Court Opinion

ID: 1001285
Source: CourtListenerOpinion
Date Created: 2013-07-04 17:53:13.79659+00
Date Added: 2024-06-11T15:12:35.519928
License: Public Domain

UNPUBLISHED

UNITED STATES COURT OF APPEALS

FOR THE FOURTH CIRCUIT

HOPE LENEE MOYERS, A Minor, by
and through her Mother and Next
Friend, Kathy Sue Moyers,
Plaintiff-Appellant,

and

KATHY SUE MOYERS, Individually;
JEFFREY MOYERS, Individually,
Plaintiffs,

v.
                                                                No. 98-2797
COROMETRICS MEDICAL SYSTEMS,
INCORPORATED,
Defendant-Appellee,

and

MARQUETTE ELECTRONICS,
INCORPORATED; BRISTOL
LABORATORIES, INCORPORATED;
BRISTOL-MYERS-SQUIBB COMPANY,
Defendants.

Appeal from the United States District Court
for the Eastern District of Virginia at Richmond.
Robert E. Payne, District Judge.
(CA-97-648-3)

Argued: January 26, 2000

Decided: April 4, 2000

Before LUTTIG and WILLIAMS, Circuit Judges, and
John T. COPENHAVER, Jr., United States District Judge for the
Southern District of West Virginia, sitting by designation.

_________________________________________________________________
Affirmed by unpublished per curiam opinion.

_________________________________________________________________

COUNSEL

ARGUED: Michael J. Miller, MILLER & ASSOCIATES, Alexan-
dria, Virginia, for Appellant. Gary Joseph Spahn, MAYS & VALEN-
TINE, L.L.P., Richmond, Virginia, for Appellee. ON BRIEF: Robert
T. Hall, Holly Parkhurst Lear, HALL & SICKELS, P.C., Reston, Vir-
ginia, for Appellant. Dabney J. Carr, IV, MAYS & VALENTINE,
L.L.P., Richmond, Virginia, for Appellee.

_________________________________________________________________

Unpublished opinions are not binding precedent in this circuit. See
Local Rule 36(c).

_________________________________________________________________

OPINION

PER CURIAM:

Hope Lenee Moyers, a minor, and her parents, Kathy Sue Moyers
and Jeffrey Moyers, (collectively, the Moyers) filed suit in the Circuit
Court for the City of Richmond against Corometrics Medical Sys-
tems, Inc. (Corometrics), seeking recovery for severe neurological
injuries Hope sustained at her birth that the Moyers alleged were
caused by defects related to the audio alert function of the Coromet-
rics Spectra 400 Extended Surveillance and Alert System. Coromet-
rics removed the Moyers' suit to the United States District Court for
the Eastern District of Virginia and, after substantial discovery,
moved for summary judgment. By order and memorandum opinion,
the district court granted summary judgment to Corometrics and dis-
missed the case with prejudice upon concluding that the Moyers
failed to establish genuine issues of material fact on the elements of
their claims for breach of implied warranty and negligence. The
Moyers noted a timely appeal of this summary judgment order. Find-
ing no error, we affirm.

                    2
I.

Corometrics designed and manufactured the Spectra 400 Extended
Surveillance and Alert System (Spectra 400 System or System), a
medical device that aids physicians and nurses in monitoring the fetal
heart rate (FHR) of multiple patients at a time. The Spectra 400 Sys-
tem consisted of a centrally located control unit, the Model 400 Con-
trol Unit, which acquired and stored data from the bedside fetal heart
monitors of patients in labor, and three different types of displays of
which the purchaser could buy some or all. In 1989, Winchester Med-
ical Center (WMC) bought a System that consisted of the Model 400
Control Unit, the Model 415C Central Display Unit, and the Model
415R Remote Display Unit. The Model 415C Central Display Unit
was a multi-function display located at the central nurses' station that
provided a pictorial display of the FHR tracings made at bedside. The
Model 415R Remote Display Unit was a limited-function display
located in the physicians' lounge that also provided a view of the
FHR tracings.

