Hip Transplant Detailed Study

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1 Hip Transplant Detailed Study INTRODUCTION This case involves four patients who underwent hip replacements with a "metal-on-metal" device designed and manufactured by "Replacement Manufacturer." The patients claim that the metal on metal replacements fail prematurely and that they have either had to undergo removal of the failed replacement parts and second hip replacements or are living in fear that their hips will prematurely fail. Replacement Manufacturer denies that its replacement hips are negligently designed or manufactured. It maintains that the fact that some hip replacements failed prematurely does not mean the replacement parts are defective. Replacement Manufacturer points out that it has paid the costs of any second replacement surgeries for parts that failed prematurely, and argues that the patients are not owed any additional compensation. In this case, you are going to be asked to determine Replacement Manufacturer s liability and the fair compensation for someone who has received a hip implant that did not perform as advertised. FACTS & ARGUMENTS FOR PATIENTS Overview This case involves a hip replacement system. Below is a picture of a hip in its natural state. A hip replacement system involves a ball section which takes the place of the Femoral Head and a cup section which is attached to the pelvis bone where the ball is intended to seat.

2 The ball is intended to fit into the cup to provide smooth operation of the joint within a normal range of motion. There are a variety of materials used for hip replacements. These include metal, ceramic, and plastic with various combinations. The case at hand deals with a metal on metal system meaning metal ball and metal cup. Metal on metal systems were originally introduced and used in the 1950s but fell out of favor due to the limitations of the technology. They were re-introduced in the 1990s. Durability is supposed to be the major advantage of a metal on metal system. Some metal on metal systems are expected to last years, which is significantly longer than systems made of other material combinations. Replacement Manufacturer a company which produces medical devices - introduced a metal on metal system in July of Unlike some medical device companies, Replacement Manufacturer sought and received a bypass of the normal clinical testing of the system prior to receiving approval of the FDA. It obtained that approval by representing to the FDA that its device was essentially the same as another device on the market that had already been approved by the FDA. There is nothing improper about that approval process, so long as the information provided to the FDA about the device is truthful and accurate. Between July of 1993 and July of 2008, over 93,000 patients received Replacement Manufacturer s metal on metal hip replacement system. Although Replacement Manufacturer represented it expected the system to last for years, it actually only guaranteed it for 7 years. Fairly early on, reports of high failure rates began to surface. Australia s monitoring organization noted failure rates of 5.4% after only three years. They also found that in populations of smaller patients (women for instance), the failure rate at three years was even higher at 8-9%. Despite failure rates in excess of what it anticipated and had represented were likely to occur, it was not until March of 2010 that Replacement Manufacturer first alerted doctors to its knowledge of the elevated failure rates. In July of 2010, Replacement Manufacturer then issued a limited recall of the system and one month later, Replacement Manufacturer issued a worldwide recall. Design/Manufacturing Issues When a metal on metal system with a faulty design is used, or one that is not manufactured properly, it will result in increased wear of the component parts. For instance, if the cup is too large or small for the ball, the system will not have adequate lubrication, resulting in greater wear and tear than intended. In either case, the unintended wear and tear causes metal bits to flake off and enter the body.

3 The patients contend these flaked off metal bits poison the region and inhibit the bone overgrowth of the patient s natural bone that is required for the successful operation of the hip joint. Because the bone over-growth does not happen, the patients contend the hardware comes loose and the system fails with painful results. The patients further contend that the size of the cup arcs used by Replacement Manufacturer are contributing to and exacerbating the problems created by the mismatched cup and ball issues discussed above. Metal Poisoning The patients contend that the flaking off of bits of metal result in metalosis a poisoning of tissue due to the metal. Metalosis can result in spontaneous dislocation, nerve palsy, noticeable mass or rash, groin or thigh pain, fatigue, or intense pain at the site of the replacement. Metalosis injuries can include metal staining, black tissue, pseudo tumors, progressive bone deterioroation, tissue and muscle necrosis (dying muscle), infections,and the development of brownish fluid around the hips. These are effects that can lurk in the body causing problems long after the hip surgery even if the system does not fail. Replacement Manufacturer disputes that the amount of metal that actually flakes off, if any, can cause metalosis. It does, however, admit that flaking off can cause a premature failure of its hip replacement system. Specific Patients Plaintiff 1 (no pain suffered) This patient is a 52-year-old woman who had one of Replacement Manufacturer s hips installed in She, like most patients who have had this system used, has experienced no pain after her recovery. However, she is concerned about the possibility that the system might fail in the future long before its expected service life. Added to her concern is the knowledge that another surgery would involve a higher risk of complications. Plaintiff 2 (pain suffered and system replaced at no charge) This 68-year-old man had his left hip replaced in early 2008 with Replacement Manufacturer s system. He chose a metal on metal system as it was supposed to be the most durable. A year later, he began to experience pain in that hip again. The pain was increasing as time went on. An X-ray ordered by his physician showed that the hip replacement system had failed to perform as intended and there were small pieces of the system rubbing in his hip and groin areas. During the second replacement surgery to replace the defective system, there was evidence that pieces of the metal parts had flaked off. He has since been compensated for that cost of the second replacement surgery. The replacement procedure was harder to do than the original because the part of the natural bone structure used in the first procedure could not be used again. This made the surgery longer. Further, since the prime area of the bone could not be used, the likelihood of complications after the second surgery is higher, but it is too early to tell whether any of those complications will materialize. Plaintiff 3 (pain suffered and system cannot be replaced) This 60-year-old man had his right hip replaced in 2007 with Replacement Manufacturer s system and has just recently started to experience increasing pain in that area. He contends the hip is failing. His doctor informed him of the recall issued this year. He also advised him that, due to loss of workable areas in his hip in the first surgery, he could not undergo another replacement surgery to correct the problem. Much more radical procedures would be required.

