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By Damian D. Capozzola, Esq.
The Law Offices of Damian D. Capozzola
Jamie Terrence, RN
President and Founder, Healthcare Risk Services
Former Director of Risk Management Services
California Hospital Medical Center
Morgan Lynch, 2018 JD Candidate
Pepperdine University School of Law
News: A woman presented to a hospital to evaluate a lump in her left breast. The hospital conducted tests and the results were concerning, but no biopsy was conducted on the mass. The patient was referred to a general surgeon for surgery secondary to persistent mastitis. After the procedure, the patient returned to the surgeon for a workup on a new lump.
The patient then presented to the original hospital for testing on the new lump, and again no biopsy was performed. The same surgeon recommended a biopsy; however, he neglected to perform or schedule the biopsy. The patient presented to a different hospital for a biopsy, revealing stage three breast cancer.
The patient filed suit against various medical professionals and entities, and received a $21.5 million jury verdict.
Background: On Sept. 21, 2013, a woman presented to a hospital to examine a lump in her breast she had felt for more than a week. At the hospital, an ultrasound was conducted and interpreted by a physician who believed the mass was caused by cellulitis. The physician recommended a follow-up appointment within the next six months for a repeat ultrasound.
On Oct. 2, 2013, the patient presented to an imaging services company with the history of the previous ultrasound, the detected mass believed to be caused by cellulitis, and a history of left breast pain and swelling, and antibiotic treatment. A physician reviewed and interpreted the ultrasound and noted that it showed no masses, but he did note skin thickening and a lymph node abnormality.
Five days later, the patient was referred to a general surgeon for breast surgery secondary to persistent mastitis. A week later, the surgeon saw the patient again for a workup on a new mass in her left breast. No biopsy was performed or scheduled. On Jan. 8, 2014, the patient attended a follow-up appointment with the surgeon, who again did not perform a biopsy.
Nine days later, the patient presented to the hospital for a repeat ultrasound and mammogram, both of which were performed by the hospital physician who conducted the original ultrasound. The physician again noted the presence of diffuse left breast skin thickening and noted the presence of a 14 mm lymph node in the left axilla, which he described as smaller since the prior exam in September. The physician’s impression of the left breast was skin thickening compatible with patient’s history of mastitis, and recommended a follow-up in six months for a repeat ultrasound. On June 11, 2014, the surgeon recommended testing for autoimmune disease and a breast biopsy, which he did not schedule or perform. After the initial hospital, physicians, and surgeons failed to perform biopsies, the patient eventually had biopsies performed at a different hospital, which revealed stage three breast cancer.
The patient filed suit against the initial hospital, the imaging company, the surgeon, the initial hospital’s physician, and medical professionals. The patient alleged several causes of action, including negligent diagnosis, negligent treatment, negligent examination, negligent follow-up prior to discharge, failure to obtain informed consent, negligent interpretation, and negligent imaging. The patient claimed that this deviation from the standard of care caused her permanent or continuing pain and suffering, disability, disfigurement, mental anguish, loss of capacity for the enjoyment of life, expense of hospitalization, medical and nursing care and treatment, loss of earnings, loss of ability to earn money, and/or aggravation of a previously existing condition. The patient’s husband also alleged that the negligence caused him to suffer loss of comfort companionship and consortium.
At trial, the physician argued that he was not liable because another defendant failed to place a transducer over the patient’s breast lump to capture it on the ultrasound. He further claimed he was not provided the original film, which was disputed by the medical record.
A jury returned a verdict in favor of the patient and her husband against the physician and surgeon for $21.5 million, comprised of $2 million for past medical expenses; $156,000 for past lost earnings; $1.4 million for lost earning capacity; $7 million for past pain and suffering; and $11 million for future pain and suffering.