In addition to acquiring and storing data from the bedside fetal
heart monitors, the Model 400 Control Unit contained software pro-
grams for the alert function of the System. These programs analyzed
FHR data and uterine activity during labor and recognized several
normal and abnormal FHR patterns. When particular parameters
exceeded pre-set limits, the Spectra 400 System provided an audio
alert that sounded at the Model 415C Central Display Unit. The Sys-
tem also provided a visual alert for these parameters on the "alert
parameter screen" (APS) of the Model 415C Central Display Unit.
The APS was activated, and hence visible, only if the user depressed
a button to bring this screen into view on the monitor of the 415C
Central Display Unit. Depicted on the APS were several parameters
for which the Spectra 400 System was programmed to sound an alarm
if the threshold limit for that parameter was exceeded, including base-
line heart rate, FHR variability, decelerations, uterine contractions,
and signal quality.

The APS also included the words "accelerations," "inc variability
with UC," "overshoot," and "sinusoidal pattern." It is undisputed that
the Spectra 400 System was not programmed to sound an audio alert
for any of these four parameters. There was no warning on the

                    3
machine or the APS to alert users that these four parameters were
inactive, although the right-hand column for these parameters was
always blank, signifying their inactive status. In addition, the Spectra
400 System Operator's Manual indicated in two different places that
the alert function for recognition of those four parameters would be
a "future capability" of the machine. The Operator's Manual also
clearly cautioned that the Spectra 400 System was not designed to
replace observation and evaluation of the mother and fetus at regular
intervals, and that the medical personnel using the machine should
regularly assess the FHR tracing that is located at the patient's bed-
side. The same cautionary note also advised that"[t]he absence of an
alert does not indicate fetal or maternal well-being" and that "[t]he
alert system will not detect every possible abnormality and cannot
detect abnormalities that have not been clinically recognized and
described in the literature." (J.A. at 105.)

Robert Farrar, the Corometrics salesperson who marketed the
Spectra 400 System to WMC, acknowledged that WMC purchased
the System in part because of its alerting capability. In his in-services
presentations given to the WMC staff following WMC's purchase of
the Spectra 400 System, Farrar explained to the staff how to operate
the System's surveillance and alert functions and explained the five
active alert parameters. Farrar was not advised, when receiving
instruction on how to conduct the in-service training, of what abnor-
malities the Spectra 400 System would not detect. At both the sales
presentation and training sessions he gave, however, Farrar did not
represent that the Spectra 400 System could detect or alert for sinusoi-
dal rhythms or sinusoidal patterns. Moreover, at each in-service train-
ing session, Farrar used a chart that set forth the cautions from the
Operator's Manual describing the System's limitations and read those
cautions aloud.

Kathy Sue Moyers, Hope Moyers's mother, was admitted to WMC
on August 27, 1991 at approximately 12:40 a.m. At that time, she was
examined by Dr. John Willey, her treating obstetrician. Elizabeth
Steinmetz, a labor and delivery nurse at WMC, was assigned to moni-
tor and care for Mrs. Moyers. As part of that process, Steinmetz
hooked up Mrs. Moyers to a fetal heart monitor that was connected
to the Model 400 Control Unit. Steinmetz stayed in Mrs. Moyers's
room from the time she began attending to Moyers at 12:45 a.m. until

                     4
between 1:18 a.m. and 1:20 a.m. At 1:18 a.m., Steinmetz adminis-
tered the drug Stadol and left Mrs. Moyers's room one or two minutes
later to care for another patient.

While Steinmetz was away from Mrs. Moyers's room, Mrs.
Moyers developed a sinusoidal FHR pattern that began at 1:27 a.m.
The FHR ranged from approximately 120 beats per minute down to
approximately 60 beats per minute in repeating sine-like waves. As
Steinmetz was returning to Mrs. Moyers's room, she met labor and
delivery nurses Carol Moulton and Nancy Laudermilk at the central
nurses' station. All three nurses observed what appeared to be a sinus-
oidal FHR pattern on the Model 415C Central Display Unit monitor.
Because the pattern was not normal, Steinmetz and Laudermilk
immediately proceeded to Mrs. Moyers's room, arriving at approxi-
mately 1:38 a.m., and Moulton called Dr. Willey. Moulton testified
that she was positive that the alert on the Model 415C Central Display
Unit sounded while she was talking on the phone with Dr. Willey, but
was unable to identify what kind of problem prompted that alarm.

