Could DePuy Hip Recall Stem From Study?

Some medical experts are wondering whether a DePuy hip recall is finally on the horizon after the Food and Drug Administration announced in May of 2011 that they were going to compel orthopedic device manufacturers to conduct post-market studies on all 145 metal-on-metal hip replacement devices in use across the country that have been approved by the Food and Drug Administration.

Metal Toxicity In DePuy Hip Patients Blamed on Bad Design and Bad Components

93,000 recipients worldwide have been informed that their DePuy replacement hip implants are defective and dangerous. The components have come loose, fracturing bone around the implant, depositing metal fragments in one’s tissues and bloodstream. After finally acknowledging that the ASR was prematurely failing in patients at rates completely unacceptable for medical devices, DePuy issued a recall of the product in August of 2010. Data from the National Joint Registry of England and Wales found that the DePuy ASR Hip Resurfacing System had a 12% revision rate and the DePuy ASR XL Acetabular System had a revision rate of 13%. ASR litigation is still in its early stages, but it is progressing. Just last month, the initial case management conferences were held regarding the consolidated DePuy lawsuits.

DePuy Acetabular Hip Recalled Too Late, Experts Say

DePuy Lawsuits filed against Johnson & Johnson have alleged that the two companies knew about problems with the DePuy hip replacements for at least two years before the recall. Although the Food and Drug Administration received at least 400 reports of problems with DePuy hip implants in the two years before the recall, the company waited for months after concerns about the products became widespread among some experts before taking them off the market. A number of health experts have stated that DePuy should have issued the hip replacement recall earlier after reports emerged that the devices were failing at a higher than normal rate.

Pinnacle Hip Litigation Consolidated in Texas

The consolidation of DePuy Pinnacle hip implant litigation in the U.S. District Court for the Northern District of Texas is an important step towards sending these cases to trial. Multidistrict litigation is a process which combines similar cases for pretrial litigation but, unlike class action, after the pretrial process is completed the cases can be sent back, or remanded, to the courts from which they originated. Once cases are remanded they will be dealt with in the courts in which they were filed. Experienced DePuy hip lawyers are hopeful about future cases.

DePuy Hip Leads to Lawsuits

The DePuy Pinnacle Acetabular Cup System, which is used in total hip replacements, is manufactured and sold by DePuy Orthopedics, a subsidiary of Johnson & Johnson. The system consists of a porous coated hemispherical outer shell and a liner that locks into the outer shell, which can be either polyethylene or metal. The liner component articulates with the femoral head, which is typically metal. Metal-on-metal hip replacements, which use cobalt and chromium in their construction, currently account for about one-third of the 250,000 hip replacements performed each year in the United States. However, in recent years, concerns over problems with metal-on-metal hip replacements have been growing. Patients are requiring a second DePuy hip revision surgery, which is a painful lengthy process.

DePuy ASR Hip Failed at Rate Too High to Be Kept On the Market

Johnson & Johnson, in conjunction with its DePuy Orthopedics subsidiary, announced at the end of August 2010 that it is recalling parts used for hip replacements. An estimated 93,000 people will be affected by the latest product recall. Affected hip replacement parts involved in the recall include the DePuy ASR XL Acetabular System and the DePuy ASR Hip Resurfacing System. Patients who reported problems in the first five years and had revision surgery reported a variety of DePuy complications including pain, swelling and problems walking. These symptoms are normal for patients following a hip replacement, but can be a sign that something is wrong if they continue or come back frequently.

DePuy ASR Found to Have Same Problems as Pinnacle Hip Implant

The DePuy ASR was approved as a substantially equivalent design to the DePuy Pinnacle hip, which appears to be causing the same or worse problems as the ASR. Last year, the FDA’s MedWatch adverse event reporting system registered at least 548 complaints about DePuy Pinnacle problems, with many reports indicating that the implants failed years before they were supposed to or caused symptoms that may be consistent with metal poisoning. These reports likely constitute only a small portion of the total number of issues from DePuy Pinnacle hips, which should have been identified by the manufacturer and led to a DePuy Pinnacle hip recall.

Pinnacle Hip Lawsuit Settlements Likely for Many

DePuy Orthopedics has been at the centre of many controversies surrounding two of their most popular hip replacement systems – the DePuy ASR and the DePuy Pinnacle artificial hips have both been cited as the cause of a multitude of side effects and DePuy hip complications patients have been experiencing. The devices are similar to one another, with the DePuy ASR system only available as a metal-on-metal implant, while the Pinnacle comes with a variety of options, including metal-on-metal, metal-on-ceramic, ceramic-on-ceramic, and other combinations of materials.

DePuy Hip Recall Lawsuits Affect Multiple Brands

DePuy’s Pinnacle and ASR systems have both been hit by DePuy lawsuits, but only the ASR system has ever experienced a recall. They are very similar products, both of which rely on a metal-on-metal ball-socket component that can contribute to problems like metal poisoning or metallosis. In a metal-on-metal joint replacement system, the metal components can scrape against each other and metal dust can flake off into the bloodstream and soft tissues of a patient, causing swelling and pain.

