Articles Posted in DePuy Hip Replacement Recall

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An association of attorneys that represent victims of personal injuries have grouped together to ask the Food and Drug Administration to be cautious and possibly amend a proposed change regarding the safety approval process of all-metal hip replacements. The concern is that the rule as it is currently proposed could possibly shift liability from the manufacturer’s of a certain type of all-metal hip replacements that have been linked to a great deal of problems.

According to Thomson Reuters, the type of hip replacements that have recently been causing problems are all-metal artificial hips, which were created because it was believed they would be more durable than those that included plastic or ceramic parts. However, recent studies have shown that the all-metal hips may shed bits of metal which can damage the person’s bone and soft tissue.

The proposed change in the safety approval procedure was brought up by the Federal Drug Administration in response to the growing problem, and would require that the manufacturers go through a more strenuous and extensive safety review process with their all-metal hip replacements. While initially this sounds like a great idea, because the metal hip replacements would have to be more thoroughly checked out before they become available to the public, there is a big concern that this new procedure will allow the manufacturers to shield themselves from liability in personal injury lawsuits that involve their products.

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It might be a while before justice is fully realized worldwide, but this is a good start.

According to Bloomberg’s Business Week, Johnson & Johnson, the pharmaceutical and consumer-goods conglomerate, has agreed to pay about $600,000 to resolve the first three cases in a series of litigation over defective hip implants that caused serious harm to thousands of consumers around the world.

Johnson & Johnson is a large American corporation that disseminates packaged goods sold in more than 175 countries. It is the largest healthcare company in the world, and has approximately 250 subsidiary companies, which include numerous household-known brand-names of medications, first-aid supplies, toiletries, and beauty products.

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Our Chicago DePuy implant attorneys are extremely familiar with the harmful consequences facing nursing home residents – primarily senior citizens – who have problems stemming from a defective hip implant. For the past year and a half, our attorneys have worked with local residents who have been hurt by problems with metal-on-metal hip implants made by DePuy Orthopaedics.

Late in August of 2010, DePuy instituted a voluntary recall of two hip replacement systems. The recall came amid growing concerns about the rate at which the devices “failed.” Defective devices caused patients to suffer severe pain, swelling, and endure difficulty with simple tasks such as walking. For some, the only way to correct the problem was a risky revision surgery.

The failure occurred as a result of design flaws in the implants; in other words, the problem wasn’t necessarily with the surgeons who inserted the implants into the body, but instead with the way in which the devices were manufactured in the first place. In some cases, the implant becomes loosened from the bone, and in others the ball and socket elements of the system (both of which are made of metal) rub against one another in a way that releases metallic particles into the blood stream.

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This past Thursday, officials from the U.S. Food and Drug Administration reiterated what our Chicago personal injury lawyers have known all along: metal-on-metal hip implants, such as Johnson & Johnson’s recalled DePuy implants, are dangerous.

According to a recent report published by MSNBC, the FDA released a statement saying that there are few reasons to continue using metal-on-metal hip implants amid growing evidence that the devices can break down early and expose patients to dangerous metallic particles.

Our attorneys are handling cases against Johnson & Johnson, manufacturer of the DePuy hip implants, for just that reason. DePuy Orthopedics is the division of Johnson & Johnson, the American pharmaceutical and cosmetic conglomerate, responsible for manufacturing the defective implants.

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In 2010, DePuy Orthopedics, a division of Johnson & Johnson, issued a voluntary recall of two of their hip replacement systems, after studies found that many patients who received these DePuy hip implants suffered from symptoms including pain, swelling, and difficulty walking, and had to undergo a revision surgery to correct painful issues with the implants. Moreover, according to the DePuy Orthopedics website, one in eight patients who received the defective hip replacement product, needed a second surgery.

But, despite the fact that their product was dangerous, healthcare-products giant Johnson & Johnson continued to market the artificial hip overseas after the U.S. Food and Drug Administration rejected its sale in the United States based on a review of company safety studies, reported the New York Times. In 2009, the FDA alerted Johnson & Johnson to the fact that blood tests of some recipients of the implant showed a “high concentration of metal ions” that it found to be “concerning.” Nevertheless, the company continued to peddle its stockpile in this country, and, after the U.S. recall, continued sales in other countries.

Johnson & Johnson is an American pharmaceutical and cosmetic conglomerate that disseminates packaged goods across more than 175 countries. DePuy Orthopedics is the division of Johnson & Johnson responsible for manufacturing the implants in question. Johnson & Johnson is the largest healthcare company in the world, and has approximately 250 subsidiary companies, which include numerous household-known brand names of medications, first-aid supplies, toiletries, and beauty products.

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Evidence points to the fact that Johnson & Johnson knew there was a serious problem with their product, but rather than stopping distribution, they sold off what was left in their inventories.

According to a recent report by the New York Times, in 2009, executives from Johnson & Johnson decided to “phase out” a defective hip implant and sell off what was already manufactured, just weeks after the Food and Drug Administration asked the company for added safety data about the implant. At the time, the FDA also alerted the company to the fact that blood tests of some recipients of the implant showed a “high concentration of metal ions” that it found to be “concerning.” Nevertheless, the company continued to peddle its stockpile.

