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Orthopaedics and the Law Abstract Understanding the relevant legal context is critical to the safe and successful practice of orthopaedic surgery. Specifically, three areas of liability are relevant to most physicians: medical malpractice, products liability, and the liability of health care organizations. Medical malpractice encompasses the professional physician- patient relationship with its implied contract, consent, fiduciary responsibilities, and duty to provide the standard of care, as well as certain common-law duties pertinent in special circumstances. Orthopaedic surgeons who design implants or who have a relationship with a device manufacturer are at risk for liability for a failed product. In general, the hospital entity is responsible for the actions of its physician-employees. Still unclear is the degree to which a physician is obligated to appeal to a third-party payor on behalf of a patient. Physicians should remember that, above all else, common sense with regard to the treatment, informed consent, and advocacy of patients is essential to avoiding many medical-legal pitfalls. U nderstanding the legal system as it relates to the practice of orthopaedic surgery has become essential. As one author recently noted: The interaction between physicians and the US legal system is one of the most fascinating and dynamic areas of law, encom- passing not only classic questions of professional liability but also the very heart of how the modern medical enterprise is or- ganized, financed, overseen, and held accountable for both busi- ness conduct and its broader so- cial obligations. 1 For this reason, it is not merely law- yers who need to understand health law. Before 1840, medical malpractice was virtually unheard of in the United States. 2 The evolution of the medical-legal interface has grown in- creasingly complex, overlapping in virtually all aspects of the law. For orthopaedic surgeons, an understanding of liability is especially relevant to how one practices, the arena in which one practices, and the tools one uses (Tables 1 and 2). A broad overview of professional liability as it specifically relates to orthopaedic surgery can serve as a foundation for understanding challenges in the practice of medicine. Such an overview also can provide an incentive for increasing one’s role in shaping and re- forming the professional environment. Specifically, three aspects of medical liability are important in this regard: professional liability (or medical malpractice), orthopaedic products liability, and the liability of health care organizations. Michael Suk, MD, JD, MPH, Ann Marie Udale, EdM, JD, and David L. Helfet, MD Dr. Suk is Assistant Professor, University of Florida College of Medicine, and Director, Orthopaedic Trauma Service, Shands Medical Center, Jacksonville, FL. Ms. Udale is Attorney, Nutter, McClennen & Fish, LLP, Boston, MA. Dr. Helfet is Professor, Weill College of Medicine at Cornell University, and Director, Orthopaedic Trauma Service, Hospital for Special Surgery, New York, NY. None of the following authors or the departments with which they are affiliated has received anything of value from or owns stock in a commercial company or institution related directly or indirectly to the subject of this article: Dr. Suk, Ms. Udale, and Dr. Helfet. Reprint requests: Dr. Suk, University of Florida – Shands Jacksonville, ACC Building, 2nd Floor/Ortho, 655 West Eighth Street, Jacksonville, FL 32209. J Am Acad Orthop Surg 2005;13:397- 406 Copyright 2005 by the American Academy of Orthopaedic Surgeons. Volume 13, Number 6, October 2005 397 Professional Medical Liability The Physician-Patient Relationship The legal concept of the physician-patient relationship com- bines elements of contract law with those of fiduciary law. Although the legal relationship is initially established by contract or agreement, the law also recognizes the imbalance in bargaining power between physician and patient. Therefore, the law de- mands that the physician uphold the patient’s trust by acting in the patient’s best interest. Medical malpractice is a breach of a duty to the patient, a duty created within a physician-patient relationship. This concept of the physician-patient relationship thus sets the framework for malpractice actions. Contract A physician enters into a professional relationship when a patient seeks treatment and the physician agrees to treat the patient. Although typically no written contract forms Table 1 Claims by 10 Most Prevalent Patient Conditions Patient Condition Total No. of Claims Percent Paid to Closed Claims Total Indemnity ($) Fracture of femur 879 31.83 29,531,365 Fracture of tibia or ﬁbula 760 29.61 31,533,639 Displacement of intervertebral disk 734 30.47 46,086,474 Osteoarthrosis, generalized or localized 699 31.26 24,338,270 Fracture of radius or ulna 636 29.81 12,618,199 Disorder of joint, not including arthritis 556 27.29 13,436,002 Fracture of medial malleolus, closed 466 35.42 19,184,075 Tear of medial cartilage or meniscus of knee 452 29.83 14,581,003 Back disorders, including lumbago and sciatica 426 23.75 18,458,511 Fracture of humerus 357 31.60 11,671,591 Total 5,965 30.23* 221,439,129 * = mean Reprinted with permission from Fountain S, Brooks D, Butler D, et al: Managing Orthopaedic Malpractice Risk: Committee on Professional Liability. Rosemont, IL: American Academy of Orthopaedic Surgeons, 2000, pp 3-78. Table 2 Comparative Claim Payment* Specialty Total No. of Closed Claims Percent Paid to Closed Claims Total Indemnity ($) Average Indemnity ($) Largest Payment ($) Obstetrics and gynecology 20,725 36.47 1,671,380,657 221,141 4,000,000 Internal medicine 19,274 27.40 846,741,532 160,307 2,900,000 General and family practice 17,034 37.12 801,544,914 126,767 2,500,000 General surgery 16,195 36.12 856,453,215 146,402 2,000,000 Orthopaedic surgery 14,979 30.19 603,418,371 133,441 2,000,000 * See also: www.aaos.org/wordhtml/bulletin/jun03/ﬂine5.htm, citing average indemnity paid to successful claimants as $196,500 in cases with error and $79,700 in cases without. These unpublished data take into account a study of Eastern seaboard states by the AAOS in 2002. Reprinted with permission