The estate of a man who died of cancer filed a $1 billion lawsuit against EHR company eClinicalWorks citing a problem with the accuracy of the company’s software.
The suit filed in the U.S. District Court in the Southern District of New York seeks monetary damages for “breach of fiduciary duty and gross negligence.” The suit also alleges that millions of patients are affected because the company’s software didn’t meet Meaningful Use certification requirements.
The lawsuit said Stjepan Tot, who died of cancer, wasn’t able to decipher when his cancer symptoms first appeared because his EHR allegedly “failed to accurately display his medical history on progress notes.”
The lawsuit isn’t the company’s first brush with concerns about its software. In May, eClinicalWorks and employees agreed to pay $155 million to settle False Claims Act charges about misrepresenting software capabilities and giving customers kickbacks for promoting the product.
That case involved a 2015 whistleblower complaint that charged the company obtained certification for its EHR software by manipulating data and hiding that it didn't meet federal standards. At the time, Colette G. Matzzie, a whistleblower attorney and partner at Phillips & Cohen, said the fine was the first time that the government "held an electronic health records vendor accountable for failing to meet federal standards designed to ensure patient safety and quality patient care.”
In response, eClinicalWorks CEO Girish Navani told Healthcare Dive in July that the company implemented a tighter compliance program.
The eClinicalWorks case opened the eyes of EHR vendors and legal experts, who predicted the settlement will be the start of greater Department of Justice (DOJ) activity in the EHR field. The DOJ has collected billions in settlements and judgments involving False Claims Act cases. The DOJ has gone after other parts of the industry for fraud, including payers, but before the eClinicalWorks case, EHR vendors avoided that level of DOJ scrutiny.