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EMR & Audit Trail Litigation

The recent trend in high-exposure health care provider litigation encompasses not only the pursuit of a case based on the medicine, but also a separate case in discovery based on the electronic medical record (EMR) and audit trail.

Given the complexity, scope and cost of producing a complete audit trail and an accurate medical chart, medical professionals and facilities can retain Marshall Dennehey for assistance with the production and preservation of the EMR audit trail, and counsel in dealing with EMR system vendors, plaintiff EMR consultants and other discovery and trial issues associated with this information system.

Marshall Dennehey’s focused legal services can readily assist in reducing litigation costs and standardizing discovery on EMR and audit trail issues. Our legal services include:

  • Coordinating with IT, medical records department, risk management and clinicians to confirm  the complete production of the EMR and audit trail.
  • Identifying and preparing IT professionals for corporate designee depositions.
  • Examining the methodology, credentials and knowledge of the plaintiff’s IT specialist who may provide adverse testimony at trial regarding EMR alteration.
  • Coordinating the technical support of EMR vendors in litigation.
  • Assisting in the preparation of witnesses for deposition by verifying that the produced record is accurate and consistent with the audit trail.
  • Procuring exhibits, budgets, affidavits and other internal information to be utilized as exhibits for motions for protective orders seeking the total or partial cost-shifting of costs associated with EMR audit trail discovery.
  • Providing guidance in responding to novel EMR discovery requests, including the use of the EMR during a deposition and review of EMR by plaintiff’s counsel prior to depositions.

As a value-added service, Practice Chair Matt Keris also provides consulting services on a national basis to attorneys grappling with EMR and audit trail discovery issues. In this capacity he is brought in as a legal consultant to provide guidance on managing this unique aspect of litigation.

Our goal in providing these services is simple: to reduce legal expenses, streamline answers to discovery, and reduce the time spent on litigation by the risk management, IT and medical records staff.

Thought Leadership

The Quarterly Dose

Electronic Medical Record & Audit Trail Litigation

May 1, 2025

AI has transformed health care as we know it, and its use is growing exponentially in ways previously unimaginable. As a result, medical malpractice cases are becoming even more complex and expensive to litigate and often involve third-party technology vendors as parties. Marshall Dennehey is at the forefront of this emerging area of law, as one of the first defense firms to devote a practice group to assisting health care clients and other counsel with EMR and audit trail preservation, production, expert and discovery issues.  Our experienced attorneys assist health care systems and their counsel every step of the way, from discovery through trial. We involve third-party electronic medical record vendors in the litigation, when necessary, to assist in explaining a production issue or clarify an ongoing discovery dispute. We routinely monitor and report legal precedent for new discovery and trial issues associated with the EMR, audit trail and AI.  As the EMR evolves into a tool that augments medicine, rather than an information repository with the integration of AI, new legal thought and litigation strategies need to be considered. We assist with the strategic decision of whether and how to include EMR and AI vendors in your cases, and we outline the legal benefits and pitfalls in doing so.  Medical negligence cases are only going to become more complex, with novel factual and legal issues. Going into these cases with the right guidance and experience is necessary, and you can rely on our Electronic Medical Record and Audit Trail Litigation Practice Group to lead the way. “Our cases are becoming more complex with the advent of AI, not less. We can help you anticipate and plan for the novel issues that are coming. Stay ahead of the curve and contact us with any health care technology issues you may have.” – Matt Keris, Practice Group Chair    The Quarterly Dose – May 2025, has been prepared for our readers by Marshall Dennehey. It is solely intended to provide information on recent legal developments and is not intended to provide legal advice for a specific situation or to create an attorney-client relationship. We welcome the opportunity to provide such legal assistance as you require on this and other subjects. If you receive the alerts in error, please send a note to tamontemuro@mdwcg.com. ATTORNEY ADVERTISING pursuant to New York RPC 7.1. © 2025 Marshall Dennehey. All Rights Reserved.

