by Peter A. Corsale (Gallop, Johnson & Neuman, L.C., St. Louis, Missouri)
The Center for Medicare and Medicaid forecasts that between 2010 and 2020, the average annual health spending growth (5.8%) will outpace the annual growth in the overall economy by 4.7% and comprise 19.8% of the GDP ($4.6 trillion). With such amounts dedicated to health services, patients expect their physicians and medical care facilities, regardless of their location (urban vs. rural), to keep abreast, adapt, and use new technology. There is little doubt that patients equate new technology with better and safer service.
As a direct corollary, this mode of thinking (newer is better) impacts whether a healthcare provider is meeting the applicable standard of care. While medical journals and academia may wrestle with what constitutes the standard of care, at the end of a trial the average juror, who will have little if any medical training, will decide whether the defendant practitioner has met the standard of care. Thus, any evidence that shows that a breach of a standard of care resulted in some detriment to the patient is powerful, no matter how “weak” it actually is.
Capnography, which has existed in one form or another since the early 1980’s, provides an illustration of how advances in technology can affect the standard of care, at least in the juror’s eyes. A capnograph monitors end-tidal carbon dioxide (CO2) – the byproduct of metabolic process in which oxygen is inhaled, used, and transformed into carbon dioxide. End-tidal CO2 is the concentration of carbon dioxide in exhaled air at the end of expiration.
Monitoring end-tidal CO2 is critical to understanding a patient’s cardio-pulmonary status because it allows medical practitioners to more quickly detect and treat respiratory distress than standard pulse oximetry, which measures oxygen levels in blood as oxygen lingers in the blood for minutes after one stops breathing. Capnography is standard practice in the operating room and during general anesthesia where patients are intubated. Advances in technology now allow practitioners to monitor end-tidal CO2 in other settings without the need for intubation. These advances push the standard of care to new heights.
Changing Practice Standards, Changing Legal Liability
One area where capnography is impacting the standard of care is in non-operative settings where procedural/conscious sedations are used. An increasing number of organizations whose practice guidelines may constitute legal standards of care recommend capnography in these settings. For example, based on a review of “sedation cases gone wrong,” the American Society of Anesthesiologists (ASA) proposed a new minimum requirement, adopted July1, 2011, that required the monitoring of exhaled CO2 during moderate and deep sedation. In developing this guideline, the ASA found that only 15% of patients who experienced moderate to deep sedation while undergoing procedures outside the operating room were being monitored with capnography. Given that 62% of the “sedation gone wrong” cases could have been prevented with better monitoring, the ASA believed that a new standard was needed.
The case of Richard Tseng v. Mazzacco Ambulatory Surgery Center, Case No. LC084435, Los Angeles Superior Court, provides an illustrative example of the “sedation gone wrong” cases that the ASA is attempting to prevent. Mr. Tseng was given midazolam, fentanyl and propofol for sedation during eye surgery for a prosthetic lens implant, a procedure that was to take 10 to 15 minutes to complete. Mr. Tseng went into a deeper state of sedation than expected, stopped breathing, and suffered an anoxic brain injury. He is now in a nursing home. His attorneys alleged that Mr. Tseng’s injuries would have been prevented if his end tidal CO2 had been monitored. They claimed the monitoring would have detected Mr. Tseng’s respiratory arrest and permitted earlier resuscitation. The Mazzacco Ambulatory Surgery Center countered that the anesthesia care met the applicable standard of care. Finding for Mr. Tseng, the jury awarded $2.25 million in damages.
Unfortunately, preventable “sedation gone wrong” cases continue to exist. The death of Michael Jackson and the criminal prosecution of his physician, Dr. Conrad Murray is Exhibit A of this problem. One of the seventeen acts of medical malpractice alleged by the prosecution in the involuntary manslaughter trial of Dr. Murray is that Dr. Murray failed to adequately monitor Michael Jackson with capnography (amongst other monitoring equipment) during the administration of propofol. A recent survey conducted among healthcare providers revealed that more than a third of them believe that medical practices are not in complete accord with the Standards for Basic Anesthetic Monitoring set by the ASA.
Capnography, once delegated only to the operating room and during general anesthesia, has now become one of the bases in a criminal trial involving the administration of in-home pain medication. Simply put, capnography is now becoming standard practice outside of the tertiary care setting.
Changing Technological Uses, Changing Legal Liability
Not only is capnography now becoming standard in non-tertiary care settings, but it is also becoming the standard in emergent care settings. In October, 2010, the American Heart Association (AHA) and the European Resuscitation Council released updated resuscitation guidelines recommending capnography for intubated patients throughout the peri-arrest period. In particular, capnography should be used “to confirm and monitor endotracheal tube placement in the field, in the transport vehicle, on arrival at the hospital, and after any patient transfer to reduce the risk of unrecognized tube misplacement or displacement.” Furthermore, “it is reasonable to consider using quantitative waveform capnography in intubated patients to monitor CPR quality, optimize chest compressions, and detect ROSC [return of spontaneous resuscitation] during chest compressions or when rhythm check reveals an organized rhythm (Class IIb, LOE C).” In early May 2011, the AHA published materials teaching clinicians how to use capnography.
