Anatomy of a Lawsuit: Legal Pearls For the Wound Care Provider

By CHASE DOYLE

With more than 17,000 lawsuits for pressure injuries alone each year, legal action can be a very real consequence of practicing clinical medicine, especially for wound care providers.

During the Symposium on Advanced Wound Care (SAWC) Spring meeting, Lee C. Ruotsi, MD, ABWMS, CWS-P, UHM, and Joyce Black, PhD, RN, discussed treatment and documentation strategies to reduce the risk for litigation, and to defend the treatment provided in a legal setting, should that become necessary.

Dr. Black, a professor at the University of Nebraska Medical Center, in Waterloo, noted that to win a lawsuit, a patient’s lawyer must prove the following elements: • a professional duty owed to the patient; • breach of such duty; • injury caused by the breach; and • resulting damages, including wound, pain, disability and medical costs.

An attorney may not file a lawsuit if they do not see proof of all four elements on initial review.

According to Dr. Black, proper documentation is a critical piece in avoiding litigation. Typical consultation notes include history of the present illness, review of systems and the physical exam, followed by a diagnostic impression and treatment plan. If the patient’s condition is believed to be misclassified, the provider should document what the etiology is per the assessment and include supporting data.

Failure to accurately identify the etiology of the wound can sometimes come at the demand of the administration. Because treatment of pressure injuries is not reimbursed, Dr. Black said, there may be pressure to instead diagnose the condition as a diabetic foot wound, for example. However, the treatment that follows is not the same, which could present serious problems during litigation.

Another question that arises frequently in legal discussions is whether the condition was present on admission or unavoidable. Present-on-admission documentation allows for deep-tissue pressure injuries that are identified as evolving at the time of admission. For deep-tissue pressure injuries to be classified as “unavoidable,” said Dr. Black, the skin condition needs to be examined at the time of admission, but this is not limited to a 24-hour period, as these types of pressure injuries are not visible for 48 hours. Accurate assessment of risk, an appropriate plan of care and documentation of care are also required by the Centers for Medicare & Medicaid Services to establish a condition as unavoidable.

Costly Mistakes

According to Dr. Black, the ability to speak to patients openly and honestly is an essential skill for a wound care provider and may even protect a provider from medical malpractice. When healing cannot occur, for example, it is imperative that the patient or family be “kept in the loop,” she said.

“A family is going to be pretty upset if they thought a wound was minor or small and the patient ends up in the emergency room,” Dr. Black said. “If a family is taking pictures of the wound, then you should be taking pictures of the wound because those photographs will come into play.”

Although mistakes in the electronic health record rarely lead directly to patient harm, she added, those errors frequently result in lawsuits. Red flags in the EHR include changes in the record, gaps in time and information, improper wound measurements and incorrect wound terminology.

Finally, if a lawsuit goes to deposition or trial, the attitude of the provider can have a significant effect on the outcome. According to Dr. Black, a wound care provider should come across as caring and compassionate and express sincere concern about patient injuries.

“Lawyers pick up on even the most subtle hints of apathy and will exploit them,” Dr. Black noted. “You must have [the] right attitude in your chart, in your deposition and at trial.”

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Continuously monitor vital signs during sedation and through the recovery period. • Resuscitative drugs, and age- and size-appropriate equipment for bag/ valve/mask assisted ventilation must be immediately available during administration of Byfavo. • Concomitant use of benzodiazepines with opioid analgesics may result in profound sedation, respiratory depression, coma, and death.

The sedative effect of intravenous Byfavo can be accentuated by concomitantly administered CNS depressant medications, including other benzodiazepines and propofol. Continuously monitor patients for respiratory depression and depth of sedation. Contraindication: Byfavo is contraindicated in patients with a history of severe hypersensitivity reaction to dextran 40 or products containing dextran 40. Personnel and Equipment for Monitoring and Resuscitation: See Boxed Warning. Consider the potential for worsened cardiorespiratory depression prior to using Byfavo concomitantly with other drugs that have the same potential (eg, opioid analgesics or other sedative-hypnotics). Administer supplemental oxygen to sedated patients through the recovery period. A during administration of Byfavo. Risks From Concomitant Use With Opioid Analgesics and Other SedativeHypnotics: See Boxed Warning. Hypersensitivity Reactions: Byfavo contains dextran 40, which can cause hypersensitivity reactions, including rash, urticaria, pruritus, and anaphylaxis. Byfavo is contraindicated in patients with a history of severe hypersensitivity reaction to dextran 40 or products containing dextran 40. Neonatal Sedation: Use of benzodiazepines during the later stages of pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) in the neonate. Observe newborns for signs of sedation and manage accordingly. Pediatric Neurotoxicity: Published animal studies demonstrate that anesthetic and sedation drugs that block NMDA receptors and/or potentiate GABA activity increase neuronal apoptosis in the developing brain and result in long-term of this is not clear. However, the window of vulnerability to these changes is believed to correlate with exposures in the third trimester of gestation through

