A recent New York Times article highlighted the fast rate of hip implant failures in the United States. (http://www.nytimes.com/2011/10/01/health/01hip.html?_r=1&scp=1&sq=hip%20surgery%20shows%20signs&st=cse)
The article notes that “[a]ll orthopedic implants, regardless of their composition, shed debris as they wear. But researchers say they believe that the particles released by some all-metal hips pose a special threat because scavenger cells dispatched by the body to neutralize the debris convert it into biologically active metallic ions. In some patients, a chain reaction begins that can destroy tissue and muscle.” Unfortunately, this failure was not a complete surprise. “More than a decade ago, some researchers had warned that the hips shed tiny pieces of metallic debris that posed potential health threats to patients. ”
If you have a DePuy or other brand of metal hip implant, please call Bill Robertson today. Bill’s direct dial phone number is 941.364.2433.
According to a story in the Archives of Internal Medicine, “medical devicesare reviewed by the US Food and Drug Administration (“FDA”) using2 alternative regulatory standards: (1) premarket approval (“PMA”),which requires clinical testing and inspections; or (2) the510(k) process, which requires that the device be similar toa device already marketed (i.e., there needs to be a “predicate” device). The second standardis intended for devices that the FDA deems to involve low ormoderate risk.” (http://archinte.ama-assn.org/cgi/content/full/archinternmed.2011.30)
A study of the FDA’s high-risk List of DeviceRecalls from 2005 through 2009 determinedthat, of the 113 recalls from this period that could cause serious health problemsor death, only 21 of the 113 devices had been approved throughthe PMA process (19%), eighty were cleared through the 510(k)process (71%), and an additional 8 were exempt from any FDAregulation (7%).
Tort lawyers play an important regulatory role. Given that nearly 80% of the medical devices recalled for life-threateningor very serious hazards were originally cleared for market usingthe less stringent 510(k) process or were considered so lowrisk that they were exempt from review, tort litigation is necessary to cause manufacturers to more safely prepare medical devices for sale.
If you have been injured by a medical device or the failure of a medical device, call Bill Robertson or Zach Ross at 941.364.2400.
Citing concerns about the crashworthiness of Beetles produced in September 2010, the National Highway Traffic Safety Administration has ordered a recall of these VWs. What makes this story interesting is that the crash standards being applied only went into effect in September i.e., cars that were “safe” in the beginning of 2010 are now “unsafe.”
As reported in torquenews, “The NHTSA would like owners of these Beetles to return them to their dealership and in return, Volkswagen will give owners an older model. Sort of like trading down, only the German automaker doesn’t have much of a choice in this situation. What makes this funny is the fact that these replacement vehicles still won’t meet these crash requirements, but because they weren’t produced in or after September 2010, it doesn’t matter. … Only 27 examples of the 2010 Volkswagen Beetle will be recalled … Volkswagen Beetle owners can contact VW at 1-800-822-8987.” (http://www.torquenews.com/109/2010-volkswagen-beetle-recall-very-confusing)
Have you been injured in a car accident? Call Bill Robertson at 941.364.2400 or contact him via email at wrobertson @ kirkpinkerton. com (remove spaces).
If you received a DePuy ASR XL Acetabular System or an ASR Hip Resurfacing System, DePuy or Johnson & Johnson may have already contacted you. Indeed, DePuy or Johnson & Johnson may have even sent you a notice and other documents regarding the August 2010 recall of these medical devices.
You should speak with a lawyer about your options before seeing a doctor and signing any documents provided by DePuy or Johnson & Johnson. The documents from DePuy or Johnson & Johnson may include a waiver which might prevent you from receiving compensation should you experience any medical complications in the future. The paperwork may also require you to give up your explant as a condition to having DePuy or Johnson & Johnson pay for some of your medical bills.
The compensation being offered by DePuy and Johnson & Johnson may not fully cover your medical bills following hip replacement surgery. The offered compensation does not cover many blood tests or diagnostic tests that a doctor may want to order to ensure you are healthy and to check for a serious condition assocaited with the devices known as “metallosis.” The initial offer may also not cover damages for your pain and suffering, lost wages, and loss of earning capacity.
Your hip replacement surgery was a traumatic experience. DePuy and Johnson & Johnson should be required to compensate you for making you go through this experience again.