from Fountain S, Brooks D, Butler D, et al: Managing Orthopaedic Malpractice Risk: Committee on Professional Liability. Rosemont, IL: American Academy of Orthopaedic Surgeons, 2000, pp 3-78. Orthopaedics and the Law 398 Journal of the American Academy of Orthopaedic Surgeons the relationship, the law views this agreement as an implied contract. As in most contracts, this original agreement to treat gives both parties some latitude to define and limit the relationship. For example, a physician may agree to perform only specific procedures. However, because of the special nature of the physician-patient relationship, there are limits to the kinds of contractual terms that courts will enforce. To elaborate, a court usually will find a contract that completely releases the physician from all malpractice liability to be unconscionable and thus unenforceable. Some courts have found physician-patient relationships to be formed through physicians’ contractual duties to hospitals or health plans, even when the physicians themselves have never met the patients in question. 3 Consent The physician-patient relationship is consensual in that both the physician and the patient are free to refuse to enter into the relationship. The relationship cannot be formed without the assent of both parties. It is important to note that, although the patient has agreed to entrust his or her care to the physician, informed consent still must be obtained for each specific diagnostic or treatment procedure. Fiduciary Responsibilities of the Physician A fiduciary is a person in a position of confidence or trust who un- dertakes a duty to act for the benefit of another in a given set of circumstances (eg, a director of a corpora- tion or the trustee of a trust). As mentioned, the law recognizes that the physician and the patient are not equals in their dealings because the physician has superior medical knowledge and skills. Because of this asymmetry, the patient is forced to trust the physician, who in turn has a special legal duty to honor that trust and to act in the best interests of the patient. It is this fiduciary as- pect of the relationship that gives rise to the limitations on contracts. Fiduciary law is especially important when a physician’s personal interests conflict with a patient’s best interests. For example, California law requires physicians whose re- search or economic interests might affect their professional medical judgment to disclose that fact to the patient. 4 Special Situations In certain situations, even in the absence of the traditional physician- patient relationship, special factors or certain common law duties, based on case law rather than on statute, may apply. In some states, attending physicians can be held liable when substandard care is rendered by residents under their supervision, even when no traditional physician- patient relationship exists between the attending physician and the patient. 5 In these states, courts have found that physicians owe a common law duty to patients because it is foreseeable that negligent supervision could cause harm to patients. To show that the supervision was negligent, a plaintiff must demon- strate that the surgeon’s supervision fell short of the standard of care for such supervision. 6 Physicians who merely consult with a patient’s treating physician via telephone will not usually be found to have entered into a physician-patient relationship with that patient. However, when a physician evaluates patient medical information provided by a nurse and makes a medical decision as to the patient’s status or treatment, a relationship may be found. 7 An Arizona court found that when a physician was paid to cover the emergency department on an on-call basis, and the hospital bylaws required that it treat all patients admitted to the emergency department, this contractual agreement established a physician- patient relationship and a resulting duty to an emergency department patient. 3 However, there are limits to this contractual responsibility. A New York court, for example, found this duty to treat is created by contract only in cases in which hospital rules require that on-call physicians treat patients or those in which physicians have undertaken to treat the patient in question. 8 On-call physicians also may have legal duties that are independent of the physician-patient relationship. For example, or thopaedic surgeons who are on call for certain hospital emergency departments may have a legal duty under the Emergency Medical Treatment and Active Labor Act of 1986 (EMTALA, colloquially known as the Patient Anti-Dumping Act) to screen and stabilize patients presenting with emergency medical conditions, whether or not a physician-patient relationship exists. This act provides for civil penalties against certain “responsible” physicians who negligently violate EMTALA. 9 In practice, there is little risk of penalty to an on-call physician who examines the patient and who, when preparing to transfer the patient, provides needed stabiliza- tion. The on-call physician also would accurately certify (according to EMTALA guidelines 10 ) that the benefits of transfer outweigh the risks. However, EMTALA obligations on hospitals also can affect orthopaedic surgeons in that such obligations sometimes lead hospitals to require physicians to provide on- call services, in some cases without compensation. The American Acad- emy of Orthopaedic Surgeons has published a position statement urg- ing hospitals and orthopaedic surgeons to negotiate guidelines for appropriate on-call coverage expec- tations and compensation. 