Artificial joints, genuine concerns

-Contra Costa Times

08/11/2008- Millions of people have hobbled into operating rooms hoping to walk out with shiny new artificial knees or hips that would carry them into futures free of pain or disability. In this country alone, orthopedic surgeons place about 1 million artificial hips and knees into American bodies every year.

An artificial joint that's surgically inserted into any human being is a genuinely big deal. Operative procedures and anesthetic risks are involved, as are thousands of health care dollars and time required for patients' post-operative recovery and physical rehabilitation. Great hopes ride upon the success of a joint replacement — the ability to get back to work, to live without pain, to walk, to garden, to sleep through the night, to remain independent in one's home.

Last week, the New York Times published a story about a prestigious orthopedic surgeon who had become suspicious that something was "very wrong" with some of his patients who had received a certain type of hip replacement. There are many joint-replacement products on the market that are manufactured by various medical device manufacturers. This particular product was a joint socket device known as the Durom cup and manufactured by Zimmer Holdings.

The orthopedist claimed that his affected patients experienced severe post-operative pain, and several of them required a second corrective operation. He reported his misgivings about the Durom cup to

Zimmer last year, but no consequences seemed to follow. So he took matters into his own hands, and in April he broadcast his concern about the Zimmer device to his colleagues through a professional organization. Subsequently, he was contacted by other doctors reporting similar experiences with the Durom cup.

This episode sadly prompts the question: Is this kind of happenstance and word-of-mouth the best way for us to learn about faulty medical devices?

Unlike the U.S., some countries — Britain, Norway, Australia, and Sweden — maintain national databases that track what happens to artificial joints and the people who receive them.

If, like them, our country routinely collected outcomes data for a national joint registry, it's likely that patients and surgeons would have been alerted earlier about potential problems with the Zimmer hip cup. This may have spared some patients the heartache and expense of failed operations.

So, why don't we have a national joint registry? As users of nearly half of the worlds' artificial knee and hip products, we're in a position — medically, financially, ethically — of really needing to know what does and doesn't work.

We can start with our beleaguered Food and Drug Administration (FDA), which is responsible for monitoring the safety and efficacy of medical devices like artificial joints. But it hasn't stood up for a national joint registry. It's already overwhelmed, understaffed, and performing poorly in most domains of its responsibility.

Think toxic toy trains from China ... lethal and contaminated heparin imports ... tainted puppy chow ... salmonella stalking the food chain for months ... Vytorin and Vioxx and Ketek ... beef safety disputes.

Still, the worrisome under-performance of the FDA ought to serve as a compelling reason to justify the establishment of a national joint registry. In addition, the Supreme Court's ruling in February that shields medical device manufacturers from personal liability lawsuits involving "FDA-approved" devices makes it seem even less likely that we will be able to hear about faulty devices through the media venues.

Taxpayer funded Medicare — which finances nearly half of the knee and hip devices usage in this country — would seem to have a major interest in avoiding costly surgical failures and joint re-operations. However, though limping along toward insolvency, it recently rejected a proposal from the American Academy of Orthopedics to pilot a national joint registry. Purportedly, it just wasn't in the business of collecting outcomes information. And, although within its purview, it has also declined to make Medicare reimbursements for joint replacements contingent upon mandatory registration of relevant data by medical personnel.

Finally, many critics point the finger at doctors who, unlike the orthopedist in the Times' article, regularly fail to report suspicious or flawed devices to product manufacturers or the FDA. Some say that too many doctors are beholding to device makers who lavish them with lucrative gifts and contracts.

In the end, when it comes to post-market medical device monitoring in the US, we are all witnessing yet another grand failure of a "Don't ask, don't tell" policy.

The estimated costs for maintaining a national joint registry range between $5 million and $10 million annually. That's a lot of money, and no one wants to be out on a limb paying for it. But the cost shrinks considerably when you compare it to the cost of only a few patients' lawsuits over a device manufacturer's foot-dragging on product safety allegations.

It shrinks further when you add to this the cost of re-hospitalizations, make-up surgeries, patient discomfort and disability.

Here's another perspective on registry costs. Last year, four artificial knee and hip manufacturers — including Zimmer — agreed to pay total penalties of $310 million to settle federal allegations against them.

The Department of Justice accused them of funneling monetary kickbacks and fake consulting contracts to surgeons to persuade them to use their products. In addition, to avoid criminal prosecution on the charges, each device manufacturer had to pay a consulting firm to monitor their compliance with the law over an 18-month period. Zimmer alone is expected to pay out $28 million to $52 million for its consulting contract.

Clearly, these penalty fees alone — representing only a portion of the unknown total — could have financed 36 to 72 years of a national joint registry.

In the midst of all this absurdity, I am reminded of that contented older woman on a swing who was featured in Zimmer's Time and Newsweek ads for hip surgery. Unlike her, I am not so happy that hip operations are advertised and marketed by Madison Avenue.

I wonder how much she will pay in cost markup for her new hip to compensate for the device manufacturer's litigation, penalty, alleged kickback, and marketing fees. I want to run to her sunny playground, hold her swing steady, and warn her about the world off the page in which she blissfully swings. As a matter of genuine respect, she deserves to know.

If you or a loved one have suffered or been injured from a defective Zimmer Duron Cup Hip Implant you may be entitled to compensation. Contact the Zimmer Hip Implant attorneys of Ennis & Ennis today for a free confidential case evaluation. Our on staff nurse and lawyers are standing by to answer any questions you may have regarding the Zimmer Hip Implants, a possible Zimmer class action lawsuit, or any other type of Zimmer hip implant litigation.