Table of Contents
Introduction
- The Problem
- Anatomy of the Knee
A. Bones
B. Articular Cartilage
C. Ligaments
D. Muscles
E. Tendons of the Knee
F. Knee Bursa
III. Knee Replacement Surgery
A. Non-Surgical Options
B. Surgery
- Total Knee Replacement
- Partial Knee Replacement
- Revision Surgery
- Legal Considerations
A. Lawsuits
B. Multidistrict Litigation
C. Ethical Issues in Multidistrict Litigation
D. Preemption
E. Causes of Action
- Bone Cement Infused with Antibiotics
F. Knee Replacement and Malpractice
G. Knee Replacement and Informed Consent
H. Revision Surgery
I. Worker’s Compensation
- Social Security Disability
Conclusion
Introduction
“Knee replacement is serious stuff. And, it actually could have made me worse.”
-Lee Majors
Billy Joel, Michael Douglas, Lionel Richie, and Jane Fonda may be celebrities with unique talents, but they are no different than the general population when it comes to needing joint replacement surgery.1 The purpose of this intervention is to replace the damaged parts of a joint with a metal, plastic, or ceramic prosthetic to restore the normal functioning of the area.2 This surgery is so commonplace that more than two million implant surgeries are performed annually in the United States,3 and this number continues to expand as the population ages.4
This surgery is a viable option for those with advanced joint disease who have failed conservative treatment but continue to suffer significant discomfort that prevents them from engaging in activities of daily living.5 No timeline exists to dictate when the procedure should be performed. That determination must be premised upon a discussion between the physician and patient that examines “psychological, social, and other issues in addition to pain, disability, and x-ray changes.”6The factors that must be balanced involve postponing the intervention thereby increasing the likelihood of a poor surgical outcome versus undergoing the operation too soon causing the prosthetic to wear out.7
Knee replacement surgery is the most common form of arthroplasty.8 However, hip, ankle, elbow, wrist, finger, and shoulders are also routinely replaced.9 In fact, “joint replacements are one of the most successful procedures in all of medicine.”10
This article cannot provide an in-depth medical and legal analysis of these various surgeries because of space limitations. Therefore, the commentary will focus on knee replacement surgery since it is the most common arthroplasty. This procedure has resulted in billions of dollars being paid in settlements because of complications, surgical errors, and defective devices.11 The analysis provided in this primer, however, is not limited to knee replacements. The discussion has application to all forms of joint arthroplasties.
I. The Problem
It is estimated that one in five people will develop arthritis in the knee with a number of these individuals seeking medical attention because of attendant pain and disability.12 Various treatment options exit to alleviate the problem, from conservative care to surgery.13 A total knee replacement (“TKA”) or knee arthroplasty is primarily performed to resurface a knee damaged by arthritis which degenerative condition isn’t a single ailment.14 This problem is associated with joint pain or joint disease, with more than 100 kinds of arthritis and associated disorders.15 Arthritis does not discriminate. It affects individuals of all ages, races, and sexes. In fact, it is the primary reason for disability in this country.16
Knee arthritis is particularly troublesome because it can interfere with most activities of daily living,17such as running, ambulating, or climbing stairs. It results in lost time from work and creates a serious disability for many individuals.18 The primary arthritic conditions of the knee include osteoarthritis, rheumatoid arthritis, and traumatic arthritis.19
Osteoarthritis is a degenerative joint disease that usually affects middle-aged and older adults. It can lead to a breakdown of joint cartilage and contiguous bone.20 This condition is responsible for 94–97% of TKA surgeries.21Risk factors “include bone density, bone morphology, meniscal derangement, sex hormones, and trauma, but the largest risk factors are age and obesity.”22
Rheumatoid arthritis is a persistent problem that attacks various joints in the body, among them being the knee.23 The disease is symmetrical in that it disturbs the same joint on both sides of the body.24 This form of arthritis is an autoimmune disorder that causes inflammation to the knee’s synovial membrane and results in an excessive build-up of fluid, leading to discomfort and stiffness.25
Traumatic arthritis stems from an injury to the knee that damages the joint’s cartilage.26 For instance, a fracture may harm the surfaces of the joint, resulting in post-traumatic arthritis. Tears of the meniscus and ligaments can also cause insecurity and extra friction on the knee, which with time, may cause arthritis.27Less frequent causes of a TKA include hemophilia, gout, unusual bone growth, and interruption of the blood supply to the knee, causing the bone to die.28
As “baby boomers” age, there has been a dramatic increase in the diagnosis and treatment of progressive arthritic changes as well as increased requests for better mobility and quality of life.29 It is no surprise, that the number of TKAs has increased, resulting in joint replacements becoming the most frequent elective surgical procedure.30 In some instances, patients will outlast their knee replacement and need a joint revision with significant costs and resource utilization.31 Since a knee replacement is generally expected to last fifteen years,32 a number of these individuals will believe someone was at fault if their implant fails prematurely and seek legal advice about a possible claim.
II. Anatomy of the Knee
Understanding the knee’s anatomy is necessary to appreciate how a knee replacement is performed. The knee is recognized as one of the most complex joints in the body.33It connects the bones of the upper and lower leg to allow people to engage in activities of daily living.34 It is a hinged joint whose anatomical construction makes it susceptible to injury. The knee is designed so it can move up and down while it can also rotate sideways.35 This four-way movement offers very little stability to provide maximum flexibility.36
A. Bones
The knee consists of multiple structures: bones, cartilage, muscles, tendons, and ligaments.37A total of four bones are involved in the joint’s construction: the femur, tibia, fibula, and patella. The femur is in the thigh and is the largest bone in the body.38 Its average adult length reaches eighteen inches long.39It plays a vital role in how people stand, move, and keep their balance.40While the upper part of this bone connects to the hip, its lower aspect forms the top of the knee joint and includes two rounded surfaces; the condyles.41These twin structures are encased in articular cartilage and serve as shock absorbers for the knee.42 The medial condyle is situated on the inside part of the knee, and the lateral condyle is positioned on the outside part of the joint.43
The second bone is the tibia or shinbone, the bigger of the two bones in the lower aspect of the limb. It forms the bottom part of the knee joint and can be found on the inside part of the lower leg.44 Functionally, this bone supports most of the body’s weight.45 The top portion of the tibia contains two flat surfaces; the tibial plateau which communicates with the corresponding bottom surfaces of the femur.46
The fibula is the smaller bone in the lower leg and sits adjacent to the tibia. It is found on the lateral side of the limb.47 Muscle attachments govern its shape. Its top aspect resembles a triangle, and the lower part is irregularly designed.48 This bone has no weight-bearing function, and its primary purpose is to join with the tibia to offer stability to the ankle.49
The last bone is the patella or kneecap.50This structure is considered a sesamoid bone and is several inches in diameter.51 During movement of the leg, it will slide up and down over the bottom aspect of the femur or femoral grove.52 The patella protects the knee and offers leverage to the thigh muscles or quadriceps.53
B. Articular Cartilage
Dense and smooth articular cartilage54 covers the ends of the bones. This slippery element assists in dissipating shock and helps the bones during movement by providing a smooth surface.55 Fluid created within the synovial joint lubricates this tissue, permitting the bones to slide over one another, such as when the knee bends.56
