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.

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.

Hip Implant Recovery Newsletter – March 2011

DePuy Hip Implant Recall: The Whole Story

DePuy Orthopedics has voluntarily recalled its defective metal-on-metal hip implant systems, including the ASR XL Acetabular device (“ASR”), which was used throughout the United States from 2005 through August 24, 2010. In this newsletter, we answer these questions: (1) how and why is the ASR implant device defective; (2) what did DePuy know about the nature and extent of the defect in the ASR; and (3) when did they know it.

Information About the Human Hip

The human hip is a ball-and-socket joint designed to allow for a wide range of motion. The hip is a complex joint which requires for normal function healthy soft tissue including ligaments, tendons, muscles, nerves, and blood vessels. The most prominent components of the hip, and the most susceptible to degenerative disease, are the “hipbones” and the joint.

The “hipbones” are the femur, commonly known as the thighbone, and the pelvis. On top of the femur is the femoral head. The femoral head is shaped like a ball and fits into a round socket, or “cup”, on the side of the pelvis. This socket, or “cup”, is called the acetabulum. Articular cartilage covers the sruface of the femoral head and the acetabulum and is about one-quarter of an inch thick in the hip join. This cartilage ahs a rubbery consistency and is slippery, allowing the surface of the femoral head to slide smoothly and easily within the join formed in the acetabulum. This design allows for the smooth, wide range of motion needed for daily activities such as walking, climbing stairs, bending and sitting.

Hip Damage and Replacement

If damaged, a hip can be replaced.

The most common cause of damage to the hip join that requires a hip implant is osteoarthritis. Osetoarthritis is a disease linked most commonly to aging. Osteoarthritis causes, among other things, degeneration of the articular cartilage and/or the underlying bones. Advanced osteoarthritis leaves the articular cartilage so rough and pitted that the femoral head no longer slides smoothly over the surface of the acetabulum causing severe pain and discomfort with virtually any movement within the hip joint. Other diseases such as osteonecrosis, which derives from a diminished blood flow to the femoral head, can also damage the hip join leading to the necessity of a hip replacement. Other factors, such as bone tumors and trauma, can also lead to the breakdown of the hip join and necessity of a subsequent hip replacement surgery.

During the hip replacement procedure, the orthopedic surgeon makes an 8-inch incision over the side of the hip, separates the soft tissues in order to enter the join capsule and then dislocates the femoral head from the acetabulum. The surgeon then removes diseased cartilage from the acetabulum and replaces it with the acetabuluar prosthesis – a new “cup” to hold a new femoral head. Next, the surgeon removes the entire diseased femoral head from the femur. The stem of the new femoral head prosthesis is inserted into the hollow center portion of the feumr. To complete the procedure, the “ball” of the new femoral head is placed within the cup, proper alignment is confirmed and the incision is closed. The patient now has a new, artificial hip join.

Hip replacement surgery is very common in the United States with significantly more than 90 percent of hip replacements considered successful in that they require no further surgical intervention. But, this has not been the case with the DePuy ASR.

DePuy’s ASR Replacement Hip Implant System

So how is DePuy’s recalled ASR hip implant different from other hip implants?

In 2003, DePuy released its ASR hip implant system. The DePuy ASR implant was a unique, metal-on-metal design. DePuy promoted the ASR implant as a breakthrough in design that would last longer and provide patients more natural movement. Published reports suggest that the ASR hip implant was designed to last for 15 years.

Unfortunately, researches have concluded that the DePUy ASR metal-on-metal hip implant has major design defects and have expressed grave concerns about its safety. First, the acetabular prosthesis the “cup”, is so shallow it is susceptible to so called “edge loading”, a situation where the joint’s ball strikes against the cup’s edge, chiseling off debris.

This defect leads to potentially severe complications. As the metal-on-metal surfaces of the implant parts rub together, microscopic ions of the heavy metals chromium and cobalt are released into the body. Elevated levels of chromium and cobalt can cause a potentially very dangerous condition know as metallosis. Metallosis is a reaction of the immune system to heavy metals in the body. Metallosis can cause severe complications such as destruction of surrounding bone and muscle. These complications can significantly increase the difficulty a doctor faces in performing a subsequent revision surgery to replace the defective DePuy ASR device.

Symptoms of metallosis include spontaneous dislocation of the join, groin or thigh pain, fatigue, and intense pain at the site of the hip replacement. Questions have been raised whether metallosis may be a cause of heart irregularities and kidney disease. There is also concern that elevated levels of chromium and cobalt can have long-term effects including chromosomal damage and cancer.

