Orthopaedic surgeons delivered online musculoskeletal services during the COVID-19 crisis with encouraging results [8]. And as we reach the tail-end of the pandemic, telemedicine is likely to become a permanent part of many, if not all, orthopaedic practices [4]. But the virtual practice of medicine creates new risks that mainly arise from the challenge of diagnosing and treating patients that a provider cannot directly observe or touch [7]. Not surprisingly, an analysis by CRICO, a medical liability insurer, showed that from 2014 to 2018, of 106 telemedicine-related claims, 66% were related to diagnostic errors [5]. Considering the rise in telemedicine use during the pandemic and the lack of rules guiding its practice, the number of legal claims in this area is bound to increase. Orthopaedic surgeons cannot afford to accept telemedicine as a convenient alternative to in-person visits without first considering the many other variables that could potentially expose them or their medical practice to legal trouble. For example, while some authors have described successful fracture care starting with an online visit [4], this is a risky proposition. Without a hands-on examination, injury severity and the need for further imaging may not be apparent, leading to misdiagnosis and/or complications such as compartment syndrome. One illustrative case involved a 62-year-old man with obesity who was 3 weeks out from an ankle injury and who was immobilized in a leg cast [5]. During a telemedicine visit with a primary care doctor, he reported new swelling of the leg. The physician advised elevation and follow-up with his orthopaedic surgeon within 24 hours, with a doppler ordered for later that day. Before the patient could get the doppler, he collapsed and died of a pulmonary embolism arising from a deep vein thrombosis. The family filed a lawsuit, alleging that the telehealth providers should have treated him emergently based on the video visit. The lesson from this case is that when, as here, a life- or limb-threatening condition is part of the differential diagnosis, a virtual visit alone is not enough. The patient should have been seen in person. Documentation and Regulatory Risks Documentation for telemedicine can create liability risk as well, especially if a provider mindlessly cuts and pastes from templates designed for in-person visits. Language like “regular heart rate and rhythm” or “5/5 muscle strength in lower extremities” may commonly be used in clinic notes [5], but they cannot appear in telemedicine records. If a lawsuit occurs, an attorney would present the provider as careless or dishonest in documenting findings that could not have been performed remotely. Until standard medical language specific for telemedicine is developed, documentation should be limited to only that which the provider can observe during a virtual visit (such as active ROM of a joint), specifically excluding those findings that require a hands-on examination (such as grading muscle strength or any physical findings that call for auscultation or palpation). Telemedicine providers should also be aware of licensing and credentialing laws that apply when telehealth delivery crosses state lines [3]. The risks of healthcare delivery across state lines were illustrated in the 2007 legal ruling in Hageseth v Superior Court of California [6]. A Colorado-licensed physician prescribed anti-depressants to a student in California, who later committed suicide. The California prosecutors alleged that practicing telemedicine violated the law because the doctor was not licensed to practice medicine in the state. The court agreed, and successfully asserted jurisdiction over the case, applying California state law to find the physician liable. Online prescription drugs were also addressed in an Arizona ruling where a pharmacy was found to have violated state law when it filled online prescriptions, relying only on physician review of internet patient questionnaires, without physical examination [1]. Until new case law changes these legal rulings, providers should be wary of prescribing medications, especially opioids, over the internet and across state lines. Hagaseth is still good law today; if a provider treats patients or prescribes medication to a patient in another state, that provider will most likely be subject to the laws of the state in which the patient resides. In our view, physicians should make sure that their malpractice insurance covers claims arising from telehealth care, including prescription medication, that is delivered to patients living outside the state where the physician is licensed to practice. Informed Consent Inadequate and/or poorly documented informed consent can lead to a claim for medical battery, in which the patient claims his or her body was touched or treated without consent [5]. In the context of telemedicine, it is not safe to assume that a patient who has consented to medical treatment also consents to getting that treatment via telemedicine. A proper informed consent specific to telemedicine should be obtained, preferably during a first in-person visit, before virtual care is delivered. Specifically, the patient must understand the limitations and risks that are specific to virtual care and consent to receiving such care. Since in-person visits were curtailed during the COVID-19 pandemic, a consent for telehealth delivery should be obtained proactively going forward for all patients, in case a future emergency precludes initial in-person visits. A recently proposed