At approximately 1:42 a.m., Dr. Willey arrived at Mrs. Moyers's
room in response to Moulton's call. Because Mrs. Moyers's FHR pat-
tern was so unusual, Dr. Willey immediately applied an internal lead
and reviewed Mrs. Moyers's FHR tracing. Dr. Willey thought that the
FHR tracing indicated a sinusoidal pattern that had begun at 1:27 a.m.
and that fluctuated between 60 and 120 beats per minute without
dropping. Over the next few minutes, however, the FHR fell rather
dramatically. According to Dr. Willey, if the FHR pattern had
remained between 60 and 120, "we might have watched a little
while," but when the baby's heart rate began to get lower, he believed
that the baby was in trouble. (J.A. at 221.) At approximately 1:45
a.m., Dr. Willey ordered that an emergency cesarean section be per-
formed. Dr. Willey could not, without speculating, state how long he
would have waited to perform the cesarean section if the FHR had not
started to diminish. Nor, without speculating, was he able to state
whether he would have performed the cesarean section any earlier if
he had been present in the room at 1:27 a.m. when the sinusoidal pat-
tern developed.

At 1:54 a.m., when Mrs. Moyers was disconnected from the fetal
heart monitor and taken to the operating room, the fetus had a heart

                    5
beat of approximately 60 beats per minute. Hope Moyers was deliv-
ered sixteen minutes later at 2:10 a.m. with no heartbeat and no respi-
ration; resuscitation efforts were commenced. Approximately twelve
to fifteen minutes after delivery, Hope registered a heartbeat. Unfortu-
nately, Hope sustained severe and permanent neurological injuries.

None of the physicians or nurses who attended to Mrs. Moyers tes-
tified that they believed that the Spectra 400 System was capable of
providing an audio alert for a sinusoidal FHR pattern or that they
relied upon the System to provide such an alert. Steinmetz testified
that she did not have any knowledge in 1991 as to whether a sinusoi-
dal rhythm pattern would trigger an audio alarm on the Spectra 400
System. Steinmetz also testified that if she was at the central nurses'
station and heard an alarm, she would "look up and notice it," but that
she did not alter her patient care or surveillance practices in reliance
upon the alarm component of the Spectra 400 System. (J.A. at 1066.)
Steinmetz also could not recall whether she had read the Spectra 400
System Operator's Manual.1 Steinmetz did testify that after Hope's
delivery, she asked her co-workers if the alarm had gone off. Dr. Wil-
ley testified that he neither changed his practices, nor instructed
nurses to do so, based upon the audio alert capacity of the Spectra 400
System. He also testified that he was not aware of any surveillance
and alert system that alerted for a sinusoidal pattern and that he never
relied upon any system at WMC to alert him or the nurses to a sinus-
oidal pattern. Like Steinmetz, Dr. Willey could not recall reading the
Spectra 400 System Operator's Manual.

The Moyers subsequently brought the instant suit against Coromet-
rics seeking recovery for the severe neurological injuries Hope sus-
_________________________________________________________________
1 Moulton, who was not attending Mrs. Moyers, testified similarly to
Steinmetz. Moulton testified that she did not know whether a sinusoidal
pattern would cause an alarm to sound and/or a signal to appear on the
APS. Moulton also testified that she did not alter any practices because
the System had an alarm feature, did not rely upon the System to alert
her to all abnormalities, and was not instructed by anyone at the hospital
to substitute the alarm for her professional care and surveillance of the
patient. Moulton acknowledged that if an alarm went off, she would react
to it. Moulton also could not recall whether she read the Spectra 400 Sys-
tem Operator's Manual.

