EHR safety goes to court

One patient's blood pressure plummeted dangerously after he was allegedly discharged with the wrong medications. In another instance, a physician couldn't place a pharmacy order for a newborn to receive vitamin K, which is given to babies to prevent serious bleeding.

On several other occasions, patients weren't accurately tracked, creating potential problems getting drugs to them.

Each of these alleged mishaps occurred at PinnacleHealth, a three-hospital system based in Harrisburg, Pa. PinnacleHealth blames each of the mishaps on its electronic health records vendor, Siemens; Cerner Corp. purchased Siemens' health IT business in February 2015.

The incidents came to light as part of a breach-of-contract lawsuit Cerner filed against PinnacleHealth last year after the system, which had used Siemens as a vendor for 20 years, sharply curtailed its relationship and entered into a contract with a competing EHR vendor, Epic Systems Corp. PinnacleHealth related the incidents in its counterclaim; the counterclaim was filed in March of this year in state court in Pennsylvania, where it is seeking damages for Cerner's alleged fraud and breach of contract.

Cerner spokesman Dan Smith declined to comment on pending litigation, but did say “patient safety is of the utmost importance to us.”

Some experts say the PinnacleHealth-Cerner battle is among the first of what could become an avalanche of legal battles over EHRs and patient safety. For years, many patient safety advocates have warned that EHR systems carry numerous potential risks due to their poor design and the ease with which data entry errors can lead to medical mistakes.

Last year, 35 professional medical associations sent a letter to the Office of the National Coordinator for Health Information Technology at HHS warning that EHRs were raising serious patient safety concerns.

And now lawsuits are making hard allegations.

Some attorneys believe many more lawsuits are imminent. “It looks like it's a round of litigation that's about to happen as the inevitable human errors in dispensing healthcare are now being traced back to negligent use of the computer technology,” said Robert Fuller, a partner at Nelson Hardiman and former chief operating officer at Downey (Calif.) Regional Medical Center.

Fuller said his firm has recently been involved in about a half dozen consultations over potential lawsuits.

Until now lawsuits involving patient safety and EHRs have been handled as malpractice cases, where it can be difficult to get a handle on exactly who has been named or the nature of the alleged EHR errors because most such cases settle out of court and include nondisclosure clauses that bar the plaintiffs from discussing them, said Ross Koppel, an adjunct sociology professor at the University of Pennsylvania and healthcare IT scholar.

But the number of such malpractice suits will likely continue to climb. Medical malpractice insurer the Doctors Co. closed 28 claims in 2013 involving EHRs, and nearly that many during the first two quarters of 2014. In all, the Doctors Co. closed 97 claims involving EHRs from January 2007 to June 2014.

EHR-related issues contributed to less than 1% of all claims closed by the malpractice insurer during that time. In that limited sample, 64%, involved user errors while 42% involved issues with the EHR system itself; some of those claims involved more than one contributing factor. Of those overall EHR claims, 10% involved a failure of system design, and 9% involved an electronic systems or technology failure.

Yet another 7% were due to a lack of an EHR alert or alarm for things like obvious gender-specific entry errors, such as the case of an elderly woman who was prescribed Flomax, a drug for treating an enlarged prostate, when she should have been prescribed Flonase, a nasal spray. The woman ended up in an emergency department, complaining of dizziness.

“Anecdotally, we're thinking we're going to continue seeing more” cases involving EHRs, said Robin Diamond, a senior vice president of patient safety and risk management at the Doctors Co. She said that will be especially true as plaintiffs' attorneys become more knowledgeable about EHR systems.

EHR vendors, however, aren't often named in malpractice suits. Typically, those filing malpractice suits go after individual doctors or their hospitals and sometimes both, Koppel said. That's partly because contracts between providers and EHR vendors typically include so-called hold-harmless clauses, saying the vendor can't be held responsible for medical errors. Lawyers can sometimes find ways around those clauses, but they present significant barriers to winning malpractice lawsuits against vendors, Koppel said.