three-question patient-engagement tool may help educate patients about telemedicine and obtain their consent for such care [8]. This tool is built on a three-pronged inquiry on behalf of the patient: (1) What are my options? (2) What are the benefits and harms of those options? (3) How likely are each of these benefits and harms to happen to me? While not a waiver of liability, informed consent based on this three-question tool can help patients to weigh the advantages versus risks of online care and make their choice. Technology Platform Surgeons should rely on established, tested platforms, much like electronic medical record systems. That alone will limit liability. Emails and texts to patients are risky because their privacy can be easily compromised. All communications should be done through portals specifically developed for telehealth care delivery. To ensure patient privacy and protect data, a dedicated HIPAA-compliant technology platform with security protocols should be in place. Digital data transmission increases the risk of unwanted interception and loss of private patient information. Secured and trusted telemedicine platforms can ensure patient privacy and confidentiality. These platforms typically support encrypted video, secure messaging, and identity verification processes, all of which can protect private health information. They can also incorporate a patient-facing portal, which allows upload of previsit intake data such as surveys and photos that would otherwise need to be handled by the clinic staff. Properly designed technology platforms can also obtain informed consent during patient intake and reduce malpractice risk. According to the patient care analytics firm Protenus, within healthcare at large, including telehealth, more than 41 million patient records were breached during 2019, an increase of 48.6% over 2018 [2]. Since compromise of telemedicine platforms is nearly inevitable going forward, liability insurance carriers have recommended that providers use HIPAA-compliant platforms, even in states that temporarily relaxed restrictions around non-HIPAA-compliant platforms during COVID-19 [2, 10]. The Future The global COVID-19 pandemic forced telemedicine onto center stage. While data from medical liability insurers show that claims relating to the practice of telemedicine are being filed [10], case law in this area is currently sparse. That will change, probably sooner than later. As the adoption of telemedicine increases, liability claims will increase correspondingly. Still, with proper patient selection, awareness of legal risks, provider training, and an understanding of risk mitigation strategies, telemedicine can be an efficient and mutually satisfying component of patient care.
Introduction In a 2013 study by Birkmeyer and colleagues [2], the authors inquired whether or not the proficiency and skill of bariatric surgeons could influence clinical outcomes. Each of the 20 bariatric surgeons who agreed to be enrolled in the study submitted a videotape of themselves performing a routine laparoscopic gastric bypass operation. Independent, blinded peers examined videotapes and graded various technical skills on a standard rating scale. Birkmeyer and colleagues examined the relationships between proficiency ratings and complication rates (risk-adjusted) from prospective, clinical-outcomes registry data that included more than 10,000 patients [2]. Consistent with intuitive expectations, surgeons with low surgical skills scores demonstrated a longer duration of surgery, more complications, higher rates of reoperation, patient readmissions, and increased patient mortality, when compared to the top quartile of surgeons. Birkmeyer et al. concluded that peer rating of surgical skills may be a possible strategy for quantifying a surgeon's ability [2]. Hospital Liability for Physician Actions The study findings by Birkmeyer et al. are provocative and raise important questions in an era of increased transparency in medicine. Consumer-driven healthcare demands more information from medical practitioners, and faced with economic pressures, payers are understandably focused on outcomes, quality, and cost measures. If we can identify a group of physicians whose clinical outcomes are measurably inferior compared to other physicians, should the hospital be held liable for those inferior outcomes? That is a complex and difficult question that we will examine in this column in two parts. In this issue, we will focus on the legal basis of hospital liability for the medical staff's actions. The model of a physician as a hospital or corporate employee is increasingly accepted in the modern healthcare arena [1]. In law, there is a doctrine adopted by the United States known as respondeat superior, which reflects the legal responsibility of an employer for the negligent acts of its employees. This doctrine is commonly tied to agency law. Agency law helps define the legal relationship between an employer and its employees. The law offers an opportunity for an injured individual to recover damages. According to respondeat superior, the employer is responsible for the injuries caused by an employee who is working within the boundaries of his or her employment. Therefore, if a physician is an employee of the hospital or healthcare system, the application of the respondeat superior doctrine is relatively straightforward — for injuries arising out of physician conduct during the scope of employment, courts have little trouble finding that the hospital (employer) should