) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) LIABILITY INTRODUCTION. Imagine you ve had a progressive severely painful debilitating disease.

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1 Stephen Csengeri, Esq. (SBN 0 Csengeri Law Offices Hawthorne Blvd., Suite 0 Torrance, CA 00 Telephone: ( -0 Fax: ( -00 Attorney for Claimants, XXXXXXXX XXXXXXXXX Claimants, vs. Zimmer Holdings, Inc., Defendant CLAIMANTS MEDIATION BRIEF LIABILITY INTRODUCTION Imagine you ve had a progressive severely painful debilitating disease. It finally reaches the point where you ll do anything. The cure is to have a large segment of your body surgically removed. You get yourself mentally ready and have the surgery. You are greatly relieved to find the cure gets rid of this progressive severely painful debilitating disease. You are so optimistic you will get your life back. Then it begins again, but in a completely different manner. You experience new and different severe pain and limitations. It gets progressively worse. You tell your MEDIATION BRIEF - 1

2 doctor about this major problem and despite all the tests, they can t find anything wrong with you. You think to yourself, I went through this major surgery and I still don t have my life back. Is this what my life is going to be from now on? This is physically and mentally devastating. The severe pain and daily limitations go on for years and affects every aspect of your life. Then, your world-renowned doctor notices an unusual pattern. He goes to the manufacturer of the device used in your surgery and notifies them of a defect in the design of this device that is causing these problems in his patients. The manufacturer ignores his advice. The doctor then publishes a letter to his peers notifying them of his findings of the abnormally high failure rate. He also notifies the FDA. The manufacturer continues to place this product on the market. The New York Times then does an expose on this defectively designed product. Now everyone knows. The manufacturer finally halts the sale of the product. As a patient, you finally learn that the symptoms you ve been suffering all these years after the major surgery aren t in your head. There s a reason the Zimmer Durom cup. Description of Zimmer Durom cup The Zimmer Durom Acetabular Component is a newer type of artificial hip part which is designed for use in combination with Zimmer s Metasul Metal-on-Metal Tribological Solution Large Diameter Heads (LDH. The hip replacement cup is a monoblock of cobal chromium alloy which was introduced in Europe in 0 and approved in the United States in 0. MEDIATION BRIEF -

3 Unlike traditional hip replacement parts, the Zimmer Durom Cup is made from a single piece of material and is designed to address some of the more common problems with hip replacement components, such as wear of the bearing, limited range of motion and instability. The Zimmer Durom cup is a unique design for cups used in hip replacement. LETTER FROM DR. DORR TO AMERICAN ASSOCIATION OF HIP AND KNEE SURGEONS April, 0 To: All AAHKS Members From: Larry Dorr, MD This NOTICE is to inform you that we have had ten revisions in hips and have four more that need to be revised using the Durom cup (Zimmer, Inc. This failure rate has occurred within the first two years. In the first year the x-rays looked perfect. We have revised four that did not have any radiolucent lines or migration (and John Moreland revised one. These early cups fooled us, but the symptoms were so classic for a loose implant that we operated the patients. When we hit on the edge of the cup it would just pop free. As time goes by the cups begin developing radiolucent lines. We now have one cup at two years that has actually migrated a short distance. It has tilted into varus. We do not believe the fixation surface is good on these cups. Also there is a circular cutting surface on the periphery of the cup that we believe prevents the cup from fully seating. We stopped using the cup after the first revisions. We have notified Zimmer. The FDA has been notified and we will notify them of our continued revisions. The company does not believe it should pull the cup from the market so I am notifying all of my colleagues of our failure rate with this cup. I went through a similar scenario MEDIATION BRIEF -