11 Another special situation arises when the physician is an employee of an organization that has contract- ed with the patient to provide care. In the Texas case Hand v Tavera, 12 Lewis Hand, a Humana Health Care Michael Suk, MD, JD, MPH, et al Volume 13, Number 6, October 2005 399 Plan beneficiary, presented at a hospital emergency department report- ing a 3-day headache. Dr. Tavera was responsible for authorizing admis- sions of Humana patients to the hospital that evening. Without seeing the patient personally, and despite the recommendation of the treating emergency department physician, Dr. Tavera denied the patient admis- sion. Shortly after discharge, Hand suffered a debilitating stroke. The Texas Court of Appeals found that Dr. Tavera had a duty to treat that patient as he would any other patient, according to the contract between Humana and Dr. Tavera’s medical group. Because of this stip- ulation in the contract, the court found that a physician-patient relationship existed between Tavera and Hand. Although this decision has not been followed extensively outside Texas, it does suggest that a medical group that contracts with insurers to provide services should consider whether the terms of the contract might be found to create a physician-patient relationship with beneficiaries of the plan. Finally, in addition to the duties of physicians under EMTALA, there may be other duties to patients outside a traditional physician-patient relationship. The Supreme Court of New Jersey recently held that a physician performing preemployment physical examinations had a duty to tell a patient of a potentially serious health problem that was discovered, although their relationship was not a traditional physician-patient relationship. 13 Generally, courts have found that physicians examining patients on behalf of insurers or em- ployers have at least a duty not to in- jure the patients; however, courts have differed on the extent of the duty. 14 Termination Once a relationship has been created, there are several ways in which that relationship may be terminated. The simplest is when the physician’s services are no longer needed. 15 A physician-patient relationship will not be assumed to continue after the episode of illness has concluded. 16 The relationship also may be terminated by mutual agreement while treatment is ongoing. Finally, the physician may legally choose to terminate the relationship while treatment is still needed but only if done in a manner that does not constitute abandonment. Medical Malpractice A medical malpractice action is a type of tort action. A tort is a civil wrong for which a remedy may be obtained, usually in the form of damages. 17 Because tort law is large- ly a common law doctrine that varies by state, the specifics of each element of a tort claim likewise var y according to state law. The underly- ing doctrine, however, is fairly uni- form. To succeed in a malpractice suit, a plaintiff generally must show that the physician had a duty to him or her, that the physician breached this duty, and that the breach caused injury to the plaintiff. Duty Once a physician-patient relationship is established, the physician has a legal duty to provide care that meets the professional standard of care. Holding physicians to this standard of care requires that they exercise the same care that a reasonably prudent physician would have exercised under similar circumstances. The standard of care varies according to specialty: an orthopaedic surgeon will be held to the standard of care of a reasonably prudent orthopaedic surgeon, which will be different from that of a general practitioner. The courts disagree about the applicable standard of care for resident physicians. Some courts have held residents to a standard of care specific to resident physicians; others have held residents to the standard for practicing physicians. Even when residents are held to a “lower” standard of care, the cour t may find that the resident’s responsibilities includ- ed the duty to obtain the guidance of an attending physician when faced with a situation that the resident physician knew to be beyond his or her skills and training. Thus, negligence may be found despite being held to a resident’s standard of care. For resident physicians training in a specialty, a related question the courts have reviewed is whether to hold them to a general practitioner’s or to a specialist’s standard of care. The Pennsylvania Superior Court has ruled that an orthopaedic resident is to be held to an intermediate standard of care, higher than that of a general practitioner but not that of a fully trained orthopaedic specialist. 18 In general, interns or first-year resident physicians with less spe- cialized training have been more likely to be held to a generalists’ standard of care, whereas residents with further training are more likely to be held to the standard of their specialty. An attending physician who su- pervises residents may possibly be liable for negligent supervision if the plaintiff can show that the supervision fell short of the standard of care. 19 In some states, evidence also must be offered showing that the attending physician had control over the acts of the resident physician. 20 Although the standard of care is objective, it is not fixed. A jury de- termines the standard of care in each case, usually after hearing expert testimony. The patient (plaintiff) bears the burden of establishing the gov- erning standard of care. If relevant clinical practice guidelines exist, they may be used by either side as persuasive evidence of the standard of care; however, expert testimony typically will be offered in addition. Therefore, the clinical practice guidelines are not necessarily deter- minative. State statutes stipulate the qualifications a physician must pos- sess to qualify as an expert witness Orthopaedics and the Law 400 Journal of the American Academy of Orthopaedic Surgeons in a medical malpractice case. To testify with regard to the standard of care for a specialist, it is commonly required that a physician have some knowledge of the specialty. For example, a general practitioner would not ordinarily be allowed to testify as an expert on the standard of care for orthopaedic surgeons. If resident physicians have the required qualifications, they usually are allowed to testify as expert witnesses. 