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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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Depuy ASR hip replacements, part of the Johnson & Johnson’s implant division, has recently been recalled due to problems with its placement during surgeries and general issues relating to the product. Along with metal shavings slowly being cast into the soft tissue of patients, the following are problems patients have noted as experiencing as a result of the implant and procedure:

Pain in the Hip Region

Problems While or Inability to Walk

Johnson and Johnson’s orthopedic division, DePuy Orthopedics, Inc., has issued a recall for two of their hip implant products, the ASR XL Acetabular System and the DePuy ASR Hip Resurfacing System. An estimated 93,000 individual’s received this implant surgery before the recall, and this has prompted many indvidual’s to file lawsuits against Johnson and Johnson as well as DePuy.

Specifically, a lawsuit was recently filed against DePuy and Johnson and Johnson for strict liability. The plaintiffs say that DePuy and Johnson and Johnson caused to be manufactured, marketed, and distributed the DePuy ASR Hip System, which has been recently recalled due to serious problems with the product’s safety. In particular, DePuy released data indicating that a greater number of patients than expected required revision surgery. DePuy’s report shows that five years after the hip implant surgery, approximately 1 in 8 individuals who received the ASR resurfacing device and 1 in 8 who had received the ASR total hip replacement, needed revision surgery. This second corrective surgery is necessary in many cases to completely remove the DePuy ASR Hip System and replace it with a different implant. This is deeply troubling, having hip replacement surgery is already a traumatic event, but having to undergo a second surgery only complicates and endangers individual’s health.

Further, plaintiff’s are claiming that the corrective surgery is necessary due to the defects of DePuy’s metal on metal hip implants. Medical problems associated with the DePuy ASR Hip System include the component device loosening, component malalignment, fracture, and dislocation. Due to these product design defects, plaintiff’s claim pain, swelling, and difficulty in walking for years after the DePuy ASR Hip System is implanted. But the implant also causes a condition called metallosis. Metallosis is a failure of the device and, in essence, occurs when the metallic ball and socket components of the DePuy ASR Hip System rub together and metal shavings are deposited in the socket and surrounding tissue. The recall notice acknowledges the issue of metallosis, recognizing that it can cause soft tissue damage that may complicate the results of the revision surgery. The plaintiff’s claim that everyday activities pose a significant challenge and pain discomfort are experienced regularly as a result of the DePuy hip implant. These issues are likely to be common for many people across the country who have received the implant as, again, the company’s own reports cite 13% failure rate and this is, most likely, a low count compared to the incidences that go unreported or unrecorded.

Also, the DePuy ASR Hip System is alleged to be defective and thus, unreasonably dangerous for ordinary use. This is important given the fact DePuy may have been aware of the problem and yet manufactured, distributed, and sold the product worldwide. Plaintiff’s further contend that the product was so dangerous that a reasonable consumer would not have contemplated receiving the implant had the dangers been known. However, again, the dangers of the product were not disclosed by DePuy, even though they have received product complaints dating back to 2005. Furthermore, the product lacked any adequate warnings or even instructions and left consumers at a complete disadvantage in dealing with their physical safety. It is important to note that DePuy, as a manufacturer, had a duty to the plaintiff/consumer to manufacture, distribute, and/or sell a reasonably safe product that would be fit for consumers, and this duty was breached by manufacturing and selling a product that resulted in thousands of individual’s experiencing pain and discomfort on a daily basis.

Financial compensation for those who have been effected by the DePuy recalled products is available. Legal representation can and will help to protect and enforce individual’s legal rights. If you have experienced pain and suffering or have had to have revision surgery after receiving one of the two recalled DePuy products, contact the Berniard Law Firm.

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