Parker McDonald Reports On FDA Hearing On Metal-On-Metal Hip Implants

FORT WORTH, Texas, June 28, 2012 – Yesterday, the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee of the Food and Drug Administration began a two-day public hearing to discuss the current  issues surrounding  the safety and effectiveness of metal-on-metal hip implant systems. According to the meeting announcement on the FDA’s website, the committee will “seek expert scientific and clinical opinion on the risks and benefits of these types of devices based on available scientific data.”

Among the topics of discussion are “…mechanisms of failure, metal ion testing, imaging methods, local and systemic complications, preoperative and postoperative patient risk factors, as well as clinical follow up considerations for patients with MoM hip systems (total and resurfacing).”

The FDA’s heightened scrutiny over metal-on-metal devices arose after DePuy Orthopaedics, Inc., subsidiary of healthcare giant Johnson & Johnson, recalled its metal-on-metal ASR XL Acetabular Hip System in the United States.  The recall came after data from the National Joint Registry of England and Wales indicated that the five-year failure rate of these products is approximately 13 percent, or 1 in 8 patients. Symptoms include loss of vision, severe pain, implant loosening, implant dislocation, and toxic heavy metal poisoning. Since the recall in August of 2010, there has been heightened scrutiny over the materials used in replacement hips. DePuy has also faced scrutiny over another one of its devices, the metal-on-metal Pinnacle Acetabular Cup System.

In May of last year, in response to the recent concerns surrounding MoM hip implants, the FDA issued 145 orders for postmarket surveillance studies to 21 manufacturers of metal-on-metal hip systems. According to a recent New York Times article, “one of the biggest problems with metal hips is detecting whether the metallic debris generated by an implant is damaging a patient’s tissue or muscle or how to best monitor for such problems.”

In the same New York Times article Dr. Malchau of Massachusetts General said, “…future patients need to better protect themselves by demanding their surgeon provide data showing that the implant they are recommending has a long, proven track record.”

Parker McDonald currently represents over 400 clients who have received a DePuy ASR or Pinnacle metal-on-metal hip implant. The firm has established a website, www.hipimplantrecovery.com , to provide the latest information for concerned defective hip implant patients and their families.

About Parker McDonald
Parker McDonald, P.C. offers comprehensive legal services for clients whose personal, business or property rights have been adversely affected. Built on years of trial experience, Parker McDonald lawyers are dedicated to a tradition of personal service and timely delivery of outstanding results. Parker McDonald has offices in Bedford, Fort Worth, Houston, Austin, and San Antonio.

Follow Parker McDonald on Facebook and Twitter.

Parker McDonald Exploring Recall Of Smith & Nephew PLC Metal Hip Socket Liner

FORT WORTH, Texas, June 11, 2012 – Orthopedic manufacturer Smith & Nephew PLC has issued a voluntary recall for its metal hip socket liner for the R3 Acetabular System, according to an update on its website. The company states that the liner is an optional component to its R3 Acetabuler System and it can still be used with non-metal liners.

The R3 Acetabuler hip implant is an all metal device when used with its metal socket liner.   The company estimates that 7,700 metal-liners were implanted since the global launch of the product in 2009. Many of these devices have been used in total hip replacement procedures.

Smith & Nephew cited the recalls from DePuy as a reason to observe and do an intensive clinical study of its liner. The results revealed that 1.6% of patients needed a revision survey – a fraction over the allowable amount by Britain’s National Institute for Health and Clinical Excellence. The unsatisfactory review led to the market withdrawal.

The metal socket has been associated with side effects similar to those of the recalled ASR XL Acetabular Hip Replacement and ASR Hip Resurfacing systems, including infections and joint dislocations. Patients with the device should contact a surgeon immediately if they are experiencing any discomfort.

Smith & Nephew has not initiated any measures to aid potential victims of its defective liner. People who have experienced failure of the R3 Acetabuler System, or any other hip replacement device, should contact an experienced attorney. Parker McDonald & Harrison Davis Steakley Morrison have composed a team of legal professionals focused on defending patient rights against negligent medical corporations. They can be contacted at 855.487.8447 or online at http://hipimplantrecovery.com.

# # #

About Parker McDonald
Parker McDonald, P.C. offers comprehensive legal services for clients whose personal, business or property rights have been adversely affected. Built on years of trial experience, Parker McDonald lawyers are dedicated to a tradition of personal service and timely delivery of outstanding results. Parker McDonald has offices in Bedford, Fort Worth, Houston, Austin, and San Antonio.