21 The standard of care is not intended to identify one specific best practice but rather to encompass a range of treatments considered to be accept- able practice in terms of sound medical judgment and the care used by the physician. Traditionally, the standard of care was deter mined relative to location. For example, to determine whether a general practitioner in ru- ral Kentucky fulfilled the standard of care, one would ask what a reasonable general practitioner in the same or a similar location would have done. However, because information about new medical knowledge and techniques has become more widely available, many states now hold physicians to a national standard of care, and most courts have abandoned this “locality rule.” (In Sheeley v Memorial Hosp., 22 for example, the Rhode Island Supreme Court discusses its explicit decision to join the growing number of states which are discarding the locality rule.) Specialists are especially likely to be held to a national standard, although this continues to dif- fer among states. 23 Holding to a national standard can be of strategic importance in a lawsuit because it gives both sides the opportunity to use experts from outside the locality in question. Breach of Duty Negligence is a necessary element of most torts. In a malpractice case, the physician’s conduct will be judged as negligent if it falls below the professional standard of care. In addition to bearing the burden of establishing the standard of care, the patient in malpractice cases also bears the burden of proving to the jury that the physician departed from the standard. An example of a common breach of duty is misdiagnosis. 24 In a recent case, a New York court awarded a plaintiff $2.5 million because an orthopaedic surgeon misdiagnosed and treated reflex sympathetic dystrophy (complex regional pain syndrome) as de Quervain’s disease and thereby caused complete loss of use of her dominant hand and arm as well as chronic pain. The plaintiff ’s expert in this case testified that the defendant surgeon breached the standard of care by failing to read the patient’s complete medical record and by “failing to conduct further tests following the surgical procedure of De- Quervain release and discovery of normal tendons.” 25 As illustrated by the Nebraska Court of Appeals’ opinion in Coran v Board of Regents of the Universi- ty of Nebraska, evidence of breach of the applicable standard of care is generally necessary for misdiagnosis to rise to the level of negligence. Here, the court affirmed dismissal of the patient’s action because, while alleging that the defendant surgeon had failed to diagnose thoracic spinal stenosis, the plaintiff did not offer evidence that the surgeon’s conduct breached the standard of care. 26 Res Ipsa Loquitor In some cases, an injury may occur during treatment that is unlike- ly to have occurred other than by negligence but for which no specific evidence of such negligence is available. An example is when a patient awakens from anesthesia with an injury that was not a known risk of the procedure. Recognizing the difficul- ties patients face in this situation, courts have sometimes applied the legal doctrine of res ipsa loquitor; which literally means “the thing speaks for itself.” In Ybarra v Span- gard, 27 the patient (plaintiff) under- went an appendectomy and awoke with paralysis of one arm. The court found negligence on the part of the medical staff in this case, even though the patient could not pro- duce a witness or describe the negligent act, because upper extremity paralysis does not normally occur during an appendectomy. Over time, however, the doctrine of res ipsa loquitor has become less popular because of concern by the courts that physicians might be held liable for rare bad outcomes even in the absence of negligence. 28 In states in which res ipsa loquitor continues to be used, the plaintiff must show that he or she was injured (1) in an occurrence that ordinarily does not happen in the absence of negligence, (2) by an agency or instrumentality within the defendant’s exclusive control, and (3) that he or she did not contribute to the injury. In some jurisdictions, the first element—the ex- traordinary nature of the occurrence—must be discernible by lay persons; that is, the use of experts is not required. Other jurisdictions allow or even require the use of experts to prove this element. When the patient can show all three of these elements, the burden shifts to the physician to show that the injury was not caused by his or her negligence. Causation Even if it is proved that a physician has violated the standard of care, the physician will not automat- ically be held liable. The plaintiff must establish that this breach of the standard of care caused an injury suffered by the plaintiff. Legal cause traditionally has been com- posed of two elements: cause in fact and proximate cause. To meet the cause-in-fact test, an act must have been necessary for the outcome, even if the act was not the only cause of the outcome. 29 Thus, if a patient with severe osteopenia sustains a wrist fracture during an unrelated surgery, the orthopaedic Michael Suk, MD, JD, MPH, et al Volume 13, Number 6, October 2005 401 surgeon can be liable for the fracture, even if it was partly the result of the preexisting condition. However, even when a physician’s action was the factual cause of a patient’s injury, liability may be limited by the doctrine of proximate cause. In cases in which the type of injury is not foreseeable, the doctrine of proximate cause recognizes that liability might contravene public policy. An example is when a patient has a rare and unforeseeable disease that causes a poor reaction to a given treatment. Although the treatment may have caused the reaction, courts may find the resulting injury too remote to have been foreseeable. Contributory Negligence One defense a physician can raise is that the patient’s own negligence contributed to the injury. For example, if a patient neglected to disclose important information regarding his or her medical history or neglected to follow discharge instructions, the jury may find contributory negligence. In some cases, patient negligence may alleviate the physician’s liability entirely; in other cases, such negligence may be deemed to be only a partial cause of the injuries and therefore may decrease the damages awarded only by a percentage relative to the patient’s contribu- tion. Damages A primary purpose of damages in a tort action is to make the plaintiff “whole.” When a plaintiff cannot ac- tually be made whole in cases of physical or emotional damage, the legal system compensates the patient with a monetary award. Com- pensatory damages reimburse the injured party