4 with the Sulzer cup failures where I was the only one experiencing revisions at the beginning and basically it was assumed that it was our technique. I can assure you that this goes beyond technique. I learned my lesson in not informing everyone about this magnitude of failures with the Sulzer cup problem, so it is my obligation to do so with this cup. If you have any questions, do not hesitate to contact me. Sincerely, Larry Dorr, M [Since this letter, Dr. Dorr has noted a much higher failure rate] ZIMMER HOLDINGS, INC PRESS RELEASE July, 0 Background on Durom Cup Status Zimmer Temporarily Suspends Marketing and Distribution of Durom Acetabular Component in the United States to Update Labeling and Implement Surgical Technique Training Zimmer Holdings, Inc (NYSE and SWX: ZMH is temporarily suspending marketing and distribution of the Durom Acetabular Component (Durom Cup in the United States, while the Company updates labeling to provide more detailed surgical technique instructions to surgeons and implements its surgical training program in the U.S. The Durom Cup will continue to be marketed without interruption outside the U.S. Zimmer is taking this voluntary action to address its concerns regarding reports of cup loosenings and revisions of the acetabular component used in total hip replacement procedures, in some patients who have been implanted with the Durom Cup in the U.S Zimmer has determined that revised surgical technique instructions and a surgical training program are required to more consistently achieve desired clinical MEDIATION BRIEF -

5 results in the U.S. The Company has shared its review and conclusions with the U.S. Food and Drug Administration (FDA and will continue to update the Agency. While the Company believes the likelihood of currently implanted patients requiring revision is low, Zimmer has sent a letter to U.S. surgeons advising them to stop implanting the Durom Cup, until the updated labeling is issued providing more detailed surgical technique instructions and they receive training. Within the next several weeks, Zimmer will issue a further communication to U.S. surgeons providing them with updated labeling, which will include the more detailed surgical technique instructions. The Company is also developing a comprehensive surgical skills training curriculum, working with experts in Europe and the U.S. Following initiation of the new training program, the Durom Cup will be made available to surgeons as they complete training. NY TIMES- Complaints Undermine Hip Device By BARRY MEIER Published: July, 0 Zimmer Holdings, the nation s biggest producer of orthopedic devices, says it will suspend sales of an artificial hip component that some doctors have complained was failing at a high rate. Zimmer s Durom cup, a shell, has been used in more than,000 surgeries. Some patients need replacements. In recent months, some doctors have complained that the device, a hip socket known as the Durom cup, was failing in their patients, who then had to undergo replacement surgery. MEDIATION BRIEF -

6 Zimmer said its investigation had determined that the product was not defective. But it stated that even some experienced surgeons had found it difficult to implant. The company said it expected to resume sales once specialized training for doctors had begun. Since it was first sold in the United States in 0, the Durom cup has been implanted in more than,000 patients. Zimmer said it expected the overall need for early replacement in patients would be low. But Zimmer data and interviews with doctors suggest that hundreds of patients might need such procedures in coming years. Some doctors said their patients had not had problems with the cup. The issue with the device surfaced in April when a surgeon in Los Angeles, Dr. Lawrence Dorr, publicly warned other orthopedists about cup failures his patients were experiencing. In response, Zimmer said it would start an investigation but said it saw no reason to take added action like halting sales. At the time, Zimmer also cited European data showing that the device was doing well there. But the version of the device used outside the United States is slightly different from the one used here. Also, while doctors here use it in traditional hip replacement, surgeons in other countries used it in a relatively new kind of hip surgery known as resurfacing, which involves somewhat different surgical techniques. Zimmer, which announced the sales suspension late Tuesday, said that its investigation found that using the cup required a higher degree of precision. Dr. Dorr, who said he had stopped using the device last year, said he did not plan to start reusing it. It is a bad design, he said. As a result of halting sales, Zimmer said that it was also suspending United States premarketing trials of its system for resurfacing, the process that is used in MEDIATION BRIEF -

7 Europe. That decision will put it further behind competitors that already have such products on the American market. NEW YORK TIMES-The Evidence Gap A Call for a Warning System on Artificial Joints July, 0 By BARRY MEIER Dr. Lawrence Dorr, a nationally known orthopedic surgeon in Los Angeles, realized last year that something was very wrong with some of his patients. Months after routine hip replacements, patients who had expected to live without pain were in agony. "The pain was grabbing me around the back," said Stephen Csengeri, who is, and a lawyer from Torrance, Calif. Dr. Dorr found he had implanted the same metal hip socket in each patient. Several needed surgery again - a replacement for their replacement. The doctor first told the device's manufacturer, Zimmer Holdings, last year about his concerns but nothing happened. Then in April, Dr. Dorr, who was a highly paid consultant for Zimmer, sounded an alarm to colleagues in a professional association and soon heard back from doctors with similar experiences. "I saw one of Zimmer's engineers at a meeting, and I told her that you should pull this cup because you are crippling patients," Dr. Dorr said. Last week, Zimmer announced it was suspending sales of the device, known as the Durom cup, until it trained doctors how best to implant it. The company said a "low" percentage of the,000 patients who got the socket would need replacements, but some doctors fear the number could reach into the hundreds. If those patients lived in other countries where artificial joints were tracked by national databases - including Australia, Britain, Norway and Sweden - many might MEDIATION BRIEF -

