A Magazine Dedicated to Mass Torts Law. The Dangers of Metal-on-Metal Hips. Details of DePuy ASR Settlement Announced.

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1 d3 Dangerous Drugs and Devices A Magazine Dedicated to Mass Torts Law The Dangers of Metal-on-Metal Hips Details of DePuy ASR Settlement Announced

2 Johnson & Johnson Agrees to Pay $2.5 Billion to Settle Langdon & Emison continues to accept and litiga FAQ About the DePuy Two key deadlines for the DePuy Settlement: January 6, 2014: Deadline to register your cases. April 1, 2014: Deadline to opt-in to the settlement. There is a substantial amount of information required prior to each deadline, so contact us as soon as possible to ensure your client is included in this settlement. What devices are covered by the settlement? This settlement resolves claims involving the DePuy ASR Acetabular hip system or the DePuy ASR hip resurfacing system. Other defective hip claims including DePuy Pinnacle hip systems and artificial hips manufactured by Wright, Biomet, Stryker, Smith & Nephew, or Zimmer are not included in the DePuy ASR settlement. Who is eligible for the settlement? Plaintiffs are eligible to participate in the settlement if they are either U.S. citizens or U.S. residents and had surgery to replace a DePuy ASR hip implanted for more than 180 days with the revision surgery occurring on or before August 31, 2013, either in the United States or at a U.S. Military hospital abroad. Patients having a replacement surgery after August 31, 2013, (or not all) are not eligible to participate in this settlement. How is the settlement structured? The settlement is structured in multiple parts. Part A provides the base award. Under the Part A base award, qualified patients will receive $250,000 subject to limited potential reductions for factors that include smoking, BMI, ASR as a revision device, length of use, and death unrelated to the revision surgery. Some plaintiffs may be eligible for an additional award under Part B of the settlement agreement. Part B supplemental awards will be made to plaintiffs who can demonstrate extraordinary injuries related to the removal of their ASR hip device. Qualifying extraordinary injuries include, for example, plaintiffs who required multiple hip surgeries following their ASR implant or re-revision surgeries; bilateral ASR implants (implants for both the right and left hip); serious or catastrophic medical events such as death, heart attack, stroke, DVT, dislocation, foot drop, or infection either during revision surgery or caused by the revision. Plaintiffs will also have an opportunity to present special circumstances to the settlement administrators if they believe such circumstances warrant a supplemental award. 2

3 Thousands of Lawsuits over Defective Artificial Hips te cases on behalf of patients with defective hips ASR Hip Settlement In addition to Part A and Part B, DePuy has also assumed responsibility for any outstanding medical bills or liens by health care providers or insurance companies directly associated with a compensable revision surgery. This means that, in addition to the $250,000 Part A payment and any Part B supplement payment, DePuy will also pay any outstanding bills related to the costs of the revision surgery. Qualified patients will receive a base award of $250,000. Plaintiffs wishing to participate in the settlement must register by January 6, Submission of all claims packages and documentation must occur on or before April 1, How do I know if I have a DePuy ASR hip? Patients with a DePuy ASR hip should have received notification from their orthopedic surgeon telling them about the product s recall. Even consumers who did not receive any letter regarding this could still have one of the recalled products implanted in your body. If you believe you might have a metal-on-metal hip implant manufactured by DePuy Orthopaedics, it may be a DePuy ASR. Medical records from the hospital where the hip was implanted, specifically a document often referred to as the Medical Device Record, will provide that information. Medical records can be complicated, but our attorneys regularly review these records as part of this body of litigation, and can tell you if you have a recalled ASR hip implant. What about plaintiffs without a revision? Unfortunately, patients not having a revision surgery by August 31, 2013, are not be eligible for this settlement. Approximately 1/3 of the plaintiffs (4,000 out of 12,000 plaintiffs) in the DePuy ASR litigation are non-revision patients. Patients without revisions will retain all legal rights and their claim will remain preserved. Plaintiff attorneys continue to work to resolve the c l a i m s decision of plaintiffs without revisions surgery. It is important to note that the to have a revision is a medical one, not a legal one. The decision to have revision surgery should be made in consultation with a physician. Should I do anything if I don t have any symptoms? You may not suffer from any of the physical symptoms of a bad ASR hip, but there are other problems reported with this defective product. (Cont. p.7) 3

