KEMUEL GOODSON v. C.R. BARD and DAVOL, INC
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SUPERIOR COURT OF NEW JERSEY
APPELLATE DIVISION
DOCKET NO. A-3280-15T1
KEMUEL GOODSON,
Plaintiff-Appellant,
v.
C.R. BARD and DAVOL, INC.,
Defendants-Respondents.
________________________________________
Argued January 10, 2018 – Decided March 19, 2018
Before Judges Koblitz, Manahan, and Suter.
On appeal from Superior Court of New Jersey,
Law Division, Atlantic County, Docket No. L-
0826-13.
William L. Hurlock argued the cause for
appellant (Mueller Law LLC and Mark R. Mueller
(Mueller Law, PLLC) of the Texas bar, admitted
pro hac vice, attorneys; William L. Hurlock
and Mark R. Mueller, on the briefs).
Daniel K. Winters argued the cause for
respondents (Reed Smith LLP, attorneys; Daniel
K. Winters, of counsel and on the brief; Shana
E. Russo, of counsel and on the brief).
PER CURIAM
This appeal requires our consideration of the Bard 3DMax Mesh
(3DMax), a polypropylene mesh used for hernia operations that is
manufactured, designed, and marketed by defendants C.R. Bard, Inc.
and Davol, Inc. (collectively defendants). Plaintiff Kemuel
Goodson alleges that the implantation of this medical device caused
multiple complications that required extensive medical care,
including numerous operations. Plaintiff alleged four causes of
action: (1) defective design of the 3DMax under the New Jersey
Product Liability Act; (2) defective design of the 3DMax Mesh
under Georgia law; (3) negligence under Georgia law; and (4) fraud
and misrepresentation under Georgia law.
Upon the completion of discovery, defendants filed a motion
seeking summary judgment which was granted. Plaintiff appeals,
arguing the trial court erred in granting summary judgment to
defendants on plaintiff's claims of design defect and negligence.
We affirm.
We discern the facts from the summary judgment record, viewing
them in the light most favorable to plaintiff, the non-moving
party. Globe Motor Co. v. Igdalev,
225 N.J. 469, 479 (2016); R.
4:46-2(c).
The 3DMax is a prescription, three-dimensional, synthetic,
and implantable hernia mesh repair product made by defendants. It
is an anatomically formed prosthesis used in laparoscopic groin
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hernia repair. The mesh used in the 3DMax is made of knitted
polypropylene monofilaments. Products that use polypropylene mesh
are regulated by the FDA as Class II medical devices. Defendants
have continued to be in compliance with the FDA requirements, and
have never been requested by the FDA to remove 3DMax from the
market.
Plaintiff is a Georgia resident who underwent a laparoscopic
bilateral inguinal hernia repair using the 3DMax in December 2006.
The surgery was performed by Dr. Mark Middleton in Hiram, Georgia.
After the surgery, plaintiff experienced right groin pain and
swelling of the right testicle. He continues to be in constant
pain.
Dr. Middleton testified he was aware of the risks and benefits
of using synthetic mesh, including the risks of chronic pain,
infertility, and nerve ingrowth. Dr. Middleton also testified he
discussed the risks of numbness and chronic pain with plaintiff
prior to the surgery. Dr. Middleton stated he did not read the
Instructions for Use (IFU) that came with the product. He
specified he "had less problems with the 3DMax Mesh than any of
the other mesh products that I've used . . . ." Dr. Middleton
does not believe the 3DMax is the cause of plaintiff's medical
complications.
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After the surgery, plaintiff was referred to urologist Dr.
James Cullison, due to complications causing pain and a swollen
testicle. Dr. Cullison performed a right epididymectomy,
spermatocelectomy, and hydrocelectomy on plaintiff, but the pain
did not subside, which ultimately led to the removal of the right
testicle. Afterwards, plaintiff continued to experience pain.
