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Gore v. 3M Co.

United States District Court, E.D. North Carolina, Western Division

November 3, 2017

FAYE GORE, Individually and Executrix of the ESTATE OF WADE MILLER GORE, Deceased, Plaintiff,
v.
3M COMPANY a/k/a MINNESOTA MINING AND MANUFACTURING COMPANY,, Defendants.

          PROTECTIVE ORDER GOVERNING RELEASE OF PATHOLOGY MATERIALS

          ROBERT B. JONES, JR. UNITED STATES MAGISTRATE JUDGE

         THIS MATTER came before the Court upon Duke University Health System, Inc.'s (hereinafter "DUHS") Motion for Protective Order Governing Release of Pathology Materials following Defendant John Crane, Inc.'s (hereinafter "Defendant John Crane") request to DUHS and Motion for the release of original pathology material. Upon review of the file and motion, it appears to the Court as follows:

         1. This matter arises out of Plaintiffs allegation of occupational disease allegedly caused by exposure to asbestos.

         2. On October 21, 2015, specimen was obtained from Wade Miller Gore ("Mr. Gore") while a patient at DUHS. Dr. Thomas A. Sporn, a DUHS pathologist, issued a surgical pathology report (Accession SP15-033526) dated November 15, 2015 regarding the specimen.

         3. On November 4, 2015, specimen was collected again from Mr. Gore while a patient at DUHS. Dr. Sporn issued a surgical pathology report (Accession SP15-035277) dated November 6, 2015 regarding the specimen.

         4. On or about April 12, 2017, DUHS received a request from counsel for Defendant John Crane for the release of the following original tissue blocks: Blocks C1-C3 and Block Dl. from Accession SP15-033526 and Block Al from Accession SP15-035277. .

         5. On receipt of Defendant John Crane's request for original pathology material in April 2017, counsel for DUHS informed both parties of DUHS's mandate to retain original pathology slides, tissue blocks, and wet tissue pursuant to the Clinical Laboratory Improvement Amendments of 1988 (CLIA 88) and College of American Pathologists (CAP).

         6. In moving for a protective order regarding the release of the requested pathology materials, DUHS, a non-party to this claim, contends that federal regulations, accreditation requirements, and North Carolina Session Law 2013-14 (previously N.C. Senate Bill 240) govern the amount of time that laboratories are required to retain and preserve original pathology materials, and the manner in which original pathology materials may be released. Specifically, federal regulations under CLIA 88 mandate that DUHS retain original tissue blocks for two years from the date of collection. In addition, CAP standards mandate that DUHS retain original tissue blocks for ten years from the date of collection. Failure to comply with these regulations and requirements may subject DUHS to sanctions, loss of accreditation, and/or loss of Medicare reimbursement.

         7. DUHS acknowledges, however, the pendency of the present litigation and Defendant John Crane's request to perform destructive, fiber analysis testing on tissue contained in the pathology blocks. Defendant John Crane contends that fiber analysis testing of the requested pathology blocks may demonstrate the liability and/or non-liability of some or all of defendants.

         8. In an effort to resolve this matter without further court intervention, DUHS will release the tissue blocks requested by Defendant John Crane, specifically Blocks C1-C3 and Block D1 from Accession SP15-033526 and Block Al from Accession SP15-035277, to the Defendant John Crane, care of Susan Brooks at O'Connell, Tivin, Miller and Burns, LLC, 400 E. Wisconsin Avenue, Suite 400, Milwaukee, WI 53202, (414) 455-8709, sbrooks@otmblaw.com, for fiber analysis testing in accordance with the terms of the Protective Order Governing Release of Pathology Materials. The proposed order is necessary to prevent an undue burden that exists given the federal regulations, accreditation requirements, and other North Carolina legislation governing the retention, preservation, and release of original pathology materials as described above.

         9. Furthermore, any unused portions of the tissue blocks shall be returned to DUHS for compliance with the CLIA 88 and CAP regulatory requirements and standards.

         10. By entry of this Order, DUHS does not waive any objections that may be asserted should additional pathology material be requested in the future, and that this Order relates to and governs the release solely of those pathology materials requested by Defendant John Crane and identified above.

         IT IS THEREFORE ORDERED, ADJUDGED AND DECREED that:

         1. Upon completion of proper authorization for release of pathology materials, DUHS will release tissue pathology Blocks C1-C3 and Block Dl from Accession ...


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