DePuy ASR Hip Lawsuit Update: Rottenstein Law Group Responds to Hip Implant Expert Testimony On ASR Design Flaws
As the nation’s first DePuy ASR trial progresses into its second week in Los Angeles, a metal-on-metal hip implant expert testified Feb. 6 that the device’s design had several alleged flaws, notes the Rottenstein Law Group, which represents clients in DePuy ASR lawsuits.
According to a Bloomberg article,* Dennis Bobyn, a McGill University professor, testified in court (In re: Loren Kransky and Sheryl Kransky v. DePuy, Inc., et al. BC456086, Los Angeles Superior Court) that the recalled ASR’s shape and function – a less-than-half-circle metal cup in which a metal ball sits – contributed to the alleged flaws, as does its one-piece cup design. (Two-pieces is considered a better approach, Bobyn said.)
The alleged design flaws can cause metallosis (metal poisoning), which is one of the most prominent conditions for which hip implant recipients pursue lawsuits with firms such as the Rottenstein Law Group. Contact between hip components results in metal ions that enter the bloodstream. Alleged side effects include the blackening of and growth of “pseudotumors” in the surrounding tissue and adverse effects in the central nervous system.
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Joint replacement surgeries became controversial due to defective hip prostheses like the ones manufactured by DePuy Orthopaedics Inc. DePuy is a subsidiary company of Johnson & Johnson (J&J). It’s possible that the hip replacement lawsuit statute of limitations will run out. DePuy Orthopaedics, Inc. is recently being charged with various lawsuits filed by law firms in UK, US and Australia, in behalf of patients who underwent hip replacement operations. Statutes of limitations are designed to ensure that claims are filed promptly and that parties do not have to litigate issues based on old documents and potentially faulty memories.
A Senate committee in Australia has asked its health officers to take action against Johnson & Johnson for the trouble that is caused by its DePuy Articular Surface Replacement (ASR) hip systems which means that the implant manufacturer is not only in trouble in the United States but also in Australia.
The Department of Health and Ageing have been told to prioritize alerting doctors, patients and the public about the issues associated with the DePuy devices as well as options for treatment and the reporting of adverse outcomes.
About 93,000 patients worldwide have been implanted with the DePuy ASR hip device according to the company. Some 5,500 of those who have received the hip implants are Australians and a lot of them had to undergo not just one but two or more revision surgeries. Also reported by patients who had the metal-on-metal hip implants is the "serious and systemic health problems extending beyond the initial complications caused by the device."
It had taken three years for the product to be recalled after evidence came out that the implants had a high failure rate back in 2006 as pointed out by orthopaedic expert Stephen Graves at a Senate committee hearing last September. Anthony Bishop, the Australian head of Johnson & Johnson, had expressed the company's regrets over the incident before the Senate committee last September. Johnson & Johnson had to shell out $21 million to reimburse more than 3,500 patients in Australia who had registered with the company's claim processor.
Australia was the first country to withdraw the two DePuy hip implants in December 2009. DePuy hip replacement lawsuit is not only rising in the United States but also in Australia after solicitors acting on behalf of people affected by the allegedly faulty hip implants filed an action against DePuy in the Federal Court last September seeking compensation for harm.
DePuy engaged the services of Broadspire Services Inc. since its recall last August 26, 2010 to manage its compensation affairs especially to administer claims, surprising business critics all over United States. The Johnson & Johnson subsidiary DePuy Orthopaedics, recalled ASR XL Acetabular System and ASR Hip Resurfacing System, its two hip replacement products. DePuy’s ASR Hip Resurfacing System is a partial hip replacement system that places a metal cap on the femur’s ball in order to preserve more bone, on the other hand, ASR XL Acetabular System is a hip socket used in traditional hip replacements. DePuy’s ASR Hip Resurfacing System was approved for use only in outside the United States and was introduced in 2003. In 2004, the ASR XL Acetabular System was introduced and made available. Worldwide, roughly 93,000 DePuy devices have been recorded.According to DePuy, the recall was due to complaints of revision surgery after the hip replacement failure.
Within a couple of years, 400 DePuy hip replacement complaints have been gathered by the US Food and Drug Administration from patients who received implants. Ever since, the company recommended their patients to consult with a surgeon to evaluate and monitor the status of their hip implant. DePuy agreed to shell out the medical expenses incurred by their patients for evaluated revision surgeries and related out-of-pocket expenses.
A traditional hip operation requires an incision in the hip joint to remove the diseased bone tissue and cartilage and replace it with artificial parts.After the operation, the prosthetic ball and socket device would restore mobility and improve one’s lifestyle. Hip replacements are usually performed for patients over 60 years of age but recently, hip procedures are undertaken among younger patients to improve their daily activities.
In the advent of new technology for artificial parts, such as DePuy’s hip replacement systems, the medical sector found the hip replacement procedure to be successful in the younger generation as well. These developments allow young patients to withstand stress and engage in strenuous physical activities with ease. DePuy’s ASR devices have been preferred by surgeons for younger patients because of its stability and decreased chance for a second operation. Unexpectedly, a high rate of DePuy patients at 13% had revision surgery due to the product’s failure. Women who used DePuy’s ASR XL Acetabular System were noted to have the highest revision. Upon recall, patients who had DePuy hip replacement pioneered the cause for quality medical devices and accountability of manufacturers to injured consumers.
A manufacturing company has once again been charged with lawsuits because of defective metal-on-metal hip replacement. The perils of metal-on-metal hip surgeries was featured earlier on the New York Times.
