SULLO & SULLO

Taking Charge: A Blueprint for DePuy Hip Implant Recipients to Follow for Successful Recovery

2012-02-05T23:24:00.000-08:00

Taking Charge: A Blueprint for DePuy Hip Implant Recipients to Follow for Successful Recovery

Introduction:

While the FDA began receiving complaints regarding the failure of hip replacement devices manufactured by DePuy Orthopedics (a subsidiary of Johnson & Johnson) for some time, there was not a DePuy hip extensive recall on the device until August of 2010. Many feel the recall should have come much sooner and that the company knew there were issues with the implant for a significant period of time before they issued the recall. Many of the patients who have been implanted with a DePuy hip replacement device later required a second surgery when their original implant failed. This DePuy hip implant failure has negatively affected the quality of life for its recipients.

Although DePuy states they did not keep records of those implanted with the artificial hip device, it is estimated there are over 100,000 of the implants worldwide. The FDA received over 400 complaints between 2008 and 2010, when the device was finally recalled. The DePuy hip replacement implements a metal-on-metal hip replacement bearing technique which can cause metal shavings to spread into the body causing inflammation and tissue damage. Early estimates by DePuy puts the number of patients who needed a second hip replacement within five years of the first DePuy implant at between 12 and 13%, although an independent study put the need for a replacement surgery as high as 49% within six years.

DePuy’s hip replacements systems, the ASR XL Acetabular and ASR Hip Resurfacing System were approved under the somewhat lax 510(k) FDA approval process which only requires that manufacturers demonstrate that new devices are substantially equivalent to preexisting devices. DePuy used this process to obtain approval for their metal-on-metal hip replacement devices, claiming their components contained standardized design characteristics.

Finding Out if Your Hip Replacement Was Recalled by DePuy
If you have received a metal-on-metal hip replacement device within the past seven or eight years, you should definitely be checked out to determine whether or not your implant device was manufactured by DePuy, and whether you are suffering any problems as a result. You may be unaware of the specific type of device you received, and therefore should call your doctor or the surgeon who performed the procedure. If you cannot find out whether your metal-on-metal hip replacement is a DePuy hip replacement recall, then try calling the hospital where your operation took place. Remember that even if you are not experiencing pain, swelling or localized discomfort your hip replacement device may still be faulty, leading to painful or dangerous side effects in the future. Your doctor or surgeon should be aware of the DePuy hip replacement recall and call you to schedule a visit however this may or may not happen meaning you must be proactive regarding your health.

Testing for Problems
Once you have an appointment with your doctor, he or she will be aware of whether the implant device you received was one of the two types recalled by DePuy and will likely have blood tests run in order to determine if you have unusual levels of the metals cobalt and chromium in your body. A second blood test may be ordered to confirm the results of the first. Some patients are subject to a cobalt allergy, and may suffer from heavy metal toxicity or heavy metals poisoning from the cobalt in their hip replacement. You may suffer from either cobalt or chromium toxicity, both of which have serious side effects. Your doctor will also conduct further tests to determine whether your hip replacement is working as it was intended to work. These tests may include x-rays which will allow your surgeon to evaluate how the ASR hip system is positioned, whether there has been any significant damage to the surrounding bone, and whether the DePuy ASR hip system has remained attached to the bone. An MRI or ultrasound could be a part of the testing procedure to determine whether your hip device requires replacement.

Who Will Pay for Your Tests?
According to DePuy’s own website regarding the recalled hip implant devices, it is stated that they will work with public and private insurers—including Medicare—to establish a simplified process for addressing financial claims. The company also asks that any person who has established they were implanted with a recalled DePuy hip implant device contact the DePuy ASR help line to initiate a claim. DePuy states they will cover recall-related patient out-of-pocket expenses however it is very important that you discuss the issue thoroughly with a product liability attorney before agreeing to anything with DePuy or signing any paperwork.

Potential Side Effects of a Defective DePuy Hip Implant
Those who have undergone a DePuy hip replacement with one of the known defective devices may have suffered continuing pain in the hip, groin, leg or lower back or may hear an audible crunching or clicking sound which comes directly from the ASR device. Some recipients of the ASR state that they feel their hip is out of place, most particularly when starting a movement such as standing from a seated position or beginning to walk. In fact, any activity which causes the hip to bear weight may cause moderate to severe pain and swelling as well as other DePuy hip recall symptoms directly related to the recalled device.

There may be noticeable declines in the ability to perform physical activities which were once considered normal, and a bone scan may show increased metabolic activity near the location of the hip implant. Just as alarming, as noted above, when the ASR hip devices begin to deteriorate, they leave small metal shavings in the recipient’s bloodstream which can lead to several serious health issues. The body can have an adverse tissue reaction to these chromium and cobalt metal flakes known as an ALVAL (asceptic lymphocyte-dominated vasculitis associated lesion) or can react to the metal by forming pseudotumors.

The blood test administered by your physician should determine whether you have heightened levels of metal shavings in the blood surrounding your hip replacement. Because it can take several years for problems with these metal particles to arise, it’s important that you continue to be monitored for problems through periodic blood tests. This is true even in the absence of pain, swelling or localized discomfort. In the most extreme cases, the DePuy ASR hip implant can completely fail. This can happen when the implant loosens from the bone, dislocates itself or when the bone around the hip implant fractures.

Corrective Procedures for a DePuy Recalled Hip Device
Just as the initial hip replacement surgery was painful, revision surgery will be equally if not more painful for those whose DePuy implant has failed. There are a number of potentially serious complications which can result from this invasive revision surgery including anesthesia issues, moderate to severe levels of infection, pulmonary embolisms and even deep venous thrombosis. In many cases dislocation occurs following a hip revision surgery due to the weakened tissues which surround the affected bone and implant device. The bones are likely in a much more fragile state than they were during the first surgery because of bone deterioration and possible metal shavings in the bloodstream.

One study found that the long-term risk of dislocation for revision hip replacements was as high as seven percent. It is generally understood that a hip revision surgery has an even less favorable outcome potential than the original hip implant surgery. Many of those who undergo a revision surgery will require a longer hospital stay as well as a longer recovery period and may need assistive devices such as canes and walkers for a considerable length of time following the surgery. Those who undergo hip revision surgery may end up with a smaller range of motion than was seen with the first surgery and long-term discomfort could be substantially higher. It is believed that a second hip implant may last only eight to ten years, while the first implants generally last for fifteen—assuming they are not one of the recalled devices which have caused health problems.

Legal Ramifications of the DePuy Hip Replacement Device
The metal-on-metal hip replacements comprise roughly one-third of the 250,000 hip replacement devices used annually in these procedures. One Cornell-based doctor estimates that tens of thousands of people will eventually have to undergo revision surgery procedures to remove the defective hip implant. As of October, 2010, over 3,500 people had filed product liability suits against DePuy, and another 560 are suing the company regarding the non-cemented version of the Pinnacle Hip Replacement System. Naturally, those who have been forced to undergo revision surgery will want DePuy to pay for these surgeries through a replacement settlement or court judgment, and insurers will want to be reimbursed for subsequent procedures.

This means that money received from a recall reimbursement could end up going right back to your insurance company. Medicare is attempting to seek reimbursement from DePuy for any procedures they have paid for or will pay for which occurred because of the hip device recall. Recipients of the recalled DePuy hip implants should be aware that a lawsuit could result in plaintiff damages for full medical expenses, lost wages, costs for transportation, reimbursement for pain and suffering and possibly even punitive damages. These recovery amounts could be considerably more than what recipients will obtain from DePuy’s own recall reimbursement process.

How Will I Choose an Attorney for My DePuy Hip Implant Product Liability Case?
Before contacting DePuy Orthopedics, you should consult a qualified hip replacement attorney who is skilled in product liability. Because DePuy has not been particularly forthcoming regarding their defective products, it would be unwise for those who have received a DePuy hip replacement device to trust that they will be taken care of. Evidence shows that DePuy and Johnson and Johnson were well aware of the problems associated with the metal-on-metal hip implants for a significant period of time before they initiated their voluntary recall of the devices. For this reason alone, a DePuy hip replacement lawsuit could be your best choice.

A DePuy lawsuit brought by a qualified product liability attorney can ensure you recover medical costs such as hospital bills, physical therapy and supplemental doctors’ visits as well as paying the costs for hiring a caregiver. Your attorney will work hard to recover these medical expenses as well as travel expenses, loss of income, scarring and disfigurement and pain and suffering—items DePuy definitely does not want to be responsible for. You may be able to receive compensation for damaged relationships, loss of satisfaction in your life, loss of independence and mobility as well as the psychological effects and chronic pain you have undergone as a direct result of the DePuy hip implant device. Ask plenty of questions before you settle on the attorney for your hip replacement lawsuit to ensure you find the most experienced attorney who will fight hard for your rights. Time, tenacity and diligence are traits you will definitely want in your chosen DePuy recall product liability lawyers.

“Hip” Definitions: A Discussion of Medical Terms Every DePuy Hip Implant Recipient Should Know

2012-02-05T23:21:00.001-08:00

“Hip” Definitions: A Discussion of Medical Terms Every DePuy Hip Implant Recipient Should Know

Introduction

July of 2003 saw the worldwide introduction of the metal-on-metal hip replacement by DePuy, although these devices were not used for hip replacement surgeries in the United States until 2005. Johnson & Johnson, the parent company of DePuy, pushed the approval of the hip implant device through the FDA under an expedited process known as the 510(k). This process allows many medical devices to skip rigorous clinical trials when the manufacturer can show the device is substantially equivalent to another device which has already received approval. At the time of the 510(k) approval, DePuy claimed the ASR hip replacement device raised no new issues of safety or effectiveness.

Complaints Regarding the DePuy Implant
Over the next few years, the FDA began receiving a flood of complaints regarding these devices, and many of the DePuy metal-on-metal hip implants had to be removed for the health of the recipient. Although a traditional metal-on-metal hip implant device can reasonably be expected to last at least fifteen years, the DePuy devices were failing at a much higher—and earlier—rate. Even though DePuy was notified of the health issues surrounding the implant as early as 2007, they continued to market the hip implants until August 26, 2010, when DePuy and Johnson & Johnson finally issued a voluntary Depuy hip extensive recall of the implant system. Those who have undergone the hip implant surgery with a DePuy implant may be confused regarding the potential health risks and uncertain of how to proceed and should be aware that a DePuy hip replacement lawsuit is an option.

Incidence of Revision Surgery Following a DePuy Hip Implant
While not all recipients of the DePuy hip implant will require replacement surgery, it is estimated that at least 13% of the hip implantations will require revision surgery within five years of the initial implantation, and that a possible 49% of the hip implants are susceptible to failure within six years. At a medical conference in Ireland in early 2011, it was stated that as many as 1700 out of 3500 Irish hip implant recipients required revision surgery—a number substantially higher than DePuy’s own 13% estimate. As you can see, there is no definitive answer as to whether or not you will require a revision surgery following your DePuy hip implant failure, and whether that device will cause you subsequent medical issues whether minor or severe.

Why Hip Implant Replacement Surgery May Be Necessary
Some of the problems noted by physicians who have replaced the defective DePuy hip implants are loosening of the cups, dislocation, lack of bone growth into the cups and inflammation or other issues related to the metal shavings which are released into the body. Some patients experience metallosis which indicates the presence of tiny metal particles which have accumulated in the fluid surrounding the tissues of the area and are tinged with a gray color. If the fluid surrounding the tissues is yellow-tinged this is known as “serous” and means the tissues are relatively normal, with only small amounts of the metal particles present.

Should the fluid be tinged with blood, it is called “sero-sanguinous” and this typically indicates a loose component in the implant which has caused trauma and bleeding to the bone. A thick, milky or cloudy fluid may first indicate infection, and can be tied to adverse reactions to the metal-on-metal bearing surfaces. In many cases, the fluids from a failed DePuy hip replacement appear to be toxic to human tissue cells, leading to damage or an unusual appearance.

When the Tissues inside the Joint are Damaged
In certain cases, the tissue within the joint capsule can break down following the original hip replacement surgery, meaning it will not be repairable because the soft-tissue hip envelope is gone. This can be quite serious for the person who needs a replacement surgery after the removal of the DePuy implant. This breakdown of tissue can also lead to a much higher dislocation rate should revision surgery be attempted. In some cases, there can be a thickening of the synovium, or joint lining, which makes it appear as though there is a tumor or cancer in the joint. This “pseudo-tumor” is actually due to chronic inflammation of the joint as a result of the metal wear particles. These pseudo-tumors can lead to serious pain, inflammation, and popping and catching of the hip joint.

Loss of bone, or osteolysis, is generally related to joint inflammation which invades the bone and breaks it down. The body may not discriminate, eating up both the metal shavings as well as the patient’s bone. If osteolysis is present in tissues surrounding the hip socket, the socket itself may be loosened, rendering revision surgery much more difficult—or impossible—as there is less bone to work with. If osteolysis is present around the femur, it can lead to a fracture at the top of the femur which is a medical issue that can be quite problematic for the surgeon to deal with. There is an osteolysis grading system based on x-rays, however it is not considered especially useful. Your surgeon might use such terms as “radiolucencies in zones 1, 2 or 3 of the acetabulum” which indicates a loss of bone behind the components which make up the hip. In any case, this loss of bone as a result of the metal-on-metal DePuy hip replacement can make revision surgery difficult to impossible.

Deciphering the Pathologist’s Report
If you are attempting to understand the pathology report from your DePuy hip replacement device, the following terms could be helpful. Lymphocytes are white blood cells which are typically involved in a reaction that is similar to an allergy reaction. Lymphocytes can also be the body’s response to chronic inflammation in the body and in both cases is known as lymphocytic infiltration. This type of infiltration is different than a poly-morphonucleocyte inflammatory infection.

When the body responds in a certain way to the metal-on-metal hip implant, this reaction may resemble an allergic reaction when scrutinized under a microscope and is termed ALVAL or aseptic lymphocyte dominated vasculitis associated lesions. The lymphocytes are believed to be a response to the hip replacements metallic degradation and they often congregate around tiny blood vessels although they can be present in tissue as well. While there is no current grading system for the severity of ALVAL, by its presence alone the physician becomes aware of a chronic metal-on-metal problem.

Necrosis may be present in any area surrounding the hip implant where the blood supply is less rich. Any tissues which don’t have a good supply of blood are at risk for poor healing, therefore potentially severe infection. Cells which eat foreign bodies are known as either macrophages or histiocytes, and in those patients who have undergone a hip replacement surgery they can be observed in the area of the hip, attempting to eat the metal debris. Once they consume these metal shavings, however, they may form granulomas which can lead to further complications.

Don’t Sign a Release without Prior Legal Advice
As you can see, there are many potentially serious problems with the DePuy hip implant device; as part of the recall, DePuy is asking hip implant recipients to sign a medical release as well as return the faulty implant once it has been removed from the body. The indication is they will only pay costs they consider to be reasonable and directly related to the removal of the hip implant. Unfortunately, this offer is less than generous, with no compensation offered for the necessity of the replacement hip surgery, the chronic pain or the lost wages the DePuy hip replacement recipient has likely undergone, not to mention the pain and suffering.

It’s important that you not sign anything without first speaking to a knowledgeable hip recall attorney who is skilled in product liability cases and who can more fully determine your legal rights. Should you sign the DePuy release without first obtaining legal counsel, you may unknowingly be giving DePuy the right to obtain your medical records and your future rights to Medicare could be compromised as well. Signing the release generally requires that your hip implant be turned over to DePuy as soon as it is removed, which can significantly limit your future legal options and recovery.

Johnson & Johnson Takes $3 Billion Dollar Fourth Quarter Charge

2012-02-05T23:20:00.001-08:00

Introduction

Johnson & Johnson, the parent company of DePuy Orthopedics recently took a fourth quarter charge of over $3 billion dollars related primarily to their voluntary recall artificial hip implants—the DePuy ASR Acetabular System and the ASR Hip Resurfacing System. The recall took place in August of 2010, after the FDA had received incident reports regarding the DePuy metal-on-metal hip implants for over two years. Approximately one in eight patients—and possibly more—will require a hip revision surgery to remove the faulty DePuy device and replace it with another hip implant device. Unfortunately, most patients have a longer recovery time and more medical issues related to the second revision surgery than they did with the first.

The DePuy recalled devices implement a specific metal-on-metal hip replacement construction which has been shown to shed metal fragments into the bloodstream and surrounding tissues, causing potentially disabling injuries. These metal fragments can lead to cobalt and chromium toxicity or poisoning. Chromium poisoning symptoms are much the same as those of cobalt poisoning, including brain damage, irregularities of the heart, and even seizures. Cobalt poisoning may even be a contributor to cancer and any form of heavy metal toxicity is not to be taken lightly.