Parker McDonald Encouraged By News That the FDA Will Review Metal-On-Metal Hip Implants in June

Fort Worth, Texas, March 30, 2012 –The Food and Drug Administration has responded to the continued concern of metal-on-metal hip implants by announcing a public meeting to discuss the safety and effectiveness of these devices.

On June 27 and 28, 2012, the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee, which is part of the FDA, will meet to discuss metal-on-metal hip implants. According to the meeting announcement on the FDA’s website, the committee “will discuss current knowledge about the safety and effectiveness of Metal-on-Metal (MoM) hip arthroplasty systems.  FDA is convening this committee to seek expert scientific and clinical opinion on the risks and benefits of these types of devices based on available scientific data.”  The FDA will allow public comments on the issues to be submitted by May 9, 2012.

The FDA’s meeting will revolve around  “…mechanisms of failure, metal ion testing, imaging methods, local and systemic complications, preoperative and postoperative patient risk factors, as well as clinical followup considerations for patients with MoM hip systems (total and resurfacing)” as noted in the announcement see on the FDA’s website.

The decision to hold a committee meeting comes almost a year after the FDA issued 145 orders for post market surveillance studies to 21 manufacturers of metal-on-metal hip systems, including Zimmer Holdings, DePuy, Wright Medical, Biomet, and Smith & Nephew.

The FDA’s heightened scrutiny over metal-on-metal devices arose after DePuy Orthopaedics, Inc., subsidiary of healthcare giant Johnson & Johnson, recalled its metal-on-metal ASR XL Acetabular Hip System in the United States.  The recall came after data from the National Joint Registry of England and Wales indicated that the five-year failure rate of these products is approximately 13 percent, or 1 in 8 patients. Symptoms include loss of vision, severe pain, implant loosening, implant dislocation, and toxic heavy metal poisoning. Since the recall in August of 2010, there has been heightened scrutiny over the materials used in replacement hips. DePuy has also faced scrutiny overanother one of its devices, the metal-on-metal Pinnacle Acetabular Cup System.

Parker McDonald currently represents over 250 clients who have received a DePuy ASR or Pinnacle metal-on-metal hip implant. The firm has established a website, www.hipimplantrecovery.com, to provide the latest information for concerned defective hip implant patients and their families.

About Parker McDonald, P.C.
Parker McDonald, P.C. offers comprehensive legal services for clients whose personal, business or property rights have been adversely affected. Built on years of trial experience, Parker McDonald lawyers are dedicated to a tradition of personal service and timely delivery of outstanding results. Parker McDonald has offices in Bedford, Fort Worth, Houston, Austin, and San Antonio.

Follow Parker McDonald on Facebook and Twitter.

 

 

 

 

 


Super Lawyers Recognizes Preston Dugas of Parker McDonald as a 2012 Rising Star

March 21, 2012 Fort Worth, Texas – Super Lawyers has recognized Preston Dugas, associate attorney at Parker McDonald, as a 2012 “Texas Rising Star”.

Dugas’ practice areas consist of plaintiff’s serious injury and wrongful death, dangerous pharmaceuticals and medical devices, property tax litigation and commercial litigation. Dugas is a member of the Texas Trial Lawyers Association, Tarrant County Trial Lawyers Association, Tarrant County Bar Association, Tarrant County Young Lawyers Association, and Eldon B. Mahon Inn of Court.

Dugas was born and raised in New Orleans, Louisiana. He graduated from Texas Christian University and later received his Juris Doctorate Degree from St. Mary’s University School of Law in San Antonio.

Lawyers in Texas were asked to nominate the best attorneys who are 40 or under, or who have been practicing for 10 years or less. In addition to the general survey, the Super Lawyers attorney-led research team reviewed the credentials of potential candidates and assigned points based on a set of defined evaluation criteria. Point totals from the general survey and research process were added to arrive at a final tally. Lawyers ranked by point totals and those with the highest point totals are named to the Rising Stars list. No more than 2.5 percent of the lawyers in the state are named to the list.

About Parker McDonald
Parker McDonald, P.C. offers comprehensive legal services for clients whose personal, business or property rights have been adversely affected. Built on years of trial experience, Parker McDonald lawyers are dedicated to a tradition of personal service and timely delivery of outstanding results.

Follow Parker McDonald on Facebook and Twitter.

