it had, at the time of the recall, received a total of 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.
The FDA said the affected devices were manufactured from 2008 to July 20, 2012.
"Medications and medical devices are constantly under scrutiny from the FDA, which is acting in the interests of consumers and any health concerns, such as a Class 1 recall, should be taken seriously and all consumers should fully inform themselves of the dangers," said Resource4thePeople.
FDA officials warned in their knee sleeve recall that health complications as drastic as death could occur if the device malfunctions.
“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 DePuy Orthopaedics LPS Diaphyseal Knee Sleeve is described by the manufacturer as an end-stage revision knee device used in numerous operations by surgeons 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 re: DePuy Orthopaedics Inc., ASR Hip Implant Products Liability Litigation, MDL-2197, U.S. District Court for the Northern District of Ohio