The Legal Intelligencer

Navigating the Digital Shift: Defending Medical Malpractice Claims in the Era of Patient Portals

April 22, 2025

Patients may be receiving test results or seeing physician clinical notes before a provider has the opportunity to review test results and educate the patient on the meaning of the medical information. Patients may also rely too much on electronic, as opposed to verbal communications, and may misunderstand the information being provided to them through the portal. What is even more concerning is that patients may neglect to review their online portal despite health care providers believing the message or test result has been received.

Firm Highlights

Thought Leadership

Featured Conversations... Key Takeaways from A.M. Best’s Webinar on the Misuse Defense in Product Liability Claims, Featuring Michael Salvati

Michael Salvati, shareholder in our Philadelphia office, was a panelist for the April A.M. Best webinar, “The Misuse Defense: Strategic Approaches to Defending Product Liability Claims for Insurers.” During the program, Michael and his fellow panelists offered practical, jurisdiction‑specific guidance on how misuse and failure‑to‑warn theories intersect in modern product liability litigation. Michael emphasized the unique challenges these claims present—particularly in states like Pennsylvania, where evidentiary rules diverge sharply from those applied in many other jurisdictions. Failure to Warn as the “Flip Side” of Misuse Salvati explained that failure‑to‑warn allegations often arise as a direct counter to a misuse defense. As he noted, “If our misuse defense is that the plaintiff didn't use a product properly or safely, then the failure to warn claim is that we didn't tell them how to use it properly.” He emphasized that these claims can stem from either the absence of warnings or criticisms of existing warnings, such as insufficient specificity or lack of clarity about risks. Pennsylvania’s Unique Evidentiary Landscape One of Salvati’s most notable points was the stark difference in how Pennsylvania treats evidence of compliance with industry standards. He highlighted that Pennsylvania is “one of the only states…where that evidence is not admissible” in strict liability cases. Manufacturers cannot rely on compliance with ANSI, UL, ISO, or even federal safety standards to defend the product against a strict liability claim—because the focus is solely on the product itself, not the manufacturer’s conduct. Salvati acknowledged the challenge this creates for defense counsel and clients who expect such compliance to carry weight. Understanding the Three Defect Theories Salvati also walked through the three primary defect theories recognized in many jurisdictions: - Design defect – a flaw in the product’s intended design - Manufacturing defect – a deviation affecting a specific unit - Failure to warn – inadequate instructions or warnings He noted that warnings claims are increasingly significant and sometimes stand alone when design or manufacturing theories are weak. As he put it, plaintiffs often default to warnings claims because “the default position seems to be, ‘If I got hurt, there must be something wrong.’” Warranties and State‑by‑State Variations Salvati addressed how breach‑of‑warranty claims fit into the broader framework, explaining that implied warranties—such as merchantability—often overlap with strict liability in Pennsylvania. He emphasized the importance of understanding local nuances, as warranty law and admissibility rules vary widely across states. Looking Ahead: The Growing Importance of Warnings In his closing remarks, Salvati stressed that warnings should never be treated as an afterthought in product liability defense. He observed that warnings‑only claims are becoming more common and urged manufacturers and insurers to continually evaluate the clarity and completeness of their instructions and warnings. His takeaway: “We should always be talking about what are the instructions that come with our products…to bolster a misuse defense.” Listen to the complete webinar here: https://www3.ambest.com/conferences/events/eventregister.aspx?event_id=WEB1074.

