Phelan v. Synthes (U.S.A.)

UNPUBLISHED
UNITED STATES COURT OF APPEALS
FOR THE FOURTH CIRCUIT
JEAN PHELAN, 
Plaintiff-Appellant,
v.  No. 01-2045
SYNTHES (U.S.A.),
Defendant-Appellee.

Appeal from the United States District Court
for the District of South Carolina, at Florence.
Patrick Michael Duffy, District Judge.
(CA-99-3047-4-23)
Argued: February 27, 2002
Decided: May 28, 2002
Before WILKINSON, Chief Judge, and WILLIAMS and
GREGORY, Circuit Judges.
Affirmed by unpublished per curiam opinion.
COUNSEL
ARGUED: Scott Bryn Umstead, SCOTT B. UMSTEAD, P.A., Myr-
tle Beach, South Carolina; Thomas Casey Brittain, HEARN, BRIT-
TAIN & MARTIN, Myrtle Beach, South Carolina, for Appellant.
Susan Pedrick McWilliams, NEXSEN, PRUET, JACOBS & POL-
LARD, L.L.C., Columbia, South Carolina, for Appellee.
2 PHELAN v. SYNTHES
Unpublished opinions are not binding precedent in this circuit. See
Local Rule 36(c).
OPINION
PER CURIAM:
Jean Phelan appeals from the district court’s orders excluding her
proffered expert testimony and directing a verdict for Appellee Syn-
thes, Inc., U.S.A. on Phelan’s claims arising from injuries she suf-
fered when a "tibial nail" manufactured by Synthes and implanted in
Phelan’s leg fractured, necessitating surgical removal of the nail. Dur-
ing the jury trial, the district court excluded the proffered testimony
of Phelan’s expert, Dr. Joseph Dyro, under Federal Rule of Evidence
702 as well as the standard of Daubert v. Merrell Dow Pharmaceuti-
cals, 509 U.S. 579 (1993), and its progeny. The district court granted
judgement as a matter of law for Synthes, finding that there was
insufficient evidence for the jury to find for Phelan. We affirm.
I.
In September of 1996, Phelan was involved in a motorcycle acci-
dent in Myrtle Beach, South Carolina. She suffered, among other
injuries, a fractured right tibia. The fracture was toward the distal (i.e.,
lower) end of the bone. To align the fractured parts of her tibia as it
healed, Phelan’s doctor, Richard W. Ward, M.D., concluded that "in-
ternal fixation with an intramedullary nail,"1 was appropriate. Ward
performed a surgical procedure on Phelan’s leg in September of 1996,
implanting the nail in her tibia.
The Synthes nail selected by Ward was accompanied by a "Pack-
age Insert" addressed to the "operating surgeon." (J.A. at 214.) Gener-
ally, this Package Insert contained warnings about the stresses placed
on a metallic surgical implant in the body, identified the various fac-
1
An intramedullary nail is a metallic surgical implant used to align a
fractured bone while it heals. The nail is inserted inside a bone and
secured in place with screws that pass through both the bone and the nail.
PHELAN v. SYNTHES 3
tors that would affect the life and strength of the nail, and listed some
general instructions and possible adverse effects of use of the nail.
In Phelan’s case, several screws were used in the initial operation
to secure the nail inside her tibia. One of the screws was placed
approximately one centimeter from the fracture, at the distal end of
the tibia. After the nail was inserted, Phelan was discharged from the
hospital and instructed by Ward not to place any weight on her right
leg. She was to use crutches or a walker to move around. In Novem-
ber 1996, Phelan returned for a follow-up visit. Ward instructed her
at that time to begin placing approximately fifty percent of a normal
load on the leg in order to stimulate healing. In January 1997, two of
the screws were removed to allow some degree of motion of the frac-
tured pieces of Phelan’s tibia. According to Ward, this process,
known as "dynamization," was intended to speed the healing process.
Ward testified that dynamization reduced the stabilization of the bone
and the nail, increasing the weight borne by both when Phelan placed
weight upon her leg.
