Prosthetic Litigation and the Effect of Increased Physical Activity among Amputees
As many young soldiers from Operation Enduring Freedom and Operation Iraqi Freedom have returned with one or more missing limbs, the amputee population has become a younger, more active community. This has lead to an increase in physical activity among the entire amputee population, military and civilian. The purpose of this paper is to explore the issues of liability and litigation within prosthetics focusing on the increased need for protection due to the trend of increasing physical activity among amputees. Through reading journals, magazines, and newspapers, and through the author’s personal observations, the research was gathered.
Due in part to young soldiers returning from war with limb loss, the amputee community has become more physically active; this has created the need to examine liability and litigation within the field of prosthetics as this new demographic begins to challenge the components of these devices.
This review explores issues regarding liability and litigation within the field of prosthetics. Amputees are becoming a more physically active group; this review examines some of the activities in which amputees are participating which may test the components of the prosthetic devices. As these amputee athletes are pushing the components to a higher level, it is important that liability and litigation concerns are addressed and understood within the prosthetic community.
Review of Literature
The risk of product liability lawsuits is great in today’s society; this risk is seen within the field of prosthetics (Ezenwa, 2006). Components making up prosthetic devices are subject to product liability, and it is important that those persons involved in the field of prosthetics understand liability and litigation in regards to product liability (Ezenwa, 2006). As the amputee population becomes more physically active and continues to challenge the integrity of prosthetic components, companies need to examine risk management plans to ensure proper coverage (Hoydicz, 2006).
Litigation in Prosthetics
Within the healthcare equipment sector, lawsuits are common (Ossur, 2006). The safety and effectiveness of products are the responsibility of healthcare equipment manufacturer (Ossur, 2006). As an example of risk mitigation in prosthetics, the following states the policy of Ossur, a leading manufacturer of prosthetic products (Ossur, 2006).
Ossur is insured against costs resulting from defective products, including damage payments rewarded in lawsuits. The insurance coverage for product liability has a cap of $20 million. There is no guarantee that liability claims will not exceed the insurance cap. If claims exceed the insurance cap, this will negatively affect the profitability of the Company. Currently Ossur is developing numerous products for future introduction to the marketplace. If any of these products turn out to have design defects after their introduction, it can delay sales and damage the reputation of Ossur. This could result in loss of revenue. (Ossur, 2006, p. 39)
This exemplifies the issue of litigation in prosthetics and shows that it is a concern faced by prosthetic manufacturing companies (Ossur, 2006).
Product Liability within Prosthetics
Prosthetics is unique among health professions because it is a co-primary product and service profession; “the incidence of product-liability malpractice legal actions is greater than in other disciplines such as physical therapy, nursing, or medicine” (Scott, 1996, ¶ 9). Most product liability lawsuits in prosthetics are triggered by defective prosthetic devices and components (Ezenwa, 2006). Typical plaintiffs in such lawsuits are patients who were injured due to the defective device (Ezenwa, 2006). “At times, device malfunctions happen and when [these] result in injury, product liability coverage may come into play” (Howdicz, 2006, ¶ 19).
Professionals operating a mail order service from the business, as many prosthetists do, must pay particular attention to product liability; “this coverage protects the owner in the event a device is damaged during shipment, if a device is recalled due to manufacturer error, or if the device is damaged as a result of tampering not precipitated by the practitioner” (Hoydicz, 2006, ¶ 20).
If a defendant is found liable for the plaintiff’s injuries, the court may choose to aware damages to the plaintiff. In product liability lawsuits, there are two kinds of damages that may be assessed against defendants: actual and punitive damages; and the defendant also may incur other defense or litigation-related costs. (Ezenwa pt. 2, 2006, ¶ 6)
Damages that are considered actual consist of the money awarded to a plaintiff that compensates him for real expenditures that were made, or losses he suffered, during the time he was injured (Ezenwa pt. 2, 2006). Punitive damages are awarded in a case where the court finds that the defendant either: “intentionally caused the product defect; or inadvertently caused the defect by being grossly negligent or reckless during the manufacturing, distribution, or retail process” (Ezenwa pt. 2, 2006, ¶ 8). Among the other defense costs the defendant might incur are: “direct and indirect costs of a product recall, lots profits, lost sales, loss of customers, reduced market share, loss of business reputation, and legal expenses” (Ezenwa pt. 2, 2006, ¶ 9). Product liability is an overlooked issue that can create problems for a company that manufactures prosthetic devices and components (Scott, 1996).
