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Category : Defective Products
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.
Stryker Orthopaedics Corporation has issued a voluntary recall on its Rejuvenate Modular and ABG II Modular Neck Stems after post-distribution reports were issued stating that these implants are susceptible to corrosion and/or fretting, which can lead to metallosis, adverse local tissue reactions, and pseudotumors.
Arthroplasty, also known as a hip replacement, is the replacement of the diseased or deteriorated hip joints with a prosthesis to relieve pain and increase mobility and function in the hip. The Stryker Rejuvenate system is a device with a stem and neck designed to replace the patient’s hip by providing a mechanism that allows the joint to pivot as it would naturally. The Stryker ABG II Modular Neck Stem is a product designed to reconstruct the hip joint area by attaching inside the femur and coming out to connect with the hip.
Hip Replacement Risk
Standard risk to patients who receive hip replacements include decrease of bone mass or bone loss, nerve damage, uneven leg length, stiffness, and decrease in immune system function. Revision surgery is usually warranted in cases where the patient is experiencing post-surgical issues such as metal sensitivity, loosening of the implant, audible sounds from the area during movement and general wear over time.
When metal pieces in hip implants constantly rub against each other, corrosion occurs. Unlike true metal-on-metal devices where the ball and socket are both made of metal components, both the AGB II and Rejuvenate products had metal stems and metal necks that rub together in a way similar to how the ball and socket devices do.
When corrosion or fretting occurs in metal hip implants made with cobalt and chromium metals, such as the Stryker Rejuvenate Modular and ABG II Modular Neck Stems, the patient can develop metallosis, a condition where metal debris collects in the soft tissues. This can cause inflammation and swelling, as well as destroy the otherwise healthy tissue surrounding the implant site. With deterioration of the tissue, the implant may become misaligned, causing severe pain, infection, swelling, and dislocations These complications can eventually necessitate a revision surgery.
While hip replacements are designed to withstand up to fifteen years of use, both the ABG II and Rejuvenate replacements began showing signs of failure after several months. This caused excessive post-surgical pain that required revision surgery in some patients.
If metallosis exists, inflammation and swelling of the area around the implant could occur, with some cases of pseudotumors and fluid in the joint. Tissue damage from metallosis can present as a rash in the affected area. An often overlooked sign of metallosis is extreme pain, which many patients dismiss as after-effects of the replacement. Metallosis can also cause the levels of cobalt and chromium metals in your blood to elevate. In some cases, this elevation of metal levels can be toxic and cause many systemic illnesses.
Further side-effects of metallosis include the following:
- Recurring infections
- Gastrointestinal issues
- Emotional imbalance
Patients who have either the Rejuvenate Modular or ABG II Modular Neck Stems should contact their doctor immediately. While not every patient who received Stryker’s ABG II or Rejuvenate products have experienced symptoms of metallosis or product failure, all ABG II or Rejuvenate recipients should contact their doctor.
For some patients, the recent hip implant recall by Stryker Orthopaedics will lead to revision hip surgery. Hip revision surgery will unfortunately be needed to replace their faulty Rejuvenate or ABG II module implants. This is truly unfortunate because the typical lifespan of a well-functioning artificial hip joint is 10-15 years and revision surgery brings a lengthier and riskier procedure, as well as greater uncertainty of its outcome.
Few Options Available for Patients
The most pressing and problematic issues with the Stryker recall devices center on its fretting and corrosion, which may lead to metallosis, a serious condition from metal debris leaking into a patient’s bloodstream, the loosening of the implant causing grave pain and discomfort, and the inflammation and damage to surrounding bone and tissue. All of these conditions may warrant a hip revision surgery and bring forth new complications that the patient and surgeon need to consider, for example:
- Quality of patient’s bone and the ability to securely fit revision hip replacement into position
- Higher chance of hip dislocation after surgery due to weaker tissue surrounding the bone as well as more fragile bone
- Lengthier surgery by having to remove old implant and securely placing new one
- Longer rehabilitation timeframe
- Possibility of smaller range of motion
- New prosthesis won’t last as long (eight to 10 years vs. 10-15 years)
If your physician is recommending hip revision surgery because of the Stryker recall and its inherent problems, contact us as soon as possible. Legal options may be available.
For more information about the Stryker hip implant recall and your legal options, visit www.seegerweiss.com/stryker-hip-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.
The Honorable Judge Eldon E. Fallon of the U.S. Eastern District Court, New Orleans, Louisiana, announced on Friday that Seeger Weiss LLP and the other members of the Plaintiffs’ Steering Committee, along with defendant Knauf Plasterboard Tianjin (KPT) had proposed a settlement in the toxic Chinese drywall case affecting thousands of American families. The victims in the case, who own close to 5,000 properties, alleged that German manufacturer Knauf sold defective drywall that was installed in their homes. The toxic ingredients in the faulty imported products caused the plaintiffs a host of problems, ranging from the corrosion of plumbing and electrical systems to respiratory problems and other physical injuries. The final settlement, which will cover remediation of the affected properties and claims of personal injury and equity loss, is expected to be between $800 million and $1 billion. Read more about the groundbreaking settlement.
For Seeger Weiss LLP, the victory is one of many in a long and complicated battle against Knauf on behalf of several homeowners who have fallen victim to the manufacturer’s defective product. In 2009, founding partner Christopher Seeger along with Stephen J. Herman of Herman, Herman, Katz & Cotlar became the first to take KPT, a division of Knauf, to trial. In the bellwether verdict, the plaintiffs were awarded $164,049. Since then, Mr. Seeger has gone on to win close to $3 million for other victims of the toxic drywall.
Seeger Weiss continues to investigate toxic Chinese drywall claims. Our defective products practice has the expertise and the track record you need to settle your claims. Learn more about our Chinese drywall investigation here.
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 a telephone interview, Dr. Nissen said that he was concerned that the administration had failed to take a more aggressive posture toward tightening the regulation of medical devices. In recent years, thousands of patients have been injured and some have died because of failed medical devices that were cleared for sale with little testing.
“This is an area where the F.D.A. has failed the public,” Dr. Nissen said.
Marie Rita Kennedy-Lebar said in a suit filed Tuesday in the U.S. District Court for the District of New Jersey that VW and its affiliates have known about but failed to fix headlights that sporadically shut off, exposing drivers to significant danger. The problem occurs in Audi vehicles equipped with an optional high intensity gas discharge headlamp system with xenon bulbs.
VW claims the high intensity gas discharge headlamp systems are superior to halogen headlights, a less expensive option for VW vehicles, because they produce a greater amount of light, consume less power and are intended to last longer.
But while touting the superiority of the product, VW has known that the systems suffer from intermittent failures due to an underlying systemic problem, the suit says.
Kennedy-Lebar is represented by lawyers from Seeger Weiss LLP, including associate Scott George.