Younger Patients Suffer the Most in DePuy Hip Recall

DePuy Orthopedics announced on August, 2010 that it was voluntarily recalling the ASR hip replacement system after receiving reports that a higher-than-normal number of patients required revision surgeries to correct or remove defective implants. The company said it was pulling the Acetabular and ASR Hip Resurfacing systems from the market "due to the number of patients who required a second hip replacement procedure." Lawsuits over the ASR implant have piled up across the country, accusing DePuy of manufacturing a defective product, failing to warn patients and doctors of problems with the implant and negligence in designing, manufacturing and selling the product. DePuy, which introduced the ASR in the U.S. in 2005 after winning clearance from the Food & Drug Administration, allegedly knew of design problems with the cup but failed to adequately warn physicians, according to the lawsuits, which have been scheduled to go ahead as an MDL. Patients are experiencing various DePuy hip complications that require an additional surgery.
On Thursday, the company officially issued a DePuy hip recall, acknowleding that data shows the ASR Hip Resurfacing System has a 12% failure rate and the ASR XL Acetabular System has a 13% failure rate. The risk of DePuy hip problems was especially high among those implanted in women and those with heads below 50 mm. The DePuy ASR hip was especially popular among younger patients because it was marketed as being more stable and less susceptible to dislocation after surgery. However, problems with the metal-on-metal implant began rolling in shortly after the devices were introduced.
All of the DePuy lawsuits involve similar allegations that the DePuy Pinnacle Acetabular Cup System was defectively designed or manufactured, and that inadequate warnings were provided about the risk of complications or problems following hip replacement. The MDL Panel determined that the actions all involve common questions of fact and that centralization of the cases will serve the convenience of the parties and witnesses, as well as promote the just and efficient conduct of the litigation. Establishing a DePuy Pinnacle Hip MDL will also help eliminate duplicative discovery, prevent inconsistent pretrial rulings on discovery and other issues, and conserve the resources of the parties, the lawyers and the court.

DePuy Tries to Limit Their Own Suffering

In August 2010, a DePuy ASR hip recall was issued for approximately 93,000 defective implants after data confirmed that the device has an unreasonably high rate of hip failure, often requiring individuals to undergo a second surgery to revise the original hip replacement. Shortly after the DePuy ASR hip system was introduced in 2005, DePuy Orthopedics began receiving a number of complaints of problems and complications associated with early failure for the metal hip implants. The hip replacement can fail within only a few years of surgery, causing pain and leading to complicated and expensive DePuy hip revision surgery. In August 2010, Johnson & Johnson's subsidiary DePuy Orthopaedics finally agreed to recall DePuy ASR hip implants. Data from the National Joint Registry of England and Wales found that the DePuy ASR Hip Resurfacing System had a 12% revision rate and the DePuy ASR XL Acetabular System had a revision rate of 13%.

DePuy Pinnacle Hip Litigation Likely to be Consolidated

Many legal experts believe that it is likely that DePuy hip lawsuits surrounding DePuy’s Pinnacle hip replacement systems will be consolidated in multidistrict litigation, a legal process that combines the pretrial processes of similar cases in order to help speed the litigation process. Unlike class action, which is a similar method of consolidating related cases, multidistrict litigation cases may be sent back to the courts from which they originated after pretrial processes such as witness testimony and evidence collection are complete.

FDA the Last to Ban DePuy Hip Replacements

At the end of August, 2010 Johnson and Johnson and its DePuy Orthopaedics subsidiary announced a voluntary recall for the DePuy ASR XL Acetabular System and the DePuy ASR Hip Resurfacing System. Nearly 100,000 people may be affected by this product recall. According to the new data, Within five years of implantation, about 12 percent of people who got the ASR resurfacing device, and 13 percent of people who got the ASR total hip replacement, have had DePuy hip complications and had them surgically removed and replaced with a different product.
The signs of trouble include swelling, pain and even difficulty walking. Persistent side effects of Depuy can signal a loose implant, fracture of the bone around it, or dislocation of the implant's ball and socket, the company reported. Metal-on-metal hip implants, like the recalled DePuy ASR hip replacement, have been linked to metal poisoning or metallosis, which could cause serious problems with the hip replacement. Symptoms often involve the development of pain, inflammation and difficulty walking as the metal-on-metal parts rub against each other and release debris or small metal fragments. Many individuals are filing DePuy lawsuits to receive compensation.