for the injury sustained, and nothing more. Special damages, which are part of compensatory damages, are for the actual out-of- pocket losses incurred by the plaintiff, such as medical expenses and lost earnings. Noneconomic damages, also part of compensatory damages, are awarded for nonfinancial losses, such as pain and suffering. In addition to compensatory damages, courts sometimes award punitive damages when a physician’s actions have been egregious. Punitive damages are unusual in medical malpractice cases and often cannot be awarded unless some other type of damages is awarded for actual injury. Nominal damages are awarded when there is no harm other than to the patient’s dignity or integrity. The award of nominal damages may sometimes serve as the prerequisite to an award of punitive damages. Informed Consent Failure to procure informed consent is a claim often brought with a malpractice claim. To be truly informed, consent must be given by a patient who understands the information presented, is capable of making a decision, and makes that decision voluntarily. Informed consent should include discussion by the physician and patient of the following information: (1) the diagnosis or medical problem for which the physician is recommending treatment; (2) a description of the proposed treatment or procedure, including its purpose, duration, methods, and im- plements used, as well as the proba- bility of success; (3) all material risks of the procedure or treatment; (4) any reasonable alternatives to the proposed procedure; and (5) the risks of not being treated. 30 Optimal informed consent is a process usually obtained through a combination of written and oral communication. To ensure that the patient is in fact adequately informed, a surgeon is best advised to review the form with the patient, at- tempt to gauge the patient’s understanding of the information, and ad- dress questions and concerns. Some states have enacted statutes mandating specific disclosures for certain procedures, although this level of statutory specificity is still uncommon. In designing an informed consent procedure, physicians should first investigate state statutory requirements for disclo- sure. Where there are no specific dis- closure requirements, an adequate informed consent procedure should generally include the five types of information previously discussed. Patients who do not know what is being asked or who are unable to comprehend the nature of the treatment and the consequences of their treatment decision may be incom- petent to give consent. Although capacity is a legal standard, it is usually physicians who make the ini- tial determination. In many situations, determining capacity is fairly straightforward—for example, when the patient is unconscious or severe- ly mentally retarded. When a physician has doubts about a patient’s ability to comprehend what is being explained, an alternative is to ask another physician with appropriate expertise to consult. 20 If the situation is not an emergency, a final re- sort is to refer the question of capacity to a court. When a patient lacks capacity to consent, it can be obtained through a surrogate. If a legal guardian has been appointed, his or her decision is authoritative. When no legal guardian has been appointed, the common practice is to rely on the consent of a family member or next of kin. This practice has explicit legal support in some states; in others, it does not. One practitioner’s guide counsels that reliance on the consent of a family member generally carries negligible risks when (1) the decision is in favor of treatment that is med- ically indicated and is the treatment recommended by the patient’s physician; (2) the treatment does not in- volve the patient’s reproductive capacity; (3) no family member objects to the decision; and (4) the patient does not object. 20 However, i f one of these factors is missing, the legal risks of relying on family consent without some sort o f Orthopaedics and the Law 402 Journal of the American Academy of Orthopaedic Surgeons authorization increase considerably. State statutes establish an age at which a child is permitted to consent to medical treatment, usually age 18 years. Before that age, in most circumstances, parental consent must be obtained. Generally, for patients to prevail in court on a theory of lack of informed consent, they must prove that they would not have consented to the procedure had they been aware of the particular risk of the complication or complications in question. In deciding whether a risk was “material,” courts in most states have looked to a physician- centered standard and asked whether a reasonable physician would have disclosed this risk to the patient. However, the modern trend is for courts to adopt the general or patient-centered standard. States that use this patient-centered standard ask whether information regarding the risk would be important to a reasonable patient in making the decision to accept treatment. In some states, the court also may ask whether the risk would have been material to the particular plaintiff. 31 Because of this, a physician in one of these states should take the time to get a sense of the patient’s values and of those risks that may be especially important to the patient. Good informed consent and communication practices may help prevent malpractice claims. One study has shown that physicians who established rapport with patients and more effectively explained the injury and treatment plan experienced fewer malpractice claims. 24 Abandonment Abandonment refers to the physician’s breaching a legal duty by unilaterally terminating the physician-patient relationship without reasonable notice at a time when the patient still has need of medical attention. This concept is an old one, and judicial decisions often quote the court in the 1935 Utah case Ricks v Budge in describing physicians’ duties with regard to the physician-patient relationship: The obligation of continuing attention can be terminated only by the cessation of the necessity which gave rise to the relationship, or by the discharge of the physician by the patient, or by the withdrawal from the case by the physician after giving the patient reasonable notice so as to enable the patient to secure other medical attention. A physician has the right to withdraw from a case, but if the case is such as to still require further medical or surgical attention, he must, before withdrawing from the case, give the patient suffi- cient notice so the patient can procure other medical attention if he desires. 