The $3 billion dollars will be set aside for the patients who were harmed by the DePuy devices as well as their attorneys who are involved in this growing product liability litigation. Wall Street’s forecasted stock earnings for the DePuy Company had been estimated to be around $5.21 per share however DePuy’s own company forecast estimates $5.05 to $5.15 per share. Even so, Johnson & Johnson reported better than hoped for fourth-quarter earnings due in part to favorable taxes and the sale of some new prescription drugs. Johnson & Johnson’s global sales for the last quarter of 2011 was a staggering $16.26 billion dollars, making it difficult for those injured by the hip recall device to feel much sympathy for the pharmaceutical giant

Finding a Qualified Product Liability Attorney
Although DePuy is encouraging those who have suffered injury from the DePuy metal-on-metal hip replacement device to contact them and file for reimbursement, those who do so are very unlikely to receive the kind of compensation they deserve for their DePuy hip implant failure. Should you hire an experienced lawyer to file a lawsuit on your behalf, you are much more likely to receive reimbursement for all medical expenses as well as for your travel expenses, lost wages and any pain and suffering you have undergone as a result of the DePuy metal-on-metal hip replacement.

A qualified attorney will be well aware of the statute of limitations deadlines in cases like this and understand that missing those deadlines can result in permanent relinquishment of your right to bring suit against DePuy. Moreover, a law firm with a competent staff can provide you with the information you desperately need as well as guide you through the lawsuit process, advising you on the best way to move forward with your claim regarding the DePuy hip implant failure. A knowledgeable attorney should be able to coordinate with you and your physician to ensure you receive the medical care you need and deserve and will fight aggressively for the highest compensation possible.

Recall of Artificial Hip Causes Johnson & Johnson 2012 Earnings Forecast to Dip

2012-02-05T23:18:00.001-08:00

Recall of Artificial Hip Causes Johnson & Johnson 2012 Earnings Forecast to Dip

Introduction

The pharmaceutical giant, Johnson & Johnson, has been given a 2012 earnings forecast which is below the previous estimates present by financial analysts due to the number of DePuy hip replacements which were recalled. In fact, recent reports state Johnson & Johnson takes $3 billion charge for hip recall. In 2010 it was discovered that the DePuy metal-on-metal hip replacement devices were shedding metal fragments and Johnson & Johnson issued a recall for those particular hip replacements. The metal fragments which were shed into the body were found to cause disabling injuries in some recipients, and the toxicity from the chromium and cobalt debris can cause the surrounding tissues to suffer necrosis or death.

Years of Potential Exposure to Toxic Metals for Hip Implant RecipientsBecause the DePuy implants were specifically designed for younger patient, these recipients may be exposed to the toxic metals for many years. Many of the lawsuits currently being filed allege that Johnson & Johnson should have recalled the devices much sooner and that they continued to sell the hip implants long after they were aware of the unusually high failure rate. As early as 2008 Johnson & Johnson received complaints regarding loosening parts, infections, sensitivity to the metals of the implant, dislocated hips and fractures, and DePuy’s own internal data revealed a 12% revision surgery rate for the resurfacing system and a 13% rate for the ASR XL.

Johnson & Johnson Reports Higher than Expected Fourth Quarter EarningsFourth-quarter charges have allowed funds in the amount of $800 million dollars to be set aside for the patients and their attorneys who are involved in the DePuy hip replacement lawsuit. Analysts are unable to determine just how high the eventual costs will be as there are strong indications that more lawsuits are to come. The 2012 Johnson & Johnson corporate earnings forecast was between $5.05 and $5.15 per share as opposed to the Wall Street view of $5.21 per share. Despite the DePuy hip extensive recall, Johnson & Johnson reported higher than expected fourth-quarter earnings due largely to the sale of new prescription drugs and favorable corporate taxation. When all was said and done, Johnson & Johnson earned $218 million dollars in their fourth quarter alone, which translated into approximately 8 cents per share.

Rise in Global Sales Due to New Drug Applications
Johnson & Johnson, based out of New Jersey, reported that global sales rose 3.9% in the fourth quarter of 2011, or $16.26 billion dollars, yet the company was only able to net $218 million of that due to the product recalls, litigation and patent battles currently waged against them. Johnson & Johnson is waiting to hear from the FDA regarding their new drug application for Xarelto, an oral anticoagulant meant to lower cardiovascular events for those who suffer from acute coronary syndrome as well as an application for Nucynta, an oral analgesic for neuropathic pain in diabetics.

Corporate Profits vs. Patient Suffering
Johnson & Johnson reported spending some $109 million dollars in DePuy hip recall litigation expenses during the third quarter of 2011, while still managing to bring in over $1.3 billion dollars in worldwide sales of orthopedic joint replacements. This level of profit feels like a slap in the face to the thousands of patients who are currently suffering from implantation of a DePuy metal-on-metal hip replacement. These patients are dealing with chronic pain and an uncertain future while DePuy, the subsidiary of Johnson & Johnson racks up sales and income.

Anyone who has undergone a DePuy metal-on-metal hip replacement and suffered negative health issues as a result should contact an experienced product liability attorney as soon as possible to ensure their subsequent surgeries and medical expenses are fully covered. Should you decide to pursue a DePuy hip replacement lawsuit, an experienced attorney can ensure your rights are protected.

Things You Should Know About Johnson & Johnson’s and DePuy Orthopedics’ Attempts to Help Hip Implant Recipients

2012-02-05T23:17:00.000-08:00

Things You Should Know About Johnson & Johnson’s and DePuy Orthopedics’ Attempts to Help Hip Implant Recipients

Introduction

DePuy hip implants were used widely throughout the world, beginning in 2003, and in the United States from 2005. Although concerns were raised regarding the safety of these hip implant devices, a recall by DePuy was not issued until August of 2010 when DePuy received data from the National Joint Registry showing the five year revision rate for the ASR hip replacement system was approximately 12-13%. This study appeared to show that the risks for revision surgery were highest among female patients who received the smaller ASR heads which were less than 50mm in diameter. The recall in 2010 was voluntary on the part of DePuy and Johnson and Johnson and the pharmaceutical giant has subsequently issued several field safety notices to physicians to enable them to help their patients whose health has been affected by the DePuy hip implant failure.

Potential Problems with the DePuy Hip Implant
The metal-on-metal construction of DePuy’s metal hip implant may allow grinding, resulting in metal particles entering the surrounding tissue. These metal shavings cause contamination and once the surrounding tissue is contaminated it will allow even more metal particles to enter the blood stream, becoming toxic to surrounding tissue. The person who may be having an issue with the DePuy implant may suffer serious or chronic pain, inflammation, possible detachment of the implant, bone fracturing surrounding the hip implant, and dislocation of the implant.

Initial Safety Notice Issued
One of the first safety notices issued to physicians stated that all patients who were recipients of the ASR system should immediately be informed of the recall, and asked to return for a follow-up visit. The notice goes on to tell physicians the procedure for addressing those patients who appear to have radiographic changes which could possibly indicate product failure. As per DePuy’s April 22, 2010 device alert, some patients may have developed a progressive reaction in the soft tissue surrounding the implant to the metal particles released from the device. The earlier the revision surgery is performed, the better, according to the DePuy safety notice.

DePuy advises physicians that any patient who is symptomatic or any whose cup was implanted at an angle greater than 45 degrees—particularly in the smaller devices—have blood measurements of cobalt and chromium ion levels performed. If the levels of the metal ions are elevated above y parts per billion for either metal, a subsequent test should be performed in three months, and a possible cross-sectional image taken as cobalt and chromium toxicity is possible. The DePuy advice for those patients whose MRI or ultrasound scan reveals reactions of the soft tissue, collections of fluids or masses of tissue is that patients should discuss revision surgery with their physician.

DePuy Financial Support for Patient Follow-up
This same initial field safety notice issued by DePuy to physicians, details the potential financial support they intend to offer to any patients who need medical services associated with the recall of the hip implant device. DePuy will cover any cost which is considered reasonable and customary and is associated with monitoring and treatment. DePuy will provide reimbursement for any necessary diagnostic testing the patient undergoes as a result of the surgeon’s concern about the safety of the hip implant device. If the surgeon recommends a revision procedure for his or her patient, DePuy agrees to provide reimbursement, however this reimbursement is subject to completion and submission of all required documentation. DePuy states they may not cover surgeries which involve size mismatches, traumatic injuries where there is no evidence of soft tissue reaction at the time of the surgery or in cases where infection caused the revision surgery. There may be other exclusions claimed by DePuy in a case-by-case basis.

Your Risk for Medical Problems Following a DePuy Hip Implant
As stated, your estimated risk for problems following your hip implant can range from 12% to possibly as high as 49%. If you had hip replacement surgery after July of 2003, you may be at risk, however since DePuy did not maintain a list of patients who received the hip implant device, they are unable to warn patients directly, meaning the burden is placed on the individual recipient. DePuy has asked patients who think they may have had a DePuy hip device implanted to call their help line and share their medical information.

It is advisable to contact an experienced product liability attorney before you provide sensitive medical information to DePuy--or anyone for that matter. Should you sign an authorization form which gives DePuy access to your medical records, they may decline to cover all the damages related to the defective artificial hip implant. Unfortunately, DePuy has failed to address the questions of tissue contamination by the metallic cobalt and chrome ions released into the body, and there is no clear medical determination as to the potential long-term effects of this metal contamination. Chromium poisoning symptoms include inflammation and necrosis of the surrounding tissue, impaired liver function, asthma and shortness of breath and hearing and vision impairments. Cobalt poisoning can lead to many of the same symptoms. It’s important that you receive experienced counsel from a DePuy hip recall attorney to ensure you do not lose any of your valuable rights of recovery.

New Updates for DePuy Hip Implant Victims

2012-02-05T23:13:00.000-08:00

The DePuy ASR Litigation Status Conference

On January 23, 2012, the DePuy ASR Litigation Status Conference in West Palm Beach, Florida was held before Judge David Katz. Judge Katz is the United States Federal District Judge assigned by the Multi District Litigation panel of judges to hear all pretrial matters in any DePuy ASR cases filed in federal court.

Judge Katz met with the Executive Committee of the Plaintiffs’ Steering Committee for about an hour privately before he met with all attorneys in open court. The Plaintiffs’ Steering Committee are the dozen or so lawyers Judge Katz assigned as leaders of all plaintiffs’ lawyers who have filed cases in the ASR litigation. The Plaintiffs’ Steering Committee is responsible for gathering evidence (Johnson and Johnson and others have turned over approximately 18,000,000 documents so far), taking depositions of fact and expert witnesses, legal analysis, submitting briefs to the court, and a variety of other tasks.

With 3,300 cases now on file in federal court, and another approximately 1,000 cases on file in state court in California and in New Jersey, you can imagine how slowly things would work if Judge Katz did not rule with a firm hand. There are 900 or so different law firms with cases on file but most firms have a very small number of cases, so Judge Katz has taken the bull by the horns and has taken effective control of the ASR litigation. While he legally has no “power” or “authority” over the state judges, he is very well respected and has more than 17 years experience as a judge. He has made it clear that he wants this case moved expeditiously and he is working with the state court judges and the parties to ensure that happens. The next hearing before Judge Katz will be on March 15 in West Palm Beach.

Cobalt & Chromium Concerns
Many metallosis victims have been frustrated that their orthopedic surgeons are not as well versed about chromium and cobalt blood poisoning as they would have thought. Please remember that asking an orthopedic surgeon about chromium and cobalt poisoning is like asking a carpenter what the most important difference is between a gas stove and an electric stove: it’s simply not something that they typically know much about. Never before in human history have so many thousands of people had metal particles of chromium and cobalt released into their body from the bearing wear from these hips. If you have or suspect you have blood metal poisoning issues, a Toxicologist may be the best person to seek out.

Recent New York Times Article

According to a January 25, 2012 New York Times article, Johnson & Johnson was recently hit with $3,000,000,000 in charges during the fourth quarter of 2011 (additional to the $800,000,000 they set aside more than a year ago). Keep in mind that Johnson & Johnson’s DePuy Pinnacle metal on metal hip is also turning into a disaster, so the money is not just for the ASR cases. It appears as if the ASR is by far the worst of the metal on metal hips, but seemingly all of the metal on metal hips are showing abnormal bearing wear and may be leading to chromium and cobalt poisoning in perhaps tens of thousands of Americans in the next few years. It is possible that this debacle could cost Johnson & Johnson between $5,000,000,000 and $10,000,000,000 before it is all over.

FAQ’s

“Just exactly how long is this litigation going to take?” and “How much is my case worth?”
That’s a hard question, but it is possible that Hip Implant victims may see a settlement of the ASR cases in 2012 but litigation could move into 2013. On value of the cases, that’s a huge question mark and depends on the individual circumstances of each case (within common categories such as extent of lost wages, lost wage earning capacity, whether the ASR has been replaced, differences in state law and the like.) The closest comparison might be the Sulzer hip implant litigation, which took place about 10-12 years ago. Sulzer also had lots of victims but the company only had assets in the U.S. and insurance of $1,000,000,000, all of which it tendered. The Sulzer litigation resulted in settlements ranging from the thousands to the hundreds of thousands of dollars, depending on individual facts. Keep in mind it was a limited asset settlement and it happened 10 years ago. Johnson & Johnson has significant culpability, as well as substantially more assets and insurance. Beyond that, any estimate of the value of the ASR cases is at best an educated guess.

Johnson Takes $3 Billion Hit on Hip Recall

2012-01-26T03:19:00.000-08:00

Johnson & Johnson took quarterly charges of more than $3 billion, largely related to the recall of artificial hips, and gave a 2012 earnings forecast below analysts’ estimates on Tuesday.

The company’s DePuy Orthopedics unit issued an extensive recall of its “metal-on-metal” hip replacement devices in 2010 after they shed metal fragments, causing disabling injuries.

The fourth-quarter charges will allow money to be set aside for patients and lawyers involved in product liability litigation.

“The hip recalls worry me because their eventual costs are unknown,” said Jeff Jonas, an analyst at Gabelli & Company, who noted that the fourth-quarter charges included $800 million for medical costs of the recall.

The company forecast 2012 earnings of $5.05 to $5.15 a share, compared with the consensus Wall Street view of $5.21.

William Price, a company spokesman, said most analysts had not factored in damage from the stronger dollar.

Johnson & Johnson reported better-than-expected fourth-quarter earnings, helped by favorable taxes and sales of new prescription drugs. The company earned $218 million, or 8 cents a share, in the quarter. That compares with $1.9 billion, or 70 cents a share, a year earlier, when it also took charges for recalls of hip replacement devices.

Excluding special charges, Johnson & Johnson earned $1.13 a share. Analysts had expected $1.09, Thomson Reuters said.

Johnson & Johnson, which is based in New Brunswick, N.J., said global sales rose 3.9 percent in the quarter, to $16.26 billion, slightly below analysts’ target.

News source : www.nytimes.com

Depuy Hip recall attorney | asr hip lawsuit | depuy pinnacle hip replacement dangers | hip recall lawsuit help

Hip Replacement Implant Complaints on the Rise

2011-09-18T21:28:00.000-07:00

Hip Replacement Implant Complaints on the Rise
By Holly Soehnge

Hip replacement is a common orthopedic surgical procedure performed to relieve pain and restore mobility to a damaged hip joint, typically for patients with arthritis or a hip injury. Diseased or damaged portions of the hip ball and socket joint are replaced by prostheses made of metal, ceramic, plastic, or combinations of these materials. Metal-on-metal (MoM) hip replacement implants use ball and socket components that are both made of cobalt or chromium metal, or titanium. The ball fits into and glides against the surface of the socket to imitate the function of the hip joint.

Hip replacement surgery is mostly successful, and hip implants are made to last 15 or more years before replacement is required. There are risks of several complications that can occur, however; as with any type of surgery. Complications that can occur include infection, dislocation of the ball implant from the socket, and implant loosening or other wear and tear over time requiring another hip replacement surgery.

In contrast to the pain relief and durability characteristic of hip replacement treatments, recently there has been a remarkable surge in complaints of early failures of metal-on-metal hip replacements within a few years of surgery. Some patients have experienced severe ongoing pain, swelling, and difficulty walking. Others have suffered damage or death to the soft tissue surrounding the hip joint. Many of these implant failures require the patient to undergo painful and expensive revision surgery.

Metal-on-metal hip implants wear over time, resulting in deposits of metal debris in the tissues surrounding the hip joint. A chiseling effect known as edge-loading can occur when the ball of the implant presses on the socket edge as a result of poor implant design or faulty surgical technique. Large amounts of metal debris are deposited in the tissues as a result, which can lead to high levels of cobalt and chromium ions in the patient’s bloodstream, possibly leading to metal poisoning. Studies to date have not shown a greater risk of cancer or other adverse effects from the metal ions, although additional data from ongoing studies is needed before the long-term effects are known.

Current research estimates that 1 to 3 percent of patients could experience an inflammatory reaction to the metal debris, causing chronic pain, damage and death to hip tissues, and bone loss. Women appear to be affected more frequently than men. A recent Harvard Medical School study looked at the effects of edge-loading from metal hip implants. The research showed an association between resulting high cobalt and chromium blood levels and patient susceptibility to soft tissue pseudotumors. Pseudotumors are a rare complication, but nevertheless a very serious problem, causing tissue destruction and the need for revision surgery. Metal debris complications are a significant safety concern and the focus of ongoing studies.