A May 17, 2011 Wall Street Journal article illustrates the benefits of the AHA’s new guidelines. The article recounts how paramedics used capnography to save patient Howard Snitzer’s life. As first reported in Mayo Clinic Proceedings and thereafter the Wall Street Journal, Mr. Snitzer survived for 96 minutes without a pulse (it is currently believed that resuscitation is futile after 20 minutes without a pulse). After collapsing from a heart attack, bystanders called 911 and initiated CPR. Mayo Clinic responders arrived 34 minutes later, inserted a breathing tube which measured end-tidal CO2and continued CPR. Twelve defibrillator shocks were needed to revive Mr. Snitzer.
The paramedics admitted that the only reason they continued with CPR was due to the capnography readings (typically expressed as a partial pressure in mm Hg (etCO2), which indicated that the metabolic process was working, i.e. oxygenated blood was being circulated throughout Mr. Snitzer’s vital organs with corresponding CO2 readings.
Under normal conditions etCO2 is in the range of 35 to 40 mm Hg. During untreated cardiac arrest etCO2 will approach zero with continued ventilation. “Persistently low etCO2 values (<10 mm Hg) during CPR in intubated patients suggest that ROSC is unlikely.” In Mr. Snitzer’s case, his etCO2 values remained in the low 30s. As a result, the paramedics continued with their life-saving measures. Not only was Mr. Snitzer’s life saved, but he suffered no neurological impairments. Not discounting the other measures taken by the paramedics, the Mayo Clinic doctors and paramedics both credited capnography as an important therapy leading to Mr. Snitzer’s survival.
Fifteen years ago ambulances did not use capnography. Now, medical professionals predict that, within the next five years, capnography will become the “staple technology” of an emergency responder’s standard of care. If true, the legal ramifications are apparent.
For example, emergency responders readily arrive on a scene to treat patients suffering cardiac arrest without capnography equipment and initiate CPR. These same emergency responders cease treatment believing that ROSC is unlikely. If capnography becomes the “staple technology” of an emergency responder’s standard of care, the emergency responder and the affiliated hospital have just become defendants in medical malpractice action.
To prove medical malpractice, the plaintiff must show that the defendant failed to meet the applicable medical standard of care; that the act or omission involved negligence; and that there was a causal connection between the act or omission and the plaintiff’s injury. Wicklund v. Handoyo, 181 S.W.3d 143 (Mo. Ct. App. E.D. 2005). In the above context, the plaintiff would attempt to show that the failure to monitor end-tidal CO2 resulted or contributed to the patient’s cause of death. Because the lack of capnography would provide little basis to believe that a patient’s end-tidal CO2 warranted continued resuscitation attempts, the causal link between the failure to use capnography and the patient’s death is difficult to establish. However, the “what if” outcome would change if the use of capnography becomes the standard of care for emergency responders as emergency responders would, as a result of capnography, now know when resuscitation efforts are futile.
Standard of Care is Not a Static Concept
The aforementioned cases should remind all medical professionals to keep abreast of the evolving standard of care. New uses of existing technology as well as the advent of new technology will expand the standard of care, regardless of the perceived costs involved. While capnography was once relegated to the operating room, plaintiffs and their experts will undoubtedly point to the new ASA and AHA guidelines as the standard of care in outside settings. Again, while some medical professionals may feel that capnography is ill-suited for these outside settings (due to “false alarms” or cost), it is a jury, and not a medical panel, who decides what the applicable standard of care is in a trial.
Dr. Conrad Murray and the medical professionals in Tseng did not keep abreast and/or accept the evolving ASA guidelines, whereas Mr. Snitzer’s first responders followed the AHA guidelines and saved someone’s life. While Mr. Snitzer’s resuscitation may now be considered miraculous, in the future, with the help of capnography, such outcomes may become more common. In the end, medical professionals should not be hesitant to accept the fact that advanced technology changes the standard of care
Peter A. Corsale is an associate in Gallop’s Litigation Department. His law practice includes serving clients in matters involving general civil litigation, commercial disputes, securities litigation, insurance coverage disputes, and product liability actions. Gallop is one of the largest law firms headquartered in St. Louis. The firm also has offices in Washington, D.C. and Oklahoma City, Oklahoma. Gallop serves public corporations; privately-held companies; entrepreneurs and start-up enterprises; individuals and families; trustees and trust beneficiaries; charities; and non-profit entities. Peter may be emailed at Peter.Corsale@galloplaw.com
“96 Minutes Without a Heartbeat”, Wall Street Journal, Tuesday, May 17, 2011.
“The Life in Every Breath”, Boston Globe, Monday, July 4, 2011.
“The risk and safety of anesthesia at remote locations: the US closed claims analysis”,
Julia Metzner, Karen L. Posner and Karen B. Domino. Current Opinion in Anaesthesiology 2009, 22:502–508
Woodtv.com/dpp/news/local/kent_county/Heart=attack-Capnograph-may-help, Anne Schieber, May 19, 2011
ASA Standards for Basis Anesthetic Monitoring, Committee of Origin: Standards and Practice Parameters (Approved by the ASA House of Delegates on October 21, 1986, and last amended on October 20, 2010 with an effective date of July 1, 2011)
2010 American Heart Association Guidelines, Part 8: Adult Advanced Cardiovascular Life Support 2010 American Heart Association Guidelines for Cardiopulmonary
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Physician-Patient Alliance for Health & Safety
Michael Jackson Autopsy Report, Anesthesiology Consultation