On February 5, 1997, Phelan again returned to Ward’s office for
an appointment. An x-ray of Phelan’s leg on that date showed that the
tibial nail had fractured at or very near the point where one of the
screws not removed in January passed through it, leaving the nail in
two pieces. In an attempt to facilitate healing in spite of the fracture,
Ward placed a cast on Phelan’s leg. Ward replaced the cast with a
brace in May 1997. Finally, because of significant "angulation"2 at the
site of the fracture in the bone, Ward performed surgery to remove the
nail.
II.
Phelan brought this action in state court in South Carolina, assert-
ing liability against Synthes on three grounds: (1) breach of implied
warranty of merchantability as to the tibial nail; (2) strict liability
2
Ward testified that the angulation was severe enough that Phelan’s
ankle was not aligned with her hip and knee, as is normal. Rather, the
lower part of her leg was bowed significantly, causing her foot to be
behind the line of her hip and knee.
4 PHELAN v. SYNTHES
under South Carolina Code section 15-73-10;3 and (3) negligence.
Synthes removed the action to the District Court for the District of
South Carolina pursuant to diversity of citizenship.
At trial Phelan proffered the testimony of Dr. Dyro, a "biomedical
engineer."4 (J.A. at 116.) After hearing Dr. Dyro’s summary of his
qualifications, his conclusions and the basis for those conclusions, the
district court excluded Dr. Dyro’s testimony on the ground that his
conclusions were not sufficiently supported by reliable scientific
methodology to satisfy the standard of Rule 702, Daubert, and its
progeny. Phelan’s challenge to the exclusion of Dr. Dyro’s testimony
is the first issue raised in this appeal.
Having excluded Dr. Dyro’s testimony, the district court stated that
3
South Carolina Code section 15-73-10 provides that
(1) One who sells any product in a defective condition unrea-
sonably dangerous to the user or consumer or to his prop-
erty is subject to liability for physical harm caused to the
ultimate user or consumer, or to his property, if
(a) The seller is engaged in the business of selling such a
product, and
(b) It is expected to and does reach the user or consumer
without substantial change in the condition in which it
is sold.
(2) The rule stated in subsection (1) shall apply although
(a) The seller has exercised all possible care in the prepara-
tion and sale of his product, and
(b) The user or consumer of the product has not bought the
product from or entered into any contractual relation
with the seller.
S.C. Code Ann. § 15-73-10 (Law Co-op. 1977).
4
Dr. Dyro holds a Ph.D. in Biomedical Electronics Engineering from
the University of Pennsylvania. He testified that "[b]iomedical engineer-
ing is the application of engineering principles to the study of biological
systems," and that "a biomedical engineer is . . . skilled in the application
of engineering principles to the solution of problems in . . . medicine and
in biology . . . ." (J.A. at 118-19.)
PHELAN v. SYNTHES 5
it would consider granting judgement as a matter of law to Synthes
and instructed the parties to prepare to argue the issue. After a recess,
Phelan and Synthes argued the question of whether any issue
remained for the jury to determine absent Dr. Dyro’s testimony. Phe-
lan contended that even without Dr. Dyro’s testimony, the evidence
was sufficient to create a question for the jury on the issue of whether
Synthes was negligent in failing adequately to warn Phelan’s doctor,
Ward, in its Package Insert of the risks involved in using the nail in
these circumstances. The district court, however, found that the evi-
dence in support of Phelan’s failure-to-warn theory did not present a
legally sufficient basis for a jury verdict in her favor and granted
judgement as a matter of law for Synthes. Phelan’s challenge to the
district court’s grant of judgement as a matter of law to Synthes is the
second issue raised in this appeal.
III.
We first address the question of whether the district court properly
excluded Dr. Dyro’s testimony. A district court’s decision to admit or
exclude expert testimony is reviewed for abuse of discretion. Cooper
v. Smith & Nephew, Inc., 259 F.3d 194, 200 (4th Cir. 2001).
