If there is anything akin to a perfect storm in the medical field, it is the combination of an aging (and sizable) segment of the population, the need and desire for artificial hips and knees to prolong an active lifestyle, and the current practice of the US Food and Drug Administration (FDA) to allow for a pass from intensive testing provided a new medical device is similar to those already on the market. The result can be hip and knee replacement implant failure on a grand scale.
But there is nothing grand about it, as noted Canadian writer and columnist Margaret Wente observes in The Globe & Mail (3/1/13), Canada’s venerable national newspaper. Writing in the first-person, Wente revisits her own journey to regain her mobility with the aid of artificial hips.
Several years ago, in her early 50s, Wente required hip implants. Based on her extensive research at the time, the new age metal-on-metal products manufactured by DePuy Orthopaedics showed much promise, and she underwent hip replacement surgery for both hips, on two separate occasions, to receive the all-metal system.
Wente is quick to point out that unlike others who have experienced problems, and as a result, have filed a hip replacement lawsuit, she is fine. There have been no problems so far.
The writer acknowledges, however, that others have not been as lucky.
Wente tells the story of hip & knee replacement implant failure victim Gloria McSherry, who received a Zimmer Durom Cup hip replacement in 2007. Wente describes the outcome as “a catastrophe” for McSherry, who was once an avid runner. “I just could not get well. I got these incredible episodes of pain where I felt as if it would exit my body,” McSherry is quoted as telling Wente.
McSherry eventually underwent revision surgery and had the problematic hip replacement removed and replaced with one featuring a more traditional design, about three years later.
Wente makes the point that an acceptable failure rate for medical devices is commonly held at about one percent. Compare that with reported failure rates of between 35 and 40 percent in Australia and the UK, and reported failure rates of nearly 40 percent in the US for the DePuy hip replacement system (the manufacturer, according to Wente, claims a failure rate of about 12 or 13 percent). Little wonder that so many hip and knee replacement patients have filed a hip replacement lawsuit.
As have knee implant patients, who have found problems with newly designed artificial knees designed to require less-invasive surgery, and to last longer than more traditional implants. Rather than increased mobility, thanks to these much-lauded marvels of modern engineering, patients are left to fight a knee replacement lawsuit.
The lawsuits are compelling. Johnson & Johnson (J&J), the largest drug and medical device manufacturer in the world with global sales of $65 billion and reported profits of $9.7 billion in 2011, holds DePuy Orthopaedics under its wing. J&J is currently facing in excess of 10,000 hip replacement lawsuits with legal documents, according to Wente, running to 50 million pages.
The first DePuy trial that just ended with a finding for plaintiff Kransky in California has been watched closely. According to the Los Angeles Times (3/8/13), Kransky was awarded $338,136 for his medical bills and $8 for pain and suffering. J&J has signaled it will appeal the jury verdict, even in the face of a “win” of its own - while the jury found Kransky’s DePuy hip to be defective, jurors did not agree that J&J failed to warn doctors about defective DePuy hips and thus did not award punitive damages. Wente, meanwhile, reports that insiders speculate that J&J is in the throes of negotiating (or attempting to negotiate) settlements in 10,750 cases that may cost the pharmaceutical and medical device juggernaut $2 billion, “a sum that will barely dent its profits,” Went writes.
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Wente herself received the DePuy hip resurfacing system, which was never approved in the US but was approved in Canada and other countries.
As for Gloria McSherry, who is participating in a hip replacement lawsuit, she told Wente: “My life will never be the same,” she says. “I never dreamed that I could ever have anything like that happen to me.”