Fertik et al v. Stevenson, et al
Chief Judge Patti B. Saris: MEMORANDUM and ORDER. This Court DENIES the defendant's motion for summary judgment (Docket No. 173 ). (Geraldino-Karasek, Clarilde)
UNITED STATES DISTRICT COURT
DISTRICT OF MASSACHUSETTS
WILLIAM FERTIK, individually
and as personal representative
and successor of the ESTATE
of GRETA FERTIK,
WILLIAM STEVENSON, M.D.;
MELANIE MAYTIN, M.D.; ABBOTT
MEMORANDUM AND ORDER
May 13, 2016
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. The
plaintiff’s sole claim against Abbott is that the Hi-Torque
Balanced Heavyweight cardiac guide wire failed due to Abbott’s
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.
negligence in manufacturing the wire. Abbott has moved for
summary judgment claiming that the plaintiff has failed to
provide reliable evidence that the wire broke as a result of
Abbott’s negligent manufacturing.2 The plaintiff responds that
the doctrine of res ipsa loquitur defeats summary judgment.
Neither party contends that the physicians were negligent in the
placement of the wire. After hearing, this Court DENIES the
defendant’s motion for summary judgment (Docket No. 173).
The facts are taken from the record and are undisputed
unless otherwise noted. On May 6, 2009, the plaintiff, William
Fertik, underwent a radiofrequency cardiac ablation procedure3 at
Brigham & Women’s Hospital in Boston to treat his cardiac rhythm
irregularities and periodic atrial fibrillation.4 Dr. William
Stevenson, who had previously performed more than 3,000 similar
The plaintiff has waived his negligent design theory and
conceded that he no longer intends to pursue a claim against
Abbott Laboratories, Inc., the parent company of Abbott
Vascular, Inc. Docket No. 192 at 2 n.2.
3 Ablation usually uses long, flexible tubes (catheters) inserted
through a vein in the groin and threaded to the heart to correct
structural problems in the heart that cause an arrhythmia.
Cardiac Ablation, Mayo Clinic, http://www. mayoclinic.org/testsprocedures/cardiac-ablation/basics/ definition/prc-20022642
(last visited April 5, 2016).
4 “Atrial fibrillation is an irregular and often rapid heart rate
that can increase [the] risk of stroke.” Atrial Fibrillation,
Mayo Clinic, http://www. mayoclinic.org/diseases-conditions/
atrial-fibrillation/home/ovc-20164923 (last visited March 11,
procedures without incident, and Dr. Melanie Maytin, a fellow at
the hospital, performed the procedure.
During the cardiac ablation procedure, Dr. Stevenson
removed the guide wire from its sterile packaging and observed
no damage or evidence of any tampering. He then threaded the
wire through Mr. Fertik’s vasculature up to his heart. The wire
served as a guide for a needle that the physicians used to
puncture the internal wall of the heart and gain access to the
left atrium. This procedure is known as a trans-septal puncture.
During the surgery, unnoticed by either physician, a
portion of the guide wire broke off inside the plaintiff’s body.
The physicians experienced nothing unusual during the procedure
and neither saw nor felt the wire break. After the surgery, the
plaintiff was discharged from the hospital. Later he
demonstrated symptoms of a stroke and hospital personnel
discovered that the wire had been left coiled up inside his
The plaintiff then returned to the hospital and, on May 10,
2009, Dr. Eisenhauer, a non-party, removed the wire remnant. Dr.
Eisenhauer, who had performed over 15,000 procedures similar to
the cardiac ablation procedure, had experienced guide wire
breakage fewer than six times. Each time that the wire broke, he
felt it break and immediately realized something had gone wrong.
After the procedure, it is disputed whether Dr. Eisenhauer gave
the wire remnant directly to the hospital’s pathology department
or to Dr. Stevenson, but the remnant ultimately ended up in the
possession of the hospital’s pathology department for testing.
After testing, through no fault of either Abbott or Mr. Fertik,
the wire was mistakenly discarded.
Summary Judgment Standard
Faced with a summary judgment motion, the Court must assess
all facts in the record, and all reasonable inferences drawn
from the facts, in favor of the non-moving party. Perry v. Roy,
782 F.3d 73, 77 (1st Cir. 2015). A summary judgment motion
succeeds “only where ‘there is no genuine dispute as to any
material fact and the movant is entitled to judgment as a matter
of law.’” Showtime Entm’t, LLC v. Town of Mendon, 769 F.3d 61,
69 (1st Cir. 2014) (quoting Fed. R. Civ. P. 56(a)). Genuine
disputes arise when the evidence would allow “a reasonable jury
[to] return a verdict for the nonmoving party.” Anderson v.
Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). “A genuine issue
of material fact must be built on a solid foundation—a
foundation constructed from materials of evidentiary quality.”
Perry, 782 F.3d at 78 (internal quotation marks omitted).
The Doctrine of Res Ipsa Loquitur
A plaintiff in a product liability case must prove at least
two elements: (1) the defendant produced or sold a defective
product and (2) the product caused the plaintiff’s injury. See
Smith v. Ariens Co., 377 N.E.2d 954, 958 (Mass. 1978). A
manufacturing defect exists when a product “deviates in its
construction or quality from specifications or planned output in
a manner that renders it unreasonably dangerous.” Brown v. Husky
Injection Molding Sys., Inc., 751 F. Supp. 2d 298, 300-01 (D.
Mass. 2010) (internal quotation marks omitted). In manufacturing
defect cases, “a particular product rather than a line of
products, is alleged to be defective because of negligence in
the manufacturing process.” Ariens, 377 N.E.2d at 958.
Here, the plaintiff is pressing a manufacturing defect
claim caused by Abbott’s negligence under the doctrine of res
ipsa loquitur. There is no present dispute over the cause of the
plaintiff’s injury. The defendant contends that the doctrine of
res ipsa loquitur is inapplicable because Abbott did not have
exclusive control over the guide wire, the use of the guide wire
was “off-label,” and the guide wire—which is delicate—has a risk
of breakage even in “on-label” uses without any physician or
manufacturer negligence. The plaintiff responds that the
doctrine of res ipsa loquitur saves his case even with the loss
of the wire because there is no evidence of any damage to the
wire prior to the surgery, and neither party claims the
physicians were negligent. The plaintiff argues that, given the
rare incidence of guide wire failures, a genuine issue of fact
exists about whether the wire broke due to a manufacturing
defect caused by Abbott’s negligence.
Under Massachusetts law, the doctrine of res ipsa
permits a trier of fact to draw an inference of
negligence in the absence of a finding of a specific
cause of the occurrence when an accident is of the kind
that does not ordinarily happen unless the defendant was
negligent in some respect and other responsible causes
including conduct of the plaintiff are sufficiently
eliminated by the evidence.
Enrich v. Windmere Corp., 616 N.E.2d 1081, 1085 (Mass. 1993)
(citing Restatement (Second) of Torts § 328D(1)(a) (1965)). “The
jury must be able to find either by expert evidence or by their
own common knowledge that the mere occurrence of the accident
shows negligence as a cause.” Id.
A jury can apply the doctrine if they find, by a
preponderance of the evidence, that: “(1) the instrumentality
causing the accident was in the sole and exclusive control and
management of the defendant; and (2) the accident is of the type
or kind that would not happen in the ordinary course of things
unless there was negligence by the defendant.” Wilson v.
Honeywell, Inc., 569 N.E.2d 1011, 1013 (Mass. 1991) (internal
quotation marks omitted). “Even where absolute exclusivity in
use is not evident, a jury may be reasonable in finding that the
defendant’s control was sufficient to warrant an inference that
the defendant was more likely responsible for the incident than
someone else.” Id. at 1013-14; see also Restatement (Second) of
Torts § 328D cmt. f (1965) (“[T]he plaintiff is not required to
exclude all other possible conclusions beyond a reasonable
doubt, and it is enough that he makes out a case from which the
jury may reasonably conclude that the negligence was, more
probably than not, that of the defendant.”).
Laspesa v. Arrow International, Inc., is a products
liability case on point involving a broken epidural catheter
lodged in a woman’s back during the delivery of her baby. No.
CIV. 07CV12370-NG, 2009 WL 5217030, at *1 (D. Mass. Dec. 23,
2009). With respect to the first element in Wilson, the Laspesa
court ruled that the requirement of exclusive control was met
when the catheter was “out of the box” and new prior to surgery.
Id. at *8. For the second element, the court ruled that res ipsa
loquitur was appropriate when “the hospital reported the event
to the FDA, the incident [was] unusual, and there [was] evidence
that the patient’s doctor was not negligent.” Id.; see also
Parkinson v. Guidant Corp., 315 F. Supp. 2d 741, 750 (W.D. Pa.
