Articles Posted in Product Defect

Recently, Johnson & Johnson’s DePuy Orthopaedics unit recalled their ASR Total Hip System due to serious issues that have caused thousands of individuals serious problems. The company said it will pay any medical expenses related to having the hip implant device; however, the patients have had to agree to certain conditions in order to receive such compensation. Many analysts warn that agreeing to such conditions may hurt individual’s legal rights and that the company is attempting to protect themselves from further legal trouble instead of protecting the people they have hurt.

The DePuy ASR hip implant became available initially in July 2003, and, from 2003-2010, over 95,000 individuals worldwide have received the implant. However, serious complications have been found after having such implantation. First, the device has been found to become loose, causing bone fractures and even bones breakage. Further, the metal on metal piece creates friction when the individual simply walks, causing soft tissue damage surrounding the device. One out of 8 individuals had to receive a second corrective surgery in order to completely remove the DePuy device, however, many remain in pain and discomfort, unable to do daily tasks that were once second nature.

The company has listed on their website a list of steps individuals should take if they have had such an operation. First, the individual is asked to, if they have had any hip implant since 2003, go to their doctor and/or hospital and receive documentation of such procedure, with proof they have had a DePuy implant. This alone is not problematic; however, the company continues to say that they will, “cover all reasonable and customary costs of testing and treatment, including revision surgery if it is necessary, and associated with the ASR recall.” This single phrase alone has a lot of indefinite terms — they “may” cover, and “reasonable,” what do they consider reasonable? How are they defining such terms? What is more troubling is the fact that patients are required to provide DePuy with their medical records, as well as the faulty hip implant. This is in addition to signing a consent form, without such signature the company stipulates that “it is unlikely that we will be able to consider the patient’s claims for reimbursement and prompt resolution of their claim may not be possible.” Thus, this forces individual’s to sign a consent form, without legal representation, and places them in a vulnerable position that may hurt their chances at receiving just compensation in the future.

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Recently, DePuy Orthopaedics, Inc., announced they were recalling the DePuy ASR Hip Replacement System as a result of serious device complications. However, DePuy has known since approximately 2005 that the ASR system was defective and causing individual’s unnecessary pain and discomfort. Additionally, the ASR system has caused almost 13% of patients to undergo a second corrective surgery that completely takes out the DePuy device due to the severity of resulting complications. In short, patients who have received the DePuy ASR Hip System have reported experiencing difficulty maintaining daily routines, or even enjoying simple acts such as walking, or bending down past the waist.

DePuy has limited its offer of compensation to the costs of medical care provided. Particularly, in DePuy’s published reports, the company states they will cover, “reasonable and customary costs of monitoring and treatment services.” However, before an individual contacts DePuy or Johnson & Johnson, they should be aware of their legal rights and have them protected throughout this process. DePuy’s limitation on compensation ignores the other experiences and factors individuals will most likely go through after having a defective DePuy hip implant. For instance, DePuy will not cover the costs associated with the daily physical pain experienced, nor the additional hospital monitoring, prescription costs, lost wages or decreased earning capacity, disfigurement, or even disability. These are just a handful of damages that may be claimed against DePuy that they are stating they will not cover.

Patients have reported time and time again that, after receiving the DePuy ASR Hip Replacement System, they experienced complications that caused them severe physical and mental stress. For instance, a plaintiff who filed recently against DePuy in Maryland claimed that the metal on metal device actually became disassociated and the neck of the device became stuck in their anterior capsule, while the other part of the device slid along the iliopsoas tendon up to the hemipelvis anterior to the acetabulum. Essentially, the device was injuring the person’s entire hip area causing severe damage. As a result of the disassociation of the device, the plaintiff had to undergo a separate abdominal incision to remove the disassociated components. The plaintiff suffered numerous complications, including deep vein thrombosis, external iliac artery thrombosis, and damage to the left hip and left foot. The plaintiff claimed permanent damage and pain associated with the defect of the DePuy device. Further, as a result of DePuy keeping the defective product on the market (when they had almost four years of complaints and reports illustrating the defects in the device)the plaintiff suffered great pain, loss of mobility, emotional upsetment and anxiety, and has incurred and will continue to incur large sums of medical care and attention.

Having legal representation can help guide affected individuals throughout these serious issues associated with the recalled DePuy ASR Hip replacement System. Financial compensation may be available to those who have received the DePuy ASR hip replacement system. Also, patients may be entitled to damages including pain and suffering, past and future pain, lost earnings, medical bills, disfigurement, monitoring, rehabilitative and pharmaceutical costs. Contact the Berniard Law Firm for help throughout this difficult process. You do not have to go through this ordeal alone, especially when an attorney can help you navigate this process.