                    6
tained at her birth that they alleged were caused by defects related to
the audio alert function of the Spectra 400 System. 2 The Moyers'
complaint set forth claims for (1) breach of express warranty by Coro-
metrics; (2) breach of implied warranty of merchantability and fitness
for a particular purpose by Corometrics; and (3) product liabili-
ty/negligence based upon manufacturing and design defect and failure
to warn. Corometrics removed the case to the United States District
Court for the Eastern District of Virginia and filed a motion for sum-
mary judgment. In a decision issued from the bench on April 9, 1998,
at the conclusion of a summary judgment hearing, the district court
granted summary judgment to Corometrics on the ground that no rea-
sonable jury could find that any defect, if there was a defect, in the
Spectra 400 System proximately caused Hope's injuries. On April 10,
1998, the district court issued an order granting Corometrics's motion
for summary judgment on all counts and dismissing the case with
prejudice.

On April 20, 1998, the Moyers filed a motion to alter or amend
judgment under Federal Rule of Civil Procedure 59(e). After holding
a hearing, the district court granted the motion to alter or amend judg-
ment for a mistake of fact, vacated its grant of summary judgment to
Corometrics, and ordered the Moyers to submit a brief in opposition
to Corometrics's motion for summary judgment. On July 10, 1998,
the district court held a second summary judgment hearing. By order
and memorandum opinion of November 12, 1998, the district court
again granted summary judgment to Corometrics on all counts and
dismissed the case with prejudice upon concluding that the Moyers
failed to establish genuine issues of material fact as to their claims for
breach of implied warranty of merchantability, breach of implied war-
ranty of fitness for a particular purpose, and negligence.3 On Decem-
ber 10, 1998, the Moyers filed a timely notice of appeal.4
_________________________________________________________________
2 Bristol Laboratories, Inc. and Bristol-Myers Squibb Co. were also
named defendants, but settled with the Moyers and are no longer parties
to this case. Prior to this suit, the Moyers brought a malpractice suit
against Steinmetz in state court, which resulted in a jury verdict in Stein-
metz's favor.
3 The Moyers did not challenge the district court's initial grant of sum-
mary judgment in connection with their claim for breach of express war-
ranty.
4 The Moyers did not appeal the district court's grant of summary judg-
ment in connection with their claim for breach of implied warranty for
a particular purpose.

                    7
II.

On appeal, the Moyers argue that the district court erred in granting
summary judgment to Corometrics because it failed to assume the
credibility of their evidence or to give them the reasonable inferences
to which they were entitled. The Moyers contend that they presented
evidence from which a jury could find that the Spectra 400 System
was defectively designed and/or accompanied by an inadequate warn-
ing under either a theory of breach of implied warranty of merchanta-
bility or a negligence theory and could find that these defects
proximately caused Hope's injuries. In particular, they assert that the
district court erred in holding that the testimony of their experts was
insufficient to create a genuine issue of material fact with regard to
their claim that the Spectra 400 System was defectively designed.5

Summary judgment is appropriate if "`the pleadings, depositions,
answers to interrogatories, and admissions on file, together with the
_________________________________________________________________

5 The Moyers also argue on appeal that the district court erred in refus-
ing to consider a negligence per se claim first raised in opposition to
Corometrics's motion for summary judgment that asserted that the vari-
ances between the product cleared by the Food and Drug Administration
and the product sold by Corometrics to WMC were evidence of alter-
ation and misbranding in violation of the Food Drug and Cosmetics Act
(FDCA). The record indicates that the Moyers' counsel conceded that a
motion for leave to amend was required for the district court even to con-
sider the FDCA-based negligence claim, and that rather than making
such a motion, the Moyers' counsel voluntarily withdrew that claim. The
docket sheet also does not indicate that the Moyers' counsel ever moved
for leave to amend the complaint. Because the Moyers failed to raise the
FDCA-based negligence claim in their complaint or in a motion for leave
to amend, neither this claim nor the argument that the district court erred
in refusing to allow the Moyers to amend their complaint is properly
before this Court on appeal. See Muth v. United States, 1 F.3d 246, 250
(4th Cir. 1993) (noting that issues not raised below generally will not be
considered on appeal unless refusing to consider them would be plain
error or would result in a fundamental miscarriage of justice); Mann v.
Conlin, 22 F.3d 100, 103 (6th Cir. 1994) (holding that the argument that
the district court should have allowed the plaintiffs to amend their com-
plaint was not properly before the court of appeals because the plaintiffs
never requested leave to amend their complaint).

