Oncology Closed Claims Study
The Doctors Company conducted a review of medical and surgical oncology claims that closed between 2012 and 2018. This study was based on claims and lawsuits filed against the more than 500 oncologists insured by The Doctors Company. There were 101 medical oncology claims and two surgical oncology claims. Due to the small number of surgical oncology claims, they were excluded from the study.
For Oncologists, COVID-19 Raises Communication Stakes
“COVID-19 has placed enormous burdens on oncologists, who are caring for especially vulnerable patients amid shifting clinical understandings while juggling uncertain healthcare resources.
“Many hematology/oncology patients are immunocompromised by either disease or treatment,” says Charles R. Kossman, MD, PhD, a hematologist and medical oncologist who serves on The Doctors Company’s Board of Governors and is a clinical professor of medicine at the University of California, San Diego. At this time, oncologists may find themselves in the impossible position of trying to build positive patient relationships while communicating pandemic-related delays in treatment access—without being able to give a definitive answer regarding when a certain treatment will be safe or available.1
The protective benefits of quality communication with patients and family members are worth striving for, since the pandemic adds health risks for patients and liability risks for providers. The literature provides ample evidence that patients’ claims are sometimes based more on how they felt they were treated than on outcomes or standard of care, and that, conversely, maintaining quality relationships with patients can lessen oncologists’ odds of being sued.2,3,4
Dr. Kossman stresses the importance of overcoming communications hurdles, such as when visitor restrictions mean that patients are undergoing treatment with “little family presence.” He says,
“This can cause emotional and logistical problems; e.g., the inability to have a concurrent meeting with patient and family. The MD can sometimes see the patient while simultaneously including the family on a streaming telemedicine platform.”
This is especially important for patients with cognitive impairment or language barriers, Dr. Kossman says.
Patients whom oncologists haven’t seen present liability risks, as well: Patient fears of contracting COVID-19 have led many to avoid seeking or resuming care, so delays in diagnosing new cancer cases could mean that more patients are diagnosed at a later stage of their disease,5 leading to potential adverse events and malpractice claims.
Now, more than ever, is the time to identify what has led to claims against oncologists in the past to elevate awareness of misdiagnoses and communication factors that can lead to suits. In so doing, oncologists can mitigate their risk of claims resulting from treatment during COVID-19 and beyond.
References
- GMoore V. Communicating with patients in oncology about care during the COVID-19 pandemic. Cancer Therapy Advisor. Published September 17, 2020. Accessed September 21, 2020. hhttps://www.cancertherapyadvisor.com/home/cancer-topics/general-oncology/communications-regarding-oncologic-care-during-a-pandemic/
- 2 Martin KL. Medscape Oncologist Malpractice Report 2019. Published January 22, 2020. Accessed September 21, 2020. https://www.medscape.com/slideshow/2019-malpractice-report-onco-6012449#4
- Scott S. Strong physician-patient relationships improve care, ward off malpractice suits. AAP News. Published July 23, 2019. Accessed September 21, 2020. https://www.aappublications.org/news/2019/07/23/law072819
- Schleiter KE. Difficult patient-physician relationships and the risk of medical malpractice litigation. AMA Journal of Ethics. Published March 2009. Accessed September 21, 2020. https://journalofethics.ama-assn.org/article/difficult-patient-physician-relationships-and-risk-medical-malpractice-litigation/2009-03
- Dillard, R. COVID-19 has affected cancer care and oncologists’ well-being. DocWireNews. Published September 15, 2020. Accessed September 30, 2020. https://www.docwirenews.com/docwire-pick/hem-onc-picks/covid-19-has-affected-cancer-care-and-oncologists-well-being/
Regardless of the outcome, all oncology claims against our members that closed within the time frame were included in the analysis. This approach helps us better understand what motivates patients to pursue claims and gain a broader overview of the system failures and processes that result in patient harm.
This study, reinforced by expert insights and relevant case examples, focused on the following areas:
- Most common patient injuries.