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On August 26, 2010, the Johnson & Johnson subdivision known as DePuy recalled the DePuy ASR Hip Replacement System due to the overwhelming number of individuals who have experienced serious complications due to the implant. The recalled DePuy Total Hip System has been implanted in individuals since 2005 in the United States and since 2001 internationally. This has resulted in over 93,000 individuals who have received the DePuy Total Hip Replacement System. Below, the DePuy Recall is discussed in a clear and understandable format to help individuals explore the issues that might be affecting them.

What are the Specific Problems?

The DePuy ASR Hip Implant system has caused thousands of individualís difficulty in performing even the most simple daily tasks, causing unnecessary stress for individuals who have already experienced the traumatic event of undergoing an invasive and serious surgery. Further, the DePuy Hip System has caused approximately 1 out of every 8 individuals to undergo at least one corrective surgery in order to completely remove the DePuy device. Some of the physical complaints patients experienced and expressed after receiving the initial operation have included:

– Pain
– Swelling
– Inflammation
– Difficulty walking
– Trouble bending
These symptoms can continue months and even years after the initial implantation of the DePuy device. Further, these symptoms may be a sign of a larger problem, such as an infection or damage to the hip area as a result of the DePuy metal on metal device defects.

Why is the DePuy Device Causing these Symptoms?

The DePuy ASR Hip Replacement System is a metal on metal device that has multiple issues that has resulted in individuals needing the second corrective surgery to completely remove it. Specifically, the ASR Hip is designed to mirror a person’s natural hip, utilizing a ball and socket that move against each other in order to function as a person’s natural hip would when moving. However, this back and forth movement of the metal ball in the metal socket creates friction and then produces metal shavings that become lodged within the socket as well as the surrounding soft tissue of the individual. A person’s body may have different reactions to this metal build up, including creating fluid to collect in the joint and in the muscles around the joint, resulting in severe pain and swelling that could damage the muscles, bones, and nerves around the person’s hip area.

Further, the DePuy ASR Hip System also has problematic issues that include the device loosening. The metal on metal device is constantly rubbing against itself, causing metal shavings, as well as becoming loose. Once the device becomes loose it may not stay attached to the bone in the correct position in the person’s hip. Thus, creating severe pain, swelling, difficulty moving, and even bone fractures.

Dislocation of the device is also a troubling element, where the two parts of the implant move against each other become dislocated, and no longer are aligned, the device may actually cause the bones in the area to break, fracture, or become severely bruised.

What You Can Do
If you have had hip surgery since July 2003, you may have received the recalled DePuy ASR Total Hip System. With medical test and legal guidance you may be awarded financial compensation. Contact the Berniard Law Firm for help throughout this difficult process. You do not have to go through this ordeal alone. Damages patients may be entitled to include pain and suffering, past and future pain, lost earnings, medical bills, disfigurement, monitoring, and rehabilitative and pharmaceutical costs.

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As over 93,000 DePuy ASR Hip Implant recipients face the reality of the recent recall that requires the replacement of the orthopedic device, many wonder if they need an attorney to represent their legal rights. The reality of the matter is that all indications show that the company, owned by Johnson & Johnson, is attempting to limit its legal responsibilities in the wake of the failing implant at the expense of government agencies and insurance companies. What’s more, the company has not shown any significant interest in compensating those who have been affected by the need to replace or fix their implant and, instead, appears to be looking out for itself.

While these are bold accusations, all signs indicate that DePuy is taking a hands-off approach from this matter. Specifically, the company has made no public statements regarding compensating people for their pain and suffering. In fact, DePuy’s only demonstration of regret and interest in paying individuals for their losses surrounds compensating patients for out-of-pocket expenses. Encouraging those with failing implants to document the costs relating to the implant, the company is, at least publicly, only encouraging claims of things like gas and medical expenses related to replacing the joint substitute.

On its own website, DePuy acknowledges this interest of repaying implant recipients for “reasonable and customary costs of testing and treatment if you need services, including revision surgery if it is necessary, associated with the recall of ASR.” Nowhere in this passage does the company acknowledge the months to years of pain and damage caused by a failing implant that the company knew, as far back as 2007, was problematic. This is not acceptable to our law firm, much less the many implant recipients who have suffered limited mobility, extreme pain, difficulty with movement or general use of the implant and issues of metal shavings in the soft tissue. What’s more, those who have had to undergo revision surgery before the recall would argue the stress and undue problems relating to undergoing another effort at replacing a failing hip is nothing to be ignored.