32 Abandonment is most easily found when a physician expressly tells a patient that he or she will no longer treat the patient. If the physician terminates the relationship in this manner without allowing the patient time to find a suitable re- placement, and if the patient is still in need of care, the physician likely will be found to have abandoned the patient. When there is an existing physician-patient relationship and a physician refuses to perform a procedure, the abandonment inquiry be- comes slightly more complicated. In this situation, there is a question of fact as to whether the physician intended to maintain the relationship, even though refusing to perform this procedure. In general, if there is no intent to abandon, there is no abandonment. One caveat to this is that when a physician’s employment with a management organization is terminated, the physician may still be under a duty to provide care to the organization’s patients until suitable substitute care is found. However, in many cases, the management organization will undertake to provide substitute care. Additionally, notice of termination is often provided far enough in advance to allow the patients ample time to find substitute care. A surgeon also can be liable for abandonment when he or she fails to ensure proper postsurgical care. Even in situations in which the physician and patient agree that the surgeon’s services are limited to perfor ming surgery, a court may view this to include ensuring imme- diate necessar y aftercare. The failure to provide for proper follow-up is a leading cause of malpractice actions against or thopaedic surgeons. 24 However, if the physician arranges for an attending physician or hospital staff member to provide aftercare and explains the follow-up recommendations clearly to the patient, the physician usually is seen as having fulfilled his or her duty not to abandon. A doctor who discharges a patient prematurely may be considered to have abandoned the patient. Similar- ly, abandonment may occur when a physician discharges a patient without giving suitable discharge instructions, and the patient is thereby injured. The abandonment doctrine does not mean that physicians have no legal right to terminate the physician- patient relationship. A physician can terminate the relationship if suffi- cient notice is given to allow the patient to find a substitute. The physician also can avoid abandonment liability by providing a competent substitute; however, usually it is required that the patient receive notice of this substitution. Finally, the patient has an obligation to cooperate and return. If the patient does not cooperate with the physician, the physician may first warn the patient of the intent to terminate care, and then do so. Furthermore, if the patient fails to comply with proper follow-up instructions, the physician may be justified in terminating the relationship. Michael Suk, MD, JD, MPH, et al Volume 13, Number 6, October 2005 403 Orthopaedic Products Liability Advances in orthopaedic surgery, perhaps more than any other surgical subspecialty, hinge on changes in technology. Progress in understanding mechanical disease has spurred innovation in all aspects of orthopaedic surgery, most notably in joint arthroplasty and spine and orthopaedic trauma surgery . Under special circumstances, orthopaedic surgeons may be subject to the risk of product liability litigation because, to facilitate biologic healing, they commonly use implants and nonbi- ologic materials created by manufacturing processes. 33 Definition Products liability refers to the liability of any or all parties along the chain of manufacture for damage caused by that product or inherent defects in the product. This liability may extend to the implant manufacturer, the distributor, and the individual orthopaedic surgeon. Legal Theory Manufacturers, distributors, and orthopaedic surgeons who harm patients through the use of allegedly defective products are sued under the theory of strict liability, not negligence. Unlike medical malpractice, the concept of strict liability elimi- nates the need to prove negligence for an injury caused by a defective product. Strict liability wrongs do not depend on the level of care exercised by the defendant. Translated into products liability terms, a defendant is liable simply when it is shown that the product is defective. Driven by the public policy interest in consumer protection, liability for manufacturing defects places the burden of proving safety on the manufacturer. Two types of defects are subject to products liability: manufacturing defects and design defects. Products with manufacturing defects are those that deviate from their intended original design and usually are easy to identify in that the product itself is flawed. Although flaws are often the result of some form of negligence during the assembly process, suits involving these types of defects are subject to the strict liability standard without regard to the manufacturer’s care in protecting its process from er ror. The test used is the consumer expectation test. Because the consumer expects a product to be free of defects, this test weighs whether a product is unreasonably dangerous beyond that danger con- templated by the ordinary consumer. 34 The leading orthopaedic example involved the recall in 2000 of the Inter-Op acetabular cup manufactured by Sulzer Orthopedics (Austin, TX). After reported failures of the cup, Sulzer noted that there had been an unacceptable level of miner- al oil–based lubricant left on the cup during the final cleaning process of the porous coating. This residue act- ed to prevent adequate bone in- growth to the acetabular cup, resulting in premature loosening and its ultimate failure. 