4 The man is naturally very concerned. He now faces spending the remainder of his life with an unexpected pain in his hip and the possibility of more severe injuries later, potentially including, the possibility of one day needing an artificial leg. He can no longer enjoy outdoor physical activities because of the pain. Plaintiff 4 (pain suffered - fearful to replace) This 70-year-old woman had her hip replaced in In 2009, she started to notice a clicking sound as she moved that hip and later in the year, she experienced increasing pain. Her doctor determined that the hip replacement system used was failing and would need to be removed. Since the patient is aware of the risks of a second procedure, she is fearful of going ahead with the replacement even though it will be done at no charge. Damages Sought Each of the patients seeks the following damages: For Plaintiff 1 who has not yet experienced any pain or failure of the system: Mental anguish damages for the greater likelihood of a system failure with the accompanying pain, suffering, and time of the additional surgical procedure. Allowances must also be made for the statistical likelihood of not being able to repair a failure or having a replacement that will have three to five times the chance of failing that an initial replacement would have. For Plaintiff 2 who had his hip replaced at no charge: Pain, suffering and mental anguish for losing the best chance for a successful replacement and now having an additional replacement with a much higher chance of failing. This includes the possibility of not being able to do yet another replacement or in having to undergo an additional painful treatment and recovery period involving months of time. For Plaintiff 3 who cannot have his hip replaced again: Pain, suffering and mental anguish for having a defective and failed hip in his body with virtually no ability to correct it without substantial risk of significant complications. For Plaintiff 4 who is experiencing trouble with her hip system: Award of the cost of replacement, treatment, and testing associated with replacing the current system with the system of her choice even if not Replacement Manufacturer s product as well as any pain, suffering, mental anguish associated with having a failed hip and the prospect of complications in the future. Replacement Manufacturer s Facts & Arguments Replacement Manufacturer disputes it did anything wrong, but instead contends that its design is adequate, that the manufacturing process is sound and that the number of failures, although slightly more than anticipated, is within the range of acceptable outcomes given the number of replacement hips manufactured and the known risks associated with hip replacement surgery. Specifically, it is a known risk that some replacement hips fail due to no fault of the manufacturer. Replacement Manufacturer further contends that the reason for the expedited FDA process was to provide a valuable solution to hip ailments to tens of thousands of patients without the considerable time delay of trial runs. As a result, over 80,000 patients have been relieved of painful hip joints using the most durable system in place today. Approaching the 7th anniversary of the first replacements, the facts demonstrate that the vast majority of the systems installed are working as promised and have met their guaranteed life span.

5 Replacement Manufacturer responded to reports from the field of higher than normal failure rates by modifying and implementing newly designed manufacturing processes to improve quality control in its factory. Replacement Manufacturer also feels it did the responsible thing in issuing a field notice to physicians and in withdrawing the product from the market prior to substantial proof that a design and/or manufacturing defect was at the root of the failures. Replacement Manufacturer further contends that in some cases, replacement hips fail prematurely because some doctors are less skilled than others at installing them. Replacement Manufacturer believes that by paying for medical visits and treatment, in addition to its guarantee of the system for seven years, it is going above and beyond the call of duty. Replacement Manufacturer points out that some patients want compensation for injuries that are feared but have not, in fact, become real. This includes those who have perfectly successful and pain free replacements. Replacement Manufacturer cannot and will not assume liability for such claims. As for the others, these patients could have received compensation for a replacement system without the expense of attorneys or lengthy legal proceedings. In other words, in exchange for accepting Replacement Manufacturer s offer of limited liability, patients affected by this replacement system agree not to pursue further damage awards. Jury Instruction Since the patients have brought the lawsuit, it is their burden to prove by a preponderance of the evidence, which basically means more likely than not, that Replacement Manufacturer was negligent in the design and or manufacturing of its hip replacement system. The patients must also prove that Replacement Manufacturer s negligence is the cause of their injuries and that claims for future damages are more likely than not to actually occur. QUESTIONS Who do you think should win the case? Plaintiff 1 (no pain or failure yet) Defendant (hip replacement system manufacturer) Please explain the reasons for your decision on Plaintiff 1: Who do you think should win the case? Plaintiff 2 (pain suffered & 2nd hip replacement at no charge) Defendant (hip replacement system manufacturer) Please explain the reasons for your decision on Plaintiff 2: Who do you think should win the case?