In January 2012, plaintiff was treated by Dr. John Galloway
at Emory University Medical Center. Dr. Galloway performed a
triple neurectomy, which included removing the 3DMax and replacing
it with biologic mesh. Dr. Galloway offered no criticisms of the
3DMax used in the original hernia repair and stated he did not
believe that the 3DMax was defective or unreasonably dangerous.
Dr. Galloway further testified that "the mesh is considered
standard of care and safe in inguinal hernia repairs."
In July 2015, due to continuing chronic pain, plaintiff
underwent a third surgery with Dr. Bruce Ramshaw in Daytona Beach,
Florida, who removed the biologic mesh and completed an exploration
of the entire groin. Dr. Ramshaw found serious scarring and a
nerve entrapped within the scar tissue. He believed those
conditions were caused by the mesh removal surgery. Dr. Ramshaw
testified he had no criticisms of Dr. Middleton's decision to use
the 3DMax. During Dr. Ramshaw's deposition, the following colloquy
ensued:
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Q. Was there any indication that [plaintiff]
has some sort of unusual response to the
mesh?
A. No. It looked like there was scar
tissue from prior surgery.
Dr. Ramshaw could not definitively say what caused plaintiff's
pain.
Plaintiff's expert, Dr. Robert Bendavid, was deposed. The
doctor was not offered as a Food and Drug Administration (FDA)
regulatory expert and did not opine as to the 3DMax specifically.
Dr. Bendavid offered no opinion as to whether the 3DMax was
appropriately marketed to physicians in the United States. Dr.
Bendavid agreed that the 3DMax was appropriate to use in some
cases, but not others. He opined that the use of synthetic
polypropylene should be used "judiciously."
Next Dr. Vladimir Iakovlev, another plaintiff's expert, was
deposed. Dr. Iakovlev, a pathologist, testified regarding his
criticism of polypropylene products in general. Dr. Iakovlev did
not offer opinions regarding the design of the 3DMax, an alternate
design, or whether defendants complied with any applicable
standard of care. In his report, Dr. Iakovlev concluded the 3DMax
caused plaintiff's pain and testicular symptoms.
A third plaintiff's expert, Dr. Kevin Petersen, was also
deposed. Dr. Petersen offered no criticism about the 3DMax and
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had no opinion about whether the 3DMax was appropriately designed
or manufactured. Dr. Peterson did not have an opinion about
whether plaintiff would have experienced a different outcome if
another mesh product was used. Dr. Petersen stated in his expert
report that the 3DMax was the cause of plaintiff's complications,
and that a hernia repair without mesh would have been the better,
safer option and would have avoided the risks associated with the
3DMax.
On February 18, 2016, after hearing oral argument, the trial
court granted summary judgment to defendants and dismissed
plaintiff's complaint. The court explained the reasons for its
ruling in a written opinion issued with its order. On the design
defect claim, the court found that plaintiff produced no evidence
that the 3DMax was defectively designed. As to defendant's claim
of negligence, the court found plaintiff had presented no proof
on the standard of care. In addition, the court held plaintiff
did not demonstrate that the proximate cause of plaintiff's injury
was the use of the 3DMax. Rather, the court held plaintiff's
proofs supported the mere possibility, rather than a reasonable
probability, that the 3DMax proximately caused plaintiff's
injuries.
Plaintiff raises the following issues on appeal:
6 A-3280-15T1
POINT I
THE LAW DIVISION ERRED IN GRANTING SUMMARY
JUDGMENT TO DEFENDANTS ON PLAINTIFF'S DESIGN
DEFECT CLAIM.
1. Plaintiff Established Specific
Factual Disputes about the
Existence of a 3DMax Mesh Design
Defect.
2. Plaintiff Established Specific
Factual Disputes Material to
Plaintiff's Proof of Proximate
Causation.
POINT II
THE LAW DIVISION PLAINLY ERRED IN GRANTING
SUMMARY JUDGMENT ON PLAINTIFF'S NEGLIGENCE
CLAIM.