It helps disperse the load between the knee’s cartilage surfaces.57These C-shaped cushions separate the femur and tibia. They also keep the femur and tibia from rubbing against each other.58 The menisci are named according to their anatomic orientation.59 The cushion on the inside of the knee is the medial meniscus and attaches to the medial collateral ligament.60The lateral or outer meniscus is the larger of the two structures.61Because it is more mobile, the lateral meniscus is less often injured.62 Together, the menisci cover about 2/3 of the tibial surface and are thicker on the outside and thinner on the inside areas.63These structures fill the space between the bones of the knee and cushion the femur “so it doesn’t slide off or rub against the tibia.”64 The outer part of the meniscus is supplied with little blood so it can’t repair itself if damaged.65
C. Ligaments
The knee is held tighter by four bands of cord-like tissue, the cruciate and collateral ligaments.66 The cruciate ligaments crisscross in the center of the joint and are essential to the main movement of the knee; flexion and extension.67 The anterior cruciate ligament (ACL) is the most well-known of these ligaments and connects the anterior aspect of the tibia to the posterior portion of the femur.68 Its task is to stop the tibia from moving forward in front of the femur and provides the knee with rotational stability.69 The average length of the ACL is between 26 mm to 38 mm.70
The posterior cruciate ligament (PCL) is a short and thick structure that starts at the back of the tibia and attaches to the femur.71 Its job is to stop the abnormal backward movement or hyperflexion of the tibia.72The PCL is about the size of a person’s finger and is the strongest ligament in the joint.73This ligament is less frequently injured because of its strength.74
The two remaining ligaments are the collateral ligaments. Their job is to stabilize the knee when it moves sideways.75The ligament located on the outside of the knee is the lateral collateral ligament. It attaches to the fibula and femur to stabilize that portion of the joint. The opposite ligament is the medial collateral ligament, and this structure connects to the inside of the femur and tibia, thereby offering stability to the inner part of the knee.76
D. Muscles
The knee contains several muscles that allow for limb movement in various directions. The quadriceps, a group of four muscles in the front of the thigh, is the largest in the leg and permits knee extension. It plays a critical role in the ability to walk by allowing the leg to move forward.77 The individual muscles in this group are the rectus femoris, the vastus lateralis, the vastus intermedius, and the vastus medialis.78Collectively, these muscles make up the bulk of the thigh and produce one of the strongest muscle arrangements in the body.79 They also assist in stabilizing the knee by keeping the patella inside a groove in the femur.80
The quadriceps work opposite to another set of muscles in the leg, the hamstring, located in the back of the thigh. The hamstring runs from the hip to just below the knee.81 Its function is to permit the lower aspect of the leg to flex at the knee.82The hamstring consists of the biceps femoris, semitendinosus, and semimembranosus muscles.83 They assist a person with bending and extending the knee, and with hip rotation.84
E. Tendons of the Knee
A tendon forms at the end of a muscle and connects the structure to bone on the opposite side of a joint. The knee has multiple tendons, but the largest is the patellar tendon.85It originates at the quadriceps and stretches downward, attaching the patella to the front of the tibia.86 A contraction of this muscles will pull the patellar tendon causing the leg to straighten.87Other tendons include the quadriceps and hamstring tendons.88
F. Knee Bursa
Bursae are small sacs that are located around the knee joint and are filled with synovial fluid.89 Their task is to reduce friction created by the movement of muscles and tendons, thereby allowing the joint to move smoothly.90 The knee has roughly fourteen sacs; the prepatellar knee bursa is the most well-known.91 This bursa sits in front of the patella. The infrapatellar knee bursae are two additional sacs situated just below the kneecap.92
III. Knee Replacement Surgery
A. Non-Surgical Options
Surgical intervention is a “last resort” for most people.93A variety of non-surgical options exist to alleviate the discomfort of a failing knee. For younger adults or those who have a medical issue that could complicate surgery, the best option is to defer surgical intervention as long as possible.94Conservative care should include lifestyle modifications such as physical therapy, weight loss, non-steroidal anti-inflammatory drug use, steroid medication, braces or splints, joint supplements like glucosamine and chondroitin, and stretching before activity.95
B. Surgery
If non-surgical treatments fail and walking supports are no longer helpful, a person may be a candidate for knee replacement surgery.96 This intervention aims to alleviate discomfort, improve the quality of life, and preserve or increase knee performance.97 Anyone is a candidate for this surgery unless they are a child, whose bones are still growing.98 A recommendation for surgery is based on a person’s pain and disability and most patients who have knee replacements are between 50 to 80.99
Total knee arthroplasty had its origins in the early 1860s when a German surgeon surgically implanted a primitive hinged joint made of iron.100The first knee replacement was performed in 1968 and it has come a long way since then.101 The procedure gained widespread favor in the 1970s and 1980s.102The initial prosthetics were created by surgical innovators in partnership with industry.103 However, it is a misnomer to say the knee is being replaced.104 Simply put, the eroded ends of the surfaces of the tibia and femur are cut off and replaced with “metal and plastic parts (a prothesis) which have been modified to fit.”105 The surgeon will perform either a total or partial replacement based upon how much deterioration the knee has sustained.106 Currently, more than 19 firms in the United States sell total knee implants of three different kinds: cruciate-preserving, cruciate-substituting, and TC-III.107 Six businesses are designing mobile-bearing knees, and future innovations include robotically guided surgery, augmented kinematics, and wear-resistant bearing surfaces with improved fixation that promise an unfailing evolution for the device.108 Surgeons are even doing minimally-invasive quadriceps-sparing TKAs that permit the physician to implant the traditional knee replacement through a much smaller incision.109 This procedure circumvents injury to the quadriceps muscle which is the most important muscle group around the knee.110
1. Total Knee Replacement
A total knee replacement has become a standard procedure that requires both surfaces of the femur and tibia to be replaced.111 However, not everyone is a candidate, and a successful outcome depends on proper patient selection.112 The major determining factors for TKA are end-stage knee arthritis and dogged severe discomfort.113These individuals receive little help from arthroscopic surgery, and osteotomy around the knee is generally limited to those younger than 55 years.114 Most patients have “end-stage radiographic disease,” and the person’s symptoms should dictate the surgery.115 These determining factors include a history of continuing pain, at night or with weight bearing, and the complaints should not abate despite a 6-month course of conservative care.116 While age or being overweight no longer disqualify a person, patients must appreciate the advantages and risks of the procedure.117
This surgery requires several steps. Initially, the doctor will make a long incision in the front of the knee to expose the patella.118 The kneecap is then retracted to reveal the joint behind it.119 The surfaces of the cartilage at the ends of the femur and tibia are cut away “along with a small amount of underlying bone.”120 The ends of the bones are carefully measured, and cuts in the bones are made to accommodate the shape of the prosthetic that will reestablish the shape of the joint.121 A sample prosthetic is placed in the area to see if it fits. The knee is then moved back and forth to ascertain if it works correctly. Following the necessary adjustments, the ends of the bones are cleaned, and the shaved surfaces are fitted with the final prosthetic.122 A curved piece of metal in the shape of the femoral condyle is inserted at the top and the tibia plateau on the bottom is replaced with a flat piece of metal.123