8 have been spared that risk. And Zimmer might have suspended sales of the cup months ago. But the United States lacks such a national database, called a joint registry, that tracks how patients with artificial hips and knees fare. The risk in the United States that a patient will need a replacement procedure because of a flawed product or technique can be double the risk of countries with databases, according to Dr. Henrik Malchau of Massachusetts General Hospital. History Repeats Itself Dr. Dorr,, is a veteran of more than,000 hip replacement surgeries, a $0,000 to $0,000 procedure lasting more than an hour in which metal tools that would look at home in a garage are clanged and bashed against bone. He has been at it for three decades, long enough to say that history is repeating itself because this country does not gather evidence of how patients fare. Eight years ago, he alerted another implant producer, Sulzer Orthopedics, that patients with one of its hip implants were having such pain they needed replacement surgery almost immediately. Sulzer withdrew the device six months later, but about,000 patients got replacements for the implant, which had become contaminated by oil during manufacturing. Sulzer, deluged by lawsuits, filed for bankruptcy protection. Last year Dr. Dorr, alarmed by a rash of problems in patients like Mr. Csengeri, first contacted Zimmer about the Durom cup. X-rays showed that the socket was separating from bone, rather than fusing with it. For patients, who had been told their new hips might last to years, it meant agony as the metal cup moved around in the hip socket and rubbed against bone. MEDIATION BRIEF -

9 Earlier this year, after Dr. Dorr urged Zimmer executives to stop selling the cup, they told him the fault was in his implantation technique, not their product - the same response he received years before from Sulzer executives. That is when he decided to alert colleagues at the American Association of Hip and Knee Surgeons. In late May, Zimmer informed surgeons that it was investigating Dr. Dorr's complaint but that it did not see a need for an action like suspending sales. Last week, in releasing a summary of its investigation, the company said that cup failure rates had varied widely among clinics, a disparity it attributed to varying surgical techniques. Some doctors did not have problems. Without the benefit of a registry, Zimmer had to painstakingly review 1,00 patient records. During that time, about the same number of new patients got a Durom cup. Some registry advocates suspect there may be another reason why a registry has not gained urgency here - the financial relationships between many orthopedists and device producers. Last year, several major manufacturers, including Zimmer and Smith & Nephew, agreed to pay $ million to settle civil charges and resolve a Department of Justice investigation into whether the firms paid illegal inducements to get some doctors to use their products. Dr. Dorr Website-Clinical Profile of Patients with a Loose Durom Cup Information for Patients and Doctors General Comments: These patients often come in and will say that they are not any better then they were before the operation. Most of them do have some improvement in pain relief at rest, but they cannot function doing the activities that they want to do and therefore they have not achieved their goals for their operation, MEDIATION BRIEF -

10 and are unhappy with their result for that reason. That is why they express that they are not better. Clinical Symptoms: The two recurring complaints are startup pain and stiffness which means they will hurt or limp badly for - steps when they first arise from a chair, or out of a car, or similar activities. This is usually similar to the preoperative situation. Patients with a good cup will have startup pain and stiffness for - steps for as long as three months. The difference in startup pain and stiffness is both in intensity and duration. Secondly, they limp. They do not have a smooth gait and they have a classic antalgic hip limp as they walk down the hall of the office. Sometimes they don t think they limp, but they do limp. A third symptom is that when they move from a bent position to an upright position they get a sharp pain in the groin that is transient, but it is so painful for them that they will avoid that activity because they do not want to experience it. The fourth symptom is difficultly in doing stairs, usually coming down stairs is difficult for them. The fifth symptom is that they can t walk with any endurance. They sometimes say that they can walk 0 yards, and that is all, before they have to stop. Lastly, many of them have to use a cane for their outdoor ambulation. Some patients have what they consider just healing symptoms in the first few months that seem to nag on and on. Then their symptoms begin to get worse and worse. As their symptoms get worse their x-ray usually shows more prominent radiolucent lines. These patients get reoperated between months and two years. Clearly their cups were held by the pressfit during the first few months and when that worked free there was no longer any fixation. Radiographic symptoms: The reason that we initially had trouble identifying the fact that these cups were loose in 0 was that the x-rays during the first six months can look normal. The position of the cup can be considered ideal and no radiolucent MEDIATION BRIEF -

