INSIGHTS On Massachusetts Personal Injury Law

Welcome to the SUGARMAN blog. We'll be sharing our perspectives on the state of the law and current legal issues in Massachusetts personal injury law. Issues relating to medical malpractice, construction site injuries, premises liability, product liability, motor vehicle accidents, insurance, and more will all be reviewed here by our team of lawyers who have prosecuted some of the most complex cases in Massachusetts personal injury law.

Articles Posted in Depuy Hip Recall

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One of the most important issues surrounding Total Hip Arthroplasty (replacement) is the future of bearing surfaces. The bearing surfaces of an artificial hip joint ideally have sound wear characteristics and durability, are bio-inert and relatively easy to implant. Hip recalls, including the DePuy ASR and Stryker Rejuvenate and ABG II, represent a loss in confidence and movement away from metal-on-metal articulating surfaces. Growing reports of cobalt and chromium toxicity, device failure and revision surgery in patients implanted with metal bearings have forced surgeons and manufacturers to look to new solutions for the composition of bearing surfaces.

Future bearing surfaces will including improved polyethylene and ceramic components. Recent short-term studies have evaluated the efficacy of Vitamin E stabilized polyethylene. By adding the antioxidant Vitamin E to polyethylene under specific controlled conditions, researchers noted that the material exhibited low wear and high strength characteristics compared to polyethylene bearing surfaces on the market. Though these short-term studies are encouraging, long-term analysis is still required to understand the longevity of the material. Research is also underway to improve upon the strength of existing fourth-generation ceramics which have been engineered to inhibit cracking. Alternative new materials are also being considered for hip surfaces. Diamond-like carbon film may be a viable solution. It is known for superior tribological and mechanical properties, as well as inertness and compatibility with biomedical devices. Carbon-based composite materials also offer a potential low wear, high durability articulating surfaces. Whatever the products of the future will be, the search is underway for alternatives to metal-on-metal bearings that permit decreased joint friction and wear rates but increased strength.

SUGARMAN has a team of lawyers dedicated to handling defective and recalled hip system claims. If you have any questions regarding DePuy or Stryker hips, please fill out a Contact Form, call us at (617) 542-1000 or e-mail info@sugarman.com.

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In recent years, there have been a number of high-profile medical device recalls and resulting lawsuits involving metal-on-metal hip implants. The first to gain widespread attention was DePuy Orthopaedics’ August 2010 recall of its ASR XL Acetabular Hip System and ASR Hip Resurfacing System. Thousands of lawsuits against DePuy and various distributors were filed throughout the country and a settlement of many of these claims appears to be imminent. In addition to the DePuy cases, there are currently thousands of lawsuits arising out of Stryker Orthopaedics’ July 2012 recall of its Rejuvenate and ABG II modular hip replacement systems.

Much of the media attention on these recalls and the hip implants has focused on the lawsuits themselves – the amount of potential settlements, the profits the manufacturers made from these recalled devices and the amount of legal fees for plaintiff and defense lawyers. What is often lost in all the lawsuit-related attention are the real-life consequences that these products can have on the patients they were designed to help.

The Stryker Rejuvenate and ABG II devices were recalled due primarily to wearing and corrosion of the metal parts of the artificial hip system. Such corrosion can result in a patient developing metal toxicity (metallosis), pseudotumors, and tissue damage in the hip area. All of these conditions can not only be painful and debilitating, but can make removal and revision very difficult for the surgeon. Further, during the corrosive process, metal ions, including cobalt and chromium, are released into a patient’s body. It is still not entirely known what the long-term adverse effects of having elevated levels of these metals may be.