- Indemnity and expense.
- Most common case types driving oncology malpractice claims.
- Factors contributing to patient injury.
- Strategies for mitigating risk.
Our approach to studying oncology malpractice claims began by studying patients’ injuries to understand the full scope of harm. Physician experts for both the plaintiffs/patients and the defendants/physicians reviewed claims and conducted medical record reviews. Our clinical analysts drew from these sources to gain an accurate and unbiased understanding of actual patient injuries.
We then looked to capture the key clinical areas or case types. These clinical drivers helped us focus on the causes of patient harm and what prompted patients or their families to file claims and suits.
We identified factors that led to patients’ injuries. Physician reviewers evaluated each claim to determine whether the standard of care was met. Contributing factor categories included clinical judgment, technical skill, patient behaviors, communication, clinical systems, clinical environments, and documentation.
Our team studied all aspects of the claims and identified risk mitigation strategies that physicians can use to decrease the risk of injury, thereby improving the quality of care.
Patient Injuries
Oncology patients suffered a variety of injuries. The seven most common injuries that prompted claims or suits included:
Patients may have suffered more than one harm, so the total is greater than 100 percent.
Indemnity and Expense
Only a small percentage of oncology patients’ claims (26 percent) resulted in a payment to the patient or their family.
$275,529
Mean Indemnity Paid
$94,340
Mean Expense Paid
The potential for large indemnity awards exists, as three claims (13 percent of paid claims) were in excess of $1 million. However, half of payments for alleged negligence were less than $100,000.
$98,750
Median Indemnity Paid
$80,551
Median Expense Paid
Range of Indemnity Payments in Oncology Claims
Indemnity Paid Between $1 and $499,999
Indemnity Paid ≥ $1,000,000
Indemnity Paid ≥ $2,000,000
Case Types Driving Oncology Claims and Lawsuits
There were three primary case types driving medical oncology claims. They were diagnosis related (29 percent), management of treatment (24 percent), and medication management (15 percent). The top three case types made up 68 percent of medical oncology claims.
Top Five Case Types Driving Oncology Claims 2012–2018
Case types not listed above had 2 percent or fewer claims. The list included delay in treatment or procedure, improper performance of treatment or procedure, premature end of treatment, failure to warn of risks, and failure to ensure safety (falls).
Driver 1: Diagnosis Related
In diagnosis-related claims, the most common diagnoses involved secondary malignancy of the bone (14 percent), malignant neoplasm of the breast (7 percent), and secondary malignant neoplasm of the liver (7 percent). There were 21 other diagnoses with only one claim each.
A 40-year-old patient was diagnosed with stage 1 left breast carcinoma with characteristics of ER-positive, PR-positive, and HER2-negative features. She underwent a left mastectomy with subsequent reconstruction. A year and a half after the reconstruction, she was seen by the oncologist for follow-up. His plan was for her to continue tamoxifen for five years as well as receive annual mammograms and MRIs. She was tolerating chemotherapy well, and her last mammogram of the right breast was normal. The patient continued to be followed by the oncologist and her primary care physician.
MRIs and mammograms continued to be negative. Approximately two years after diagnosis, the patient began to complain of left rib pain. Also, around this time, the patient complained of a new small, hard nodule in her left reconstructed breast. The oncologist referred her for a biopsy. The result of the biopsy demonstrated ductal carcinoma grade III, ER- and PR-negative, and HER2/neu 1+. A PET scan revealed extensive metastatic disease. She was restarted on chemotherapy but succumbed six months later.
The plaintiff alleged failure to biopsy timely the suspicious nodes in the patient’s right axilla and negligent failure to follow a breast cancer patient at intervals of less than one year. The plaintiff also alleged failure to evaluate the patient’s rib pain with greater urgency. Defense experts supported the care by the oncologist. The plaintiff failed to pursue the claim, and it was ultimately dismissed.