Many different types of prosthetics can be implanted. While most physicians use a metal-on-plastic implant, they can also be constructed of ceramic on plastic, ceramic on ceramic, and metal on metal.124 More than 150 variations of these devices exist based on the recipient’s size and activity level.125 However, the critical factor in selection is whether the replacement will cover the entire joint or only a portion.126
Most implants are affixed to the patient’s bone with a quick-drying cement mixed in the operating room.127 A second method uses an implant that has a textured surface, known as a press-fit implant, designed to stimulate bone growth.128 This procedure allows the patient’s bone to incorporate into the implant to form a solid fusion.129
The back of the patella is then removed, and a plastic spacer may be inserted between the pieces of metal.130This spacer acts like a meniscus to provide a smooth gliding surface.131 Once the physician ascertains that the knee is mechanically sound and working properly, the wound is stitched, and the area is bandaged to provide a sterile environment.132 The procedure generally takes between one to three hours.133
2. Partial Knee Replacement
Unicompartmental osteoarthritis occurs when only a portion of the knee is affected by advanced degenerative changes.134 At the same time, the remaining aspect of the joint is healthy.135This condition permits a surgeon to perform a less extensive revision to remedy the problem; a partial knee replacement. This process involves either resurfacing the medial or lateral component of the joint with the insertion of a prosthetic limited to the affected area.136Traditionally, this intervention was restricted to less active older adults.137This thought process has changed, and a partial knee replacement is frequently performed in younger patients since their recovery is faster with less discomfort.138 It is estimated that 5% to 6% of people with arthritic knees qualify for this procedure.139
There are several advantages to this surgery.140 A partial knee replacement results in a better range of motion and knee function since it “preserves healthy tissue and bone in the knee.”141 The procedure only requires a 3-to-4-inch incision in the front of the knee, and there is no disruption of the quadriceps tendon.142 This results in less trauma and blood loss.143 Since the knee ligaments are maintained, the joint feels more normal, particularly with strenuous activities.144However, the benefits of this surgery must be offset against the high rate of revision surgery mandated to remove, or replace segments of the partial knee replacement.145
3. Revision Surgery
Knee replacement surgery is very successful, but it has a shelf-life. Most implants last 15 to 20 years.146Statistically, 3.9% of patients require revision surgery within ten years, and 10.3% need additional surgery by their twentieth anniversary.147 However, as the number of surgeries has increased, knee revisions multiple as well.148 It is estimated that 572,000 knee revisions will be performed annually by 2030.149 The longevity of a TKS is dependent on a variety of influences including the skill of the surgeon and technique employed, the frequency the procedure is performed at the medical facility, and patient factors such as age, weight, and activity level.150
A knee replacement may fail for various reasons. The prosthetic must be affixed to the bone for it to work correctly.151 This is usually achieved by cementing the implant onto the bone. While the device may be firmly secured during surgery, it may loosen over time.152 The reason for this failure may not always be appreciated, but “high impact activities, excessive body weight and wear of the polyethylene component may all act as contributing factors.”153 Over time, the joint surfaces will also deteriorate from the friction created by rubbing against each other. This activity allows small elements to collect around the joint.154 Known as aseptic loosening, these particles disrupt the bond between the implant and the bone.155
Infections are one of the most serious complications of a knee replacement and the primary cause of failures involving prosthetics.156 It extends the hospital stay by two to three weeks and doubles the need to be hospitalized with the frequent outcome requiring one or more surgeries.157 The infection rate can be as high as 3%. Various influence account for this development.158 Infections occur because harmful bacteria contaminate the surgical site or body.159Bacteria are routinely present in people but are neutralized by the immune system. Because the prosthetics used in a TKA are made of metal or plastic, they present a challenge for the immune system’s ability to attack these microorganisms.160Once the bacteria invade the implant, they can increase in number and trigger an infection.161
The symptoms and severity will depend on whether the infection is superficial or more pervasive.162 A superficial infection occurs at the surgical site. In contrast, a deep knee infection develops around the prosthetic.163 A superficial infection typically surfaces shortly after surgery. While it is easy to remedy, the infection can become much more sinister if not treated adequately.164 Treatment includes surgery to cleanse the area and at least a six-week course of antibiotics tailored to the specific pathogen.165 On the other hand, a deep infection is problematic. It can develop weeks, months, or even years after the operation. Most infections occur, however, within the first twenty-four months of surgery.166 Unfortunately, this type of complication can result in additional surgery to remove the infected prosthetic.167
Counsel investigating a knee infection claim should ascertain if the surgeon investigated the patient’s risk factors for developing a complication during the preoperative consultation, such a conversation should always be a focal point of the patient’s initial meeting since it influences the treatment decision.168 It is also standard practice for the physician to order preoperative tests to discover comorbidities or other ongoing treatments that may increase the chances of an infection.169 Eighty percent of surgical candidates have modifiable risk factors such as obesity, smoking, alcoholism, anemia, malnutrition, rheumatoid arthritis, and diabetes.170 These risks can be controlled, so it is important to take prophylactic measure to minimize them as much as feasible.171
Revision surgery is more complex and takes longer than the initial replacement. It involves several steps.172 The first measure requires the removal of the original prosthetic. The physician will attempt to follow the original incision line.173 However, the new opening may be more extensive than the original scar to accommodate the removal of the old device.174 Bone grafts may be employed to fill any holes that have occurred due to deteriorating bone.175 In that case, new bone must be harvested from the patient’s body, or a bone bank will be employed.176 Occasional, the bone may need to be secured with metal wedges, plates, or screws.177 The next step requires the insertion of specially crafted revision knee implants.178 Drains may be used for a few days to retard the swelling of the joint. Attempts to improve wound healing are made by applying negative pressure incisional dressings. This remedial measure has been shown to reduce complications in high-risk patients.179 Revision surgery does not enjoy the same success rate as the initial TKA and is subject to more significant complications. The replacement device also does not last as long as the original prosthetic.180
IV. Legal Considerations
A. Lawsuits
Research, planning, and care in the design of a knee prosthetic does not prevent a defect or recall.181 Implants are amazingly sophisticated, but issues still arise. A defect in the product or negligence on the part of the physician can have significant repercussions.182For instance, Sulzer Medica was required to pay $1 billion to resolve 4,000 hip and knee implant claims.183Other manufacturers like DePuy, Stryker, Zimmer, and Exactech are facing thousands of knee replacement lawsuits resulting from various alleged defects in their products.184 Many of these matters maintain the manufacturers did not adequately warn patients about the risks presented by their devices.185It is further asserted the prosthetic loosened, causing instability, and requiring revision surgery.186
