By 2008, roughly three years after it came on the market, the U.S. Food and Drug Administration (FDA) had already received some 300 complaints about the <"http://www.yourlawyer.com/topics/overview/DePuy-Hip-Implant-Recall-Johnson-and-Johnson">DePuy ASR hip implant. Most complaints concerned early failures that required revision surgeries. It took until 2010 for DePuy to alert physicians about the higher-than-expected failure rate and until late last year for the device maker to issue a recall of the defective devices.
Now, the North Jersey Municipal Employee Benefits Fund, a fund that manages health benefits for 25 northern New Jersey towns, has filed a class action lawsuit against DePuy Orthopaedicsâ€™ parent company, Johnson & Johnson, said Mass Device. The civil suit was filed in U.S. District Court for New Jersey late last week.
The Fund accused the device giant of â€œfraud and unjust enrichmentâ€ and alleged that it was aware of the implantsâ€™ defects and problems, but opted to keep it on the United States market, despite the growing number of complaints, wrote Mass Device.
The fund hopes the court will mandate Johnson & Johnson to cover its members impacted by the DePuy device recall under its stateâ€™s consumer fraud act and also allow defendants to recover damages from the device makerâ€™s “wrongful profits, revenues and benefits to the extent, and in the amount, deemed appropriate by the Court,” said the complaint, quoted Mass Device.
A metal-on-metal device made of chromium and cobalt, the DePuy ASR Hip Implant System consists of a cup implanted into the hip with a ball joint that connects to the leg. In August, DePuy Orthopaedics issued a recall for the ASR XL Acetabular Hip Replacement System after data from the National Joint Registry of England and Wales showed that 1 out of 8 patients (12%-13%) who had received the devices had to undergo revision surgery within five years of receiving the surgery. Since, other data suggests that the failure rate is actually as high as 49 percent.
A hip implant should last for roughly 15 years, but many DePuy ASR hip implant recipients have had to undergo new surgeries just a few years after implantation.
The DePuy ASR hip implant was approved by the FDA via the 510(K) process. As weâ€™ve reported in the past, this process allows a manufacturer to obtain market approval with very little clinical testing of the deviceâ€”including no human testingâ€”if a manufacturer can prove the device is â€œsubstantially similarâ€ to another product already on the market.
The 510(k) approval process has received a great deal of criticism in recent years. In fact, shortly after the DePuy hip implant recall was issued, an internal FDA review found numerous flaws with the process. Just this past February, a study published in the Archives of Internal Medicine said most high risk medical device recalls over the past five years involved products subject to the streamlined 510(K) process.
Lawsuits continue to be filed nationwide and globally with accusations that include, said Mass Device, that DePuy produced a defective medical device; that DePuy neglected to warn patients and physicians of problems with the device, even after being made aware of the problems; design negligence; and being negligent in how it produced and sold the device.