be held liable as well. However, medical staff members may not necessarily be employees of the hospital. Admission to a hospital medical staff association with attendant privileges does not create or imply an employer-employee relationship because most medical staff members are not hospital employees. On the other hand, a medical staff member differs from an independent contractor since a staff member must formally apply to a hospital's medical staff, and the hospital must clearly delineate the scope of the physician or surgeon's hospital-based practice. Credentialing is the process of applying for and being accepted to a hospital medical staff. Privileges, or privileged delineations, are the physician or surgeon's permissible scope of practice within a hospital. How does the legal system create hospital liability for the actions of medical staff members who are not hospital employees? TheDarlingCase The classic ruling in Darling v Charleston CommunityMemorial Hospital [3] established hospital liability for medical staff actions. Beginning with the landmark Darling case in 1965, the courts have since created and enforced “Hospital Corporate Liability.” Hospital Corporate Liability refers to the direct responsibility of a hospital to ensure the competency of its medical staff, as well as appropriate limitations on a medical staff member's privileges. According to the Darling case [3], an 18-year-old boy fractured his leg during a football game. He was examined in the emergency room at Charleston Memorial Hospital by Dr. Alexander, an emergency call physician. Dr. Alexander treated the patient with traction, placed the leg in a plaster cast, and used a heat cradle to dry the cast. Shortly thereafter, the patient complained of increasing pain, and his toes became swollen and dark. Eventually, the toes became cold and unresponsive. In response, Dr. Alexander tried to partially valve the cast. Two days later, while splitting the valve cast with a cast saw, the boy's leg was inadvertently cut on both sides, releasing foul-smelling blood from necrotic tissues. The patient was transferred and placed under the care of Dr. Fred Reynolds, the head of orthopaedic surgery at Barnes Hospital in St. Louis. Dr. Reynolds diagnosed the patient with tissue necrosis from compartment syndrome and attempted to salvage the leg. Despite several operations, the patient underwent a below-knee amputation. The case was brought to trial on a new theory that a hospital was responsible for the medical staff's competency. As a result, it was alleged that the hospital had an obligation to ensure its patients that they were only treated by competent medical staff members. Ultimately, the appellate court agreed with the plaintiff. The court stated that the trial evidence revealed “… the hospital failed to review Dr. Alexander's work … its failure to do so was negligence. On the evidence before it, the jury could reasonably have found that [the hospital] was [negligent].” [3, 6] The hospital argued that it simply hired doctors and nurses to act on their own responsibility, and that the hospital was not accountable for the treatment of the patient. The court rejected this argument. Evolution of Hospital Corporate Liability The Darling case was followed by a series of legal cases firmly establishing the doctrine of Hospital Corporate Liability. One such case was Elam v College Park Hospital [4]. In Elam, the plaintiff alleged that a podiatrist negligently performed surgery to correct bilateral bunions and bilateral hammertoes. The hospital's peer-review committee had voiced serious concerns about the podiatrist's incompetence and lack of qualifications, but failed to notify the hospital administration of these apprehensions. Armed with the doctrine of Hospital Corporate Liability, the Elam court held that “the hospital owed a general duty to ensure the competency of its medical staff and to evaluate the quality of medical treatment rendered to its patients.” [4] More recently, there has been a body of litigation initiated by the Hospital Corporate Liability doctrine directed at a hospital's duty to appropriately grant privileges, particularly as it relates to new surgical procedures. This litigation arose out of the introduction of laparoscopic cholecystectomy. Experienced general surgeons took weekend courses, and were taught the procedure using swine cadavers [5]. As expected, there was a learning curve for general surgeons who were now operating in a different kind of surgical field, one relying entirely on indirect visualization. Some of the surgeons never acquired the necessary skills and aptitude to convert from safely performing open procedures to the laparoscopic method. The voluminous lawsuits that followed the introduction of laparoscopic cholecystectomy invariably included hospitals. These lawsuits alleged that the hospital should not have granted privileges to perform laparoscopic cholecystectomy until it had assured itself through proctorship and monitoring that the general surgeon was qualified, competent, and proficient to perform the new procedure [5]. Surgeon Risk from Hospital Corporate Liability While few would doubt the wisdom of the Darling decision, every doctrine has a potential dark side. The dark side of Hospital Corporate Liability is that in a highly competitive orthopaedic marketplace, individual practitioners who may lack economic or political power could unjustly lose medical staff membership or have their privileges severely limited by competitors. While these competitors