CBS 11 News Investigation Finds Recalls For Replacement Body Parts

Dan McDonald and a Parker McDonald hip implant client were interviewed by Ginger Allen, a reporter from CBS 11 News in Dallas, to discuss the DePuy ASR hip implant recall.

Parker McDonald Supports House Democrats’ Push for Hip Implants Review

U.S. House Representative Waxman Urges Hearings on Metal-on-Metal Hip Implants

FORT WORTH, Texas – The Parker McDonald Law Firm anticipates a bipartisan effort to investigate the safety of metal-on-metal hip implants. In a letter dated October 12, 2011, United States House Democrats of the Energy and Commerce Committee, led by Rep. Henry Waxman (Calif.), petitioned the Republican leadership to begin hearings on the defective medical devices.

In past hearings, committee members focused on delays in the device approval process. The panel wants to shift their efforts to determine how fees should be reallocated in the federal review process of new medical devices.

Problems with these implants began to grab public attention when in 2010, DePuy Orthopaedics, a subsidiary of healthcare giant Johnson & Johnson, recalled its hip replacement device: the ASR XL Acetabular System. The implant demonstrated a 13% or higher failure rate and created adverse reactions in thousands of patients across the United States. The DePuy metal-on-metal Pinnacle Acetabular Cup System has also been associated with a number of patient complaints similar to the recalled ASR device, though it has not yet been recalled. The FDA has already received 1,000 complaints since its release in 2003.

Rep. Waxman cited the more than 5,000 complaints filed with the Food and Drug Administration about metal-on-metal hip implants. Thousands of patients fitted with the metal-on-metal hip implants have experienced adverse reactions, one of which is metallosis.

“Tiny metal particles may wear off…” said Waxman, allowing cobalt and chromium from the implants to be absorbed by the blood stream, poisoning various parts of the body. Other symptoms include loss of mobility, chronic pain, muscle fatigue, bone deterioration and hip dislocation. The letter also noted the FDA’s mandate for “20 manufacturers of these devices to submit a plan to the FDA to study how frequently they were failing and to examine the health implications of device failures.”

Parker McDonald Law Firm stands ready to represent anyone fitted with a defective metal-on-metal hip implant. Parker McDonald has established http://www.hipimplantrecovery.com to specifically help victims of this tragedy. Parker McDonald represents patients and their families throughout the United States. All cases are reviewed under a contingency fee basis, which means there are no attorney fees unless a recovery is obtained.

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 Law Firm Concerned By FDA Reports Of Skyrocketing Hip Implant Complaints

New York Times Article Notes 5,000 New Complaints about Metal-on-Metal Hip Implants

FORT WORTH, Texas,Aug. 25, 2011,– According to an investigation completed this week by the New York Times, the U.S. Food and Drug Administration has received more than 5,000 complaints in 2011 about faulty hip implants, with the DePuy Articular Surface Replacement (ASR) as the prime culprit. The New York Times reports that’s about double the total number of complaints filed in 2010, which more than doubled the number filed in 2009.Parker McDonald, P.C., a Texas law firm representing a large number of plaintiffs affected by the DePuy ASR recall,is alarmed at the extreme rate that the hip system is failing.

According to the FDA, medical studies found that more than 1 in 8 patients would have their DePuy ASR hip implants fail within 5 years, when the device was approved to last for 15 or more years. A growing number of victims have implants that lasted only a fraction of that time with some experiencing pain within less than a year.Considering that an estimated 500,000 metal-on-metal hip replacements have been implanted in patients, an untold number of failures have yet to be reported.

In the New York Times reporting, the DePuy ASR device accounts for 75 percent of the reports, or nearly 4,000 cases, where patients experienced adverse reactions to the defective hip implant. DePuy Orthopedics, a division of Johnson & Johnson, marketed and sold the ASR hip system as a safe and reliable solution to bone deterioration and mobility complications. In addition, the article notes that there are hundreds of complaints about another DePuy device, the all-metal Pinnacle hip implant.

Parker McDonald patients who filed reports with the FDA have elevated symptoms of pain and hip dislocation.DeeDee Hill-Morgan has battled nausea, dizziness, metallosis (blood poisoning) and blurred vision allegedly because of herhip implant failure.

