Depuy Lawsuit Blog

Another defect found on a metal-on-metal hip replacement eventually leads to litigation against a manufacturer. An article about the risks of metal-on-metal hip replacement surgeries was earlier published on the New York Times.

Specifically, in the case of Johnson & Johnson, there are around 93,000 recipients of the ASR XL Acetabular System and the ASR Hip Resurfacing System worldwide.  Following the release of data showing defectiveness in one out of eight patients to whom they were implanted, the two device models were pulled back.

According to Dr. Stephen Graves, the director of the National Joint Replacement Registry in Australia, “It is a complete untruth that DePuy did not have reason to withdraw the ASR before now; we have been telling them since 2007, but they allowed it to be used on thousands of people.”

Mindy Tinsley, DePuy spokeswomen, says “We believe we made the appropriate decision to recall at the appropriate time given the available information.”

Transporting of microscopic metal parts into the body due to metal components rubbing against each other is one effect of design problems with  metal-on-metal hip implant devices, like the DePuy.  The metal particles shed from metal-on-metal hip replacement implants may increase the amount of some metals in the blood, such as chromium and cobalt. This condition may result in genetic damage (genotoxicity) and blood poisoning (metallosis). Furthermore, tumors and cancer may also arise because of cobalt and chromium in the patient’s blood.

In worse cases, complete failure of hip devices happen, resulting in more serious health problems.   This happens when:

•    • the unit is dislocated and misaligned;

•    • the device is not attached to the bone correctly; and

•    • the bone around the implant is fractured.

The  hip replacement recall positively urged the manufacturer to make an action on the need of the public for safe medical services and products. With DePuy lawsuit piling up worldwide, DePuy should duly address the hip replacement problems encountered by its clients.  To facilitate medical attention for men and women who had bought the devices from it, DePuy should provide wide-ranging information dissemination on the flawed hip replacement symptoms.

References:

•    bloomberg.com/news/2010-09-03/johnson-johnson-sued-over-recalled-implanted-hip-replacement-devices.html

•    arthritistoday.org/news/asr-depuy-hip-replacement-recall078.php

•    nursinghomesabuseblog.com/defective-products/defects-with-depuy-hip-replacement-hardware-may-be-responsible-for-complications-following-hip-surgury/

•     internalmedicinenews.com/news/rheumatology-immunology/single-article/rigorous-exercise-may-delay-hip-replacement/e680cecb64.html

•     orthopedics.about.com/od/arthritis/p/exercise.htm

The filing of lawsuits continue against DePuy Orthopaedic Inc. for its allegedly defective metal-on-metal Articular Surface Replacement (ASR) hip systems.  The case filed by Michael Schaff in the Circuit Court of Cook County, Illinois, is the latest and it seeks more than $75,000 in damages allegedly for DePuy’s negligence. The lawsuits that were filed ahead of Schaff’s were consolidated into a multidistrict litigation (MDL) under Judge David A. Katz of the U.S. District Court for the Northern District of Ohio who called for a status conference of the DePuy hip replacement lawsuit this month.

Filed last Oct. 11, 2011, Schaff’s case claimed that he had suffered injuries which resulted from a faulty DePuy ASR hip replacement system.  Schaff underwent a hip replacement surgery in November of 2009 and required a revision surgery in February 2011, just less than two years later.   Schaff claimed that he had suffered severe and permanent injuries both externally and internally because of the implant.

Because of Depuy’s “careless and negligent acts,” including improperly designing and fraudulently marketing the implant as safe and effective, Schaff suffered “great pain and anguish, both in mind and body, and will in the future continue to suffer,” the lawsuit further alleged.  As a preliminary step to transferring the case to the pending MDL in the Northern District of Ohio under Judge Katz, Schaff’s lawsuit has been removed to the U.S. District Court for the Northern District of Illinois.

Several orthopedic specialists said that they believed that the design of the ASR Cup, which is shallower than some similar devices, was at the heart of the implant’s problems, according to an article published in the “New York Times.”

With the idea of allowing patients a wider range of motion, DePuy had designed a shallower cup and removed the plastic liner from the inside of the implant.  Instead, cobalt and chromium particles from the device flakes off into the soft tissue around the area leading to several problems, one of them metallosis, as a result of the friction of the ball portion of the hip implant against the socket.  