may assert that their efforts to remove an orthopaedic surgical staff member is a legal responsibility under the Hospital Corporate Liability doctrine, their motives may be driven by economic interests rather than improved quality. Accordingly, it is important to ensure due process procedures (which could even include outside evaluators) to protect the interests of orthopaedic surgeons who may be unfairly targeted for removal from the medical staff or reduction in the scope of their hospital-based practices. Hypothetical Case Given the recent introduction of new technologies in orthopaedic surgery, coupled with the finding that bariatric surgeons’ clinical outcomes were related to independently derived measures of their surgical skills, it is likely that Hospital Corporate Liability will become an increasingly important aspect of orthopaedic professional liability cases. Take, for example, the following hypothetical case: Dr. George Z is a 72-year-old orthopaedic surgeon and a solo practitioner. He has been practicing at Grace Memorial Hospital for more than 40 years. His solo orthopaedic practice is the largest in town. The other orthopaedic surgeons at Grace Memorial are all partners in a separate orthopaedic group, and one of those partners is the Chairman of the Division of Orthopaedic Surgery at Grace Memorial. The Chairman recommended revoking Dr. Z's privileges to perform orthopaedic surgery to the hospital administrator and the hospital governing board. This recommendation is based upon the filing of four malpractice lawsuits by patients within a 2-year period, several complaints by nurses of abusive verbal encounters with Dr. Z, and his observation that Dr. Z refuses to embrace new technologies in orthopaedic surgery. In response to these allegations, Dr. Z asserts that he provides the highest quality care, noting that of the four lawsuits, three were determined to lack merit and, while admitting he made a mistake in the fourth lawsuit, it was the only successful lawsuit against him in his 40 years of practice. He further asserts that he provides care to more indigent patients in town than all of the competing orthopaedic surgeons in the chairman's group. Dr. Z claims that because he provides so much indigent care his patients are more likely to have poor health status and poor followup, thus creating more exposure to malpractice claims and lawsuits. While he admits that he has been harsh with the nurses in the past, he states that the quality of the nursing care in the orthopaedic unit has diminished significantly during the past 10 years, exposing his patients to potential postoperative complications. Finally, Dr. Z believes that many of the new technologies, such as minimally invasive total hip replacement, do nothing to enhance a patient's outcome while exposing them to injuries and poor outcomes. He sees no reason to change his surgical approaches when his patients have done so well over the course of many decades. Analysis Dr. Z's case presents compelling and competing arguments. The proposed action against him is either based upon principles of quality or that he is the target of ambitious competitors driven by economic interests rather than concerns about patient care quality. If you were the attorney for Dr. Z, what would you argue, and what evidence would you present in opposition to the efforts to remove him from the medical staff? We will touch upon this question in part two of our column, as well as examine how to balance the need for medical competency with principles of fairness that expose vulnerable orthopaedic surgeons to unfair actions by their competitors.
IntroductionThe in vivo evolution of surface material properties is important in determining the longevity of bioceramics. Fracture toughness is particularly relevant because of its role in wear re...
Introduction Informed consent and its application in clinical practice are of vital interest to surgeons because allegations of medical battery (that is, the intentional treatment of a patient without informed consent) can accompany medical malpractice lawsuits if the court perceives that there was an insufficient or defective informed consent [14]. Physicians are trained to discuss informed consent with patients. This discussion should include documentation of the known risks, benefits, and alternatives to a proposed treatment or surgical intervention [3]. Complicating the full-disclosure requirement of the law is the increasing awareness that the exact benefits of many common operations and medical interventions are uncertain. In our technology- and information-driven world [1], patients have access to many sources of healthcare statistics that are outside the physician-patient interaction. As such, the focus of medical practice has moved away from a paternalistic view to one that is consultative—the physician presents options to the patient, who then makes a choice [11]. In this model, the law offers little guidance about how to convey uncertainty during the informed-consent discussion. Questioning Basic Assumptions While no one single study is dispositive in resolving the clinical effectiveness of a medical procedure, there are compelling and thoughtful arguments that question basic assumptions in US healthcare. Authors Norton Hadler MD in Worried Sick [5], and David H. Newman MD in Hippocrates’ Shadow [9] write about the lack of scientific support for many commonly accepted treatments in contemporary medicine. In Hippocrates’ Shadow, Dr. Newman refers to certain medical practices as