Can the defense successfully argue that an ED patient was harmed not because of the EP’s negligence, but because of a problem with the electronic medical record (EMR)? “There are not a lot of cases like that right now, but they are starting to emerge,” says Sharona Hoffman, JD, professor of law and bioethics at Case Western Reserve University School of Law in Cleveland, and author of Electronic Health Records and Medical Big Data: Law and Policy (Cambridge University Press, 2016).
“There are a tiny percentage of cases where lawyers bring up EMRs. Lawyers are still not educated about them,” says Hoffman, who expects to see a surge in allegations that EMRs harmed patients. “These claims will become routine in the future. We are still in the very earliest stages of realizing how much these systems have the potential to contribute to patient care.”
Raj Ratwani, PhD, acting center director and scientific director at the Washington, DC-based National Center for Human Factors in Healthcare, also says there will be a dramatic increase in adverse events linked to EMRs.
“We see numerous circumstances where the poor design of an [electronic health record] leads to a misdiagnosis or poor clinical outcome in ED patients,” Ratwani says. “I think we’re going to see an explosion in this area.”
‘Horrific’ Data Presentation
Ross Koppel, PhD, FACMI, calls the way the EMR presents data on ED patients “horrific. Pieces of information that should be contiguous require 17 clicks and scrolling across the screens.”
Data are organized differently within some EMRs, depending on the screen the EP is viewing. “On one screen, it’s in chronological order; on another, it’s in reverse chronological order; on the next, it’s alphabetical,” says Koppel, an adjunct professor of sociology at University of Pennsylvania, and chair of the American Medical Informatics Association’s Clinical Information Systems Working Group.
Some drop-down menus continue for multiple screens but don’t tell the EP to click down for more information. “Fonts and background colors differ, sometimes making the EMR look like a ransom note,” Koppel adds.
Koppel is aware of one case in which an EP ordered a test that never appeared in the EMR audit trail. “The test was not ordered, and the patient died from the problem that would have been discoverable,” he says.
If the EMR returns only part of the results of the lab work that was ordered, this, too, can be dangerous to an ED patient. “In many EMRs, the way the system is designed, it doesn’t show that a lab value is missing,” Ratwani explains. A busy EP may see the returned lab values are all normal and discharge the patient, without realizing that not all the results are back. Ratwani says this was a contributing factor in the 2012 case of Rory Staunton, a 12-year-old boy who died after being discharged from an ED with undetected sepsis.1 “In that case, one of the lab values that was an indicator of sepsis became available hours after the patient was discharged,” Ratwani notes.
Another EMR-related risk involves patient identification. If the EP is about to click on a patient’s name, and the data refresh at the moment he or she is about to click, the wrong patient could be selected. “You can end up with a medication being ordered on the wrong patient,” Ratwani warns.
Are Vendors Liable?
If a poorly designed EMR contributed to harming an ED patient, it’s possible that plaintiff attorneys could add additional defendants to the malpractice lawsuit. “That could enable the plaintiff to bring in the vendor, who might have a deep pocket,” Hoffman says; however, she is unaware of any such cases. “Some contracts reportedly have ‘hold harmless’ clauses that protect the vendor from liability.”
Koppel co-authored a 2009 paper arguing that “hold harmless” clauses shift liability to physicians, nurses, hospitals, and clinics, even when they are using the EMR as it was intended.2
“The vendors say they simply create a tool that is used by a learned intermediary, with unique knowledge, meaning a medical degree; therefore, the vendor is not responsible for any screw-up, even if the vendor has been informed about the problem 1,000 times,” Koppel says.
A 2011 Institute of Medicine report stated that nondisclosure agreements in contracts between vendors and healthcare providers, and “hold harmless” clauses that shift the liability of unsafe health IT features to care providers, greatly discourage information sharing.3 “Yet, the ‘hold harmless’ clauses are still there,” Koppel notes. “I think people are more aware of them, and more frightened of leaving them in, but nobody wants to do anything about it.”
However, the mere existence of a “hold harmless” clause doesn’t tie the hands of a good defense lawyer. The lawyer still can explain to the jury that the EMR contributed to an ED patient’s bad outcome. “A jury might decide to disregard the ‘hold harmless’ clause, even if the plaintiff lawyer mentions it repeatedly,” Koppel says.
Since many cases are settled out of court, it’s unclear how often EMRs are linked to ED adverse outcomes. “The doctor involved with a problem doesn’t want to talk about it, the vendor sure doesn’t want to talk about it, the family member who signed a nondisclosure clause doesn’t want to talk about it,” Koppel says. “So, the cases are unavailable to us to learn from.”
‘Easy Argument to Make’
At first glance, taking the stance that the EMR contributed to an ED patient’s bad outcome may seem like a hard sell. Most defense attorneys shy away from making this kind of allegation, not wanting it to seem like a negligent EP is pointing the finger elsewhere. Ratwani adamantly disagrees with that stance. “If it’s approached properly, I think it’s an easy argument to make,” he says. This is because the general public is used to seeing well-designed systems, such as Amazon, Google, and Twitter. “These are all good examples of interfaces that support the tasks and goals we want to accomplish,” Ratwani says. A defense attorney could compare these systems with the shortcomings and poor design of EMRs. “This conveys the argument that EMRs should never have been designed that way in the first place,” Ratwani says.
Ratwani expects to see additional experts become commonplace in ED malpractice litigation, on both the plaintiff and defense sides. These include IT experts to explain how the EMR was used in the ED setting, and to inform jurors about how the EMR was designed, developed, and tested before implementation.
To prevent EMRs from causing patient safety issues in the ED, Ratwani urges getting “deep insight and consensus” from frontline EPs early in the process. Take what they say seriously.
“EPs often have very clear descriptions of near-misses, and things that are likely to become actual harm events. They are often just not listened to,” Ratwani says. “Only after it becomes a claim do people say, ‘We need to go fix that.’”
REFERENCES
- Dwyer J. An Infection, Unnoticed, Turns Unstoppable. The New York Times, July 11, 2012. Available at: http://nyti.ms/1P8l3uR. Accessed May 8, 2017.
- Koppel R, Kreda D. Health care information technology vendors’ “hold harmless” clause: Implications for patients and clinicians. JAMA 2009;301:1276-1278.
- Institute of Medicine. Health IT and Patient Safety: Building Safer Systems for Better Care. The National Academies Press; 2011.
SOURCES
- Sharona Hoffman, Professor of Law and Bioethics, Case Western Reserve University School of Law, Cleveland. Email: [email protected].
- Raj Ratwani, PhD, Acting Center Director and Scientific Director, National Center for Human Factors in Healthcare, Washington, DC. Phone: (202) 244-9815. Email: [email protected].
- Ross Koppel, PhD, FACMI, Adjunct Professor, Sociology, University of Pennsylvania; Chair, Clinical Information Systems Working Group, American Medical Informatics Association. Phone: (215) 576-8221. Email: [email protected].
Experts warn cases soon will become routine.
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