UNPUBLISHED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Affirmed by unpublished per curiam opinion.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., Myrtle Beach, South Carolina; Thomas Casey Brittain, HEARN, BRITTAIN & MARTIN, Myrtle Beach, South Carolina, for Appellant.

Susan Pedrick McWilliams, NEXSEN, PRUET, JACOBS & POLLARD, L.L.C., Columbia, South Carolina, for Appellee. 
Unpublished opinions are not binding precedent in this circuit.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 Synthes, Inc., U.S.A. on Phelan’s claims arising from injuries she suffered when a "tibial nail" manufactured by Synthes and implanted in

Phelan’s leg fractured, necessitating surgical removal of the nail. During 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 Pharmaceuticals, 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 accident 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 "internal 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 "Package Insert" addressed to the "operating surgeon." (J.A. at 214.) Generally, this Package Insert contained warnings about the stresses placed

on a metallic surgical implant in the body, identified the various fac1An 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.

2 PHELAN v. SYNTHES
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 November 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 fractured 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, asserting liability against Synthes on three grounds: (1) breach of implied

warranty of merchantability as to the tibial nail; (2) strict liability

2Ward 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. 

PHELAN v. SYNTHES 3
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

3South Carolina Code section 15-73-10 provides that 

(1) One who sells any product in a defective condition unreasonably dangerous to the user or consumer or to his property 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 preparation 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). 

4Dr. Dyro holds a Ph.D. in Biomedical Electronics Engineering from

the University of Pennsylvania. He testified that "[b]iomedical engineering 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.) 

4 PHELAN v. SYNTHES
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. Phelan 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 evidence 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 determine 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

PHELAN v. SYNTHES 5
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 "application" — 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 opinions was not sufficiently specific to the issues at hand to render those

opinions admissible. 

A district court determining whether to admit expert scientific testimony must determine, under Rule 702 and Daubert, whether the testimony 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 publication; (3) whether a technique has a high known or potential rate of

error and whether there are standards controlling its operation; and (4)

6 PHELAN v. SYNTHES
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 opinions 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 neither examined nor performed any tests on tibial nails in forming these

opinions. 

Dr. Dyro’s first proffered opinion, that the Synthes nail is "defective and unreasonably dangerous in this application," refers to the "application 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 biomechanical 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 "defective 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

5A "cantilever" is defined as "a projecting beam or member supported

at only one end." Webster’s Third New International Dictionary 329

(1986). 

6The 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: 

PHELAN v. SYNTHES 7
not abuse its discretion in determining that this opinion was not supported by reliable methodology where Dr. Dyro’s opinion was based

largely on extrapolation from a simple principle of engineering without 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 simply too great an analytical gap between the data and the opinion proffered"). 

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 condition. (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 reliability 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 liability 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). 

8 PHELAN v. SYNTHES
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 dangerous situation," (J.A. at 137-38) both rest upon the same basic conclusion 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 dangerous, 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. 

8Phelan argues that the district court did not allow sufficient time for

full explanation of the basis for Dr. Dyro’s proffered opinions. Specifically, Phelan contends that the district court was "extraordinarily impatient 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. 

PHELAN v. SYNTHES 9
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. Russell, 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 contends, 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 rendered 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). 

10 PHELAN v. SYNTHES
danger of the nail’s breaking if "nonunion"10 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 argument 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 application. Cf. Allen, 505 S.E.2d at 537 (noting that "unreasonably dangerous 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).

11The parties disagree as to when nonunion or delayed union may technically 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. 

PHELAN v. SYNTHES 11
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 conclude 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 references 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 contends, 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. Recognizing that the circumstances in which the nail may be used will vary,

the insert cautions that absent union, not only in the event of nonunion 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

12 PHELAN v. SYNTHES
union occurs. Before union occurs, by definition, there is an "absence

of solid bony union." It is in these circumstances that the warning specifically 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 defective 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

PHELAN v. SYNTHES 13