Going after an EHR vendor despite a hold harmless clause can mean added expense, time and complications for plaintiffs and their attorneys, said Dr. Scot Silverstein, an adjunct professor of healthcare informatics at Drexel University. “It's only now getting on the radar of the plaintiffs' attorneys to start to go after the actual makers of these systems,” he said.

Silverstein, who serves as an independent expert witness in cases involving health IT issues, and Koppel said they know of a number of cases that name EHR vendors, but they're not at liberty to discuss them.

Re Knack, a member at law firm Ogden Murphy Wallace who represents providers, also said more claims against EHR vendors might start surfacing. She said the Cerner-PinnacleHealth lawsuit may foreshadow what's to come.

Knack said she'll be interested to learn whether PinnacleHealth's complaints are legitimate or if the system is just trying to get out of its financial obligation to Cerner. Cerner has alleged in court documents that PinnacleHealth hasn't paid it for services since February 2015 and owes it more than $20 million. Cerner has accused PinnacleHealth of violating the terms of its contract, which was supposed to run through 2020.

PinnacleHealth, however, alleged in its counterclaim that “the software solutions and related information technology services provided by Siemens to Pinnacle have been an utter failure that has jeopardized the care and safety of the patient population served by Pinnacle.”

PinnacleHealth CEO Michael Young said the system isn't trying to end its contract with Cerner early, but instead wanted to negotiate with the vendor about lowering Cerner's staffing levels at the system per their contract. Cerner wouldn't discuss lowering staff levels, so the system stopped paying the vendor, he said.

Young, who took over as CEO in 2011, said PinnacleHealth wanted to have the same EHR systems for ambulatory and inpatient care, which it did not have with Siemens. Having ambulatory and inpatient care on the same EHR systems will make it easier for doctors and nurses to keep track of patients' medications, Young said.

Cerner, however, said in court documents that many of PinnacleHealth's allegations in the countersuit should be dismissed.

PinnacleHealth's counterclaim “is rife with scandalous and impertinent averments of alleged issues and problems PinnacleHealth claims it has had with Siemens going back to 1996, during PinnacleHealth's entirely voluntary two-decades-long contractual relationship with Siemens,” according to Cerner.

Optimists, noting that EHR systems have improved, counter the idea that lawsuits involving EHRs will proliferate. Future versions may cause fewer patient safety problems and may actually result in fewer lawsuits, they say.

Dr. Sarah Corley, vice chair of the HIMSS Electronic Health Records Association, said in a statement that EHR-related safety problems—and lawsuits over them—are minimal. She pointed to another study by a malpractice insurer, in this case CRICO, that, like the Doctors Co. study, found that EHR issues were associated with less than 1% of malpractice claims.

That “is a remarkable low number given how widespread EHRs have become,” she said.

Dr. Bob Wachter, who wrote the book The Digital Doctor, said EHRs have made care safer by eliminating records scrawled in physicians' handwriting, by making patient information more easily accessible and by offering built-in reminders for healthcare workers about patient care.

But he acknowledges that EHRs have also introduced some safety hazards, such as one instance he describes in his book when a young patient was given 39 pills of an antibiotic instead of one. The doctor thought she had ordered a certain amount of milligrams of medication when she had actually ordered that amount of milligrams per kilogram of the patient's weight. The doctor and pharmacist then ignored the EHR's alerts about the error, having grown accustomed to routinely getting alerts about less important matters, Wachter said.

The boy spent a week in the intensive-care unit but survived. No legal action was taken, he said.

Still, Wachter expects EHRs to improve over time.

In the future, “We'll have worked on fixing these problems,” he said.

Even PinnacleHealth's Young expects that lawsuits making the kinds of safety allegations PinnacleHealth is now making against Cerner will eventually fade away.

“I think the machines are much smarter now in identifying areas of risk,” he said. “The ability to really see what's going on across the whole spectrum of care will be a vast improvement.”