How liability is determined
Within health-care malpractice liability, the legal bases are: “professional negligence, breach of contract [or warranty], strict product liability from providing dangerously defective products and strict liability incident for abnormally dangerous activities” (Scott, 1996, ¶ 6).
Negligence within prosthetics is determined the same way it is in any other case of negligence; there must be duty, breach of duty, proximate cause, and damages (Ezenwa, 2006). Manufacturers “may be found negligent for failing to warn consumers of the hazards of a product, or of the existence of a potentially dangerous condition in the product” (Ezenwa, 2006, ¶ 9). Product safety laws and medical device regulations and guidelines are issued by the United States Food and Drug Administration’s Center for Devices and Radiological Health and may be entered as evidence in a case of negligence (Ezenwa, 2006).
The breach of contract or warranty is established when a product does not conform to a warranty and this nonconforming feature causes injury to the plaintiff (Ezenwa, 2006). A warranty is “a promise or statement of fact about the quality of a product sold, made by the seller to induce the sale, and relied upon by the buyer” (Ezenwa, 2006, ¶ 10). A warranty may be either expressed or implied; express warranties are written or oral terms made by the salesperson in the sales agreement that assure performance, quality, and description of the product; implied warranties are created in that the product is sold and should be fit for the purpose the seller has reason to know the consumer requires (Ezenwa, 2006). “Express warranties can be created by a salesperson’s statements, pictures or writing on a product’s packaging, advertisements, or product samples or models” (Ezenwa, 2006, ¶ 11). Implied warranties are triggered by the mere fact the product is being sold, which means that it is arising by operation of law; the buyer relies upon the judgment or skill of the seller in selecting a product that will be suitable for use (Ezenwa, 2006).
Strict product liability occurs when the plaintiff can prove that:
A product was defective and unreasonably dangerous when it left the manufacturer’s control; and the defect caused the plaintiff’s injury. A product may be unreasonably dangerous because of a defect in manufacturing, design, or marketing. A defendant’s failure to warn of a product’s potential dangers when warnings are required is a type of marketing defect. Liability will attach if lack of adequate warnings or instructions render an otherwise adequate product unreasonably dangerous. (Ezenwa, 2006, ¶ 5)
With such a case, the defendant may only be held liable if the injured person was a foreseeable plaintiff, meaning she is someone whom an ordinary person could be expected to realize may be injured by the product; patients are the most obvious foreseeable plaintiff in cases of defective prosthetic devices or components (Ezenwa, 2006). It is not necessary that defendants utilize state-of-the-art technology in order to comply with standards of care, just that the product is a reasonable product for the specific patient (Scott, 1996).
The two main defenses against liability lawsuits against manufacturers of prosthetic devices are contributory negligence and assumption of risk (Scott, 1996). Under the defense of contributory negligence, the defendant;
Can argue that the plaintiff should be barred from recovering any damages, because the plaintiff’s own negligent or careless conduct while using the defective product contributed in causing his injury. However, in many states, the defense of contributory negligence has been replaces with ‘comparative negligence,’ which means that the plaintiff’s own negligence cannot totally bar him from recovering damages, but the damages he does receive will be reduced in proportion to his own negligence. (Ezenwa pt. 2, 2006, ¶ 4)
Under this defense, the court may determine that the manufacturer was responsible for a certain percentage of the liability, and the plaintiff is responsible for the remaining percentage (Ezenwa, 2006).
The assumption of risk defense argues that the plaintiff should be barred from recovering damages because the plaintiff understood that “the product was dangerous; appreciated the nature or extent of the danger; and voluntarily exposed himself to the danger” (Ezenwa, 2006, ¶ 5). The author notes that this defense is similar to the assumption of risk defense seen in many other situations of sport and recreation.
