MARTIN REIDINGER, District Judge.
I. FACTUAL AND PROCEDURAL BACKGROUND
On October 1, 2012, Billy David Harris and his wife, Robin L. Harris, filed a Complaint alleging that Mr. Harris developed mesothelioma as a result of breathing asbestos that had been contained in products and/or equipment of the Defendants sued. [Doc. 1]. Mr. Harris died on January 12, 2013, and Robin Harris thereafter filed motions to substitute herself as Plaintiff, as Executor of the Estate of her deceased husband, and for leave to file the First Amended Complaint containing a cause of action for wrongful death. [Docs. 69, 70]. After these motions were granted [
Before Mr. Harris died, tissue samples ("pathology materials") were obtained from different locations in his lungs and lymph nodes by doctors at Duke University Health System, Inc. ("Duke"). Such pathology materials, usually consisting of tissue slides or tissue blocks, can assist treating physicians and pathologists retained by parties in asbestos cases in forming opinions about the nature of the purported disease and its causes. There were 22 blocks of biopsy tissues obtained from Mr. Harris, and each is anatomically different.
On May 8, 2013, in response to a written request for pathology materials, Duke provided a total of 156 pathology slides, including 12 unstained recut pathology slides from tissue blocks SF-11-422266, A1-3, and D1-10, to Plaintiff's counsel. On June 13, 2013, a replacement pathology slide for one recut pathology slide was sent to Plaintiff's counsel. These slides were shared with Defendants' counsel.
On November 26, 2013, Duke provided one set of recut pathology slides, including one slide from SL-11-38785 and 18 slides from SF-11-422266, to Steve Williamson, counsel for the Defendant Cleaver-Brooks, Inc. for testing by all of the Defendants.
After receiving the tissue slides on October 7, 2013, Mr. Williamson's paralegal/nurse sent them to Defendants' expert, Dr. Tim Oury, on October 10. After examining the slides, Dr. Oury informed the Defendants that analysis of some additional tissue blocks would be necessary for more specific findings. The Defendants therefore contacted the Duke pathology lab to request additional tissue. In response, the Defendants were advised that it was Duke's policy not to release original materials but that recut sections were available. Therefore, the Defendants agreed to receive re-cut slides from two specifically-identified tissue blocks, which the Defendants received on November 27, 2013.
After Dr. Oury had the opportunity to review the recut tissue slides, he concluded that he still needed certain specific tissue blocks to examine and to undertake a digestion analysis, and that he could not do such an analysis with the previously provided pathology materials. Accordingly, the Defendants again requested original tissue blocks (specifically, SF11042266, blocks F1 and G1) from Duke. In response, the Defendants were again advised that it was Duke's policy not to release original tissue blocks.
On December 12, 2013, the Defendants filed a motion seeking the entry of an order authorizing the release of Mr. Harris's pathology materials from Duke.
Duke moves for a protective order pursuant to Rule 26 of the Federal Rules of Civil Procedure, arguing that the Defendants' request for pathology materials is overly broad and unduly burdensome.
As an initial matter, Duke's argument that it is entitled to a protective order because it has already provided pathology samples to the Defendants is simply without merit. The Defendants have shown that the materials previously provided by Duke were not sufficient for Dr. Oury to complete the kind of testing that the Defendants require. The Defendants' request for further pathology materials, therefore, is reasonable, and the fact that Duke has already provided some pathology samples does not insulate it from complying with the Defendants' additional request or otherwise entitle it to a protective order.
More importantly, contrary to Duke's central argument, the Clinical Laboratory Improvement Amendments (CLIA) requirements do not prevent this Court from ordering the release of tissue blocks or sections of tissue blocks. CMS (The Centers for Medicare & Medicaid) implements the CLIA program, which is based on regulations found in 42 Code of Federal Regulations (CFR) Part 493.
Pursuant to the federal regulations, CMS may impose sanctions on any facility that is out of compliance with one or more CLIA requirements, including suspension, limitation, or revocation of any type of CLIA certificate.
Duke also cites the College of American Pathologists (CAP) guidelines, which require an accredited laboratory to retain surgical pathology specimens for a specified period of time. The CAP guidelines, however, are entirely voluntary.
Furthermore, CAP has procedures for accredited laboratories to follow when requests are made to those laboratories for the release of pathology materials. As part of those procedures, CAP expressly recognizes a court's ability and authority to order the release of pathology materials:
The CAP Manual also discusses at length what a laboratory should do when surgical pathology materials are requested by a physician, another institution, or an attorney (although it is assumed in this discussion that an attorney making such a request would be contemplating filing a malpractice claim against the healthcare provider housing the laboratory). The CAP Manual first notes that "[w]hen the pathologist is responding to a request for review of patient slides or other patient materials, it is preferable to obtain consent from the patient permitting release of these materials."
The CAP Manual goes on to say that "[i]f the court orders the release of the original materials, the pathologist will then be under the protection of the court, should these materials be lost or destroyed."
For all of these reasons, the Court concludes that the CLIA and CAP requirements do not prevent Duke from complying with the Court's Order.
Finally, the Court notes that in bringing this motion, Duke challenges the manner in which it was directed to produce the pathology samples in this case (i.e., a court order as opposed to a Rule 45 subpoena). The Court, however, does not find that Duke suffered any prejudice by the procedure utilized by the Court; in fact, Duke was probably afforded more protection by the method followed by the Defendants in seeking a court order rather than the usual method of defense counsel themselves issuing a subpoena without any intervention of or consideration by the Court. Once the Pathology Order was entered, Duke was able to file its motions and present its arguments against production, and therefore was afforded the same opportunity it would have had if a subpoena for the pathology materials had been served and Duke sought protection from complying with the subpoena. While the Court does not find that Duke suffered any prejudice in the instant case, the Court encourages the parties to utilize the Rule 45 procedures for any further pathology material requests. Utilization of the subpoena process will allow the parties to resolve or at least minimize any disputes regarding the scope of the production prior to seeking the involvement of the Court.
In sum, the Court concludes that Duke's Motion for Protective Order must be denied. The Court specifically finds that the Pathology Order directing Duke to release to defense counsel pathology materials of Mr. Harris will not detrimentally affect Duke's accreditation; it does not require Duke to violate any law or legally-enforceable regulation; and the Order is not oppressive or unduly burdensome. The Court further finds that if the requested materials were not produced, the Defendants would be unduly prejudiced in defending the Plaintiff's claims.