procedures that are believed to be effective simply because of cultural norms, rather than scientific proof. For example, commonly prescribed antidepressant medications may be no more effective than placebos, except in rare cases [7, 8]. Even a well-ingrained practice such as dental flossing may have no identifiable benefit for the maintenance or improvement of dental health [4]. He notes that our science is ultimately limited, and where there is an absence of evidence, the best we can do is make (what we believe to be) educated guesses. He writes: “In some cases, physicians don't know the evidence that contradicts their practice, having blindly accepted the teachings of their predecessors. And in other cases, physicians are well aware of the evidence but obstinately refuse to reexamine their practice and themselves” [9]. In Worried Sick, Dr. Hadler questions the efficacy of many expensive, well-entrenched standards of care. According to Dr. Hadler, an underlying assumption in US healthcare policy is that everyone needs a large amount of expensive care, in doses that are determined by pharmaceutical companies and the medical establishment. A familiar orthopaedic example is knee arthroscopy degenerative meniscal tears; a multicenter, randomized, double-blind, sham-controlled study showed no benefit of surgery over placebo surgery [13]. Drs. Newman and Hadler advise consumers to view recommended medical treatments with skepticism, and to get information on their own to decide what healthcare is really necessary. Patients are encouraged to understand that there is uncertainty about the benefits of many medical treatments, despite the confident recommendations of their doctors. The practical implications are that patients are more likely to seek information about their treatments outside the traditional physician-patient relationship. As such, the informed-consent process should anticipate a more engaged and questioning patient in contrast to the traditional deference shown to physicians in the past. The Courts While the courts have never directly clarified the boundaries of complete disclosure during informed consent, some rulings have supported incomplete disclosure under limited circumstances. For example, a doctrine called “therapeutic privilege” allows a doctor to withhold information if full disclosure might psychologically harm the patient or cause a patient to forego an operation that is medically necessary. Therapeutic privilege was addressed in Nishi v Hartwell, a 1970 Hawaii Supreme Court ruling where the Court held that the primary duty of a physician is to do what is best for his patient, and in executing that duty, he/she can withhold information that might adversely affect the patient's best interest [10]. Of note, subsequent legal decisions have diluted the therapeutic privilege exception considerably, adopting a much narrower interpretation of it. Those subsequent rulings have increasingly supported a patient-centric approach, whereby full disclosure is required, even in the face of medical uncertainty. In other words, a physician cannot withhold information on the justification that other, reasonable physicians in a similar situation would also withhold that information for fear of upsetting the patient, or causing the patient to refuse necessary care. Rather, the legal standard has evolved to asking whether or not another reasonable patient in similar circumstances would desire disclosure of withheld information to formulate a decision about their healthcare. The seminal case in informed consent is the 1972 ruling in Canterbury v Spence that required physicians to convey those risks that a reasonable person would consider material to deciding whether or not to undergo a medical procedure [3]. Canterbury makes the assumption that the physician obtaining informed consent has an accurate understanding of the benefits of the proposed treatment. In reality, while physicians may be aware of medical uncertainty in clinical practice, the communication during informed consent rarely addresses it. Audiotaped patient-physician discussions found that uncertainty was communicated only 5% of the time when obtaining informed consent [2]. This lack of communication was particularly true in discussions for decisions of high complexity; only 0.5% of such decisions were fully informed [2]. Informed Consent and Uncertainty The true benefits of a medical intervention are complicated by the placebo effect (patient improvement following treatment with an intervention that has no demonstrable therapeutic efficacy) especially if the provider believes in the proposed treatment and the patient trusts the provider. To be clear, knowingly administering a placebo, or performing sham surgery to achieve a placebo benefit has serious legal and ethical implications, and is not endorsed. Patient improvement after medical interventions that lack evidence-based proof may have other explanations as well. Physician demeanor and confidence in the recommended treatment may be important because of patient reassurance that the doctor trusts the treatment, and has had good experience with it [9]. Another explanation for patient improvement is the Hawthorne effect, which refers to the alteration of behavior by subjects in a study because of their awareness of being observed [12]. Clearly, patient recovery after surgery is related to a number of complex variables, in addition to the objective, scientifically proven merits of the operation itself. Discussion Several communication strategies can help