Initial Approval; Current ASR Recall

DePuy obtained FDA approval for its ASR hip implant in 2005 through a shortcut process known as the 510(k) approval process. That process preapproves any product that is deemed “substantially equivalent” to those products already marketed for sale and requires no clinical trials. DePuy gained its approval through this system by asserting the “the subject device does not raise any new issues of safety or effectiveness.”

On March 6, 2010, DePuy issued a warning to surgeons in the United States that its ASR hip implant had a higher than expected failure rate. This warning was finally provided a year after DePuy was presented with findings that the ASR implant was failing early and required revision surgery. Shockingly, the March warning letter came nearly three months after DePuy voluntarily withdrew the ASR hip implant from Australian market in December 2009. DePuy continued to promote and sell the ASR hip implant in the United States for over six months after the Australian withdrawal before finally recalling the ASR device in the United States in August 2010.

The Consequences for ASR patients

Estimates are that as many as 93,000 patients worldwide were implanted with the DePuy ASP hip implant. Depuy itself estimates that at least 13 per cent of these patients will experience product failure and will require revision surgery to remove and replace the defective hip implant device. Our review of anecdotal evidence suggests that as many as 30 per cent of patients may experience product failure and will require revision surgery. These procedures will be performed on a predominantly elderly patient population particularly susceptible to potentially sever complications such as deep vein thrombosis, systemic infection, implant dislocation, injury to the arteries or nerves of the leg, shortening of the leg, fat embolism, femur fracture, permanent loss of range of motion and intractable pain. These patients have substantial claims for damages for pain and suffering, metal anguish, physical incapacity, disfigurement, future medical expenses, and costs of future care.

We Can Help

Parker McDonald and Harrison Davis Steakley Morrison have teamed together to form what we believe is the most dynamic and effective DePuy ASR hip implant litigation and trial team in the country. We have decades of experience and an outstanding record of many, excellent successes in representing victims of defective drugs and medical devices. We have committed the substantial financial and manpower resources of both our firms to the cause of the innocent victims of the DePuy ASR hip implant.

It is vital that patients with a DePuy ASR hip implant consult with us before revision surgery to remove and replace an ASR hip implant. It is critical that the patient does not sign the release that DePuy’s agent, Broadspire, may require as condition for paying any part of the cost of revision surgery. On this issue, we stand ready to fund in full and in advance the entire cost of revision surgery in order that our clients have the surgery as soon recommended by the orthopedic surgeon. In addition, it is important that the patient undergo blood tests for chromium and cobalt levels before revision surgery. Finally, it is also important that the patient provide the surgeon with written instructions concerning the preservation of tissue samples and the retention and possession of the explanted ASR device before the revision surgery.

The campaign on behalf of DePuy ASR hip implant victims will be long and challenging and will require special experience, knowledge, talent and resources. We would be honored to accept your referral of ASR hip implant clients. We pay customary referral fees to referring attorneys on all referrals.

Contact us today.
855-487-8447
Dan@ParkerMcDonaldLaw.com
www.HipImplantRecovery.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.

Hip Implant Seminar Schedule

Austin, TX (PRWEB) March 18, 2011

What: DePuy Hip Implant Seminars
Where: Austin: Hyatt Regency—208 Barton Springs Rd. (512-477-1234)
San Antonio: Marriott Plaza—555 South Alamo (210-229-1000)
When: Saturday, March 19
Austin: 9:30 AM
San Antonio: 3:00 PM
Who: The event, sponsored by Parker McDonald P.C. and Harrison, Davis, Steakley, Morrison, P.C., will feature a panel of experts including:

  • Melissa Neiman, M.D., J.D., medical malpractice lawyer and former practicing neurosurgeon, Houston, Texas
  • Brad Parker and Dan McDonald, attorneys from Parker McDonald, P.C., with offices in five Texas cities including Austin and San Antonio.
  • Steve Harrison, Billy Davis, Zollie Steakley, and Matt Morrison, attorneys from Harrison, Davis, Steakley, Morrison, P.C. in Waco.
Why: To address concerns and questions about the DePuy Orthopaedics voluntary recall of its defective metal-on-metal hip implant systems that were used throughout the United States from 2005 through August 24, 2010. These sessions are free and open to the public.
Details: No cost, and no reservations necessary. Call ahead with questions: 800-990-4884.