Concerned for their patients’ safety, most orthopedic surgeons have stopped using metal-on-metal hip implants. Metal-on-metal hip implants were used in about one third of the 250,000 hip replacements performed in the United States until the past two years, when use of the implants has dropped to only about 5 percent of the market.

The Food and Drug Administration (FDA) has received over 5,000 reports of adverse events in connection with metal-on-metal hip implants since January 2011, according to a study by the New York Times. In response to the complaints, the FDA is encouraging patients who have received metal-on-metal hip replacements to contact their surgeons immediately if they experience problems, and to participate in safety surveillance studies.

The FDA has required 21 manufacturers of metal-on-metal hip implants to submit plans to conduct post-marketing surveillance studies to address safety issues related to the implants. Among these manufacturers are DePuy, a division of Johnson & Johnson, Zimmer Holdings, Wright Medical, and Biomet. The FDA has until November 2011 to decide whether the proposed plans are adequate to address safety concerns.

Of the metal-on-metal complaints received by the FDA this year, about 75 percent relate to complications with the DePuy ASR hip replacement systems. Depuy has attributed the failure of the devices to implant loosening, infection, bone fracture, dislocation, metal debris reactions, and accompanying pain. Some orthopedic surgery experts have said they believe these devices have a design flaw that makes them difficult to implant properly. DePuy refuted these statements, but announced last year that it was discontinuing the ASR systems because of declining demand.

In August 2010, Depuy voluntarily recalled its two ASR systems as a result of new data from the National Joint Registry of England and Wales showing that roughly 1 in 8 ASR patients would experience implant failure within 5 years, an unacceptably high failure rate. There have been over 90,000 DePuy metal hip implants sold; so that according to the data, over 11,000 patients are likely to experience implant failures that require painful and expensive revision surgery.

The two DePuy systems under recall are the ASR XL Acetabular System, a metal cup and ball replacing the hip joint, and the ASR Hip Resurfacing System, a metal cap that fastens onto the head of the femur. Only the ASR XL Acetabular System is FDA-approved for use in the US. Depuy has encouraged surgeons having implanted these devices to request patient evaluations and metal sensitivity testing, since not all patients with metal debris-related tissue damage would necessarily show symptoms. Depuy has stated that it will cover the costs of patient monitoring and treatment, including revision surgery costs.

DePuy is facing criticism from orthopedic experts that it should have recalled the devices much sooner considering the large number of complaints. The first of many lawsuits filed against DePuy claims the devices are defective and alleges that DePuy knew about problems with the implants early on, but did nothing to alert patients or surgeons.

Metal hip implants made by Zimmer Holdings branded “Durom” are also coming under increased scrutiny for potentially causing high blood levels of chromium and cobalt and soft tissue damage from metal debris. Studies at the University of British Columbia found that patients implanted with a Durom socket implant had 2.6 times or 10 times higher than normal blood levels of chromium and cobalt, respectively. The researchers recommended that Durom implants no longer be used in standard implants because of the metal ion levels.

The rise in the incidence of severe medical complications from metal-on-metal hip implants is a rapidly growing concern for patients and orthopedic surgeons. It is difficult to know the full extent of the problem; the use of the latest metal-on-metal devices is still relatively new, and it is estimated that only one to ten percent of all complications from medical devices are actually reported to the FDA. More information is needed from ongoing studies to determine to what extent metal debris represents a threat to patient health, and whether implants made by some manufacturers are more or less safe than others.

What Does the U.S. Food and Drug Administration’s Letter to Hip Makers Mean?

2011-06-28T22:33:00.000-07:00

The U.S. FDA ordered 21 manufacturers to collect information from patients.

The U.S. FDA ordered 21 manufacturers to collect information from patients in a recent letter to hip manufacturers. Click here for report. The three-page letter demands blood tests and other studies within thirty days. Here is a summary of the information and questions the FDA is requiring from manufacturers:

The harmful events observed in patients with Metal-on-Metal (MoM) total hip replacement (THR) systems.
The levels of serum and chromium in patients prior to THR.
The patient population's average levels of chromium and serum in the blood for a minimum of eight years after the implant (patient population is the demographics and other particulars of a particular population).
Do the average levels of chromium and serum in the blood increase during the first eight years (or the length of time on the market)?
Reasons for revision (alteration of a medical device) and patient population's average levels of chromium and serum in the blood at the time of the revision.
The number of patients with pain and biological and psychological symptoms associated with the THR.
The quantity of harmful reaction of body tissues in patients who did not have a revision.
How differences in revisions vary over time after the initial implant?
What demographics have higher metal ion concentrations in their blood?
What demographics have higher risks of needing revisions?
What causes the THRs to fail?

Will New FDA Orders Lead to a Recall of All Metal-on-Metal Hip Implants?

2011-06-28T22:30:00.000-07:00

U.S. Food and Drug Administration orders 21 hip makers to blood test their patients for metal.

The U.S. Food and Drug Administration, the governmental organization that protects public health, entered the battlefield with the Johnson & Johnson's DePuy recall and ordered 21 manufacturers to collect information from patients - including blood tests for metallic ions. This broad use of the agency's authority will clarify failure rates of metal-on-metal implants and drop the hammer on Johnson & Johnson.

"This is a disaster for J&J," said James Moriarty, senior partner at Moriarty Leyendecker. "It will be a public health nightmare and show how metal-on-metal hip implants can cause metallosis." (the swelling around metal implants as a result of corrosion or an allergic reaction).

What could this mean for Johnson & Johnson and the healthcare industry?

- New data could magnify the defects of the recalled DePuy ASR.

- Will create an apples-to-apples study for the DePuy ASR to be compared to other devices.

- Will cause pandemonium in hospitals as all metal-on-metal hip patients rush to test for metal in their blood.

- Send lawyers, lawsuits and patients swarming after irresponsible hip manufacturers.

- Cause the recall of the DePuy's Pinnacle Acetabular device, another device that is repeatedly failing with hip patients.

In 2010 doctors implanted a nurse with the DePuy ASR Pinnacle device. After the procedure, the patient complained, "The pain in groin is worst when I lift left leg 45, 60 and 90 degree, it feels like a click/catch and the pain is worst at those points. I am a registered nurse and have taken care of pts [patients] with hip replacements, this is not normal recovery. Something is wrong with this device." These complaints are typical of patients suffering from metallosis after hip implant surgery.

The risk of metal-on-metal devices is that metal may enter a patient's bloodstreams after the procedure as tiny particles wear off the device and enter the space around the implant. The FDA stated its concerns in a February 2011 report, "Concerns about Metal-on-Metal Hip Implant Systems" The report spotlights the uncertainty of the device's failure rates - hence the need for more studies.

New information must be submitted to the FDA within 30 days and could lead to a recall of all metal-on-metal hip replacement devices. It's the first battle in the war on metal-on-metal hip makers that could destroy Johnson & Johnson and DePuy.

2011-05-19T00:50:00.001-07:00

New Data from Britain about DePuy ASR Acetabular Hip Replacement Devices

Is Johnson and Johnson Telling the Truth About the Failure Rate?

Johnson and Johnson claimed the failure rate was 13% when it recalled the DePuy product in 2010, according to its press release. Johnson and Johnson started using the device in the United States in 2005 and based its failure rate on five years of research. However, England has a hip registry dating back well before 2005.

This week a report by The British Orthopedic Association revealed the DePuy ASR XL hip replacement unit fails as often as 49% of the time. This is an astounding four times what Johnson and Johnson reported stated when it recalled the device last year.

Dr. David Beverland, an Irish orthopedic surgeon who does massive numbers of hip and knee replacements reported that he started implanting the ASR devices in his patients in September 2004 and stopped in May 2007. He declined to say why he stopped the implants, but reported that 32% of his ASR XL patients have been or will need a second hip replacement (revision) and 44% are symptomatic. Only about 22% of his ASR XL patients seem to have achieved a good result and three of his patients died after receiving the implant. This is a serious problem for the defense since Beverland has been a major consultant and product champion for DePuy.

Here are the real facts:

- August 2010 - Johnson and Johnson recalled the ASR XL Acetabular System and DePuy ASR Hip Resurfacing System used in hip replacement surgery due to the number of patients who required a revision.

- April 2011 - Johnson and Johnson agreed to pay $70 million in civil and criminal fines for bribing European doctors to induce them to prescribe their drugs or implant medical devices in patients unaware of their doctors' financial incentives, according to The New York Times.

- May 2011 - The British Orthopedic Association and British Hip Society released data that the DePuy ASR XL hip replacement unit fails as often as 49% of the time - four times more than reported by Johnson and Johnson in 2010.

Based on the evidence there are thousands of patients that appear to be healthy now, yet likely will have complications in the next 3-5 years as a result of the ASR XL device.

The U.S. Food and Drug Administration’s Letter to Hip Makers Mean

2011-05-19T00:30:00.000-07:00

What Does the U.S. Food and Drug Administration’s Letter to Hip Makers Mean?

The U.S. FDA ordered 21 manufacturers to collect information from patients.

The harmful events observed in patients with Metal-on-Metal (MoM) total hip replacement (THR) systems.
The levels of serum and chromium in patients prior to THR.
The patient population's average levels of chromium and serum in the blood for a minimum of eight years after the implant (patient population is the demographics and other particulars of a particular population).
Do the average levels of chromium and serum in the blood increase during the first eight years (or the length of time on the market)?
Reasons for revision (alteration of a medical device) and patient population's average levels of chromium and serum in the blood at the time of the revision.
The number of patients with pain and biological and psychological symptoms associated with the THR.
The quantity of harmful reaction of body tissues in patients who did not have a revision.
How differences in revisions vary over time after the initial implant?
What demographics have higher metal ion concentrations in their blood?
What demographics have higher risks of needing revisions?
What causes the THRs to fail?

TV Ads Promote Consumer Requests For Expensive, Often Inappropriate Hip Devices

2011-04-15T21:04:00.000-07:00

Gary Schwitzer writes on his blog “Health News Review” that he was “jolted” by a television commercial he saw recently for an artificial hip joint sold by medical device-maker Smith & Nephew.

The ad features athletic, fit, male body forms engaged in all sorts of strenuous pursuits; playing soccer, surfing, rock climbing up a craggy peak (!). The figures are rendered as stylized silhouettes but if I had to guess, I’d say they were designed with highly active men, age 40 to 50, in mind. Triatheletes and Ironmen wouldn’t be a stretch. Read more about this post>>

2011-02-26T04:01:00.000-08:00

Johnson & Johnson Accused of Concealing Ortho Evra Risks

2011-02-10T03:05:00.000-08:00

By Megan Breckenridge, Staff Writer

SULLO & SULLO, LLP

HOUSTON — Millions of women across the country rejoiced in 2002 when a new, convenient alternative to daily oral contraceptive pills hit the market.

Ortho Evra, a hormone-containing patch, was praised by public health experts and consumers alike because it eliminates one of the major barriers to perfect birth control use: Remembering to take a daily pill. The patch can be placed on the arm, back or abdomen—anywhere it adheres well and won’t be damaged—and needs only to be changed once a week. Since it’s introduction, over 40 million prescriptions for Ortho Evra have been written, and TIME Magazine named it one of the best inventions of 2002.

But in 2005, the Food and Drug Administration (FDA) warned that women using Ortho Evra were exposed to approximately 60 percent more estrogen than those who use oral contraceptive pills. It is believed that the difference in exposure is related to the delivery mechanism of the birth control patch. Hormones in birth control pills are partially diluted by the digestive system, while those in the patch are absorbed directly into the patient’s blood stream. The latter causes a higher concentration of medication, specifically estrogen, to enter a patient’s body, increasing the risks of pulmonary embolism—a specific type of blood clot—as well as stroke and heart attack.

The first fatality publicly blamed on Ortho Evra occurred in April 2005, when a Manhattan fashion student collapsed in a New York City subway station. An autopsy found that a blood clot had moved into the victim’s lung, which the medical examiner ruled a side effect of the birth control patch.

By November of 2005, the FDA had received 21 reports of life-threatening blood clots and other ailments associated with Ortho Evra. But it wasn’t until 2006, when a study was published that confirmed women using the patch were twice as likely to suffer from venous thromboembolisms (VTEs) as those taking oral birth control pills, that the FDA requested that the Ortho Evra label be changed to include a stronger safety warning.

According to an NBC news report, broadcast September 22, 2010, leaked patient reports from Johnson & Johnson show that the company knew users of the patch were 12 times more likely to suffer stroke and 18 times more likely to have blood clots than Pill takers. Further, NBC revealed, a vice president of research at Johnson & Johnson, Dr. Patrick Caubel, quit over frustration that the company ignored his data showing elevated levels of complications and mortality associated with the patch.

Another former vice president, Dr. Joel Lippman, claimed in a lawsuit that he was fired by Johnson & Johnson because he expressed concerns about the patch’s dangerously high estrogen levels prior to its coming to market. The company, he says, “disregarded his concerns and launched the product anyway.”

According to NBC, 24 deaths have been attributed to blood clots induced by the patch, and more than 2,400 women currently have personal injury lawsuits filed against Johnson & Johnson. To date, the company has spent $68 million to quietly settle Ortho Evra lawsuits.

Unfortunately, Ortho Evra remains on the market, despite countless calls to have it pulled. In spite of its risks, the patch is still a big money maker for Johnson & Johnson, which has earned $1.6 billion on its sales.

In response to NBC’s news report, the company issued the following statement:

Thank you for your inquiry to Ortho Women’s Health & Urology, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. We believe it is inappropriate to comment on the details around ongoing litigation and therefore are not providing responses to your individual questions beyond the statement below:

ORTHO EVRA has been a safe and effective birth control option for women and their healthcare providers since 2002. It addresses a birth control need and provides another choice for women who, with the counseling of their healthcare provider, do not want or are unable to take a birth control pill every day. Ortho Women’s Health & Urology has regularly disclosed scientific data regarding ORTHO EVRA to the FDA, the medical community and the public in a timely manner, and when used according to the FDA-approved label, ORTHO EVRA remains a safe and effective method of hormonal birth control. It also, like all methods of hormonal birth control, has benefits and risks which, as a prescription medicine, should be the subject of discussion between a woman and her healthcare provider. These benefits, risks and other important safety information are contained in the Detailed Patient Labeling, which is part of the ORTHO EVRA® Prescribing Information, and can be found at http://www.orthoevra.com/sites/default/files/assets/OrthoEvraPI_0.pdf.”

— Jeff Christensen, spokesperson, Johnson & Johnson

If you or someone you know were injured while using Ortho Evra, please contact the experienced team at Sullo & Sullo, LLP. We will aggressively represent women who have suffered heart attacks, strokes, blood clots and other serious injuries while using this drug. Call us at 713.839.9026 or visit our website at www.sullolaw.com for a free legal consultation today.

Defective Hip Implant

2011-02-02T05:50:00.000-08:00

Defective DePuy ASR Hip Implants Should Consider The ARP Wave

2011-01-31T22:31:00.000-08:00

Patients With Defective DePuy ASR Hip Implants Should Consider The ARP Wave

By Andre Sullo

SULLO & SULLO, LLP

HOUSTON — In the wake of DePuy Orthopedics, Inc.’s recall of defective ASR hip implant devices, patients and their physicians have been searching for ways to mediate the potential health risks involved. With complications ranging from dislocation of the implant components and bone fractures at the hip, to metal poisoning, or metallosis, finding an accessible, effective treatment is imperative.

Enter the Accelerated Recovery Performance Wave (ARPwave) System, a revolutionary method that has been used by professional athletes and weekend warriors alike to treat muscle-related injuries and speed post-surgical rehabilitation for years. The invention of Denis Thompson, an exercise physiologist based in Burnsville, Minnesota, the ARPwave uses a patented bio-electrical current, simultaneously with active range-of-motion and other exercise techniques, to significantly speed up the body’s natural recuperative ability.

The ARPwave is a Class 2 medical device that is FDA authorized for muscle re-education; relaxation of muscle spasms; increased local blood circulation; prevention and retardation of disuse atrophy; and maintaining and increasing range of motion. Protocols can also be specifically used with the ARPwave to accelerate post-surgical muscle rehabilitation of the shoulder, elbow, wrist, hip, knee, ankle, foot, and cervical and lumbar spine. For this reason, the device would be useful to patients experiencing complications related to a defective DePuy hip implant device. Treatment of the affected area could significantly lessen long-term damage to muscles and bone surrounding the faulty implant.

To use the ARPwave, a valid prescription is required. The devices are licensed only to medical practitioners and select athletes for personal use. Treatment is not currently covered by most insurance plans, and individual sessions cost about $100. The number of sessions required depends on the severity of the damage to the muscles being treated.

A typical ARPwave session requires the patient to move, so wearing loose, comfortable clothing is recommended. Because the device is used to find the origin of the injury, the physician providing treatment moves electrodes around the affected area to search for “hot spots”. These are areas of electrical disturbance in the muscle tissue that represent the root of the injury. Sessions can be intense and physically demanding, so it is recommended during the course of treatment that patients take measures to ensure their bodies recover properly. Typically, this means getting a good night’s sleep, eating healthy meals with adequate protein, avoiding/limiting alcohol consumption, etc.