The recall of DePuy ASR Hip implants by the company and its parent corporation Johnson & Johnson demonstrates a problem that has has raised the ire of watchdog groups for years. This device, designed to replace the failing hip of individuals across the United States, is merely one in a line of products that have been recalled by Johnson & Johnson this year and in the past decade. The orthopedics division, in particular, has been hit especially hard and extensive criticism has befallen CEO Bill Weldon.

When a company faces consistent problems with their sold goods, especially at the manufacturing stage, suits develop alleging product defect. As information has come out that indicates DePuy may have known of problems relating to their hip implant some three years ago in 2007 raises the legal assertion of negligence. Failing to notify the public that their product was causing problems has put many up in arms, and rightfully so. The amount of pain, suffering, lost time and emotional distress that undergoing revision surgery has caused patients who have the DePuy implant is significant.

Some are wondering just what can be done if their orthopedic device is failing. The first step that can be taken is to begin immediately documenting expenses related to the failed implant. Whether doctor appointments, prescriptions, travel expenses, etc., all of these records should be written down. Doing so can help you and your attorney while calculating your damages related to this matter. The courts will be in charge of calculating pain and suffering damages and other extraneous efforts you and your attorney may pursue but this is one specific and tangible way in which you can help your attorney best introduce your case.

When people undergo surgery to repair an injured joint or body part, they hope that life will return to as close to “normal” as possible. Despite the fact that surgery is an extensive process that can be taxing mentally and physically on the patient, people obviously expect the best due to the amount of time, money and pain that goes into it. When thousands of DePuy ASR hip recipients began to experience problems with their implant, the idea that another surgery to remedy the matter was likely the last thing they had to hear. However, with a recall in full swing for the tens of thousands of people who received the ASR hip implant, this is the unfortunate reality.

This blog has covered the extensive details relating to this matter because it stands as a clear example of a company attempting to maintain the semblance of success while secretly knowing the truth about their product. Reports indicate that as early as 2007 DePuy, and its parent company Johnson & Johnson, became aware that there were problems with the implant, yet waited until 2010 to issue a recall. What’s more, this is not the first implant the companies were forced to recall. This fact is crucial because it lends credibility to patient complaints that the companies failed in their duty to provide a safe and well-manufactured product.

Left in the dark about the problems relating to their implant, recipients now ask what their options are. Representing a variety of patients who have experienced problems, our firm is now accepting clients who are suffering problems with their DePuy ASR hip implant. Whether suffering from limited mobility, increased pain, a lack of flexibility, metal-on-metal grinding or several other symptoms of a failing implant, patients whose replacement has gone awry are entitled to damages. Even those who have already undergone corrective surgery to fix complications relating to their implant can pursue a case against DePuy and its parent company Johnson & Johnson.

The DePuy ASR Hip System, which has recently been deemed unworthy of use and subsequently recalled, has caused thousands of individuals severe pain, discomfort, and difficulty performing daily tasks that were once easy to carry out due to its failure. Lawsuits have been filed against Johnson & Johnson and their unit DePuy for numerous claims including negligent design and the manufacture of a defective product that has caused severe damage and injury. Individual complaints have included pain, swelling, and difficulty walking for years after the DePuy ASR Hip System is implanted. This is deeply troubling, since over 93,000 individuals have received the ASR implant, and now 12-13% are experiencing considerable problems. These numbers indicate that thousands upon thousands of individuals who relied upon a successful implant have suffered difficulties and problems related to the DePuy hip implant.
The majority of plaintiffs in the lawsuits against Johnson & Johnson and DePuy claim significant medical problems associated with the ASR Hip System. The stories of the affected individuals are upsetting due to the severe hardships they have encountered as a result of having a surgery that was intended to help and not hurt them. For instance, one woman who underwent the hip operation in 2006 began to instantly experience severe hip pain, preventing her from standing for long periods of time or even sleeping comfortably. Further, her hip dislocated twice within a two year time span. After consulting her physician, she was advised to get a corrective surgery, called revision surgery, to completely remove the DePuy ASR Hip System. After she received the corrective surgery, it was discovered that she was suffering from severe metallosis which happened as a result of the metal on metal DePuy implant rubbing against itself and causing friction. This friction, in turn, created metal shavings that deposited in the metal socket of the device as well as her surrounding soft tissue. This condition can make revision surgery difficult for the operating physician and, thus, creates a danger for the individual receiving the operation. Additionally, it was discovered that the metallosis caused detachment of and degeneration to her hip abductor muscle. The fact that she experienced pain, discomfort, and a constant fear of further surgery for over three years illustrates the serious impact the DePuy Hip System has had upon individual’s lives.
Significantly, the revision surgery is necessary for 1 out of every 8 individuals who have received the DePuy ASR Hip System. However, many report that the pain from having the initial surgery and complications due to the implant is not completely solved by having the second corrective surgery. Many individuals, post revision surgery, require a cane or walker to get around and may experience trouble moving or bending at the waist. Thus, the pain and difficulty performing everyday activities continues as a result of having the initial DePuy implantation.
If you have received the DePuy Total Hip System, and have experienced pain and discomfort, contact the Berniard Law Firm. You do not have to go through this ordeal alone. The Berniard Law Firm will provide the best advice and guidance and is fully capable of meeting your litigation needs.

