Medical errors that can be traced to the automation of the U.S. health care system are increasingly an issue in medical malpractice lawsuits.
Some of the doctors, attorneys and health IT experts involved in the litigation fear that safety and data integrity problems could undercut the benefits of electronic health records unless HHS and Congress address them aggressively.
“This is kind of like the car industry in Detroit in 1965,” says physician Michael Victoroff, a liability expert and a critic of the federal program encouraging providers to adopt EHRs. “We’re making gigantic, horrendous, unsafe machines with no seat belts, and they are selling like hot cakes. But there’s no Ralph Nader saying, ‘Really?’”
According to a review by The Doctors Company, the largest physician-owned U.S. medical malpractice insurer, EHR issues were involved in only 1 percent of a sample of lawsuits concluded from 2007 through 2013. But that finding could be deceptive since it takes five or six years to close a suit, and during that period the numbers of such cases grew rapidly as electronic health records become more pervasive in hospitals and physician offices. The pace of these cases doubled from 2013 to early 2014.
The lawsuits allege a broad range of mistakes and information gaps — typos that lead to medication errors; voice-recognition software that drops key words; doctors’ reliance on old or incorrect records; and nurses’ misinterpretation of drop-down menus, with errors inserted as a result in reports on patient status.
In addition, discrepancies between what doctors and nurses see on their computer screens and the printouts of electronic records that plaintiffs bring to court are leading some judges and juries to discredit provider testimony and hand out big awards. In one case, a patient in septic shock had suffered gangrene and a severe skin rash, but computer records read “skin normal.” They also showed repeated physician interviews with the patient — when she was comatose.
“If I’m testifying for a plaintiff, I say, ‘Get the EHR,” says Keith Klein, a UCLA professor of medicine who has testified in 350 malpractice cases. “If I’m with the defense I say, ‘The EHR is going to be a problem.’ Because it always is.”
The details in the record printout do not reflect the decision options on the screens, with their drop-down menus, prompts and alarms, that confront medical staffs, said Beth Cushing, vice president of claims at CRICO, the liability and risk management firm. “Irrelevant things are carried forward and more up-to-date information isn’t presented.”
In court, “there’s a general feeling that you don’t have the whole story, or that someone is hiding something,” she said.
While the percentage of EHR-related cases is still low, “this is going to become a bigger and bigger issue,” said David Troxel, medical director of The Doctors Company. “I get more calls from frustrated, angry doctors about their EHRs than any other subject.”
Users customarily sign contracts with vendors that exempt the latter from most legal responsibility under a doctrine known as the “learned intermediary.” The idea is that while computers carry information and sometimes provide advice based on mathematical data processing, responsibility for care lies with the medical professional.
The Electronic Health Record Association, which represents most EHR vendors, says it is working in collaborations that address EHR-related safety issues.
The industry “takes very seriously the need to enhance the well-documented ability of EHRs to increase patient safety,” an association spokesperson said. “It also recognizes the importance of looking for opportunities to identify and reduce any potential risks associated with development and use of EHRs. All these efforts are essential to the goal of learning more about the ways in which technology, training and configuration can be rolled out in the safest possible ways.”
But providers and health care systems are eventually going to start suing vendors, analysts said, in part because software companies are viewed as having deep pockets. “It’s only a matter of time before a company like athenahealth or Allscripts or Epic or Cerner gets sued,” said Klein.
Plaintiffs’ attorneys are already eyeing such cases, according to Scot Silverstein, a Drexel University health IT expert and internist who is suing a hospital over a lapse in care of his mother that Silverstein claims was caused by poor EHR implementation. Silverstein and two plaintiff’s attorneys met with Rep. Matthew Cartwright (D-Pa.) and other lawmakers in November to plead for more government regulation of EHRs.
When the government’s EHR incentive program started in 2009, officials predicted that electronic records would usher in a safer medical era by doing away with doctor scribble and making the patient’s medical chart legible and available for all.