Under Rule 702 of the Federal Rules of Evidence, "trial judges act
as gatekeepers to ‘ensure that any and all scientific testimony . . . is
not only relevant, but reliable.’" Id. at 199 (quoting Daubert, 509 U.S.
at 588). Rule 702 provides that
[i]f scientific, technical, or other specialized knowledge will
assist the trier of fact to understand the evidence or to deter-
mine a fact in issue, a witness qualified as an expert by
knowledge, skill, experience, training, or education, may
testify thereto in the form of an opinion or otherwise, if (1)
the testimony is based upon sufficient facts or data, (2) the
testimony is the product of reliable principles and methods,
and (3) the witness has applied the principles and methods
reliably to the facts of the case.
Fed. R. Evid. 702. Under this standard, it is the duty of a trial judge
before whom expert scientific testimony is proffered to "conduct a
preliminary assessment of whether the reasoning or methodology
6 PHELAN v. SYNTHES
underlying the testimony is scientifically valid and of whether that
reasoning or methodology properly can be applied to the facts in
issue." Cooper, 259 F.3d at 199 (internal quotation marks omitted).
"‘[T]he trial judge must have considerable leeway in deciding in a
particular case how to go about determining whether particular expert
testimony is reliable.’" Id., 249 F.3d at 200 (quoting Kumho Tire Co.
v. Carmichael, 526 U.S. 137, 152 (1999)).
Dr. Dyro’s proposed testimony in this case included three opinions:
(1) that the Synthes nail "is defective and unreasonably dangerous in
this application"; (2) that the Package Insert included with the nail "is
defective because it does not instruct the physician concerning the
unreasonably dangerous application"; and (3) that pre-market testing
performed on the nail "was deficient . . . and even misleading, in that
it did not . . . employ a protocol which would have revealed this
unreasonably dangerous situation." (J.A. at 137-38.) Each of these
opinions was premised on Dr. Dyro’s underlying conclusion that the
nail is more likely to break when one or more of the screws securing
it is placed very near the site of the bone fracture. It is in that "appli-
cation" — when one or more of the screws is near the fracture site
— that Phelan contended the nail is unreasonably dangerous.
The district court excluded Dr. Dyro’s testimony despite finding
that he was "a very accomplished man and . . . qualified to render
expert opinions in a good many areas . . .," because he had not
"brought his expertise to bear on the issues in this case except in a
very general way." (J.A. at 165.) In other words, the district court
found that the reasoning or methodology underlying Dr. Dyro’s opin-
ions was not sufficiently specific to the issues at hand to render those
opinions admissible.
A district court determining whether to admit expert scientific testi-
mony must determine, under Rule 702 and Daubert, whether the testi-
mony has a sufficient foundation in valid scientific methodology to
be reliable. The Daubert Court enumerated four factors relevant in
this analysis: (1) whether a theory or technique can be or has been
tested; (2) whether it has been subjected to peer review and publica-
tion; (3) whether a technique has a high known or potential rate of
error and whether there are standards controlling its operation; and (4)
PHELAN v. SYNTHES 7
whether the theory or technique enjoys general acceptance within a
relevant scientific community. Daubert, 509 U.S. at 592-94.
In the instant case, Dr. Dyro proposed to testify to the three opin-
ions listed above after a review and analysis of the literature dealing
with tibial nail fractures, an examination of an FDA database
cataloguing similar failures, and an application of "basic mechanical
engineering analysis." (J.A. at 152-59.) He admitted that he had nei-
ther examined nor performed any tests on tibial nails in forming these
opinions.
Dr. Dyro’s first proffered opinion, that the Synthes nail is "defec-
tive and unreasonably dangerous in this application," refers to the "ap-
plication where the fracture is very close to . . . the point of fixation
. . . by the locking screw," and the "fracture is in the distal end of the
tibia . . . ." (J.A. at 137.) This opinion, he stated, was based upon his
review of literature dealing with tibial nail fractures and "upon biome-
chanical principles" with which he was familiar through his work.
(J.A. at 138.) When asked by the district court whether there was
"anything specific that you have used in applying [your] education or
experience" to form this opinion, Dr. Dyro responded that he had
referred to "[s]pecific things like the stress applied to a cantilever
beam and the point of where that stress is applied."5 In essence, then,
Dr. Dyro’s first proffered opinion was based on little more than the
assertion that a tibial nail would be subject to the stress placed on a
"cantilever beam" when it is secured to the bone only at the distal end,
and the stress placed on the nail would make it "more likely" to break.