                    8
affidavits, if any, show that there is no genuine issue as to any mate-
rial fact and that the moving party is entitled to a judgment as a matter
of law.'" Celotex Corp v. Catrett, 477 U.S. 317, 322 (1986) (quoting
Fed. R. Civ. P. 56(c)). Once a party properly makes a motion for sum-
mary judgment by demonstrating to the court that there is no genuine
issue of material fact, the non-moving party must by affidavits or by
"`depositions, answers to interrogatories, and admissions on file,' des-
ignate `specific facts showing that there is a genuine issue for trial.'"
Id. at 324 (quoting Fed. R. Civ. P. 56(e)). Although "[t]he evidence
of the non-movant is to be believed, and all justifiable inferences are
to be drawn in his favor," Anderson v. Liberty Lobby, Inc., 477 U.S.
242, 255 (1986), in order to survive summary judgment, "[t]he mere
existence of a scintilla of evidence in support of the [non movant's]
position will be insufficient; there must be evidence on which the jury
could reasonably find for the [non-movant]," id. at 252. This Court
reviews a grant of summary judgment de novo. See Higgins v. E.I.
DuPont de Nemours & Co., 863 F.2d 1162, 1167 (4th Cir. 1988).

Under Virginia law, which controls resolution of this diversity
action, a plaintiff may bring suit against a manufacturer or seller of
a defective product under either a theory of breach of implied war-
ranty of merchantability or a negligence theory. See Bly v. Otis Eleva-
tor Co., 713 F.2d 1040, 1042 (4th Cir. 1983). Under either theory, a
plaintiff must show "(1) that the goods were unreasonably dangerous
either for the use to which they would ordinarily be put or for some
other reasonably foreseeable purpose, and (2) that the unreasonably
dangerous condition existed when the goods left the defendant's
hands." Logan v. Montgomery Ward & Co., 219 S.E.2d 685, 687 (Va.
1975). "A product is unreasonably dangerous if it is defective in
assembly or manufacture, unreasonably dangerous in design, or unac-
companied by adequate warnings concerning its hazardous proper-
ties." Morgen Indus. v. Vaughan, 471 S.E.2d 489, 492 (Va. 1996).
Although the duties imposed under the theories of negligence and
implied warranty of merchantability vary slightly, 6 under both theo-
_________________________________________________________________
6 With regard to a cause of action asserting that a product is unreason-
ably dangerous because of its defective design, a theory of breach of
implied warranty of merchantability focuses on the product and its attri-
butes, while a negligence theory focuses on the defendant's conduct. See

                     9
ries, the plaintiff must prove that any breach of duty by the manufac-
turer or seller was the proximate cause of the plaintiff's injuries. See
Butler v. Navistar Int'l Transp. Corp., 809 F. Supp. 1202, 1207 (W.D.
Va. 1991).

The Moyers claim that, under both a theory of breach of implied
warranty of merchantability and a negligence theory, the Spectra 400
System was unreasonably dangerous for the following reasons: (1) the
Spectra 400 System was defectively designed because the words "si-
nusoidal pattern" appeared on the APS when the System indisputably
lacked the capacity to alert for such a pattern, (2) the Spectra 400 Sys-
tem was defectively designed because Corometrics had the capability
to install an alert detection to recognize a sinusoidal FHR pattern, but
failed to do so when it sold the System to WMC in 1989, and (3)
Corometrics inadequately warned the users of the Spectra 400 System
that the alert function on the Model 415C Central Display Unit did
not alert for the sinusoidal pattern.