Thought Leadership

Legal Update for Special Education Law: Recent Positive Outcomes From the Group

Hearing Officer Confirms District Acted Appropriately Under IDEA and Section 504 William J. McPartland (Scranton) obtained a finding in favor of our client, a school district, on all issues following a due process hearing. The parent had filed a due process complaint alleging that the school district had breached its child find duty under the IDEA and Section 504, that the school district had discriminated against the student on the basis of disability in violation of Section 504, and that the school district had denied a free and appropriate public education to the student both by developing inadequate IEPs and via an actionable procedural violation.  Specifically, the student had received a Section 504 evaluation in October 2023, after a number of behavioral infractions culminating in a fight in September 2023, was identified as having anxiety and a sleep disorder, and received appropriate Section 504 accommodations. The student had never previously demonstrated signs of a learning disability, and the parent denied the school district permission to evaluate the student for special education needs in November 2023, and January 2024. The parent granted the district permission to evaluate the student in October 2024, after a private psychologist diagnosed the student with Attention Deficit Hyperactivity Disorder, possible Oppositional Defiance Disorder, a learning disorder, and anxiety. The school district issued a special education evaluation report in December 2024, finding that the student had an emotional disturbance and other health impairment, and an IEP providing an itinerant level of emotional support, as well as instruction in academics and social skills, was issued in January 2025, and amended in February, March, and April 2025. The student withdrew from the school district in April 2025, to attend a cyber charter school. The hearing officer determined that the school district had not violated its child find duty to the student in violation of either the IDEA or Section 504 where the district developed a Section 504 plan for the student within a month and a half of the parent’s first request for a Section 504 evaluation and where the parent repeatedly denied consent to conduct an IDEA evaluation of the student. The hearing officer noted that the student’s sporadic record of behavioral infractions prior to September 2023, did not suggest that the student had a disability prior to the parent’s initial request for an evaluation. The hearing officer further determined that no evidence had been produced to suggest that the student was discriminated against on the basis of disability in violation of Section 504. Additionally, the hearing officer determined that the IEP offered to the student was substantively adequate and that, to the extent the social and emotional programming offered by the school district was not received by the student, this resulted from the parent’s refusal to accept the same. The hearing officer finally determined that the school district did not commit an actionable procedural violation by delaying development of an IEP for the student where the parent repeatedly denied consent to evaluate the student. Court Dismisses Three of Four Claims Against School District Christopher J. Conrad and Daniel P. McGannon (Harrisburg) achieved a significant early victory on behalf of a school district client in. The team successfully obtained dismissal of three of the four claims asserted in the plaintiff’s amended complaint. The former district superintendent brought multiple claims arising out of his alleged “forced resignation,” including age discrimination under the ADEA, a Section 1983 Equal Protection claim, a Pennsylvania Whistleblower claim, and breach of contract. On behalf of the district, the defense team moved to dismiss the complaint in part, arguing: The plaintiff failed to plead sufficient facts to support a prima facie case of age discrimination. The equal protection claim was barred because the ADEA provides the exclusive federal remedy for age-based employment claims. The breach of contract claim could not stand because the underlying employment agreement had expired prior to the alleged breach. The court agreed, dismissing the ADEA, equal protection, and breach of contract claims in their entirety. As a result, only a single claim under the Pennsylvania Whistleblower Law remains pending. This outcome substantially narrows the scope of the litigation and positions the client for a more efficient defense moving forward.

Result

No-Cause Jury Verdict Secured in Wrongful Death Trial

We successfully obtained a no-cause jury verdict in a 13-day wrongful death trial. The decedent, a 59-year-old man, was admitted to the emergency room on February 15, 2019, with complaints of abdominal pain, decreased appetite, and constipation, despite the use of laxatives. The patient did not complain of any nausea, vomiting, or diarrhea. He had a significant medical history including diabetes, hypertension, prior coronary artery stenting, morbid obesity (with past gastric bypass surgery), longstanding ventral hernia, and back pain. A CT scan revealed multiple hernias and a potential closed-loop bowel obstruction, leading to a surgery consultation. Our client, an emergency general surgeon, interpreted that the patient did not have a closed loop or any significant obstruction and recommended non-surgical management. The patient was approved to have clear liquids, and had a vomiting incident shortly after, but our client was not notified. The patient was returned to NPO status, and after improving overnight, he was returned to “clears” and additional medical and renal consults were ordered. Our client did not receive any communications from the residents/nurses of any changes in the patient’s condition. On February 18, 2019, two rapid responses were called due to increased heart rate and vomiting. It is believed that the vomiting resulted in aspiration, causing sepsis, ultimately leading to the patient’s death. During the trial, the plaintiff’s sole medical expert highlighted imaging on the wrong hernia, which called into question all of his opinions in the case. We made key objections related to the expert testimony, limiting what the allegations were, and preventing new allegations from being made. After approximately two and a half hours of deliberating, the jury returned a no-cause verdict.