HAS YOUR HIP BEEN RECALLED?
DePuy Orthopaedics, a subsidiary of Johnson & Johnson, has recalled its ASR XL ACETABULAR SYSTEM and ASR HIP RESURFACING SYSTEM. But evidence shows that the company was aware of the problem for over two years before taking any action.
What went wrong?
ASR is introduced in the U.S. after J&J and DePuy get special permission from the FDA to skip clinical trials and begin selling the devices right away. Many orthopedic doctors believe that the companies knew their device was flawed from the start.
A report to the Medicines and Healthcare products Regulatory Agency (the British equivalent of the FDA) finds “evidence of genetic damage in patients with certain metal hip implants” (such as the ASR system).
The FDA receives approximately400 individual complaints from patients who received ASR hip replacements.
DePuy voluntarily withdraws the ASR system from the Australian market.
J&J/DePuy announce that they will phase out sales of the ASR hip replacement system by the end of the year, and sends letters to doctors warning of the devices’ high early failure rate.
March 10, 2010
The New York Times
The New York Times reports that DePuy sent letters warning that data from the Australian Medical Device Registry show a higher-than-expected failure rate of the ASR system within just a few years of surgery, and especially in smaller patients or those with weak bones. Some people consider this a “silent recall.”
The London Times reports: “Doctors are warning that metal debris originating from the defective implants can cause non-cancerous tumors, severe swelling and sinew damage.”
A Florida woman files the first lawsuit against DePuy for harm caused by the ASR system. The federal suit claims that the woman received a DePuy ASR acetabular cup in March 2008 and began experiencing “extreme weakness in her hip and quadriceps” following surgery. Less than one year later, she required a second surgery, during which doctors found that the device had catastrophically failed.
The FDA notifies the public that DePuy is recalling its ASR hip implant cups.
J&J/DePuy issues a worldwide recall of both the ASR Hip Resurfacing System and the ASR XL Acetabular System.
What’s the problem?
Each ASR device replaces a worn or weakened part of the hip, which consists of a socket and a rounded bone that fits into that socket like a ball.
The ASR can fail by becoming loose …
… fracturing the bone around the implant …
… dislocating the implant’s ball and socket.
ASR devices can cause swelling, pain, difficulty walking and possibly pseudotumors.
Metal particles can flake off the ASR and enter the bloodstream, causing:
ALVAL (aseptic lymphocyte-dominated vasculitis associated lesion)
- adverse tissue reaction to metal particles and ions that have chipped off and been absorbed into the bloodstream.
WOMEN are especially susceptible to these problems.
is just another term for a second surgery. The recall means that patients who have already undergone one surgical procedure to replace a hip now must undergo another.
13% of patients require a second surgery to replace their failed artificial hip within five years of receiving an ASR device — which is much higher than the industry standard failure rate of 3%.
Typically, replacement hips are expected to last three times as long — 15 years or more.
What took so long?
J&J knew its device was faulty in 2008. Why did it take two years to issue a worldwide recall?
J&J and DePuy were selling what they knew were malfunctioning and dangerous implants to people hoping for a quick and relatively painless recovery back to a normal life. The companies netted billions of dollars during a time when reports — and even the manufacturers themselves — were warning doctors of the products’ risks.
Who has a case?
If you received an ASR device manufactured by J&J/DePuy, you might have a case against the manufacturers.
Although J&J has announced that it intends to assist recipients of the recalled devices and pay for the costs of doctor visits, tests, and procedures associated with the recall, you might have suffered harm that the manufacturer is not volunteering to compensate you for. To recover damages, you might need to sue. The amount of your potential monetary recovery will relate to the severity of your harm.
Damages (a money award) can include compensation for your actual medical costs (including expected future costs), lost earnings, and pain and suffering.