11 lines can be present. The patients can be having the clinical symptoms listed above. When these cups are operated they are loose even without radiographic findings. For patients who have progressive symptoms there are almost always progressive radiolucent lines. One characteristic feature of the failure of these cups, that differs from the Sulzer Interop cup, is that there is no migration that we have seen to date. Of course the finding with no radiolucent lines is also a different radiographic finding. We think that the pressfit, which ironically keeps the cup from getting fixation, does also help prevent it from migrating which does save bone. Revision: At the time of revision the cup can be hit on the inferior medial edge with a bone tamp and sometimes with 1 or blows, and sometimes with or blows the cup will pop free. It can then be lifted out with a clamp. The acetabular bone is almost always in good condition with a very thin membrane behind the cup. The membrane is not thick as it was behind the Interop cup. The capsule also does not appear to be inflammatory. The revisions that we performed have all been done with trabecular metal cups and those have performed well in all of the patients to date. We would recommend that the trabecular metal cup be used for these revisions. We have not had to use screws with the trabecular cup because the bone is in such good condition that a good initial fixation can be achieved. ZIMMER-URGENT DEVICE CORRECTION - UPDATE August, 0 Dear In our July, 0 letter to you regarding the temporary suspension of marketing and distribution of the Durom Acetabular Component (Durom Cup in the United States, Zimmer announced it would take the necessary steps to address the MEDIATION BRIEF -

12 surgical training needs the Company identified through its extensive clinical investigation The updated surgical technique instructions are the subject of our Urgent Device Correction of July, 0. Please discard all previous versions of surgical technique instructions for the Durom Cup in the U.S., including Surgical Technique # and Tips and Pearls # and # (DVD. Zimmer Durom Cup BLOG Forum for Zimmer Durom Acetabular Component patients. Contemplating Hip Joint Replacement Durom, Durom The purpose of this BLOG is to facilitate information sharing between patients who have Zimmer Durom Acetabular Component (cup implants. Contemplating hip replacement surgery? So you have a Zimmer Durom cup implanted in you. Now what? Well for starters, you are in a relatively small group. Somewhere between,000 and,000 patients in the United States have been fitted with the Durom cup since 0. The Durom cup has been marketed in Europe since 0. Hopefully by now, everyone with a Durom cup implant knows that Zimmer voluntarily stopped distributing the U. S. version of the Durom cup in July 0 due to reports from surgeons that abnormally high failure rates were occurring. The cup is not cemented or screwed in place during implantation. The patient s bone is supposed to bond to the implant. In over % of implant patients, bonding fails to occur allowing the cup to grind against the acetabulum causing pain and loss of movement. In a few cases, the cup actually tilts into varus sufficiently to cause intense pain and incapacitation. MEDIATION BRIEF -

13 The U. S. Food & Drug Administration (FDA was notified as early as 0 of concerns with the Durom cup. The notification was in the form of AERs (adverse event reports submitted by orthopedic surgeons. The FDA took no action regarding the Durom cup and Zimmer continued actively marketing the cup. Dr. Larry Dorr, world-renowned orthopedic surgeon and Director of the Dorr Institute for Arthritis Research and Education, reported an abnormally high failure rate among his patients ( of ; % in a memo to the American Association of Hip and Knee Surgeons (AAHKS dated April, 0. Dr. Dorr also notified Zimmer and the FDA. The U. S. version differs from the model distributed in Europe. According to Zimmer: In compliance with FDA requirements for abrasion testing of plasma-sprayed coatings, the coating on the Durom Cup sold in the U.S. has a slightly different structure and is slightly thicker (0 µm, or 0.1 mm compared to that sold outside the U.S. In spite of Dr. Dorr s warning, Zimmer continued actively marketing and distributing the Durom cup until July 0. Zimmer has denied any liability related to the Durom cup failures citing successes in Europe and blaming the failures on U. S. surgeons for incorrectly installing the Durom cups due to inadequate training and surgical skills. Zimmer claims the surgeons in Europe had more training in implanting the Durom cup than their U. S. counterparts. What s wrong with this picture? If Durom cup implant surgery requires special training and skills beyond those normally found in U. S. orthopedic surgeons, why weren t the U. S. surgeons required MEDIATION BRIEF -

