Thursday, July 5, 2012

DePuy Patients Become Complainants

depuy hip replacement lawsuit
About seven years after its release in the world market, DePuy hip implants had been recalled due to its high failure rate. Formal complaints have already been filed by patients who were affected by the defective artificial hip devices. Moreover, a recent study published in the medical journal, Lancet, and funded by the National Joint Registry for England and Wales recommends orthopedists not to utilize all-metal hip devices in their patients. The British Hip Society proposes for an informal all-metal hip replacement ban. Speaking of healthcare system, Rochelle Rottenstein, principal attorney and founder of the Rottenstein Law Group, shared her criticisms on the law, named Medical Device User Act.

DePuy's former endorser has now become one of its latest vocal critics. After receiving the ASR hip resurfacing system in 2004, former British gymnast Penny Brown joined DePuy and became its poster lady. For years, she has been part of DePuy's campaign and has delivered testimonials about how her life was changed after her operation. Roughly five years later in 2009, symptoms of implant failure started to become evident, starting with a severe pain in her groin. As was reported in a Daily Mail article, she regretted both the implant and advocating for them. Brown is now joining a 300-person DePuy hip replacement class action lawsuit.

DePuy Orthopaedics released its ASR XL Acetabular System and the ASR Hip Resurfacing System in 2003. Orthopedic surgeons quickly adopted the all-metal hip implant as renowned personalities root for the device's safety and effectiveness. The device instantly became well-known, even if it wasn't subjected to a premarket trial, because a large number of patients became recipients and famous stars gave assurance of its effectivity and safety. Alongside its popularity are negative criticisms and feedbacks.

Nearly one in three of the patients monitored by the National Joint Registry for England and Wales have reportedly shown signs of implant failure. Approximately 29% of the 2,100 ASR patients monitored by the registry had implant failure in six years. This is higher than the failure rate of other metal-on-metal hip implants, which is 9.5 percent. Additionally, the Australian National Joint Replacement Registry has issued seven reports to DePuy starting in 2007 indicating flaws with the implant. In 2006, the registry had detected a 50% higher-than-normal failure rate in the ASR.

The number of complaints filed by patients who had metal-on-metal hip implants have surged this year, according to the New York Times in an articlepublished in August 2011. More than 5,000 adverse reports had been received by the US Food and Drug Administration since the start of this year. The number is higher when compared to the combined number of the four previous years. Seventy-five percent of the total complaints are against the ASR hip, the New York Times report says.

Responding to negative reports, DePuy has ordered a hip replacement recall on its ASR device. "We're setting the right high bar for the industry in how we're managing the recall," says Michael Mahoney, Johnson & Johnson chairman for medical services. "But it is something that we're continuing to work through."

References:
  • arthritistoday.org/news/asr-depuy-hip-replacement-recall078.php
  • thelancet.com/journals/lancet/article/PIIS0140-6736%2812%2960353-5/fulltext