Does a hospital committee that includes outsiders qualify for protection against litigation inquiries that is typically afforded to hospital “staff committees?” In overturning a trial court judge who did not think so, the state Court of Appeal noted that non-hospital members could actually improve the effectiveness of quality-control committees.
In an ongoing dispute over the use of a bone-growth putty by physicians at a licensed acute-care hospital, a plaintiff-patient sought documents from the hospital’s Institutional Review Board (IRB) regarding the hospital’s communications with the putty’s manufacturer and regarding the hospital’s approval of the putty for use in treatment. According the Court of Appeal opinion, the putty is an investigational device that was granted a humanitarian device exemption by the Food & Drug Administration.
The hospital’s bylaws define “medical staff” as the formal organization of all licensed physicians, dentists, and podiatrists who are privileged to attend to patients at the facility. The bylaws further state that the creation of the IRB is the responsibility of the medical staff president and that in addition to its hospital-based members, the IRB must include at least two laypersons from the community. The criteria used by the hospital follow federal requirements that an IRB include one person not affiliated with the hospital and one member whose primary concern is non-scientific. The IRB is charged with the responsibility of evaluating and approving proposed investigational studies and monitoring ongoing studies.
When the hospital declined to provide the information sought by the plaintiff in her litigation over injuries attributed to the surgical putty, her attorney argued in court that the IRB is not entitled to protection against litigation “discovery” under California’s evidence Code Section 1157 because the panel’s two lay members disqualify it as a “medical staff” committee. By including such outsiders on the IRB, the plaintiff argued, the hospital could have no expectation of confidentiality in its proceedings. The trial court judge agreed and ordered the hospital to produce the documents sought. The hospital appealed.
Commonly cited to protect peer review proceedings from inquiry by patient-plaintiffs, Section 1157 states that “neither the proceedings nor the records of organized committees of medical… staffs in hospitals… having the responsibility of evaluation and improvement of the quality of care rendered in the hospital… shall be subject to discovery.”
In its ruling supporting the hospital, the Second District Court of Appeal in Pomona Valley Hospital Medical Center v. Superior Court (April Christine Cabana, Real Party in Interest) noted that “although membership on a ‘medical staff’ may be restricted by statute to physicians and other licensed practitioners, this statutory requirement does not preclude the medical staff from organizing a committee which includes other than licensed practitioners.”
The Court of Appeal pointed out that Section 1157 does not limit its protections to committees composed solely of licensed practitioners and “the Legislature’s goal to encourage candor and objectivity for committees performing these functions is not altered by the inclusion of lay people as committee members.”
In fact, the Court of Appeal articulated why expanding a committee’s roster is a good idea: “the inclusion of lay people on the IRB who are not affiliated with a hospital is likely to increase objectivity, leading to increased patient protection and improved quality of care.”
Author Gordon Ownby is General Counsel for the Cooperative of American Physicians, Inc. (CAP).
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