Parker McDonald Reports on the MHRA Releasing New Advice for Metal-On-Metal Hip Replacement Patients

Fort Worth, Texas (PRWEB) March 05, 2012

The hip implant recovery team of Parker McDonald and Harrison Davis Steakley Morrison reports on the recent health advisory from the Medicine and Healthcare products Regulatory Agency (MHRA). On Tuesday, the MHRA in the UK released information advising surgeons that patients with metal-on-metal total hip replacements with head diameter of 36 millimeters or more should be monitored annually for the life of the hip replacement. This is an update from April of 2010 when the MHRA advised surgeons that patients only need monitoring for a minimum of five years after the initial operation.

According to Dr. Susanne Ludgate, Clinical Director of the MHRA, “As a precautionary measure, we have today issued updated patient management and monitoring advice to surgeons and doctors that they should annually monitor patients for the lifetime of their metal on metal total hip replacements that are sized 36 millimetres or more because this particular type of hip replacement has a small risk of causing complications in patients. … By monitoring patients every year, any complications will get picked up earlier and more complex surgery on the patient can be avoided.”

Metal-on-metal devices can create metal toxicity or metal ion debris due to the friction and wear between the metal cup and metal ball. These ions may destroy surrounding tissue, bone, and muscle. The BBC reported that Tony Nargol, a consultant surgeon at the University Hospital of North Tees, has seen “…patients with 10, 20, 50 times normal levels,” of chromium and cobalt in the blood.

In August of 2010, DePuy Orthopaedics, Inc. , subsidiary of Johnson & Johnson, voluntarily recalled both of its all metal ASR hip replacement systems – the ASR XL Acetabular Hip Replacement System and the ASR Hip Resurfacing System. This recall came after data from the National Joint Registry of England and Wales indicated that the five-year failure rate of these products is approximately 13 percent, or 1 in 8 patients.

Additionally, Nargol has performed research which suggests there is a problem with another DePuy metal-on-metal hip implant, the Pinnacle, which is currently still on the market. According to the BBC, Nargol’s hospital tested the nearly 1,000 patients who had been fitted with the all-metal Pinnacle there. Nargol said, “… that out of about 970 patients, 75 failures related to metal debris, which is really quite high.”

Meanwhile, as reported by The New York Times, the Food and Drug Administration maintains its current recommendations for metal-on-metal hip patients. Erica Jefferson, a spokeswoman for the FDA, told The New York Times that the agency continues “to recommend that hip replacement patients undergo regular follow-up with their physicians.”

Parker McDonald and Harrison Davis Steakley Morrison currently represent hundreds of clients across the country who have received the DePuy ASR XL Acetabular Hip System or Pinnacle metal-on-metal hip implant. The firms have established a website, http://www.hipimplantrecovery.com, to provide the latest information for concerned defective hip implant patients and their families.

About Parker McDonald

Parker McDonald, P.C. offers comprehensive legal services for clients whose personal, business or property rights have been adversely affected. Built on years of trial experience, Parker McDonald lawyers are dedicated to a tradition of personal service and timely delivery of outstanding results. Parker McDonald has offices in Bedford, Fort Worth, Houston, Austin, and San Antonio.

Follow Parker McDonald on Facebook and Twitter.


 

The Statute of Limitations Will Bar Late Filed Claims

Hip implant lawsuits must be filed before the legal deadline, also known as the statute of limitations. The two year anniversary of DePuy’s recall of the ASR hip implant will be in August 2012. It is possible that this may serve as the deadline for filing an ASR hip implant lawsuit. We believe that ASR patients should attempt to file a lawsuit prior to the two year anniversary of the ASR recall in order to ensure their legal rights are preserved.

Parker McDonald Reports On Recent Depuy Email Revealed By The New York Times

The New York Times recently has published an internal email from an executive at DePuy.
Fort Worth, TX  February 27, 2012

Parker McDonald, P.C. recently reported on The New York Times investigation which showed DePuy Orthopaedics, Inc. continued to market one of its hip devices after it was rejected by the Food and Drug Administration. On February 21, 2012, The New York Times published an internal email that Pamela Plouhar, vice president for worldwide clinical affairs at DePuy, sent regarding a “non-approval” letter from the FDA revolving around a DePuy hip device.

In the email Pamela Plouhar explained that the FDA refused to approve the ASR Hip Resurfacing System due to company studies showing that there were “…a significant number of revisions within the ASR group…as opposed to very few in the control group.” According to the New York Times, these statements contradict those made by DePuy and Johnson & Johnson in recent years.