A knee replacement is also subject to recall. This action occurs when an implant needs corrective action or is being withdrawn from use.187 A correction focuses on a problem with the unit where “it was sold or used.”188 A removal withdraws the implant from sale to examine an issue that has developed.189 This remedial action can be voluntarily initiated by the manufacturer or mandated by the government.190According to the Food and Drug Administration, almost 1,300 knee prosthetic products were recalled between 2003 and 2019.191These notices were primarily based on device design and process control. “Tibial components accounted for 35.33% of [the recalled devices], polyethylene implants for 38.67%, and femoral components for 15%.”192
Studies reveal that the cost of patient care and litigation can be driven by the efforts of the medical healthcare industry to sell products, devices, drugs, and pharmaceuticals.193Cases involving product liability law in the context of medical devices are illustrative of the difficulty of holding medical device manufacturers accountable for defective products.194
Also, the Federal Food & Drug Administration cannot be counted upon to protect the patient. As stated in the amicus curiae brief in Melissa Ebert v. C.R. Bard, Inc., “[s]trict reliance on the FDA to police manufacturers and safeguard the public is likely to jeopardize the consumer/patient given the limited resources of the FDA, its sometimes revolving-door environment, and the political pressures brought to bear by the medical device industry.”195
B. Multidistrict Litigation
About 20% of TKA patients are unhappy with their surgical outcomes.196 Certain demographic traits have been linked to this dissatisfaction. These include being a woman, a younger or older patient, having rheumatoid arthritis, pain that has worsened following the intervention, and a pessimistic personality.197 This dissatisfaction often leads to litigation, and the most frequent complaints are complications due to a prosthetic failure, such as a device loosening or a defect involving the product.198 patients harbor a belief that when something goes wrong with a knee unit, the surgeon committed malpractice.199 However, the problem may have arisen during the manufacturing process. These types of lawsuits are often premised on products liability theories that: (1) the manufacturer marketed the implant as safe when it was faulty; (2) implant was poorly designed; or (3) the manufacturer failed to adequately warn the user of the risks or potential harm of the implant.200 In many cases, the alleged defect caused the implant to fail early, resulting in additional surgery.201
The sheer number of these claims has caused many of the matters to be joined together into multidistrict litigation (“MDL”).202 This is a process whereby federal civil cases are consolidated into one court action. A single judge handles the litigation during the pretrial and discovery proceedings.203 The matters retain their individual identity. Those that do not settle will be sent back to the federal courts in the states where the plaintiffs live.204About 15 percent of all civil litigation is part of multidistrict litigation. This consolidation may consist of thousands of separate lawsuits and many attorneys from around the United States to be placed in one MDL action.205
For instance, on October 7, 2022, the court consolidated all Exactech lawsuits involving defective knee implants into the Eastern District of New York to “serve the convenience of the parties and witnesses and promote the just and efficient conduct of the litigation.”206 The court noted that “All actions can be expected to share factual questions concerning the design, manufacture, testing, marketing, packaging, and performance of the polyethylene components of their Exactech devices.”207
These lawsuits stemmed from a recall dealing with the vacuum seal packaging that caused the knee replacements to fail prematurely.208 Allegedly, the manufacturer failed to include a protective barrier that allowed oxygen to contaminate the polyethylene insert.209This omission caused the implant to degrade and lose its ability to function properly.210 In the summer of 2021, the manufacturer recalled all its knee replacement units made after 2004. This Exactech action affected almost 150,000 implants made in the United States.211 If the plaintiffs can successfully demonstrate these units are defective, the financial implications are enormous. One source estimates that each claim will yield a settlement or verdict of between $70,000 to $400,000.212
213Zimmer Biomet is another distributor that issued recall notices and ended up being sued. The company sent an announcement that the threads of its NexGen Complete Knee Solution Tibial Component may be “out of specification.” This recall affected more than 40,000 implants.214 It was not the first time this company had a problem with its devices. In 2010, it recalled multiple components of a knee replacement product that allegedly caused pain and immune system reactions.215 As consumers started filing claims, more than 1,000 lawsuits were consolidated into multi-district litigation in the District Court of Illinois.216 It was alleged that the defendant’s “high flex” femoral and tibial components used in knee replacement surgery are prone to premature loosening.217This defect was said to cause consumers to suffer pain, loss of knee movement, and revision surgery.218 The defendant steadfastly denied that it did anything wrong, “including both design defect and failure to warn claims.”219
The first case proceeding to trial resulted in a defense verdict. The factfinder concluded that the plaintiff failed to prove the device “was defectively designed and that the company failed to warn her about the potential dangers.”220The defendant again prevailed in the second matter that went to trial.221The court determined that that the plaintiff did not satisfy its burden of proof that the design of the prosthetic was the proximate cause of the loosening.222 This multi-district litigation eventually resolved in June 2018, when it was announced that a settlement of the litigation had been achieved, but the terms of that agreement were sealed.223
These two manufacturers are merely examples of companies that have issued recalls or have been sued by dissatisfied knee replacement patients. More than 18 businesses have issued notices involving 300 knee implant devices over the years.224 It is anticipated that the number of recalls will only increase as the industry continues to expand because of product demand. In addition, device manufacturers estimate that about one-third of its medical devices may fail or loosen intraoperatively or post-surgery.225Little wonder problems with knee prosthetics have spawned a cottage industry for litigation involving these products.
Firms brought into MDL can use a variety of strategies to reduce liability and depart the litigation as quickly as possible.226 The bureaucratic quagmire of this complex litigation allows the defense to repeat useful themes, thereby establishing uniformity and credibility.227 There are occasions when the seller will candidly acknowledge a problem with its product.228Other times, they will dig in for the long haul and vigorously defend the allegations to prevent bad publicity or the financial consequences.229
These are not easy cases, and questions arise about available insurance coverage and how that coverage may apply to the many claimed losses and their expenses.230 However, manufacturers have vast sums of money available to defend these matters.231 For example, Becton Dickinson and Company is a multinational medical technology company that manufactures and sells medical devices. Its annual revenues exceed $18.5 billion a year.232 This revenue stream demonstrates the resources a pharmaceutical and medical device manufacturer may have at its disposal to defend an alleged defect in knee replacement litigation.233Even well-organized counsel for the plaintiffs, with strong common bonds and excellent litigation teams, have difficulty keeping pace with the volume of “paper” that can be generated by the manufacturers of medical devices and pharmaceuticals.234 Afterall, these firms are among the wealthiest corporations in the world and are not intimidated by plaintiffs’ lawyers.235
C. Ethical Issues in Multidistrict Litigation
The rules of ethics concerning client representation, settlement of claims and conflicts of interest were crafted with a single party and incident in mind.236If counsel represents more than one person in the same matter, potential conflicts arise. In addition, disparity involving the gravity of the injuries suffered by the claimants may foster dilemmas when the matter settles.237 These ethical issues are only exacerbated in MDL.