4 Brands Involved in Metal Firm Continues to Represent Individu BIOMET M2A MAGNUM The Biomet Magnum has three all-metal components: a metal femoral head, metal taper insert, and metal acetabulum cup. As the metal parts rub against each other, microscopic shavings of metal may be released into the hip joint, causing inflammation, loosening, and other problems associated with metal hip poisoning. DePUY PINNACLE More than 4,600 DePuy Pinnacle lawsuits involving a version of the Pinnacle hip system that utilizes the Ultamet liner are now pending in a multidistrict litigation underway in U.S. District Court, Northern District of Ohio. The complaints allege that metal debris from the hip can accumulate to dangerous levels in a patient s body, resulting in serious complications. Plaintiffs also assert that the all-metal Pinnacle shares similarities in design to the ASR hip. SMITH & NEPHEW The metal liner of the Smith & Nephew R3 Acetabular System is a common complaint for lawsuits filed against this UK-based manufacturer. This metal liner is made of cobalt and chromium. Cobalt-chromium implants have been shown to release ions into the body. Studies have revealed that chromium and cobalt ions are carcinogens linked to blood poisoning and genotoxicity. STRYKER REJUVENATE The Stryker Rejuvenate and ABG II hip replacement systems are not metal-on-metal devices, but they do include a metal-on-metal component the modular neck hip stem. The Stryker Rejuvenate is somewhat different from other metal-on-metal hip systems such as the DePuy ASR. Its components are ceramic, but it also has metal-onmetal parts, and they can fail just like other hip implant system. In May 2012, the Stryker Rejuvenate was recalled in Canada so that instructions for use could be updated, according to Stryker Orthopedics. In July 2012, Stryker voluntarily recalled its Rejuvenate and ABG II modularneck stems from the U.S. market. The products were recalled due to reports of fretting and corrosion. According to the company s recall notice, post-marketing surveillance data suggests that the recalled products may be prone to fretting and/or corrosion at or about the modular-neck junction, which may lead to pain, swelling and other adverse reactions in the surrounding tissue. STRYKER ABGII MODULAR NECK SYSTEM Unlike other hip implant systems that have a one-piece fixed femoral neck and stem, Stryker s Rejuvenate and ABG II systems include several mix-and-match neck and stem components. The necks are an alloy of chromium and cobalt, and the stems are coated with titanium. According to this body of products litigation, when the two metal components wear against each other in the course of normal movement, they can shed minute metallic particles into the body the same problem seen in other hip implants mentioned above. 4

5 -on-metal Hip Litigation als Injured by Defective Artificial Hips WRIGHT CONSERVE Plaintiffs allege that Wright Medical Technology released a defective line of hip implants and failed to properly warn patients of the Conserve model s potential risks. Again it is the metal-onmetal design of this particular product which can lead to excessive levels of metal debris causing metal toxicity or early failure of the device. The metal cup and metal ball of the hip replacements are causing excessive heat and friction, resulting in the release of metal particles into the patient's surrounding tissue and bloodstream. WRIGHT PROFEMUR The Wright ProFemur Total Hip System is comprised of three separate components assembled during surgery: a femoral head, a modular neck, and the femoral stem. According to suits filed in these cases, there is an alleged design defect in the femoral implant that causes it to fracture just below the neck. When the implant fractures, emergency surgery is required. The complaint points out that studies have shown that modular neck adapters made from titanium alloy, such as the ProFemur modular neck adapter are more likely to suffer fretting corrosion and fatigue fracture than those made from cobalt-chromium. A 2009 report by the Australian Orthopaedic Association showed that the Wright ProFemur Z femoral stem had a high failure rate, requiring approximately 11.2 percent of all patients receiving the implant to need revision surgery. ZIMMER Zimmer one of the world s largest manufacturers of hip replacement parts suspended sales of the Durom Acetabular Component (Durom Cup) until it could update the label with instructions about special surgical techniques to be followed during total hip replacements. Because the company reported finding no evidence of any manufacturing defect or design defect, a recall was not issued on this particular product. Nevertheless, MDL and individual lawsuits have been filed against Zimmer over Durom Cups, claiming they failed to provide proper warnings, instructions, and training to surgeons. In April 2008, Dr. Larry Dorr, a prominent orthopedic surgeon, wrote an open letter to members of the American Association of Hip and Knee Surgeons complaining of Zimmer Durom Cup problems: of 165 Zimmer Cup implants he performed, 14 were revised or required revision within the first two years after surgery. Dr. Dorr indicated that the Cup was defective: the fixation surface on the cup was problematic and a circular cutting surface on the periphery of the cup prevented it from fully seating. 5