6 Plaintiff 3 (pain suffered & cannot have a 2nd replacement) Defendant (hip replacement system manufacturer) Please explain the reasons for your decision on Plaintiff 3: Who do you think should win the case? Plaintiff 4 (experiencing pain but fearful of 2nd replacement) Defendant (hip replacement system manufacturer) Please explain the reasons for your decision for Plaintiff 4: Do you think Replacement Manufacturer provided a product that was negligently designed? Yes No When thinking about the amount of damages to award, if any, please take into consideration the following: The average hip replacement surgery costs $50,000. The patient generally stays in the hospital for 4 to 5 days. The average recovery time is 60 days. If you find that Plaintiff 1 (no pain suffered yet) was injured as a result of the negligence of Replacement Manufacturer, what amount do you award in each of the following categories to fairly compensate her? *If you do not find Replacement Manufacturer responsible, please enter a 0 in each category. Mental anguish Medical testing for status of hip

7 Surgical replacement of the system Please TOTAL all of the amounts awarded above and enter the TOTAL AWARD below; if you do not find Replacement Manufacturer liable, please enter a zero: If you find that Plaintiff 2 (pain suffered & 2nd hip replacement at no charge) was injured as a result of the negligence of Replacement Manufacturer, what amount do you award in each of the following categories to fairly compensate him? *If you do not find Replacement Manufacturer responsible, please enter a 0 in each category. Pain, suffering and mental anguish Please TOTAL all of the amounts awarded above and enter the TOTAL AWARD below; if you do not find Replacement Manufacturer liable, please enter a zero: If you find that Plaintiff 3 (pain suffered & cannot have a 2nd replacement) was injured as a result of the negligence of Replacement Manufacturer, what amount do you award in each of the following categories to fairly compensate her? *If you do not find Replacement Manufacturer responsible, please enter a 0 in each category. Pain, suffering and mental anguish Future medical and life care needs equivalent to the loss of a leg Please TOTAL all of the amounts awarded above and enter the TOTAL AWARD below; if you do not find Replacement Manufacturer liable, please enter a zero: If you find that Plaintiff 4 (experiencing pain but fearful of 2nd replacement) was injured as a result of the negligence of Replacement Manufacturer, what amount do you award in each of the following categories to fairly compensate her? *If you do not find Replacement Manufacturer responsible, please enter a 0 in each category. Medical cost of replacement, treatment, and testing associated with replacing the current system Past pain, suffering and mental anguish Future pain, suffering and mental anguish Please TOTAL all of the amounts awarded above and enter the TOTAL AWARD below; if you do not find Replacement Manufacturer liable, please enter a zero:

8 What do you consider to be the strongest argument in favor of Plaintiffs (patients)? What do you consider to be the Plaintiffs' weakest argument? What do you consider to be Replacement Manufacturer s strongest argument? What do you consider to be Replacement Manufacturer s weakest argument? Do you think Replacement Manufacturer should be liable for the lost opportunity for a successful replacement? Yes No Do you think Replacement Manufacturer should be liable for the increased likelihood of a replacement failure once the defective system is replaced? Yes No Do you think the Plaintiffs are entitled to damages for possible metal poisoning? Yes No How persuasive is Replacement Manufacturer s argument that failures may be a result of improper surgical technique? Very persuasive Somewhat persuasive

9 Not persuasive How persuasive is Replacement Manufacturer s argument that failures may be a result of unrelated hip injury or trauma? Very persuasive Somewhat persuasive Not persuasive How persuasive is Replacement Manufacturer s argument that failures may be a result of the statistical likelihood that some replacement hips will fail prematurely with even the best of systems? Very persuasive Somewhat persuasive Not persuasive How persuasive is Replacement Manufacturer s argument that there should be no awards for damages that may happen in the future but have not yet happened? Very persuasive Somewhat persuasive Not persuasive What additional information, if any, would you have found helpful to reach a decision in this case? Is there any additional information that you would like to share about your background or experiences that have or may have affected your perspective on this case?

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