1. The Law Division Erred in
Holding That Plaintiff Cannot
Satisfy the Standard of Care Element
as Matter of Law.
2. The Law Division Erred in
Holding That Plaintiff Cannot
Satisfy the Proximate Cause Element
for Negligence as Matter of Law.
We first address plaintiff's arguments regarding the design
defect claim. Pursuant to the agreement of the parties, as did
the trial court, we apply Georgia law.
"An appellate court reviews an order granting summary
judgment in accordance with the same standard as the motion
judge." Bhagat v. Bhagat,
217 N.J. 22, 38 (2014) (citing W.J.A.
v. D.A.,
210 N.J. 229 237-38 (2012)). We "must review the
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competent evidential materials submitted by the parties to
identify whether there are genuine issues of material fact and,
if not, whether the moving party is entitled to summary judgment
as a matter of law." Ibid. (citing Brill v. Guardian Life Ins.
Co.,
142 N.J. 520, 540 (1995)); see also R. 4:46-2(c).
We consider all facts in the light most favorable to
plaintiff, the non-movant, Robinson v. Vivirito,
217 N.J. 199, 203
(2014), keeping in mind "[a]n issue of fact is genuine only if,
considering the burden of persuasion at trial, the evidence
submitted by the parties on the motion, together with all
legitimate inferences therefrom favoring the non-moving party,
would require submission of the issue to the trier of
fact." R. 4:46-2(c). "The practical effect of this rule is that
neither the motion court nor an appellate court can ignore the
elements of the cause of action or the evidential standard
governing the cause of action." Bhagat,
217 N.J. at 38.
Since the grant of summary judgment calls for a review of the
"trial court's interpretation of the law and the legal consequences
that flow from established facts," the trial court's decision is
"not entitled to any special deference," and is subject to de novo
review. Manalapan Realty, LP v. Twp. Comm.,
140 N.J. 366, 378
(1995) (citation omitted).
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Plaintiff argues that summary judgment was improperly granted
as to his design defect claim and the court improperly weighed the
competing evidence presented. Plaintiff contends his experts
opined that the risks of the 3DMax outweighed the benefits, and
thus plaintiff satisfied his burden of proof. We disagree.
Under Georgia law, the three types of product defects are
manufacturing, design, and marketing/packaging defects. S K Hand
Tool Corp. v. Lowman,
479 S.E.2d 103, 106 (Ga. Ct. App. 1996). To
recover on a design defect claim, the plaintiff must establish:
(1) the product's design is defective, and (2) the defective design
caused the plaintiff's injuries. In re Mentor Corp. ObTape
Transobturator Sling Prods. Liab. Litig.,
711 F. Supp. 2d 1348,
1364 (M.D. Ga. 2010). The standard the trier of fact uses to
determine defectiveness in design defect cases, under a strict
liability cause of action, is a "risk-utility" test. S K Hand
Tool Corp.,
479 S.E 2d at 106. The "risk-utility" test "set[s]
out a non-exhaustive list of factors for a jury to consider in a
balancing analysis of whether a product is defective." Ibid.
Essentially, the test is a balancing test where the risks inherent
in the product design are weighed against the benefits. Banks v.
Ici Ams.,
450 S.E.2d 671, 673-74 (Ga. 1994); Dean v. Toyota Indus.
Equip. Mfg.,
540 S.E.2d 233, 237 (Ga. Ct. App. 2000). Therefore,
9 A-3280-15T1
[t]his risk-utility analysis incorporates the
concept of "reasonableness," i.e., whether the
manufacturer acted reasonably in choosing a
particular product design, given the
probability and seriousness of the risk posed
by the design, the usefulness of the product
in that condition, and the burden on the
manufacturer to take the necessary steps to
eliminate the risk.
