EMAIL TO A FRIEND COMMENT

 

Institutional Review Board’s Records Regarding Evaluating and Improving Care Protected From Discovery Despite Including Lay Persons


A woman underwent back surgery at the defendant hospital. During the procedure, the surgeon used a combination of two medical products: a putty to promote bone growth and a bone void filler. As this combination of medical products was experimental, the hospital's institutional review board (IRB) was required to review and approve the use of the putty before the surgeon could use it. Prior to the surgery, the woman did not receive any consent form or information about the products that were used. After the surgery, the product migrated to other areas of her body and the woman experienced excessive bone growth which required additional surgery. During the second surgery the surgeon used a different bone graft product in a manner that was not approved. The woman never recovered from the surgeries and suffered from disabling pain.

 

The woman sued the surgeons and hospital for negligence. In the course of discovery, the woman 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 grounds that the responsive documents were in the possession of the hospital’s IRB. The hospital argued that the California Evidence Code exempts the IRB’s records from discovery because the IRB is an organized committee of medical staff or a peer review body having the responsibility of evaluation and improvement of the quality of care.

 

The plaintiff filed a motion to compel arguing that the IRB is not medical staff as defined under the California Evidence Code, 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. Additionally, the plaintiff argued that the IRB is not a peer review committee, because its function is not to review medical peers.

 

The Superior Court, Los Angeles County, concluded that the IRB was not a medical staff committee because the committee members included lay people. The court granted the plaintiff’s motion to compel. The defendant hospital filed a petition for a writ of mandate seeking to compel the trial court to vacate its order.

 

The California Court of Appeal, Second District, Division 5, granted the petition holding that the IRB is a medical staff committee whose records are exempt from discovery under the California Evidence Code. The inclusion of people other than licensed practitioners on the IRB does not remove it from protection. While the IRB is not purely a peer review committee, it evaluates the proposed use of experimental devices before physicians may use them at the hospital, monitors the ongoing use of the devices, and ensures that patients are provided informed consent about use of the devices. These activities are necessary to evaluate and improve the quality of care rendered to patients at the hospital who are receiving experimental treatments. The court concluded that the activities of the IRB are of the type that the California Evidence Code sought to protect.

 

However, information developed and obtained by hospital administrators or others which was not derived from an investigation into the quality of care or the evaluation of care by a medical staff committee, and which does not disclose the investigative and evaluative activities of such a committee is subject to discovery, regardless of whether it was later placed in the possession of the IRB.

 

See: Pomona Valley Hosp. Medical Center v. Superior Court, 2012 WL 4336245 (Cal.App. 2 Dist., September 24, 2012) (not designated for publication).

 

 

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