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 Stryker Hip Recall

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On November 3, 2014, Howmedica Osteonics Corp. (Stryker) announced a National Settlement Program for patients meeting certain criteria who had received these Stryker implants. Stryker invited patients affected by the recalled Rejuvenate and ABG II hip systems to participate with the condition that substantially all eligible patients participate. The settlement program is only available to those patients who have had their Stryker implant removed prior to November 3, 2014; who registered with the program online by December 16, 2014; and who enroll in the program by a deadline which has now been extended to March 30, 2015.

We believe that there are many patients with meritorious claims who may not be aware of their rights and options. Every patient who has received one of these Stryker hip implants should immediately seek legal advice and representation including patients who (i) are not eligible for the program because they have not yet had their hip revised; (ii) believe they have already forfeited their rights by not registering or enrolling in the program; or (iii) whose claims need to be evaluated to determine whether they are appropriate for the program. We also believe that there are many patients who have not been told of the recall, or have been led into a false sense of security that their Stryker hip will not have to be removed. These patients may have meritorious claims as well and are in need of legal counsel.

The statute of limitations is rapidly approaching for some of these patients. If you know of anyone who has a Stryker Rejuvenate or ABG II hip implant, please contact or ask the patient to directly contact Ben Zimmermann or Stephen Sugarman at 617-542-1000 or e-mail bzimmermann@sugarman.com or ssugarman@sugarman.com.

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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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After a mediation, Stryker, the manufacturer of the defective and recalled Rejuvenate hip implants, has agreed to settle four claims currently pending in New Jersey Superior Court. After announcing a recall of the Rejuvenate hips in July, 2012, Stryker has been sued in thousands of lawsuits brought by patients who suffered serious and sometimes lifelong injuries as a result of having the defective hip system implanted in them. In addition to these four cases that have reportedly settled for undisclosed terms, three additional cases are scheduled to be mediated in January, 2014. It remains unclear whether these four settlements will have an impact on the thousands of product liability claims that exist against Stryker throughout the country.

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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Since Stryker recalled its Rejuvenate and ABG II hips in July of 2012, medical science has been quickly evolving to identify and diagnose metal-on-metal complications harming patients. Surgeons have been using metal artifact reduction sequence MRIs, also referred to as “MARS” MRIs, to identify suspected prosthetic hip complications
including metallosis, pseudotumors, inflammatory responses, and tissue and bone necrosis. (See prior blogs on these Stryker hip-related injuries.) Traditionally, metal from prosthetic implants produces a large area of signal and extensive distortion around the defective implant on an MRI. The MARS MRI, however, minimizes this metal “artifact” effect and allows undistorted visualization of bone marrow, soft tissues, fluids, tumors and even cement adjacent to implant hip screws.

Recent studies have also shown that ultrasound is a very useful tool for detecting pseudotumors in hip implant patients. Some current medical studies find that ultrasound may be superior to MRI for diagnosing pseudotumors in asymptomatic patients. In some instances where a MARS MRI generates equivocal results, surgeons may order additional follow-up ultrasonic evaluation to rule in or out metal-on-metal disease.
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Under federal law, a federal judiciary panel is empowered to create a Multi-District Litigation (“MDL”) in situations where there are many lawsuits pending in the federal district courts that involve issues of “common fact”. MDLs are typically created in situations, such as the present one involving the recalled Stryker Rejuvenate and ABG II hip implants, where there are thousands of patients who have been injured by the same defective product. In practice, a patient wishing to be part of the MDL can, through his or her attorney, file an action in the appropriate federal court in the patient’s home state. That case can then be consolidated in the MDL with all of the other pending cases. Once the case is in the MDL, a panel of attorneys conduct discovery (taking depositions, exchanging written questions and answers) that applies to all of the cases in the MDL – there is no case-specific approach. At the end of the discovery, each case will be sent back to the appropriate federal district court to be tried by the patient’s attorney.
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After the filing of many lawsuits resulting for the FDA’s recall of Stryker Rejuvenate and ABG II modular-neck hip replacement systems, a federal judicial panel created a consolidated docket for all Stryker cases. The June 12, 2013 order from the Judicial Panel of MultiDistrict Litigation will transfer almost 50 cases and all future Stryker cases to a single judge in Minnesota, Judge Donovan Frank. The cases will now be consolidated for pre-trial proceedings. The MDL process will not preclude the filing of Stryker claims in Massachusetts State Courts.