(J.A. at 163-64.) Dr. Dyro did not identify or quantify the stresses that
would be placed on the nail other than to say generally that the
stresses would be those placed on "a cantilever beam." He proposed
to testify, however, that this principle made the Synthes nail "defec-
tive and unreasonably dangerous," as used in Phelan’s tibia, triggering
liability under S.C. Code Ann. section 15-73-10.6 The trial court did
5
A "cantilever" is defined as "a projecting beam or member supported
at only one end." Webster’s Third New International Dictionary 329
(1986).
6
The South Carolina Court of Appeals has stated the required elements
of a claim of negligence or strict liability in a products liability action as
follows:
8 PHELAN v. SYNTHES
not abuse its discretion in determining that this opinion was not sup-
ported by reliable methodology where Dr. Dyro’s opinion was based
largely on extrapolation from a simple principle of engineering with-
out quantitative or otherwise specific examination of the properties of
the Synthes nail itself. See General Elec. Co. v. Joiner, 522 U.S. 136,
146 (1997) (noting that the trial court "may conclude that there is sim-
ply too great an analytical gap between the data and the opinion prof-
fered").
Further, Dr. Dyro’s first proffered opinion was to serve as the link
between the unreasonably dangerous condition he identified and the
failure of the nail in Phelan’s case. He proposed to testify that the nail
was unreasonably dangerous "in this particular case of Jean Phelan
where the nail is inserted and locked at a point within a, very close
to the fracture," and thus to suggest that the nail in Phelan’s leg broke
because of what he identified as its unreasonably dangerous condi-
tion. (J.A. at 155.) Missing from Dr. Dyro’s proffer, however, was
any basis for believing that this nail broke because of the stresses he
suggested would have been placed on it in the position it was in, or
for eliminating equally plausible causes for the nail’s breaking —
excessive loads placed on the nail by Phelan, for example. See
Oglesby v. General Motors Corp., 190 F.3d 244, 250 (4th Cir. 1999)
(holding that expert’s testimony did not have sufficient indicia of reli-
ability under Daubert where the expert’s theory did not, "as a matter
of logic, . . . eliminate other equally plausible causes" of the incident
in question). Moreover, Dr. Dyro did not testify (nor did he identify
In a product liability action under both negligence and strict lia-
bility theories, the plaintiff must establish (1) that he was injured
by the product; (2) that the product, at the time of the accident,
was in essentially the same condition as when it left the hands
of the defendant; and (3) that the injury occurred because the
product was in a defective condition unreasonably dangerous to
the user. Further, [l]iability for negligence requires, in addition
to the above, proof that the manufacturer breached its duty to
exercise reasonable care to adopt a safe design.
Allen v. Long Mfg. N.C., Inc., 505 S.E.2d 354, 356-57 (S.C. Ct. App.
1998) (internal quotation marks omitted, alteration in original, and
emphasis omitted).
PHELAN v. SYNTHES 9
any basis on which he could testify) regarding how likely the nail was
to fail in this application. Because he did not conduct any tests nor
perform any calculations regarding the nail in question, Dr. Dyro
could not even identify the extent of the stress or force that would be
placed on a nail in the circumstances under which this nail was used.7
The district court did not err, therefore, in concluding that Dr. Dyro’s
first proffered opinion was not demonstrably reliable enough to be
admissible.
Dr. Dyro’s second proffered opinion — that the Package Insert
included with the nail "is defective because it does not instruct the
physician concerning the unreasonably dangerous application" (J.A.
at 137) — and his third — that pre-market testing performed on the
nail "was deficient . . . and even misleading, in that it did not . . .
employ a protocol which would have revealed this unreasonably dan-
gerous situation," (J.A. at 137-38) both rest upon the same basic con-
clusion as his first — that the nail was defective and unreasonably
dangerous in this application. Because Dr. Dyro had no reliable basis
on which to assert that the nail was defective and unreasonably dan-
gerous, these opinions were likewise not sufficiently supported by
reliable methodology. In sum, then, the district court did not abuse its
discretion in excluding Dr. Dyro’s proffered expert testimony.8
7
Indeed, unlike Roger Dean Harris, an expert in metallurgy called by
Phelan, Dr. Dyro could not identify specifically the extent of the forces
that would have to have been placed on the nail to cause it to break.