If you or someone you know received a defective DePuy ASR hip implant, you should also obtain the counsel of an experienced personal injury attorney. The skilled team at Sullo & Sullo, LLP will aggressively defend your rights and make sure you get the compensation that you deserve, including coverage of the cost of treatments such as the ARPwave. Call us at 1-800-730-7607 or visit our website at www.sullolaw.com for a free legal consultation today.

Combating Chromium and Cobalt Blood Toxicity After An ASR Hip Replacement

2011-01-26T05:42:00.000-08:00

By Megan Breckenridge, Staff Writer
SULLO & SULLO, LLP

HOUSTON—If you are one of more than 93,000 people worldwide affected by the recent recall of DuPuy, Inc.’s ASR Hip Replacement System, you may be in more danger than you realize. Countless patients have already come forward with horrific stories of pain and suffering as a result of the defective devices; the most common of which are related to metal poisoning, or metallosis, which is a reaction to the chromium and cobalt metal debris that is shed when components of the device rub together.

If you have experienced symptoms of chromium and cobalt toxicity, which include pain, inflammation, tumors and difficulty walking, it is imperative that you seek medical attention immediately. Specialized blood tests can be used to detect levels of these toxic metals in ASR Hip Replacement patients. In some cases, patients with DePuy ASR implants have been found with 100 times the normal levels chromium and cobalt in their bodies.

One method of treating ASR Hip Replacement patients with high levels of chromium and cobalt in their blood is chelation therapy. The process involves the administration of chelating agents—the most common of which is ethylenediaminetetraacetic acid (EDTA)—to remove the poisonous metals from the body.

Chelating agents may be administered intravenously, intramuscularly, or orally, depending on the agent and the type of poisoning. They bind to heavy metals in the body and prevent them from binding to other agents, creating a compound that can then be excreted from the body.

For many patients, intravenous Vitamin C and replacement mineral infusions are also recommended to support the body through the metal removal process. Symptoms will often begin to improve within weeks of commencing treatment, but some may linger, indicating residual organ damage. Therapy may last as long as six months to two years.

At present, the Food and Drug Administration (FDA) has not approved chelation therapy, though both traditional doctors and alternative medicine practitioners do offer this service. A single chelation treatment usually lasts from two to four hours and costs between $50 and $100. In the first month, patients receive between five and 30 treatments (with 30 being most common), and are often advised to continue preventive treatment once a month.

Individuals must pay for the treatment themselves. Because chelation therapy isn’t a medically accepted procedure, standard medical insurance and Medicare do not cover it. It is believed to be safe for patients of all ages, including children and the elderly, but no scientific data currently exists to support this claim.

Side effects of chelation therapy include a burning sensation at the injection site, fever, a sudden drop in blood pressure, headache, nausea, vomiting, inability to create new blood cells, and mineral deficiencies. Some patients have experienced permanent kidney damage or failure, and deaths have occurred in some chelation studies. Because of the known risks and unknown benefits of chelation therapy, talk to your doctor before trying it as a treatment chromium and cobalt poisoning.

Although a full recovery from chromium and cobalt toxicity is possible with early detection and removal of the defective DePuy ASR implant, many people suffer the effects of metallosis for extended periods. Some of the damage, for instance to the liver or brain, may not be fully reversible, and many find that their food intolerances are never completely remedied. Unfortunately for those affected, only time will tell.

If you or someone you love received a defective DePuy ASR device, it is imperative that you obtain the counsel of an experienced personal injury attorney. The skilled team at Sullo & Sullo, LLP will aggressively defend your rights and make sure you get the full compensation that you deserve. Call us at 800.730.7607 for a free legal consultation today.

Chromium Poisoning Just as Dangerous as Cobalt Poisoning

2010-12-21T22:47:00.000-08:00

Early this year, DePuy issued their recall for the ASR XL Acetabular System sold in the United States. Doctors began recommending revision surgery to those of their patients who reported pain or an overall failure of the DePuy hip implant. In many cases, the doctor was wise enough to run a blood test to determine whether there was excess metal in the bloodstream, as many medical studies have shown that elevated levels of metal are common for patients with metal-on-metal hip implants.

Patient after patient with the ASR Acetabular DePuy hip implant began turning up with cobalt and chromium levels that were well over 100 times normal.

Cobalt poisoning has been getting a great deal of attention and for good reason: the symptoms of cobalt poisoning include many serious side effects including neurological (brain) damage, heart irregularities, and seizures. Cobalt poisoning has also been linked to cancer. It's small wonder that many people, when they first learn that the DePuy hip implant leaks metal ions into the body, are primarily concerned about cobalt poisoning.

However, chromium poisoning is equally dangerous. And the symptoms are just as troubling.

What is Hexavalent Chromium?

When discussing chromium poisoning, the most significant problems have been linked to a particular compound, hexavalent chromium (Chromium (VI)). Hexavalent chromium is the agent that turned up in the water supply of the California town of Hinkley, later made famous by Erin Brockovich's activism work. Many people remember the Erin Brockovich story - if not for the event itself, certainly for the award-winning movie based on it. They remember that there were many cases of cancer in the town; 196, to be precise.

Few of them remember that the problem with the water was hexavalent chromium.

Hexavalent chromium has been deemed a cancer-causing agent by the World Health Organization, which means that both chromium and cobalt can elevate a DePuy hip implant patient's cancer risk. In fact, studies show that elevated levels of any heavy metal increase the risk of cancer.

Our research indicates that hexavalent chromium is the type of chromium being released by the ASR Acetabular system; it degrades in the body into trivalent chromium, or Chromium (III). Anywhere from 18-30% of a typical metal-on-metal implant is composed of chromium; we do not have current numbers on the amount of chromium included in the DePuy hip implant.

Patients with elevated chromium levels show similar symptoms as those with elevated cobalt levels. There are notable differences; cobalt poisoning can cause cardiomyopathy, for example, while elevated chromium levels do not appear to cause heart problems but can cause problems with the reproductive system. The table below gives an overview of the symptoms shown by patients with elevated chromium levels vs. those with elevated cobalt levels.

If a particular type of chromium or cobalt has been specifically linked to a symptom, it is noted in parentheses next to the symptom. For example, mutated DNA is noted as being linked specifically to Chromium III.

	Elevated Cobalt (Co) Levels	Elevated Chromium (Cr) Level
Genetic Information	Inability to repair DNA, reduce gene expression Co (II)	Can mutate DNA (Cr III) Inability to repair DNA, reduced gene expression Cr (VI)
Localized tissue around the implant	Hypersensitivity Inflammation Infiltration of lymphocytes	Hypersensitivity Inflammation Infiltration of lymphocytes
Liver		Necrosis at high levels of Cr (VI)
Kidney	Co excreted by the liver	Can impair liver function
Respiratory System	Asthma Shortness of breath	Asthma Shortness of breath
Nervous System		Oxidative Damage (Cr VI)
Heart and Vascular Systems	Possible cardiomyopathy
Endocrine System	Potential to alter the production of sex hormones Co (II) Potential to induce hyothyroidism Co(II)	Potential to alter the production of sex hormones Cr (VI)
Visual and Auditory System	Loss of hearing Vision Impairments	Loss of hearing Vision Impairments
Reproductive System		Decreased sperm Cr (VI) Abnormalities in sperm Cr (VI) Reduced number of follicles Cr (VI)
Carcinogenesis	May lead to an increased risk of cancer	May lead to an increased risk of cancer

What Does This Mean for My Health?

Chromium poisoning and cobalt poisoning are both very serious; however, there is no way to tell if you have either problem without getting a blood test to find out what your chromium and cobalt levels are. Even if you have elevated levels, you may still not have chromium or cobalt poisoning; slightly elevated levels are normal for patients who have metal-on-metal hip implants and among the doctors we've consulted, they do not consider slightly elevated levels to be cause for alarm.

For those DePuy hip implant patients who have presented with 100 and 500 times the normal level of these two metals in their systems, however, doctors are quite concerned. Cobalt and chromium can both be retained in the bodily tissues for a long period of time, and if the body is subjected to excess levels, it will have a more difficult time processing the metal ions through the normal elimination process, especially if the kidneys are damaged - a problem sometimes caused by chromium poisoning. Little research has been done on the long-term effects of elevated metal ion concentrations.

When speaking to your doctor, we have a medical crib sheet that may be prove useful if you are uncertain what to ask about or worried you may forget important questions. We would also highly recommend you read this article on DePuy trying to get patients to agree to give the company access to their medical records; if you are thinking of pursuing a legal case against DePuy, signing away your medical records can be severely detrimental to your case.

If you have received a DePuy hip implant and are concerned about the effects chromium and cobalt poisoning may have on your health, please give us a call at 1-800-730-7607 or send us an email through our online system. We're here to answer your questions and help you build a case against DePuy if you think that is the best course of action for you. The health risks you've been asked to shoulder are immense and surely very upsetting; we will do our best to help in any way we can.

Cobalt Poisoning: DePuy ASR Hip Implants Are a Serious Risk

2010-12-21T22:32:00.000-08:00

DePuy ASR Hip Implants Are a Serious Risk

A person with 1 microgram of cobalt in their bloodstream has nothing to worry about.

Someone whose blood contains more than 25 micrograms has cobalt poisoning.

And a patient whose blood contains more than 100 micrograms? Probably has a DePuy ASR hip implant.

As more and more patients who received DePuy ASR Acetabular hip replacement systems ask their doctors for blood tests, the numbers of people who have extraordinarily high levels of cobalt in their bloodstreams become staggering. Several of our own clients have received the worrying news that their cobalt levels are far above normal, and at least one doctor has published a case study of two DePuy hip implant recipients who have cobalt levels that are 100 to 500 times normal.

How Much Cobalt Is Normal?

If you go to a doctor and get a blood test, the amount of metal (including cobalt) in your bloodstream will be calculated in micrograms per deciliter. A healthy person has approximately 0.019 micrograms per deciliter - about one microgram for their entire body. The metal in your bloodstream only presents in very, very small amounts; someone with normal cobalt levels could gather all the cobalt in their system together and come up with an amount smaller than a grain of sand.

Even at highly toxic levels, the actual amount of cobalt looks very, very tiny. 0.5 micrograms per deciliter of cobalt is considered toxic. That's about five grains of sand in a giant bucket of water. Seems small - but those tiny grains of metal can throw the entire chemistry of your body wildly out of order.

In Britain, there are regulations for keeping close observations on patients who have metal-on-metal bearings in any hip implants, including the ASR hip implants. At cobalt levels of 0.7 micrograms per deciliter, patients must be kept under observations. Symptoms at those levels include hip pain, dying tissue, and pseudotumors - masses under the skin. Generally doctors recommend revision if a patient with a hip implant has a cobalt concentration of 1.9 micrograms/deciliter or above.

Revision isn't suggested until cobalt concentrations are one hundred times the mean average - even though levels are considered toxic at twenty-five times the average.

One patient with severe cobalt poisoning had levels of 6.6 micrograms/deciliter. That's nearly three hundred and fifty times the mean average. The dangers of cobalt levels so high were quite apparent: in addition to hip pain, the patient showed declining cognitive function, was losing control of his senses like hearing and sight, suffered from seizures, heart failure, and multiple other problems.

The amount of cobalt that patient had in his blood was still small enough that it wouldn't have filled a teaspoon. But the damage was great enough to threaten his life.

What is Cobalt Poisoning?

Cobalt is one of the many metals that is found naturally in the body, but as with all other metals, in excess amounts it becomes toxic and leads to many harmful and potentially permanent side effects. Cobalt poisoning has caused cardiomyopathy, hypothyroidism, and neurological damage as well as impairing the senses. It can cause neuropathy, seizures, blindness, headaches, and liver damage. Cobalt has also been linked to cancer.

For DePuy hip implant recipients, it can also mean that future hip revisions have a lower chance of success. Excess amounts of cobalt in the bloodstream lead to metal sensitivity and metallosis, which can seriously damage surrounding tissue and make a second implant less likely to succeed.

Doctors Unaware of Risk

For many patients with DePuy ASR hip implants, the symptoms of cobalt poisoning either go unnoticed initially or are chalked up to other pain and problems related to the hip implant failure. For example, a patient might have deteriorating mental function, mood disorders, or vertigo - but if the patient is also in a great deal of pain because the hip implant is failing, it is very possible that he might assume the other symptoms are related to his pain and will go away if he has a revision surgery.

Meanwhile, doctors who are fully aware that DePuy ASR XL Acetabular System is failing at inordinate rates may recommend a revision surgery to solve problems of pain and inflammation. Those doctors may not know that the friction of the hip implant is releasing excess amounts of metal ions into the bloodstream and causing potential problems with far more long-reaching effects.

A patient could walk out of surgery with heavy metal poisoning - and not be aware until the symptoms become extreme enough to return to the hospital.

What Should You Do?

If you have a DePuy ASR Acetabular hip implant and are concerned about cobalt poisoning, see your doctor as soon as possible to discuss your options and express your concerns. Our medical crib sheet for DePuy ASR hip implant patients can give you some guidance on questions you may want to ask your doctor and tests you may wish to request.

If you'd like some advice on any legal case you may have against DePuy because of the danger this implant may present to your current and future health, we're here to answer any questions you may have. Call our offices at 1-800-677-7095 or use our online contact form, and we'll do everything in our power to get you the answers you need.

Who Is Johnson & Johnson?

2010-12-14T23:06:00.000-08:00

Home Personal Injury DePuy Hip Recall Traffic Tickets Family Law Criminal Defense Get Informed

Johnson & Johnson

"No more tears."
"The #1 choice of hospitals."
"Everything in life should be this pure."

Johnson & Johnson's slogans over the years have assured consumers, particularly mothers, that their products are - above all else - safe. However, a recent, seemingly endless stream of recalls suggests otherwise.

Children's Tylenol, Motrin Infant Drops, and Children's Benadryl are among the many medications recalled this year for manufacturing and labeling issues. Those products join recalls of Acuvue contact lenses, the allergy medication Zyrtec, and the ASR hip implant, which was sold to approximately 93,000 adults needing hip replacement surgery. A consistent pattern emerges: the company recalls products only as a last resort, and its quality controls seem to allow an inordinate number of dangerous products to reach the market - and enter the bodies of consumers.

J&J may once have cared that its products were safe. Now, it appears the company only cares if they're sold. The company consistently sells products long after it is fully aware that the products present a danger to the public.

And the FDA is helping.

Silent Recalls

In a report by ABC News, an inventory company employee named Lynn Walther tells reporters that J&J hired him to quietly purchase specific lots of Motrin IB. His instructions stated that he should, "simply act like a regular customer while making these purchases. There must be no mention of this being a recall of the product. Run in, find the product, make your purchase and run out."

Johnson & Johnson's Head of Consumer Affairs, Colleen Goggins, stated that the company had nothing to do with the buy-back, and that she didn't "believe there was any intent to mislead or hide anything." It's difficult to believe the now-retired Goggins, considering J&J has a long history of "phantom" or "silent" recalls.

In 2007, the Australia joint registry sent seven separate reports to the company identifying specific problems with the ASR device and detailing the high failure rate. The device was withdrawn for "commercial reasons" in December of 2009 and only officially recalled in March of 2010. Meanwhile, thousands of people received an implant that may cause permanent tissue and bone damage or require a revision, which could mean they will be unable to have a successful future implant.

Other recalls show a similar pattern of attempting to minimize the amount of product recalled - or avoid a recall altogether. Where one might hope that a company would issue a recall as rapidly as possible after being informed of problems, J&J's usual response is to "wait and see", followed by an attempt to remove the product by some other means than a recall. If it does recall the product, the company issues the smallest recall possible, expanding by minute degrees to keep products on the shelves as long as possible.

Hundreds of wrongful death claims were issued over the Duragesic pain-killing patch. The jury determined that J&J was aware of the defects in the Duragestic patches, but neglected to inform doctors and consumers. the company recalled the patch that administered a 75mg/hour dose in 2004 - and waited until 2008 to recall the same patch that administered a 25mg/hour dose.

In Japan, J&J expanded a recall of its Acuvue TruEye lenses five times, from the initial 100,000 boxes to half a million. The expanded recall was only announced in Japan. At the time of the recall notice, J&J rather cavalierly noted that the recall represented less than 1% of all contact lenses made by the company worldwide.

This fact is surely a great comfort to the 500,000 people who put acidic lenses in their eyes. We're surprised a similar statement was not made about the Duragesic pain-killing patches; surely the hundreds of people who died represented only a small - negligible, really - fraction of the product consumed worldwide.

When it comes to consumer safety, though, Johnson & Johnson would almost always prefer to look at the numbers than the people.

Fine Print in Invisible Ink

Johnson & Johnson has been reprimanded, and occasionally sued, repeatedly over the last ten years for not giving their customers adequate warning about the risks of their products. Many jokes are made about reading the fine print - but the fine print can be rather difficult to read if the warnings simply aren't put on the labels at all.

