NEW YORK, Aug. 24, 2011 /PRNewswire/ -- The Rottenstein Law Group, which represents clients with claims stemming from the surgical implantation of hip replacement devices manufactured and sold by DePuy Orthopaedics, a subsidiary of Johnson & Johnson, notes with some concern evidence of a groundswell of grievances stemming from the early failures and other dangers of hip replacement devices and systems.
According to an August 23, 2011, New York Times article, the federal government "has received a surge in complaints in recent months about failed hip replacement [devices], suggesting that serious problems persist with some types of artificial hip even as researchers scramble to evaluate the health dangers."
The Times reportedly performed its own analysis of data accumulated by the U.S. Food and Drug Administration (FDA), which had since January received more than 5,000 reports about "several widely used devices known as metal-on-metal hips." That number is "more than the agency had received about those devices in the previous four years combined."
And the "vast majority" of those reports received by the FDA "appear to [have come from] patients who have had an all-metal hip removed, or [who] will soon undergo such a procedure because a device failed after only a few years; typically, replacement hips last 15 years or more," according to the Times piece.
The mounting complaints "confirm what many experts have feared -- that all-metal replacement hips are on a trajectory to become the biggest and most costly medical implant problem" since the 2007 recall of a popular heart device. And although "immediate problems with the hip implants are not life-threatening, some patients have suffered crippling injuries caused by tiny particles of cobalt and chromium that the metal devices shed as they wear."
One of the most problematic devices, according to the Times, is the ASR system sold by Johnson & Johnson subsidiary DePuy and recalled in 2010. ASR devices "accounted for 75 percent of the complaints reviewed" by the Times. (Another DePuy device, the all-metal version of the Pinnacle system, was the subject of "some 200 complaints" reviewed by the Times, "as well as 400 additional complaints that noted metal-related problems in Pinnacle patients.") Under FDA rules, "many all-metal devices were sold without testing in patients or without a requirement that producers track their performance. But in an unusual intervention, the [FDA] in May ordered producers to study how frequently the devices were failing and to examine the threat to patients. Now, researchers say, producers face substantial hurdles in recruiting the hundreds of patients needed to conduct sound studies because of the lack of patient registries."
Because of the effectiveness of other countries' registries, there are at least two efforts to create similar institutions in the United States. The American Academy of Orthopaedic Surgeons is initiating a pilot program, the American Joint Replacement Registry (AJRR), in 15 hospitals to track recipients' basic information and data on their doctors and implants. The AJRR is privately funded, however, and its primary purpose will be to serve manufacturers and doctors. The federal government is also creating a registry, the National Orthopaedic Outcome Registry (NOOR). Its scope is much smaller than AJRR: It will survey six hospitals that frequently host artificial implant surgeries. But NOOR will gather more data on the recipients' post-surgery experiences.
"These projects are not without their obstacles, though," comments Rochelle Rottenstein, principal of the Rottenstein Law Group. "One is that manufacturers don't want their revenues reduced as a result of criticism of their products. And surgeons don't want to be graded on their performance, either. But these concerns must give way for the good of the public." Rottenstein notes that it was the National Joint Registry for England and Wales that provided DePuy with the data that ultimately led to the global recall of the faulty ASR devices. "U.S. registries won't help those whose ASR devices now have to be removed and replaced, but perhaps others will be spared similar misfortune."
The Rottenstein Law Group maintains a DePuy Pinnacle Lawsuit Information Center at www.depuypinnaclelawsuit.com and a DePuy ASR Hip Replacement Recall Information Center at www.depuyhipreplacementlawsuit.com. Both sites have features that allow for easy sharing, including links for automatic posting on Facebook and Twitter.
About THE ROTTENSTEIN LAW GROUP
The Rottenstein Law Group is a New York-based law firm that represents clients in mass tort actions. The firm was founded by Rochelle Rottenstein, who has more than two decades of experience as a lawyer, to represent clients in consumer product injury, mass tort, and class action lawsuits in a compassionate manner. http://www.rotlaw.com
|SOURCE The Rottenstein Law Group LLP|
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