The FDA implemented new testing requirements for medical device companies, in addition to enlisting their own research team to determine the causes of the defective metal-on-metal hip implants. Although the FDA is taking appropriate action to resolve the cases, the attorneys at Parker McDonald fear that the results will come too late for some of the victims of the DePuy recall. Lead scientists predict that the new standards will take years to fully implement after testing is complete.

Parker McDonald represents DePuy hip implant patients across the country and has established http://www.hipimplantrecovery.com/to provide the latest information for concerned DePuy ASR and Pinnacle hip implant patients and their families. The firm has offices in five Texas cities. For more information visit the Parker McDonald website.

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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: One Year Milestone of DePuy ASR Metal-on-Metal Hip Implant System Recall Approaching

(Fort Worth, Texas)… Parker McDonald P.C., a Texas law firm, is now one year into its work representing plaintiffs seeking remedies for medical issues arising from the failure of metal-on-metal hip implant devices, many of those issues coming to light after an August 2010 recall of DePuy Orthopaedics, Inc.’s ASR XL Acetabular Hip Replacement System. Twelve months ago, DePuy, a subsidiary of healthcare giant Johnson & Johnson, recalled the ASR system following release of data from a study by the National Joint Registry (NJR) of England and Wales that indicated the five-year failure rate of this product was approximately 13 percent, or one in every eight patients receiving one of the hip implants, according to DePuy’s website.

According to Parker McDonald, in the recalled ASR device, the cup is so shallow that it is susceptible to so called “edge loading,” a situation wherein the joint’s ball strikes against the cup’s edge and causes the implant parts to rub together and chisel off debris that releases microscopic ions of the heavy metals chromium and cobalt into the body. Such elevated levels can cause metallosis, a reaction of the body’s immune system to heavy metals with potential negative affects on multiple organs and organ systems. Many patients have required an additional surgery, known as a revision surgery, to remove the defective implant.

“The system had been released to consumers in the United States in 2005. In March of 2010, DePuy issued a warning to surgeons in the United States that its ASR hip implant had a higher than expected failure rate but didn’t recall its ASR hip implant system until August,” said Dan McDonald, principal with the firm. “The company had voluntarily withdrawn the ASR hip implant from the Australian market in December 2009, nearly a year before it was pulled from the US market”.

DePuy is also under scrutiny for its metal-on-metal Pinnacle Acetabular Cup System. In May of this year, the United States Judicial Panel on Multidistrict Litigation (MDL) filed a transfer order consolidating all lawsuits involving the Pinnacle Acetabular Cup System in In Re: DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation, MDL No. 224. The litigation will be overseen by the Honorable Judge James E. Kinkeade in the U.S. District Court of the Northern District of Texas.

Pinnacle patients have reported experiencing problems similar to those receiving the recalled ASR device, according to reports. The lawsuits involved raise the questions of whether the Pinnacle device was defectively designed and/or manufactured and whether DePuy failed to provide adequate warnings concerning the device. These hip implants have been available nationwide since their release into the market in 2002.

“We’re working with patients who have received a DePuy ASR or metal-on-metal Pinnacle hip implant who may qualify for compensation for the costs of additional surgeries and related medical care, physical incapacity, disfigurement, pain, suffering, and mental anguish,” Mr. McDonald explained. Parker McDonald has established an online website, www.hipimplantrecovery.com to provide the latest information for concerned DePuy ASR and Pinnacle hip implant patients and their families.

To date, according to a recent Wall Street Journal article, nearly 1,000 lawsuits have been filed in federal and state courts across the country against DePuy Orthopaedics for its defective hip implant devices.
Recently, as reported by Bloomberg, the FDA ordered all metal-on-metal hip device manufacturers to conduct studies of patients who received a metal-on-metal device. Problems encountered by patients dealing with hip implant defects have also been reported in The New York Times and other national publications.

Parker McDonald has offices in five Texas cities and is accessible via Twitter and Facebook. Website is www.ParkerMcDonaldLaw.com.