The antibiotic Levaquin is associated with tendon ruptures, particularly in older patients. The company did not warn doctors before changing its label, which meant doctors with previous lots of the medication (or ones who do not read new labels in every new lot) were unaware of the problem. The label change, plaintiffs say, remains inadequate.

The ASR hip implant may have similarly inadequate warning problems. The company's literature on the ASR implant states that it must be placed at precisely a 45-degree angle, rather than the usual range of between a 30-45 degree angle. Though it has yet to be proven that the company did not make sufficient efforts to inform doctors of the dangerous results of placing the implant incorrectly, our sources indicate that surgeons were largely unaware that this particular implant was so sensitive to proper placement.

The company recalled 12 million bottles of Mylanta and 85,000 of Alterna Gel due to insufficient labeling as well: no mention is made of the presence of alcohol in the products from flavoring agents. The company also recalled 9.3 million bottles of Tylenol cold treatments for the same reason, including 40 types of J&J medication specifically made and marketed as being for children.

There's Something in the Water

The range of foreign matter found in J&J products encompasses everything from the aforementioned alcohol to metal and wood particles to glass shavings.

Perhaps most disturbing, however, is the bacteria found at the Johnson & Johnson plant that produced the now-recalled children's medicines. It's called Burkholderia cepacia, and while it produces little risk to healthy people, it can cause serious infections in those with weakened immune systems.

Such as, say, sick children whose concerned mothers gave them Children's Tylenol to combat fever.

The bacteria was found during an investigation by the FDA of the facilities operated by McNeil Consumer Healthcare, a unit of Johnson & Johnson that manufactures many popular medications for the company. J&J executives had previously said that the recall problems were limited to a single plant in Fort Washington, PA, that was shut down for an overhaul. However, the FDA's principal deputy commissioner states that all of the facilities operated by McNeil Consumer Healthcare have deficiencies that could affect the qualtiy of the products being sold.

"The company had an inadequate quality system," Dr. Joshua M. Sharfstein said.

It's a mild rebuke for a serious problem. Johnson & Johnson's quality control system has allowed multiple dangerous products to get to market over the last 10 years - some of which have caused permanent physical damage or even death.

But then, the FDA has never been all that inclined to look closely at Johnson & Johnson's proceedings.

Getting Cozy with the FDA

The House Committee on Oversight and Government Reform recently investigated the "phantom" recall of Motrin as well as individual manufacturing issues that led to the recall. They found that the FDA had visited the McNeil plants multiple times and characterized the relationship between J&J and the FDA as " too cozy."

This isn't the first time that we at Moriarty Leyendecker noted that the FDA seems to be doing an inadequate job of ensuring quality controls are met on Johnson & Johnson products that they endorse. The FDA approved the ASR medical devices too - without asking the manufacturers to put the product through clinical testing and without seeming to notice that of the multiple devices to which the J&J company DePuy claimed the ASR was "substantially equivalent", not a one had ever actually been clinically tested by the FDA.

The FDA also claimed that it was unaware J&J was re-purchasing defective Motrin without informing consumers - a claim that was later refuted in a report by ABC News. In emails obtained by ABC, the company's employees appear to be in cahoots with FDA officials who agreed to allow the company to buy back their product instead of issuing a formal recall

Cozy, indeed.

Cutting Corners Where it Counts

In November, J&J announced that it intended to cut 8,000 jobs globally. It also decided to give its chief executive, William C. Weldon, an 11% increase on his salary. His new paycheck? $25.6 million. Weldon is currently the worldwide chairman of Johnson & Johnson and is currently testifying to Congress about the recent medication recalls.

Of the 8,000 employees cut by Johnson & Johnson, no mention is made of their official job titles. However, we'd like to propose that Weldon's salary might be better spent in hiring some of those employees back - to manage quality control.

Perhaps then Johnson & Johnson might be able to keep dangerously faulty products like the ASR hip implant from reaching the market. Of course, such a proposal precludes the assumption that J&J executives care more about the safety of real people than about lining their own pockets - and there isn't much evidence to support that theory.

What is Metallosis?

2010-12-14T22:53:00.000-08:00

Home Personal Injury DePuy Hip Recall Traffic Tickets Family Law Criminal Defense Get Informed

Metallosis occurs when metallic debris builds up in the periprosthetic soft tissues. In the case of the DePuy ASR Acetabular system, the two parts of the hip implant abraded against one another, creating friction and releasing metallic ions of cobalt and chromium into the body.

Those microscopic metal ions cause an autoimmune response. The immune system identifies the metal ions as foreign bodies and automatically inflames the area around the debris. The body is essentially trying to "trap" the foreign particles in the inflamed area so that the metal can't spread to the rest of the body. In the case of the DePuy hip implant, it appears that the immune system sends inflammatory cells to the synovial membrane as well, causing synovitis. Synovitis is generally quite painful, since the membrane is too inflamed to allow the joint to rotate properly.

Metallosis can be complicated by metal sensitivity, which is essentially an allergic reaction to metal. The normal autoimmune response to foreign matter in the body is to inflame the area and attack the foreign cells. When the body is hypersensitive to a particular substance (like metal), the immune system overreacts and multiplies its efforts to eliminate the foreign body. In the process, normal healthy tissue can get caught in the crossfire as the body mounts an ever-growing campaign against the foreign body.

In patients with a DePuy ASR Acetabular System, the immune system is fighting a losing battle, even after its efforts are multiplied through metal sensitivity. Your white blood cells (leukocytes) attack any foreign organism, but they also "tag" and remember the organisms that have attempted to invade before and come up with secretions designed to wipe out those specific invaders.

In the ASR hip implant, the device's friction constantly releases new metal ions into the bloodstream, which means the immune system continually receives a message that its efforts are not enough to eliminate the foreign matter.

A simple analogy for the metallosis is a food allergy, which occurs when the body identifies a food as so dangerous to the body that its autoimmune reaction is exaggerated. Essentially, it identifies the food as a poison and reacts strongly so that the brain will realize the food is dangerous and move the body away from it. In extreme allergies, the body's immune response can be so overly strong that it can actually kill the person.

Generally, this sort of over-reaction occurs if the immune system is completely unfamiliar with a foreign body and can find no parallels with other objects it has encountered in the past. It can also occur if the body is over-subjected to the object; for example, it is possible to give yourself an allergy to just about any food if you consume excess amounts for months at a time.

Symptoms of metallosis generally include pain around the site of the implant, pseudotumors (a mass of inflamed cells that resembles a tumor but is in fact merely collected fluid), and a noticeable rash that indicates dying tissue. The damaged and inflamed tissue can also contribute to loosening the implant or causing dislocation, since the tissue that would normally hold the implant in place is weakened.

Women, the small in stature, and the obese are at greater risk for metallosis because their body structure causes more tension on the implant and contributes to the release of the metal ions into the bloodstream.

If you're concerned that you have an ASR XL Acetabular hip implant and would like to speak to someone about getting compensation for your medical problems now and in the future, please give our offices a call at 800-730-7607 or fill out our online form. We're here to answer any questions you have and advise you of your rights.

Why DePuy Hip Recall Won't Be a Action Lawsuit

2010-12-10T05:32:00.000-08:00

In a recent article, we explained the difference between bringing an individual lawsuit against DePuy vs. becoming part of a mass action lawsuit. In this article, we're delving into the differences between mass action and class action.

Historically, class action lawsuits are the stuff that give lawyers a bad name. The senior partner at our firm, Jim Moriarty, likes to say that class action lawyers represent people who don't know they've been harmed and don't care.

He's not just speaking metaphorically. It's entirely possible in a class action lawsuit to represent people who have no idea a lawsuit is being conducted in their name. Statistically, it's likely that you yourself have been involved in a class action lawsuit without ever knowing it.

In the case of the DePuy hip recall, it's extremely unlikely that any judge would allow the case to be brought as a class action. Here's why:

Advantages of a Class Action Lawsuit

When a class action lawsuit is filing, it must name one or several plaintiffs on the behalf of a proposed "class" of people. The "class" of people are individuals or business entities who have suffered a common injury or injuries.

The rules vary by state (in Virginia, for example, there are no class action provisions) but in general the idea is that the group is so large that individual lawsuits are impractical, and the claims are so similar that they can be considered by the judge as a single problem that many people have in common.

Class actions have several advantages. As we noted in our article on the advantage of bringing a mass action lawsuit against DePuy, any lawsuit that involves many people working under a single lawyer or collaboration of law firms has distinct financial advantages, since it will cost far more to bring each case individually than it will to bring a group of cases with similar problems. Another oft-cited advantage of class actions is that there is no advantage to plaintiffs who file early as opposed to plaintiffs who file late, and a third advantage is that class action suits have often been used historically to purposely change the behavior of a group of individuals such as physicians or companies.

Of course, all of these advantages only apply to lawsuits that are brought with the plaintiffs' best interests in mind. Unfortunately for our legal system, class action lawsuits have been used repeatedly to benefit unethical lawyers rather than plaintiffs.

The Missing Money

The biggest problem in class action lawsuits is that the plaintiffs often do not receive a share of the money recouped - or the share they receive is so small as to be negligible. Lawyers often take a large share of the awarded compensation while leaving plaintiffs with coupons of little or no value.

Lawyers are required to inform members of the "class" for whom they are filing suit that those individuals are now a part of a class action lawsuit. In theory, this means the people whose names are being used in the class action lawsuit have an opportunity to opt out of being a part of the lawsuit. In practice, most people either do not read such notices, viewing them as junk mail, or do not understand them.

Even if the notices are read and understood, it is extremely unlikely that the individual can do very much to forestall the class action lawsuit unless that person has significant personal funds. It is possible to sue a lawyer who uses your name without your consent in a class action lawsuit, but it would require significant funds and the lawyer often wins such cases, claiming that he brought a suit in the plaintiffs' best interest and had nothing but good intentions.

Meanwhile, the lawyer pockets much of the settlement. For those willing to spend their careers in such shills, it's a process with great rewards and little risks.

Why Can't the DePuy Hip Recall Be Filed as a Class Action Lawsuit?

Lawyers must seek approval to bring a case as a class action lawsuit, and as we've already explained, class actions must include a group of individuals with similar damages. Though all the people who received an ASR XL Acetabular System and a notification of the DePuy hip recall have the same hip implant, the injuries they have suffered are extremely wide and varied.

The future consequences, and the damages they are due for pain, suffering, and loss of wages will also vary widely. One person may receive a hip revision that fails as a direct consequence of the faulty ASR Acetabular System he originally received. As a result, he may be completely incapable of doing his former job as a construction worker.

That person will have an entirely unique case from someone who had a few minor medical consequences as a direct result of the ASR Acetabular System and whose hip revision was successful. The latter case still has merit and that person should still be compensated, but the evidence, the harm done, and the consequences for which the plaintiff should receive compensation will be very different.

In a case where the injuries to the plaintiffs are this varied but it is still to the plaintiffs' disadvantage to bring an individual lawsuit, a mass action lawsuit is best. A mass action suit means that plaintiffs will have all the advantages of a class action suit (lower costs to bring the case, no advantage to early filers, etc.) without the disadvantages of receiving a negligible sum for their grievances.

It is extremely unlikely that any judge would allow the DePuy hip recall case to be brought as a class action lawsuit, since it clearly does not fit the parameters for such a suit.

Why Mass Actions Don't Dip into Plaintiffs' Pockets

In a mass action lawsuit, most lawyers will agree to bring the case on a contingent fee basis, which means that you owe nothing if the case is lost. The lawyer takes the risk of funding the case up front in exchange for a portion of the awarded compensation at the conclusion of the case.

This is also true for class actions, with one significant difference: there are limits on the percentage of the compensation a lawyer is permitted to recoup at the conclusion of the case. In most states, the limits are between 30-40% of the total compensation. Though that number may seem high, recall that the lawyer is funding the case throughout the time period it is being brought, which may be years. The lawyer is taking significant risk and asking for no fees until the case is successfully concluded.

And, of course, the lawyer earns nothing if the case is lost. In fact, the lawyer is out of pocket if the case is lost, since there is no way to recoup the money already spent on bringing the case in the first place. This gives the lawyer strong incentive to bring the best case possible.

In a class action, lawyers often retain the majority of the funds awarded. In a mass action, that number is limited to a reasonable fee and the plaintiffs are assured of proper compensation for their injuries.

One More Significant Advantage to Mass Action Lawsuits

In a class action, plaintiffs are treated like numbers. In a mass action lawsuit, plaintiffs are treated as individuals. This is both a personal and professional choice for us at Moriarty Leyendecker. Every plaintiff's story and personal experience is valuable to the case, so it is only logical that we should want to hear every word and learn all about the client's history.

We also do it simply because it is important that these stories be heard. Every story we've heard so far from our clients has been heartbreaking. It isn't enough to say "some people got hurt and we settled the case." It's important that your story is heard, and that the compensation you receive is directly tied to your life and your losses.

If you'd like your story to be heard and you have questions about your particular situation or about becoming a part of the lawsuit against DePuy, we're here to listen and to give you the best answers we have. Give us a call at 1-800-730-7607 or contact us online. We'll do everything we can to help.

For DePuy plaintiffs - and our legal team - Ohio is the place to be

2010-12-10T05:14:00.000-08:00

Two weeks ago, the U.S. Panel on Multidistrict Litigation conducted a hearing to discuss where the DePuy Hip Implant MDL should be placed. Today, the Panel announced that the litigation will take place in the Northern District of Ohio.

Complaints about the DePuy ASR hip implants have been reported throughout the United States, which prompted a hearing to consolidate the cases into multidistrict litigation. Counsel for DePuy Orthopaedics, Inc. did not object to doing so. The Multidistrict Litigation (MDL) Panel determined that the DePuy cases qualified for consolidation and created DePuy Mulitdistrict Litigation.

There were many different courts in the running for the federal district in which the pretrial proceedings would take place, including Kentucky, Indiana, New Jersey, Ohio, and Florida. Counsel for DePuy and several Plaintiffs' lawyers who represent people harmed by the DePuy devices submitted arguments to the Panel as to which court they felt was most appropriate for these cases.

As we've explained in previous articles, consolidating a case conserves resources for the attorneys as well as the judiciary, and bringing individual lawsuits for each case can make the costs so prohibitive as to present an obstacle to getting a fair settlement for the plaintiffs. The fact that DePuy Multidistrict Litigation has been formed creates a more efficient way for our legal team to pursue claims for our clients and ensures we are better able to give them the individual attention they need.

To better serve our clients in this case, Moriarty Leyendecker is working in conjunction with The Law Offices of Sullo & Sullo and The Law Offices of Howard L. Nations, the latter of whom was among the lawyers who proposed the Northern District of Ohio as the best venue based on that court's current docket and the speed and efficiency at which they move cases to resolution; the convenience of location for all parties; and the experience of the presiding judge.

The Honourable David A. Katz is highly experienced with a successful MDL track record. Judge Katz is exceptionally well qualified to handle a matter of this size and complexity. Mr. Nations and his legal team were recently before Judge Katz in litigation regarding Ortho Evra Products Liability, a matter which was successfully resolved in the same Ohio court.

At Moriarty Leyendecker, we are looking forward to working with Judge Katz and his staff on this important matter, and we are confident that this choice of district is in the best interest of our clients.

DePuy Wants You to Give Your Defective Hip Implant Back

2010-12-10T05:08:00.000-08:00

After DePuy issued its recall notice, it sent a letter to the surgeons who had conducted hip replacement surgeries using the ASR XL Acetabular System. In part, the letter informed the surgeons that DePuy was offering to pay for their patients' hip revision surgery.

In exchange, the company wanted just one minor thing: the hip implant.

On the face of it, this doesn't seem like an out-of-line request. After all, DePuy was offering to replace the faulty hip implants and told the surgeons that it wanted to see the explants to figure out what was wrong with the design and make improvements in future models. Many patients may very well have thought that returning the hip implant to DePuy was actually returning the device to its proper owner.

Not so. DePuy has no right to your hip implant - emphasis here on your. You bought and paid for the hip implant when you first had a hip replacement surgery. It belongs to you.

The other problem, of course, is that handing over the explant is as bad as handing over the keys to your case.

Why Your Hip Implant is Valuable to Your Case

When archaeologists discover human bones buried thousands of years ago, they can discern amazing things about how those people lived, interacted, and died. Sometimes they can even determine the profession or position they held in society depending on the way the bones had been worn down over time.

Your hip implant tells a similar story. The way that it has deteriorated over time will reveal whether it is your behavior or DePuy's poor design that has caused the medical problems you and others have experienced as a direct result of the implant. DePuy would very much like to prove that your lifestyle since the surgery has caused the breakdown of your hip implant. Failing that, the company would like to prove that the way your doctor placed the implant has made it ineffective.

If DePuy holds the explant, it can attempt to imply that you caused your hip implant's failure. If you hold it, your legal representation can prove otherwise.

