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Category : DePuy Orthopaedics Recall
Earlier this week, The New York Times uncovered a 2009 email authored by an executive at DePuy Orthopaedics, a Johnson & Johnson subsidiary, that seems to refute the company’s later claims that it believed its artificial surface replacement (ASR) hip replacement to be safe. The message was sent in August 2009, just days after the Food and Drug Administration confidentially informed DePuy that it would not approve the ASR device. In the email, vice-president Pamela Plouhar explains the reasons for the FDA’s decision to three other top executives, including then president, David Floyd. The New York Times writes that Ms. Plouhar, “reported in an internal e-mail that the Food and Drug Administration had refused to approve the device, after reviewing company studies that showed it had failed prematurely in ‘significant’ numbers, requiring repeat surgeries for patients.”
Although the ASR implant was denied approval by the FDA, it was sold overseas and was placed in 30,000 patients in the United States before it was officially recalled in 2010. While DePuy’s apparent lack of transparency does not alone constitute a violation of the law, the 2009 email certainly contradicts statements from Johnson & Johnson prior to the recall. After the metal-on-metal hip implants were indeed found to be defective in a number of cases in 2010, the company maintained that its internal studies had demonstrated the safety of the device, and shifted blame onto the doctors and surgeons who were responsible for the implant procedures. The 2009 email, however, proves that DePuy knew the ASR hip implant was unsafe, even when applied by doctors the company hand-picked itself. As The New York Times notes, “DePuy’s decision not to publicize the agency’s findings to doctors, patients and others while continuing to market the device may undercut its defense in the 5,000 related lawsuits pending against it…”
If you are the victim of a defective ASR hip implant, contact Seeger Weiss LLP today. Our experienced defective products attorneys will make sure your case receives the attention and retribution you deserve.
For information on the current 2012 Stryker hip implant recall, visit http://www.seegerweiss.com/stryker-hip-recall.
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.
For information on the 2012 Stryker hip implant recall, visit http://www.seegerweiss.com/stryker-hip-recall.
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.
At the beginning of this month, yet another wrinkle was added to the recent news coverage on DePuy Orthaepedics’ controversial Artificial Surface Replacement (ASR), a hip implant for patients suffering from severe arthritis. In this story, the United Kingdom Press Association reports that retired gymnast Penny Brown, who appeared in ads for the product after she received a hip replacement herself, is now joining a class action against her former employer. Brown and the 300 other patients involved claim that wore out prematurely leading to further complications or – as in Brown’s case, – the need for additional surgery.
Seeger Weiss is currently investigating claims of patients who were harmed by the hip replacement. For more information, please visit our DePuy Hip Replacement page.
Information on the current recall of Stryker Rejuvenate and ABG II hip replacements is available here.
Last week, an Australian Senate Committee discovered that DePuy Orthaepedics waited until three years after they learned of reported problems with their metal-on-metal hip implants to remove them from the market. In a segment on NBC Nightly News with Brian Williams on Tuesday, Nancy Snyderman elaborates the dangers of this type of hip implant, using the DePuy recall as a case study. Watch the clip below.
If you feel you’ve been hurt by your DePuy ASR hip implant, visit our DePuy Orthaepedics Investigation Page to learn about steps you can take to seek justice.
During a hearing before an Australian Senate committee last week, it was revealed that it took three years after problems with DePuy’s ASR hip were detected for the hip implant to be removed from the Australian market. Orthopedic expert Stephen Graves testified that it was first noticed that the metals in the product were poisoning patients in 2006. The implant was not removed from the market in Australia until late 2009, and DePuy did not issue a recall in the United States until August 2010.
Information on the current recall of Stryker Rejuvenate and ABG II hip replacements is available here.
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.
Six plaintiffs’ lawyers will lead federal litigation against Johnson & Johnson over recalled devices used in hip-replacement surgeries.
U.S. District Judge David A. Katz in Toledo, Ohio, appointed the plaintiffs’ executive committee on Jan. 26 after dozens of lawyers vied for the positions. The group will make major decisions on the litigation, which has been consolidated before Katz for pretrial proceedings.
Lawyers for patients said they expect thousands of lawsuits over the ASR XL Acetabular System, which J&J’s DePuy Orthopaedics unit recalled on Aug. 26.
New Brunswick, New Jersey-based J&J, the world’s largest health-care products company, and Warsaw, Indiana-based DePuy said they recalled the devices because researchers found some patients needed a second operation, or “revision surgery,” after five years at rates higher than the company expected.
“There is no doubt there will be thousands of cases,” said the committee’s co-lead counsel, attorney Ellen Relkin of Weitz & Luxenberg in New York. “The damages will be in the billions of dollars.”
The group includes Christopher Seeger of Seeger Weiss LLP in New York.
“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.”
If you’re looking for information about the 2012 Stryker hip implant recall, please visit http://www.seegerweiss.com/stryker-hip-recall.
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.