35 A claim based on a design defect alleges that a product is inherently unsafe despite meeting all design and manufacturing specifications. An example of the design defect is the production of the Hylamer Dur- aloc acetabular liner manufactured by DuPuy (Warsaw, IN). Hylamer was introduced by DuPuy in 1990 as a modified implant-grade polyethylene developed to reduce wear in total joint arthroplasty components. Initially, all Hylamer components were sterilized by gamma radiation in air. As a result of surprising early failures in the Hylamer liners, an investigation revealed that the pres- ence of oxygen during gamma steril- ization and storage of sterilized components caused a progressive de- generative oxidation that was associ- ated with decreased wear resistance and increased brittleness. Patients with failed Hylamer liners ultimately required revision total hip arthroplasty. 36 Although this set of events presented a new standard for investigation in total joint arthroplasty and dramatically increased knowledge of polyethylene cross-linking, the ini- tial product was made according to manufacturer guidelines. Individual orthopaedic surgeons are at risk for liability for a failed product in several ways: as the de- signer of the implant or product, or as a consultant or clinical investiga- tor whose responsibility is to pro- mote the device under investigation. Where the link between independent practitioner and employee exists is the subject of much litigation. 33 Liability of Health Care Organizations Historically, physicians in the practice of medicine were often independent of the hospital environment in which they often practiced. Begun as charitable institutions, hospitals typically enjoyed immunity from lawsuits for the actions of the profes- sionals working within their walls. Today, however, the hospital no longer has this immunity as a result of the increasing application and acceptance of two legal doctrines: respondeat superior and corporate or enterprise liability. Respondeat Superior In medical malpractice actions, the physician is typically individual- ly liable for negligent acts that cause a patient harm. However, in special circumstances, that physician may be shielded from personal liability under the doctrine of respondeat superior (literally, “let the master an- swer”). Under this doctrine, the hospital entity is responsible for the actions of its employees or agents, and the physician is considered an employee of the health care organization. When the negligent act per- formed by the physician-employee is Orthopaedics and the Law 404 Journal of the American Academy of Orthopaedic Surgeons found to have occurred within the scope of his or her duties, the health care organization may be held joint- ly or ultimately responsible. A physician may be considered to be an employee of a hospital in two ways: as a direct employee under contract with defined duties, or indirectly, when circumstances are such that an “employment-like” relationship can be construed. Determining the connection between the physician and hospital can be difficult; it often rests on the level of suppor t the hospital provides to the individual physician (eg, billing services, ancillary services, uniforms). For example, if a hospital represents to the patient that a physician is a hospital employee although in fact the physician is an independent contractor, a court may still hold the hospital liable for the physician’s acts. Under this legal theory, known as ostensible or apparent agency, the patient is viewed as relying on the hospital through its physician agents to provide reasonable and safe health care. A plaintiff relying on the ostensible agency theory need only show that he or she looked to the hospital for treatment and that the assigned attending physician negligently injured the patient during treatment. Enterprise Liability Under the theory of corporate or enterprise liability, the hospital itself is viewed as having a nondelega- ble duty to its patients to ensure the proper selection, retention, and supervision of its medical staff. Negli- gent acts that might arise from a lapse in these duties can result in the direct liability of the health care institution. To hold a hospital liable based on the theory of corporate negligence, a plaintiff must show that the hospital knew or should have known that the physician was providing substandard care. In the watershed decision Dar- ling v Charleston Memorial Hospi- tal, the court held that a hospital owed a duty to the patient for the proper supervision of a physician covering the emergency department. In Darling, a physician in general practice close-reduced an injured patient’s tibia-fibula fracture and placed it into a circumferential cast. The patient subsequently developed a compartment syndrome and required a below-knee amputation. Apart from the physician’s individual negligence, the court determined that the hospital failed in its duty to require the physician to obtain the appropriate orthopaedic consultation for diagnosis and management. 37 The legal basis for its decision was the hospital’s direct responsibility to see that independent practitioners obtain the appropriate specialist consultation and act on the specialist’s recommendation. Third-Party Liability On occasion, physicians and patients are faced with an insurer’s decision to deny coverage for a recommended procedure. Many states have passed laws that guarantee the right to appeal these decisions in the form of a n independent review. Most recently, the United States Supreme Court in Rush Prudential HMO, Inc v Moran 38 upheld an Illinois law that guaranteed patients the right to an external review of denial of coverage. When confronted with this situation, physicians should encourage patients to pursue every avenue of appeal and to document the entire appeal process. There is some debate about the extent to which a physician is ethi- cally or legally obligated to be involved in the appeal process on behalf of the patient. A California Court of Appeals suggested in Wick- line v State that a physician who dis- charged a patient against his or her medical judgment because the insurer refused to authorize a longer inpa- tient stay could be held liable for negligence because he or she did not challenge the denial of authorization. 