The Art of Misdirection

DePuy offered patients a free hip revision surgery as an enticement. For patients who are fearful that their hip implant is faulty and causing problems like metal sensitivity, metallosis, heavy metal poisoning, and bone deterioration, the offer of a no-cost revision is extremely appealing. Worried that the longer they retain the hip implant, the worse off they will be, those patients are likely to sign the consent forms presented to them without reviewing them properly. Even if they do review the forms, it's not likely the full ramifications will become clear until it's too late.

If DePuy lacked sufficient talent to properly design and engineer a functioning implant, they've made up for that shortcoming by perfecting the art of misdirection. Distracting patients with the offer of a free hip revision surgery, DePuy is making the removed hip explants disappear into thin air - or, at the very least, into the hands of their legal defense.

It's a clever con, and it is very easy to be taken in by it. Many patients have already signed away their own hip explants to DePuy in exchange for the free hip revision surgery, and have undermined their case by doing so. However, even if you have already signed the consent forms, there are ways to reverse the trick and bring the faulty hip implant out of the shadows and back into the light.

Bad Intentions

It is entirely possible that DePuy intends to use the explants to improve on their current model and produce a better ASR Acetabular System. However, the evidence thus far is not in favor of that story. Leaving aside the fact that DePuy never put the hip implant through clinical trials in the first place, in previous litigation on another implant case, the company's defense team used the explants to try to prove the plaintiff caused the problems himself.

In one particularly frightening story recounted to us by an attorney who referred a client to us, a hip explant was "lost" after a revision surgery. The hospital and surgeon's staff insisted that the explant was being held at the hospital after surgery. Another staff member said the explant had been thrown out along with other surgical waste, admitting later that a DePuy representative was present at the hospital on the day of the operation.

We cannot offer irrevocable proof of this story and we have no reason to believe that DePuy representatives are actively attempting to scoop up explants immediately after surgery. However, it is a troubling story and we have no reason to disbelieve the word of the attorney who recounted it. If nothing else, it would seem to indicate that DePuy's motives are not as benign as they claim.

Unless, of course, the representative merely wanted the explant to help the company's engineers improve the design. It must be a great comfort to the patient whose personal property was lost to know that her case was undermined for such a worthy cause.

Don't Sign Your Rights Away

You are entitled to a hip revision surgery without submitting your explant to DePuy. We believe you should be compensated for all medical costs related to the faulty hip implant, which would include the revision surgery.

To put it another way, you can allow them to pay for the surgery now and lose a great deal of future compensation in the future - or you can retain your own explant and receive the compensation you are due, including the cost of the revision, after we have used your explant to make a strong case against DePuy in a mass action lawsuit.

If you are asked to sign a document waiving your right to keep your own explant, we strongly advise you not to sign it. If you have already done so, please contact our offices immediately at 1-800-730-7607 or via our online contact form. We may be able to help retrieve the explant or show that DePuy obtained it improperly.

How Soon Did DePuy Know About the High Failure Rates for the ASR Acetabular System?

2010-12-10T04:27:00.000-08:00

Soon enough to save thousands of people from revision surgery and severe medical consequences.

When DePuy issued its recall of the ASR XL Acetabular System and the ASR Hip Resurfacing System, it claimed to be doing so because the revision rates were higher than normal. Surgeons, the company said, needed to be fully informed before making the decision to implant the devices.

Up until this point, the company had consistently blamed the surgeons for implanting the device improperly. The high revision rates were due, DePuy claimed, to surgeons placing the device at the wrong angle.

So it was somewhat surprising that DePuy should suddenly decide to recall a hip implant that it had been planning to "phase out" by the end of 2010 anyway. If the high revision rates were no fault of the company's, surely a recall was unnecessary.

And if a recall was so necessary that the device could not justifiably stay on the market for another nine months, it seems peculiar that DePuy should have waited three years before issuing the recall - considering they had data showing failure rates that were many times the usual for their ASR systems. The ASR hip resurfacing system failed at a 12% rate, over twice the accepted norm of 5%. The ASR XL Acetabular System failed at a 13% rate, topping the average of .5-3% by a hefty margin.

DePuy had the information on those failure rates in 2007. The recall wasn't issued until 2010, and until a month before the recall, the company insisted that its revision rates were equivalent to any other products' on the market.

We believe this timeline proves the company knew otherwise, and allowed the ASR device to stay on the market anyway. We believe they did so for profits: the ASR was an expensive device in both incarnations, and if DePuy had issued a recall in 2007, it would have lost out on several years' worth of device sales.

That said, these are the facts: You can deduce for yourself what DePuy knew, and when, and how despicable it was that they did nothing at all to stop their device from being implanted in thousands upon thousands of people who never suspected what a risk they were really taking.

In 2005, the FDA clears the ASR cup for use in traditional hip replacement through the 510(k) approval process. It claims the product is "substantially equivalent" to several other devices already on the market. None of the products to which the ASR product was claimed to be "substantially equivalent" had ever been clinically tested by the FDA.

Beginning in 2007, the Australian National Joint Replacement Registry issued seven separate reports to DePuy identifying the problems being reported by surgeons throughout the country with the ASR Hip Resurfacing System, and warning the company of unusually high failure rates.

By the beginning of 2008, the U.S. Food and Drug Administration has received approximately 400 complaints about the failure of the ASR XL Acetabular total hip replacement system.

In early 2009, DePuy sends a brochure to doctors describing the importance of proper acetabular cup positioning for all hip implants. The brochure did not specifically mention the ASR as a point of concern.

In December of 2009, DePuy withdraws the ASR from the Australian market for "commercial reasons" - but does not recall the device.

In February of 2010, DePuy officials grant an interview to the New York Times in which they state that the ASR's performance is equal to that of competing devices.

In a letter dated March 6, 2010, DePuy issues a formal recall of both the ASR Hip Resurfacing System and the ASR XL Acetabular System.

In April of 2010, DePuy maintains in the New York Times that the ASR XL Acetabular System is safe, despite the recent recall.

On August 26, 2010, Johnson & Johnson announces that DePuy is issuing a worldwide recall of the ASR Hip Resurfacing System and the ASR XL Acetabular System.

DePuy clearly attempted to get the device off of the market without having to go through the loss of reputation that accompanies a formal recall. It claimed it was taking the ASR system off the Australian market because of declining sales, rather than declining success rates. It claimed to the New York Times that the device performed at equal levels to other competing hip implants, even when it could not possibly have believed that statement to be true.

And most damning at all, even after issuing a recall in the United States in March of 2010, DePuy kept selling the faulty hip implants worldwide for the next five months before extending the recall overseas.

To keep selling a device even when the company was fully aware it was risking one in every eight patients' future health is unconscionable. For the sake of every patient who received a hip implant from DePuy, and every surgeon who placed one in good faith that the product would perform well, we would like to see justice done.

If you have a DePuy hip implant and would like to join the mass action case against the company, we're here to answer your questions. Give our offices a call at 1-800-730-7607 and we'll have you talking directly to one of our lawyers in short order. It's important to us that you get the personal attention you deserve.

Learn how the ASR Acetabular System passed the FDA Approval process.

Learn more about revision rates and why DePuy's device failures shouldn't have been ignored.

See how the ASR XL Acetabular System is made and where the failures are.

How do I find a good lawyer?

2010-11-25T23:42:00.000-08:00

With so many lawyers out there, how should you go about finding a good one? How can you tell a strong lawyer from a weak one? You need solid legal advice, and you want the right attorney. Do not, we repeat, DO NOT just open the phone book, close your eyes, and point to a name. Here are some guideposts to help you.

A good lawyer is ethical.

You're probably laughing right now. Can the words "ethics" and "lawyer" exist in the same sentence? Actually, it is possible, and you should absolutely insist on it. But how can you tell if a lawyer is ethical? There are some pretty good indicators.

What types of cases does he take? Lawyers have a choice about which cases they take. Look at her winning cases as well as the losing ones. No lawyer wants to lose a case, but an ethical lawyer will often be willing to take a case because it is the right thing to do and fight to the very end.Look at whether the lawyer actually tries the cases he takes in court or whether he just gathers cases for others. Ask the attorney when he last went to trial. Ask him how often his cases settle and how often his cases make it to a jury. Be sure that the lawyer specializes in your type of case. You really don't want a tax attorney to represent you in your personal injury case. An ethical attorney will only take cases in her area of expertise.

What types of clients does he represent? Does he represent big corporations or everyday people? Does he fight for the underdog? Does he hold wrongdoers accountable for their behavior?

Is he honest? Is she candid about the strengths and weaknesses of your case? A good lawyer will almost never tell her clients that the case is a "slam dunk." Those types of cases are extremely rare. Moreover, is he honest about his own strengths and weaknesses as an attorney? A good lawyer will tell you if he's particularly good in one area, but that he may ask his partner to help out in another area. He knows that two heads are better than one, and he can be honest about it. Is the lawyer truthful about his fees and costs? He should tell you what his services will cost, and there should not be any hidden fees.

What is the lawyer's reputation in the community? Is he known for his honesty, his pro bono work, his strong relationships in the legal and general community? Google the lawyer's name. See what comes up. Look for newspaper articles, websites and blogs. Make sure the attorney is in good standing with the state. Any sort of disciplinary action is a red flag. Ask around the community. Does the lawyer have a good name around town? Have any of your friends or acquaintances had experiences with him? Check his references.

A good lawyer values you as a person.

Does he look you in the eye when he's talking with you? Are you treated as a person or as just some client? Does the lawyer remember personal information about you, including your spouse's or children's names? Do you actually get to meet with him personally, or are you always sent to talk with a secretary? A good lawyer will make time for you and will return your phone calls quickly. Does he show that he understands that you have a unique situation that is quite unlike anyone else's? Has he shown that he respects your time and obligations, or does he talk on and on? Remember, a good lawyer will listen at least as much as he speaks.

Trust your gut.

It all really comes down to trusting yourself. Ask yourself: Do I like the guy? How does he treat his office staff? Do I trust this guy? Does it feel like he's trying to sell me the Brooklyn Bridge? If you don't like how you feel at that first meeting, chances are that it's not going to get any better. Listen to that little voice inside - odds are, you're exactly right.

How do I know if Sullo & Sullo is right for me?

Please browse our site and give us a call. We'd like to answer any questions you may have. Give your gut a chance to test our ethics and people skills.

Hip Implant Risks May Include Premature Failure.

2010-11-25T23:39:00.000-08:00

In 2003, DePuy released the ASRTM XL Acetabular System, a hip implant that was touted to last up to 20 years with a stronger, more durable metal-on-metal design. Approximately 93,000 people around the world weighed the risks of surgery against their current level of pain and discomfort and chose to receive a hip implant that they believed would give them 15 to 20 years of pain-free movement.

DePuy issued a hip recall earlier this year, which means a disturbing number of those patients will likely have to undergo a hip revision surgery-years ahead of schedule.

With a typical hip replacement, the patient is able to resume a normal life after three to six months of recovery. There are a number of "common" problems, such as loosening joints, fractures, and occasionally dislocation. Hip implant recipients are informed beforehand that the risk of these types of failure is .5-3%

The admitted failure rate of the ASR XL Acetabular System is 13%-meaning, this is the number acknowledged by DePuy. Mounting evidence suggests that the failure rate is higher than that, especially if one doesn't limit the definition of "failure" to DePuy's narrow view.

The major flaw, as we've said in other articles about the problems with the XL Acetabular System, is the engineering. The two pieces of the implant rub together as the patient moves, releasing microscopic particles of chromium and cobalt into the bloodstream. Some patients experience pain when this happens; others have no idea of the damage being done to the bone and tissue surrounding the hip implant. Some patients and doctors have reported a loosening of the joints in the hip implant, fracturing of the surrounding bone, and full-out dislocation.

Every hip implant releases small particles of the device's materials into the bloodstream, but the quantities are so small that the body can release them from the bloodstream as waste. In the ASR XL Acetabular System, the quantities being released are sometimes so great that the body can't get rid of them efficiently, causing metallosis.

According to DePuy's website, "the patients who reported problems in the first five years and had revision surgery reported a variety of symptoms." So far, DePuy hasn't listed those symptoms on their website, but the current evidence reveals metal poisoning, bone deterioration, and tissue necrosis, as well as metallosis.

Before any surgery, the surgeon is required to meet with the patient and go over the potential risks. Most people are familiar with the idea of informed consent, which essentially states that patients should understand the facts, implications, and future consequences of any medical decision they're being asked to make.

With hip implant surgery, the potential problems include malignant hyperthermia, infections, respiratory issues, and blood clots that can cause strokes. These are the basic risks for any major surgery; a hip implant patient would've been informed of that fact. The recovery process also has risks, as does refusing to have the surgery. Risks are part of the decision to receive or not receive a hip implant.

However, DePuy never informed the patients who were receiving the ASR XL Acetabular System that their hip implant might have a number of risks above and beyond those of major surgery. DePuy never informed the surgeon performing the procedure that the hip implant's engineering hadn't been tested by the FDA-or that many patients, especially women, had already reported problems only a few years into the life of their hip implant.

DePuy certainly failed to inform both the surgeons and the patients that their product could mean a revision surgery in less than three years-a fraction of the 15- to 20-year time frame their advertising campaign promised.

The hip implants recall issued by DePuy was voluntary-but it was too little too late. According to their website, "DePuy intends to cover reasonable and customary costs of testing and treatment associated with the ASR recall, including revision surgery if it is necessary... This will allow DePuy to process other reasonable out-of-pocket costs, such as lost work time and travel expenses, which may be reimbursed. These costs will be more clearly defined shortly and are subject to review on a case-by-case basis."

"Out-of-pocket costs" means everything that's not covered by the insurance company-and insurance companies haven't exactly developed a reputation for being forthcoming with treatments that keep the patient's health at the forefront of considering factors. They're more likely to choose the least costly option, which means that many of these patients will find themselves in a lawsuit over what is and is not a necessary medical procedure.

This is the last thing any of these patients with failing hip implants needs. They needed a hip implant-not costly procedures and legal battles to make sure they get the care they need to replace the damage that was done. They also need full compensation for all their losses and damages, not just out-of-pocket costs.

Every patient who undergoes major surgery takes a risk. Those who received a DePuy ASR XL Acetabular System weren't merely asked to take a risk, however-they're being asked to take the fall.

If you received an ASR XL Acetabular System, we're here to answer your questions and let you know how we can help. Give us a call at 1-800-730-7607.

FDA Approval Process Changes: Too Little, Too Late.

2010-11-25T23:35:00.000-08:00

In August 2005, the FDA approved an application for the DePuy ASRTM XL Acetabular System, allowing DePuy to market the new, metal-on-metal system to patients needing total hip replacement surgery. To those patients, this FDA approval meant one thing: the DePuy ASRTM XL Acetabular System was safe.

But, in its first five years, the ASR System failed at such catastrophic rates that DePuy issued a voluntary recall in August 2010, affecting tens of thousands of patients who have to undergo revision surgery.

How could this happen? Isn't it the FDA's job to verify and ensure the safety and effectiveness of medical devices sold in the United States?

The DePuy ASRTM XL Acetabular System gained FDA approval through the 510(k) process, which bypasses clinical testing altogether if the product is "sufficiently equivalent" to other products already on the market.

Which means the ASR System was never clinically tested before it was sold to patients, and it underwent only the most rudimentary safety tests. DePuy only had to state that their new product raised no new safety concerns. The FDA - evidently - took them at their word.

Congress and consumer advocacy groups have been calling for of the 510(k) process,in part due to similar recalls from DePuy and other medical device companies. As of August 2010, the FDA has issued two preliminary reports that recommend sweeping changes.

The reports indicate that consumer advocacy groups had strong concerns about "predicate quality"-that is, the quality of the already approved devices to which DePuy claimed their new product was substantially equivalent.

Per the current 510(k) requirements, a company can claim its product is substantially equivalent to a product that never underwent clinical testing, was made before 1976, or had been recalled. That's right: the ASR System got through on a kind of loophole, and now another manufacturer can come along and claim their product is substantially equivalent to it-and be approved.

Had this negligence been rectified years ago, the ASRTM XL Acetabular System might never have gone to market.

The preliminary reports also recommend getting rid of the rule that allows a company to base its substantial equivalence claims on more than one product. This change would almost surely have invalidated DePuy's ASRTM XL Acetabular System application, because DePuy based its substantial equivalence claim on no fewer than three devices.

Perhaps most important, the reports call for an improvement in the quality of the clinical data submitted to support substantial equivalence. How has the FDA justified making an educated decision about a new product's safety and effectiveness without strong clinical data?

If DePuy had been mandated to conduct clinical studies before the ASR System was sent to market, the terrible fact of a one-in-eight revision rate might've been avoided. Tens of thousands of patients might've been spared the painful truth that will need to undergo a second hip implant just a few years after receiving the first.

Critics have long argued that companies use the 510(k) process is a loophole that allows companies to get around the more arduous premarket approval process otherwise required by the FDA. While it's true that the 510(k) process saves companies a lot of time and money, the cost is merely passed on to the patients, who pay with their money, pain, and quality of life.

