Since 1976, all medical devices must be classified and approved by the U.S. Food and Drug Administration (FDA) before they can be legally marketed to the public. It is the fond belief of many Americans that FDA approval is a ringing endorsement of a product's safety, a guarantee that the device has been tested and re-tested by professionals who are presumably trained to put the device through all kinds of rigor to triple-check its safety and effectiveness before allowing it anywhere near our fragile human bodies.
It is, as we say, a fond belief, but not an accurate one. It seems that many medical devices - including the recently recalled DePuy ASR XL Acetabular System - are given an FDA approval and subsequently placed inside people's bodies without ever going through a single test at the FDA.
The FDA department responsible for the regulation and review of medical devices is the Center for Devices and Radiological Health (CDRH). CDRH divides medical devices into three classes: life-sustaining, life-supporting or implantable devices are designated as Class III.
Hip replacements, including the ASR XL system, qualify as a Class III device and are considered high risk to the patient's health.
Class III devices can be approved by the FDA through one of two processes. The first, the premarket approval process (PMA) is more or less what we think of when we imagine our device being tested by the FDA: an extensive review including rigorous clinical trials that show it to be safe for use in humans. The PMA is quite detailed, lengthy, and expensive, usually costing the manufacturing company upwards of $250,000 and taking as much as two years to complete.
A quarter of a million is a large chunk of change - but thankfully for companies with a firm eye on their bottom line, there's always the second FDA approval process.
The premarket notification approval process, also known as the 510(k) approval process, is a sort of shortcut to approval that lowers the price point considerably - and also, conveniently, doesn't involve any pesky testing that might reveal a flaw in the product that would then have to be revamped and retested for another quarter-million.
The 510(k) process basically pre-approves any product that is deemed "substantially equivalent" to another product already legally approved for sale. It costs less than $5,000, requires no clinical trials, and only takes an average of 3-6 months to complete. It's a good shortcut for products that are essentially identical to their forebears. After all, it hardly makes sense to waste the FDA's time when they could be helping get new, innovative, life-saving products to market. But what's to stop companies from claiming their products are "substantially equivalent" to other FDA-approved devices even if they're not remotely the same? Read more .....
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Taking Charge: A Blueprint for DePuy Hip Implant Recipients to Follow for Successful Recovery
Taking Charge: A Blueprint for DePuy Hip Implant Recipients to Follow for Successful Recovery
Introduction:
While the FDA began receiving complaints regarding the failure of hip replacement devices manufactured by DePuy Orthopedics (a subsidiary of Johnson & Johnson) for some time, there was not a DePuy hip extensive recall on the device until August of 2010. Many feel the recall should have come much sooner and that the company knew there were issues with the implant for a significant period of time before they issued the recall. Many of the patients who have been implanted with a DePuy hip replacement device later required a second surgery when their original implant failed. This DePuy hip implant failure has negatively affected the quality of life for its recipients.
Introduction:
While the FDA began receiving complaints regarding the failure of hip replacement devices manufactured by DePuy Orthopedics (a subsidiary of Johnson & Johnson) for some time, there was not a DePuy hip extensive recall on the device until August of 2010. Many feel the recall should have come much sooner and that the company knew there were issues with the implant for a significant period of time before they issued the recall. Many of the patients who have been implanted with a DePuy hip replacement device later required a second surgery when their original implant failed. This DePuy hip implant failure has negatively affected the quality of life for its recipients.
“Hip” Definitions: A Discussion of Medical Terms Every DePuy Hip Implant Recipient Should Know
“Hip” Definitions: A Discussion of Medical Terms Every DePuy Hip Implant Recipient Should Know
Introduction
July of 2003 saw the worldwide introduction of the metal-on-metal hip replacement by DePuy, although these devices were not used for hip replacement surgeries in the United States until 2005. Johnson & Johnson, the parent company of DePuy, pushed the approval of the hip implant device through the FDA under an expedited process known as the 510(k). This process allows many medical devices to skip rigorous clinical trials when the manufacturer can show the device is substantially equivalent to another device which has already received approval. At the time of the 510(k) approval, DePuy claimed the ASR hip replacement device raised no new issues of safety or effectiveness.
