History shows that wound care providers have faced litigation for many reasons. This article discusses the state of malpractice and related law as it impacts wound care clinicians, and provides good practice recommendations that can help clinicians avoid liability.
Editor’s Note: The contents herein are not intended as legal advice, nor does this article purport to be a comprehensive review of the malpractice landscape facing wound care providers. Whether any specific patient has been provided appropriate care sufficient to avoid legal liability depends upon a complete evaluation of all facts and circumstances in that case.
Two well-established demographic trends — the overall aging of the United States population and the rise in obesity across all age groups — have dramatically increased the number of persons living with serious chronic (and often overlapping) health conditions, such as diabetes and heart disease, that increase the risk of chronic wound development. The inherent difficulty of achieving closure in wounds that have failed to heal and the compliance challenges presented by a significant subset of these patients means that suboptimal outcomes are not uncommon. The healthcare provider’s failure to deliver treatment that conforms to current standards of care can also contribute to poor outcomes. When a chronic wound continues to deteriorate despite treatment, resulting in prolonged suffering and other adverse sequelae, the outcome may be perceived by the patient (as well as his/her family and caregivers) as having been avoidable but for the type of care received. Consider the case of Warnick v University of Pittsburgh Medical Center Passavant, in which a patient brought suit that alleged improper wound care in the hospital despite failing to follow physician instructions.1 In these circumstances, lawsuits are all but inevitable. This article will discuss specific malpractice and negligence issues that may arise in the outpatient wound clinic setting and provide an overview that highlights the need for scrupulous attention to ensuring that patient care meets the highest standards, to fostering effective communication with the patient, and to maintaining detailed recordkeeping in order to reduce the provider’s legal exposure.
FAILURE TO DIAGNOSE & TREAT WOUNDS APPROPRIATELY
A common malpractice allegation against wound care providers is a failure to properly diagnose a wound that results in serious adverse consequences for the patient. For example, in Bartlett v Coppe, the patient sued a wound center physician, alleging that a failure to diagnose an infection led to a partial foot amputation.2 In McComas v Miller, the patient’s family sued a podiatrist for failing to diagnose and treat the patient’s nonhealing wound, which was ultimately determined to be melanoma.3 And in Ruggiero et al v V.M. Chafizadeh, MD, the plaintiffs alleged, among other things, failure to make a timely, proper diagnosis that resulted in unnecessary amputation.4
The importance of determining etiology when deciding upon the treatment that is most likely to heal a wound cannot be overstated. Additionally, an appreciation of the full picture comprising the patient’s medical and behavioral history, and current medical conditions, in addition to the characteristics of the wound, is essential for comprehensive wound assessment. A lack of response to treatment or an appearance, distribution, or location of a wound that is unusual in relationship to other wound characteristics or patient factors should lead a careful clinician to closely examine his or her assumptions about a wound’s etiology or prognosis. Perhaps the most common allegation in malpractice litigation against wound care providers is a failure to administer appropriate care. Examples of this type of action include Gonzalez v Padilla, where a patient sued due to alleged medical malpractice in the treatment of a leg wound that became infected and required amputation;5 Integrated of Amarillo Inc. v Kirkland, where a patient sued the healthcare center after a leg amputation due to treatment of blisters with an antibiotic cream that was contraindicated due to an allergy history;6 Coopman v Buffalo Clinic P.A., where a patient sued the wound care clinic for failure to treat an infected surgical leg wound properly, resulting in disfigurement and impaired gait;7 Melendez v Olson, where a patient sued his physician who treated a foot lesion that became infected and resulted in leg amputation, alleging inadequate or improper care;8 Howard v TMW Enterprises Inc., where a patient sued his physician, alleging that a delay in wound care breached the standard of care and led to amputation of multiple fingers);9 and Poleri v Salkind, where a patient filed suit alleging improper care of a surgical wound.10
Careful consideration of the patient’s unique circumstances can help drive appropriate interventions and avoid those that could be ineffective or detrimental, reducing potential malpractice liability. Furthermore, wound care providers must appreciate that medical science in the area of regenerative medicine is evolving rapidly. It is critical for physicians treating patients living with chronic wounds to keep abreast of the latest advances in medical science, because failing to do so can result in legal liability. Although it may once have been sufficient for physicians to adhere to customary local medical practice, even if that practice had become outdated, courts today seem to be moving toward a consensus that “something more” is required. In Pennsylvania, for example, the accepted jury instruction is that “a physician must be kept informed of contemporary developments in the medical profession or his specialty, and must use current skills and knowledge. A physician must have up-to-date medical skills and knowledge, and if he fails to keep current or fails to use current knowledge in the medical treatment of the patient, the physician is negligent.”11 This principle is becoming the rule in other jurisdictions as well. As one Wisconsin court explained, “should customary medical practice fail to keep pace with developments and advances in medical science, adherence to custom might constitute a failure to exercise reasonable care.” That court went on to say that “a reasonably competent practitioner is one who keeps up with advances in medical knowledge.”12