We can only hope that the proposed reforms to the current process take effect soon and prevent more tragedy from prematurely approved devices like the DePuy ASRTM XL Acetabular System.

If you think you have a DePuy hip implant and would like to know more about this case, give our offices a call at 1-800-730-7607. We have people standing by to answer your questions and explain how we can help.

DePuy Asks Hip Implant Patients to Sign Away Their Legal Rights

2010-11-25T23:24:00.000-08:00

If you received an ASR XL Acetabular System, your doctor has probably already informed you that DePuy is offering to pay for hip revision surgery.

What they may not have mentioned - and what they may not themselves realize - is that agreeing to DePuy's hip revision offer means that you must agree to sign a waiver that essentially waives your rights in litigation and allows the Johnson & Johson-owned company to access your medical records.

They want to use your own medical records to show that they don't owe you anything for the serious repercussions of the faulty hip implants they allowed to get to market without sufficient testing.

Hip Revision Dependent on Loss of Patient Rights

DePuy sent a letter to health care professionals explaining the recall and informing the doctors and surgeons that they needed to contact their patients about the problems with the ASR XL Acetabular System. In the letter, DePuy said they intended "to cover reasonable and customary costs of monitoring and treatment for services, including revisions, associated with the recall of ASR."

Laying aside for the moment that "reasonable and customary" probably does not mean the same thing to DePuy as it does to the patients, the real problem comes in the next paragraph.

Eligibility for this medical treatment, DePuy says, is dependent on the patient having "consented to provide DePuy with x-rays, explants, and any other requiested medical information after the revision surgery."

In other words: DePuy won't pay for your revision surgery unless you sign away your private medical records so they can examine them.

What do they plan to do with your medical records? DePuy states that they will use this information "to process claims efficiently and to help DePuy to better understand the causes of the problems with the ASR Hip System."

If this were true, then the information would surely be scrutinized by their engineers to determine exactly what went wrong with the design of this hip implant. That's commendable, but unfortunately it is far from the most likely scenario, as the history of DePuy's previous encounters with faulty implants shows.

The DePuy professionals that will be scrutinizing your medical information aren't engineers, nor even doctors.

They're lawyers.

What's Wrong With DePuy Having Access to Your Hip Implant Records

To give you an idea of what you can expect from DePuy in litigation about the ASR XL Acetabular System, it may help to look at a previous case about another medical device: the DePuy Limb Preservation System. It's a knee replacement approved by the FDA using the same loophole in the 510(k) process that the ASR hip implant slipped through: DePuy claimed the knee replacement to be "substantially equivalent" to another product.

It later transpired that the product to which the knee replacement was supposed to be substantially equivalent was completely different. The LPS system was never tested. It also had serious design defects.

If all of these problems sound familiar, it's because they are identical to the issues with the ASR XL Acetabular System: cleared through the 510(k) process, claimed "substantially equivalent" to a device that was nothing like the new hip implant, clinically tested by the FDA, and serious design problems.

In the knee replacement case, DePuy's defense avoided talking about any of these issues.

Instead, they pointed the blame at the patients.

The device failed because the patient was overweight. Because the patient was over-active. Because the patient had fallen. Sometimes, they also blamed the surgeon - for improper implementation.

But mostly, they blamed the patient.

What are they going to do with your medical records? They're going to use them to build a case that they did nothing wrong.

They're going to claim that you did.

Where Is This Form Going to Come From?

DePuy sent copies of their Medical Release Form, also called the Authorization to Use or Disclose Information, to each medical professional who implanted an ASR XL Acetabular System.

The form signs over all medical records, explants and x-rays from the original surgery that implanted the ASR XL Acetabular System, the hip revision surgery, and "all follow up visits and records." Records include "telephone message slips," "copies of lab work," "physical therapy reports," "progress records," and other private medical information.

This means your surgeon is likely going to be the one who asks you to sign the form, which in turn means you must stay alert. There is a lot of paperwork surrounding any surgery, and it is important that you make sure you don't accidentally sign a form that loses you legal rights.

There are accusations that DePuy has offered the surgeons money for every Medical Release Form they can get signed. They have good reason to offer incentives: all of this information can be used to build a case against you. More importantly, giving DePuy the explant means that your lawyer no longer has access to it and cannot use that evidence to build a solid case against DePuy.

The surgeon who placed the implant may not be aware that these are DePuy's intentions. In fact, all the communications we have seen between DePuy and the medical professionals who implanted the ASR XL Acetabular System claim that the only reason they want this information is to improve their medical devices. This means your surgeon may have no idea that by encouraging you to sign the form, he or she is also encouraging you to sign away your chance for legal compensation.

Please don't blame your doctor. We certainly don't. They're doing their best to make sure you get the hip revision surgery you need right now.

We're doing our best to make sure you get everything else you need - including just compensation.

Have You Already Signed a Medical Release Form for Your DePuy Hip Implant?

You may have already signed one of these forms. If you have, please don't panic. There are measures we can take to help you get your medical and legal rights back. For example, we can put out a revocation of authorization to use or disclose your medical information, which compels DePuy to stop asking for new information and to return the information they've already received.

If they don't comply, we can use that refusal to respect your rights in the case against them.

If you have questions about the ASR XL Acetabular System hip recall or you're concerned that you may have already signed a form giving DePuy access to your medical records, give us a call at 1-800-730-7607 or contact us online. We're here to help.

What is Heavy Metal Poisoning?

2010-11-25T23:00:00.000-08:00

As we try to describe the reasons the DePuy ASR XL Acetabular System present such a danger to your health, we occasionally use terms you may be only vaguely familiar with. This is an ongoing series of articles on the medical terms related to the DePuy hip recall and hip revision surgeries.

Heavy metal poisoning, by its strictest definition, is simply the build-up of heavy metals in the soft tissues of the body. It is also referred to as heavy metal toxicity. The most common heavy metals associated with poisoning are lead, mercury, arsenic, and cadmium; the ones that are in the structure of the DePuy ASR XL Acetabular hip implant are chromium and cobalt.

One doctor who analyzed several patients who were tested for metal poisoning said that these were some of the highest levels for chromium and cobalt ions he has ever seen. Despite this, he also said that many of the patients had no symptoms, which makes for a very good argument that any patients who received an ASR XL Acetabular System should be monitored closely and receive regular blood tests.

For any kind of heavy metal poisoning, the symptoms largely revolve around the digestive system: nausea, vomiting, diarrhea, and stomach pain, for example. Patients may also have headaches or get a metallic taste in their mouths. In extreme cases, heavy metal poisoning may make patients lose cognitive, motor, and language function.

Chromium and cobalt have also both been linked to cancer. One study recommended that human beings should not have more than 1 part per million of cobalt or chromium in the bloodstream many patients with the ASR XL Acetabular System have exceeded 7 parts per million.

The standard treatment for metal poisoning is chelation therapy; however, this process does not reverse any neurological damage done.

It is essential, if you have a DePuy ASR XL Acetabular System, to get tested for heavy metal poisoning, particularly your cobalt and chromium levels. If you have any questions or would like some help understanding your legal rights, please do give our offices a call at 1-800-677-7095 or simply fill out our online contact form.

Why Women Are Affected More Than Men by the DePuy Hip Recall

2010-11-25T22:55:00.000-08:00

Several news sources, among them the New York Times, have already commented on the mounting data that more women than men are reporting problems with the ASR XL Acetabular System. We'd like to explain exactly why that is.

Problem: Hip Implant Not Designed Ideally for Wider Hip Sockets

Women, as you may have heard, are structured differently anatomically than men. The differences aren't merely on the surface, however; they extend into the skeletal structure and particularly in the pelvis region. Women have wider hips with bigger hip sockets to accommodate the process of giving birth, which means they often have more problems in hip implant surgery because those large hip sockets allow the implant to dislocate more easily.

In the DePuy ASR XL Acetabular System, however, the problems go beyond the norm. One of the reasons is that the hip implant was designed to be extremely shallow, exacerbating the problems women already have with hip implants.

Problem: Women More Likely to Require Hip Implants

Women are more prone to osteopenia, osteoporosis, and often have weaker bones overall than men, particularly as they age. The onset of menopause, and the subsequent drop in estrogen, have been linked to rapid bone deterioration. Because of all of these factors, women are more likely than men overall to require a hip implant because of a hip fracture.

Problem: Small, Shallow Hip Implant

The DePuy ASR XL Acetabular System was designed to give patients a greater range of motion. If you'll recall, the design of the hip implant included two parts: an implant inserted into the femur bone with a rounded top that fit into a cup placed in the hip bone.

In the design of the ASR XL Acetabular System, the cup was made very shallow, which meant that the patient could move their leg in a wider arc before the other part of the implant might dislocate.

Good in theory. And if DePuy had tested their product properly, it might have worked quite well. In real life, it went a little differently.

The shallow hip implants meant that all of the friction caused by everyday movement was focused on a much smaller area. There was more force on a smaller amount of material. The hip implant was under more stress and was more prone to the friction that caused small metal ions to break off into the bloodstream. It was also more likely to break altogether.

Especially in women. Their smaller, shallower hip implants meant there was even more strain on the material. Women who have an ASR XL Acetabular System are reporting problems in greater numbers than men in part because their hip implants are simply breaking down faster. They have the same problems, forced upon a smaller area.

Our consulting doctor offered some sobering statistics for smaller hip implants in general: the risk of a hip revision surgery for a hip implant with a head size of 44 mm is five times that of a hip implant with a head size of 55 mm.

Problem: Bone Deterioration Exacerbated in Women's Hip Implants

Because women are more prone to bone deterioration in general and have less bone density than men, the problems caused by the ASR XL Acetabular System are multiplied. We've explained the problem of bone deterioration at length, but here's the issue in a nutshell:

For a non-cemented hip implant like the ASR XL Acetabular System to work properly, the surrounding hip bone needs to be healthy and growing. DePuy's hip implant design caused an inordinate number of metal ions to be released into the bloodstream, causing problems with metallosis, heavy metal poisoning, and metal sensitivity - all of which adversely affect the bone.

One reason why women may be reporting problems with their hip implants sooner than men is because they have less bone to sacrifice to the effects of the metal ions floating in their bloodstream. The symptoms become painful more quickly, and more women are going to their doctor with concerns about the hip implant.

Handicapped with less dense, weaker bones, women now face the additional problem of attempting a hip revision with severely damaged hip bones from the previous DePuy hip implant.

It is already more difficult for a woman to have a successful hip replacement surgery than a man. DePuy's ASR XL Acetabular System made it even more difficult - not to say dangerous.

If you have any questions about your hip replacement surgery or your options moving forward, we'd like to help. Give us a call at 800-730-7607 or fill out our online form and we'll explain your legal options and try to answer any of your questions about the DePuy hip implant and how it's affecting your health.

Why Mass Action is Best for the DePuy Hip Implant Lawsuit

2010-11-25T22:48:00.000-08:00

Many different law firms are suing DePuy Orthopaedics over the faulty ASR XL Acetabular System. In a personal, vulnerable situation like this hip implant case, it can be difficult to assess the situation and make the right legal decision for you. In this article, we'd like to break down the difference between mass action, class action, and solo cases so you can make a well-informed choice for yourself.

"One Riot, One Ranger"

When a single person with a single lawyer brings a case against one organization, our firm's Jim Moriarty likes to call it a "one riot, one ranger" case: one person was harmed, and one person needs to set it right.

Let's take a hypothetical. Company X has a trucking business. One of its drivers runs into a pedestrian and causes serious injury. The driver was clearly negligent and the pedestrian was clearly hurt. The damages amount to $1 million. If the lawyer presents a good case, it's likely that the case will be settled for the $1 million, and Company X won't bother spending much on its own legal defense.

Company X could, of course, spend $1 million to avoid paying the $1 million to the plaintiff, but this would take up time, company resources, and would likely land them some bad press. If the money will be spent anyway, it's in Company X's best interest to simply pay the plaintiff with it instead of using up those resources.

"One riot, one ranger" is a very effective way to settle a case with a single client who has a single complaint, because it simply isn't worth the legal fees to Company X to defend the case when it can be settled for its fair value. They would rather settle the case, reluctantly compensate the plaintiff for his injury, and move on.

So if "one riot, one ranger" cases are effective, why isn't that the best way to bring a case against DePuy for their faulty hip implant?

If a single person had received a single faulty hip from DePuy, it would be a great way to bring the case. Unfortunately, we're dealing with 93,000 people who received recalled hip implants, many of whom will now have medical consequences.

And in that situation, the math starts to work against the plaintiffs.

Bluffing Without a Hand

Going back to Company X for a moment, let's say that instead of the truck running into a single pedestrian, the truck ran into a plane full of people. 200 people are seriously injured. Each of those 200 people runs out and gets a lawyer. The cost of the injuries is far beyond our original case scenario - perhaps a few people have injuries totaling $1 million worth of compensation, but others will have lower or higher damages.

Instead of paying a one-time settlement of $1 million, Company X is now looking at paying several hundred million, because there are so many people to settle with.

Suddenly, shelling out a couple million in lawyer's fees to defend against the lawsuits is a much better deal for Company X.

Each individual lawyer (assuming they are working on a contingent fee basis) will have to put up his or her own money to fight the case. Company X can afford to put a lot more money into the case than the lawyers can because they are ultimately saving themselves from the even more expensive consequences of settlement.

One plaintiff might have a $10,000 case, and the plaintiff's lawyer might be willing to put in up to that amount of his own money to see justice served. But Company X can afford to put in millions - even if the case isn't actually worth that amount - just so they won't have to settle with the other 200 individual cases as well.

In a case where there are many people who have been harmed, it's a case of "divide and conquer." The more lawyers who are depending only on their own funds to bring a case against Company X, the more power and leverage Company X has. They know the lawyer can only afford to put in a certain low amount of money, so when the bargaining starts, the lawyer is bluffing with a bad hand. Company X knows it can outbid him. The lawyer knows Company X can outbid him. He's got nothing to bargain with.

Enter the mass action lawsuit.

The Pocket Ace: Mass Action Lawsuit

Every individual client needs personal attention in a case like this. Everyone has different injuries, different changes to their lifestyle that need to be recompensed, and different problems that need to be addressed.

However, there is a great deal of overlap when it comes to researching the case. All of the plaintiffs in the Company X case were struck by the same vehicle, for example. If 200 different lawyers are working each of the plaintiff's individual cases, each of those lawyers has to do their own research on the driver, the vehicle, and the circumstances that led to the accident.

If one lawyer brings a lawsuit on behalf of all of those 200 plaintiffs, he only has to do that research once. That lowers his costs, which means he can start to compete with Company X in the game of who has the most money to bring to the case.

With a single case, it might cost $200,000 to bring the lawsuit even though the client only recovered $200,000.

With ten cases, it might cost $400,000 to bring the lawsuit, but it's now possible to recover $2 million.

With 100 cases, it might cost $1 million to bring the lawsuit, and the recovery might be $20 million.

The more clients a law firm or a collaborative group of law firms has, the better their position when it comes to bargaining with DePuy about how much money his clients should ultimately get. When the potential recovery is quite high, it's still possible for lawyers to stay in the game even though the company is willing to put in a large amount of money defending the case.

These aren't necessarily the numbers for the DePuy hip recall case. The damages we've seen have been widely varied, but they share a single common denominator: it will be easier to get everyone recompensed properly if everyone bands together in a single mass action suit. The more clients a legal partnership has, the better its position when it comes to bargaining with DePuy about how much money their clients should receive.

New Game: DePuy ASR XL Acetabular System

There are a great many lawyers out there billing themselves as a "hip recall lawyer" or a "faulty hip lawyer." We aren't those things. At Moriarty Leyendecker, we have a history of bringing mass action lawsuits against major corporations and winning. Usually, when a normal, everyday citizen brings a case against a huge corporation with a lot of money to spend on a lawsuit, he's going to lose.

We tip the scales. We gather together the people who have been harmed and we draw power from those numbers. Our firm's history, bringing and winning lawsuits against Shell Chemical, Prudential Bache, Tenet Healthcare, and National Medical Enterprises, shows that this is the most effective way to win cases when thousands were injured.

No company should get away with causing you serious harm simply because they have deeper pockets. If you have questions about your legal rights in the case against DePuy Orthopaedics, we're here to answer them. More than anything, we want to be sure the thousands of people who were harmed by the ASR XL Acetabular System have the legal and medical information they need to move forward.

Give us a call at 800-730-7607, or fill out our online form. We're here to help.

How the ASR XL Acetabular System is Constructed

2010-11-25T22:44:00.000-08:00

In a previous article we wrote on bone deterioration, we discussed how the bones of your hip are constructed and how a hip implant strives to mimic the qualities so that you can maintain a normal range of movement and a fairly active life.

In this article, we'd like to show you how the ASR XL Acetabular System was constructed - and why it fell so short of what hip implant patients needed to give them back their previous quality of life.

What a Hip Implant is Up Against

Any hip implant is going head-to-head against the natural construction of your body, which is no easy feat. What we think of as our hip is actually two bones: the acetabulum (also called the hip socket) and the femoral head, which is the rounded top of your femur (the main bone that runs the length of your thigh).