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Johnson & Johnson’s DePuy Orthopedics unit has recently recalled two hip implant products, the ASR XL Ace tabular System and the ASR Hip Resurfacing System. The recall was announced in late August 2010, yet reports have surfaced showing that DePuy may have been aware of problems relating to their hip implant product as far back as 2007. This means that thousands of individuals received the hip implant system and may have been subjected to needless pain and suffering, had the product been recalled when the problems were first brought to DePuy’s attention.

The DePuy Hip Implant System was recalled after data revealed that 12-13% of individuals who received the implant system needed a second corrective surgery to remedy problems related to the DePuy product. The issues that the hip implant has caused individuals is concerning to say the least, the metal on metal hip implant has led many to suffer bone fractures, broken bones, and metallosis, which is when friction of a metal device produces metal shavings that become deposited in the socket of the device and in the surrounding soft tissue. Additionally, individuals have reported experiencing hip pain, loosening of the hip implant, the implant failing completely, additional surgery, and difficulty performing daily tasks that were once easy to do. The fact all of these problems have been occurring after having an implant that was supposed to offer freedom from these very problems is a significant problem.

Over the years, negative reports of the hip implant system grew steadily, with over 100 reports made in 2007, 200 in 2008, and over 300 in 2009. However, DePuy waited until 2010 to recall the product. In fact, the Food and Drug Administration (FDA) has released records which show that, as early as 2008, they received hundreds of complaints on the hip implant system in the United States. This has led the FDA to closely monitor parent company Johnson & Johnson since the hip implant system is the 11th recalled product in the past 11 months for the companies. In addition, the FDA sent DePuy on August 19, 2010, a warning letter requiring the company to halt the sale and production of two of the company’s products (a knee replacement device and a hip implant device) because they were both without FDA’s marketing clearance and in violation of the Federal Food, Drug, and Cosmetic Act (FFDCA).

Individuals who have received a DePuy ASR hip implant are advised to contact legal representation. Financial compensation may be available against Johnson & Johnson and DePuy as a result of the negligent design of the device and the failure to warn recipients about the risk of problems or issue an ASR hip recall earlier. If you have received the ASR hip implant system, than please contact the Berniard Law Firm. The Berniard Law Firm is fully capable of meeting your litigation needs by providing consistent, viable advice and guidance that you can depend on.

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Recently, lawsuits have been filed against Johnson and Johnson’s orthopedic division, DePuy Orthopedics, Inc., for injuries caused by the ASR XL Acetabular System and the DePuy ASR Hip Resurfacing System. Both of these metal on metal hip implants have been recalled as a result of the exceptionally high number of individuals experiencing severe pain and discomfort after having the hip implantation. Reports released by DePuy show that 1 in 8 individuals who received the ASR total hip replacement needed revision surgery in order to correct the first implantation. One form of the revision surgery takes the DePuy device completely out of the individual and implants a different device or resettles it to fit the joints properly while others merely reattach and fit the device upon the bone more properly. Numerous issues have arisen as a result of these hip products, many of which have caused individuals significant hardships in their daily lives.

Lawsuits filed against DePuy and Johnson & Johnson allege that the companies are strictly liable for the defective product they put on the market worldwide. Complaints about the two metal on metal hip implants go back as far as 2005; yet, the company just recently recalled the products in 2010. This has allowed over 93,000 individuals to receive the implant and, for too many, be subjected to pain, discomfort, and, most likely, a second corrective surgery. This surgery is carried out to prevent the device from loosening and causing hip fractures, device malalignment, dislocation, and even bone breakage. DePuy acknowledges that the product may even cause Metallosis, a complication of metal-containing total joint replacements that involves the metal rubbing together and causing parts to fragment. This is a serious issue, especially in light of the fact that, if revision surgery is needed, this soft tissue damage may complicate the operation and in turn, the individual’s health.