Unfortunately, the only true treatment option is the removal of the hip implant. This is far from simple, and has serious short and long-term implications for the patient. A primary hip revision is a large, invasive, and painful surgery to recover from. A revision is worse. Further, because the stems of these devices are inserted down the center of the femur bone, removal is quite traumatic, and frequently results in fractures to the femur itself, which then have to be repaired with more metal hardware. The end result is a complicated and prolonged recovery process with a high potential for permanent loss of function. In addition, patients who have already gone through one hip implant surgery are again subjected to extended periods of rehabilitation, meaning there is another round of bed rest, another round of physical therapy and more time lost from work. The revision surgeries can also pose additional complications for certain patients. For example, elderly patients in need of a revision may not be surgical candidates due to other health conditions, and must retain the device in their body despite its release of ions. Some patients have such extensive tissue damage that a new hip system cannot be implanted once the recalled hip is removed, forcing them to be disabled for the rest of their lives.
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Johnson and Johnson has tentatively agreed to pay up to $4 billion to settle claims brought by patients who were implanted with defective DePuy ASR artificial hips. The plan is subject to court approval and has not been formally announced. According to reports, the $4 billion settlement would be distributed amongst all patients who required replacement of their ASR hip with the per patient payout being dependent on several factors, including the patient’s age and medical condition. As more patients undergo revision surgeries to replace their failing ASR hip implants, the cost of the settlement could rise even higher. In total, approximately 60,000 patients in the U.S. received a defective ASR hip. The formal deal is likely to be announced later this week.

In addition to representing patients implanted with the recalled DePuy ASR hips, SUGARMAN has formed a team led by partners Stephen Sugarman and Benjamin Zimmermann to represent clients who have been injured as a result of defective Stryker Rejuvenate and ABG II hip implants. If you have any questions regarding a Stryker hip implant, please fill out a Contact Form, call Stephen or Ben at 617-542-1000 or email ssugarman@sugarman.com or bzimmermann@sugarman.com.

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In advance of a trial scheduled to begin in less than a month, Johnson & Johnson and DePuy have agreed to settle a claim in San Francisco Superior Court involving a defective and recalled ASR metal-on-metal hip system. The trial was to be the first out of the nearly 2,000 DePuy hip cases currently pending in California courts; often referred to as a bellwether case. Terms of the settlement were not disclosed. This case was one of approximately 11,500 cases currently pending against Johnson & Johnson and DePuy across the country. Several more trials are scheduled to occur in the upcoming months in New Jersey, Illinois and California.

If you have any questions regarding a DePuy hip, please complete a Contact Form, call Stephen Sugarman or Benjamin Zimmermann at 617-542-1000 or email ssugarman@sugarman.com or bzimmermann@sugarman.com.

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In our November 13, 2012 Blog posting, we told you about the newly recalled Stryker Rejuvenate and ABG II modular hip implants. These devices were recalled in July 2012 because of wearing and corrosion of the metal parts of the artificial hip system. This corrosion results in metal toxicity, pseudotumors, and tissue damage, similar to that caused by the recalled DePuy ASR hip systems.

Unfortunately for Stryker patients, it is now clear that the treatment required to stop the tissue damage caused by the defective Stryker hips is a complicated revision surgery. The DePuy ASR typically fails because the metal ball rubs against the metal socket, causing debris. A revision surgery usually involves removing the ball at the very end of the stem and replacing the cup. The metal rod, or stem, that had been inserted into the center of the femur bone is not touched.

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On July 6, 2012, the FDA announced that Stryker Orthopaedics had recalled its Rejuvenate and ABG II modular-neck hip replacement systems. In a press release, Stryker claimed that the recall was initiated due to potential risks with these hip replacement systems, including fretting and/or corrosion at the modular-neck junction of the system. Reports indicate that the Stryker systems had a high early failure rate, resulting in the need for patients to undergo revision surgeries to replace the devices more often than with other hip replacement systems. This announcement ended ongoing speculation concerning whether the Stryker hip replacement systems would be recalled.