As you can see, the two bones of your hip are actually attached to each other securely by two ligaments. The shorter ligament at the center of the femur head is the transverse acetabular ligament, while the longer ligament that runs from the ilium down to the femur itself is the iliofemoral ligament.

These ligaments, along with the cartilage surrounding the hip joint, are the reason your hip doesn't dislocate on a regular basis. The iliofemoral ligament in particular is extraordinarily strong - in fact, the strongest ligament in the human body - and when you are standing or sitting, this ligament flexes or releases to allow a range of movement without letting the hip move out of the socket.

For its part, the transverse acetabular ligament and the surrounding cartilage make up the acetabular labrum, whose purpose is to deepen the hip socket so that the head of the femur can't slip out. The deeper the hip socket, the more secure the femur bone becomes and the less likely your hip will dislocate.

When your natural hip is removed to make way for a hip implant, neither of those ligaments is in place, and the cushion of cartilage is removed to make way for an artificial replacement. Removing the labrum means that your hip is 92% more likely to suffer contact stresses and 40% more likely to allow the femur and acetabulum to touch.

As you can see, your hip is a sophisticated and well-constructed mechanism, and it is extremely difficult to create a man-made replacement for it. Let's take a look at some of the best attempts available in the form of conventional hip replacement and total hip replacement systems, including the ASR Acetabular System.

Conventional Hip Replacement (also called Conventional Hip Arthroplasty)

In a conventional hip replacement, the acetabulum is resurfaced with a new socket, replacing the ring of cartilage as pictured above with an artificial cup made of plastic, ceramic, or metal. The head of the femur is then removed and replaced with a long stem capped with a ball meant to mimic the femur head, as shown below:

In the conventional hip replacement, the plastic cup above is meant to act as the bearing surface, which means that it is the location where the ball and socket contact each other. The liner cushions the point of contact, but it also makes the socket more shallow, which can mean less range of movement and a higher likelihood of dislocation.

The creators of the total hip replacement system hoped to eliminate the problems associated with conventional hip replacement by boldly doing away with a piece of the original design.

Total Hip Replacement

The socket on a conventional hip replacement was technically composed of two pieces: the acetabular cup and the plastic liner, the latter fitting snugly into the former. In a total hip replacement, the design simply eliminated the plastic liner, fitting the femoral head directly into the acetabular cup.

You can see the difference in the image below. The top implant [Fig. 3] is a conventional hip replacement system, with an acetabular cup, a poly (plastic) liner, and a femoral head. The lower implant [Fig. 4] is a total hip replacement system, with only an acetabular cup and femoral head.

This design allowed the femoral head to be much larger, which made it more stable and less likely to dislocate. It also meant, however, that there was no cushion between the two hard surfaces of the acetabular cup and the femoral head.

Many total hip replacement systems are extremely successful, and many surgeons prefer them over the two-piece conventional hip replacement systems, particularly for younger patients who are more active and more likely to dislocate their hip implant by testing the limits of its range of movement.

However, the one-piece system made meticulous design engineering absolutely essential to avoid friction between the acetabular cup and the femoral head.

Which is where DePuy's ASR Acetabular System went wrong.

ASR XL Acetabular Total Hip Replacement System

The ASR XL Acetabular System is a total hip replacement system that uses the model in Fig. 4 above. It uses a traditional femoral ball and stem, and has a 1-piece metal bearing socket placed in the acetabulum. The "ASR" in the title is simply DePuy's trademark designation for this class of single-piece sockets, while the "XL" refers to the fact that DePuy made their implant available in larger sizes for patients whose bodies could accommodate them.

As we've already explained, much of the cushioning and connecting tissue that would normally keep your hip bones properly in place have been removed to accommodate a hip implant. Much of the cartilage is missing, which studies have shown decreases the amount of synovial fluid available to lubricate the joint. The synovial fluid will have an even more difficult time lubricating the joint if the implant has been poorly designed, restricting the flow of fluid between the pieces of the hip implant.

Poor lubrication can cause patients a great deal of pain, but it can also cause friction between the femoral head and socket, encouraging particles of the implant to detach and enter the bloodstream. If the friction is sufficient, the accumulation of metal ions in the bloodstream and the surrounding tissue can cause metallosis, heavy metal poisoning, metal sensitivity, bone deterioration and tissue damage.

The evidence is mounting to show that the DePuy ASR XL Acetabular system was so poorly designed that the friction between ball and socket is far beyond normal, and in fact may be causing all of the problems above in an inordinate percentage of patients.

Furthermore, several doctors who have analyzed the case say that even without the medical consequences to patients' overall health, the ASR XL Acetabular System is still failing at catastrophic rates purely because the design is not made to wear well over time. DePuy has acknowledged a failure rate of 13%, which is astronomically higher than the usual failure rate for hip implants overall at .5-3%.

A hip implant is the only option for many people who have suffered extreme trauma or have arthritis, osteoporosis, or other debilitating diseases. It is unconscionable that any company allowed an insufficiently tested hip implant to get to market and be placed in thousands of people. DePuy compounded this error with their decision to keep the ASR Acetabular System on the market for three years after it had received notification of high revision rates in Australia.

If you believe you have an ASR Acetabular System and would like more information on your legal rights and your medical health, we'd like to help. Please give us a call at 800-730-7607 or fill out our contact form, and we'll do everything we can to make sure you have the information you need to move forward

Glossary of Medical Terms Related to the DePuy ASR Acetabular System

2010-11-25T22:26:00.000-08:00

When you receive a hip implant, your doctor does his or her best to give you all the information you need to make an informed decision. However, it's unlikely that you will ever be as informed as your doctor is on any medical issue, no matter how relevant to your health. All those years of medical school amount to a wealth of knowledge that simply can't be communicated in a few hours.

That said, there are a number of medical terms to which we frequently refer in these articles, and we'd like to make sure you have them available in an easy-to-access location if you need to describe your concerns to your doctor or your legal counsel.

Acetabulum

The acetabulum is more commonly called the hip socket, and it is simply the cup-shaped impression in your pelvis where the top of your femur bone fits. The acetabulum and the head of the femur connect to form the hip joint.

Acetabular cup

When inserting a hip implant, the acetabulum is kept intact, but is hollowed out to make room for a cup that is inserted into the hip socket to make the other half of the hip joint fit smoothly. This cup is called the acetabular cup.

Articular Surface Replacement (ASR) Hip Resurfacing System

The ASR Hip Resurfacing System is a hip resurfacing system that uses the trademarked ASR 1-piece metal bearing acetabular cup. Unlike the ASR Acetabular System, the ASR Hip Resurfacing System does not replace the head of the patient's femur. Instead, the femoral head is merely "resurfaced" with metal prosthesis that fits into the acetabular cup. It is secured to the patient's femur with a short stem inserted into the top of the femur bone.

This hip resurfacing system was recalled in August of 2010 along with the ASR XL Acetabular System, but it is a separate and unique medical device. The ASR Hip Resurfacing System was never approved for use in the United States, though it was released worldwide. The National Joint Registry of England and Waves reported a 5-year revision rate of approximately 12% for the ASR Hip Resurfacing System.

For more information on the difference between a total hip replacement and hip resurfacing, please scroll down to Total hip replacement and Hip resurfacing.

Articular Surface Replacement (ASR) XL Acetabular System

The ASR XL Acetabular System is a total hip replacement system that uses the trademarked ASR 1-piece metal bearing acetabular cup, which is placed in the hip socket. This hip implant uses a traditional femoral ball and stem (see conventional hip replacement). The "XL" in the device's name refers to the fact that the sockets are available in larger sizes.

This total hip replacement system was recalled in August of 2010 along with the ASR Hip Resurfacing System, but it is a separate and unique medical device. The ASR XL Acetabular System was sent to market in 2004 and made available worldwide. Currently, it is believed that approximately 93,000 have an ASR XL Acetabular System. The National Joint Registry of England and Wales reported a 5-year revision rate of an estimated 13% of recipients.

Criticisms of the ASR XL Acetabular System include insufficient testing, a lack of clinical testing, a high rate of failure, a delayed recall after problems were reported, poor design and engineering, and medical complications including metallosis, heavy metal poisoning, metal sensitivity, bone deterioration, tissue damage, and hip implant failure. Currently, DePuy has only recommended that recipients of the ASR XL Acetabular System who are experiencing pain or system failure have hip revision surgery.

Femoral component

In a hip implant, there are two parts to the hip joint that need replacing: the acetabular cup and the femoral component. The femoral component is the part of the implant that connects to the patient's femur bone, which runs the length of the thigh.

There are several different types of femoral components: it may be attached with cement or without, and the femoral component may replace part of the patient's femur or simply cap the top of the femur bone with a prosthetic surface and a stem inserted into the bone.

Femoral head

The top of your femur bone forms a smooth, rounded ball that fits into your acetabulum (also called your hip socket). The part of your femur that fits into the acetabulum is called the femoral head.

In a hip implant, the term for the corresponding replacement is the same. The rounded top of the femoral component which connects to the acetabulum is also called a femoral head.

Hip implant failure

Hip implant failure occurs when a hip implant no longer performs its function properly. Often, hip implant failure requires hip revision surgery (see hip revision, below). The most common causes of hip implant failure are loosening of the hip replacement device, infection, breakage or wear, and damage to the surrounding bone. Hip implant failure may also occur due to poor design and engineering.

Heavy metal poisoning (see metal poisoning, below)

Hip replacement (total and partial)

A hip replacement is any surgical procedure in which the hip joint is replaced by a prosthetic hip implant. There are two parts to the hip joint and therefore two parts to a hip replacement: the acetabular cup and the femoral component.

Hip replacement (total)

A total hip replacement, also called a total hip arthroplasty, replaces both the acetabulum and the femoral head with prosthetics.

Hip replacement (partial)

A partial hip replacement, commonly referred to as a hemiarthroplasty, generally only replaces the femoral head, though it may in some cases only replace the acetabular cup.

Hip resurfacing

A hip resurfacing system is a total hip replacement system that does not remove a part of the patient's femur to accommodate the femoral component. Instead, the top of the femur is simply capped with a prosthetic replacement and a stem is inserted into the bone.

Hip revision

A hip revision surgery is any surgery after the original hip replacement surgery.

Metallosis

Metallosis is a reaction to the immune system attacking metal objects within the body. In the case of a metal hip implant, the immune system reacts to the amount of metal being released into the bloodstream and concludes that the implant is a foreign body that needs to be attacked and destroyed.

As the immune system attempts to attack the foreign substance, it can over-compensate and kill healthy bone and soft tissue around the area. The surrounding area may also become infected, cutting off blood flow and leading to necrosis.

Metallosis has been linked directly to devices that release metal into the bloodstream via friction. Women, people of small stature, and the obese are more susceptible to metallosis.

Metal poisoning

Also referred to as heavy metal poisoning, metal poisoning is the build-up of metals in the soft tissues of the body. The most common heavy metals associated with poisoning are lead, mercury, arsenic, and cadmium; the heavy metals associated with the ASR XL Acetabular System are chromium and cobalt.

Metal poisoning causes nausea, vomiting, diarrhea, stomach pain, headaches, metallic taste in the mouth, and in extreme cases the loss of cognitive, motor, or language function. Chromium and cobalt have also been linked to increased cancer risk.

Metal sensitivity

Metal sensitivity can be viewed as an allergic reaction to metals. Metal sensitivity affects approximately 10-15% of the population, and as with other allergies, it can develop over time if the patient is over-exposed to certain metals. The most common reactions include hives, eczema, redness and itching; however, in patients who have received metal implants, the metal sensitivity may also cause pseudotumors (see pseudotumors).

Necrosis

Necrosis is the premature death of living cells and tissue. Usually, necrosis occurs as a result of infection, toxins, or trauma to the area.

Pseudotumors

A pseudotumor is essentially an enlargement that resembles a mass of abnormal cells, but is in fact an inflammation. In the case of the DePuy ASR Acetabular System, doctors who have found pseudotumors in their patients have found that they are filled with fluid.

If you have any questions about the ASR XL Acetabular System or the impending lawsuit against DePuy, please do give us a call at 800-730-7607 or contact us via our online form. We're here to help.

DePuy ASR Hip Implant Failure Symptoms

2010-11-24T23:24:00.000-08:00

By Megan Breckenridge, Staff Writer
SULLO & SULLO, LLP

HOUSTON — In late August 2010, DePuy Orthopedics, Inc., a subsidiary of Johnson & Johnson, announced a voluntary recall of two of its metal-on-metal hip replacement devices — the ASR Hip Resurfacing System and the ASR XL Acetabular System. The recall was issued after the U.S. Food and Drug Administration (FDA) received upwards of 500 patient complaints about early system failure, and a British study confirmed that nearly 12 percent of those who received the implants required corrective procedures, called revision surgeries, within five years.

If you or a loved one are among the 93,000 people worldwide who received the ASR Hip Resurfacing System or ASR XL Acetabular System, there are some important details that you should be aware of.

While it is normal to experience pain immediately following a metal-on-metal hip replacement surgery, if the pain persists or returns after a period of time, it may be a sign that the implant has failed. Patients who have received faulty ASR hip implants have reported symptoms such as:

Swelling or pain in the effected hip or surrounding areas
Difficulty walking or pain in the hip when doing so
Grinding or popping noises originating in the hip area
Inflammation or infection in the affected hip
Dislocation or improper positioning of the implant

DePuy implant patients who experience one or more of these symptoms are encouraged to consult their doctor immediately, as a revision surgery may be required or advisable. Symptoms can be caused by several problems, including:

Loosening of the implant when the device is not attached in the correct position to the bone
Dislocation of the implant components
Bone fractures at the hip
Metal poisoning, or metallosis, which is a reaction to the metal debris that is shed when components of the device rub together

The known risks of failure of DePuy ASR hip implant devices are clear and substantial. All patients should consult their physicians about regular monitoring in order to detect potential problems before at the earliest possible time. If you or someone you know received a defective DePuy ASR hip implant, you should also obtain the counsel of an experienced personal injury attorney. The skilled team at Sullo & Sullo, LLP will aggressively defend your rights and make sure you get the compensation that you deserve. Call us at 1-800-730-7607 or visit our website at www.sullolaw.com for a free legal consultation today.

Consumer Alert: FDA 510(k) Clearance Does Not Guarantee Safety

2010-11-24T23:20:00.000-08:00

By Megan Breckenridge, Staff Writer
SULLO & SULLO, LLP

HOUSTON — In the eyes of the average American consumer, U.S. Food and Drug Administration (FDA) approval signifies that a medical device has been thoroughly tested and has been found to be safe and effective. The average consumer, however, is typically unaware of the various methods of obtaining FDA approval, one of which does not require formal product testing of any sort.

Standard protocol for receiving FDA approval is the premarket approval process (PMA), which involves an extensive review of the product in question, including rigorous clinical trials. The process often takes nearly two years to complete and can cost the manufacturer upwards of $250, 000. It seems understandable then, that companies might seek a less involved option if one were available.

Enter premarket notification, or 510(k) Clearance, which requires manufacturers to notify the FDA of their intent to market a medical device at least 90 days in advance. If, during that period of time, the FDA determines that the “new” product is substantially similar to one that is already on the market, it will be approved without having to go through the normally required clinical trials.

Shockingly, only about 10 percent of 510(k) applications are referred back to the manufacturer for further testing; which means that roughly 90 percent of devices made available through this process have scarcely been studied, and may never have undergone a single clinical trial.

One such product that has recently come under fire for gross failure is the Depuy Orthodics, Inc. hip implant system, which includes the ASR XL Acetabular System and ASR Hip Resurfacing System. Approved through 501(k) Clearance in 2005, the device has since been implanted in more than 93,000 patients across the globe, and was originally anticipated to last for 15 years.

The ASR implant, a metal-on-metal ball-and-socket device used in hip replacement surgery, was touted by manufacturer Johnson & Johnson as a “high performance” replacement system that had significant advantages over other brands. However, the FDA began receiving complaints from patients and doctors regarding problems associated with the device as far back as 2008, and finally ordered a recall of the product in August 2010. A British study has since confirmed that nearly 12 percent of those who received the implants required corrective procedures, called revision surgeries, within five years.

While DePuy considered the metal-on-metal feature of the ASR device a notable attribute, some experts believe that it is to blame. The metal-on-metal contact of the ball and socket creates microscopic metal debris that damages nearby muscles and soft tissues. Some experts also believe that the design of the ASR hip replacement cup was too shallow making the system more difficult to position during surgery.

The premature failure of a hip implant can result in considerable physical, emotional, and financial hardship, none of which should become the patient’s responsibility. The fact that DePuy’s products were approved via an expedited FDA process means that defects the company may have been aware of were easily swept under the rug.

If you or someone you know received a defective DePuy ASR hip implant, you should also obtain the counsel of an experienced personal injury attorney. The skilled team at Sullo & Sullo, LLP will aggressively defend your rights and make sure you get the compensation that you deserve. Call us at 800-730-7607 for a free legal consultation today.