Dr. Lawrence Dorr is a nationally known orthopedic surgeon and founder of the Dorr Arthritis Institute in Los Angeles.
He has performed roughly 5,000 hip replacement surgeries over his 30 year career. But last year, Dr. Dorr noticed problems with routine hip replacement surgery.
Surgery using the Durom cup, a metal artificial hip socket made by Zimmer Holdings, was causing extreme agony in his patients as the hip rubbed against the bone instead of fusing with it.
10 out of the 165 Durom hip systems he implanted had to be removed and replaced. Instead of lasting 15 to 20 years, the devices had to be removed after three to six months.
Dr. Dorr, a “consultant” for Zimmer, began asking around and found colleagues with similar negative experiences with the Zimmer joint.
“I saw one of Zimmer’s engineers at a meeting, and I told her that you should pull this cup because you are crippling patients,” Dr. Dorr said to the New York Times.
Now Zimmer has now done just that.
Last week, Zimmer, based in Warsaw, Indiana, announced it was suspending marking and distribution of the Durom Cup. Surgeons are receiving letters from the company advising them to stop implanting the medical device.
Zimmer admits that some U.S. surgeons may need better training and the label on the product needs to be updated.
The company in a withdrawal announcement, says it plans to “provide more detailed surgical technique instructions to surgeons and implements its surgical training program in the U.S. The Durom Cup will continue to be marketed outside of the U.S. where Europeans have enjoyed “excellent clinical outcomes since the product launched in 2003.”
Patients are being given an 800-number to report any concerns and problems, though the company believes that a “low” percentage of the 13,000 who’ve received the socket will need replacement.
Zimmer hopes to remarket the device by 2009.
The move has cost the company about $20 to $30 million and could open the company to defective product litigation. Not that it hasn’t faced that before.
While Zimmer representatives would not talk to IB News about this topic, Zimmer has successfully argued a blanket immunity defense used by many medical device makers.
It’s called federal pre-emption. Since the FDA oversees and conducts pre-market review of a devices design and label and okays the device for the market, the manufacturer is protected from lawsuits filed in state courts.
Stephen Sheller, of Sheller P.C., a Philadelphia lawyer who handles defective drug and medical device cases (and an IB member), predicts if litigation results from the Durom Cup withdrawal, Zimmer’s admission may preclude a pre-emption argument.
“The company says the fact is that the reason the problem is occurring is that doctors are not adequately trained by the Zimmer people on how to use product,” he tells IB News. “The complaint could be negligent training and a failure to train doctors properly, not the medical device per se. The doctor is not necessarily at fault. It takes it out of pre-emption.”
Litigation or not, how is a consumer to know if an artificial hip or knee is causing problems and has to be replaced in patients?
If you live in countries such as Australia, Britain, Norway and Sweden, Zimmer may have had to pull the controversial hip socket before 13,000 were implanted, and consumers and doctors would have access to that information.
Those countries track problems with artificial joints in a national data registry, called a joint registry. Not so in the U.S.
While this country tracks automobiles, trademarks, voters, refrigerators, domain names, clinical trials, and even, occasionally – sex offenders – the U.S. lacks a federal registry to monitor artificial joints.
Elsewhere, a registry works like this – a patient number is matched with information on the device, including the manufacturer, the surgeon who implanted it and the outcome of the procedure.
A registry could potentially police poor performing artificial hips and knees. Their manufacturers would have to justify their continuation on the market.
As it stands now - for the roughly one million U.S. patients who need artificial hips or knees - the lack of oversight that ultimately shields manufacturers at the expense of consumers, means patients have roughly double the risk of a problematic replacement procedure, whether with the device or the surgical technique, Dr. Henrik Malchau of Massachusetts General Hospital tells the New York Times.
Who would oversee the registry?
The Food and Drug Administration (FDA) could oversee such a federal registry but - as the recent search for the elusive salmonella tomato highlighted- the agency has its plate full trying to regulate 80 percent of the food Americans eat and all of the prescription drugs we take.
Medicare has the incentive to oversee a federal registry, saving billions in procedures that need to be repeated. And patients would be saved from enduring the pain and suffering associated with having an artificial hip or knee removed and replaced.
In Sweden, where a federal registry exists, doctors knew there was a problem with the Sulzer Orthopedics artificial hip after 30 patients experienced complications. In the U.S., Sulzer took six months to withdraw the device after Dr. Dorr’s patients began experiencing problems, but not before 3,000 patients had the procedure.
Earlier this year when Zimmer began investigating complaints about the Durom Cup failures, because there is no federal registry the company had to go through 1,300 patient records.
Meanwhile 1,300 new patients had the procedure.
At an estimated $5 to $10 million annually, the cost of a federal registry is far less than the cost of settling lawsuits.
Last year, Zimmer was among five medical device companies that agreed to pay $310 million to avoid criminal charges and to settle civil charges resulting from a Department of Justice investigation into doctor kickbacks.
The investigation, from 2002 to 2006, found that orthopedic surgeons were paid “exorbitant” amounts (tens to hundreds of thousands of dollars) and were given trips to be consultants and to use their products exclusively.
Zimmer paid more than $1 million to 21 consultants in 2007, according to Bloomberg News. The company paid $169.5 million and was to be monitored (by former U.S. Attorney General John Ashcroft).
Zimmer did not admit any wrongdoing.
Today, Zimmer and the other manufacturers are paying lawyers tens of millions to ensure compliance.
“We could have used some of that money for a registry,” Dr. Malchau tells the New York Times.
The hip and knee replacement business generated about $9.7 billion worldwide in 2007, according to one analyst speaking to Bloomberg News.
Zimmer’s 2007 sales of orthopaedic, spinal and trauma devices, dental implants, and orthopaedic surgical products in more than 25 companies totaled approximately $3.9 billion, according to a company statement.
There were 220,000 total hip replacements performed in the United States in 2003 according to CDC statistics. 60% are performed on women and two-thirds are older than age 65.
Replacement is done to relieve the pain and degeneration in the hip due to arthritis or trauma. #