2004) (denying summary judgment because of res ipsa loquitur
theory where the guide wire broke inside the plaintiff based on
evidence that the operating physician had not been negligent and
that tip separation of a guide wire is not an incident that
ordinarily occurs in the absence of negligence).
In this case, Abbott has produced no evidence that the wire
used in the plaintiff’s surgery was mishandled from the time it
left Abbott’s control to the time the defendant physicians
removed it from the package during surgery. Dr. Eisenhauer, the
physician who removed the guide wire remnant, testified that
guide wires, like the one used in the plaintiff’s surgery, are
packaged in a sterile pouch by the manufacturer and the pouch is
only opened by a technician in a sterile field during surgery.
The defendant physicians provided testimony that neither they,
nor any member of the surgical team, mishandled the guide wire
prior to the surgery. They also testified that the guide wire
appeared undamaged when it was removed from the packaging. This
evidence is sufficient to satisfy the first prong of exclusive
control for res ipsa loquitur under Wilson.
With respect to the second prong, the plaintiff has
presented evidence that the guide wire would not have broken in
the absence of manufacturer negligence. The plaintiff points to
Dr. Stevenson’s testimony that he had performed more than 3,000
similar procedures without a guide wire breaking. Dr. Eisenhauer
testified that, in 15,000 similar procedures, he had experienced
guide wire failure fewer than six times. In rebuttal, Abbott
points to the Food and Drug Administration (FDA) website which
states: “The most common adverse event associated with guide
wires that is reported to the FDA is breakage of the tip or
wire, most commonly because of handling use error.” Docket No.
178, Ex. 24 at 2. In the circumstances of this case, however,
all parties agree there was no negligence or misuse by the
doctors or other third parties handling the guide wire.5 Cf. Ryba
v. LaLancette, 417 F. Supp. 2d 199, 208 (D. Mass. 2006)
(rejecting res ipsa loquitur where plaintiff had not eliminated
third parties as probable causes).
Abbott also points to evidence that the wire is described
as “delicate” and Abbott contends there is a risk of breakage
even in the ordinary course without negligence or misuse.
However, when all reasonable inferences are drawn in the
plaintiff’s favor, given the testimony of the doctors, a jury
could find the wire broke as a result of a defect, and not in
the ordinary course of this kind of medical procedure.
III. “Off-Label” Use
Abbott’s primary argument rests on evidence that the
physicians were using the guide wire in an “off-label” manner,
and that its guide wires were manufactured with sufficient
Instead, the plaintiff asserts that his “negligence theory
against the physician defendants is not that their negligence
caused the wire to fail, but rather that they were negligent in
their failure to ensure that once broken, they recognized the
problem.” Docket No. 192 at 17 n.21 (emphasis in original).
strength for the uses approved by the FDA. The plaintiff
responds that the defendant has overstated the level of scrutiny
the FDA applied in clearing the guide wire for use, has
misstated the actual “on-label” uses of the guide wire, and has
failed to provide any controlling authority for the proposition
that a manufacturer in a product defect case is immune from suit
if its product was used in an “off-label” manner.
The Medical Device Amendments of 1976 (MDA) classify
medical devices in “three categories based on the risk that they
pose to the public.” Medtronic, Inc. v. Lohr, 518 U.S. 470, 476
(1996). Class III devices must go through the Premarket Approval
Process (PMA) and “submit detailed information regarding the
safety and efficacy of their devices, which the FDA then
reviews, spending an average of 1,200 hours on each submission.”
Id. at 477. Class II devices, such as the guide wire in this
case, are subject to a more limited form of review known as the
§ 510(k) process; “in contrast to the 1,200 hours necessary to
complete a PMA review, the § 510(k) review is completed in an
average of only 20 hours.” Id. at 478-79. “If the FDA concludes
on the basis of the § 510(k) notification that the device is
substantially equivalent to a pre-existing device, it can be
marketed without further regulatory analysis.” Id. at 478
(internal quotation marks omitted). Section “510(k) notification
requires little information, rarely elicits a negative response
from the FDA, and gets processed very quickly.” Id. at 479.
