Reporting Ginger Allen
FORT WORTH (CBSDFW.COM) – When you think of a manufacturer recall, cars, toys, food or electronics probably come to mind. But, a CBS 11 investigation exposes a recall that involves parts put into a patient’s body during surgeries.
Dee Dee Hill Morgan, a retired probation officer from Fort Worth, had two of those parts implanted in her body. “I was a more active grandmother.”
Morgan has been physically active her entire life. When doctors told her she needed to have her hips replaced, she wanted a quick recovery to get back into her routine. Doctors chose the ASR XL Hip System, a product they say was marketed to the younger, more active patient. Morgan seemed like the perfect candidate.
In March of 2009, she received her first implant, and by the following March, doctors replaced her other hip with the device. “March has not been a good month for me.”
Morgan says she started experiencing bouts of pain, blurred vision and nausea. “It’s frightening. It’s a helpless feeling.”
She says doctors told her that she was poisoned. She says her chromium and cobalt levels were off the charts. Doctors explained that they may have leaked into her blood stream after she had her hips replaced. “It was almost like a metal taste and upset stomach.”
Morgan and her doctors say they did not know the implant had been recalled outside of the United States. DePuy Orthopaedics, Inc. is the manufacturer. DePuy had voluntarily recalled the very same implant in Australia before Morgan had her second implant here in the United States.
“If DePuy had withdrawn here at the same time as Australia, DeeDee would not have had a second hip implant,” says Attorney Dan McDonald of Parker McDonald Trial Lawyers.
McDonald says patients in other parts of the world had been complaining of “component loosening” “metal sensitivity and pain.” He says, in short, metal grinding on metal was sending particles of cobalt and chromium into the blood streams of those who had the implants. “Why in the world would they have left this product in us for nine months when they decided to withdraw it from the Australian market in 2009?” says McDonald.
Attorneys all over the country are now filing lawsuits for patients who have had, or will have to have, total hip replacements again. And now, these lawsuits are exposing more about how hip implants and many more medical devices are getting to the market in the first place.
For 35-years, the Food and Drug Administration has given some products a “fast track pass” to the market. It’s called the 510K rule. The rule allows medical products to go straight to the market without requiring the same testing for efficacy and efficiency that other products must prove. All the manufacturer has to do is prove that the device is “substantially equivalent” to another similar device on the market that has already been deemed safe and effective.
McDonald argues, “It would have been very helpful for DePuy to put this product through clinical trials to see how many early failures and how manty adverse reactions they were going to have to this chromium and cobalt.”
Instead, in 2005, the FDA gave the DePuy ASR™ XL Acetabular System and DePuy ASR™ Hip Resurfacing System clearance because the manufacturer said it was similar to another hip implant on the market.
Dr. Jay Mabrey, Chief of Orthopaedics at Baylor University Medical Center, tells CBS 11 that the “similar” implant has not caused the same problems.
Dr. Mabrey says he understands why the device was given the “fast track pass” years ago, but he now says “that was not the right thing to do and it should have never come before the US market.”
The Institute of Medicine is now asking the FDA to scrap the 510K Medical Device Clearance Process. It published a report this summer urging the FDA to revise its approval policies and to make sure more testing is required for products like the DePuy ASR as well as contact lenses, defibrillators, hospital pumps, artificial hearts, and all other medical devices that qualify for this approval.
Dr. Mabrey says, in retrospect, the 510K process appears to be putting patients at risk in this hip recall case.
“The process is flawed. The Institute of Medicine is right in saying it needs to be changed, to what degree I don’t know, but it needs to be changed.”
Any change comes too late for Dee Dee Morgan. Now, she’s focused on her health and her future.
“I don’t know what the long term effects are…you don’t have control of your own life because that part was snatched away.”
Morgan’s case is one of about two-thousand now headed to court nationwide. Morgan’s will likely be one of the first cases tried.
A spokesperson with the FDA told CBS 11 News that the FDA is now considering all feedback on the IOM’s recommendation in an open forum on the FDA’s website. The medical device makers and associations in favor of keeping the 510K rule in place argue that the 510K rule is needed because patients should not have to wait the normal five-to-ten years to get a product approved that has subtle differences to those on the market.
The FDA is expected to make some decision regarding the status of this three-decade old procedure next year.
CLICK HERE to read the FDA’s public comments and an open forum on the IOM report.
Statement from DePuy Orthopaedics, Inc.
In August 2010, DePuy issued a voluntary recall of the ASR Hip System after receiving new information from the UK National Joint Registry as part of the company’s ongoing surveillance of post-market data concerning the ASR Hip System. DePuy decided it was in the best interests of patients to voluntarily recall the ASR Hip System.
This data showed a five-year revision rate of approximately 12% for the ASR Hip Resurfacing System and approximately 13% for the ASR XL Acetabular System, which was not in line with data previously reported to DePuy.
We understand that this recall is concerning for patients, their family members and surgeons. Since the recall decision was made, DePuy has worked to provide patients and surgeons with the information and support they need.
DePuy is committed to working with patients and their health insurers to address medical costs directly associated with the recall. DePuy will also cover recall-related patient out-of-pocket expenses, such as co-pays, deductible expenses, lost wages and travel costs.
DePuy’s efforts to support ASR patients and their surgeons remain a top priority. Through the ASR Help Line, nearly 30,000 ASR patients have been assisted; the program for reimbursing ASR patients for recall expenses is well-established; and DePuy has provided information and support to surgeons who are treating ASR patients. We encourage ASR patients to visit http://asrrecall.depuy.com and contact the Help Line at 1-888-627-2677 for assistance.
DePuy conducted laboratory testing on the ASR™ XL Acetabular System and DePuy ASR™ Hip Resurfacing System, including tests on simulators that evaluate how the device wears over time, the materials used in the device and device strength. The ASR XL Hip System was cleared for marketing by the U.S. Food and Drug Administration under the 510k regulatory process established by Congress, which is used for a majority of medical devices on the market.
Director, Worldwide Communications
DePuy Orthopaedics, Inc.