14 to successfully complete the necessary training and be certified by Zimmer before the cups were distributed to them? On August, 0, Zimmer sent a letter to surgeons in the United States announcing new product labeling and indicating they would make the Durom Cup available again to doctors who complete an on-line training program. The Internet training, which was made available starting August, 0, covers aspects of the Durom Cup design, pre-operative planning and detailed instructions on the surgical techniques needed to implant the device. The program includes videos, information from experts and questions to evaluate comprehension. Zimmer has also developed web casts which provide an opportunity for surgeons to ask live questions of experts, hands-on training courses involving the Durom Cup and surgeon-to-surgeon training. I somehow got the impression that surgeons developed their operating skills under the close supervision of experienced surgeons in an operating room. I m at a loss to understand how the alleged gap in knowledge and surgical skills surrounding the Durom cup implant failures can be adequately addressed by an Internet-based training program. If you were an orthopedic surgeon having to perform revision surgery on your Durom cup patients, would you be eager to recommend it to future patients? Better yet, if you re a hip joint replacement candidate would you allow a Durom cup to be implanted in you? Just a passing thought. Where is the protection of FDA regulation when you really need it? Come on, is the FDA really going to allow Zimmer to distribute the Durom cup again under these circumstances? By the way, how thoroughly did the FDA evaluate the Durom cup MEDIATION BRIEF -

15 before granting initial approval for distribution in the United States? We probably don t want to know the answer to that question. Suggestion: Send an to your U. S. Senators and Representatives and inform them of your Zimmer experience. Ask them to contact FDA and find out why the Durom cup was allowed to be distributed again. Also ask them to actively back legislation to create a NATIONAL JOINT REGISTERY so problems like those with the Durom cup can be detected as early as possible and distribution halted. On August, 0, a law suit (case # :0cv0 was filed in U. S. District Court for Western Pennsylvania alleging that Zimmer, among other companies, blocked Intermedics-McCullough, Inc. out of the market by offering a host of allegedly inferior, but more costly products. The suit also alleges that Zimmer provided kickbacks to orthopedic surgeons to use their products. On August, August 0, a class action suit (case # 1:0cv00, on behalf of stockholders, was filed against Zimmer in U. S. District Court for the Southern District of Indiana. The complaint alleges that Zimmer materially misrepresented the company and its products. Specifically, the Zimmer class action suit was filed because they failed to disclose material flaws in the quality systems at their Dover, Ohio facility, which makes Zimmer Orthopedic Surgical Products, and because they failed to disclose that a large number of hip replacement patients who received the Zimmer Durom Acetabular Component, which is used during total hip replacements, were experiencing cup loosening and requiring hip revision surgeries. Some symptoms of possible Durom cup failure Reported symptoms appear as early as months after surgery. 1. Recurrence of pain in the affected joint after the six-week recovery period. MEDIATION BRIEF -

16 . Pain in the pelvic area nearest the Durom cup implant after walking or exercising. Ex. After using a treadmill, you experience pain or an increase in pain level in the pelvic area nearest the Durom cup.. Slippage and clicking noises in the joint. The noise and slippage is analogous to that produced by a 0 s model rear-drive car with a worn U-joint. If you detect slippage, feel a binding sensation in the joint, or hear distinct clicking noises emanating from the joint, you should report this to your surgeon as soon as possible. In some situations, this symptom only appears under load bearing conditions. Ex. You pick up an object and while carrying it you experience the symptoms.. Reduced range of motion in the affected joint.. Difficulty in climbing stairs and ladders.. Decrease in capability to perform certain physical activities. Ex. You were able to play holes of golf after recovery but no longer can.. Pain or an increase in pain level in the affected hip joint and/or pelvic area when sitting on low chairs or toilet seats.. Fatigue and lower energy level. You can perform a simple test that may help you determine if you are experiencing problems with your Durom cup implant. Lie flat on you back on a bed and perform several consecutive slow leg raises using the leg with the implant. Try to raise your leg until it is vertical and then see if you can go further than 0. Repeat the leg raises using the other leg. Note the relative ranges of motion between your legs and whether or not the motion causes pain in the hip with the implant. Patients MEDIATION BRIEF -

