Superior Court of New Jersey, Law Division, Essex
STEPHANIE A. MITTERHOFF, J.S.C.
matter comes before the court on Plaintiffs motion to bar
testimony. For the reasons stated herein, Plaintiffs motion
to bar testimony is GRANTED in part.
motion arises from two consolidated civil actions. (Pl.'s
Br. at 8.) On October 3, 2013, Plaintiff Ilene Klinger filed
a Complaint in the Superior Court of New Jersey, initiating a
Track III medical malpractice action against Michael Dardik,
M.D. and Saint Barnabas Medical Center. (Ibid.) An
amended complaint was filed on March 31, 2014 to join
Livingston Pathology Associates as a defendant.
(Ibid.) Ms. Klinger filed a separate Complaint
against Jonathan F. Lara, M.D., Marietta Kintiroglou, M.D.,
Livingston Pathology Associates, and St. Barnabas Medical
Center. (Ibid.) An order for consolidation was
entered on February 6, 2015. (Id. at 8-9.) During
the pendency of this case, Dr. Lara died, and an amended
complaint was filed in the second action, naming the Estate
of Jonathan F. Lara as a defendant. (Id. at 9.) The
events leading up to the filing of these actions are
Klinger has undergone twice yearly screening for breast
cancer since at least December 1998. (Id. at 3.) In
May 2009, Ms. Klinger's doctor, Nancy Elliot, M.D.,
recommended that she undergo genetic testing for mutations to
the BRCA genes. (Ibid.) A test, dated May 12, 2009,
revealed that Ms. Klinger had a "6174delT mutation"
of the BRCA2 gene. (Ibid.) Ms. Klinger's expert,
Steven Narod, M.D., a preeminent epidemiologist widely
published on breast cancer risk, observed that a 6174delT
mutation of the BRCA2 gene indicates "the risk of
developing breast cancer for Ms. Klinger is increased beyond
that of women in the general population."
(Ibid.) However, the specific mutation that Ms.
Klinger has "is associated with a cancer risk that is
much lower than that of other BRCA2 mutations."
(Ibid.) In the absence of prophylactic therapy, the
risk that Ms. Klinger would develop breast cancer is 34%
through age 70 and 39% through age 80, including
consideration of Ms. Klinger's family history of breast
cancer. (Ibid.) This results in an annual risk of
developing breast cancer of 1.3% per year at the current
time, meaning it is not probable that Ms. Klinger would have
developed breast cancer in her life. (Id. at 4.)
discovery of the BRCA2 gene mutation, Ms. Klinger was
counselled regarding her options for risk reduction, which
included: prophylactic bilateral mastectomies;
chemoprevention with tamoxifen; or enhanced surveillance with
mammography, physician visits, and annual MRIs.
(Ibid.) Ms. Klinger felt having mastectomies would
be drastic, since she did not actually have cancer, so she
chose to undergo enhanced surveillance. (Ibid.)
October 1, 2012, Ms. Klinger had a bilateral breast MRI,
which revealed a ''[l]ow level new enhancing nodule
within the left breast.'' (Ibid.) As a
result, she had a vacuum-assisted ultrasound-guided left
breast biopsy on October 4, 2012 and an MRI-guided needle
biopsy of her left breast on December 6, 2012.
(Ibid.) The surgical specimen, taken on December 6,
was sent to the Department of Pathology at Saint Barnabas
Medical Center, where it was interpreted by Defendant Dr.
Michael Dardik, who concluded it was cancer. (Id. at
4-5.) At the time of his review, Dr. Dardik was unaware that
Ms. Klinger had a BRCA2 gene mutation. (Id. at 5.)
Dr. Dardik then showed the specimen to Defendants Dr.
Jonathan F. Lara, now deceased, and Dr. Marietta Kintiroglou,
who both agreed with Dr. Dardik's diagnosis of invasive
ductal carcinoma. (Id. at 5.) On December 10, 2012,
Dr. Dardik issued a Surgical Pathology Consultation Report
announcing that the biopsy revealed invasive ductal
tests were performed on the biopsy sample, reflected in
addendums to the pathology report entered by Teresita
Redondo, M.D., a Saint Barnabas pathologist, on December 14,
2012. (Ibid.) Dr. Redondo conducted estrogen
receptor ("ER") and progesterone receptor
("PR") tests, in order to guide oncologists on how
to treat the presumed cancer. (Ibid.) The specimen
produced negative ER and PR results, which Dr. Redondo
thought unusual because a grade one invasive ductal carcinoma
would normally produce positive ER and PR results.
(Id. at 5-6.) Due to the unusual results, Dr.
Redondo repeated the test, and it produced the same results.
(Id. at 6.) Dr. Redondo testified that it was her
custom to inform the diagnosing pathologist if she found
anything unusual when she did her tests, so the pathologist
could take another look. (Ibid.)
December 13, 2012, Ms. Klinger met with Dr. Elliott to
discuss the cancer diagnosis and her treatment options, and
she was advised to undergo bilateral mastectomies.
(Ibid.) The surgery was done on January 10, 2013.
(Ibid.) After the surgery, Dr. Lara reviewed the
mastectomy specimen and again concluded there was cancer.
(Ibid.) On January 22, 2013, Ms. Klinger saw Dr.
Richard A. Michaelson, a Saint Barnabas oncologist, to
determine whether she should have chemotherapy. (Id.
at 6-7.) Dr. Michaelson noted the unusual ER and PR negative
test results previously observed by Dr. Redondo and asked for
the test to be repeated. (Ibid.) The test that Dr.
Michaelson ordered confirmed the negative ER and PR test
results. (Ibid.) Dr. Michaelson testified that he
found the results "unusual" because "the tumor
seemed to be not a very aggressive looking tumor under the
microscope.'' (Ibid.) Dr. Michaelson
recommended "some type of chemo, " but Ms. Klinger
wanted a second opinion, which Dr. Michaelson
"encouraged . . . [and] [o]ffered to help her
February 6, 2013, Ms. Klinger went to Memorial
Sloan-Kettering ("MSK") for a second opinion.
(Ibid.) The MSK pathology department reviewed the
biopsy slides from Saint Barnabas and found no evidence of
invasive or in situ carcinoma. (Ibid.) Dr. Teresa
Ann Gilewski, a MSK oncologist, and Dr. Melissa P. Murray, a
MSK pathologist, concluded that Ms. Klinger had
microglandular adenosis, which "may be a precursor to
the development of cancer" but was not cancer itself.
(Id. at 7-8.) MSK did not recommend further
treatment. (Id. at 8.)