Call Bill Robertson regarding your options before signing any paperwork provided by DePuy or Johnson & Johnson. Bill’s phone number is 941.364.2400 or 941.364.2433.
After DePuy issued its recall notice, it sent a letter to doctors and clinicians and informed them that DePuy was willing to pay for their patients’ hip revision surgeries, BUT DePuy conditioned its offer on getting back the defective hip implants. (Here’s the web address for DePuy’s letter – http://asrrecall.depuy.com/sites/default/files/DPYUS1%20Recall%20Notice.pdf)
Never mind the fact that the patients with the defective hardware are the owners of the defective hardware, the real problem is that the explant is critical evidence in the effected patients’ cases against DePuy.
The hardware is critical evidence because it will allow an expert to determine whether the hip malfunctioned because of DePuy’s defective design and materials or whether the patient’s lifestyle caused the hip problems. Obviously, DePuy will argue in response to lawsuits that the damages patients suffered are their own fault (or that of their doctors) and are not the fault of the manufacturer.
Hold on to your DePuy explants! You do not need to agree to DePuy’s demands to get the health care and compensation you deserve. If you have DePuy’s ASR XL Acetabular Hip System or ASR Hip Resurfacing System, do not sign any paperwork from DePuy and do not agree to release the DePuy explant without consulting with Bill Robertson, 941-364-2400.
DePuy, a Johnson & Johnson subsidiary, has issued a voluntary recall of a metal hip implant amid complaints of severe pain and worries that it might put patients at a risk for dementia and heart failure.
Since 2003, DePuy has sold nearly 100,000 units of the artificial hip device all across the country. According to experts, problems have arisen because of friction between two portions of the device. The friction of these parts, which are made of metal, cause small particles to shave off and enter the patient’s tissue and bloodstream which then cause severe pain and the risk of deafness, dementia, and heart failure. In August, DePuy issued a recall of these devices and now recommends that implant patients have a blood test to check for high levels of the metals used in the implant, chromium and cobalt.
Kirk Pinkerton’s Bill Robertson is representing people who have been harmed by this defective product. “The pain and suffering caused by this defective hip device is excruciating,” Robertson said. “Worse, the need to undergo additional, major surgeries and the costs and expenses associated with medical care and recovery make this both a physical and economic nightmare for those effected. These damages can be devastating over the long term for younger people who were the specific target of some DePuy and Johnson & Johnson marketing.”
Hip replacement devices could be linked to frequent surgeries after a recall of 90,000 systems manufactured by DePuy Orthopaedic Devices. The recall was announced by DePuy due to concerns from the Food and Drug Administration. Personal injury attorneys from the Sarasota-based law firm Kirk Pinkerton will be available for consultations regarding the recall, including William E. Robertson, head of the firm’s personal injury department.
The two systems involved in the recall include:
1. ASR XL Acetabular System which is a hip socket and
2. ASR Hip Resurfacing Platform, which is a partial hip replacement device.
Components in both systems were the subject of a voluntary recall which began on August 26, 2010. The company has already stopped selling both products in the United States. Reports from the FDA cited by the New York Times and other media outlets indicate that the agency had concerns the implants would require repeat surgery in approximately 10-12% of all patients.
DePuy itself says that all 93,000 patients who received the devices would need to have their surgeons monitor their progress on a yearly basis, a step not initially required in the product literature. The company also noted that the revision rate, or percentage of patients needing additional surgeries, was higher than that of other hip replacement devices in its class.
Bloomberg wire services note that similar product recalls have led to medical device liability cases throughout the world in the wake of the recall. However, there is no indication in a court of law that similar lawsuits will yet bring damages to clients.
If you would like to consult a personal injury attorney regarding the DePuy hip replacement recall or other medical devices, call Bill Robertson at Kirk Pinkerton toll-free: 1-800-439-8911.
DISCLAIMER:
The facts and circumstances of your case may differ from the matters in which results and testimonials have been provided. All results of cases handled by Kirk-Pinkerton are not provided and not all clients have given testimonials. The results and testimonials provided are not necessarily representative of results obtained by Kirk-Pinkerton or of the experience of all clients or others with Kirk-Pinkerton. Every case is different, and each client’s case must be evaluated and handled on its own merits.
DePuy, a Johnson & Johnson subsidiary, has issued a voluntary recall of a metal hip implant amid complaints of severe pain and worries that it might put patients at a risk for dementia and heart failure.