However, it appears that the problem is not confined to the DePuy hip replacement recall alone but to metal-on-metal hip implants in general.   The thousands of complaints received by the US Food and Drug Administration (FDA) for this year alone proved that.   Despite DePuy accounting for 75 percent of the complaints, the rest involved some other metal-on-metal hip implant manufacturers.

Some 21 manufacturers of metal-on-metal hip systems, including DePuy Orthopaedics, Stryker, Zimmer, Biomet and Wright Medical Technology were ordered for post-market surveillance studies by the FDA last May 2011.  This required the companies to provide additional studies regarding the possible adverse health consequences of the implants. These studies, however, will not be completed for at least five years.

References:

depuyhipreplacementlawsuit.com/depuy-hip-replacement-lawsuit-status-conference-this-month/

world.einnews.com/pr_news/59900568/asymptomatic-metal-on-metal-hip-replacement-patients-may-still-be-experiencing-tissue-damage

forthepeople.com/depuy-metallosis-depuy-hip-implant-recall--12-3189.html

nytimes.com/2010/03/10/business/10device.html

moriarty.com/depuy_hip_recall/Stay_Informed/What_is_Metallosis/

orthosupersite.com/view.aspx?rid=40090

After hundreds of complaints against the defective product, August 2010, ASR hip replacement device has been recalled by the its manufacturer the DePuy Orthopedic unit of Johnson & JohnsonAn investigation under the US Senate on FDA’s approval process of the product has been made on April 2011.This hip replacement system has a surprisingly high failure rate. As more and more recipients of ASR Hip replacement see their doctors for blood exams, the number of people with extreme levels of cobalt increased drastically. Excessive amounts of cobalt in the blood is toxic and may lead to many harmful and potentially permanent side effects.

Cobalt make corrosion and wear-resistant alloys.This makes them useful in the medical field, where cobalt is often used for orthopedic implants that do not wear down over time. But it will not be the case with the patients of ASR Hip Replacement System and they may be at actual risk of cobalt poisoning (cobaltism)As the parts of this metal-on-metal device constantly rub against each other, particles of cobalt and chromium ions are scraped off due to friction. The metal particles build up in the surrounding tissue of the implanted joint and eventually flow through the bloodstream. Increasing level of cobalt particles would further lead to cobalt poisoning.

Cobalt is a natural element found in the body. Normally the level of cobalt in the blood is only 1 microgram every liter, more than 5 microgram and the cobalt level in your body is already toxic. Cobalt poisoning can cause systemic problems such as cardiomyopathy, hypothyroidism, and neurological damage as well as impairing the senses. Furthermore, it has been thought to cause neuropathy, seizures, blindness, headaches, and liver damage. Cobalt poisoning has been closely linked to cancer.On a case study of two patients of DePuy’s ASR hip replacement system, the cobalt levels were 100 to 500 times higher than normal. Both of them have felt comparable neurologic and cardiac manifestations to previously reported findings cobalt poisoning from Hip Arthroplasty.

Recipients of the ASR hip implants need to see their doctor to have their cobalt levels checked. Ask your doctor for options and express your concerns especially regarding future health problems related to hip replacement device.If you have been a victim of this recalled hip replacement system, acting immediately is advised since there is a deadline for filing a claim and its future effects to your health may be devastating. The Hip replacement recall information center provides free consultation.

DePuy's hip replacement recall which occurred in August 2010, prompted 12 to 13 percent of recipients to undergo a hip revision surgery to extract the defective device. Recently in the Multidistrict Litigation set for all hip recall cases, the DePuy lawsuit judge ordered the explanted devices to be preserved to ensure no tampering of device would occur. This came as a relief to the plaintiffs involved in the case.

Recpients of any of DePuy's ASR XL Acetabular System and ASR Hip Resurfacing System paid more attention and lawsuits against the company have been piling up since then. Affected individuals often wonder if they would be compensated for the damages inflicted upon them. Oftentimes, people believe that filing a lawsuit against the company would take them a long time to actually be reimbursed, so they choose to have a quick settlement instead. But legal experts believe that filing a DePuy lawsuit would be more beneficial for you than accepting to settle.

DePuy's official website stated that the company is willing to reimburse patients for “reasonable and customary” expenses for testing and treatment. However, this reimbursement might not include expenses for additional doctor's appointments, any past, present and future medical therapies, lost wages, pain and suffering. In order to be certain you have the best opportunity to be compensated fairly by DePuy, speaking with a product liability lawyer would be a good step.