Multidistrict litigation depends upon state law. That jurisprudence concerning warnings, product liability, recall, learned intermediary doctrine, and a host of other issues vary from state to state.238 Counsel’s understanding of the law in jurisdictions where there may be different rules can be a crucial factor in the success of the case.239
Choice of law requirements may mandate applying the state law where the plaintiff resides.240 Lawyers in one state who accept clients from a jurisdiction where they are not admitted, can run into difficulties.241 When lawyers accept thousands of cases, all of which may be legitimate, it is difficult to prosecute all of them. Rather, a key case will be tried. Still, others may be resolved on an algorithm or some other method of agreed values.242This process may be fair to most litigants in the MDL, but not to all of them. The result is that these matters may be remanded to the individual courts where the suits were initially filed.243
Many lawyers do not want to deal with the remanded case or the so-called “one off” case.244 That is a complexity of multidistrict litigation. An ethical and competent lawyer will have a method for screening the cases they accept, being able to address local law issues, and dealing with matters on an individual basis if they do not fit the mold of the settlement mechanism.245 However, multidistrict litigation is a hornet’s nest of ethical dilemmas because typically, a common fund will be created.246 The lawyers and costs are then paid out of that fund. This money represents a percentage of the gross settlement before the client is compensated. 247
D. Preemption
Patients filing claims over knee replacement devices will face various obstacles. One hurdle aggressively used by manufacturers is that the lawsuit is preempted by federal law.248 The Food, Drug, and Cosmetic Act gives the FDA the power to regulate medical devices and cosmetics and to create benchmarks for foods.249 This Act was revised in 1976 to include the Medical Device Amendments.250
Two ways exist for medical devices to gain approval by the FDA; they “may be approved through the Premarket Approval ([“]PMA[”]) method or be allowed by the 510(k) premarket notification process.”251 PMA demands scientific and regulatory proof that demonstrates the safety and usefulness of a device for its intended uses.252 This method can be expensive and lengthy since it requires proper scientific evidence for approval.253 On the other hand, the 510(k) premarket process is a quick and usually excludes medical devices from scientific trial mandates.254 New products under this more relaxed method must be found “substantially equivalent” to established devices that have previously entered the market.255
The Medical Device Amendments expand the need for premarket approval to Class III devices.256 This classification is “the most stringent regulatory category for medical devices.”257 Implantable pacemakers and breast implants are examples of items that fall within this category.258 A device with this designation may only enter the marketplace following an FDA assessment that finds the product has demonstrated a “reasonable assurance of safety and effectiveness.”259 Knee implants initially received a Class III designation which required premarket approval.260 However, in 1999, the FDA lowered the classification for many knee implant products to Class II, which category is reserved for safer products like blood pressure cuffs, syringes, contact lens, and surgical gloves.261 The agency approves most Class II products by using the Premarket Notification 510(k) process.262 This classification means that the device is safe and effective and equal to another medical item already on the market.263
The reclassification avoids the scrutiny of a Class III investigation which requires the applicant to show that the product is safe and effective through “the development of a data-driven benefit/risk profile.”264 This method requires clinical trials to produce sufficient data analyses.265 The designation of a product as a Class II device is important because lawsuits are no longer barred by the preemption doctrine in state court actions,266 “absent regulation other than identification regulation.”267 A preemption clause is contained in the Medical Device Amendments:
No state or political subdivision of a state may establish or continue in effect with respect to a device intended for human use and requirement (1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.268
This provision has been construed by the Supreme Court “to preempt most common-law duties.”269 The Court’s rationale is that state-law tort claims would obstruct the mandates implemented by the FDA for a Class III device requiring premarket approval.270 Preemption, however, is not a complete bar to all state law remedies that parallel federal legislation.271 As noted in Haudrich v. Howmedcia, Inc., Congress did not intend to preempt common law tort actions by enacting the Medical Device Amendments.”272
The success of this preemption defense is not guaranteed, and the doctrine has been applied inconsistently with different court interpretations.273 For instance, federal circuit courts are split concerning the scope and interpretation of this preemption. Some have allowed plaintiffs to pursue state law actions while others bar these claims.274 McNeil-Williams v. DePuy Orthopaedics, Inc. provides an example.275 This litigation involved a matter where the FDA obtained premarket approval for a knee implant.276 This action was followed by the defendant’s notice to the FDA of various changes to its implants.277 Several years later, the plaintiff received one of these knee implants which allegedly proved to be defective requiring revision surgery.278
The plaintiff instituted suit and alleged negligence in the design and labeling of the prosthetic. McNeal-Williams claimed that the defendant failed to warn the FDA of the risks of the device.279 DePuy Orthopaedics, Inc. moved for summary judgment arguing that the lawsuit was preempted by the government’s approval of the device under the Medical Device Amendments.280 It asserted that only the government could institute suit for noncompliance with the legislation.281 The lower court agreed, and this ruling was upheld on appeal. It was noted that North Carolina law does not require manufacturers to notify the FDA of adverse reactions and risks associated with the device.282 That duty of notification only extends to consumers and physicians.283
A claim for a defective knee implant was not preempted in Howard v. Sulzer Orthopedics, Inc.284 The plaintiff received a knee implant made by the defendant through a new manufacturing process that inadvertently permitted machine oil to remain on the device.285 This contamination caused the prosthetic not to bond with the bone, and the plaintiff had to have revisions surgery.286 Litigation ensued, and the claimant alleged negligence per se in the failure of Sulzer Orthopedics, Inc. to follow the FDA premarket- approved manufacturing process.287 The district court granted the defendant’s motion for summary judgment finding that it did not have to take any additional steps in the production process that had not already gained FDA premarket approval.288 Therefore, the claim was preempted by the Medical Device Amendments.289 The court found that the manufacturer only had to comply with a validated cleaning process. The law did not mandate a specific result, i.e., the removal of the oil.290
This determination was reversed on appeal.291 The FDA mandates require the actual removal of the contaminate and that risk should remain with the manufacturer and not the patient.292 The FDA may demand an implant be kept oil-free, but a state may also provide a damages remedy for violations of an identical state requirement.”293
Not all products used in knee replacement surgery are subject to the preemption defense, especially if they enjoy an FDA Class II classification. Bone cement is an example. This compound is subject to FDA control under the Medical Device Amendments to the Food, Drug, and Cosmetic Act.294 Its formal name is polymethyl methacrylate (PMMA). The cement enjoys widespread adoption in implant fixations.295 The product is an acrylic polymer that acts like grout to establish “a tight space which holds the implant against the bone.”296 It is not an adhesive. Still, it utilizes a close meshing between the bone’s surface and the implant.297 Its consistency allows substances to be added like antibiotics. This infusion system delivers the medicine directly to the surgical site to help reduce infections.298 The product was originally labeled as a Class III device which required pre-market approval by the FDA.299 This classification meant the preemption defense could be asserted to lawsuits by patients when the cement allegedly caused the harm.300
As a word of caution, the FDA is not the insurer of a product’s safety despite the classification’s mandates. This agency is responsible for the oversight of more than $2.8 trillion in food consumption, medical products, and tobacco. There are more than 6,700 different medical device product categories.301 Only 10 percent of the FDA’s total budget is spent on Devices and Radiological Health regulatory activities and only 34 percent of those costs are paid for by industry user fees.302 Therefore, the certification process can be overwhelming for the FDA. One might say that the review process consists of nothing more than a “notification” of the product rather than any meaningful review. Indeed, a significant number of medical devices bypass the FDA’s normal premarket approval process by submitting a § 510(k) notification.303
Studies also reveal that the cost of patient care and litigation can be driven by the efforts of the medical healthcare industry to sell products, devices, drugs, and pharmaceuticals.304 Cases involving product liability law in the context of medical devices are illustrative of the difficulty of holding medical device manufacturers accountable for defective products.305 Also, the Federal Food & Drug Administration cannot be counted upon to protect the patient. As stated in the amicus curiae brief in Melissa Ebert v. C.R. Bard, Inc., “Strict reliance on the FDA to police manufacturers and safeguard the public is likely to jeopardize the consumer/patient given the limited resources of the FDA, its sometimes revolving-door environment, and the political pressures brought to bear by the medical device industry.”306 Even the United States Supreme Court opined “product clearance accomplished through the 510(k) process as ‘a qualification for an exemption rather than a requirement.’ … in part because the ‘process impose[s] no requirements with respect to the design of the device.’”307
Statistics reveal that a more significant number of knee arthroplasty devices approved by the 510(k) process are recalled as contrasted to implants endorsed by the more rigorous PMA process.308 Perhaps altering the 510(k) procedure may facilitate manufacturers to improve the safety of their products.309
E. Causes of Action
Lawsuits involving knee replacements are not limited to product liability, breach of warranty, or malpractice claims. They may arise in various contexts, such as disability, worker’s compensation, and personal injury lawsuits. A Westlaw search reveals 7,028 reported cases and more than 10,000 administrative decisions involving knee replacement surgeries.310 Not surprisingly, a Google search of “knee replacement litigation” shows many advertisements and attorney websites dealing with the topic.
The following is a representative sampling of cases.