a clinician express medical uncertainty to a patient during informed consent. These strategies include recommending other sources of information such as professional websites, and encouraging questions related to all aspects of the patient's healthcare [6]. During informed consent, a physician should be open-minded, sympathetic, and when presenting alternatives, should explain his/her own treatment preferences, values, and goals [6]. Communication skills and training are central in this model. Indeed, an orthopaedic surgeon's ability to convey his/her beliefs about the benefits of a procedure accurately may require skills that equal—or even exceed—the technical expertise required for successful surgery. The law recognizes that the practice of medicine has been (and always will be) complicated by uncertainty. In dealing with the unproven scientific benefits of medical procedures, one approach that can balance the competing values of full disclosure versus achieving the most patient benefit is for the surgeon to express his/her opinion and experiences about the benefits of the intervention. In treating a meniscal tear in a mildly degenerative knee joint, for example, a surgeon can convey that in his/her experience, arthroscopy is one effective option toward pain relief, but it adds the risk of a minor operation. Other alternatives include anti-inflammatory medication, rest, injections, and/or physical therapy—all of which avoid surgery. There is no evidence that surgery has any benefit over the nonsurgical treatments [13]. Medical practice, regardless of specialty, is an art and a science. Statistical comparisons of the efficacy of an operation to scientifically appropriate controls cannot tell the whole story. Whether improvements after surgery are derived from the surgeon-patient relationship, measurable outcomes, or other imprecise variables, the procedure itself is related to how the surgeon views the benefits of the recommended intervention, and how effectively he/she communicates those beliefs to the patient.
Introduction In civil and criminal cases, judges in the US legal system often are faced with conflicting societal norms that ultimately influence the outcome of a lawsuit, and set legal precedent. Of interest to medical professionals is the recent concern about the increasing use of opioid analgesics by patients. While it is recognized that opioid drugs have legitimate uses for some patients who suffer from pain, there is also a serious social concern about prescription drug-related addiction and deaths related to prescription-drug overdoses in the United States, and the problem may have reached epidemic proportions [10]. The problem may arise, at least in part, because of overprescription of opioids by US physicians [10]. According to the Centers for Disease Control and Prevention (CDC), opioids and heroin were implicated in 28,647 overdose deaths in 2014 [16]. In the preceding year (2013), the Drug Enforcement Agency (DEA) reported 46,471 deaths from drug overdoses in the United States; more than half of these resulted from prescription painkillers and heroin [9]. To place the figure in perspective, fewer people died from car crashes or from firearms in the United States during that year, according to the CDC [9]. The issue of how to balance the competing risks of treating pain (whether acute postsurgical pain or chronic pain from conditions like cancer) and causing addiction (particularly in otherwise healthy people) is a current and lively social debate [11, 17]. From a societal standpoint, the risk of creating addiction to powerful drugs in patients who do not really need such medications is a valid public health concern. On the other hand, as Daniel B. Carr MD, MA, Professor of Public Health and Community Medicine at Tufts School of Medicine, has remarked, CDC guidelines should not “inadvertently encourage undertreatment, marginalization, and stigmatization of the many patients with chronic pain that are using opioids appropriately” [5]. The Prescription Drug Era In 1994, Purdue Pharma—a developer of prescription analgesic medications—introduced a website that targeted physicians and their patients who were experiencing pain [15]. The website informed patients with chronic or acute pain that they were being undermedicated because of a general reluctance on the part of physicians to prescribe narcotic pain relief medications. This reluctance, according to the website, was based on unfounded physician fears about creating dependence on prescription analgesics [15]. In the book, Our Daily Meds [14], author Melody Peterson suggested that pharmaceutical companies used marketing and promotional materials to suggest to patients that their suffering was needless, because doctors were too hesitant “to propose narcotics like OxyContin, which offered powerful relief” [14]. OxyContin is an extended-release form of the opioid oxycodone, and was introduced to the market by Purdue Pharma in 1996. The drug would prove to be a resounding commercial success, accounting for USD 1.6 billion in sales, or about 94%, of the company revenue in 2003. In time, patient deaths from OxyContin use or abuse began to occur, and several states, such as Kentucky, filed lawsuits against Purdue Pharma for illegally promoting OxyContin and downplaying its addictive potential. Purdue Pharma marketed OxyContin on its ability to last 12 hours (versus their competitors pain meds, which only lasted 8 hours). In reality, OxyContin rarely, if ever, lasted 12 hours [17]. Physicians often increased