17 experiencing failure with Durom cups progressively lose range of motion in the affected joint and have difficulty raising the leg vertically from a horizontal position. The first step in the clinical evaluation process consists of standard X-rays, questionnaire, and a consultation with your surgeon. With the exception of extreme cases involving discernible physical migration of the cup, standard X- rays will not indicate loosening of the cup. The second step in the diagnostic process is usually a step bone scan of the affected joint. The procedure requires a dye injection and a series of X-ray scans. You will go in for the injection and two sets of scans. Then you will report back three hours later for the final scan. A Radiologist will evaluate the scans, write a report, and forward the report and the X-ray images to your surgeon. The third step in the diagnostic process is a consultation with your surgeon regarding the radiology report. The consultation has three possible outcomes. Outcome #1 The radiology report states the bone scan showed no signs the cup has loosened. Outcome # The radiology report states the bone scan showed signs the cup has loosened. Abnormally dense radiolucent lines concentrated around the cup is an indication of loosening. Outcome # The radiology report states the bone scan results are inconclusive. Zimmer Sets aside funds for Durom Hip Implant Lawsuits October th, 0 Zimmer Holdings, Inc. disclosed last week that they have set aside $. million to pay claims related to their Durom hip replacement part which was temporarily MEDIATION BRIEF -

18 pulled from the market in July 0 after a number of patients experienced loosening of their hip implant and the need for hip replacement revisions. The Zimmer Durom Cup was approved in 0 for use in the United States, and over,000 people have had the device implanted by doctors who may not have been properly informed by Zimmer about the special surgical techniques required to reduce the risk of problems. As a result, a surprising number of hip patients have had their hip replacement fail. In July 0, Zimmer suspended sales of the Durom Acetabular Component, or Durom Cup, after confirming that some clinics using the hip implant were experiencing failure rates as high as.%. The Zimmer Durom cup was reintroduced in August after revisions were made to the product labeling and training programs were developed to instruct surgeons about the techniques necessary to reduce the risk of the hip implant loosening after surgery. Physicians are required to complete the new internet-based training program before the Zimmer Durom hip implant is made available to them. So far, Zimmer indicates that only half of the hip replacement surgeons who were using the Durom Cup have elected to go though the additional training. According to a statement released Thursday, the medical device manufacturer has adjusted their third quarter earnings statement to set aside $. million for potential Zimmer Durom cup lawsuits. Although hundreds of potential cases are being reviewed by products liability lawyers, at this time Zimmer is only setting aside money to cover revisions associated with surgeries that predate the company s voluntary suspension and which also occur within two years of the original surgery date. Zimmer has not disclosed how many MEDIATION BRIEF -

19 reports they have received of hip replacement failures among patients receiving their hip implant. Several Durom implant lawsuits have already been filed against Zimmer and the company s liability will likely exceed the money they are setting aside at this time. Zimmer Hip Replacement Patients Caught in the Middle November, 0 By Gordon Gibb Washington, DC: Pity the Zimmer hip replacement patients who 'benefited' from the new Zimmer Durom Cup during hip surgery. Many Durom Acetabular Components have failed, requiring expensive revision surgery and this past summer Zimmer suspended sales of the so-called Durom Cup. "The issue, it appears, is that implantation of the Durom Cup requires specialized training on the part of the surgeon, in an effort to mitigate the failure rate for the relatively new device. However, was that fact properly communicated to surgeons? A surgeon with years of experience with hip replacements might be forgiven for assuming that he or she was eminently qualified to carry out a hip replacement, regardless of the type of medical device used. However that appears not to be the case or at the very least, that's Zimmer's response to a failure rate of about. percent. So far,,000 patients have had Zimmer Durom Cups installed as their replacement hips since they were approved for use in the US in 0. That percentage translates to patients who will likely need, or have already suffered through a second surgery to append the first. Like health care in general, the medical devices industry is constantly evolving, and there are always improvements and new designs introduced that surgeons are MEDIATION BRIEF -