39 However, this precedent has been limited by a later California decision 40 and has not been followed by any other state. Further, the Fed- eral Court of Appeals for the Third Circuit expressly found that there was no duty to advocate for a patient under New Jersey law. 41 Many states have passed laws that protect physicians who do advocate for their patients from retalia- tion by the managed care organizations that employ the physicians. In addition, some state laws assume that physicians will present evidence on behalf of their patients before the review committee, but no state law directly mandates that physicians must appeal decisions on behalf of their patients. Given the current state of the law, a physician will fulfill his or her legal duty by giving accurate information to a re- viewer when called on to do so. However, the American Medical As- sociation Code of Ethics states that in certain circumstances, physicians have an ethical obligation to initiate appeals on behalf of their patients when a managed care organization denies care that, in the physician’s judgment, would “materially benefit” the patient. 42 According to the Code, in some instances, physicians should advocate against particular denials of coverage or against guidelines that operate unfairly. Summary Understanding the relevant legal context is critical for the safe and successful practice of orthopaedic surgery. Confronted with legal situations that challenge the orthopaedic environment, the prudent physician may use this information to develop a risk-management strat- egy. Particularly in regard to medical malpractice and products liability, practicing orthopaedic surgeons should be aware of the areas of po- tential liability inherent in the physician-patient relationship and in relationships with device manufacturers. In general, however, common Michael Suk, MD, JD, MPH, et al Volume 13, Number 6, October 2005 405 sense with regard to the treatment, informed consent, and advocacy of patients is paramount and essential to avoiding many medical-legal pitfalls. References 1. Rosenbaum S: The impact of United States law on medicine as a profes- sion. JAMA 2003;289:1546-1556. 2. Mohr J: American medical malpractice litigation in historical perspec- tive. JAMA 2000;283:1731-1737. 3. Hiser v Randolph, 617 P.2d 774, 776 (Ariz. 1980). 4. Moore v Regents of University of Cal- ifornia, 793 P.2d 479 (Cal. 1990). 5. Mozingo v Pitt County Memorial Hospital, 415 S.E.2d 341 (N.C. 1992). 6. Dine v Williams, 830 S.W.2d 453 at 465 (W.D.Mo. 1992),Perdieu v. Black- stone Family Practice Center, Inc, 568 S.E.2d 703 (Va. 2002). 7. Wheeler v Yettie Kersting Memorial Hospital, 886 S.W.2d 32 (Tex. Ct. App. 1993). 8. Cintron by Burton v. New York Med- ical College Flower Hospital, 597 N.Y.S.2d 705 (App. Div. 1993). 9. 42 U.S.C. § 1395dd (d)(1)(B) (2004). 10. 42 U.S.C. § 1395dd (c)(1) (2004). 11. American Academy of Orthopaedic Surgeons: Emergency Department On-Call Coverage, Position State- ment, (Sept. 2002), available at http://www.aaos.org/wordhtml/pap- ers/position1157.htm Accessed July 27, 2005. 12. Hand v Tavera, 864 S.W.2d 678 (Tex. Ct. App. 1993). 13. Reed v Bojarski, 764 A.2d 433 (N.J. Sup. Ct. 1999). 14. Ludington JP: Annotation, Physi- cian’s Duties and Liabilities to Person Examined Pursuant to Physician’s Contract with Such Person’s Prospec- tive or Actual Employer or Insurer, 10 A.L.R. 1966;3d:1071. 15. Jewson v Mayo Clinic, 691 F.2d 405 (8th Cir. 1982). 16. Engle v Clarke, 346 S.W.2d 13 (Ky. Ct. App. 1961). 17. Garner BA (ed): Black’s Law Dictio- nary, ed 7. St. Paul, MN: West Group, 1999, p 1496. 18. Jistarri v Nappi, 549 A.2d 210 (Pa. Su- per. 1988). 19. Dine v Williams, 830 S.W. 2d 453 at 465 (W.D.Mo. 1992),Perdieu v. Black- stone Family Practice Center, Inc, 264 Va. 408 (2002). 20. Becker S: Health Care Law: A Practi- cal Guide, ed 2. New York, NY: Mat- thew Bender & Co, 2003:16.06, 19.05. Available at: http://www.lexis.com. Accessed August 3, 2005. 21. Carper v Minichan, 44 Va. Cir. 484 (1998). Swanek v. Hutzel Hospital, 320 N.W.2d234 (Mich. Ct. App. 1982). 22. Sheeley v Memorial Hosp., 710 A.2d 161, 167 (R.I. 1998). 23. Jordan v Bogner, 844 P.2d 664, 666 (Colo. 1993). 24. Gould MT, Langworthy MJ, Santore R, Provencher MT: An analysis of orthopaedic liability in the acute care setting. Clin Orthop 2003;407:59-66. 25. Valentine v Lopez, 283 A.D.2d 739, 741 (N.Y. App. Div. 2001). 26. Coran v Board of Regents of the Univ. of Nebraska, 1993 Neb. App. LEXIS 283 (1993). 27. Ybarra v Spangard, 154 P.2d 687 (Cal. 1944). 28. Furrow BR, Greaney TL, Johnson SH, Jost TS, Schwartz RL: Liability and Quality Issues in Health Care,ed4. St. Paul, MN: West, 2001. 29. Courtade C, Levin J, Reiser L, Smyth T, Waldman M: 57A Am Jur 2d Negli- gence § 464 (2003). 30. Noah L: Informed consent and the elusive dichotomy between standard and experimental therapy. Am J Law Med 2002;28:361-408. 31. Canterbury v. Spence, 464 F.2d 772 (D.C. Cir. 1972). 32. Ricks v Budge, 64 P.2d 208, 211-212 (Utah 1937). 33. Dorr L, Sirianni L: The risk of products liability: Orthopaedic surgeons can betrapped. Clin Orthop 2003;407: 50-58. 34. MacNeill M, Sanbar S: Medical product liability, in Baxter S (ed): Legal Medicine, ed 4. St Louis, MO: Mosby, 1998, 158-166. 35. Letter from Larry Beeman: Director of Quality Assurance, Sulzer Orthope- dics, Inc, Sulzer Orthopaedics Hip Im- plant Recall News and Information. Saunders & Walker, P.A. Available at: http://www.sulzer-information.com/ article4.cfm. Accessed August 5, 2005. 36. Graeter JH, Nevis R: Early osteolysis with Hylamer acetabular liners. JAr- throplasty 1998;13:464-466. 37. Darling v Charleston Memorial Hos- pital, 211 N.E.2d 253 (Ill. 1965). 38. Rush Prudential HMO, Inc. v Moran, 536 U.S. 365 (2002). 39. Wickline v State of California, 239 Cal. Rptr. 810 (Cal. Ct. App. 1986). 40. Wilson v Blue Cross of Southern Cal- ifornia, 271 Cal. Rptr. 876 (Cal. Ct. App. 1990). 41. Pryzbowski v. U.S. Healthcare, Inc., 245 F.3d 266 (3d Cir. 2001). 42. American Medical Association, Council on Ethical and Judicial Af- fairs: Code of Medical Ethics. Chica- go, IL: American Medical Associa- tion, 2002, Op. 8.13(2)(d). Orthopaedics and the Law 406 Journal of the American Academy of Orthopaedic Surgeons

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