6 The Failures of Metal-on-Metal Hips Metal-on-Metal Hips: A Common Defect As artificial hips have become increasingly common, metal-on-metal (MoM) total hip replacement has become a popular alternative to traditional hip replacement. According to one study, metal-on-metal hip replacement now accounts for more than one-third of hip replacements in the U.S. MoM hips had been touted as more durable than traditional hip implants. Hip manufacturers said large diameter metal-on-metal bearing surfaces would reduce wear and lower rates of dislocation. However, later studies found MoM hips to be no more durable than traditional hip implants while MoM hips subjected patients to severe side effects including metallosis poisoning. Metal-on-Metal Hip Quick Facts Metal-on-metal artificial hips all suffer from a similar defect. Cobalt and Chromium ions can cause irreversible damage to DNA. Metal-on-metal hips fail 300% more than traditional hip implants. Metal-on-metal artificial hips all suffer from a similar defect. MoM hip implants permit the metal components to grind together and shed metallic particles into the surrounding tissue where the particles are then spread throughout the body. In 2010, the State of Alaska Epidemiology Bulletin found that cobalt and chromium ions are commonly detected in the blood and urine of MoM hip patients. The accumulation of metallic debris in the a r e a s surrounding the joint can cause metallosis and fibrosis, destroying the surrounding tissue. After hip replacement, metallic particles disseminate throughout the body and can be found in many organs, including marrow, blood, liver, kidneys, and bladder. Cobalt and chromium have the ability to damage DNA, even across an intact cellular barrier. Studies have suggested high exposure to metallic ions is associated with an increased risk of certain cancers. The New England Journal of Medicine found that MoM hip implants failed 300% more often than other traditional hip implants. The FDA has ordered 21 hip manufacturers to conduct further studies on the devices and potential adverse effects for patients. Remarkably, most these devices many already recalled by the FDA were approved under less stringent regulations that did not require human testing, meaning the devices were never tested in human patients before being implanted into hundreds of thousands of people. Making matters worse, not only are these devices not properly tested, but the hip manufacturers pay doctors to actively promote the defective products. For example, DePuy paid more than $80 million to doctors across the country to promote, research, and consult on DePuy s defective hips. 6

7 FAQ About the DePuy ASR Hip Settlement (Cont.) DePuy s internal estimates suggested that more than onethird of patients receiving an ASR hip replacement would need a revision surgery within 5 years. A blood test can determine if you have high levels of metal debris in your hip, which can still be dangerous even if you don t know about it. The metal debris is a side effect of the metal-on-metal hip cups rubbing together and shearing off metal shards into your body, causing metal poisoning. What is wrong with the DePuy ASR artificial hip? The DePuy ASR artificial hip is defective because its metal-onmetal design resulted in an abnormally high failure rate and permitted toxic metals to be leached into the body as particles were ground away from the device. DePuy s internal estimates suggested that more than a third of patients receiving an ASR hip replacement would need a revision surgery within five years. Despite that knowledge, DePuy executives decided in 2009 to phase out but sell off ASR inventories to unsuspecting patients after the FDA asked the company for additional safety data and voiced safety concerns about the high concentration of metal ions in patients receiving the implant. Other Mass Torts Cases Here is a list of the pharmaceutical & medical device cases we are currently accepting in addition to metal-on-metal hips: Actos Lexapro Mirena IUD SSRI s/antidepressants Yaz/Yasmin Zimmer knees Zoloft Our team of mass torts lawyers has represented clients across the country in cases related to dangerous drugs and defective medical devices. For a free evaluation of your potential case, please call us toll-free at langdon & emison Attorneys At Law 7

8 1828 Swift, Suite 303 N. Kansas City, MO Main Street Lexington, MO *110 E. Lockwood, Suite 150 St. Louis, MO *55 W. Monroe Street, Suite 3700 Chicago, IL *By appointment only $2.475 Billion Settlement in DePuy ASR Defective Hip Litigation Langdon & Emison continues to accept and litigate defective hip cases Deadlines are approaching for plaintiffs wishing to participate in the DePuy ASR settlement announced in November, The nearly $2.5 billion settlement will result in base awards of $250,000 to each claimant, subject to reductions or additions based on specific, limited factors. The settlement should resolve about two-thirds of the approximately 12,000 pending cases. Litigation will continue to resolve the remaining DePuy ASR claims as well as claims involving other metal-on-metal hips, including hips manufactured by Biomet, DePuy, Smith & Nephew, Stryker, Wright, and Zimmer. Turn to Page 2 for additional information about the DePuy ASR settlement. Turn to Page 4 for information about other metal-on-metal hip claims.

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