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Category : Defective Hip Replacements
FDA Issues Another Warning to DePuy
In a warning letter published last week, the Food and Drug Administration announced that fourteen types of devices sold by DePuy Orthopaedics Inc. lacked necessary approval. The letter, sent by Steven D. Silverman, director of the office of compliance, was the result of a near month-long inspection of the Warsaw, Indiana-based company. The inspection also found that DePuy’s quality system did not comply with FDA requirements.
DePuy Orthopaedics Inc., a subsidiary of Johnson & Johnson, has been the subject of significant FDA attention in the past. In 2010, the FDA released another warning letter regarding the manufacturer’s defective hip replacements, the ASR Hip Resurfacing System and the ASR XL Acetabular Cups System. These “metal on metal” hip replacements released dangerous metal shavings in patients, often leading to debilitating pain and other health complications. DePuy recalled the hip implants in 2010, and since then, Seeger Weiss LLP has been working with victims to restore their health and recover compensation for their suffering. If you have been affected by the DePuy ASR hip replacement recall, contact Seeger Weiss today. One of our experienced attorneys will review your case for free.
Video: CBS Philadelphia Reports on Defective DePuy Hip Implants
A recent health report from CBS Philadelphia investigates DePuy Orthopaedics’ defective hip replacements, and asks, “Why were so many people being injured by implants that are FDA approved?” The hip implants, which due to their design have been shown to lead to blood poisoning, were recalled in August 2010. Before they were however, they caused many of the patients who received them life-threatening conditions, toxic injuries and debilitating pain. Visit CBS Philadelphia to watch a video featuring two of these stories and read the entire report.
Seeger Weiss LLP is currently investigating the claims of those harmed by the DePuy ASR Hip Implant. If you or someone you know has suffered complications from the DePuy ASR Hip Implant, contact Seeger Weiss LLP today. An attorney with our award-winning drug injury class action practice will assist you in evaluating your claim. Attorney consultations incur no obligation on your part and all initial consultations are free of charge. Seeger Weiss LLP has office locations in New York, New Jersey, Pennsylvania and California.
Hip Makers Told to Study More Data
In an unusual move, the Food and Drug Administration has ordered all producers of a popular category of artificial hip to undertake studies of the implants, which have been linked to high early failure rates and severe health effects in some patients.
Under the order, producers of “metal-on-metal” hips will have to conduct studies of patients who received the device to determine, among other things, whether the implants are shedding high levels of metallic debris. Some patients have encountered that problem, including soft tissue damage that has disabled them.
Litigation mounts over hip implant
From the Wisconsin Law Journal:Edit
“We think it’s going to be a pretty big litigation,” agreed Chris Seeger, a principal at Seeger Weiss, a New York-based personal injury law firm.
DePuy sold about 93,000 ASR Hip Resurfacing Systems and ASR XL Acetabular Systems. The company has reported that about 12 percent of patients required revision surgery within five years after implantation.
…
Seeger said the problem appears to be with the metal-on-metal design of the device, which “seems not to adhere well in the hip joint.”
“The problem is that if there’s a surgical revision required, the whole thing has to be re-done,” he said. “That’s a nasty, messy surgery.”
Johnson & Johnson and DePuy Orthopaedics Recall Defective Hip Replacements
On August 26, 2010, DePuy Orthopaedics, Inc. a subsidiary of Johnson and Johnson recalled both its ASR acetabular cups used in hip replacement arthroplasty and total hip replacements. The Johnson and Johnson recall comes more than two years after the Food and Drug Administration began receiving complaints and follows a determination that the failure rate for both ASR acetabular cups was more than 12%.
The ASR acetabular cups are a metal-on-metal device, a design that according to the New York Times, is coming under increasing scrutiny due to the potential for generating large amounts of metal debris during normal wear and tear. Such debris can negatively impact soft tissue and evolve into a health issue for some patients.
DePuy’s ASR cup, was approved for use in 2005 by the FDA but “was cleared through a regulatory pathway that did not require it to undergo clinical trials,” reports the New York Times.
Are you a victim?
Don’t wait. If you think you have had your hip replaced using DePuy’s ASR acetabular cups, contact Seeger Weiss today. Our experienced defective hip replacement attorneys can immediately assist you and discuss your legal options.
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