DePuy continued to market the device overseas without notifying regulatory agencies, nor did the company address the non-approval letter to patients or doctors. Even so, it is not suggested that either DePuy or Johnson & Johnson violated the law.

According to The New York Times, DePuy placed the failure of the ASR on orthopedic surgeons and maintained its safety and effectiveness. However, the findings rejected by the FDA came from ASR studies performed by surgeons chosen by DePuy, including some who had developed it.

Another model in the ASR hip device family, the DePuy ASR XL Acetabular Hip System, was cleared for use in the U.S. in 2005 through the highly controversial 510(k) process. The company used the 510(k) clearance process to fast track its XL Acetabular Hip System without conducting clinical trials, because DePuy claimed it was “substantially equivalent” to a device previously marketed in the U.S.

The New York Times reports that documents dated from September 2009, just weeks after the FDA’s decision, “…indicate that top DePuy executives decided to phase out the device.” DePuy executives reportedly made this decision based on declining ASR sales while maintaining that the device was safe.

In August of 2010, DePuy voluntarily recalled both of its ASR hip replacement systems – the ASR XL Acetabular Hip Replacement System and the ASR Hip Resurfacing System. This recall came after data from the National Joint Registry of England and Wales indicated that the five-year failure rate of these products is approximately 13 percent, or 1 in 8 patients. Symptoms include severe pain, implant loosening, implant dislocation, and toxic heavy metal poisoning. The recall in the United States came nearly a year after the company withdrew the device from the Australian market.

Parker McDonald currently represents hundreds of clients across the country who have received the DePuy ASR XL Acetabular Hip System. The firm has established a website, http://www.hipimplantrecovery.com, to provide the latest information for concerned defective hip implant patients and their families.

About Parker McDonald
Parker McDonald, P.C. offers comprehensive legal services for clients whose personal, business or property rights have been adversely affected. Built on years of trial experience, Parker McDonald lawyers are dedicated to a tradition of personal service and timely delivery of outstanding results. Parker McDonald has offices in Bedford, Fort Worth, Houston, Austin, and San Antonio.

Follow Parker McDonald on Facebook and Twitter.

Parker McDonald Concerned Over Recent British Study Connecting Metal-On-Metal Hip Implants to Increased Cancer Risks

A recent British study connects metal-on-metal hip implants to cancer risks.

Parker McDonald, P.C., a Texas law firm representing hundreds of patients who received DePuy metal-on-metal hip implants, is concerned of suggested early findings from a British study on the effects of metal-on-metal hip implants reported by The Telegraph on January 28th, 2012. According to the article, the British study is thought to suggest that metal particles from metal implant devices may increase the risk of cancer and genetic damage. The study included 72 patients, 17 of which experienced genetic damage to the bladder, and three patients developed “full blown” cancer.

Metal-on-metal devices can create metal toxicity or metal ion debris due to wear from the metal cup and metal ball rubbing against each other. These ions may destroy surrounding tissue, bone, and muscle. The report released last week on the British study implies that these metal ions can cause major organ damage and increase the risk of cancer. According to the proposed study, in the article, it detected changes to cells in the bladders of more than one in five patients who were monitored after receiving metal-on-metal hip implants.

The DePuy metal-on-metal hip implant U.S. recall in August of 2010 created heightened scrutiny over the materials used in replacement hips. Manufacturers have used metal, ceramic and plastic pieces to construct the ball-and-socket structure. The metal-on-metal combination was marketed to be more durable, but high failure rates and metal toxicity has compromised the health of thousands of patients.

In May of last year, the FDA issued 145 orders for post market surveillance studies to 21 manufacturers of metal-on-metal hip systems, including Zimmer Holdings, DePuy, Wright Medical, Biomet, and Smith & Nephew. According to the FDA, data from the studies conducted will enable the agency to better understand metal-on-metal devices and their safety profiles.

If you or a loved one has a DePuy ASR or Pinnacle metal-on-metal hip implant you may have a claim against the manufacturer, contact Parker McDonald today. Visit http://hipimplantrecovery.com/ for more information on the defective hip implants, symptoms, and how to process a legal claim.

About Parker McDonald
Parker McDonald, P.C. offers comprehensive legal services for clients whose personal, business or property rights have been adversely affected. Built on years of trial experience, Parker McDonald lawyers are dedicated to a tradition of personal service and timely delivery of outstanding results.