the dosage of OxyContin or patients simply chose to self-medicate. In 2007, in a consolidated federal legal action, Purdue Pharma agreed to pay more than USD 600 million in fines related to the improper branding and promotion of OxyContin. More recently, a Kentucky judge ordered Purdue Pharma to unseal secret documents related to the marketing of OxyContin [2]. Not surprisingly, the company has challenged the judicial order in an appeal filed with the Kentucky Appeals Court [3]. From this experience, and because of a general increase in the incidence of narcotic prescriptions at the time, the federal government expressed concern that patient access to several highly addictive pain killers may be too easy. The CDC modified its guidelines earlier this year to advise that physicians should adopt an even more conservative and cautious practice toward prescribing long-acting narcotic pain medications [6]. Federal Prosecution As part of its effort to control narcotic use, the Department of Justice prosecutes prescribing physicians when it determines that opioid use is inappropriate. We believe that this stance may have a chilling effect on those clinicians who adhere to ethical and appropriate standards of prescribing opioids. Unlike a medical malpractice case, which is a civil lawsuit with damages usually limited to monetary remedies, criminal liability arising from opioid prescriptions can result in lengthy periods of incarceration for physicians who are convicted—up to life imprisonment [7]. Physicians and surgeons need to also understand that criminal indictment for the alleged overprescribing of opioids is not in the same category of prosecution as healthcare fraud cases. Rather, opioid overuse cases are governed by a subset of federal laws that address the illegal distribution of drugs under the Controlled Substances Act (CSA), 21 U.S.C. §841 [1]. That particular federal statute makes it illegal to knowingly or intentionally distribute or dispense a controlled substance [1]. In these cases, therefore, the government essentially accuses the physician or surgeon of being a drug dealer. Case Law In 1971, the Nixon administration created the federal DEA, which became the leading administrative body for enforcing the CSA. In United States v Moore (1975), the US Supreme Court addressed the prosecution of physicians under the CSA, 21 U.S.C. §841 [19]. In a lower-court ruling, Dr. Thomas W. Moore had been convicted for prescribing large amounts of methadone to patients without the proper physical examinations or specific instructions for the use of methadone. Furthermore, Dr. Moore had charged fees according to the amount of methadone prescribed, instead of billing for the medical services provided. The Moore conviction was reversed by the US Court of Appeals on technical grounds, and the US Supreme Court admitted it for further review [19]. The Supreme Court held that registered physicians could still be prosecuted under §841 when their activities fell outside the usual course of professional practice. In its ruling, the Supreme Court in Moore made two points. First, the Court clarified that doctors were not exempt from liability under the CSA by virtue of being authorized and registered to prescribe such substances. Second, the Court held that doctors can be prosecuted under §841 “when their activities fall outside the usual course of professional practice” [19]. The Court also set forth an objective good-faith standard to determine the culpability of a doctor who may have acted in good faith (ie, generally accepted standard of medical practice). Since this 1975 ruling, other legal cases have reflected societal tensions concerning public policy and judicial enforcement of controlled substance laws against physicians and surgeons. A somewhat more lenient view than that reflected in the Moore decision was taken in the 4th Circuit ruling in United States v Hurwitz [18]. In this case, the question was whether a doctor violated §841 by acting “without a legitimate purpose or beyond the bounds of accepted medical practice.” Dr. William E. Hurwitz ran a pain-management clinic in Virginia to treat patients with chronic pain. Some of his patients had developed a preexisting addiction to opioids and were illegally selling prescription drugs, although later Dr. Hurwitz would profess ignorance of this. Dr. Hurwitz was convicted in 2004, on several counts of distributing narcotics. A lengthy prison term was ordered, with a USD 2 million fine and seizure of his property. This ruling was then overturned on appeal by the US Appellate Court on grounds that the trial judge had erred in not letting jurors consider Hurwitz's defense (that the doctor had prescribed the medications in good faith, and as part of his regular practice of medicine). The Court ruled that “some latitude must be given to doctors trying to determine the current boundaries of acceptable medical practice” and that a doctor “should not be held criminally liable if the doctor acted in good faith when treating his patients.” The case went on to a second trial in 2007, in which Dr. Hurwitz was convicted, and ended up serving approximately 4 years in prison. Legal Notice One possible alternative to the aggressive prosecution and conviction of physicians for illegal narcotic prescriptions is to create a safe-harbor provision based on notice. Under this model, no criminal prosecution would occur unless notice of unusual prescribing patterns or misuse of narcotics by patients was first served upon the physician. After such