During the Post implantation period, individuals who have had the surgery have described pain and discomfort on a daily basis, making even the most simple daily activities a challenge. Thus, the lawsuits focus primarily on the fact that DePuy had a duty to consumers not to introduce into the market a product that was defective and dangerous. There is various atttributes of each cause of action that will now be discussed in turn.

Strict Liability in Tort
Plaintiffs are suing DePuy for strict liability, which means that the court will hold the manufacturer responsible for the goods and products they produce, especially if they cause consumers injury. Significantly, DePuy had a duty of care to the plaintiffs/consumers to manufacture, distribute, and/or sell reasonably safe products that were fit for use by consumers. This duty was breached by DePuy, in our opinion, because a failure or omission to do what the company is bound by law to do took place. The fact that DePuy manufactured, distributed, and/or sold the defective products, placing them into the stream of commerce and jeopardizing consumers health illustrates DePuy’s breach of duty. Additionally, under strict liability, DePuy’s products resulted in individual’s being injured and experiencing ongoing pain and discomfort, thus, allowing DePuy to be held responsible for introducing to consumers a dangerous product.

Further, patients with the implant contend they suffered injury and damages as a direct and proximate result of the defective and unreasonably dangerous condition of the DePuy ASR Hip System, and that they would not have used the product had they known of the serious consequences. A proximate result is traceable directly to an act or omission, without the occurrence of another culpable and efficient agency intervening. Thus, the serious problems these patients experienced as a result of having DePuy’s product implanted was the proximate result of placement of an unreasonably dangerous product into the stream of commerce. Further, DePuy did not place any warnings or even instructions on the product to place the plaintiff/consumer on notice of any potential product risk, and, therefore, the company is subject to liability for placing a dangerous product into the stream of commerce and causing individual’s injuries as a result of the dangerous product.

Negligence
Because DePuy’s product was designed to go into the human body, the utmost care and safety should have been taken in order to protect individual’s health. DePuy had a duty to exercise reasonable care to sell reasonably safe medical devices so as not to subject the ultimate consumer to an unreasonable risk of harm. To have a metal on metal hip implant potentially fracture or break bones in the hip area, or release shredded metal component parts damaging soft tissue, does not illustrate DePuy’s reasonableness in distributing such a dangerous defective product. Therefore, those who have received the implant would assert, through their attorney, that DePuy was negligent, careless, reckless, grossly negligent, and wanton, and breached their duties in the manufacture, distribution, and sale of the DePuy ASR Hip System.

DePuy manufactured a product that they now acknowledge was not proper for public use and in need of further testing and analysis. More than 90,000 people have received DePuy implants and are, thus, in danger of going through a second surgery or having their daily lives severely affected because of pain and discomfort. Many say that DePuy actually failed to warn hospitals and patients that the ASR Hip System was defective and that the company placed and permitted the placement of the hip implant into the stream of commerce when DePuy knew or should have known that the product was defective and unsafe for individuals to have implanted in their bodies. Also, DePuy failed to employ corrective safety mechanisms to limit the harm caused by the hip implant, and did not properly and adequately test and inspect the product before selling it worldwide. As the defective product became widely utilized and placed thousands in jeopardy, our firm asserts that the company knowingly placing the dangerous product into the stream of commerce and causing injuries.

DePuy has had complaints dating back to 2005, yet, the defective products were not recalled until 2010. As such Depuy failed to keep abreast of and/or react appropriately to public, government, and/or industry studies, information, documentation, and recommendations and may be deemed negligent.

Due to the suffering that patients underwent, both physically and mentally due to the trauma of going through pain, discomfort, and the threat of a second surgery, DePuy is arguably the cause of these injuries due to the expectations placed upon a manufacturer. Individuals relied on the safety of the product to feel confident enough to follow through with having such an invasive procedure. The fact that they are now physically injured is a result of trusting a company to put out a safe product, not one that would imperil their daily routines and lives.

Beyond all of this, what is beginning to draw even more ire towards Johnson and Johnson is the extensive time (five years) that it took for the company to recall the hip implants despite receiving data and responses that indicated a significantly high number of patients were suffering pain and discomfort related to the product. What’s more, the need for a second corrective surgery was a reported fact the company was aware of over time as revealed by their recent document releases relating to the recall.

Individuals who received the implants and have suffered the myriad of symptoms relating to it are likely entitled to monetary damages under the law. By hiring an attorney, individuals who have suffered pain, financial hardship, depreciation in quality of life, surgery or a wide variety of other harms can begin the process of receiving what they deserve in a court of law. If you have received one of these implants, and experienced problems relating to the DePuy ASR hip implant, contact the Berniard Law Firm.

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