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Category : Defective Hip Replacements
Stryker is a prominent medical device and orthopedic product manufacturer that supplies hip implants, knee implants and surgical equipment used at major medical centers. Over the past several years, some of Stryker’s products have been recalled due to defects in their design or construction which have resulted in devastating injuries. These defects can make medical products unsafe for their intended use. Under product liability law, a manufacturer is responsible for ensuring that its products meet safety standards and do not pose a threat to consumers. Manufacturers are also responsible for warning patients of the risks associated with their products.
Here are a few of the major lawsuits and recalls that have affected Stryker and unsuspecting consumers across the country.
The Stryker Neptune Waste Management System
Stryker issued an urgent Class I recall for its Neptune series of waste management systems. This recall was issued on June 8, 2012, after the company received reports of serious and fatal injuries. These systems collect fluids during surgery by using a vacuum-like apparatus. When operated at high-pressure, the device can cause serious tissue damage, organ damage and fatal complications. This recall covered all six waste management models in the Neptune series. Stryker is facing a growing number of product liability lawsuits for injuries caused by these dangerous devices. Investigations show that these systems were not approved by the FDA and were not labeled properly.
Stryker Ceramic Hip Recall
In January 2008, Stryker voluntarily recalled its ceramic Trident Acetabular PSL Cup and Trident Hemispherical Cup implants. Stryker’s Trident hip implants were recalled due to contamination at a manufacturing plant. These particular ceramic hip implants were prone to premature failure. A number of patients reported embarrassing squeaking and popping noises during normal activities. These issues are related to ceramic fragments, hip fractures and the loosening of components. Patients who were affected by faulty Trident hip implants are still coming forward, and more lawsuits are being filed.
Stryker Metal-on-Metal Hip Implants
On July 6, 2012, Stryker voluntarily recalled its ABG II and Rejuvenate modular neck stems that are used in hip replacement surgeries. The first product liability lawsuit alleging problems with the ABG II and Rejuvenate neck stems was filed on August 7, 2012. An increased risk of corrosion and metal poisoning were cited as the reasons for the recall. Stryker admitted that the systems were prone to wear and tear near the neck junction. These problems may cause pain, swelling and adverse local tissue reactions. If left untreated, these conditions can lead to aseptic loosening and sepsis.
More than 50,000 defective implants were sold before the recall, and people have begun to file suit. These plaintiffs are requesting a case consolidation that would allow patients from Arizona, Florida, Minnesota and New Jersey to move their cases to New Jersey’s Bergen County Superior Court where they will receive individual trials and settlements. This venue was requested due to the proximity to the Stryker headquarters.
Since 2007, Stryker has received several urgent warnings and complaints from the FDA and the U.S. Department of Health and Human Services. These citations were for failing to test problematic devices and for failing to fix the defects. The company also received multiple contamination warnings. Sterile medical implants were allegedly cleaned and packed in unsanitary areas where microbes exceeded allowable levels.
Between 2007 and 2008, Stryker, DePuy, Zimmer, Smith & Nephew and a host of high-profile orthopedic manufacturers were sued by the Department of Health for engaging in unfair sales strategies and offering unlawful kickbacks to surgeons who directed hospitals to purchase their orthopedic implants and other devices. The FDA has noted several serious design flaws and sterilization issues associated with Stryker’s surgical implements and orthopedic implants. Problems with Stryker’s Duracon, Scorpio and EIUS Unicompartmental Knee Implants have lead to more recalls and lawsuits.
Product liability issues are particularly dangerous when medical devices are involved. Due to the implications of defective medical devices, patients can often sue to recover medical expenses and punitive damages. Victims might also be eligible to request compensatory damages for pain, suffering and loss of consortium.
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.
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.
“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.