Johnson & Johnson is an American pharmaceutical and cosmetic conglomerate that disseminates packaged goods across more than 175 countries. DePuy Orthopedics is the devision of Johnson & Johnson responsible for manufacturing the implants in question. Johnson & Johnson is the largest healthcare company in the world, and has approximately 250 subsidiary companies, which include numerous household-known brand names of medications, first-aid supplies, toiletries, and beauty products.

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Once again, Johnson & Johnson, the American pharmaceutical and medical device conglomerate, is the subject of yet more instances of defective products.

According to the U.S. Food and Drug Administration, the latest scare came to light when investigations found that Johnson & Johnson continued to sell their Animas brand of insulin pumps after learning of malfunctions with the devices that later prompted them to make design changes. Despite known failures, defective products made their way into the hands of consumers who were injured as a result.

Customers have an inherent right to expect that products and medical devices they use are safe. When dangerous or defective products are sold to consumers and those products cause injury, illness, death, or any other kind of harm to the customer, the producer of the good may be held legally responsible for the injury and may be required to pay for damages caused by the injury. Moreover, in some cases, Illinois personal injury law affords the opportunity for the trier of fact to award punitive damages, or damages that send a message to companies to be more careful when manufacturing their products.

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Many readers of our Illinois personal injury lawyer blog are well appraised of the DePuy hip recall that was issued last August in response to growing evidence that the metal-on-metal devices were a danger to patients who had received them. Recently, national regulators have begun questioning the safety of all similar hip implants, including those not manufactured by DePuy. Specifically, according to an NPR story, last month the United States Food and Drug Administration asked at least twenty manufacturers to conduct more throughout analysis of the safety of their metal-on-metal hip implants. The FDA is specifically asking these companies to report more detailed information on how long the hips last and the side-effects that some patients are experiencing.

The instigation for this new call was likely the growing list of complaints that the body has received from patients of all stripes who have suffered complications following their hip replacement surgery.

While metal-on-metal implants have made headlines for their potential problems over the past year, hip implants come in a variety of forms. Many other versions use ceramics, plastics, and metal in various ways to help replace the ball and socket of a hip. The metal-on-metal devices have posed particular problems because of wear on the metal in the rubbing between the two parts of the device. The main issue is the increasing risk that the device will let loose small metal particles into the patient’s body-including the surrounding tissue and bloodstream. Various complications exist when that happens. The metal particles could cause infection, necrosis, and allergic problems. In the worst cases, enough metal is released to affect a patient’s heart and neurological system.

All those who have had hip replacements should be aware of warning signs. Medical professionals urge these individuals to pay attention to numbing or swelling around the area of the implant. If changes are noticed it is important to visit with a doctor to ensure that no long term complications develop.
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News about the defective hip implants given to patients by the DePuy company continues to roll in. This week the U.S. Senate Special Committee on Aging heard testimony on the Depuy recall as well as other medical device problems and complications. Mass Device reports that the hearing was part of a larger investigation by the federal legislative body into the approval process currently available for medical devices and the effect that process has on overall patient safety. As the DePuy hip recall made clear, devices that are rushed to the market and given to unsuspecting medical patients pose huge risks that circumvent the very purpose of the regulatory process.

The hearing put Johnson & Johnson–the parent company of DePuy–in the middle of the federal investigation evaluating that medical device approval process. Besides hearing from those executives, the committee was briefed on the situation by one of the victims of the recall-many Illinois patients found themselves in a similar circumstance to the victim who attended the hearing.

Following the first-hand account of hardship, a national researcher discussed her new data which indicates that there are more recalls of devices that are approved through the 510(k) pre-market notification program. The less stringent alternative process allows devices to reach consumers sooner abrogating many of the usual requirements of the Food and Drug Administration’s more comprehensive PMA protocol.

The subcommittee holding the hearing explained, “Internal reviews by FDA officials and other outside sources have found troubling lapses in the procedures by which a number of medical devices were approved. The results of these investigations caused procedural and management changes to be implemented at the Center for Devices and Radiological Health in recent months.”
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Stories of hardship and suffering of those who were given defective DePuy hips implants continue to be heard across the country. The State Journal-Register recently shared the story of one Illinois hip recall victim whose life has been turned upside down by the medical device problem.

The 58 year old construction worker loves horseback riding and water skiing. However, it’s unclear whether he will ever be able to do those things again. His problems began last year when the Illinois victim had hip revision surgery in early March. Later that year he had blood tests performed which indicated dangerous levels of chromium in his bloodstream.

The metal particles had entered his body from the DePuy hip implant that he had gotten the previous March. The metal-on-metal device has since been discovered to have caused dangerous complications in thousands of patients who received the product.

The Illinois victim ultimately required a second hip implant operation-a dangerous revision surgery that itself poses complication risks. He is now unable to put any weight on that side of his body. The man hopes to attend therapy, but he must wait a few more weeks before further medical tests are taken to understand the best way to begin therapy.

The DePuy hip implants problem was uncovered last year, prompting the official recall in August of 2010. However, complaints about the devices go back to 2005. Nearly 100,000 patients received the specific metal-on-metal implant in question in the six years it was used. At least 12,000 of those patients will likely face severe complications as the device fails, requiring corrective surgery. Many of those patients may not be aware of their risk.

The failure of the devices caused metallic particles to be released in patient bodies. The particles then may enter the bloodstream ultimately risking a range of problems from deafness and dementia to heart failure. The consequences cannot be overstated.
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