The FDA is Holding Hip Implant Manufacturers Accountable

FDA holds hip implant manufacturers accountable for defective productsLike thousands of people around the world, Michael Stieler depended on a DePuy hip implant to help him regain his mobility. Only a year after the procedure, Stieler realized that his implant was giving him debilitating pain and kept him from walking. He received a recall notice last year explaining the implant’s malfunction and the possibility for metal poisoning. Stieler now had to worry not only about losing his ability to walk but also if his very life was in danger.

Many people like Michael Stieler had active lives and subsequently needed hip replacement surgery. However, the DePuy hip implant recalls have only served to hinder a patient’s ability to return to the life they enjoyed.

The Food and Drug Administration is stepping up its enforcement on the 21 companies that market metal-on-metal hip replacements. The FDA now requires that hip implant manufacturers to actively observe and assess any reactions that implants may cause in recipients.

These new measures by the FDA are a result of consumer complaints over the high failure rates and their adverse reactions. The FDA hopes to target the cause of the high failure rates by cross-examining the information from the 21 manufacturers.

They focus on:

  • device performance
  • blood testing
  • body imaging

Representatives from the 21 companies, along with some surgeons, insist that a majority of these implants are not failing and there shouldn’t be cause for alarm.

However, what about the thousands of people who have had their implants fail? What are these companies doing to protect them now?

The American Academy of Orthopedic Surgeons reports that more than 250,000 hip replacements are performed annually with 30 percent involving metal-on-metal implants. That represents more than 75,000 people who are at risk for metal blood poisoning and tissue infections that ultimately lead to painful revision surgeries. Many of these patients don’t have the finances to pursue yet another costly medical procedure. Many may find themselves living with the pain rather than getting the help they need.

If you’re like Michael Stieler and received a DePuy hip implant from 2005-2009, you too may be at risk. Pain in the hip area, inability to walk or stand, and a metal taste to food are clear indicators that your hip implant is failing. It is best that you contact a trusted physician immediately to assess your situation.

If you happen to be one of the thousands with a failed implant, contact the lawyers at Parker McDonald Law. Let us be your defense against the negligence of DePuy.

Follow and like us on Twitter and Facebook for more updates and information about our services and DePuy hip implant seminars.

Parker McDonald: FDA Approves First Ceramic-on-Metal Total Hip Replacement System; Firm Hopes for Different Outcome Than Current Metal-on-Metal Implant Systems

(Fort Worth, Texas)… Parker McDonald P.C., a Texas law firm representing plaintiffs seeking remedies for medical issues arising from the failure of metal-on-metal hip implant devices, is hopeful upon hearing the recent news of the Food and Drug Administration’s approval of a new ceramic-on-metal total hip replacement from DePuy Orthopaedics, a subsidiary of Johnson & Johnson.

The newly approved Pinnacle CoMplete Acetabular Hip System is the first ceramic-on-metal total artificial hip system for patients with osteoarthritis.  As the FDA’s news release explains, “…previous total hip replacement systems cleared or approved by FDA have used different combinations of metal, ceramic and polyethylene (a form of plastic).”

Parker McDonald is hopeful the Pinnacle CoMplete will be a new, reliable option for those patients requiring hip implant surgery and will be free of the problems plaguing patients implanted with the DePuy ASR or the Pinnacle Acetabular Cup System. The firm represents patients with claims originating because of two DePuy hip replacement systems: the defective ASR XL Acetabular metal-on-metal hip replacement system, which was recalled in August of 2010 and the other is the Pinnacle Acetabular Cup System.

As a condition of FDA approval of the Pinnacle CoMplete system, DePuy is required to conduct a post market study, monitoring patients receiving the Pinnacle CoMplete system for adverse events and metal ion concentrations in their blood.

Parker McDonald notes that many patients who received the recalled DePuy metal-on-metal ASR device and the metal-on-metal Pinnacle device have experienced complications including severe pain, implant loosening, and early failure. Additionally, as the metal-on-metal surfaces rub together, the implant may deteriorate, resulting in the release of the toxic metals chromium and cobalt into the blood; such blood poisoning can lead to heart complications, death of tissue in the hip joint, and loss of surrounding bone, and, eventually, create more problems if an additional hip surgery is required, according to Parker McDonald.

