Executive Summary
Claims involving routine medical procedures — scopes, injections, punctures, biopsies, insertion of tubes, or imaging — resulted in $215 million in incurred losses, according to an analysis of 1,497 cases. In this study, legal outcomes often hinged on these factors:
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failure to obtain or document a thorough, voluntary informed consent;
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lack of appropriate credentials or experience with the procedure;
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failure to follow published safety policies.
The fact that routine medical procedures — scopes, injections, punctures, biopsies, insertion of tubes, or imaging — were involved in a large percentage of malpractice claims didn't come as a surprise to researchers at CRICO Strategies.
"We are all aware of punctures or perforations from misdirected NG [nasogastric] tubes, nerve injuries from blood draws, and tissue damage from IV [intravenous] infiltrates. These events are typically related to technical skill," explains Gretchen Ruoff, MPH, CPHRM, program director of patient safety services for CRICO Strategies, a Cambridge, MA-based patient safety and medical professional liability company. One claim involved a splenic laceration during a screening colonoscopy, which resulted in an extended hospital course and admission to an intensive care unit.
The researchers were surprised, however, by these factors that were consistently correlated with the technical errors across multiple procedure types:
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working without adequate training or supervision;
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working with unfamiliar equipment;
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performing a procedure on an inappropriate candidate or in an unsuitable setting due to the patient's health status or comorbidities.
Researchers analyzed 1,497 malpractice cases filed from 2007 to 2011 that alleged malpractice involving a non-surgical procedure. More than two-thirds of the injuries were relatively minor or temporary, but 14% involved patients who died. The cases represent $215 million in incurred losses, and most involved skill-based errors.
Whether the injury was a known possible complication of the procedure or resulted from a judgment failure, the legal outcomes of these cases often hinged on these factors:
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failure to obtain or document a thorough, voluntary, informed consent;
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a provider's lack of appropriate credentials or experience with the procedure;
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failure to follow published safety policies.
"While these factors do not indicate negligence per se, cases with these factors are harder to defend in a court of law and in the court of public opinion," says Ruoff. She recommends that physicians take these actions to reduce liability risks:
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Diligently and thoroughly explain the risks, benefits, and alternatives of a procedure to the patient prior to a procedure. Accurately document these conversations in the medical record.
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Adhere closely to procedural protocols.
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Recognize that the end of a procedure does not mark the end of the provider's responsibility for monitoring, communication, and follow-up with the patient and the rest of the care team.
"Close monitoring and swift responses to signs of a complication are critical to patient, and provider, safety," says Ruoff.
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In the event of an untoward outcome, offer patients compassionate and informative communication and, when appropriate, disclosure and apology.
"This not only serves to minimize patients' worries, but also begins to rebuild the trust necessary for thorough recovery and healing," says Ruoff.
Red flag: unmet expectations
Missed diagnosis following routine medical procedures can cause the relationship between the healthcare provider and the patient to deteriorate and cause the patient or a family member to seek representation for their harm.
Carmen Lester, RN, JD, CPHRM, co-owner of Yin Yang Medical Services, an Omaha, NE-based provider of risk management services, says, "Red flags should be raised when the patient's outcome differs from the patient's expectations."
For example, a patient with rectal bleeding undergoes a colonoscopy with negative results, only to find out later that colon cancer was missed on exam during the procedure. "The reassurance that she was initially given has now been replaced with anger and mistrust," says Lester.
Other examples of malpractice involving routine medical procedures include a failure to communicate pathology reports to appropriate physicians, often seen in cases involving biopsies; delayed diagnosis, when the diagnostic workup does not include all of the testing components needed to arrive at the definitive diagnosis; and complications or infections following routine procedures, such as insertion of a Foley catheter. "It is important to point out that there are surgical procedures that are considered 'routine,' such as appendectomies and cholecystecomies, that can have adverse outcomes," adds Lester. "We are currently seeing a case in the national news of a 13-year-old girl that was declared brain dead following a tonsillectomy."
When adverse events occur, physicians should notify their malpractice insurer of the potential compensatory event. "The family is most likely seeking counsel for representation," says Jan Kleinhesselink, RN, CPHQ, co-owner of Yin Yang Medical Services.
Physicians can take steps to prevent the same incidents from happening again by completing a root cause analysis. "Don't sweep adverse events under the rug," says Kleinhesselink. "Rather, focus on prevention of future occurrences."
Focus on underlying condition
Cases involving routine medical procedures are more defensible if the defense can convincingly argue that the patient's underlying condition ultimately caused the patient's bad outcome, says Phillip B. Toutant, Esq., an attorney in the Southfield, MI, office of The Health Law Partners.
Toutant recalls a wrongful death case in which a middle-aged woman with a history of alcoholic liver cirrhosis had a routine colonoscopy at an ambulatory surgery center. During the procedure, she suddenly became hypotensive, and it soon became evident that she was bleeding internally. "The ambulatory surgery center did not have packed red blood cells available, let alone platelets or even whole blood, which would have been far preferred for a patient with severe liver disease," says Toutant.
It was discovered that the patient had a varix between her ovary and her large bowel, which ruptured during the procedure. The defense argued that the abnormality was significant and highly unexpected. The defense said that it was caused by portal hypertension, which was caused by her cirrhosis, which ultimately was caused by the patient's alcoholism. This alcoholism, they argued, resulted in the patient bleeding to death in what otherwise would have been a routine procedure.
Because the case involved a woman who was a co-owner of a sizeable business with significant income, there was potential for substantial wage loss damages in this wrongful death case. The case was settled for a dramatically lower amount than the plaintiff's lawyer's wage loss projections. The disparagement in the settlement amount was largely due to challenges in terms of proving violations of the standard of care.
"In cases where routine procedures result in significant morbidity or mortality, oftentimes the bad outcome is the result of latent, unpredictable, pre-existing pathology," says Toutant. "Needless to say, this aids in defending the providers." (See related story, below, on the elements of negligence that a malpractice claim must meet to survive.)
SOURCES/RESOURCE
- Jan Kleinhesselink, RN, CPHQ, Yin Yang Medical Services, Omaha, NE. Phone: (402) 326-9489. Email: [email protected].
- Carmen Lester, RN, JD, CPHRM, Yin Yang Medical Services, Omaha, NE. Phone: (402) 871-4801. Email: [email protected].
- Gretchen Ruoff, MPH, CPHRM, Program Director, Patient Safety Services, Crico Strategies, Cambridge, MA. Phone: (617) 679-1312. Fax: (617) 495-9711. Email: [email protected].
- Phillip B. Toutant, Esq., The Health Law Partners, Southfield, MI. Phone: (248) 996-8510. Fax: (248) 996-8525. Email: [email protected].
- CRICO Strategies' 2013 report, "Malpractice Risks in Routine Medical Procedures," is available free of charge. Go to http://bit.ly/1eIGvl7 and next to the report title, select "PDF" or "Paper."