notice, the physician should be given the opportunity to remediate existing practice patterns, or provide evidence to prove to the US Department of Justice that the nature of one's practice (such as particularly sick patients with severe pain, or a high volume of chronic pain patients) justifies aggressive prescription of controlled substances. As it stands today, no such model exists to protect physicians who might be legitimately prescribing more opioid pain medications than their peers. The proposed safe harbor would offer a level of comfort to those physicians whose good-faith objective is to help patients through the proper use of opioids without having to worry about criminal charges. Errant physicians who deliberately overprescribe narcotic medications for reasons unrelated to patient welfare could still be investigated and prosecuted, after being put on notice that their prescription practices were outside normal patterns. Thus, legislative tools such as safe harbors created by requiring notice before prosecution can facilitate a balance between the competing societal interests of allowing doctors to serve their patients’ legitimate pain control needs, while focusing prosecutorial resources on those select individuals who cross the line in willfully and recklessly overprescribing controlled substances. Physician Guidelines Both the Moore and Hurwitz rulings suggest that physician caution is in order when it comes to prescribing narcotics to patients. The conflicting views of the courts means that there is an ostensible lack of a clear, definitive guiding principle for physicians who want to treat legitimate pain, whether chronic or severe, without fear of inciting criminal liability. The risk of ambiguity in prescription guidelines is that most reasonable physicians will probably err on the side of caution and prescribe opioids reluctantly, even if their sound clinical judgement dictates otherwise. Pain is highly subjective, and its experience varies from patient to patient, often influenced by complex cultural and social factors, in addition to individual patient variables and circumstances. The fear of potential exposure to federal criminal liability creates the risk that physicians will make clinical decisions tainted by the fear of criminal prosecution, ultimately compromising the quality of patient care provided. One assurance for physicians is that the risk of legal sanctions related to prescribing narcotic pain medications is miniscule. This subject was investigated by Goldenbaum and colleagues [8], who identified cases where medical boards criminally prosecuted physicians for offenses related to inappropriate prescribing of opioid analgesics. The study found that only 725 doctors (or approximately 0.1% of practicing patient-care physicians) were charged with criminal and/or administrative offenses related to prescribing pain killers from 1998-2006. Of those charged, a majority (39%) were general practice/family medicine physicians. Only 3.5% were self-identified or board-certified pain specialists, the study found. Physicians charged with opioid prescription misconduct were statistically more likely to be older, male, and not board-certified. According to the study, there were an average of 658 DEA criminal and complaint investigations per year from 2003-2006 [8]. Goldenbaum and colleagues concluded that criminal or administrative charges for pain killer prescriptions are rare. Of note, these data are at least 10-years-old, and whether the risk of physician prosecution for prescribing narcotic drugs has increased in the meantime remains unknown. For orthopaedic practices, narcotic prescriptions are necessary to treat the severe pain that follows musculoskeletal trauma and surgery. Many orthopaedic operations are being performed on an outpatient basis, using less invasive surgical methods. There is an emphasis in the profession on the preemptive use of painkillers and regional nerve blocks, and surgeons are generally alert to narcotic prescriptions. In multimodal analgesia approaches to elective outpatient surgery, orthopaedic surgeons should be alert to FDA recommendations that warn against using long-acting narcotics, particularly in patients who do not ordinarily use such drugs [4, 12, 13]. Outpatient surgery is particularly risky in that there may be a temptation to use long-acting narcotics that will continue to exert physiologic effects, such as respiratory depression, long after the patient has been discharged to the unmonitored, home environment. For most orthopaedic patients, a short course of narcotic pain medications during the acute recovery from surgery should suffice. The risk of patient addiction to a prescription drug in an orthopaedic practice certainly exists, but it is manageable. Patient education, use of modern pain relief measures, judicious use of narcotic pain medications, proper documentation, physician knowledge of the current recommendations and warnings relevant to narcotic medications, and timely referral of patients showing dependence on pain killers to another specialist are practical steps that can avoid the legal risk related to prescribing narcotic pain killers.
'%3e%3cpath fill='%23012169' d='M0 0v30h60V0z'/%3e%3cpath stroke='%23fff' stroke-width='6' d='m0 0 60 30m0-30L0 30'/%3e%3cpath stroke='%23C8102E' stroke-width='4' d='m0 0 60 30m0-30L0 30' clip-path='url(%23b)'/%3e%3cpath stroke='%23fff' stroke-width='10' d='M30 0v30M0 15h60'/%3e%3cpath stroke='%23C8102E' stroke-width='6' d='M30 0v30M0 15h60'/%3e%3c/g%3e%3c/svg%3e)