Johnson & Johnson Continued to Market ASR Hip Device After Rejected by FDA

Fort Worth, Texas, Feb. 21, 2012 – Parker McDonald, P.C. reports on a recent investigation by The New York Times which found that healthcare giant Johnson & Johnson continued to market its DePuy ASR Hip Resurfacing System overseas after it was rejected by the Food and Drug Administration in the United States.

According to The New York Times, in a confidential letter sent to Johnson & Johnson, the F.D.A. told the company that studies and clinical data submitted to gain approval in the United States were inadequate to determine its effectiveness and safety.  Johnson & Johnson continued to market the device overseas without notifying regulatory agencies, nor did the company address the nonapproval letter in financial reports or in presentations to analysts. Even so, it is not suggested that Johnson & Johnson violated the law.

Another model in the ASR hip device family, the DePuy ASR XL Acetabular Hip System, was cleared for use in the U.S. in 2005 through the highly controversial 510(k) process. The company used the 510(k) clearance process to fast track its XL Acetabular Hip System without conducting clinical trials, because DePuy claimed it was “substantially equivalent” to a device previously marketed in the U.S.

In August of 2010, DePuy voluntarily recalled both of its ASR hip replacement systems – the ASR XL Acetabular Hip Replacement System and the ASR Hip Resurfacing System. This recall came after data from the National Joint Registry of England and Wales indicated that the five-year failure rate of these products is approximately 13 percent, or 1 in 8 patients. Symptoms include severe pain, implant loosening, implant dislocation, and toxic heavy metal poisoning. The recall in the United States came nearly a year after the company withdrew the device from the Australian market.

Parker McDonald currently represents hundreds of clients across the country who have received the DePuy ASR XL Acetabular Hip System. The firm has established a website, www.hipimplantrecovery.com, to provide the latest information for concerned defective hip implant patients and their families.

###

About Parker McDonald
Parker McDonald, P.C. offers comprehensive legal services for clients whose personal, business or property rights have been adversely affected. Built on years of trial experience, Parker McDonald lawyers are dedicated to a tradition of personal service and timely delivery of outstanding results. Parker McDonald has offices in Bedford, Fort Worth, Houston, Austin, and San Antonio.

Follow Parker McDonald on Facebook and Twitter.

Parker McDonald Concerned Over Recent British Study Connecting Metal-On-Metal Hip Implants to Increased Cancer Risks

Fort Worth, Texas, February 22, 2012 Parker McDonald, P.C., a Texas law firm representing hundreds of patients who received DePuy metal-on-metal hip implants, is concerned of suggested early findings from a British study on the effects of metal-on-metal hip implants reported by The Telegraph on January 28th, 2012. According to the article, the British study is thought to suggest that metal particles from metal implant devices may increase the risk of cancer and genetic damage. The study included 72 patients, 17 of which experienced genetic damage to the bladder, and three patients developed “full blown” cancer.

Metal-on-metal devices can create metal toxicity or metal ion debris due to wear from the metal cup and metal ball rubbing against each other. These ions may destroy surrounding tissue, bone, and muscle. The report released last week on the British study implies that these metal ions can cause major organ damage and increase the risk of cancer. According to the proposed study, in the article, it detected changes to cells in the bladders of more than one in five patients who were monitored after receiving metal-on-metal hip implants.

The DePuy metal-on-metal hip implant U.S. recall in August of 2010 created heightened scrutiny over the materials used in replacement hips. Manufacturers have used metal, ceramic and plastic pieces to construct the ball-and-socket structure. The metal-on-metal combination was marketed to be more durable, but high failure rates and metal toxicity has compromised the health of thousands of patients.

In May of last year, the FDA issued 145 orders for post market surveillance studies to 21 manufacturers of metal-on-metal hip systems, including Zimmer Holdings, DePuy, Wright Medical, Biomet, and Smith & Nephew. According to the FDA, data from the studies conducted will enable the agency to better understand metal-on-metal devices and their safety profiles.

If you or a loved one has a DePuy ASR or Pinnacle metal-on-metal hip implant you may have a claim against the manufacturer, contact Parker McDonald today. Visit http://hipimplantrecovery.com/ for more information on the defective hip implants, symptoms, and how to process a legal claim.

###

About Parker McDonald 
Parker McDonald, P.C. offers comprehensive legal services for clients whose personal, business or property rights have been adversely affected. Built on years of trial experience, Parker McDonald lawyers are dedicated to a tradition of personal service and timely delivery of outstanding results.

# # #