According to Dr. Ruotsi, the medical director at Saratoga Hospital Center for Wound Healing and Hyperbaric Medicine, in Saratoga Springs, N.Y., pressure injury is the single leading source of medical-legal litigation, and longterm care facilities and hospitals are the main targets. Common pitfalls of pressure injury include the following: • Failure to perform and document initial skin exam • Failure to establish accurate staging (staging drives dressing and surface choices) • Failure to implement proper wound care • Failure to evaluate and implement plan for nutrition • Failure to implement proper pressure redistribution surface(s) • Failure to implement and document turning and repositioning schedule • Delay in recognition and intervention for worsening wound

“It is useful and instructive to base your care and documentation on a hypothetical review of your own chart,” Dr. Ruotsi said. “If you reviewed your chart, would you be satisfied with your care?”

With this approach, providers should consider the things that they would not want to see in a chart, such as missing or incomplete initial skin exam, inappropriate or missing wound care orders, and failure to address skin issues in a timely fashion.

“At the end of the day, what we’re looking for is simply good-quality, well-documented patient care,” Dr. Ruotis said. “Do the right thing; document that you did it; and be sure that your charting reflects your policies and procedures.” ■

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age in humans. Anesthetic and sedation drugs are a necessary part of the care of children needing surgery, other procedures, or tests that cannot be delayed, Decisions regarding the timing of any elective procedures requiring anesthesia the potential risks. Adverse Reactions: of patients (N=630) receiving Byfavo 5-30 mg (total dose) and undergoing colonoscopy (two studies) or bronchoscopy (one study) were: hypotension, hypertension, diastolic hypertension, systolic hypertension, hypoxia, and diastolic hypotension. Pregnancy effects of Byfavo on pregnancy. Benzodiazepines cross the placenta and may produce respiratory depression and sedation in neonates. Monitor neonates exposed to benzodiazepines during pregnancy and labor for signs of sedation and respiratory depression. Lactation—Monitor infants exposed to Byfavo through breast milk for sedation, respiratory depression, and feeding problems. A lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk during treatment and for 5 hours after Byfavo administration. Pediatric Use—Safety and effectiveness in pediatric patients have not been established. Byfavo should not be used in patients less than Geriatric Use—No overall differences in safety or effectiveness were observed between these subjects and younger subjects. However, there is a potential for greater sensitivity (eg, faster onset, oversedation, confusion) in some older individuals. Administer supplemental doses of Byfavo slowly to achieve the level of sedation required and monitor all patients closely for cardiorespiratory complications. Hepatic Impairment—In patients with severe hepatic impairment, the dose of Byfavo should be carefully titrated to effect. Depending on the overall status of the patient, lower frequency of supplemental doses may be needed to achieve the level of sedation required for the procedure. All patients should be monitored for sedation-related cardiorespiratory complications. Abuse and Dependence: Byfavo is a federally controlled substance (CIV) because it contains remimazolam which has the potential for abuse and physical dependence.

Please see the Brief Summary of Prescribing Information for Byfavo on next page. ASA=American Society of Anesthesiologists Physical Status. of Alertness/Sedation. 1. 2. Pastis NJ, et al. Chest 3. Rex DK, et al. Gastrointest Endosc 4. Data on File. Acacia Pharma Inc. 5. Pambianco D, Cash B. Tech Gastrointest Endosc.

Research Examines Effect of Age on Pathologic Complete Response After Neoadjuvant Chemo

No Difference Seen in Study Of Women With Stage I to III Breast Cancer

By MONICA J. SMITH

In clinical trials of neoadjuvant chemotherapy, younger women tend to have higher rates of pathologic complete response (pCR), which is linked with a better prognosis. New research, however, finds no difference in pCR in a range of age groups, and similar rates of downstaging in the breast and axilla.