20 eager to try, and manufacturers are eager to introduce. There is also a bit of a loophole with the approvals process for new medical devices that improve on an existing protocol. When a new medical device is introduced to address an existing procedure, only a cursory approval is usually required by the US Food and Drug Administration (FDA, given that the device is not a new device addressing a new procedure. Thus, procedure improvements with new devices can usually be brought to market much more rapidly, allowing the manufacturer to realize a return on investment much more quickly. The rigorous, real world testing normally required to vet a new device, doesn't happen. The Zimmer Durom Acetabular Component is a newer type of artificial hip part, which is designed for use in combination with Zimmer s Metasul Metal-on-Metal Tribological Solution Large Diameter Heads (LDH. The hip replacement cup is a monoblock of cobal chromium alloy, which was introduced in Europe in 0 and approved in the United States in 0. Unlike traditional hip replacement parts, the Zimmer Durom Cup is made from a single piece of material and is designed to address some of the more common problems with hip replacement components, such as wear of the bearing, limited range of motion and instability. Little wonder that so many surgeons embraced the technology. However, it wasn't long before patients began having problems. Zimmer communicated to healthcare providers in May that there were reports of problems, and that it was investigating. Following a review of,0 cases, Zimmer made the decision to suspend sales of the Durom Cup pending an update to the product labeling, and the MEDIATION BRIEF -

21 implementation of a new surgical training program in the US to train surgeons on the proper way to install the devices. According to the manufacturer, the technology and design parameters of the Durom Cup require a higher degree of precision. Regardless of whether, or not this last fact was communicated with surgeons at the time the Durom Cup was introduced, the fact remains upwards of,000 patients have served as guinea pigs for the new device, with heartbreaking results. Angeline's husband had his hip replaced by a Durom Cup in February of this year. Within months the femoral head had dislocated from the shell, resulting in severe and debilitating pain and he'll be a candidate for revision surgery just a few short months after his initial procedure. Then there's Kevin, who reports that his wife received the Durom Cup in March of this year. It has since dislocated times; she has difficulty walking and is in constant pain. While it is not known if Zimmer has agreed to foot the bill for any and all required revision surgeries to address a failed Durom Cup, it was reported that Zimmer has set aside about $ million in reserve to settle any expected claims. It is also interesting to note that while sales of the Zimmer Durom Cup have been suspended pending label changes and the implementation of a surgical training protocol, the Durom Cup was never recalled, nor will it. It is Zimmer's position that in spite of the failures, there was no manufacturing, or design defect inherent with the components. That throws it back to the surgeons, who supposedly bear the responsibility for not installing the devices properly. All this is of little help to a Zimmer hip replacement patient who probably waited months for surgery, and either paid for, or took a major hit through their health MEDIATION BRIEF -

22 care insurer for hip surgery that has in effect come undone mere weeks and months later, due to the failure of the Zimmer Durom Cup. While the manufacturer, and those in the surgical camp sort this out, the patient is left twisting in the wind, painfully CONCLUSION The Zimmer Durom cup is defectively designed. Zimmer has acknowledged that they failed to provide the proper information to surgeons in the use of this unique hip replacement device. Causes of action of negligence, strict liability, express and implied warranties are alleged. World-renowned orthopedic surgeons Dr. Dorr and Dr. Long are prepared to testify regarding all issues of Zimmer s history of this device and the defect in design. As time has progressed, more and more patients have been discovered to have severe problems with the Durom cup and the revision rate has thereby increased. Not only have these patients experienced several years of devastating physical and mental injury, with the significantly increased risk of dislocation they will have the rest of their life subject to further damage from the defectively designed Zimmer Durom cup. Dated: Csengeri Law Offices By: Stephen Csengeri Stephen Csengeri, Attorney for Claimants, XXXXX MEDIATION BRIEF -

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