A 51-year-old female underwent surgery to remove a stage I lesion in her right breast that was hormone receptor positive, HER2/neu negative, 1.2 cm in size, but poorly differentiated. The patient had aggressive cancer that was even more concerning due to her young age, high Oncotype DX score, and the need for multiple attempts to obtain clear margins. There was at least a 30 percent chance that there would be a recurrence of this type of cancer because of micrometastatic disease. As a result, radiation therapy to the chest, as well as chemotherapy and hormone therapy, was deemed necessary following the initial surgery to eliminate any micrometastatic disease. However, the patient refused adjuvant cancer treatment.
The patient transferred her care to another oncologist nearly one year after her surgery. Hormonal therapy was recommended but refused. The patient was monitored for two years with no signs of recurrence. The patient continued to complain of chest pain. Based upon an elevated CEA, imaging studies were ordered, which showed that the breast cancer had metastasized to the sternum, liver, and ribs. The patient continued to refuse all radiation, chemotherapy, and hormonal therapy. The patient passed away.
The claim alleged failure to diagnose breast cancer in a timely manner. Physician reviewers were supportive of the defense, stating that the patient’s failure to undergo radiation therapy to reduce the risk of local recurrence and chemotherapy and hormonal therapy to reduce the risk of systemic recurrence ultimately caused her death. The defense prevailed on a motion for summary judgment.
The factors that contributed to patient injury in diagnosis-related claims included patient behavior factors (52 percent), inadequate patient assessments (38 percent), communication among providers (21 percent), and communication between the patient (or family members) and providers (17 percent).
Patient behavior factors were important in diagnosis-related claims. More than half of the claims and suits filed against oncologists in such cases included patients’ decisions not to attend all appointments or follow medication or treatment plans. Thus, oncologists were unable to discuss results, conduct additional studies to continue the diagnostic process, or to perform evaluations that may have uncovered symptoms of recurring cancer. Some patients also went to other, non-oncology providers when they were unhappy with their care.
Clinical assessments in oncology diagnosis-related claims were different from primary care claims. In primary care, such claims commonly demonstrated inadequate histories and physicals and/or failure to establish a differential diagnosis. Oncology diagnosis-related claims involved failure to reconcile relevant signs, symptoms, and test results, or a narrow diagnostic focus where it was presumed that the patient’s chronic condition was the cause of current symptoms.
A 56-year-old male with history of hormone refractory prostate cancer saw an oncologist for ongoing PSA elevation. The patient was treated with chemotherapy and later radiation therapy.
The patient complained of low back pain radiating down his leg. He was placed on fentanyl and Norco with good relief.
During later visits, the patient complained of bone and worsening back pain. A CT scan suggested metastatic disease in the sacrum and the lumbar spine. A month later, the patient was having difficulty walking and was diagnosed with thoracic cord compression. Decompression surgery was not successful. The patient became paralyzed and later expired.
The claimant alleged that delay in diagnosis of metastasis to the T-spine resulted in paralysis. Physician reviewers were supportive of the defense, stating that there was no delay. They stated that the spinal canal is very small, so compression can occur very rapidly. Also, strong analgesics can mask pain, delaying patient complaints and attempts to diagnose the source. The plaintiffs failed to pursue the claim.
A 57-year-old patient with a history of asthma, diabetes, coronary artery disease, and COPD was diagnosed with stage IV renal cell cancer with metastasis to the lungs. She was admitted to the hospital in respiratory distress with possible pneumonia. The oncologist ordered several consultations, including pulmonology and infectious disease. He also ordered cardiology and nephrology consultations as the patient’s condition deteriorated.
Multiple tests for bacterial, viral, and fungal diseases were ordered. The patient developed a fever and hypotension, so she was transferred to the ICU and placed on a ventilator. The working diagnosis was opportunistic infection as a result of a compromised immune system due to chemotherapy. The patient was treated with antibiotics but expired.
The autopsy revealed that the patient had suffered from diffuse alveolar damage to both lungs. No infectious source was identified by histology or culture.