We need not determine whether the Moyers established a genuine
issue of material fact as to whether Corometrics breached a duty owed
to the Moyers, because we conclude that the Moyers failed to estab-
lish a triable issue on whether any act or omission by Corometrics
proximately caused Hope's injuries. The Supreme Court of Virginia
has held that "[t]he proximate cause of an event is that act or omission
which, in natural and continuous sequence, unbroken by an efficient
intervening cause, produces the event, and without which that event
would not have occurred." Banks v. City of Richmond, 348 S.E.2d
_________________________________________________________________

Abbot v. American Cyanamid Co., 844 F.2d 1108, 1115-16 (4th Cir.
1988). With regard to a cause of action asserting that a product is unrea-
sonably dangerous because it is accompanied by inadequate warnings,
the most notable differences between a theory of breach of implied war-
ranty and a negligence theory are that (1) a theory of implied warranty
focuses on whether the inadequate warnings render the product unrea-
sonably dangerous while a negligence theory looks at whether the manu-
facturer's conduct is unreasonable; and (2) under a negligence theory, the
duty to warn is continuous and is not interrupted by manufacture or sale
of the product. See Bly v. Otis Elevator Co., 713 F.2d 1040, 1045-46 (4th
Cir. 1983).

                     10
280, 282 (Va. 1986) (internal quotation marks omitted). Although
proximate cause is ordinarily a question of fact for the jury, it
becomes a question of law for the court when reasonable minds could
not disagree about the conclusion to be reached. See Phillips v. South-
east 4-H Educ. Ctr., 510 S.E.2d 458, 460 (Va. 1999). Evidence of
proximate cause "must be sufficient to remove the case out of the
realm of speculation and conjecture and into the realm of legitimate
inference before submitting it to a jury for its determination." Id. at
461 (internal quotation marks omitted).

Essentially, the Moyers' argument on the issue of proximate causa-
tion is that if Steinmetz had not left Mrs. Moyers unattended, in reli-
ance upon the Spectra 400 System's capability to alert for a sinusoidal
pattern, Steinmetz would have alerted Dr. Willey of Mrs. Moyers's
sinusoidal pattern sometime between 1:27 a.m., when the pattern
developed, and 1:38 a.m., when she returned to Mrs. Moyers's room.
Furthermore, the Moyers assert, had Dr. Willey been informed of the
sinusoidal pattern earlier, he would have performed the cesarean sec-
tion earlier, thus averting Hope's severe neurological injuries.

To survive summary judgment, the Moyers must establish a genu-
ine issue of material fact for each link in this chain of causation. This
the Moyers cannot do. First, the Moyers fail to establish a genuine
issue of material fact as to whether Steinmetz or Dr. Willey acted in
reliance upon the Spectra 400 System's capability to alert for a sinus-
oidal pattern. Both Steinmetz and Dr. Willey testified that they did
not know whether the Spectra 400 System alerted for a sinusoidal pat-
tern and that they did not alter their practices based upon the existence
of an audio alert function. Moreover, neither Steinmetz nor Dr. Wil-
ley even recalled reading the Spectra 400 System Operator's Manual.
Based upon this testimony, no reasonable factfinder could conclude
that any defect in the design of the Spectra 400 System or the warn-
ings accompanying it proximately caused the delay in Dr. Willey
learning of Mrs. Moyers's condition.

In an attempt to create a triable issue, the Moyers contend that
Steinmetz testified that she was "surprised" that the alarm did not
sound at 1:27 a.m. when the pattern appeared, and that the district
court should have drawn from this statement the inference that Stein-
metz expected the System to alarm for the sinusoidal pattern and

                    11
relied upon it to do so. This argument misreads Steinmetz's testi-
mony; she only testified that following Hope's delivery she asked her
co-workers whether any of them had heard an alarm. The Moyers also
assert that Steinmetz's testimony that if an alarm sounded she would
"look up and notice it" and that she did not rely upon the audio alert
function of the Spectra 400 System "a lot" leads to the permissible
inference that she relied upon the System to some extent to alert her
to abnormalities. (J.A. at 1066.) Contrary to the Moyers' argument,
however, this portion of Steinmetz's testimony is a rather unremark-
able statement that she would react if an audio alert went off; this
statement is not at all inconsistent with her testimony that she did not
alter her patient care or surveillance practices in reliance upon the
alarm component of the Spectra 400 System. Finally, the Moyers
argue that Steinmetz's testimony that she left Mrs. Moyers because
Mrs. Moyers was being monitored and Steinmetz "didn't feel there
was anything else necessary right then" leads to the reasonable infer-
ence that Steinmetz relied upon the Spectra 400 System to alert her
for sinusoidal patterns. (J.A. at 1592.) This snippet of testimony does
not even mention the alert function of the Spectra 400 System or
sinusoidal patterns, and, therefore, also does not call into question
Steinmetz's testimony that she did not alter her patient care or surveil-
lance practices in reliance upon the alarm component of the System.
Because the Moyers presented no evidence to remove the issue of
reliance from the realm of speculation and conjecture and into the
realm of legitimate inference, summary judgment is appropriate on
this ground.7
_________________________________________________________________