Unlike DePuy Orthopaedics’ ASR hip systems that were recalled in August, 2010, the Stryker Rejuvenate is not a true metal-on-metal hip device. It does, however, have metal-on-metal components. In addition to the high early failure rate, these metal-on-metal components are believed to be responsible for the development of metallosis in a percentage of patients. Metallosis is a painful condition that a patient can develop when metal-on-metal components rub against each other, causing friction and the release of metal ions into surrounding bone and tissue. The Stryker hip systems are, however, similar to DePuy Orthopaedics’ ASR hip systems in that both systems were approved through the FDA’s controversial 510(k) medical device approval process.
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Recent information further implicates DePuy Orthopaedics for the problems associated with its ASR artificial hip replacement system. On September 27, 2011, the Australian Senate Community Affairs Committee conducted an inquiry into that country’s regulatory standards for medical devices. During the Senate hearing, witnesses testified that in 2006 DePuy had evidence of failure rates greater than 50% associated with the ASR hip. That information was not acted upon for over three years. Australia became the first country to issue a DePuy ASR hip recall in December 2009. The DePuy ASR hip was not recalled in the United States until August 2010.

Failure of the metal on metal ASR hip device can occur in a variety of ways, including fractures, dislocations, and soft tissue damage. Metal debris inside the body can cause inflammatory reactions, bone loss, genetic damage, aseptic fibrosis, local necrosis or other problems. failures often require revision surgery to remove the defective hip, but tissue and bone damage caused by metal debris greatly complicates subsequent procedures. Even with successful revision surgery, patients are often left with a substantial functional impairment due to bone and tissue damage. The long term effects of systemic cobalt and chromium poisoning are still being evaluated.
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When DePuy issued the United States recall of the ASR artificial hip systems, it announced that it would pay for the necessary, medical replacement treatment for patients suffering complications as a result of the ASR hip.  But the manner in which DePuy is handling patient reimbursement is gaining criticism on several fronts. It is not uncommon when a medical device is recalled for the company to voluntarily pay out of pocket patient expenses associated with the recall. Usually the company will handle both the recall and the resulting expense claims directly.  When subsequent medical treatment is required, the recalling company typically accepts a treating physician’s recommendation about the need to remove or replace the device, and the cost associated with the necessary treatment.

Rather than follow this established procedure, DePuy has hired a third party — Broadspire Services Inc, — to administer patient claims for out of pocket expenses associated with the ASR hip recall. Broadspire advertises itself as providing “risk management services” for “employers and insurance companies.” Before being retained by DePuy, it typically managed workers compensation and other medical claims on behalf of insurance companies and employers.
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On August 22, 2011 the NY times published the results of its own study of Adverse Event Reports to the Food and Drug Administration (FDA) by patients with metal on metal artificial hip systems. The results confirm widespread failures with the DePuy ASR hip system.

Read the full NY Times Hip Implant Complaints Surge, Even as the Dangers Are Studied article.

The Adverse Event Reporting System (AERS) is a database the FDA uses to monitor problems with products it has approved. The reporting system compiles information submitted by doctors, pharmacists, and nurses, as well as patients and their family members. The database also includes reports from manufacturers. This type of reporting is entirely voluntary for healthcare professionals and the public, but is supposed to be mandatory for manufacturers. An Adverse Event Report will include device information, the reaction or problem, and the ultimate outcome for the patient. The database is an important tool for the FDA because it helps keep track of products after their initial approval. The FDA uses research teams to continuously evaluate this system for safety concerns. Depending on the scope and severity of reports it receives, the FDA may issue warnings, change required labeling, restrict uses, or–in rare cases–take a product out of use entirely.
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Recalled DePuy Replacement Hip Failure Rate: Revised Data Released

In August of 2010, when DePuy first issued a voluntary recall of its ASR XL Acetabular and its ASR Hip Resurfacing Systems, DePuy referenced data suggesting a hip replacement revision rate of 13 percent, or 1 out of every 8 patients. (a revision is when a second surgical procedure is required to modify or replace an artificial joint that has failed). But recent data released from the United Kingdom suggests a revision rate as high as 49 percent, or four times what DePuy cited in recalling the hip replacement device last year.

The British Orthopaedic Association and the British Hip Society released a statement in early March stating that “Data on the ASR XL Acetabular System from … show the rate of second operations, or revisions, ranges from 21 percent after four years to 49 percent after six years.” Said group Chairman John Skinner “It’s probably the best indicator so far of what the failure rate is likely to be …. As far as I can tell, it’s reliable.” Skinner said the data hasn’t yet undergone the peer review process required for publication.
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