8
Phelan argues that the district court did not allow sufficient time for
full explanation of the basis for Dr. Dyro’s proffered opinions. Specifi-
cally, Phelan contends that the district court was "extraordinarily impa-
tient and prevented any meaningful development of proffered expert
testimony." (Br. of Appellant at 13.) Synthes contends that Phelan has
waived any objection to the district court’s handling of their proffer by
failing to object to it at trial. Regardless of whether the issue has been
waived, we find no merit in the contention that the district court abused
its discretion in limiting the length of the proffer of expert testimony.
Indeed, Phelan has not identified any basis for Dr. Dyro’s conclusions
that she was prevented from presenting as a result of the district court’s
claimed impatience, except to state very generally that more time would
have allowed her to go into greater detail.
10 PHELAN v. SYNTHES
IV.
After excluding Dr. Dyro’s proffered expert testimony, the district
court granted judgment as a matter of law for Synthes, concluding
that no reasonable jury could find for Phelan. We review de novo the
district court’s grant of judgment as a matter of law. Anderson v. Rus-
sell, 247 F.3d 125, 129 (4th Cir. 2001).
Phelan does not argue that her claims of strict liability and breach
of implied warranty of merchantability should have been submitted to
the jury absent Dr. Dyro’s testimony. Rather, she argues only that
"enough evidence had already been adduced to create a jury issue as
to the adequacy of the warning in [Synthes’] product package insert."
(Br. of Appellant at 26.)
The district court was correct to grant judgment as a matter of law
to Synthes on the strict liability and warranty claims because those
claims required Phelan to show that she was injured when the nail
broke as a result of an unreasonably dangerous weakness when
screws were placed through it near the fracture site, a conclusion for
which Dr. Dyro’s testimony was her only direct evidence. She con-
tends, however, that even absent Dr. Dyro’s testimony the evidence
created a jury question regarding whether Synthes negligently failed
to include in its Package Insert a warning that the nail was likely to
fail if used in the circumstances it was used in here.
Specifically, Phelan asserts that she should have been allowed to
present to the jury the claim that Synthes failed to warn in its Package
Insert of the danger of the nail’s breaking if "union"9 did not occur
within three to four months, and that Synthes’ failure to warn ren-
dered the nail unreasonably dangerous and caused her injuries. She
argues that "[t]he record is replete with testimony from Dr. Ward
which clearly shows there was substantial evidence from which a jury
could reasonably infer that Appellant’s injuries were caused by
Appellee’s inadequate warning." (Br. of Appellant at 27 (emphasis
added).) Her contention is that because the Insert referred only to the
9
"Union" is defined as "the renewal of continuity in a broken bone or
between the edges of a wound." Dorland’s Illustrated Medical Dictionary
at 1911 (29th ed. 1994).
PHELAN v. SYNTHES 11
10
danger of the nail’s breaking if "nonunion" or delayed union were
to occur, it did not warn of the danger of the nail’s breaking before
nonunion could technically be said to have occurred.
To prevail on her negligent failure-to-warn claim, Phelan was
required to show that the Synthes nail was a defective product in a
condition unreasonably dangerous to her and that Synthes breached
its duty to exercise reasonable care to adopt a safe design. Allen v.
Long Mfg. N.C., Inc., 505 S.E.2d 354, 357 (S.C. Ct. App. 1998). It
is well settled under South Carolina law that "a seller may prevent a
product from being unreasonably dangerous if the seller places an
adequate warning on the product regarding its use." Id. Phelan’s argu-
ment that her failure-to-warn claim should have been submitted to the
jury rests on the proposition that the nail was unreasonably dangerous
because the Insert’s warning did not reveal the danger that it could
break before such time as "nonunion" or "delayed union" could be
said to have occurred.11 As her counsel clarified at oral argument,
Phelan argues that the nail was unreasonably dangerous here because
the Insert lulled her and her surgeon, Dr. Ward, into a false sense of
security, believing that the nail would not fail for several months
when in fact it was in danger of failing at any time and thus causing
her injury, by inducing the assumption that the nail was not in danger
of failing until approximately six months after it was implanted.