FAILURE TO KEEP DETAILED RECORDS
The duty to maintain thorough and accurate records is considered one of the healthcare provider’s fundamental responsibilities, and breaching that duty could give rise to liability if it causes or contributes to ineffective treatment by that provider or subsequent providers. Properly assessing a wound and determining an appropriate course of care requires a clinician to know the patient’s medical history and general health, the level of pain experienced, and his/her ability to participate in any treatment plan. A patient’s medical records are also critical for continuity of care and for ensuring that new providers or facilities have the benefit of an accurate understanding of the patient’s treatment history. For all of these reasons, incomplete or unclear records increase the likelihood of mistakes being made and/or ineffective treatments being administered.
Avoiding the mistakes or misjudgments that can lead to lawsuits depends (particularly in a busy practice) on ensuring that all of this information is collected and is completely, concisely, and unambiguously documented (and that the critical pieces of information are easy to locate in the patient’s file). In addition to ensuring that all of the providers treating the patient have the complete information required to treat a patient competently, well-kept patient records play another role in reducing liability risks. In lawsuits related to medical errors or malpractice, typically the medical experts are engaged by both sides to review the medical record and render an opinion as to whether the treatment delivered met an acceptable standard of care. In fact, it has been said that “documentation is so vital to healthcare that, from a legal standpoint, the documentation of care has become equivalent to the care itself. If an action has not been documented, the law may presume or infer that the action was not performed.”13
Inadequate records undermine a provider’s ability to prove that a patient received competent care and that neither negligence nor other malfeasance contributed to a suboptimal outcome. Thus, documentation that is inaccurate, incomplete, or unclear can undermine a provider’s defense in litigation arising from such outcomes. In fact, in some states, a healthcare provider may be directly liable for breach of his or her duty to maintain records. (Consider, for example, the case of Foster v Lawrence Memorial Hospital, which found that a physician had a duty to the plaintiff to maintain the records of his treatment.14)In other jurisdictions, if a patient’s ability to prove negligence is impaired by the defendant’s breach of the duty to create or maintain adequate records, the courts will shift the burden of proof to the defendant to prove by a preponderance of the evidence that it was not negligent.15 Conversely, consistent, concise, and organized documentation tends to work in favor of the clinician because it explains treatment choices and undermines the potential argument that treatment was poorly considered or careless. (Consider that in Melendez v Olson, a malpractice action was defeated because there was substantial evidence that the patient failed to follow physician’s sound instructions.16)
FAILURE TO COMMUNICATE RISKS & POTENTIAL OUTCOMES, OBTAIN CONSENT
The doctrine of informed consent imposes on a healthcare provider the duty to explain contemplated procedures to patients completely and clearly, and to warn them of material risks or dangers inherent in or collateral to the therapy, so as to enable them to make intelligent, informed treatment choices.17-20 This duty to disclose is said to require a physician to reveal to his patient the nature of the ailment, the nature of the proposed treatment, the probability of success of the contemplated therapy, its alternatives, and the risk of unfortunate consequences associated with such treatment.21,22
The importance of explaining all procedures, obtaining the patient’s written consent, and maintaining the documentation in the file cannot be overstated. Malpractice and negligence suits may also occur when rendered treatment has met the standard of care and effective informed consent was obtained, but the patient experiences negative outcomes due to his or her actions (or inactions) following treatment. In these cases, the patient may assert that the healthcare clinician(s) failed to provide adequate or complete instructions. An example includes the case of Shelton v United States, in which the patient was treated for a bite wound at an emergency department, the wound subsequently became gangrenous, and a partial amputation of his finger was required. The patient sued, alleging, among other things, that the hospital failed to instruct him as to appropriate wound care upon discharge.23 Cases like this highlight the importance of clear, effective communication (well documented for the aforementioned reasons) that is appropriate to the particular patient, taking into account his or her age, level of education, cognitive status, sobriety, and home and family situation.