To examine the impact of age on pCR and downstaging, Francys Verdial, MD, MPH—who, at the time of the research, was a fellow at Memorial Sloan Kettering Cancer Center (MSKCC) in New York City—and her colleagues evaluated outcomes on 1,385 women with stage I to III breast cancer who had undergone neoadjuvant chemotherapy. (Dr. Verdial is currently a surgeon at Massachusetts General Hospital, in Boston.)

The researchers stratified the patients into three groups: those aged 40 years and under (300 patients), 41 to 60 (772 patients) and those over 60 (311 patients).

“In the case of triple-negative tumors, we also examined the association of tumor-infiltrating lymphocytes [TILs] in BRCA status with pCR,” Dr. Verdial said in a presentation at the 2021 meeting of the American Society of Breast Surgeons.

The distribution of receptor subtypes was similar across age groups. Patients in the youngest cohort were significantly more likely to have ductal histology, poorly differentiated tumors and BRCA mutations than older patients.

As would be expected, among the

for Byfavo© • Only personnel trained in the administration of procedural sedation, and not involved in the conduct of the diagnostic or therapeutic procedure, should administer Byfavo. • Administering personnel must be trained in the detection and management of airway obstruction, hypoventilation, and apnea, including the maintenance of a patent airway, supportive ventilation, and cardiovascular resuscitation. • Byfavo has been associated with hypoxia, bradycardia, and hypotension. Continuously monitor vital signs during sedation and during the recovery period. • Resuscitative drugs, and age- and size-appropriate equipment for bag-valve-mask–assisted ventilation must be immediately available during administration of Byfavo. Concomitant use of benzodiazepines, including Byfavo, and opioid analgesics may result in profound sedation, respiratory depression, coma, and death. The sedative including other benzodiazepines and propofol. Continuously monitor patients for respiratory depression and depth of sedation. Hypnotics Pregnancy—Risk Summary:

entire cohort, pCR was more frequent in patients with HER2-positive or triple-negative tumors than in those with hormone-positive, HER2-negative tumors, but the rate of pCR (34%) did not differ across age groups.

Comparing the rate of pCR by age group across subtype, younger women achieved pCR more frequently among those with triple-negative disease, but there were no differences by age in other subtypes.

“Exploring the potential reasons behind the differences in pCR by age in triple-negative tumors, we looked at BRCA status and TILs in this subgroup, and found young women significantly more likely to have a BRCA mutation compared with ‘I think a lot of it has to do with understanding why the patient is making the decision she’s making, and how you can provide her with the information she needs.’

—Francys Verdial, MD, MPH

Clinical Considerations—Fetal/Neonatal Adverse Reactions Data— Human Data: Lactation—Risk Summary: Pediatric Use Geriatric Use Hepatic Impairment Clinical Presentation Management of Overdosage Alcohol and Current Medications— Pregnancy Lactation—Advise women in older age groups,” Dr. Verdial said.

“Among women with a BRCA mutation, 67% of young women had a pCR compared to 44% and 0% of older women. Among those who were BRCAnegative, the rate of pCR did not differ significantly by age.”

Consistent with the literature, women with tumors high in stromal TILs had significantly higher rates of pCR than women without TILs, but stratified by age, the association between TILs and pCR was significant only in the 41- to 60-yearold cohort. “This may be at least partly explained by sample size,” Dr. Verdial said.

After neoadjuvant chemotherapy, about half of the women initially ineligible for breast-conserving surgery became candidates for it, and this conversion rate was seen across all ages. “Despite similar rates of downstaging, however, young women were significantly more likely to opt for bilateral mastectomy than older patients,” Dr. Verdial said.

Downstaging of the axilla after neoadjuvant therapy was higher in women 40 years of age and younger, of whom 94% with biopsy-proven cN1 disease were clinically node-negative after chemotherapy, compared with 89% and 85% in patients aged 41 to 60 and 60 years and older, respectively. More than half of the younger patients (52%) were able to avoid an axillary dissection, compared with 39% and 37% of women in the older cohorts.

Preeti Subhedar, MD, FACS, an assistant professor of surgical oncology at Emory University School of Medicine, in Atlanta, pointed out that even when young women are eligible for breast-conserving surgery, many continue to choose bilateral mastectomy regardless of their response to neoadjuvant chemotherapy.

