United States District Court, E.D. North Carolina, Western Division
FAYE GORE, Individually and Executrix of the ESTATE OF WADE MILLER GORE, Deceased, Plaintiff,
3M COMPANY a/k/a MINNESOTA MINING AND MANUFACTURING COMPANY,, Defendants.
PROTECTIVE ORDER GOVERNING RELEASE OF PATHOLOGY
B. JONES, JR. UNITED STATES MAGISTRATE JUDGE
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:
matter arises out of Plaintiffs allegation of occupational
disease allegedly caused by exposure to asbestos.
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
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.
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
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).
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.
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
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, email@example.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.
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.
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.
IS THEREFORE ORDERED, ADJUDGED AND DECREED that:
completion of proper authorization for release of pathology
materials, DUHS will release tissue pathology Blocks C1-C3
and Block Dl from Accession ...