The claim alleged failure to diagnose and treat the patient’s adverse reaction and lung toxicity from Torisel chemotherapy. Plaintiff’s experts opined that pneumonitis should have been included in the differential diagnosis and treated with high-dose steroid therapy. Defense experts supported the care provided by the oncologist. They noted that the care was being coordinated by the hospitalist, and that the oncologist brought pulmonology and infectious disease specialists into the discussion in a timely manner. Defense experts noted that the patient was in the end stage of the disease, and that it was unlikely that high doses of steroids would have altered the outcome. The case was dismissed.
In diagnosis-related claims, communication among providers was sometimes found to be deficient. Information regarding patients’ conditions was not always conveyed when critical information was found. In one case, results of a CT scan were communicated to the physician’s assistant but not to the attending physician or patient. Neither was aware of metastasis until 10 months later. A second case involved a patient who was incorrectly diagnosed with metastatic lesions of the lung. Other physicians doubted the diagnosis but did not communicate their concerns until the patient had received chemotherapy and a node biopsy demonstrated the lesion was benign.
A patient presented to his primary care provider with symptoms of a CVA. The patient’s blood pressure was elevated, so the patient was started on hypertension medications. Lab results were normal except for elevated platelets (>1,000,000). The patient was referred to an oncologist.
The patient’s platelet counts continued to be elevated, so the patient was placed on anagrelide. Tests for JAK-2 mutation, BCR-ABL, and serum erythropoietin were ordered for a possible diagnosis of polycythemia vera. The patient had a positive BCR-ABL test; JAK-2 was negative.
The oncologist’s office received a report that was indicative of chronic myeloid leukemia (CML). However, the oncologist did not see the report, due to unfamiliarity with the new electronic health record. The patient was assigned to the oncology office’s nurse practitioner and was treated for the next year as though he had only essential thrombocytosis.
The patient presented to an emergency department with symptoms of a second CVA. He was sent to his primary care physician’s office for follow-up to his elevated blood pressure.
Three months later, the patient returned to the oncologist’s office with new test results confirming CML. He was started on Gleevec.
The patient filed a claim alleging that delay in treatment for CML resulted in his second CVA. Reviewers were mixed in their opinions. Some defended the care of the oncologist, stating that the CVA was due to elevated blood pressure. Others were critical of the failure to track test results and view the first report indicating CML. Also, they criticized follow-up by a nurse practitioner without periodic assessments by the oncologist as being below the standard of care. The case settled.
Lack of communication between patients (or their families) and their physicians impacted the outcome in diagnosis-related claims. In a case where the patient had a low platelet count from chemotherapy, the patient fell at home and did not communicate this to her treating physician until after being diagnosed with an intracranial bleed. Language barrier was also a factor.
Driver 2: Improper Management of Treatment
The second-most common driver of claims was improper management of treatment (24 percent). Physician reviewers found inappropriate selection of treatment, including failure to order medications and ordering medications that were contraindicated by other medications or were not the most appropriate for the patient’s condition.
In one case, the patient’s white blood count was very low, but the decision was made to give the next chemotherapy dose. The patient’s white blood count dropped even lower. The patient began to experience intense weakness with fever and chills. She was admitted to the hospital but before medications or a blood transfusion could be started, the patient expired.
Some experts opined that the chemotherapy dose should not have been given. Others said that the patient would have experienced a poor outcome regardless of the interventions.
In another case, two numbers for the chemotherapy order were transposed, increasing the dose five-fold. The patient received the excessive dose for five days before the error was discovered, resulting in hearing loss, neuropathy, and kidney damage.
A 39-year-old male was referred to the oncologist for probable CML. The patient’s white blood cell (WBC) count was 230,000 with no blasts. His hemoglobin was 12.6 and platelet count was 240,000. Fluorescent in-situ hybridization (FISH) for BCR-ABL mutation test was ordered. The patient was started on hydroxyurea while waiting to confirm the diagnosis. Allopurinol was also ordered.