“The message that overall survival is not different between breast-conserving surgery and mastectomy doesn’t seem to be getting across, especially to younger patients. Maybe we should reframe the conversation; instead of thinking about less treatment, which sounds negative, we should talk about reducing morbidity from procedures they don’t need, which is more positive.”

Dr. Verdial said she’s observed that her surgical colleagues at MSKCC are particularly adept at swaying patients away from larger and potentially more morbid procedures when they are good candidates for breast-conserving surgery.

“I think a lot of it has to do with understanding why the patient is making the decision she’s making, and how you can provide her with the information she needs. This sometimes takes a little extra work, but it’s very important that we understand where patients are coming from, what information they’re using to make their decisions, and what their priorities are,” she said. ■

Substance Use and Bariatric Surgery: What to Look for, What to Do

continued from page 1

Tobacco

Ivy Haskins, MD, an assistant professor of surgery at the University of Nebraska Medical Center, in Omaha, pointed out that smoking cessation is often a requirement for bariatric surgery at many medical centers or by insurance. Landmark articles have detailed the increased risk for early pulmonary and wound morbidity events in current smokers in both open and laparoscopic bariatric surgery, Dr. Haskins said. A recent systematic review describes the short- and long-term effects of smoking on bariatric surgery outcomes (Surg Endosc 2021;35[6]:3047-3066). In addition to early pulmonary and wound events, this review showed that active smokers also experience an increased rate of marginal ulcer formation and vitamin and mineral deficiencies. Guidelines from the American Association of Clinical Endocrinology, The Obesity Society and ASMBS state that tobacco use should be avoided at all times by all bariatric surgery patients (Surg Obes Relat Dis 2013;9[2]:159-191).

“Some studies have shown that patients who have had a longer period of time between smoking cessation and bariatric surgery are more likely to abstain from smoking over the long term, and perhaps requiring a longer period of smoking cessation preoperatively may decrease the likelihood of resuming smoking postoperatively,” Dr. Haskins said. She noted that a multimodal approach to smoking cessation works best, and clinicians should watch for addiction transfers, such as a patient quitting smoking and then becoming a sugar craver.

Although one in seven adults smoke cigarettes the year before undergoing weight loss surgery and nearly all successfully quit at least a month before their operation, smoking prevalence steadily climbs to presurgical levels within seven years after surgery (Ann Surg 2020 Feb 20. doi:1092SLA 0000000000003828). “There are likely many explanations for this observation, but one that I think that is worth highlighting is patient counseling,” Dr. Haskins said. “According to an American College of Surgeons statement, only 13% of general surgeons provide smoking cessation counseling to their patients. Additionally, many surgeons do not know the resources available to their patients either within their own hospital system or because of differences in insurance coverage for these types of programs. One program that may offer guidance is the Quit Smoking Before Surgery program, which is offered through the American College of Surgeons and has resources for both physicians and patients.”

Dr. Haskins said at the University of Nebraska Medical Center, smoking history is part of the bariatric intake process, and is discussed at every subsequent visit that occurs at the bariatric center. She said bupropion is often the first-line medication used to assist with smoking cessation. “When counseling bariatric surgery patients, it is important that they understand that smoking cessation is part of their lifelong lifestyle change, and that the success of their operation not only depends on the changes in their eating and exercise habits, but also on avoidance of smoking, which can negatively impact the long-term success of their surgery,” she said.

Marijuana

According to Allyson Diggins, PhD, an associate staff psychologist at the Cleveland Clinic Bariatric and Metabolic Institute, in Cleveland, between 6% and 8.3% of all individuals who are pursuing bariatric surgery endorse marijuana use. “There is a lot of debate about whether marijuana is a contraindication for bariatric surgery,” Dr. Diggins said. “When we look specifically at bariatric surgery, we see that studies have demonstrated an increased risk in two different areas: pain management as well as problematic eating behaviors.”

A study of 434 bariatric surgery patients found that 8.3% endorsed marijuana use. Those patients who endorsed marijuana use had significantly higher perioperative opioid requirements (natural log morphine equivalents of 3.92 vs. 3.52; P=0.0015) (Perm J 2018;22:18-002). Another study found that patients who used marijuana after surgery were more likely to have disordered eating (Surg Obes Relat Dis 2016;12[1]:171-178).