Complaints Regarding the DePuy Implant
Over the next few years, the FDA began receiving a flood of complaints regarding these devices, and many of the DePuy metal-on-metal hip implants had to be removed for the health of the recipient. Although a traditional metal-on-metal hip implant device can reasonably be expected to last at least fifteen years, the DePuy devices were failing at a much higher—and earlier—rate. Even though DePuy was notified of the health issues surrounding the implant as early as 2007, they continued to market the hip implants until August 26, 2010, when DePuy and Johnson & Johnson finally issued a voluntary Depuy hip extensive recall of the implant system. Those who have undergone the hip implant surgery with a DePuy implant may be confused regarding the potential health risks and uncertain of how to proceed and should be aware that a DePuy hip replacement lawsuit is an option.
Introduction
July of 2003 saw the worldwide introduction of the metal-on-metal hip replacement by DePuy, although these devices were not used for hip replacement surgeries in the United States until 2005. Johnson & Johnson, the parent company of DePuy, pushed the approval of the hip implant device through the FDA under an expedited process known as the 510(k). This process allows many medical devices to skip rigorous clinical trials when the manufacturer can show the device is substantially equivalent to another device which has already received approval. At the time of the 510(k) approval, DePuy claimed the ASR hip replacement device raised no new issues of safety or effectiveness.
Complaints Regarding the DePuy Implant
Over the next few years, the FDA began receiving a flood of complaints regarding these devices, and many of the DePuy metal-on-metal hip implants had to be removed for the health of the recipient. Although a traditional metal-on-metal hip implant device can reasonably be expected to last at least fifteen years, the DePuy devices were failing at a much higher—and earlier—rate. Even though DePuy was notified of the health issues surrounding the implant as early as 2007, they continued to market the hip implants until August 26, 2010, when DePuy and Johnson & Johnson finally issued a voluntary Depuy hip extensive recall of the implant system. Those who have undergone the hip implant surgery with a DePuy implant may be confused regarding the potential health risks and uncertain of how to proceed and should be aware that a DePuy hip replacement lawsuit is an option.
Johnson & Johnson Takes $3 Billion Dollar Fourth Quarter Charge
Johnson & Johnson Takes $3 Billion Dollar Fourth Quarter Charge
Introduction
Johnson & Johnson, the parent company of DePuy Orthopedics recently took a fourth quarter charge of over $3 billion dollars related primarily to their voluntary recall artificial hip implants—the DePuy ASR Acetabular System and the ASR Hip Resurfacing System. The recall took place in August of 2010, after the FDA had received incident reports regarding the DePuy metal-on-metal hip implants for over two years. Approximately one in eight patients—and possibly more—will require a hip revision surgery to remove the faulty DePuy device and replace it with another hip implant device. Unfortunately, most patients have a longer recovery time and more medical issues related to the second revision surgery than they did with the first.
Introduction
Johnson & Johnson, the parent company of DePuy Orthopedics recently took a fourth quarter charge of over $3 billion dollars related primarily to their voluntary recall artificial hip implants—the DePuy ASR Acetabular System and the ASR Hip Resurfacing System. The recall took place in August of 2010, after the FDA had received incident reports regarding the DePuy metal-on-metal hip implants for over two years. Approximately one in eight patients—and possibly more—will require a hip revision surgery to remove the faulty DePuy device and replace it with another hip implant device. Unfortunately, most patients have a longer recovery time and more medical issues related to the second revision surgery than they did with the first.
Recall of Artificial Hip Causes Johnson & Johnson 2012 Earnings Forecast to Dip
Recall of Artificial Hip Causes Johnson & Johnson 2012 Earnings Forecast to Dip
Introduction
The pharmaceutical giant, Johnson & Johnson, has been given a 2012 earnings forecast which is below the previous estimates present by financial analysts due to the number of DePuy hip replacements which were recalled. In fact, recent reports state Johnson & Johnson takes $3 billion charge for hip recall. In 2010 it was discovered that the DePuy metal-on-metal hip replacement devices were shedding metal fragments and Johnson & Johnson issued a recall for those particular hip replacements. The metal fragments which were shed into the body were found to cause disabling injuries in some recipients, and the toxicity from the chromium and cobalt debris can cause the surrounding tissues to suffer necrosis or death.
