Implanted Artificial Knees Hips Causing Significant Problems

This is the next of a series of columns on how the law can impact your life. Each month we will focus on various aspects of the law relating to personal injuries, those that happen both on-the-job and otherwise, including mishaps which occur in driving vehicles, using products and receiving medical care. The column will also respond to legal questions relating to personal injury that are sent to us.

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IMPLANTED ARTIFICIAL KNEES & HIPS CAUSING SIGNIFICANT PROBLEMS

As the baby-boomer generation advances in age, they are more likely to become artificial joint replacement candidates. Knee and hip replacements are the most common and have been the subject of recent controversy and litigation. Now, not only do joint replacement patients need to be concerned with working towards a healthy recovery after the implant surgery, they may now need to be concerned with faulty implants in their bodies.

THE STORY OF A SURGEON VS. IMPLANT MANUFACTURER

A prominent Chicago orthopaedic surgeon installed a certain manufacturer's artificial knees into patients for more than a decade. He helped the manufacturer design joint implants and the surgical tools used to install them. He also trained surgeons across the country to use this particular manufacturer's implants. The manufacturer promoted and praised this surgeon. The surgeon talked up the manufacturer's products. The two had a thriving relationship. But when the surgeon started noticing defects in the manufacturer's knee implants, he alerted the manufacturer of his findings; in turn, the manufacturer blamed any failure of the implants on the surgeon's technique.

Because the manufacturer would not heed the surgeon's concerns, the surgeon conducted and published a study demonstrating the defect in the knee replacement. The study showed that over 8% of the knee implants were failing. Again, the manufacturer responded by questioning the surgeon's techniques, not its own product. The manufacturer then conducted its own studies on this knee implant and concluded, arguably self-servingly, that it was indeed a safe product.

The once prosperous association between this Chicago surgeon and the implant manufacturer culminated into a not-so-amicable separation.

A MANUFACTURER'S CONDUCT IN A RECENT HIP IMPLANT RECALL

Hip replacement surgery is fairly common in the U.S. Studies have shown that 90% of hip replacements are considered successful. However, a certain manufacturer, DePuy Companies, recently recalled its ASR hip implant system due to defects.

In 2003 DePuy released its ASR hip implant system, marketing it as unique in that it was a metal-on-metal design. The design was intended to last longer and provide more natural movement in the hip socket. However, the ASR hip implant did not live up to its intended design. The prosthetic "cup" was too shallow, making it susceptible to "edge loading," a process where the joint's ball rubs up against the cups edge, chiseling off metallic debris.

The wearing away of the metal-on-metal condition creates a situation where metal debris is released into the body, causing a dangerous condition known as metallosis. Metallosis can destroy surrounding bone and tissue as well as increase the difficulty of a subsequent surgery to revise the implant. All the residual effects of metallosis are still yet unknown.

In March 2010, DuPuy issued a notice to surgeons in the United States that the ASR hip implant had a higher than expected failure rate. However, even more concerning, these notices to U.S. surgeons came months after DuPuy voluntarily withdrew the same ASR hip implant from the Australian market. DuPuy continued to market and sell the ASR hip implant in the United States for approximately six months after the Australian withdrawal finally recalling the ASR device in the U.S. in August 2010.

Estimates indicate that over 90,000 worldwide were implanted with this ASR hip system. DuPuy has since conceded that at least 13% of these patients will experience an implant failure and will require revision surgery. Studies conducted by others indicate that as many as 30% of the patients may experience this product failure.

Unfortunately, these revision procedures will be performed most predominantly on the elderly population, who are more susceptible to surgical complications such as infections, deep vein thrombosis, femur fractures, continued pain and suffering, and, of course, the incurring of significant future medical expenses.

GOVERNMENT OVERSIGHT, OR LACK THEREOF?

Of concern is that the DuPuy's ASR hip received Food and Drug Administration (FDA) approval. There is a loop hole in the FDA approval process whereby when a manufacturer submits a new medical device that is "substantially equivalent" to a medical device already on the market, no clinical trials are required and the new medical device is automatically approved.

It is disturbing to know that many artificial joints, including the ones subject to recent controversy, were cleared by the FDA without comprehensive testing.

Manufacturers can initiate their own recalls. However, when medical device manufacturers fail to act responsibly and regulators fail to hold them accountable, it falls on the patient and the public to file complaints to ensure these defective products don't harm more people in the future.

If you have any questions regarding medical implants, feel free to contact our offices.

BY: MATTHEW J. HEALY