[Banks,
450 S.E 2d at 673.]
An important factor to consider in the balancing test is the
availability of alternative designs that may be safer. Id. at
674. Other factors, although not exclusive, include:
the usefulness of the product; the gravity and
severity of the danger posed by the design;
the likelihood of that danger; the
avoidability of the danger, i.e., the user's
knowledge of the product, publicity
surrounding the danger, or the efficacy of
warnings, as well as common knowledge and the
expectation of danger; the user's ability to
avoid danger; the state of the art at the time
the product is manufactured; the ability to
eliminate danger without impairing the
usefulness of the product or making it too
expensive; and the feasibility of spreading
the loss in the setting of the product's price
or by purchasing insurance.
[Id. at 675 n.6.]
Factors that concern the beneficial aspects of the product include:
"the appearance and aesthetic attractiveness of the product; its
utility for multiple uses; the convenience and extent of its use
. . . ; and the collateral safety of a feature other than the one
that harmed the plaintiff." Ibid.
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"In general, weighing the risk-utility factors is left to the
jury." In re Mentor,
711 F. Supp. 2d at 1365. Thus, "[t]o prevail
at summary judgment, a defendant must 'show plainly and
indisputably an absence of any evidence that a product as designed
is defective.'" Ibid. (alteration in original) (quoting Ogletree
v. Navistar Int'l Transp. Corp.,
522 S.E.2d 467, 470 (Ga. 1999)).
In the instant case, none of the experts specifically opined
that the 3DMax is defective and that this defective design caused
the medical complications complained of by the plaintiff. Instead,
plaintiff’s three experts gave general opinions about the various
medical risks of the product that can cause complications. This
is not enough to overcome the summary judgment standard. See
Brill,
142 N.J. 520 (1995).
In addition, no expert presented an alternative, feasible
design for the 3DMax. As previously stated, this is one of the
determining factors in a defective design case. Banks,
450 S.E 2d at 674. For instance, Dr. Iakovlev testified:
Q: And you're not going to say that if there
had been some different design for the
3DMax Product, that a patient would have
had a different clinical outcome, correct?
A: That's correct.
Further, Dr. Petersen testified:
11 A-3280-15T1
Q: You are not offering anything about how
tissue-based products are better in
general, are you?
A: No.
Q: And you are actually not offering any
specific opinions about some sort of
adjustment or change in the specific design
of the PerFix Plug that would have avoided a
risk of what you considered to be chronic
disabling pain, correct?
A: Yes.
Q: You're not doing that?
A: I'm not doing that.
Q: . . . For the 3DMax product, you're not
offering any opinion that there was some
change in the design or configuration of the
product that would have avoided or minimized
the risk of what you think is chronic or
disabling pain, correct?
A: Correct.
In the absence of the requisite proof that the 3DMax was
defectively designed, plaintiff's claim on this score fails. Given
this failure of proof, it follows that plaintiff's proximate
causation argument is rendered moot.
We next address plaintiff's negligence claim. Plaintiff
asserts the court erred in holding plaintiff did not satisfy its
burden of proof on his negligent warning claim. Plaintiff argues
the court erred in weighing the evidence and that it applied the
wrong standard of care. Specifically, plaintiff argues his experts
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did not have to opine as to the standard of care because Georgia
law does not require expert testimony as to defendants’ standard
of care. We disagree.
The court held that plaintiff's negligence claims failed as
"[p]laintiff's experts d[id] not opine as to the standard of care
owed by [d]efendants and thus whether they breached it . . . ."
Similar to plaintiff's design defect claim, the court found that
plaintiff provided insufficient evidence to support the negligent
warning claim.
In order to establish a claim of negligence under Georgia
law, the following elements must be met:
(1) A legal duty to conform to a standard of
conduct raised by the law for the protection
of others against unreasonable risks of harm;
(2) a breach of this standard; (3) a legally
attributable causal connection between the
conduct and the resulting injury; and (4) some
loss or damage flowing to the plaintiff's
legally protected interest as a result of the
alleged breach of the legal duty.
