Fertik et al v. Stevenson, et al

Filing 253

Chief Judge Patti B. Saris: MEMORANDUM and ORDER entered. The Court ALLOWS Abbott's motion to strike the June 27, 2016 Supplemental Report of Dr. Medlin (Docket No. 242 ). The plaintiff's motion for a protective order and to quash the defendant's deposition subpoena (Docket No. 247 ) is now MOOT. Finally, Abbott' s motion in limine to exclude the testimony of Dr. Medlin (Docket No. 179 ) is ALLOWED in part in accordance with this order.(Geraldino-Karasek, Clarilde)

UNITED STATES DISTRICT COURT
DISTRICT OF MASSACHUSETTS
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WILLIAM FERTIK, individually
and as personal representative
and successor of the ESTATE
of GRETA FERTIK,
Plaintiff,
v.
WILLIAM STEVENSON, M.D.;
MELANIE MAYTIN, M.D.; ABBOTT
VASCULAR, INC.,
Defendants.
______________________________

Civil Action
No. 12-10795-PBS

MEMORANDUM AND ORDER
August 4, 2016
Saris, C.J.
INTRODUCTION
William and Greta Fertik1 filed this action against two
physicians and the manufacturer of a surgical guide wire, Abbott
Vascular, Inc. (Abbott), after the guide wire broke and was left
inside William Fertik’s heart during cardiac surgery. Abbott
moved for summary judgment and to exclude the opinion testimony
of the plaintiff’s expert, Dr. Dana Medlin, under Daubert v.

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On June 12, 2015, Greta
death. Docket No. 86. Her
a plaintiff in this case.
himself and the estate, I

Fertik’s attorney filed a suggestion of
estate, through William Fertik, is now
Because William Fertik is representing
will refer to him as the plaintiff.
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Merrell Dow Pharm., Inc., 509 U.S. 579 (1993). In an earlier
order, this Court denied Abbott’s motion for summary judgment,
ruling that the plaintiff’s case could proceed to trial on the
doctrine of res ipsa loquitur. Fertik v. Stevenson, No. 12-cv10795-PBS, 2016 WL 2851315, at *1 (D. Mass. May 13, 2016). The
Court declined to rule on Abbott’s Daubert motion at that time,
allowing the parties to supplement the record with any new
evidence they discovered about the length of the wire remnant
left in the plaintiff’s chest. Id. at *6.2 The Court assumes
familiarity with that opinion, which sets forth the factual
record of this case. The Court held an evidentiary hearing at
which the plaintiff’s expert, Dana Medlin Ph.D., P.E., FASM,
testified. After hearing, the defendant’s Daubert motion (Docket
No. 179) is ALLOWED in part.
DISCUSSION
Abbott argues that Dr. Medlin’s theory that the guide wire
separated at the hypotube junction is not supported by the
measurement of the wire remnant, and that, because he could not

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The Court did not allow the submission of a new expert report
by Dr. Medlin, particularly a report based on information from a
previously undisclosed consulting expert, Dr. Pilichowska.
Therefore, the Court ALLOWS Abbott’s motion to strike the June
27, 2016 Supplemental Report of Dr. Medlin (Docket No. 242).
Based on this supplemental report, Abbott served a deposition
notice on Dr. Medlin and a subpoena on Dr. Pilichowska. Because,
the Court has struck this supplemental report, the plaintiff’s
motion for a protective order and to quash the defendant’s
deposition subpoena (Docket No. 247) is now MOOT.
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test the actual wire remnant, he has no reliable scientific
basis for claiming that it was more likely than not that the
guide wire broke as a result of a manufacturing defect.
Admissibility of expert testimony is guided by Federal Rule
of Evidence 702, which provides that:
A witness who is qualified as an expert by knowledge,
skill, experience, training, or education may testify in
the form of an opinion or otherwise if:
(a) the expert’s scientific, technical, or other
specialized knowledge will help the trier of fact
to understand the evidence or to determine a fact
in issue;
(b) the testimony is based on sufficient facts or
data;
(c) the testimony is the product of reliable
principles and methods; and
(d) the expert has reliably applied the principles
and methods to the facts of the case.
Milward v. Rust-Oleum Corp., 820 F.3d 469, 473 (1st Cir. 2016)
(quoting Fed. R. Evid. 702). The district court “serves as the
gatekeeper for expert testimony by ‘ensuring that it both rests
on a reliable foundation and is relevant to the task at hand.’”
Id. (quoting Daubert, 509 U.S. at 597 (alterations omitted)).
The second requirement “seeks to ensure that there is an
adequate fit between the expert’s methods and his conclusions.”
Samaan v. St. Joseph Hosp., 670 F.3d 21, 32 (1st Cir. 2012).
“This prong of the Daubert inquiry addresses the problem that
arises when an expert’s methods, though impeccable, yield
results that bear a dubious relationship to the questions on
which he proposes to opine.” Id. “The party seeking to introduce
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the evidence has the burden of establishing both its reliability
and its relevance.” Milward, 820 F.3d at 473.
The geography of the guide wire is critical to Dr. Medlin’s
analysis. The guide wire itself is composed of two wires—one
steel and one Elastinite—which meet at the hypotube junction,
and are held together by adhesive. As the two wires enter the
hypotube junction, they taper, or become thinner. The parties
agree that the Elastinite “distal” end of the guide wire was
inserted first into the plaintiff’s body and would have been the
portion left inside Mr. Fertik.3
In his five expert reports, Dr. Medlin opined that it was
“highly likely” that the guide wire at issue “fractured or
separated at the Elastinite Hypotube junction,” based on “a
manufacturing defect.” Docket No. 251, Ex. 1 at 9; Docket No.
251, Ex. 2 at 5. Dr. Medlin was unable to test the actual wire
remnant removed from the plaintiff because it was discarded
after removal, through no fault of either the plaintiff or
Abbott.
The only record of any testing performed on the remnant is
a one-page pathology report, dated May 14, 2009, which reported
the remnant to be 39.5 centimeters (cm) long. Docket No. 240,
Ex. 1 at 6. In their depositions, Drs. Brock and Agoston,