1. Bone Cement Infused with Antibiotics
The risk of infection makes it standard practice to use antibiotics during joint replacement surgery.311 The insertion of a foreign device in the body enlarges the danger of deep infections because of “bacterial colonization and biofilm formation on implant surfaces.”312 While infections occur in only 0.5% to 3% of cases, they can lead to death and must be viewed as a serious complication of joint replacement surgery.313 Perioperative antibiotic use shortly before surgery has been shown to lower microbial shelf life and growth from surgical areas and to lower the incidence of staphylococcus aureus.314 The American Academy of Orthopedic Surgery recommends antibiotics administration for all joint replacement surgeries “prior to any invasive procedure that may cause bacteremia.”315 In this regard, it is suggested that patients take antibiotics orally one hour before surgery.316
Some physicians use bone cement laden with antibiotics because it releases a high antibiotic concentration at the operative site.317 This practice has gained worldwide adoption for more than 30 years as a preventative application with orthopedic implants.318 However, FDA approval is limited to low-dose antibiotic use.319 Enlarging the viscosity of bone cement may cause a greater heat-releasing response, possibly causing thermal harm to bone and lower interference depth.320 This change may diminish the strength of the bond.321 Therefore, the use of antibiotic cement in primary knee replacements is controversial because of the development of antibiotic resistance over time as well as other complications.322 Some say that cement containing high levels of antibiotics may even increase the chance that the implant will loosen because the mechanical properties of the cement are altered.323
Thompson v. DePuy Orthopedics involves a knee replacement where bone cement was infused with Gentamicin.324 The court noted that bone cement is a liquid and powder compound that is mixed in the operating room.325 The cement is not considered an adhesive but acts as grout between the implant and bone.326 The cement is a class II device regulated by the Food and Drug Administration and must satisfy specific standards required by this government agency.327 In this matter, the defendant obtained approval from the FDA to alter the antibiotic-laced bone cement to change the polymethyl methacrylate content to 84.73%.328
The plaintiff underwent a partial knee replacement four years after this change, and the surgeon used the new mixture of bone cement with Gentamicin.329 The patient made an uneventful recovery. Two years later, however, she developed discomfort and swelling in her knee.330 A bone scan revealed the device had loosened because of cement failure at the cement/bone junction.331 Revision surgery was needed, and the surgeon found loosening of both the tibial and femoral components of the prosthetic.332
A suit was instituted against the defendant as the seller of the product.333 The surgeon testified that the “Gentamicin bone cement failed at a higher rate than expected and the risks of the product outweighed the benefit.”334An expert in bone cement noted the implant loosened because the antibiotic bone cement failed to correctly connect the implant to the bone.335 He went on to state that implants fail because of factors relating to the patient, surgery, or device.336 The expert then opined that the device loosened because “the viscosity of the DePuy bone cement changed after non-micronized Gentamicin was introduced,” and the viscosity of the new cement mixture “was too high requiring a deviation from the manufacturing specifications.”337 This variation allegedly created a design and manufacturing defect.338
The defendant filed a motion for summary judgment which the court denied in part. The manufacturer asserted that the claim was barred because of federal preemption that bars state and local claims pertaining to medical devices.339 The court disagreed and noted that the alteration in the cement was only a reclassification and the FDA never considered the safety or efficacy of micronized or non-micronized Gentamicin that are related to the design or manufacturing of the product.340 The court denied the motion since it found sufficient circumstantial evidence existed of a manufacturing defect to deny the motion.341 The plaintiff’s experts testified that a knee replacement is expected to last ten to twenty years. In this case, it failed after a few years. The surgeon also noted that since he switched to a different bone cement, he has had no incidents of loosening.342 The court did dismiss the counts dealing with an inadequate warning, fraud, negligent misrepresentation, and punitive damages.343
F. Knee Replacement and Malpractice
Medical malpractice is a recognized tort in the United States. While the volume of claims requiring payment in recent years has declined, the average disbursement has increased and varies by state.350 A cause of action requires the patient to prove that the healthcare provider negligently rendered care and that negligence was the proximate cause of the injury.351 One study discovered that the most frequent causes of a malpractice claim for primary TKA were chronic pain or dissatisfaction, followed by nerve palsy, postoperative in-hospital falls, deep vein thrombosis, and pulmonary embolism.352 The average settlement or verdict was $325,369, with $2.42 million representing the largest award. The average cost of defending a claim was $66,365.353
A medical malpractice case, typically against a physician, is a problematic case to advance.354 The knee is a highly complex structure and is subject to significant stresses and strains from movement, occupation, weight, and the aging process.355 Physicians often maintain that the knee is incapable of being restored to normal through surgery or replacement, given the forces that it must withstand.356 As noted by one orthopedic surgeon, “If I had my way, and if my hospital employer would permit, physicians would send every knee patient home, tell them to lose 25 pounds and come back in a year.”357 A number of these patients should not be subject to surgical intervention, but the demand to “fix me, doctor” is overwhelming.358
An example of a medical malpractice claim involving a knee replacement is Blendowski v. Wiese.359 A lawsuit was filed against a resident physician who severed the plaintiff’s peroneal and tibial nerves while drilling into the femur during knee replacement surgery.360 This claim was dismissed because a resident who assists a surgeon during an operation and does not employ independent judgment is not liable as long as the supervisor’s instructions “did not so greatly deviate from normal practice that the resident should be held liable for failing to intervene.” 361 The undisputed facts demonstrate that the surgeon dictated the procedure to be performed and the location and angle of the drill.362 Therefore, the defendant did not use independent medical judgment.363
In Heubish v. Baez, the plaintiff underwent a total knee replacement.364 It was claimed that the surgeon did not correctly size the knee implant, overstuffed the knee, and failed to exercise the proper postoperative care.365 These deviations caused the need for revision surgery.366 The jury found in favor of the defendant and that decision was appealed. 367
The higher court upheld his finding. The surgeon’s habit testimony demonstrated that he operated the same way from patient to patient. His practice for measuring and dissecting 10 millimeters of the plaintiff’s kneecap was consistent with his prior performance standards and was carried out deliberately and similarly on every patient.368 Therefore, this testimony was properly admitted and supported a finding that the surgeon was not negligent. 369
G. Knee Replacement and Informed Consent
A knee replacement is a relatively safe procedure, but complications can occur. Setting aside the general risks of surgery, these perils include wound infection, unexpected bleeding, soft tissue or nerve damage, blood clots, a bone fracture around the artificial joint, excessive scar formation, chronic knee pain, and an allergic reaction to the prosthetic.370 Statistically, most people are happy with their intervention, and the general satisfaction rate one-year post-surgery is 77.8%.371 While significant advances in surgical methods and prostheses have occurred, 20% of TKA recipients are displeased following their operation, and this rate has not changed over time.372 Continued pain, restricted function, poor patient selection, and surgical technique, malalignment of limbs, and postoperative difficulties are the most common reasons for this displeasure.373
These risks make it essential for the surgeon to discuss the procedure’s complications and likely outcomes with the patient. This process, known as informed consent, is an ethical and legal requirement imposed upon physicians. 374 The doctrine stems from a patient’s right to dictate what happens to their body.375 When patients are dissatisfied with their surgery or suffer an adverse consequence, lack of informed consent is one theory of liability advanced by the aggrieved party.