Risk Management in Prosthetics
The risk of litigation within prosthetics is high; it is important that manufacturers take a proactive approach to risk management (Hoydicz, 2006). Of concern to these manufacturers are outcomes measure and quality assurance standards (Moser and Polliack, 1997). “Outcomes measure can provide an objective gauge of service delivery; to date, [these measures] can serve as the most effective manner in which to conduct quality measurement and analysis of all aspects of [prosthetic] patient management” (Moser and Polliack, 1997, p. 127). When performed in a routine manner, these outcome measures can assist in minimizing the risk of litigation (Moser and Polliack, 1997). It is recommended that companies “practice effective communication, friendliness and empathy for patients’ problems….and review incident reports to improve overall patient safety and assess other risk factors” (Hoydicz, 2006, ¶ 17).
Quality assurance standards should be developed by a company as a part of the risk management plan (Hoydicz, 2006). The set of standards developed should cover many areas, including; product design, product performance, product safety, product marketing, express warranties, monitoring of customer complaints, monitoring of compliance with product safety, labeling, and other applicable laws, and documentation and record keeping (Ezenwa pt. 2, 2006). Product design must be in compliance with specifications set by both the industry and the government, and product performance must be inclusive of post-production testing (Ezenwa pt. 2, 2006). Product safety should include “post-production inspections; tracking procedures, such as serial or lot numbers, to help identify and locate products after distribution and sale; and recall procedures to recover defective products already in the hands of distributors, retailers, or consumers” (Ezenwa pt. 2, 2006, ¶ 11). The marketing aspect included in quality assurance includes product literature reviews, such as advertisements and labels; these should state proper use of the product and any potential dangers should be expressed (Ezenwa, pt. 2, 2006). Express warranties should be included in the quality assurance to ensure that there is a verification of truthfulness regarding the warranty (Ezenwa pt. 2, 2006). When monitoring the customer complaints for quality assurance, it is important to include which product is involved, what the defect is, and the outcome or resolution of the complaint (Ezenwa pt. 2, 2006). As is true with all health-care professions, proper documentation and record keeping is important for quality assurance standards (Ezenwa, 2006). These standards are an important part of risk management in prosthetics.
Examples of Amputees Pushing the Limit in Athletics
Amputees are pushing the limits of prosthetic products and components to a higher level of athletic capability than has been seen in the past (Fairley, 2006). The influx of young, fit, otherwise healthy soldiers returning from war with limb loss has played a part in this increased demand placed on prosthetics (Baker, 2007). Following, there are examples of amputees pushing the limit of prosthetics through participations in athletics.
O&P Extremity games
The extremity games are hosted by College Park Industries, a leader in production of prosthetics (Fairley, 2006). Skateboarding, wakeboarding, rock climbing, and BMX biking are all included in these games; cash prizes are awarded to the top three winners of each event (Fairley, 2006). These games showcase amputees who seek thrills and have little regard for living in a safe comfortable world (Fairley, 2006). During the 2006 O&P Extremity Games, soldiers participated in the “Wounded Warrior Project Kayak Exhibition,” which is a race showcasing the abilities of amputee soldiers from the conflicts of Iraq and Afghanistan” (Fairley, 2006, ¶ 4). The author has witnessed the Wounded Warrior Project firsthand through time spent at Walter Reed Army Medical Center in Washington, D.C. from March to May of 2009. This program creates opportunities for soldiers to participate in athletic endeavors, and assists these young men and women in striving to achieve personal goals. Wounded Warriors are encouraged to remain active in the community, and in athletic events.
Military advanced training center
Walter Reed Army Medical Center spent ten million dollars building a new facility geared toward rehabilitation and training of soldiers returning from war after losing a limb; this facility is known as the Military Advanced Training Center, or MATC (Burton, 2008).