Recently, as reported by Bloomberg, the FDA ordered all metal-on-metal hip device manufacturers to conduct studies of patients who received a metal-on-metal device. Problems encountered by patients dealing with hip implant defects have also been reported in The New York Times and other national publications.

Parker McDonald, P.C. represents DePuy hip implant patients across the country and has established this website to provide the latest information for concerned DePuy ASR and Pinnacle hip implant patients and their families. The firm has offices in five Texas cities and is accessible via Twitter and Facebook. Website is www.ParkerMcDonaldLaw.com.

Is the New DePuy Hip Replacement Implant Really Safe for Patients?

With all the recalls, could you trust a hip replacement implant manufacturer that has given you debilitating pain and impaired health? DePuy Orthopedics believes that you can and will. DePuy has a dangerous history of supplying up to 96,000 patients worldwide with faulty hip implants. As they try to promote their new system, questions arise among healthcare professionals and patients if it is truly safe.

In June of 2011, the U.S. Food and Drug Administration (FDA) approved DePuy’s restructured PINNACLE® CoMplete® Acetabular Hip System. This revised device features a ceramic-on-metal combination instead of previous implants that were metal-on-metal. DePuy boasts that the CoMplete system is stable, durable, and friction has less of an impact on the implant. Previously, systems like the ASR XL Acetabular Replacement, ASR Resurfacing, and Pinnacle Acetabular were all marketed with descriptions of very similar characteristics. All three reported failures that damaged the expectations of consumers and forever changed their lives.

There are, however, improved options that allow surgeons to select from five possible component combinations based on patient requirements. Nevertheless, the potentially poisonous metal-on-metal selection is still available.

Prior to approval, the FDA preformed a two-year clinical trial of the CoMplete system. They compared results from controlled, random, and two other experimental sets before making their ruling to accept the new specifications. Regardless of their ruling, potential risks remain for patients who elect to use this new hip replacement implant. Patients may still encounter joint dislocation, tissue infections, and deterioration of the implant. Although DePuy states that they will initiate post-market analysis of this new system, it’s hard to know how many patients may have adverse reactions during this time.

So, how do you avoid becoming a victim of DePuy Orthopedics? The best way is to contact a trusted orthopedic surgeon for their expert opinion about the CoMplete hip implant. They can assess your unique situation and suggest what will work best for you. This is especially important for previous DePuy implant patients who are looking to undergo a revision surgery. No one should have to endure the pain of yet another hip implant disaster.

Contact the lawyers at Parker McDonald law for their legal expertise on DePuy hip replacement cases if you are currently experiencing problems with your implant. We are prepared to litigate your claim in a court of law.

Read more about the history of DePuy’s defective hip implants.

Parker McDonald Notes Positive Aspects of Centralization of Hip Implant Cases through Pinnacle MDL

(Fort Worth, Texas)…Dan McDonald, principal of Parker McDonald P.C., a Texas law firm representing plaintiffs seeking remedies for medical issues arising from hip implant failure, recently acknowledged the significance of the United States Judicial Panel on Multidistrict Litigation (MDL) announcement that the panel has filed a transfer order consolidating all lawsuits involving DePuy Orthopaedic, Inc.’s Pinnacle Acetabular System hip implants in In Re:DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation, MDL No. 2244. The litigation will be overseen by the Honorable Judge James E. Kinkeade in the U.S. District Court of the Northern District of Texas.

“After careful consideration of both the plaintiffs’ and defendants’ Motion to Transfer, the panel determined that since common questions are involved and for the convenience of parties and witnesses, pretrial hearings can be held in the Northern District of Texas,” said Mr. McDonald.

The MDL Order stated, “On the basis of the papers filed and the hearing session held, we find that these three actions involve common questions of fact, and that centralization under Section 1407 will serve the convenience of the parties and witnesses and promote the just and efficient conduct of the litigation.”

The lawsuits involved raise the questions of whether the Pinnacle Acetabular System, a device used in hip replacement surgery, was defectively designed and/or manufactured and whether defendants failed to provide adequate warnings concerning the device. These implants have been sold nationwide since their release into the market in 2002.

“The Pinnacle MDL was established less than a year after DePuy recalled its ASR hip implant system that was released in 2003,” Mr. McDonald explained.