Devices that “enter the market through § 510(k) have never been
formally reviewed under the MDA for safety or efficacy.” Riegel
v. Medtronic, Inc., 552 U.S. 312, 323 (2008) (internal quotation
“Use of a device (or a drug) in a way not approved by the
FDA—called ‘off-label use’—is a widespread practice in the
medical community.” Holland v. Smith & Nephew Richards, Inc.,
100 F. Supp. 2d 53, 55 (D. Mass. 1999). “The FDA has recognized
that it cannot regulate the medical judgments that lead to offlabel use.” Id. “Off-label” usage of medical devices is an
“accepted and necessary corollary of the FDA’s mission to
regulate in this area without directly interfering with the
practice of medicine.” Buckman Co. v. Plaintiffs’ Legal Comm.,
531 U.S. 341, 350 (2001).
“A manufacturer always has a duty when designing products
to consider the environment in which the product will be used
and must design against all reasonably foreseeable uses which
could arise from that environment.” Cigna Ins. Co. v. Oy
Saunatec, Ltd., 241 F.3d 1, 15 (1st Cir. 2001) (applying
Massachusetts law). On the other hand, a “defendant is not
liable for the consequences of the unforeseeable misuse of a
product.” Back v. Wickes Corp., 378 N.E.2d 964, 969 (Mass.
1978). Whether or not a misuse is foreseeable is an issue of
fact for the jury. See Gillespie v. Sears, Roebuck & Co., 386
F.3d 21, 28 (1st Cir. 2004).
As a threshold matter, the plaintiff disputes Abbott’s
claim that the physicians used the guide wire in an “off-label”
manner, and contends that the use of the guide wire in the
cardiac ablation procedure was within the scope of uses cleared
by the FDA. According to Janet Benson,6 Abbott’s director of
regulatory affairs, the wire has four approved and labeled uses:
(1) to facilitate the placement of balloon dilation catheters
during percutaneous transluminal coronary angioplasty and (2)
percutaneous transluminal angioplasty,7 (3) for the placement of
intravascular stents,8 and (4) intravascular directional
atherectomy devices.9 Docket No. 178, Ex. 1 at 1-2. Abbott relies
on Dr. Stevenson’s affidavit in which he admits that the use of
The plaintiff has moved to strike this affidavit because Ms.
Benson was not identified as an expert on device labeling and
has asserted a legal conclusion in her affidavit. Docket No.
197. The motion is denied with respect to the challenge to her
qualifications as to this information.
7 A guide wire with a balloon at the tip is inserted into the
artery to the site of the blockage. The balloon is inflated
flattening the blockage against the artery walls. Percutaneous
Transluminal Angioplasty, Johns Hopkins Medicine, http://www.
visited April 5, 2016).
8 Slender thread, rod, or catheter, lying within the interior of
a tubular structure, such as an artery, and used to provide
support. Stedman’s Medical Dictionary 998, 1674 (26th ed. 1995).
9 Removal of coronary device with an instrumented catheter. See
Stedman’s Medical Dictionary 162 (26th ed. 1995)
the guide wire “was an off-label use of the device.” Docket No.
178, Ex. 3 at 2.10 The plaintiff retorts that even though the
cardiac ablation procedure is not specifically listed in the
guide wire labeling as a cleared use, the product
classification, submitted by Abbott and cleared by the FDA,
states: “The wire is also intended to facilitate the placement
of equipment such as atherectomy and compatible stent devices
during other diagnostic and therapeutic procedures.” Docket No.
193, Ex. 4 at 6. Without providing any expert testimony on FDA
labeling, the plaintiff contends that a plain reading of this
broader statement covers the facilitation of the placement of a
transseptal needle (stent device) during a cardiac ablation
Assuming the use of the guide wire here, a cardiac ablation
procedure, is “off-label,” the plaintiff has produced evidence
that this use was foreseeable. Leading surgeons in a prominent
Harvard-teaching hospital have used the Abbott guide wire in
this manner thousands of times and Abbott has provided no
evidence that this use was an unforeseeable misuse of the wire.
There is also no evidence that the stress incurred by the guide
The plaintiff has moved to strike this affidavit because Dr.
Stevenson has no basis from which to draw this legal conclusion
as he is not an expert on FDA labelling or “off-label” uses.
Docket No. 196. The motion is denied because of his expertise in
this medical procedure.
wire in this “off-label” procedure was greater than in the “onlabel” procedures enumerated in the guide wire’s label.