Two days later the complete blood count (CBC) showed 189,000 WBCs, so emergency leukapheresis was ordered. Five days later, the CML diagnosis was confirmed, so the patient was started on 400 mg of Gleevec.
Two weeks after starting Gleevec, the patient’s WBC dropped to 3.4, with hemoglobin 9.9 and platelets 252,000. He complained of bone pain and other symptoms that the patient attributed to Gleevec. Gleevec was reduced to 200 mg.
Two weeks later, the patient was evaluated by the oncologist, who recommended increasing the dose of Gleevec to 400 mg. The patient refused.
Five months later, tests indicated that the patient had entered the accelerated phase, with 19 percent blasts in the WBC differential. The oncologist explained the seriousness of the illness and the need to increase Gleevec to 400 mg. The oncologist planned to restart allopurinol and hydroxyurea. He also ordered Sprycel.
When the accelerated phase was confirmed, the oncologist discontinued Gleevec and continued Sprycel. The patient asked for a second opinion. The second oncologist restarted Gleevec and continued Sprycel.
The oncologists consulted with others, who recommended a bone marrow transplant. The patient agreed to the transplant, but had two CML relapses and chronic graft-versus-host disease following transplant.
Experts were mixed in their reviews. Some were critical, stating that the FISH testing should have been repeated at three months, since the patient was on a substandard dose of Gleevec. Others stated that the patient was on the low dose for too long. When the patient experienced side effects, the oncologist should have stopped and then restarted the medication.
Some reviewer oncologists observed that if the patient was reacting to Gleevec, he should have been switched to a different medication like Sprycel. The reaction to Gleevec showed an increased chance that the medical management with this drug would fail. The patient should have been counseled earlier on the need for a bone marrow transplant. There was poor documentation on informed refusal for the risks of not taking the recommended doses of medications. The case was settled.
This study found that patients’ behaviors not only affected clinicians’ ability to diagnose reoccurring malignancies, they affected physicians’ ability to manage treatment. In more than one in five cases (21 percent), patient behaviors had an impact on the outcome of care. In some cases, patients looked to other providers when they were dissatisfied with care, thus eliminating the treating oncologists' ability to address patients’ concerns. Other troubling patient behaviors included failure to adhere to treatment or medication plans.
A third factor that affected oncologists’ ability to manage patients’ treatment was inadequate communication between providers and patients or their families. In some cases, patients failed to report important clinical information. In other cases, physicians did not provide adequate information about the risks of medications or inform patients about other treatment options. There were occasions of tension between physicians and patients when the physicians’ responses were not viewed as sympathetic by their patients, thus widening the communication gap. In a few cases, language barriers made communication difficult.
In one case, a patient on chemotherapy began having low-grade fevers. Her physician ordered a CBC, but the patient did not have the test performed. There was no follow-up discussion about the CBC or its importance.
At subsequent office visits for chemotherapy injections, the patient’s vital signs were not checked (or not documented). The patient’s family recorded her body temperatures during treatment, but it appears that as she became febrile, the information was not reported to her physician.
The patient presented to the emergency department in septic shock and subsequently died. Although this claim against the physician was unsuccessful, it demonstrates how failure to share information between patients, families, and providers can harm patients.
In other communication cases, patients refused to continue with treatment. Documentation was limited or did not exist regarding physicians’ conversations with patients about the consequences of refusing treatment or about other treatment options.
Driver 3: Improper Medication Management
The third driver of medical oncology claims was inadequate medication management. The factors that contributed to patient injury included inappropriate selection of therapy (47 percent), patient assessment issues (33 percent), communication among providers (33 percent), and communication between patient/family and providers (33 percent).
Inappropriate selection of therapy included ordering medications that were inappropriate for the patient’s condition or were contraindicated by other medications.
Patient assessment issues included failure to appreciate and reconcile relevant signs, symptoms, and test results. Communication among providers was most often related to changes in patients’ conditions. Communication between patient/family and provider was usually about the risks of medications.