The company voluntarily withdrew the ASR hip implant from the Australian market in December, 2009, and from the United States market in August, 2010. The Pinnacle implant incorporates a metal-on-metal construction similar to DePuy’s ASR.

Parker McDonald, P.C. represents DePuy hip implant patients across the country and has established www.hipimplantrecovery.com to provide the latest information for concerned DePuy ASR and Pinnacle hip implant patients and their families. The firm has offices in five Texas cities and is accessible via Twitter and Facebook. Website is www.ParkerMcDonaldLaw.com.

Parker McDonald Law Firm Launches Revamped Information Website hipimplantrecovery.com

Fort Worth, Tx (PRWEB) June 06, 2011 — The hip implant lawyers of Parker McDonald announced today that they have taken yet another step to ensure that those suffering from failed DePuy hip replacement systems receive the care they need, launching an exhaustive, updated website covering everything about hip implant failure and featuring several new areas of interest.

“Parker McDonald is committed to sharing updates on the DePuy Pinnacle Acetabular system,” stated principal Dan McDonald. “While this unit has not been recalled like the ASR XL Acetabular System and ASR Hip Resurfacing System, increasingly more Pinnacle Acetabular system patients are reporting pain as well as increased levels of chromium and cobalt in their bloodstreams.

“DePuy hip replacement patients can use hipimplantrecovery.com to keep up with the rapidly changing medical and legal environments,” he continued. “Staying informed is an important step to patients and their families.”

Site visitors can now find informative videos about hip implant failure. The video “3 Things You Need to Know about a DePuy Hip Replacement Lawsuit” highlights key concerns like cancer and kidney failure. Another shares a first-hand account of a patient who suffered negative effects from a DePuy hip implant, including toxic metal blood poisoning.

“If you or a loved one received a DePuy hip implant, you may qualify for compensation for the costs of additional surgeries and related medical care, physical incapacity, disfigurement, pain, suffering, and mental anguish,” Dan McDonald emphasized.

To contact the hip implant lawyers of Parker McDonald Law Firm, call toll free 800-990-4884 or review information online.

About Parker McDonald
Founded in 2010, 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. The firm’s website is www.ParkerMcDonaldLaw.com.

Parker McDonald Law Firm Accepting Cases in the Johnson & Johnson DePuy Hip Implant Recall

April 11, 2011 FORT WORTH, Texas – DeeDee Hill-Morgan noticed that her scrambled eggs at breakfast tasted like metal. She also battled bouts of nausea, dizziness and blurred vision. The problems started shortly after DeeDee, a client of Parker McDonald Law Firm, received her second DePuy ASR hip implant, manufactured by DePuy Orthopaedcis, Inc., a subsidiary of Johnson & Johnson. DeeDee, and potentially thousands of other DePuy hip replacement recall patients, suffers from metal poisoning from her hip implant. The defective DePuy ASR hip implant releases particles of the toxic heavy metals, cobalt and chromium, into the bloodstream.

Studies by the Center for Disease Control (CDC) indicate these cancer-causing metals may damage the heart, brain, and kidneys. The New York Times recently reported that, because of DePuy’s hip replacement failure, “many patients … developed inexplicable pain, and surgeons, when replacing the implant, discovered mysterious masses of dead tissue near the thighs of some patients.”

DeeDee tells her story in this video, http://www.youtube.com/watch?v=kCAye__7pBQ.

In August of 2010, DePuy recalled two of its hip replacement systems – the ASR XL Acetabular Hip Replacement System and the ASR Hip Resurfacing System. This recall came after data from a study 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.

Some patients have required a second surgery, also known as a revision surgery, to replace the defective DePuy implant. Even if you are not experiencing problems at this time, the implants may eventually cause hip pain, difficulty walking, damage to the hip joint, and loss of bone cells. Thus, it may be necessary for you to have the system removed and replaced by another hip replacement system to avoid future problems.

If you or a loved one received a DePuy ASR hip implant, you may qualify for compensation for the costs of additional surgeries and related medical care, physical incapacity, disfigurement, pain, suffering, and mental anguish. You can contact the hip implant lawyers of Parker McDonald Law Firm at 855-HURT-HIP (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. The firm’s website is www.ParkerMcDonaldLaw.com.