A class action lawsuit filed Thursday in the U.S. District Court in the Southern District of New York alleges that electronic health records vendor eClinicalWorks failed “millions of patients by failing to maintain the integrity of patients’ records.”
A cover sheet filed with the complaint lists a monetary demand of just under $1 billion, or $999 million.
The class action lawsuit comes six months after eClinicalWorks agreed to pay $155 million to resolve a False Claims Act lawsuit and settle allegations that it violated federal law by misrepresenting the capabilities of its software. In the False Claims Act lawsuit, the U.S. Department of Justice also alleged that eClinicalWorks paid kickbacks to certain customers in exchange for promoting its product.
The Justice Department charged that the Westborough, Mass.-based EHR vendor “falsely obtained that certification for its EHR software when it concealed from its certifying entity that its software did not comply with the requirements for certification.” And, the DOJ alleged in its compliant that, as a result of the deficiencies in eClinicalWorks’ software, providers using eClinicalWorks’ software submitted false claims for federal incentive payments.
The lawsuit was filed by Kristina Tot as an administrator of the estate of Stjepan Tot, and the suit alleges that the class action was brought against eClinicalWorks for its “breach of fiduciary duty and gross negligence in failing to provide, secure and safeguard accurate and reliable health information of patients throughout the United States and for falsely representing that its software complied with requirements for payment of incentives under the Meaningful Use program.”
Further, the lawsuit stated, “By mispresenting to the federal government that its software could protect the integrity of patients’ records when it could not, ECW also falsely obtained certification from the federal government for its software. As a result, the medical records of millions of patients have been compromised. Patients and doctors cannot rely on the veracity of those records.” The suit noted that more than 850,000 healthcare providers use eClinicalWorks.
Stjepan Tot died from cancer, and the suit alleges that prior to his death, Tot learned about ECW’s failure to maintain his medical records in a manner that maintained their integrity. “In particular, he was unable to determine reliably when his first symptoms of cancer appeared in that his medical records failed to accurately display his medical history on progress notes,” the lawsuit claims.
The lawsuit touches on many of the allegations in the DOJ’s false claims act lawsuit against ECW. The class action lawsuit alleges ECW falsely represented to its certifying bodies that its software complied with the requirements for certification and the payment of incentives under the MU program, and therefore, caused its users to falsely attest to using a certified EHR technology. “As a result of ECW’s failure to meet the certification criteria, ECW’s software periodically displayed incorrect medical information in the right chart panel of the patient screen, periodically displayed multiple patients’ information concurrently, in specific workflows and failed to accurately display medical history on progress notes,” the lawsuit states.
The lawsuit also alleges that ECW audit logs did not accurately record user actions, and in certain cases, the audit logs misled users as to events that were conducted in the course of a patient’s treatment.
“As a direct result of these deficiencies in ECW’s software, millions of patients have had their medical records compromised, i.e., they can no longer rely on the accuracy and veracity of their medical records,” the lawsuit states. “In other words, as to the Progress Notes recorded by a health professional at a patient’s visit, the patient is unable to be certain as to which date any number of symptoms first appeared.”