Introduction
The pharmaceutical giant, Johnson & Johnson, has been given a 2012 earnings forecast which is below the previous estimates present by financial analysts due to the number of DePuy hip replacements which were recalled. In fact, recent reports state Johnson & Johnson takes $3 billion charge for hip recall. In 2010 it was discovered that the DePuy metal-on-metal hip replacement devices were shedding metal fragments and Johnson & Johnson issued a recall for those particular hip replacements. The metal fragments which were shed into the body were found to cause disabling injuries in some recipients, and the toxicity from the chromium and cobalt debris can cause the surrounding tissues to suffer necrosis or death.
Things You Should Know About Johnson & Johnson’s and DePuy Orthopedics’ Attempts to Help Hip Implant Recipients
Things You Should Know About Johnson & Johnson’s and DePuy Orthopedics’ Attempts to Help Hip Implant Recipients
Introduction
DePuy hip implants were used widely throughout the world, beginning in 2003, and in the United States from 2005. Although concerns were raised regarding the safety of these hip implant devices, a recall by DePuy was not issued until August of 2010 when DePuy received data from the National Joint Registry showing the five year revision rate for the ASR hip replacement system was approximately 12-13%. This study appeared to show that the risks for revision surgery were highest among female patients who received the smaller ASR heads which were less than 50mm in diameter. The recall in 2010 was voluntary on the part of DePuy and Johnson and Johnson and the pharmaceutical giant has subsequently issued several field safety notices to physicians to enable them to help their patients whose health has been affected by the DePuy hip implant failure.
Introduction
DePuy hip implants were used widely throughout the world, beginning in 2003, and in the United States from 2005. Although concerns were raised regarding the safety of these hip implant devices, a recall by DePuy was not issued until August of 2010 when DePuy received data from the National Joint Registry showing the five year revision rate for the ASR hip replacement system was approximately 12-13%. This study appeared to show that the risks for revision surgery were highest among female patients who received the smaller ASR heads which were less than 50mm in diameter. The recall in 2010 was voluntary on the part of DePuy and Johnson and Johnson and the pharmaceutical giant has subsequently issued several field safety notices to physicians to enable them to help their patients whose health has been affected by the DePuy hip implant failure.
New Updates for DePuy Hip Implant Victims
New Updates for DePuy Hip Implant Victims
The DePuy ASR Litigation Status Conference
On January 23, 2012, the DePuy ASR Litigation Status Conference in West Palm Beach, Florida was held before Judge David Katz. Judge Katz is the United States Federal District Judge assigned by the Multi District Litigation panel of judges to hear all pretrial matters in any DePuy ASR cases filed in federal court.
Judge Katz met with the Executive Committee of the Plaintiffs’ Steering Committee for about an hour privately before he met with all attorneys in open court. The Plaintiffs’ Steering Committee are the dozen or so lawyers Judge Katz assigned as leaders of all plaintiffs’ lawyers who have filed cases in the ASR litigation. The Plaintiffs’ Steering Committee is responsible for gathering evidence (Johnson and Johnson and others have turned over approximately 18,000,000 documents so far), taking depositions of fact and expert witnesses, legal analysis, submitting briefs to the court, and a variety of other tasks.
The DePuy ASR Litigation Status Conference
On January 23, 2012, the DePuy ASR Litigation Status Conference in West Palm Beach, Florida was held before Judge David Katz. Judge Katz is the United States Federal District Judge assigned by the Multi District Litigation panel of judges to hear all pretrial matters in any DePuy ASR cases filed in federal court.
Judge Katz met with the Executive Committee of the Plaintiffs’ Steering Committee for about an hour privately before he met with all attorneys in open court. The Plaintiffs’ Steering Committee are the dozen or so lawyers Judge Katz assigned as leaders of all plaintiffs’ lawyers who have filed cases in the ASR litigation. The Plaintiffs’ Steering Committee is responsible for gathering evidence (Johnson and Johnson and others have turned over approximately 18,000,000 documents so far), taking depositions of fact and expert witnesses, legal analysis, submitting briefs to the court, and a variety of other tasks.
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