But there are no randomized trials examining whether marijuana is a contraindication for bariatric surgery. “In the studies that we do have, we see that there is no increased risk in short-term or 90-day complications [with marijuana]. There is no difference in weight loss at two weeks to three years after surgery. We also find that there is similar surgical site infections as well as similar 30-day readmissions and similar 30-day ED [emergency department] visits. Of note, in a lot of these studies, we don’t see the longterm effects of marijuana and what happens after that two-year point,” Dr. Diggins said.

Dr. Diggins said there is a dearth of research exploring marijuana use in bariatric surgery, and there are more questions than answers on this topic. ‘It is important that [bariatric patients] understand that smoking cessation is part of their lifelong lifestyle change, and that the success of their operation not only depends on the changes in their eating and exercise habits, but also on avoidance of smoking, which can negatively impact the long-term success of their surgery.’

Alcohol

Scott Engel, PhD, the director of behavioral research at Sanford Health in Fargo, N.D., said it is well established that bariatric surgery increases the risk for alcohol disorders. In one study of 2,348 patients who underwent Roux-en-Y gastric bypass (RYGB) or laparoscopic adjustable gastric banding (LAGB), 20% of patients reported incident alcohol use disorder (AUD) symptoms within five years of undergoing RYGB, and undergoing RYGB versus LAGB was associated with twice the risk for incident AUD symptoms (Surg Obes RelatDis 2017;13[8]:1392-1402). Numerous other studies highlight the risks for AUD after bariatric surgery (Obesity 2013;21[12]:2444-2451; JAMA Surg 2013;148[4]:374377). “We find that after bariatric surgery, patients become much more intoxicated, and we see significant changes in the pharmacokinetics of alcohol after surgery,” Dr. Engel said.

According to the ASMBS, patients undergoing bariatric surgery should be screened and educated about AUD and bariatric surgery, and active AUD is a contraindication for weight loss surgery.

Opioids

According to Sanjeev Sockalingam, MD, a professor of psychiatry at the University of Toronto, and vice president, education and clinician scientist, at the Center for Addiction and Mental Health, and the director of the Bariatric Surgery Psychosocial Program, University Health Network, opioid use post-surgery is a concern and can lead to surgical and psychosocial sequelae. “In the U.S., 38 people die every day from overdoses involving overdoses of prescription opioids,” Dr. Sockalingam said. “We know that the initial prescription of opioids after surgery for pain management can lead to more persistent and continued use.”

In a study involving 56,183 bariatric surgery patients, preoperative opioid use was an independent risk factor for adverse events including severe complications (odds ratio [OR], 1.67), reoperation (OR, 1.87), length of stay (relative risk, 1.11) and readmission (OR, 1.70) (SurgObes Relat Dis 2021;17[7]:1256-1262). Risk factors for continued or post-surgery initiated opioid use are more pain at baseline or less pain improvement, continued benzodiazepine use, subsequent bariatric procedures, improvement in mental health after surgery, and history of orthopedic surgery (Surg Obes Relat Dis 2017;13[8]:1337-1346). In a recent study involving 27,779 patients undergoing bariatric surgery, 21% had presurgical opioid use, and the rate of new persistent opioid use after bariatric surgery was 6.3% (Surg Endosc 2019;33[8]:2649-2656).

According to Traci Speed, MD, PhD, an assistant professor of psychiatry and behavioral sciences and the chief psychiatrist of the personalized pain program at the Johns Hopkins University School of Medicine, in Baltimore,patients undergoing bariatric surgery who are on chronic opioids have decreased quality of life, worse clinical outcomes, less weight loss, worse body image and a higher rate of depression.

“Broadly speaking, risk factors for opioid use disorder include individuals with a family history of substance use, less education or who are unemployed, certain personality traits such as impulsivity or being antisocial, having a mood disorder or anxiety disorder, as well as those with exposure to trauma or stress early on in life,” she said.

Dr. Speed said there is evidence that patients who have undergone bariatric surgery tend to get prescriptions of opioids in excess of what they actually use. An approach to minimizing opioid exposure during the perioperative period is to use collaborative care approaches, such as the enhanced recovery after surgery protocol, or ERAS.

“Those who receive higher doses and a greater duration of opioids are going to be at greater risk for developing a disorder. In the bariatric surgery population, we know that opioid-naive patients are at risk of developing persistent opioid use, and that is true for about 4% of the population. Those on preoperative opioids are at risk of continuing postoperative opioids, and that is true for 50% to 75% of the population.” ■

—Ivy Haskins, MD