DePuy Hip Lawsuits On the Rise After Recall

A series of DePuy hip lawsuits have slammed the orthopedics manufacturer DePuy Orthopedics, a subsidiary of Johnson & Johnson, since the August 2010 recall of their ASR hip replacement system. The recall came only after two separate reports by the Australian National Joint Replacement Registry that linked the device to an extraordinarily high rate of revision surgery, and the National Joint Registry in the United Kingdom reported in 2009 that the number of revision surgeries related to the ASR device were unreasonably high. Newcastle University hospital also determined in 2008 that ASR recipients were at risk for high levels of chromium and cobalt in the blood, a condition which could lead to metallosis or metal poisoning.
It was only after the Food and Drug Administration’s adverse event reporting system, or AERS, was flooded with reports of DePuy hip complications from surgeons and plaintiffs alike that a recall was initiated, and DePuy ASR devices had already been implanted in 93,000 patients worldwide – about 37,000 in the United States.
Many of the lawsuits related to the DePuy ASR devices make the claim that the recall should not have had to happen in the first place – the device should have been safe enough as soon as it was introduced to the market, and there was some hesitation in the medical community when it was introduced due to the metal-on-metal nature of the device. A metal-on-metal setup has been known to cause complications in joint replacement systems more frequently than other types of device.
Around 10,000 recipients of the DePuy ASR device are eligible to file suit against DePuy, although experienced DePuy hip lawyers think that there could be more plaintiffs by the time litigation gets underway. The first trial could begin in a year or more, leaving plenty of time for new cases to be filed.
Johnson & Johnson, a multinational corporation with billions of dollars in yearly revenue, could be facing responsibility for settlements and damages that could amount to a billion dollars or more.
Due to the recall it is very likely that there will be a settlement in the future for most, if not all, of the plaintiffs who have filed DePuy hip replacement lawsuits.

DePuy ASR Cases Centralized in New Jersey Take Shape

A significant number of cases in DePuy ASR hip implant litigation have been filed in Indiana, New Jersey, and California. California is the home of major ASR engineers, and Indiana is the headquarters of DePuy Orthopedics itself. New Jersey is the location of the headquarters of Johnson & Johnson, the pharmaceuticals giant of which DePuy is a major subsidiary.
In April, the New Jersey state judiciary issued an order centralizing New Jersey DePuy lawsuits in the Superior Court of Bergen County, which would help coordinate them with federal cases – which have been consolidated and centralized in Ohio – as well as contribute to the simplification of the legal process, which could lead to expedited trials and results for some plaintiffs. Although a decision to this effect has not yet been made, it is possible thatIndiana lawsuits may also be consolidated with the New Jersey lawsuits.

Metal Poisoning Common In DePuy Hip Patients

The DePuy ASR hip replacement is said to be defective. One of the issues is that the system (made out of cobalt and chromium) can cause metal poisoning. Both of the metals used are dangerous metals.
The metal poisoning occurs when the DePuy hip metal components undergo wear and tear while in constant contact with each other. They shed metal particles (microscopic in size) into the DePuy hip patient’s bloodstream. The shedding of microscopic metal particles can cause localized damage to both bone and tissue. It can also cause additional health problems.
There are several forms of DePuy hip metal poisoning; all have been observed by doctors since 2008 when the first DePuy hip related complaints were received by the manufacturer, Johnson & Johnson. The most serious of the various forms of DePuy hip metal poisoning is cobalt toxicity.

Users’ Metal Poisoning Sparks Problems for Johnson & Johnson

DePuy Orthopaedics, a subsidiary of Johnson & Johnson, recently recalled their ASR hip implant due to the ineffectiveness and possible danger related to the metal-on-metal ball joint of the device. Whether the design process was flawed or the problems are simply a result of negligence remains to be seen. However, it is the case that the artificial joints, due to the way they scrape together as the patient moves, create a buildup of metallic dust within the socket, resulting in metal poisoning, or metallosis. Metal poisoning causes irritation, pain, and swelling in the tissue and flesh around the affected joint. It can also cause other complications, such as bone loss.
Although cobalt is found naturally in the body, the high concentrations of it that lead to metal poisoning have the potential to cause permanent bodily harm in sufferers of the condition. Side effects of metal poisoning related to cobalt include depression, hearing loss, fatigue, tinnitus (ringing of the ears), loss of coordination, headaches, and nerve damage – among many other serious side effects. It can also cause diseases of the heart muscle, seizures, and even heart failure. These complications can make a revision surgery, or a second surgery designed to help the patient by replacing the hip replacement system, even more difficult and dangerous to perform.
A healthy adult body will store about 1mg of cobalt in the bloodstream, but patients of the hip replacement system have been found to have between 100 and 500 times that amount in their body. Unfortunately for patients, many doctors were unaware of these potential side effects involved in the replacement system, and simply could not warn their patients adequately. In addition, there is evidence that an improper clinical trial was conducted by DePuy Orthopaedics before their release of the device. Medical professionals are recommending that any DePuy ASR hip replacement system patients get their blood tested for increased cobalt levels as soon as possible, in order to prevent serious complications in the future.