Smith v. Lincoln General Hospital is an example of an informed consent case.376 In this matter, the patient knee replacement failed because of an infection.377 This complication generated a lawsuit for the defendant’s failure to properly inform the patient of the risks of the surgery. The plaintiff had rheumatoid arthritis and was a heavy drinker and smoker.378 The patient was told that both knees had to be replaced, and he had a “5–10% chance of significant complications, including infection.”379 Smith had both knees replaced one week apart and was given antibiotics each time a few days before the operations.380 However, soon before the right knee replacement, the surgeon learned the middle of the patient’s knee contained a lesion which is common in those with rheumatoid arthritis.381 The doctor believed this was an old finding posing no additional risk, so he proceeded with the surgery by cutting around the lesion and inserting the implant.382
A few days later, the plaintiff developed a temperature, an elevated white blood cell count, and a rapid pulse. The physician believed these developments were normal postoperative findings and did not indicate an infection.383 Two weeks later, an indentation was discovered along the incision line.384 The defendant prescribed antibiotics to treat the problem, but no wound culture was taken. The next day, a visiting nurse discovered the area was very red and had a foul odor.385 Nine days elapsed, and no one came to the patient’s home to check the wound. When the knee was finally examined, two holes were present, along with a yellow discharge.386 A reexamination of the knee by a nurse occurred two weeks later, and the wound was described as “healed.” While the two holes were still present, the knee had no drainage, redness, or swelling.387
The plaintiff subsequently saw the surgeon for his first post-surgery visit, and the doctor discovered an ulcer on the patient’s knee with “necrotic debris.” While the physician was concerned about finding the ulcer, blood tests were normal, so the surgeon did not suspect an infection.388 One month later, the patient’s pain increased, and he returned to the doctor’s office. At this time, a deep-seated infection of the joint was diagnosed.389 Aggressive intravenous antibiotic treatments were started, but the implant could not be saved, and the knee had to be fused.390
Litigation ensued, and the judge charged the jury that malpractice occurs “when a physician fails to disclose relevant information to the patient, and this failure to disclose causes damage to the patient.”391 The jury found in favor of the doctor, and the patient claimed that there was an error because the physician did not tell him of the increased chance of infection because the patient had rheumatoid arthritis and drank and smoked heavily.392 He also claimed that a reasonable person would not have submitted to the operation had he been adequately advised of the increased risk.393
On appeal, the court upheld the finding for the defendant. It noted that when the situation allows, a patient should be informed of the character of the condition, the nature of the suggested treatment, the attendant risks, chances of success, and alternate methods of treatment.394 In this case, all of the experts agreed that those with rheumatoid arthritis who smoke and drink heavily are more likely to develop an infection than healthy patients.395 An infection, in this case, was a material risk of which the plaintiff should have been told. The plaintiff claimed that while the surgeon may have revealed some risks of infection, he was negligent for not disclosing that the risk was as high as 15–30%.396 The patient admitted that the surgeon noted that the risk was as high as 10%. Simply put, the jury found in favor of the defendant because it accepted the defendant’s explanation of the risk level.397
H. Revision Surgery
A Westlaw search of jury verdicts and settlements for knee revisions disclosed 75 cases in which an award was rendered over five million dollars.398 On the other hand, 1,607 cases were reported in which no money was given.
Cipriani v. Valley Hospital is an unusual case in which a surgeon treated the plaintiff for knee pain that resulted in a knee replacement.399 This intervention did not control the discomfort, and the patient was told that she might need knee revision surgery. However, following a course of physical therapy, her pain diminished until she fell and twisted her knee.400 Because her knee swelled, she returned to the surgeon, and a knee revision was performed.401 According to the patient, the doctor only told her that the revision surgery “was much more serious.”402 When the post-surgical pain failed to abate, x-rays, an MRI, and a bone scan were performed, which were normal.
Several months later, the plaintiff developed severe pain in her leg while at work that “felt like an explosion.”403 A medical workup discovered a stress fracture.404 This new development prevented her from working, and she had to use a scooter and wheelchair to ambulate.405 Following a second opinion that confirmed the diagnosis, the patient underwent another knee revision which left her with a limp and unable to work.406 This situation caused financial distress, and she had to remortgage her home.407
The plaintiff sued the surgeon, and her expert opined that the physician was negligent because of the incorrect placement of the prosthetic, and this misalignment caused the premature loosening of the implant.408 He further noted that revisions fail more frequently than in initial replacement surgery at the rate of 2% a year, even when the surgeon “does everything correctly.” With knee revisions, 20% of patients will have continued knee pain.409 At the conclusion of the evidence, the jury found in favor of the defendant, and the plaintiff appealed.410
On appeal, the patient attacked the judge’s ruling prohibiting the mentioning of a $2,500 check the doctor gave the plaintiff at her visit following the second revision surgery.411 The defendant admitted that he issued the check but said he gave it to the plaintiff because she was upset about her situation and inability to pay her debts.412 According to the surgeon, his actions were a show of compassion because the patient had been with him for so many years.413 The trial judge excluded this evidence because he thought its probative value substantially outweighed its undue prejudice.414 The plaintiff countered that the check was an admission of liability and to keep the doctor in good graces with the patient.415 The appellate court disagreed and noted that the ruling to admit or exclude the check was within the trial court’s sound discretion.416 Furthermore, the check was neither an offer to compromise pursuant to settlement negotiations nor an admission of liability.417 The court found that the check was merely intended to help the patient pay her mortgage while recovering from the stress fracture. 418
I. Worker’s Compensation
The premise of workers’ compensation is to compensate a person hurt at work or who becomes ill because of their employment.419 These benefits are paid regardless of fault.420 The purpose of this law is to safeguard employers and their workers from monetary loss, and benefits are awarded to defray medical expenses, lost wages, and funeral costs.421 The initial burden of proof is upon the claimant to show the medical problem is work-related. Nevertheless, many states have presumptions that shift the burden of proof to the employer to disprove the causal connection for certain types of diseases and claimants.422 However, these inferences are “rebuttable,” and the employer is permitted to “argue against the presumption.”423
A common defense related to knee replacement surgery is that the intervention was not caused by a work-related accident but is the result of preexisting arthritis or degeneration.424 This defense has been met with varying degrees of success, as demonstrated by the following cases.
