ORIGINAL PROCEEDINGS; petition for writ of mandate. Michael P. Linfield, Judge. Writ granted. (L.A. Super. Ct. No. BC465313)
The opinion of the court was delivered by: Kriegler, J.
CERTIFIED FOR PUBLICATION
Petitioner Pomona Valley Hospital Medical Center (the Hospital) contends the records of its institutional review board (IRB) are exempt from discovery under the protection of Evidence Code section 1157*fn1 for records of organized committees of medical staffs that have the responsibility of evaluation and improvement of the quality of care rendered in the Hospital. The Hospital seeks a writ of mandate directing respondent court to vacate its order compelling interrogatory responses and production of documents concerning information held solely by the Hospital's IRB. We hold the IRB is a medical staff committee whose records are exempt from discovery under section 1157. Therefore, we grant the petition.
In order to engage in biomedical research under federal law, a hospital must have an IRB to approve and provide continuing review of clinical investigations. An IRB is "any board, committee, or other group formally designated by an institution to review, to approve the initiation of, and to conduct periodic review of, biomedical research involving human subjects. The primary purpose of such review is to assure the protection of the rights and welfare of the human subjects." (21 C.F.R. § 56.102(g).) An IRB is also referred to under federal law as an "institutional review committee." (Ibid.)
In addition to approving and monitoring clinical investigations, the IRB's responsibilities include requiring documentation of informed consent from subjects (21 C.F.R. § 56.109(b), (c)) and maintaining certain records (21 C.F.R. § 56.115). The records must be retained for at least three years after the research has been completed and must be accessible for inspection and copying by the United States Food and Drug Administration (FDA). (21 C.F.R. § 56.115(b).) The FDA may refuse to consider an application if the IRB or institution doesn't comply with the federal regulations. (21 C.F.R. §§ 56.115(c), 56.120, 56.121.)
An IRB must be composed of at least five members of varying backgrounds, including one member who is not affiliated with the hospital and one member whose primary concern is non-scientific. (21 C.F.R. § 56.107(a)-(d).) "In addition to possessing the professional competence necessary to review the specific research activities, the IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards or professional conduct and practice." (21 C.F.R. § 56.107(a).)
California law similarly requires that medical research projects must have "the prior approval of a broadly represented committee which shall assure maximum patient safety and understanding." (Cal. Code Regs., tit. 22, § 70708.)
Facts and Procedural History
The Hospital is a licensed acute care hospital with a governing body and an organized medical staff. The Hospital's bylaws define "medical staff or staff" as "the formal organization of all licensed physicians, dentists, and podiatrists who are privileged to attend patients in the Hospital." The bylaws establish several committees, including an IRB. The president of the medical staff is responsible for selecting IRB members pursuant to the bylaws. The membership must consist of physicians representatives of the board of directors, hospital administration, nursing administration, the director of pharmacy, and at least two lay persons from the community. The members of the IRB must be capable of judging the acceptability of clinical investigations with respect to institutional requirements, standards of professional practice, and community acceptance. The stated purpose of the IRB is to provide assurance to the medical staff, the governing board, and the community that the rights and welfare of patients involved in investigational studies are protected and patients are fully informed about the risks involved in the investigational study before they consent. The IRB is charged with responsibility for the evaluation and approval of proposed investigational studies, as well as monitoring ongoing studies. It is the IRB's duty to require that each patient be adequately informed of the nature of the study and the possible side effects, risks and consequences of an investigational drug or device. It is also the IRB's duty to require that each patient sign an informed consent.
In September 2008, plaintiff and real party in interest April Cabana had a surgical procedure to correct back pain through the fusion of two vertebrae. According to the allegations of the complaint, Cabana's surgeon used a combination of two medical products during the surgery: a putty to promote bone growth and a bone void filler. The FDA had granted limited approvals for use of the putty and the filler individually, but not in combination. The putty is an investigational device that was granted a humanitarian device exemption by the FDA. Therefore, the Hospital's IRB was required to review and approve the use of the putty before Cabana's physician could use it. However, Cabana did not receive any consent form or information about the products that were used. The product migrated to other areas of her body and she experienced excessive bone growth that she attributes to the combined medical products. The bone growth required additional surgery in July 2009. Her surgeon used a different bone graft product during the second surgery in a manner that was not approved. Cabana has never recovered from the surgeries and continues to suffer from disabling pain.
Cabana filed a negligence complaint on July 13, 2001, against several defendants. On October 11, 2011, she filed an amendment to the complaint naming the Hospital as a Doe defendant. Cabana sought responses to interrogatories and production of documents from the Hospital concerning communications with the manufacturer of the putty and approval of the putty for use in treatment. The Hospital objected on the ground that any documents required to provide responses were possessed by the IRB and the IRB was a committee of the Hospital's organized medical staff. Therefore, the Hospital argued, the information was exempt from discovery under the protection of section 1157 for the records of an organized committee of medical staff or a peer review body having the responsibility of evaluation and improvement of the quality of care.
In April 2012, Cabana filed a motion to compel the Hospital to provide responses to the interrogatories and produce documents. Cabana asserted that the IRB is not medical staff as defined under section 1157, because federal law requires the IRB to include at least one person who is not a scientist and one person who is not affiliated with the Hospital. Cabana also argued ...