[Heston v. Lilly,
546 S.E.2d 816, 818 (Ga.
Ct. App. 2001).]
Georgia law provides that in order to establish a failure to
warn claim, plaintiff must show: "the defendant had a duty to
warn, that the defendant breached that duty, and that the breach
proximately caused the plaintiff's injury." Dietz v. Smithkline
Beecham Corp.,
598 F.3d 812, 815 (11th Cir. 2010) (citing Wheat
13 A-3280-15T1
v. Sofamor, S.N.C.,
46 F. Supp. 2d 1351, 1362 (N.D. Ga. 1999)).
"Within the context of prescription drugs [or medical devices],
however, Georgia employs the learned intermediary doctrine, which
alters the general rule that imposes liability on a manufacturer
for failing to warn an end user of the known risks or hazards of
its products." Ibid. (citing Wheat,
46 F. Supp. 2d at 1363).
Under the learned intermediary doctrine, the manufacturer of:
a . . . medical device does not have a duty
to warn the patient of the dangers involved
with the product, but instead has a duty to
warn the patient's doctor, who acts as a
learned intermediary between the patient and
the manufacturer. The rationale for the
doctrine is that the treating physician is in
a better position to warn the patient than the
manufacturer, in that the decision to employ
prescription medication [or medical devices]
involves professional assessment of medical
risks in light of the physician's knowledge
of a patient's particular need and
susceptibilities.
[McCombs v. Synthes,
587 S.E.2d 594, 595 (Ga.
2003).]
At the outset, we note that we are in agreement with the
trial court that jurors would lack the requisite knowledge,
training and experience to reach a determination relative to the
standard of care absent expert testimony. Here, none of
plaintiff's experts offered an opinion on the standard of care or
whether that standard was breached. During his deposition, Dr.
Iakovlev testified:
14 A-3280-15T1
Q: You're not going to offer any opinions
about whether Davol complied with any standard
of care applicable to a medical device
manufacturer, are you?
A: No, I'm not going to offer that
opinion.
Although Dr. Petersen testified he believed the IFU should have
contained information about chronic pain, he testified that his
opinion on the IFU was general and could apply to any polypropylene
mesh product. Dr. Bendavid similarly testified he was not offering
an opinion of whether the instructions for the 3DMax were adequate
or appropriate.
Concerning the issue of a learned intermediary, during Dr.
Middleton's deposition, he testified:
Q: Has any mesh manufacturer ever told you
that infertility was a risk of implantation
of mesh?
. . . .
A: A mesh manufacturer has never told
me directly that infertility is a
possibility. As part of my training in
residency, I was made well aware that
infertility was a possibility associated
with this particular procedure.
Q: Okay. How about the risk of
dysejaculation?
A: Yes.
Q: From your training as well?
A: Yes, the same.
15 A-3280-15T1
Q: Okay. Were you aware from any material
from a manufacturer such as the instructions
for use or the warnings that nerves would grow
into the mesh and that could cause chronic
debilitating pain?
. . . .
A: I've never directly read through the
instructions of the manufacturer or
anything, but I'm well aware that that
is a possibility in this particular
procedure in my training.
Q: . . . Were you aware of these things that
we've previously discussed, these risks before
December of 2006?
A: Yes.
Notwithstanding, Dr. Middleton testified he went over the risks
of the mesh surgery with plaintiff prior to the surgery, including
the risk of chronic pain, numbness, hematoma, and mesh infection.
As plaintiff's physician, Dr. Middleton was serving in the
role of a learned intermediary. Despite the doctor's decision to
not read the manufacturer's warnings, that decision does not alter
his learned intermediary role nor does it impose liability on
defendants for failure to warn.
Having considered the motion record in conjunction with our
de novo standard of review, we discern no error in the holding
that defendants were entitled to summary judgment.
Affirmed.
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