Moore v. Sleepy Creek Farms involves a worker who sustained a compensable right knee injury when hit by boxes that struck his leg.425 Following unsuccessful arthroscopic surgery, he underwent a right knee replacement six months later.426 The claimant’s treating physician noted that while the worker had preexisting arthritis and chronic osteonecrosis conditions, the accident aggravated and accelerated these problems resulting in severe pain and the need for knee replacement.427 The employer denied the TKA was related to the industrial accident.428
The court found in favor of the plaintiff.429 It noted that where a claimant’s initial injury is deemed compensable, there is a presumption that any additional medical treatment is related to the accident. The employer must then rebut that presumption.430In this case, the court noted that just because a preexisting condition may have partially caused an employee’s TKA, it did not preclude recovery.431 The facts show that the worker had no problems with his knee before the accident, and the work-related injury accelerated the condition leading to the knee replacement.432
A contrary result was reached in Pearson v. Archer-Daniels-Midland Milling Company.433 Pearson was hurt at work and received an award for back and knee injuries.434 The facts show that the worker had injured his knee five years earlier and was diagnosed with significant pain in his right knee the year before the accident, with similar complaints after the accident.435 While there was a causal link between the knee complaints and the accident, he had reached maximum medical improvement.436 Therefore, the aggravation of his preexisting knee problem was not persuasively established as being permanent. Nevertheless, the Workers Compensation Court ordered the defendant to pay future medical expenses.437
Following this determination, Pearson had continued problems with his knee and underwent a total knee replacement.438 He then sought to modify the original award and asserted that the TKA caused a “material and substantial change in his physical condition.”439 Following an appeal of his denial of additional benefits, the court found worker’s compensation did not cover the knee replacement surgery.440 Relying upon the opinions of two physicians, the court determined that the claimant’s knee injury was only an exacerbation of a preexisting condition, and the TKA was not persuasively established as being related to the accident.441 In fact, the claimant had developed symptoms in the opposite knee that were identical to the symptoms in the right knee he injured in the incident.442
V. Social Security Disability
Social Security Disability Insurance (SSDI) is a federal program whereby workers obtain benefits in a time of need by paying Social Security taxes on their wages. Disabled parties and their dependents receive assistance if the insured individual is unable to work for a specified period.443 Disability is a word of art that refers to a person who is unable to engage in gainful employment because of a severe medical condition that “has lasted, or is expected to last, at least one year or results in death.”444 That medical condition must preclude the worker from engaging in tasks that they previously did, and it must bar them from accepting modified job responsibilities.445
Benefit eligibility is based upon a listing of impairments outlined in the Blue Book.446 This guide lists specific measurements and symptoms that must be present.447 Knee replacement surgery is examined in Section 1.00 – Musculoskeletal System and is listed as a “major weight-bearing joint.448 This section provides that a person may qualify for benefits if they present medical evidence that either:
You have a major joint dysfunction that includes anatomical deformity and chronic joint pain, stiffness, and limitation of motion that affects your knee and severely interferes with your ability to walk, [or] You have had reconstructive surgery or surgery on your knee because of your severe inability to walk, and you are not expected to return to normal movement for at least 12 months after surgery.449
Section 1.17 is another section of the Blue Book that comes into play. This clause is entitled “Reconstructive Surgery or Surgical Arthrodesis of a Major Weight-Bearing Joint.” It provides for a finding of disability if the applicant has had reconstructive surgery to the knee, the impairment has lasted or will last for more than 12 months, and there is a documented need for a walker, cane, crutches, or a wheeled and seated mobility device requiring the use of both hands.450
Over the years, knee replacement surgery has become a refined art with few complications and excellent results. As noted by the American Academy of Orthopedic Surgeons, 90% of knee replacement patients achieve significant pain relief.451 In fact, 82% of knee replacements are still in use 25 years after their implantation.452 These statistics are not lost upon those who adjudicate Social Security claims involving knee replacement surgery. A review of Social Security disability cases demonstrates that judges are not predisposed to award benefits merely because a person has had replacement surgery, even if it involves both knees. Instead, they want to see a person whose life’s activities have been severely curtained as the result of the surgery with a continued narrative of pain and inability to function. Multiple instances can be found where the factfinder has discounted the claimant’s testimony of continued knee complaints and limitations following surgical interventions. The following is a representative sample of cases.
In Fletcher-Silvas v. Saul, the claimant had bilateral knee replacements.453 Although she had not fully recovered, her application for disability benefits was denied.454 Her medical records demonstrated good progress, and her pain level was three or four out of ten, with an improved range of motion. She admitted that she engaged in regular physical activities even though they produced pain.455 The claimant demonstrated no complications from her surgery, and her discomfort fell short of being disabling.456 The appellate court upheld these findings because there was clear and convincing evidence to discredit her testimony about the severity of her symptoms.457 The plaintiff claimed that her left leg only had slight improvement, and her right leg was no better after surgery.458 However, this testimony conflicted with the self-reports to her physicians about continued improvement in range of motion, strength, mobility, and gait mechanics.459 She also failed to engage in self-help remedies such as losing weight and seeing a nutritionist.460
A similar result was demonstrated in Pyles v. Astrue.461 The claimant had a severe impairment following surgery to the cruciate ligaments, which was followed by a right knee replacement.462 However, the ALJ did not believe these issues satisfied the requirements of impairment for disability under the law.463 The claimant had the functional capacity to sit for six hours and stand or walk for two hours in an eight-hour workday.464 This finding was appealed but to no avail.465 The court defined a disability under the Social Security Act “as an inability to engage in any substantial gainful activity by reason of any medically demonstrated physical or medical impairment which can be expected to result in death or which has lasted or can last for a continuous period of not less than twelve months.”466 To be declared disabled, the applicant must demonstrate an impairment that is so severe that the person is not only unable to perform his previous job “but cannot, considering his age, education, and work experience, engage in any other kind of substantial gainful work which exists in the national economy.”467
The facts demonstrate that Pyles had his cruciate ligaments and medial meniscus surgically repaired. Several months later, most of his knee motion had been restored, but some instability was present.468 Two years later, a total knee replacement was performed, and within a few months, the surgeon’s records indicated that the patient had reasonable pain control and functioning.469 While some pain was present, the surgeon told him to work through it.470
At the time of the administrative hearing, Pyles was 47 and trained as a cement finisher. He testified that he was still recovering from his TKA, could not stand for more than 30 minutes, and could only ambulate for 40 to 50 feet.471The court was unimpressed with this narrative and upheld the denial of benefits. It cited the ALJ’s findings that pointed to the treating doctor’s notes, which indicated that Pyle could get on and off the examining table without a problem and that he should be able to return to work in six months.472 The patient’s range of motion was reported as “good,” and his pain was under control.473 While the claimant may have had some continuing knee issues, he was not disabled for twelve months.474
An administrative law judge’s denial of benefits was reversed in Wilson v. Commissioner of Social Security.475Wilson suffered a severe leg injury in a motorcycle accident. He had not engaged in any substantial gainful employment since that time.476 He needed crutches and braces to bear weight on his leg, and the doctor noted that the plaintiff had “suffered a complete destruction of his left knee.”477 Two years later, Wilson underwent a TKA, but his problems continued.478 The court on appeal was dismissive of the ALJ’s findings, which relied upon the reports of consultative examiners. The trial judge characterized one expert as saying that the claimant could return to “full” weight-bearing status.479 In reality, the expert noted that Wilson could “bear weight without the use of an ambulation aid.”480 In the following sentence, however, the expert was “not able to state when the plaintiff was expected to “return to full weight bearing.”481 Also, the x-ray report relied upon by the defendant did not state that the fracture was “healed and solid” as reported. Rather, the surgeon noted that during the operation, he visualized the knee joint, and observed “some fibrous union but no solid union of the fracture.”482 Based upon the totality of the evidence, the ALJ should have concluded that the objective medical evidence supported the claimed disability for a lower extremity injury.483
Conclusion
Knee replacement surgery is one of the most frequently performed arthroplasty.484 Its purpose is to resurface a damaged knee joint.485 This intervention is a last resort for most people. However, surgery should be suggested only after all conservative treatment has been exhausted.486 The goal of this intervention is to replace the eroded surfaces of the joint with replica parts.487 The patient may undergo a total or partial knee replacement depending upon the severity of the joint’s deterioration. While the implant is crafted to last fifteen to twenty years, any number of problems may arise, causing the device to fail prematurely.488 Revision surgery is more complex, and the replacement prosthetic has a shorter life than the original implant. 489
Knee implant manufacturers and surgeons can employ the utmost care in their craft. However, patient dissatisfaction still occurs with some frequency.490 Infections develop, prosthetics loosen or prematurely wear out, and the device may be subject to a recall. Regardless of the reason for the patient’s unhappiness, litigation is always a possibility, with causes of action sounding in negligence, product liability, and breach of warranty. Knee replacement claims also arise in disability, worker’s compensation, and personal injury contexts. Billions of dollars have been paid to settle claims, so counsel needs to understand the medical and legal implications of this type of litigation. It is hoped that this article provides counsel with that type of primer for handling or defending TKA claims.
*Samuel D. Hodge, Jr. is a professor at Temple University where he teaches law and anatomy. He is an award-winning author who has written more than 700 publications, six medical/legal texts and two law books. His most recent book is Anatomy and Physiology for Legal Professionals, PBI Press. He is also a mediator and neutral arbitrator for the Dispute Resolution Institute and a national public speaker on medical/legal matters.