7 The Moyers also argue that Moulton's reply of "No, not totally" to the
question of whether she relied upon the System to alert her to all abnor-
malities leads to the clear inference that she relied upon the alert function
of the System in part. (J.A. at 1609.) Because Mrs. Moyers was not
Moulton's patient, and Moulton did not leave Mrs. Moyers unattended,
the issue of Moulton's reliance upon the alert capability of the Spectra
400 System is immaterial. In any case, this reply is insufficient to contra-
dict Moulton's unequivocal testimony that she did not alter any practices
because the System had an alarm feature, did not rely upon the System
to alert her to all abnormalities, and was not instructed by anyone at the
hospital to substitute the alarm for her professional care and surveillance
of the patient.

                     12
Moreover, even if the Moyers established a genuine issue of mate-
rial fact as to reliance, they fail to establish a genuine issue of material
fact as to whether Dr. Willey would have performed the cesarean sec-
tion earlier if he had been called to Mrs. Moyers's room earlier. Dr.
Willey testified that he could not, without speculating, state how long
he would have waited to perform the cesarean section if the FHR had
not started to diminish. He also testified that he could not state
whether he would have performed the cesarean section any earlier if
he had been present in the room at 1:27 a.m. when the sinusoidal pat-
tern developed. Based upon Dr. Willey's testimony, no reasonable
factfinder could conclude that any defect in the design of the Spectra
400 System or the warnings accompanying it proximately caused the
delay in Hope's delivery.

In an attempt to create a triable issue, the Moyers presented the
expert testimony of Dr. Lawrence Borow, an obstetrician and gyne-
cologist. Dr. Borow testified that a reasonable obstetrician, if alerted
promptly at 1:27 a.m. or 1:28 a.m. when this pattern emerged, "could"
have delivered the baby sooner, and that had he been alerted to Mrs.
Moyers's sinusoidal pattern at that time, he would have delivered the
baby sooner. Whether the issue is what Dr. Willey would have done
or what a reasonable obstetrician would have done, Dr. Borow did not
specifically testify as to what an obstetrician in the exercise of reason-
able care would or should have done. He only testified as to what he
personally would have done or what a reasonable obstetrician could
have done. Moreover, Corometrics's expert, Dr. James Christman, a
Virginia board-certified obstetrician, testified that the standard of care
would not have required the decision to proceed with a cesarean sec-
tion until shortly after 1:42 a.m., when the FHR baseline clearly
dropped below 120 beats per minute. As noted above, Dr. Willey
could only speculate as to whether he might have performed the
cesarean section earlier had he been in the room at 1:27 a.m. Because
the Moyers presented no evidence to remove the issue of whether Dr.
Willey would have performed the cesarean section earlier had he been
informed of the sinusoidal pattern earlier from the realm of specula-
tion and conjecture and into the realm of legitimate inference, sum-
mary judgment is appropriate on this ground as well.

                     13
III.

In sum, we conclude that no jury could reasonably find that any
defect in the design of the Spectra 400 System or the warnings
accompanying it proximately caused Hope Moyers's severe neurolog-
ical injuries.8 Because the Moyers failed to establish genuine issues
of material fact as to proximate causation, we affirm the district
court's order granting summary judgment to Corometrics on all
counts and dismissing the case with prejudice.

AFFIRMED
_________________________________________________________________
8 By this disposition we need not determine whether the district court
erred in determining that the testimony of the Moyers' expert witnesses
was insufficient to create a genuine issue of material fact with regard to
the Moyers' claim that the System was defectively designed.

                    14