Abbott insists it is not liable for manufacturing defect
claims relating to “off-label” uses of its products. The
defendant unsuccessfully attempts to turn the screws on the
plaintiff relying on cases largely involving surgical screws. To
be sure, while a physician may use any device legally on the
market in any way the physician deems appropriate, including in
an “off-label” use, courts have held that a seller is not liable
for the physician’s decision to use the device “off-label”
absent a defect. See Cox v. Depuy Motech, Inc., No. 95-CV-3848L(JA), 2000 WL 1160486, at *8-9 (S.D. Cal. Mar. 29, 2000) (case
involving a broken spinal screw). Moreover, a seller is not
liable even if it knows of the “off-label” use of a product
unless there is a product defect. Id. at *8; Little v. Depuy
Motech, Inc., No. 96CV0393-L JAH, 2000 WL 1519962, at *9 (S.D.
Cal. June 13, 2000) (holding that the manufacturer cannot be
held liable for the doctor’s decision to implant a device in an
“off-label” manner even if it knows of the “off-label” use);
Holland, 100 F. Supp. 2d at 56 (even if the seller improperly
promoted screws for “off-label” uses, the fact that the
defendant promoted the product without permission does not tend
to establish that the product was defective or unfit for its
intended use, even if the intended use was forbidden by the
regulatory authorities). However, there is no controlling
authority that immunizes Abbott from a product defect claim
based on a foreseeable “off-label” use. Therefore, Abbott’s
motion for summary judgment is denied.
Abbott argues that the testimony of the plaintiff’s expert,
Dana J. Medlin, Ph.D., an engineering and metallurgy expert,
should be excluded because his theory of how the guide wire
broke is not consistent with the pathologist’s measurement of
the wire remnant removed from the plaintiff. Dr. Medlin believes
that the failure of the wire is more likely due to a defect in
the wire than some other cause. The plaintiff responds that the
pathologist’s measurement was inaccurate and Dr. Medlin’s theory
is still applicable to the specifics of this case. Because the
wire was discarded and the pathologist remains out of the
country and has not been deposed, the record contains no other
alternative measurement for the guide wire remnant.
The Abbott guide wire consists of a longer Elastinite wire
and a shorter steel wire. These two wires are joined at the
hypotube junction, which is a sleeve 1.6 inches long with a
slightly wider diameter than the wires. Both wires are inserted
into the hypotube junction and are bonded with adhesive. The end
of the wire that is inserted into the body, the distal end, is
15.7 inches long from the distal tip to the beginning of the
hypotube junction. Therefore, if the wire were to separate at
the hypotube junction, the remnant would measure at least 15.7
inches. Dr. Medlin opines that “it is much more likely than not
that failure of the subject guide wire . . .  resulted from
inadequate adhesion between the Elastinite core wire and the
Hypotube,  inadequate hypotube wall strength, and/or
 defects induced into the hypotube junction.” Docket No. 181,
Ex. 1 at 17. All of Dr. Medlin’s theories involve the wire
separating or fracturing at the hypotube junction.
The pathologist’s report states that the wire remnant was
39.5 centimeters (15.55 inches) long. The plaintiff disputes the
accuracy of this measurement since the report notes that the
“specimen is for gross diagnosis only.” Docket No. 178, Ex. 18
at 2. Additionally, the report identifies the wire as a
“pacemaker wire,” which it is not, and gives only a rough
approximation for the measurement of the wire’s diameter. Id.
The defendant’s expert, Dr. Eager, testified that he interpreted
the report to mean that the wire remnant was between 39 and 40
centimeters or 15.35 and 15.75 inches based on the precision of
the measurement. If the measurement were at the high end of this
range, 15.7 inches or greater, Dr. Medlin’s opinion that it
separated at the hypotube junction would be reliable.
The Court need not decide the admissibility of the expert’s
opinion now because, under the plaintiff’s res ipsa loquitur
theory, he has provided evidence, sufficient to survive summary
judgment, from the medical experts that fracture of the wire was
not an ordinary occurrence during similar medical procedures
even in the absence of Dr. Medlin’s expert testimony. See
Laspesa, 2009 WL 5217030, at *8; Parkinson, 315 F. Supp. 2d at
750. The Court will allow the parties to supplement the record
with any new evidence they discover with respect to the
measurement of the wire remnant by June 30, 2016. The Court will
address the Daubert motion in a separate proceeding.
This Court DENIES the defendant’s motion for summary
judgment (Docket No. 173).
/s/ PATTI B. SARIS
Patti B. Saris
Chief United States District Judge
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