As for Johnson & Johnson’s case in particular, after information was out saying that the devices have defects in one out of eight clients, the ASR XL Acetabular System and the ASR Hip Resurfacing System were withdrawn. There are about 93,000 recipients of these products worldwide.
According to Dr. Stephen Graves, the director of the National Joint Replacement Registry in Australia, “It is a complete untruth that DePuy did not have reason to withdraw the ASR before now; we have been telling them since 2007, but they allowed it to be used on thousands of people.”
In a statement, a spokeswoman for DePuy, Mindy Tinsley, said, “We believe we made the appropriate decision to recall at the appropriate time given the available information.”
Transporting of microscopic metal parts into the body due to metal components rubbing against each other is one effect of design problems with metal-on-metal hip implant devices, like the DePuy. The metal particles shed from metal-on-metal hip replacement implants may increase the amount of some metals in the blood, such as chromium and cobalt. This may cause metallosis (blood poisoning) and genotoxicity (genetic damage). Chromium and cobalt have also been linked to cancer, and might lead to the development of tumors.
In worse cases, complete failure of hip devices happen, resulting in more serious health problems. This take place when:
• • the unit is dislocated and misaligned;
• • the device is not attached to the bone correctly; and
• • the bone around the implant is fractured.
The hip replacement recall definitely prodded the manufacturer to act on the need of the consumers to have safe medical treatments and medications. With the number of filed DePuy lawsuit increasing worldwide, DePuy should properly face the hip replacement problems encountered by its clients. It should circulate a wide range of information regarding malfunctioning hip replacement symptoms so that its patrons would be provided with due medical attention.
Severe and progressive hip pain usually leads to the choice of having a hip replacement operation. The surgical operation proved to be effective in most cases and the efficiency of the artificial hip joint almost rivals that of the original ball-and-socket joint which is the femoroacetabular joint (the part of the hip where the head of the femoral bone fits into the concave portion of the hip bone known as the acetabulum).
However, some hip implants proved to be disadvantageous and reports regarding complications experienced by some recipients of artificial hip products arose. Two of the reported faulty hip
replacement products are DePuy ASR XL Acetebular System and DePuy ASR Hip Resurfacing System. As a result, DePuy hip replacement lawsuits were filed and the approval of a Multidistrict Litigation
to consolidate related cases in DePuy was set. There are instances though wherein the DePuy hip replacement lawsuit was not approved for the MDL consolidation.
Hip Replacement Process
It is advantageous to know what are the various hip replacement devices available in order to properly weigh ones options in choosing the safest and most efficient hip implant. The purpose of a hip implant is to replace the damaged hip joint and to perform the functions which was previously accomplished by a femoroacetabular joint. After the surgery, gradual healing and crucial sessions of physical therapy, the artificial hip joint typically allows the person to rotate their legs, stride, adduct and abduct, sit and raise their legs using their hip joint with ease and without pain or discomfort.
Various Hip Replacement Devices Used
You have the right to know your options before consenting to have the invasive operation. The hip implant must be compatible for you and your case that is why the doctor carefully selects what is the ideal design for you and how successful it could be in giving you the chance to perform a whole wide range of movements. The following are some of the types of artificial hip devices:
* Metal Ball and Polyethylene Liners
* Ceramic Ball and Polyethylene Liner
* Metal Ball and Metal Liner
* Ceramic Ball and Ceramic Liner
These hip implants vary in the materials used and consequently has different advantages and disadvantages. If you are interested about filing your very own DePuy hip replacement case and you feel at a loss what are the necessary guidelines and options in making it, you can try to consult an adept hip replacement lawyer to help you get through the process of filing a DePuy hip replacement case and know more updates on the DePuy hip replacement recall. If you want to learn more about this case, there are related sites available that one can look into.
DePuy Ignored Warnings about Its Hip Replacement Systems
Many people, including those in the legal profession, believe that DePuy ignored warnings of the serious health risks associated with its recalled hip implants and intentionally endangered the health of tens of thousands of recipients. The DePuy hip replacement recall has created lawsuits in which the plaintiffs contend that DePuy and its parent company, Johnson & Johnson, knew about the high failure rates of their devices, as well as the significant health risks associated with them, yet continued to distribute these defective devices anyway.
Events leading to the recall began in 2004 when DePuy made a request to the U.S. Food and Drug Administration (FDA) for 510(k) approval of its metal-on-metal hip implants. The provisions of the 510(k) approval allowed DePuy to distribute these implants as long as they can demonstrate that the new devices were “substantially equivalent” to other implants already on the market. But the DePuy implants differed from similar implants since the ASR devices required bone to grow around the implant to secure it in place instead of using screws. With FDA approval to market and sell these implants, DePuy began receiving complaints as early as 2005 from both orthopedic surgeons and implant recipients of loose and dislocated implants. Other serious health problems included the following:
- Persistent pain and swelling
- Difficulty walking
- Hip fractures and bone erosion
- Metallosis caused by toxic and oncogenic metals, such as Chromium and cobalt, being released into the bloodstream and surrounding tissue due to friction between the metal components
- Tumors and other abnormal tissue growth
- Increase risk of cancer, stroke, and other health problems
Several articles documented problems with the DePuy ASR devices in other countries and hundreds of Adverse Event Reports were received by the FDA over the next several years. DePuy withdrew the implants from the Australian market in December of 2009 and officials in the United Kingdom issued a Medical Device Alert in May of 2010. Reported failure rates reaching 13 percent forced DePuy to recall the defective implants from the American market in August 2010.
Depuy ignored mounting evidence that there were serious problems with their ASR implants, jeopardizing the health of thousands of patients. Recipients of defective hip replacements should know their legal options and seek proper compensation. For more information, visit the DePuy hip recall website.