It is not clear whether a product may be shown to be unreasonably
dangerous under the South Carolina negligence standard by proof that
the product’s warning suggests that it will not fail in a particular
application and that the product did subsequently fail in that applica-
tion. Cf. Allen, 505 S.E.2d at 537 (noting that "unreasonably danger-
ous condition" must be shown in a failure-to-warn negligence case,
but not indicating whether a warning’s suggestion that a product is
10
"Nonunion" is defined as "failure of the ends of a fractured bone to
unite." Dorland’s Illustrated Medical Dictionary at 1232 (29th ed. 2000).
11
The parties disagree as to when nonunion or delayed union may tech-
nically be said to have occurred. Phelan contends that until six months
have elapsed since treatment, neither may be declared to have occurred.
Synthes contends that either may generally occur between three months
and six months after treatment. As we explain, it is not necessary to our
holding to resolve this disagreement.
12 PHELAN v. SYNTHES
safe for use in a particular application may by itself render the product
unreasonably dangerous); id. at 359 (noting that a product that is not
unreasonably dangerous does not require a warning). Thus it is not
clear whether Phelan has posited a cognizable legal theory here. We
need not resolve this question, however, because even assuming that
Phelan’s failure-to-warn theory was a legally cognizable one, we con-
clude that the Insert warns against the danger that Phelan suggests it
ignores and does not make the kind of "guarantee" she claims it does.
Phelan’s argument rests largely on a portion of the Insert which
reads "[i]f there is delayed union or nonunion of bone in the presence
of weight bearing or load bearing, the implant could eventually break
due to metal fatigue." (J.A. at 214.) This language and other refer-
ences to delayed union and nonunion in the Insert, argues Phelan,
essentially suggest that the nail will not break before "nonunion" or
"delayed union" could be declared. Because "union" does not occur
for some time after a bone begins the healing process, Phelan con-
tends, the nail’s breakage in the period before union or nonunion
could be identified — i.e., when it is too soon to declare either result
— is not covered by the Insert’s warning, and indeed, is impliedly
declared not to be a danger.
Phelan’s argument, however, is not supported by the text of the
Insert itself. The Insert contains a general warning that
[l]oads produced by weight bearing and activity levels will
dictate the longevity of the implant. The patient should
understand that stress on an implant can involve more than
weight bearing. In the absence of solid bony union, the
weight of the limb alone, muscular forces associated with
moving a limb, or repeated stresses of apparent relatively
small magnitude, can result in failure of the implant.
(J.A. at 214.) This warning clearly spells out the danger that absent
union, various stresses on the nail could cause it to break. Recogniz-
ing that the circumstances in which the nail may be used will vary,
the insert cautions that absent union, not only in the event of nonun-
ion or delayed union, the nail may fail under a certain amount of
stress. This statement cannot be construed as an indication that the
nail will not fail in the months after the nail is implanted but before
PHELAN v. SYNTHES 13
union occurs. Before union occurs, by definition, there is an "absence
of solid bony union." It is in these circumstances that the warning spe-
cifically indicates the nail may break under any of a number of
stresses. Cf. Anderson v. Green Bull, Inc., 471 S.E.2d 708, 710 (S.C.
Ct. App. 1996) (noting that "[a] product bearing a warning that the
product is safe for use if the user follows the warning is neither defec-
tive nor unreasonably dangerous"). Thus, even assuming she posits a
cognizable legal theory of unreasonable dangerousness and causation
under South Carolina law, Phelan was unable to present evidence here
of the inadequacy of the warning, and the judgment of the district
court must be affirmed.
V.
For the foregoing reasons, the judgment of the district court is
affirmed.
AFFIRMED