Chronic wound patients, particularly those living with nonhealing wounds of the lower extremities, now represent a large and rapidly growing segment of the American healthcare system. Wound care providers should ensure that medical treatment for these patients meets the highest standards and takes into account the most recent medical developments, including approvals by the U.S. Food & Drug Administration of cutting-edge therapies, and that they effectively communicate with their patients both before and after procedures. Additionally, meticulous records must be kept concerning treatments, consents, and discharge instructions in order to avoid (or successfully defend) lawsuits by or on behalf of patients who have experienced negative outcomes.
Naomi J.L. Halpern is a counsel at Arent Fox LLP, Washington, DC, and advises clients on regulatory issues involving the FDA. James R. Ravitz leads the food, drug, medical device, and agriculture practice at Arent Fox.
1. Warnick v University of Pittsburgh Medical Center Passavant, 29 Nat. J.V.R.A. 5:3 (2013).
2. Bartlett v Coppe, 159 A3d 1065 (2017).
3. McComas v Miller, 2014 WL 5823138 (2014).
4. Ruggiero v Chafizadeh, 2010 WL 195227 (2010).
5. Gonzalez v Padilla, 485 SW3d 236 (2016).
6. Integrated of Amarillo Inc. v Kirkland, 424 SW3d 131,133-4 (2014).
7. Coopman v Buffalo Clinic P.A., 2012 WL 1470187 (2012).
8. Melendez v Olson, 2002 WL 31382404 (2002).
9. Howard v TMW Enterprises Inc., 32 F Supp 2d 1244 (1998).
10. Poleri v Salkind, 453 Pa Super 159, 683 A2d 649 (1996).
11. Davis v Bykov, 2017 WL 1291819 (2017).
12. Nowatske v Osterloh, 198 Wis 2d 419, 440, 543 NW2d 265, 273 (1996).
13. Cavico FJ, Cavico NM. The nursing profession in the 1990’s: negligence and malpractice liability. Clev State Law Rev. 1995;43(4):1-71.
14. Foster v Lawrence Memorial Hospital, 818 F Supp 319 (1992).
15. Nayokpuk v United States, 848 F Supp 2d 1030, 1033 (2012); citing Sweet v Sisters of Providence, 895 P2d 484 (1995).
16. Melendez v Olson, 2002 WL 31382404 (2002).
17. McQuitty v Spangler, 410 Md 1, 20-1, 976 A2d 1020, 1032 (2009); quoting Sard v Hardy, 281 Md 432, 439, 379 A2d 1014, 1020 (1977).
18. Salgo v Leland Stanford Jr. University Board of Trustees, 154 F2d 560 (1957).
19. Bang v Charles T. Miller Hospital, 251 Minn 427, 434, 88 NW2d 186, 190 (1958).
20. Scaria v St. Paul Fire & Marine Ins. Co., 68 Wis 2d 1, 227 NW2d 647, 654 (1975).
21. Scaria v St. Paul Fire & Marine Ins. Co., 68 Wis 2d 1, 227 NW2d 647, 654 (1975); citing Natanson v Kline, 187 Kan 186, 354 P2d 670 (1960).
22. Louisell D, Williams H. Medical Malpractice. Newark, NJ. Matthew Bender & Co. 1973.
23. Shelton v United States, 804 F Supp 1147 (1992).