What this means to you: This case illustrates the need for reviewing medical records in their entirety, and the need to establish a risk analysis procedure for each patient’s circumstances and symptoms. This case also provides an opportunity to survey the treatment options and procedures for persistent mastitis. To provide competent medical services for a patient, medical professionals must review the patient’s medical record. Given the burden of reviewing a potentially voluminous record, this can be a difficult balancing decision between taking the time to fully review and thoroughly understand a patient’s medical record and efficiently treating a large volume of patients. One method for increasing efficiency of medial record review is to improve organization of the record through standardization and implementation of optimized electronic recordkeeping. Standardization reduces time spent interpreting patient data, allowing for more analysis and patient interaction time. Electronic medical records can display different types of patient data and multiple provider data in one view, suggest diagnoses based on keywords, and aid in verifying diagnoses. Optimizing patient recordkeeping has tremendous benefits and can boost hospital efficiency significantly.
However, this patient did not have mastitis, and the first set of medical professionals failed to recognize this for multiple reasons. First, mammography, the gold standard for visualizing breast abnormalities, was not performed. While an ultrasound is the appropriate test to focus on a specific finding following an abnormal mammogram, the mammogram provides useful diagnostic information about the general health of breast tissue. Second, the assumption of a diagnosis without the confirmation of a consulting radiological oncologist is problematic. While a diagnosis of mastitis is much less traumatic for a patient to deal with, further review of the ultrasound results should have been performed by a consulting radiologist. Additionally, when the patient’s symptoms failed to respond to the initial treatment plan, a biopsy should have been the next option and the appropriate standard of care. Physicians place their patients and themselves at risk when following the “path of least resistance” to save time, money, or a patient’s peace of mind. All physicians involved in the first round of care for this patient relied on the first diagnostic assumption without confirmatory data.
To reduce the frequency of injured patients and medical malpractice claims, hospitals should encourage professionals to engage in a risk-benefit analysis with each patient based on their unique circumstances and symptoms. A common test for whether a defendant acted negligently is whether the burden of performing an act outweighs the product of the gravity of the potential harm and the probability of that harm occurring. If the burden outweighs the potential harm to the plaintiff, the defendant is not negligent. While this test should not be the final determinate of whether to provide medical services, it can be a useful tool for medical professionals.
As applied to this case, the burden is performing a biopsy, which includes factors such as the level of invasiveness of the biopsy, the cost to the patient, and the cost to the hospital in terms of surgeon time and equipment costs. Breast biopsies can be performed with minimal invasion of the patient via fine needle aspiration, a core biopsy, a vacuum-assisted breast biopsy, or an image-guided needle biopsy. The cost to the patient often is subsidized by insurance companies to encourage early diagnosis, and the cost to hospitals is offset by a reduction in defending medical malpractice claims and judgment payouts.
The gravity of harm associated with failing to timely diagnose breast cancer is significant. Early diagnosis increases a patient’s chances of survival, reduces the chances of the cancer spreading, and reduces the overall harm to the patient. It is difficult to estimate the probability that any individual patient will develop breast cancer; however, one interesting data point from a 2008-2010 study is that 20-30% of breast biopsies reveal cancer. The relatively low burden associated with performing a biopsy coupled with the high gravity of harm and high probability of harm show that, based on her symptoms, failure to biopsy the patient in this case was not worth the risk.
Ultimately, it is up to each individual hospital and medical professional to balance the risks of providing a specific service or performing a specific test, compared to the potential harms of not providing or performing those. Regardless of those balancing efforts, patients should be informed of the options and should have the opportunity to engage in their own risk analysis and reach informed decisions on their treatment.
Decided on April 20, 2017, in the Florida Circuit Court, Eleventh Judicial Circuit, Miami-Dade County; Case No. 2015-028411-CA-01.
Financial Disclosure: Author Greg Freeman, Editor Jill Drachenberg, Editor Jonathan Springston, Editorial Group Manager Terrey L. Hatcher, Nurse Planner Maureen Archambault, and Guest Columnist Jeanne Braun report no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study. Consulting Editor Arnold Mackles, MD, MBA, LHRM, discloses that he is an author and advisory board member for The Sullivan Group and that he is owner, stockholder, presenter, author, and consultant for Innovative Healthcare Compliance Group.
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