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A diagram of the guide wire illustrating this geography is
attached to this order under seal.
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pathologists at Brigham & Women’s Hospital, testified that a
non-tissue specimen, like the guide wire at issue, was usually
measured to the nearest 0.5 cm. Docket No. 241 at 3; Docket No.
242, Ex. 2 at 6-7. With this range of measuring error, the wire
remnant could have measured between 39 cm and 40 cm.
Dr. Medlin advanced two theories: separation and fracture.
His separation theory posits that the guide wire pulled apart at
the hypotube junction because of “inadequate adhesion between
the Elastinite core wire and the Hypotube.” Docket No. 251, Ex.
2 at 18. At the hearing, the parties referred to this theory as
the “pull-out theory.” Hearing Tr. at 106. Because the pathology
report is the only recorded measurement of the remnant, the
specifications of the guide wire are critical to the likelihood
of the pull-out theory. According to the specifications, the
Elastinite end of the guide wire, including the portion inside
the hypotube junction, measured 40.7 cm ± .2 cm. Therefore, the
Elastinite end could measure between 40.5 cm and 40.9 cm. For
the pull-out theory to be possible, the wire remnant must
measure somewhere in that range. Here is where the separation
theory comes apart. Taking the best case scenario for the
plaintiff, the remnant could have measured, at most, 40 cm,
which is 0.5 cm less than the Elastinite end, measuring, at
least, 40.5 cm. Based on this 0.5 cm gap, the pull-out theory
could not have occurred. As the plaintiff and Dr. Medlin
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conceded, the pull-out theory is unsupported by reliable facts,
and therefore, Dr. Medlin may not testify about it at trial.
Dr. Medlin’s alternative theory is that the wire fractured
at or near the hypotube junction. This theory, at least as to
the place of the fracture, is consistent with the measurement of
the wire remnant. He further opined that, because the Elastinite
wire becomes thinner as it enters the hypotube junction, it
would take less than eight pounds of force to fracture the wire
there. At the thickest part of the wire, he testified that it
would take closer to twenty-eight pounds of force. To calculate
these forces, Dr. Medlin took the minimum tensile strength of
the wire from the specifications along with the wire diameter
and conducted “a basic engineering calculation.” Hearing Tr. at
96. As plaintiff’s counsel conceded at the hearing, Dr. Medlin
did not disclose these calculations in any of his expert
reports. Hearing Tr. at 97. Therefore, he may not testify about
these force calculations at trial.
Dr. Medlin relies largely on the operating physicians’
deposition testimony that they did not experience anything
unusual or feel the wire break as they conducted the surgical
procedure. Because the guide wire is designed to withstand
normal forces, he then concludes that it must have been
defective or it would not have broken during a normal,
foreseeable medical procedure. This testimony is essentially the
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rationale behind the Court’s res ipsa loquitur ruling.
Therefore, he may testify that, in his opinion, there was a
defect at the hypotube junction. Dr. Medlin may also testify
about the specifications, measurements, and materials of the
guide wire and that the wire likely broke at or near the
hypotube junction based on the measurement of the wire remnant.
Dr. Medlin admitted that, because he could not test the
wire remnant itself, his theories about the reason for the
fracture were “based on possibility.” Hearing Tr. at 109.
Because Dr. Medlin admitted that he was providing possible, not
probable, explanations for the wire breakage, I find that his
opinion that it is more likely than not that the guide wire
broke due to a defect related to the tapered wire’s ability to
withstand the force used lacks adequate factual support under
Daubert. Therefore, Dr. Medlin may not testify about this theory
at trial. Additionally, the plaintiff has waived his negligent
design theory. Docket No. 192 at 2 n.2. Dr. Medlin may not
testify about this now-abandoned theory.
ORDER
The Court ALLOWS Abbott’s motion to strike the June 27,
2016 Supplemental Report of Dr. Medlin (Docket No. 242). The
plaintiff’s motion for a protective order and to quash the
defendant’s deposition subpoena (Docket No. 247) is now MOOT.
Finally, Abbott’s motion in limine to exclude the testimony of
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Dr. Medlin (Docket No. 179) is ALLOWED in part in accordance
with this order.

/s/ PATTI B. SARIS
Patti B. Saris
Chief United States District Judge

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