Some recent studies show that EHRs do make hospitals safer. But the data isn’t conclusive, said William Marella, executive director of the ECRI Institute Patient Safety Organization. Last year, ECRI convened a partnership of EHR vendors, safety experts, academics and medical groups to share and analyze health IT problems.
The effects on malpractice insurance also aren’t clear. Some carriers are said to have lowered rates for early EHR adopters, but Troxel says that overall, EHR use hasn’t affected liability rates one way or the other.
In about 200 EHR-related legal cases that the liability firm CRICO analyzed, the glitches rarely led directly to patient harm, said Dana Siegal, the company’s director of patient safety services. But she added, “We’re seeing failures to communicate or providers acting on inaccurate information that was driven in part by an EHR issue.”
Take the case of an elderly Illinois woman who stabbed herself with a garden fork. An emergency room nurse clicked the “unknown/last five years” tab for the woman’s tetanus shot status, and a physician interpreted this to mean she did not need a shot. In fact, she had never been immunized. The woman later died of tetanus, said Chicago plaintiff’s attorney Kenneth Lumb, who handled the case.
“Sometimes to really see what happened, you have to take a deposition for someone at a computer station where they pull up every single screen for your client,” Lumb said. “Knowing what click option the physician chose is only part of the value … knowing what the choices were is significant.”
A complex interplay of technology and medical practice underlies many problems. EHR safety issues are frequently misdiagnosed — and thus under-diagnosed — by providers, according to ECRI’s Marella. “They say, ‘wrong site surgery,’ or ‘drug error,’ which can make it hard to ferret out the cases where IT is responsible.”
And often, a problem can’t be blamed directly on a computer but rather on the way it was installed or how doctors were trained to use it.
For example, the cut-and-paste function of EHRs allows doctors to enter information without retyping it. That’s useful for billing purposes but can lead to inaccuracies and confusion. “There are cloned records everywhere, and if you get sued, you’re going to have a problem in court,” Klein said.
At the recent annual conference of the Healthcare Information and Management Systems Society, Klein presented several disturbing case studies in which a court’s dissatisfaction with the medical record led to large awards.
In one case, the plaintiff contended that inappropriate use of an antibiotic caused him to require dialysis. The same date appeared on each of the 3,000 pages in the record. “You have a problem,” the judge told the defendant’s attorney. “Neither you nor your client can make sense of this.” The case eventually settled for about $10 million.
While the effect of EHRs on malpractice suits is still modest, many analysts worry about the overall uncertainty concerning information in such systems. Confusing or inaccurate records, if they proliferate, not only cast doubt on a doctor in court but could taint clinical research that draws on these large pools of data.
A recent report by the HHS Office of Inspector General said the department has failed to assure that EHR data are secure and accurate. Many hospitals have unsecured audit trails—meaning that information in the record could be altered without detection, it said.
“There’s really no one with a vested interest in the integrity of the record besides you, the patient,” said Reed Gelzer, a physician and health IT expert.
Vendors, with some justification, blame many of the errors on poor implementation by providers. But that doesn’t diminish the safety risk.
Concerns led the Institute of Medicine in 2011 to propose the creation of a dedicated IT safety center with the power to investigate EHR risks. ONC has since settled on a center that would have no investigatory power but would provide a safe environment in which real-life problems could be analyzed and solutions developed.
The safety center is a “critical priority right now for ensuring the transformation from a world of paper to a world of electronics and connectedness,” said Patricia McGaffigan, COO and a senior vice president at the National Patient Safety Foundation.
Some in industry, however, say the center is unnecessary. FDA already collects some EHR incident reports, as do Patient Safety Organizations created under a 2005 law. So far, Congress has refused to fund the ONC proposal.
Victoroff believes the country eventually will require a fund, similar to one that the federal government uses to pay parents of children with suspected vaccine injuries, to compensate victims of injuries in which an EHR is implicated.
“The vendors are very right that if they had true product liability they wouldn’t make these things,” he said.