Most of the drugs associated with oncology claims were chemotherapy/immunosuppressants. A patient with lung and metastatic brain cancer was simultaneously treated with chemotherapy and radiation. The patient received conservative doses of radiation. However, the patient expired suddenly from a suspected brain hemorrhage.
Some experts were critical of the aggressive treatment, noting a decreased quality of life and diminished life expectancy. Some noted that the oncologist failed to warn of the dangers of receiving simultaneous chemotherapy and radiation treatment. A few experts observed that while the treatment was aggressive, it was not outside the standard of care. The case was not pursued.
In several cases, patients received excessive doses of chemotherapy. Pump malfunctions or incorrect settings resulted in patients receiving very large doses. In other cases, patients reacted to the drugs but were maintained at a high level or kept at a low dose for too long. Some patients experienced severe neutropenia, thrombocytopenia or pancytopenia, sepsis, and/or lung and cardiac damage. In one case, experts opined that the patient had been expected to recover but suffered life-altering injuries from excessive medication doses.
In a few cases, anticoagulants were not managed properly, resulting in hemorrhages and brain damage or loss of an appendage. In one case, the physician was aware of the heparin-induced thrombocytopenia but failed to change to an appropriate anticoagulant immediately. This resulted in below-the-knee amputations.
Risk Mitigation Strategies
- In 29 percent of oncology claims, patients alleged that there was a failure or delay in diagnosing the patient’s illness. Some were initial diseases and others were secondary malignant neoplasms of the bone or marrow (14 percent of diagnosis-related claims). The most frequent factor contributing to patient harm was inadequate assessments. Physicians are responsible for thorough assessments and documentation of their findings. This is especially true when patients’ conditions change.
- The second-most common case type (24 percent) was related to treatment management. In some cases, patients did not have tests performed. In other cases, tests were completed, but information was not reviewed by the ordering physicians. It is essential to track and review all test results for tests that are ordered. Failure to log and track orders for diagnostic tests increases the chance that important information will not be received.
- Patients are important members of the healthcare team. They need to receive information required for making informed decisions about care and treatment. When patients refuse to proceed with treatment recommendations from their physicians, physicians should document the information provided, the patient’s decision-making process, and their final decision.
- Patients are an important source of information, but they may not know what information should be shared with their physicians. Physicians should help patients understand the information that physicians need, such as changes in their condition, reactions to medications, falls and other trauma, and supplemental treatments that patients adopt that are not part of their oncologist’s recommendations.
- In 9 percent of oncology claims and suits, patients chose to seek care from a different physician. This eliminated the opportunity for original treating oncologists to address patients’ concerns. Open communication with patients is essential for eliciting important information and encouraging candid revelations from patients. It also appears to improve adherence to treatment plans.
- The healthcare team is essential for catching inadvertent errors in medication orders and other medication-related treatment. Create an environment where anyone can raise a concern, thus increasing the chance that errors will be identified and communicated before patients are harmed.
- Practices should fulfill their obligations to provide language assistance for patients whose treatment may be impeded by language barriers. Translators should accompany patients who have language barriers.
- Physicians should supervise nurse practitioners and/or physician assistants as appropriate in their respective states.
Oncology patients are often very ill and fragile. Medical errors can be devastating. Healthcare environments that encourage open communication increase the chances that patients or staff will speak up when they have concerns. Well-designed office systems can identify missing consult reports and test results.
Use every tool available to maintain current information on patients. This information provides the opportunity to respond quickly to patients’ changing conditions and to address patients’ needs. The quality and length of patients’ lives often depend on it.
The guidelines suggested here are not rules, do not constitute legal advice, and do not ensure a successful outcome. The ultimate decision regarding the appropriateness of any treatment must be made by each healthcare provider considering the circumstances of the individual situation and in accordance with the laws of the jurisdiction in which the care is rendered.
10/20
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