Having legal counsel in this case could prove useful to you. You should have a lawyer review any settlement offer the company gives you before signing anything. Additionaly, your attorney would be handy in case you wanted to file a hip replacement lawsuit against DePuy. A no-charge, risk-free consultation is available for recipients to find out if you are entitled to acquire compensation. More details are found at the DePuy Hip Replacement Recall information center.

(April 4, 2011, New York, NY) DePuy Orthopaedics, a division of Johnson & Johnson, recalled 93,000 of its metal-on-metal hip replacement devices in August 2010. The recall was precipitated by publicized data from the National Joint Registry of England and Wales showing that DePuy’s ASR XL Acetabular and ASR Hip Resurfacing Systems were failing between 12 and 13 percent of the time within 5 years of implantation.

Since DePuy does not keep records of its hip replacement recipients, it is relying upon orthopedists worldwide to contact their patients to inform them of the circumstances surrounding the hip recall.

This is a poor assumption on the part of DePuy, however, since not all of these physicians are likely going to stay in contact with their patients. Individuals remaining asymptomatic for the time being might not be aware that their hip replacement device has been recalled. They have no idea that the device implanted in their bodies could be a ticking time bomb.

This scenario is problematic due to the severity of symptoms that can occur because of the recalled hip implant. Not only have recipients reported instances of pain, swelling, and decreased mobility, but there is a chance of toxicity in the bloodstream, due to the flaking off of metal particles from the defective devices.

Some patients may believe these symptoms are a by-product of a hip replacement procedure, choosing to ignore them altogether. If they are unaware of the reason behind their symptoms, they are not only jeopardizing their health and well-being, they are in danger of being barred from suing for damages by statutes of limitations.

Hip replacement recipients should contact their orthopedists to determine whether they were implanted with one of the recalled DePuy devices, and if they are currently symptomatic, they should address these issues with their physicians.

The Rottenstein Law Group has been working with patients who have been affected by the DePuy hip recall. Their hip replacement lawyers are evaluating cases and advocating on behalf of those who have been injured by these devices. It is imperative to stay informed about the ongoing litigation, and to determine whether patients are eligible to participate. Individuals are advised to consult the Web site set up by the Rottenstein Law Group to stay informed of the latest developments.

DePuy Orthopaedics, subsidiary of leading healthcare company Johnson & Johnson, have issued a recall of two of their hip replacement devices: the ASR XL Acetabular System and the ASR Hip Resurfacing System. These hip products were found out bythe National Joint Registry of England and Wales to have a dangerously high failure rate than the average hip implant. In fact, one in eight recipients would require revision surgery because too much damage to the implant and surrounding bone and tissue was inflicted. Additionally, metal ions were said to flake of from the DePuy hip replacement devices leaving the patient with toxic levels of cobalt and chromium in their system. These and more complications could eventually lead to cancer, experts say.

The ASR implants are classified as metal-on-metal devices that was designed to last longer than the typical metal-on-plastic devices. It was also expected to prevent too much bone and tissue loss resulting from the hip procedure. The Wisconsin Law Journal even estimates that the litigation against DePuy would be huge. One attorney even predicts that the company would be facing about 4,000 lawsuits in the future. The plaintiffs are filing charges in the hopes that the monetary and non-monetary losses they had to endure would be aptly compensated by DePuy. However, the manufacturer clearly stated that insurance companies and government programs such as Medicare should pay for the costs the damage entailed.

Recipients of the devices have started to consult with their physician regarding their increased cobalt and chromuim levels in their bloodstream. Inflammation and benign tumors could result from elevated levels of these metals in the body and potentially make revision surgery extremely difficult.

It is your right to demand that the company that has brought you harm should pay for the expenses you have spent relating to your injury. Not to mention the pain and suffering you have had to go through as a result of using a product you though was safe to use. If you want to know more about the DePuy hip replacement recall, you could check out the site online.

In 2005, DePuy Orthopaedics manufactured 93,000 units of the ASR XL Acetabular System and the ASR Hip Resurfacing System. It was then subsequently recalled in August which have incited an outcry among recipients severely affected by it. A flaw in implant design have caused health problems ranging from dizziness and difficulty walking to tremendous pain. A closer inspection uncovered the fact that the devices leak off metal particles that is being absorbed by the body making the patient susceptible to metallosis. Studies indicate about twelve percent of total ASR recipients require a revision surgery.

