Posts Tagged ‘MetalonMetal’
Hip Replacement Patients Researching Metal-on-Metal Hip Dangers Surged in 2011, According to Kershaw, Cutter & Ratinoff
Hip Replacement Patients Researching Metal-on-Metal Hip Dangers Surged in 2011, According to Kershaw, Cutter & Ratinoff
Sacramento, California (PRWEB) January 11, 2012
According to the medical device lawyers at Kershaw, Cutter & Ratinoff, 2010 brought what New York Times* recently called “the most widespread medical implant failure in decades.” 2011 brought widespread interest in the effects of cobalt and chromium toxicity. And 2012 could usher in one of the largest payouts in orthopedic device history.
The DePuy ASR hip replacement system was recalled in August 2010 due to a flaw in the design that caused excessive friction between the metal parts, releasing cobalt and chromium ions into the patients’ blood stream. In many hip replacement patients, this resulted in higher infection rates, the formation of “pseudo tumors” and the rejection of the hip implant itself. Since then, other metal-on-metal hip implants have come under scrutiny by the FDA and claims have arisen involving another DePuy metal hip, the DePuy Pinnacle system. In May of 2011, the FDA required 21 manufacturers of metal hips to participate in post market surveillance studies and gather blood test results of their patients’ cobalt and chromium levels.
According to medical device lawyers at Kershaw, Cutter & Ratinoff, who developed a website that specifically addresses the implications of high cobalt and chromium blood levels, web traffic surged as patients anxiously researched the potential dangers of their metal-on-metal hip replacements. Since they launched http://www.cobalt-chromium-toxicity.com last March, the site has received over 875,000 hits and their online videos have received over 16,000 views from concerned patients and their loved ones trying to understand the meaning of their high cobalt blood levels.
“We’ve never seen anything quite like this,” says medical device lawyer Stuart Talley. “The device was recalled over a year ago, but many patients are only recently becoming aware of their cobalt and chromium blood levels and the implications to their health.”
According to Talley, they set up the cobalt toxicity website after interviewing an expert in metal toxicology in an effort to answer the many questions their clients were asking.
“Nobody’s giving them direct answers, and the medical data unfortunately hasn’t been widely circulated on the internet,” Talley explained. “So we took matters into our own hands by contacting experts, attending conferences and researching medical journals to find the answers our clients were seeking.”
As patients learn more about their cobalt and chromium blood levels, speculation has begun to buzz about how much this will cost the hip replacement manufacturers. Forbes Magazine** ran a story last month predicting that Johnson & Johnson (parent company to DePuy) and Zimmer Holdings, two of the main manufacturers of metal-on-metal hip implants, may end up paying out over $ 5 billion in settlements and legal costs arising from hip replacement lawsuits.
Patients who have received a metal hip implant, particularly the recalled DePuy ASR or the all metal version of the DePuy Pinnacle, are encouraged to discuss their situation with a medical device lawyer before it’s too late to make a claim. Most states have time limits that restrict how long a person can wait after they learned of their medical issue before making a claim against the negligent party, and for many this time is drawing near.
Additionally, for patients concerned about their cobalt or chromium blood levels, this article explains the proper protocol for requesting cobalt and chromium blood testing from a laboratory: http://www.cobalt-chromium-toxicity.com/accurate-cobalt-chromium-testing.html
Sources:
*http://www.nytimes.com/2011/12/28/business/the-high-cost-of-failing-artificial-hips.html?hp
**http://www.forbes.com/sites/petercohan/2011/12/28/will-flawed-all-metal-hip-replacements-cost-jj-and-zimmer-5-billion/
Kershaw, Cutter & Ratinoff represents individuals and businesses in personal injury lawsuits, insurance bad faith cases, product liability cases and class action lawsuits. They have demonstrated their ability to devote substantial resources in pharmaceutical lawsuits, traumatic brain injuries, spinal cord injuries, consumer fraud, defective medical devices and wage and hour lawsuits, generating hundreds of millions of dollars in recoveries for their clients and the classes they have represented.
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Rottenstein Law Group Commends Subcommittee Recommendation of Greater Investigation of Metal-on-Metal Hips to Curb Underregulation at USFDA
Rottenstein Law Group Commends Subcommittee Recommendation of Greater Investigation of Metal-on-Metal Hips to Curb Underregulation at USFDA
New York, NY (PRWEB) October 24, 2011
By letter dated October 12, 2011, members of the United States House of Representatives Committee on Energy and Commerce—including ranking member Henry A. Waxman of California—opined to committee chairman Fred Upton, Subcommittee on Health chairman Joseph Pitts, and Subcommittee on Oversight and Investigations chairman Cliff Stearns that hearings on FDA regulation of medical devices held in the past year “have not provided a balanced and accurate picture that fully reflects the role [the] FDA plays in reviewing device applications; nor have they spoken to the potential dangers posed to patients if medical devices are not appropriately regulated.” The letter can be viewed in its entirety here.
The authors of the letter urge the committee as a whole to “hold hearings that examine medical devices that have developed serious defects after being implanted in patients. Specifically, we believe that looking further into the ‘metal-on-metal’ hip implants and brain stents, two high-profile devices that appear to have resulted in significant harm to human health, would shed further light on the regulation of medical devices.”
The authors note that both items are “examples of devices that were found to be associated with major health problems after being approved or cleared by the FDA. As such, we believe they could provide important lessons about the device clearance and approval process as well as the adequacy of our postmarketing safety system.”
The letter notes that several metal-on-metal hip implant devices “were cleared under the 510(k) clearance process, meaning that the devices [sic] had to demonstrate they were ‘substantially equivalent’ to one or more devices already on the market. Although clinical data can be required under this clearance process, many submissions are cleared without such data…. As of December 31, 2010, [the] FDA had cleared for marketing 175 submissions for metal-on-metal hips through the 510(k) process, many of which were components of larger systems.” But metal-on-metal hip implant systems have “unique risks in addition to the general risks of all hip implant systems,” the Representatives remarked, quoting an FDA report. “Because the metal rubs against the metal, ‘tiny metal particles may wear off of the device and… cause damage to the bone or tissue surrounding the implant and joint.’”
The letter authors mention that concerns about the dangers of all-metal hip implants “led [the] FDA to order 20 manufacturers of these devices to submit a plan… to study how frequently [the devices are] failing and to examine the health implications of device failures.” One of those manufacturers is DePuy Orthopaedics, a subsidiary of Johnson & Johnson, which manufactured and sold the recalled ASR hip implant system and which currently sells the embattled Pinnacle system.
The Rottenstein Law Group maintains a website with information about DePuy’s problematic hip implants at http://www.hiprecalllaw.com. The site has 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 hurt by defective medical devices. http://www.rotlaw.com
Contact:
The Rottenstein Law Group LLP
Rochelle Rottenstein, Esq.
1259 Veeder Drive
Hewlett NY 11557
(212) 933-9500 (office phone)
(212) 933-9980 (facsimile)
rochelle(at)rotlaw(dot)com
http://www.rotlaw.com
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©Copyright 1997-
, Vocus PRW Holdings, LLC.
Vocus, PRWeb, and Publicity Wire are trademarks or registered trademarks of Vocus, Inc. or Vocus PRW Holdings, LLC.
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