Pennsylvania Medical Malpractice – Beware the Privilege Traps

By James P. Goslee, Esq.

May 9, 2024

Bringing a successful medical malpractice claim against a Pennsylvania hospital is a formidable undertaking. It necessitates not only a sophisticated grasp of both medicine and the legal landscape but also a relentless pursuit of evidence to substantiate a claim. In Pennsylvania, hospitals bear responsibility for the negligent acts committed by their doctors. To establish hospital liability, a plaintiff must prove that the doctor’s care fell below the standard of care, resulting in harm to the patient. However, what often escapes patients and practitioners alike is the nuanced interplay of Pennsylvania and federal laws, which may allow hospitals to withhold critical evidence under the guise of a patient safety or peer review privilege. As medical malpractice attorneys, it becomes imperative to challenge these designations when warranted, as the outcome of the case can hinge on the application of privilege.

Understanding the Difference Between State and Federal Patient Safety Privilege

At the outset, it is important to understand the purpose of patient safety privileges.  Patient safety privileges exist not to protect individual providers or hospitals but to improve the entire healthcare system. The purpose of these privileges is to facilitate a culture of learning from mistakes and enhancing patient care.

Unfortunately, in practice, hospitals often misuse this privilege in order to withhold inculpatory evidence. Thus, well-prepared Pennsylvania Medical Malpractice Attorneys must understand the elements and exceptions to both state and federal law upon which these privileges are claimed. Patient safety privileges under both Pennsylvania and Federal law are construed very narrowly but are often abused by hospitals in order to withhold potentially damaging evidence.  To combat and overcome misapplication of state and federal privileges, Pennsylvania medical malpractice attorneys need to understand the purpose, application and nuances of both state and federal law.

A. Pennsylvania’s Patient Safety Privilege

Pennsylvania’s patient safety privilege is statutory and is codified in the MCARE Act. The Pennsylvania MCARE Act requires medical facilities to establish patient safety committees for reporting and investigating serious events and incidents, who are in turn obligated to perform certain functions as set forth in Section 310(b) of the Act. See 40 P.S. §§ 1303.309-1303.310. The MCARE Act contains a confidentiality provision (usually referred to as “Patient Safety Privilege”) that shields certain materials from discovery. But this protection only extends to “documents, material or information solely prepared or created for the purpose of compliance with Section 310(b)” which “arise out of matters reviewed by the patient safety committee.”

Over the past several years, Pennsylvania courts have significantly narrowed the scope of the Patient Safety Privilege.  Under Pennsylvania law, a hospital asserting the Patient Safety Privilege must establish that the nondisclosed materials (1) were “solely prepared or created for the purpose of compliance with” the MCARE Act’s “serious events” reporting requirements or the patient safety committee’s responsibilities; (2) “arise out of matters reviewed by the patient safety committee … or the governing board”; and (3) are not otherwise available “from original sources.” These elements were set out in a seminal case dealing with the Pennsylvania Patient Safety Privilege, Venosh v. Henzes.

With respect to the first element of the Patient Safety Privilege, the Pennsylvania Superior Court has emphasized that the critical term is “solely,” which “means ‘without another or others,’ or ‘only, exclusively, merely, or altogether.’” Thus, for a hospital to assert a privilege under this section, it must meet its burden of demonstrating that the documents at issue were exclusively prepared or created to comply with MCARE.

In sum, under Pennsylvania law, a hospital can only withhold records if they can show that the records were: (1) created for the sole purpose of compliance with an MCARE Act duty; and (2) arose out of materials actually presented to an MCARE-defined Patient Safety Committee or governing board.

B. Federal Privilege

The Patient Safety and Quality Improvement Act (“PSQIA” for short) was passed in 2005 and is a federal statute relating to medical peer review. The PSQIA’s primary goal is to enhance patient safety by establishing a system for healthcare providers to voluntarily collect, review and report information related to patient safety, healthcare quality and outcomes. Under the PSQIA, hospitals can share information with Patient Safety Organizations (PSOs), which aggregate and analyze this data

It is critical for Pennsylvania medical malpractice attorneys to recognize that the PSQIA, like the Pennsylvania privilege, is a “limited privilege” possessing “narrow bounds.” See Dunn v. Dunn.  The statute “was not intended to provide a blanket protection for all information and communications generated for quality control purposes.” Rather, the PSQIA privilege extends only to material constituting “patient safety work product” (often shortened to “PSWP”) which is narrowly defined to include data, reports, records, memoranda, analyses (such as root case analyses), or written or oral statement which:

(1) are assembled or developed by a provider for reporting to a patient safety organization and are reported to a patient safety organization; or;

(2) are developed by a patient safety organization for the conduct of patient safety activities, and which could result in improved patient safety, health care quality or health care outcomes.

Records which identify or qualify as the deliberations or analysis of a patient safety evaluation system can also be privileged under the PSQIA.

The PSQIA statutory language is vague and difficult to parse.  To address confusion as to when the PSQIA should apply, in 2016, the Department of Health and Human Services published guidance summarizing “the three basic ways that certain information can become PWSP.” To qualify, the material must meet the following three elements:

(1) the information is prepared by a provider for reporting to a PSO and it is reported to the PSO (this is sometimes called the “reporting pathway”);

(2) the information is developed by a PSO for the conduct of patient safety activities; or

(3) the information identifies or constitutes the deliberations or analysis, or identifies the fact of reporting pursuant to, a patient safety evaluation system (sometimes referred to as the “deliberations and analysis pathway”).”

Courts carefully scrutinize the assertion of PSQIA privilege and generally require factual assertions to be supported by evidence.  It is always the hospital’s burden to establish the privilege applies.

Overcoming Misuse of Patient Safety Privileges

Patient safety privileges serve a valuable purpose, but they shouldn’t obstruct justice. As we’ve explored, patient safety privileges—both at the state and federal levels—exist not to shield individual providers or institutions but to elevate the entire healthcare system. The purpose is noble: fostering a culture of learning from mistakes and enhancing patient care.

Yet, at times the reality diverges from intent. Hospitals, wielding the cloak of privilege, may misuse it to withhold crucial evidence. Pennsylvania medical malpractice attorneys must be prepared to identify and zealously challenge misuse of this privilege, Here’s a roadmap:

  1. Know the Nuances: Familiarize yourself with the elements and exceptions of both state and federal patient safety privileges. These protections are narrow by design but are frequently exploited by hospitals to conceal inculpatory evidence.
  2. Pennsylvania’s MCARE Act: The state’s patient safety privilege, codified in the MCARE Act, shields certain materials from discovery. However, it extends only to documents created for compliance with Section 310(b) and arising from patient safety committee reviews.
  3. The Burden of Sole Purpose: The critical term is “solely.” Hospitals must demonstrate that the undisclosed materials were exclusively prepared for compliance with reporting requirements or patient safety committee responsibilities.
  4. Venosh v. Henzes: This seminal case set the parameters for the Pennsylvania Patient Safety Privilege. Courts have narrowed the scope, emphasizing transparency over secrecy.

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