A product liability lawsuit covers an area in law that allows an individual to file charges against person/s responsible for designing, fabricating and selling a product that can cause harm or injury. In the case of the recent hip recall, generally speaking, DePuy is held liable for injuring ASR recipients. Still, a unique case tells of a plaintiff suing his orthopedist in the wake of the recall.

California-based surgeon, Dr. Thomas Schamlzried performed a hip replacement surgery on a patient in 2006. It was later discovered that the doctor has had financial ties with DePuy. Allegations toward Dr. Schmalzried points at him breaching his fiduciary duty. By keeping mum about his royalty payments from DePuy amounting to $10 million, Dr. Schmalzried is faced with charges.

The following statement was made by principal of Rottenstein Law Group, Rochelle Rottenstein: “While we generally discourage our clients from suing doctors who have unwittingly implanted defective devices, the Schmalzried lawsuit is a unique situation, since that surgeon allegedly participated in the design of the ASR and was on DePuy’s payroll.”

As there are consultants being paid by DePuy to promote their products, it might be best to consult with another orthopedist and seek a second medical opinion. With the help of an experienced lawyer to guide you through the process of filing a DePuy hip lawsuit, you can still recover the damages that has been inflicted on you.

In eight patients who have received either one of DePuy's ASR XL Acetabular System and ASR Hip Resurfacing System, one would need to undergo a revision surgery due to complications. It was found that these devices have an inherent design flaw that makes parts of its components rub together and flake off metal debris that cause much damage to tissues and muscles.

It would be understandable if recall patients are skittish about going through another round of surgery. After all, rehabilitation takes a lot of time and energy not to mention the expenses are exorbitant at times. Revision surgeries even have a low success rate as opposed to initial procedures. All these taken into account would make every patient question, “What if the second hip implant fails as well?” An ineffective corrective surgery raises the following concerns:

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      The need for a third hip replacement surgery. After the first hip replacement procedure, an estimated six-month time frame is expected for a patient to fully recover from the operation. Succeeding procedures however, take much longer than that and requires more intense rehabilitation.

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      Pain associated with failed operation. Going through another surgical procedure should lessen the pain, not increase it. A failed implant would aggravate your condition rendering the surgery useless.

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      Loss of mobility. Stiffness around hips and difficulty walking are often reported by patients who have received a failed hip prosthesis.

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      Dislocation and leg length discrepancy. Hip implants coming loose is not a rare occurrence among recipients of damaged devices. This would affect a person's gait and cause intense pain.

A second, or third, hip replacement is not something one looks forward to. The pain, trauma and financial implications of the situation would be hard on anyone. DePuy should be earnest in giving the fair amount of compensation to those affected by the recall. Sadly, this is not the case. Contacting a lawyer regarding the DePuy hip replacement lawsuit would serve as a first step in recovering the losses inflicted by the company.

Joint reconstruction and sports medicine product manufacturer DePuy Orthopaedics is currently in a legal battle with hundreds of victims of their defective hip replacement recall. Johnson & Johnson, the company which owns DePuy may have to ultimately shell out a hefty price to serve as compensation to these recipients who underwent tremenduous physical pain and losses and are filing DePuy hip recall lawsuits. If their medical device sales is any indication, the company is  suffering a downturn in their revenue.

In 2010, the company's first quarter sales figures showed a total of $4.53 billion in net earnings-- a $1.02 billion increase from their earnings in 2009. Significantly, the majority of this increase is attributed to their medical device division. A 12.5 percent increase was seen in the sales of their medical devices in the first quarter.

From a revenue of $3.21 billion in 2009, it shot up to $3.4 billion in the second quarter of 2010. Medical devices have shown a 4.1 percent increase over last year as well.

The most recent sales figure reports before the hip replacement recall in August were in the third quarter of 2010 which posted quite a different story. The earnings from by the company was down by 0.7 percent. The medical device sales also slowed for a second straight quarter.

Representatives of Johnson & Johnson blames the recession for the decrease in sales for the third quarter. A new reform law on health-care, weak consumer sales and currency exchange rate changes all account for the company's slow growth. In addition to DePuy's hip replacement recall, several more products from Johnson & Johnson have been recalled as well which includes Tylenol, Motrin and Velcade among others.

In the wake of the recall DePuy Orthopaedics made on their ASR XL Acetabular System and ASR Hip Resurfacing System, recipients have been searching for ways to acquire compensation. To communicate with a with a competent hip lawyer and know more about the DePuy hip replacement lawsuits, you could visit the DePuy Hip Replacement Lawsuit Center.