The center includes computer simulation training for use of advanced prosthetic devices, weapons simulators and equipment to train for military-specific tasks, an automobile engine repair work area to work on fine motor skills, climbing ropes, a climbing and rappelling wall, a running track, cardiovascular equipment, bicycles, treadmills, elliptical trainers, a multi-axis virtual reality platform for training balance and coordination, uneven terrain features for advanced ambulation training, and an ultra-modern gait lab. (Burton, 2008, ¶ 5)
This equipment is used by soldiers to assist in rehabilitation post-injury, and offers an in-house opportunity to explore athletic opportunities after losing a limb (Burton, 2008). The author spent time in the MATC from March to May of 2009 and has seen soldiers utilizing this equipment to the fullest extent. New prosthetic feet have been developed which allow the amputee to climb with more natural stability. The author has witnessed one soldier in particular who spends at least an hour each morning working on the climbing wall; he practices going up and down, as well as side to side, in hopes that he will soon be able to leave the hospital and climb a real rock wall. As a unilateral above-the-knee amputee, he is pushing the limits of his prosthetic knee and foot.
The author has witnessed amputee soldiers running both on the treadmill and around the hospital. These soldiers include unilateral and bilateral below-the-knee amputees, as well as unilateral and bilateral above-the-knee amputees. Many amputee soldiers are equipped with Cheetah Feet, produced by Ossur, which are designed for running at high speeds. Amputee soldiers are pressing the limits of these prosthetic devices, and have the mentality that nothing is impossible. The author asked one soldier if his stump got sore when he ran long distances and if this caused him to slow down; his response was that he had already lost a leg, and that no pain was greater than that. Even when in physical pain, these warriors will continue to push; the prosthetic products and components endure the same pressure and are expected to withstand the intensity of these athletic endeavors.
On May 24, 2009, the author accompanied a team of Wounded Warriors to the Ski to Sea relay competition in Bellingham, Washington. The seven legs of the race were: cross-country skiing, snowboarding, running, road cycling, canoeing, mountain bicycling, and sea kayaking. Of the eight team members, four were amputees; the upper extremity amputee who completed the running portion did not wear a prosthetic device during the race, so he will not be discussed further. The road cycling portion of the race was completed by a left below-the knee-amputee, meaning his amputation level is below the knee and on his left side. He rode for over two hours using a specialized prosthesis created specifically for bicycling. The mountain biker was a right above-the-elbow amputee, meaning his amputation level is above the elbow on the ride side. His prosthetic arm clips into a specialized locking system attached to the handle of his bike; he does have the ability to release this lock through a quick-release system that is attached to the handle of his left, sound side, arm. The sea kayaker was a right below-the-knee amputee; once in the kayak safety of the prosthetic device is of little concern, but he had to run to meet the mountain biker for the timing chip, and then run to his kayak where he had to carry it down a steep ramp to the water. As soldiers with a natural competitive spirit, these amputees pushed themselves and the prosthetic devices necessary to complete the competition; finishing 255th out of 414 teams, these warriors were not out for a light stroll through the woods of Bellingham. This one example of the ways prosthetic devices are being pushed to new heights through increased athletic activity of the amputee population.
Unchanging View of Liability in Prosthetics
With increased activity and stressors being placed on prosthetic products, the issue of liability should be gaining attention and concern within the prosthetic community; however, the author found this was not the case when she polled the prosthetists at Walter Reed Army Medical Center. Responses varied from “no, I am not worried about liability in prosthetics,” to “I guess that could something that we should start considering,” to “yes, it is definitely going to be an issue, but nobody is really looking into it.” Of the seven prosthetists working at this advanced army medical center, which is the hub of amputee care for the military forces, not one could tell the author, with any clarity, about liability issues in prosthetics. This shows that despite the increased stress being placed on the prosthetic products due to increased athletic activity, little time has been put into dealing with the legal issues should something go wrong with a product.
Summary and Conclusion
Product liability can lead to detrimental outcomes when something goes wrong and little has been done to protect the manufacturing company. These companies do not have a proactive approach to product liability or risk management. Amputees are pushing the limits of these prosthetic products and components to higher levels with increased physical activity. The demands placed on these products increase as amputees become increasingly active. Despite this, there has been little change in attitude towards protecting prosthetic companies from liability and litigation.
Liability and litigation within the prosthetic community is an issue that demands more attention. As amputees continue to increase physical activity, stressors placed on products and components are directly affected. Though there have been few cases dealing with the issue at present, it is potentially a major concern for companies; these companies should develop more specific risk management plans and more well-defined liability policies.
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