Please continue to check in our INSIGHTS blog for more updates and information on the ongoing Stryker Rejuvenate and ABG II Hip Implant litigation. If you have any questions regarding Stryker Rejuvenate and ABG II hips or a resulting Broadspire reimbursement claim, please fill out a Contact Form, call one of our personal injury attorneys, Stephen Sugarman or Benjamin Zimmermann, at 617-542-1000 or e-mail ssugarman@sugarman.com or bzimmermann@sugarman.com.

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Since recalling the Rejuvenate and ABG II hip implants, Stryker has provided some updated suggestions for recipients of these artificial hips (these suggestions are further explained on Stryker’s company website). Stryker suggests at this time that recipients of the Rejuvenate and ABG II products get medical evaluation and consultation for the hips. Stryker informs patients with these hip implants to contact their surgeons for an examination, even if they are not experiencing any symptoms such as localized swelling, redness or discomfort in the hip region.

Stryker explains that a surgeon should still evaluate an asymptomatic Rejuvenate or ABG II hip patient because, despite a lack of complaints, the prosthesis may not be operating properly, causing physical harm. Stryker acknowledges reports of patients with mild or no symptoms that have tested positive for elevated metal ion levels or have been diagnosed with adverse local tissue reaction. A surgeon may therefore order blood tests to detect microscopic metallic particles, and order imaging such as MRI, ultrasound or x-ray to evaluate the hip, muscles and tissues. The surgeon will also try to determine whether any swelling or pain is related in whole or part to an infection in the prosthesis and surrounding tissues.
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Patients who had the recalled Stryker Rejuvenate or Stryker ABGII artificial hip systems implanted in them may have recently received a letter from Stryker Orthopaedics announcing that it hired Broadspire Services, Inc. to coordinate and manage the payment of medical expenses incurred by patients who receive medical treatment as a result of the defective nature of these hip systems. As you may likely be aware, Stryker Orthopaedics recalled its Stryker Rejuvenate and ABGII hip implants in July, 2012 due to what the company described as vulnerability to fretting and corrosion at the modular-neck junction, which can lead to tissue damage surrounding the hip implant as well as pain and swelling. Like other metal-on-metal hip implants, the Stryker Rejuvenate and ABGII systems pose severe health risks to patients who received them, including a high early failure rate, severe pain and metallosis.

Just as DePuy Orthopaedics hired Broadspire Services, Inc., with respect to the recalled DePuy ASR hip systems, Stryker has hired Broadspire to administer patient claims for out-of-pocket and medical expenses associated with the Stryker Rejuvenate and ABGII recalls. Stryker’s tactic of hiring Broadspire, a third-party administrator who works closely with the insurance industry, has drawn the same criticisms that were leveled at DePuy when it hired Broadspire. Through Broadspire, Stryker will reimburse patients for any “necessary” testing, treatment, revision surgery or other costs relating to the recall of its hip implants. Curiously, neither Broadspire nor Stryker define what constitutes “necessary” medical treatment as a result of a recalled hip implant, nor do they define what other costs they will reimburse a patient for. In addition, Broadspire requires a patient to provide copious amounts of information and medical records that may later be used against the patient, should the patient file a formal lawsuit. What may seem on its face to be an altruistic gesture by Stryker may have much more sinister intentions.
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Like most lawsuits involving claims for defective medical devices, the geographic areas where the recalled Stryker Rejuvenate hips were implanted may play a large role in determining which jurisdiction sees the greatest amount of lawsuits filed. The Stryker Rejuvenate hip implant was marketed to and used in discrete parts of the United States. Boston was one of the principal locations where surgeons implanted the Stryker hip until the FDA announced its recall on July 6, 2012.

Because Boston-area hospitals were within the epicenter for Stryker Rejuvenate implants, it is likely that Massachusetts will become a hotbed of litigation surrounding the defects in the Stryker hip system and its eventual recall. Thankfully, Boston-area doctors and medical providers have become more familiar than health professionals in other parts of the country with the harmful effects of the metal-on-metal hip implants. Massachusetts litigants will likely benefit from local doctors who are highly qualified to testify about the dangers of Stryker hips and the harm which these defective products, and other metal-on-metal hip implants, have caused their patients.
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