United States District Court, S.D. West Virginia, Charleston Division
December 21, 2016
JOYCE JUSTUS, Plaintiff,
ETHICON, INC., ET AL., Defendant.
MEMORANDUM OPINION AND ORDER (DEFENDANTS' MOTION
FOR SUMMARY JUDGMENT)
R. GOODWIN UNITED STATES DISTRICT JUDGE.
before the court is a Motion for Summary Judgment [ECF No.
115] filed by defendants Ethicon, Inc. and Johnson &
Johnson (collectively “Ethicon”) against
plaintiff Joyce Justus. As set forth below, the
defendants' Motion is GRANTED in part and DENIED in part.
case resides in one of seven MDLs assigned to me by the
Judicial Panel on Multidistrict Litigation concerning the use
of transvaginal surgical mesh to treat pelvic organ prolapse
(“POP”) and stress urinary incontinence
(“SUI”). In the seven MDLs, there are more than
58, 000 cases currently pending, approximately 28, 000 of
which are in the Ethicon MDL. In an effort to efficiently and
effectively manage this massive MDL, the court decided to
conduct pretrial discovery and motions practice on an
individualized basis so that once a case is trial-ready (that
is, after the court has ruled on all summary judgment
motions, among other things), it can then be promptly
transferred or remanded to the appropriate district for
trial. To this end, the court ordered the plaintiffs and
defendant to submit a joint list of 200 of the oldest cases
in the Ethicon MDL that name only Ethicon, Inc., Ethicon,
LLC, and/or Johnson & Johnson. These cases became part of
a “wave” of cases to be prepared for trial and,
if necessary, remanded. See Pretrial Order No. 193,
In re Ethicon, Inc. Pelvic Repair Sys. Prods. Liab.
Litig., No. 2:12-md-002327, Aug. 19, 2015, available
Plaintiff's case was selected as a Wave 1 case.
Justus was surgically implanted with Prolift on April 29,
2008 at Mission Hospital in Asheville, North Carolina by
Doctor Nancy S. Howden. Am. Short Form Compl. ¶¶
9-12 [ECF. No. 21]. She is a resident of North Carolina.
Id. ¶ 4. Ethicon moves for summary judgment on
all of Ms. Justus' substantive claims. Defs.' Mem.
Supp. Mot. Summ. J. 1 [ECF No. 116].
obtain summary judgment, the moving party must show that
there is no genuine dispute as to any material fact and that
the moving party is entitled to judgment as a matter of law.
Fed. R. Civ. P. 56(a). In considering a motion for
summary judgment, the court will not “weigh the
evidence and determine the truth of the matter.”
Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 249
(1986). Instead, the court will draw any permissible
inference from the underlying facts in the light most
favorable to the nonmoving party. Matsushita Elec. Indus.
Co. v. Zenith Radio Corp., 475 U.S. 574, 587-88 (1986).
the court will view all underlying facts and inferences in
the light most favorable to the nonmoving party, the
nonmoving party nonetheless must offer some “concrete
evidence from which a reasonable juror could return a verdict
in his [or her] favor.” Anderson, 477 U.S. at
256. Summary judgment is appropriate when the nonmoving party
has the burden of proof on an essential element of his or her
case and does not make, after adequate time for discovery, a
showing sufficient to establish that element. Celotex
Corp. v. Catrett, 477 U.S. 317, 322-23 (1986). The
nonmoving party must satisfy this burden of proof by offering
more than a mere “scintilla of evidence” in
support of his or her position. Anderson, 477 U.S.
at 252. Likewise, conclusory allegations or unsupported
speculation, without more, are insufficient to preclude the
granting of a summary judgment motion. See Dash v.
Mayweather, 731 F.3d 303, 311 (4th Cir. 2013); Stone
v. Liberty Mut. Ins. Co., 105 F.3d 188, 191 (4th Cir.
Choice of Law
28 U.S.C. § 1407, this court has authority to rule on
pretrial motions in MDL cases such as this. The choice of law
for these pretrial motions depends on whether they involve
federal or state law. “When analyzing questions of
federal law, the transferee court should apply the law of the
circuit in which it is located. When considering questions of
state law, however, the transferee court must apply the state
law that would have applied to the individual cases had they
not been transferred for consolidation.” In re
Temporomandibular Joint (TMJ) Implants Prods. Liab.
Litig., 97 F.3d 1050, 1055 (8th Cir. 1996) (internal
citations omitted). In cases based on diversity jurisdiction,
the choice-of-law rules to be used are those of the states
where the actions were originally filed. See In re Air
Disaster at Ramstein Air Base, Ger., 81 F.3d 570, 576
(5th Cir. 1996) (“Where a transferee court presides
over several diversity actions consolidated under the
multidistrict rules, the choice of law rules of each
jurisdiction in which the transferred actions were originally
filed must be applied.”); In re Air Crash Disaster
Near Chi., Ill., 644 F.2d 594, 610 (7th Cir. 1981);
In re Digitek Prods. Liab. Litig., No.
2:08-md-01968, 2010 WL 2102330, at *7 (S.D. W.Va. May 25,
plaintiff files her claim directly into the MDL in the
Southern District of West Virginia, however, I consult the
choice-of-law rules of the state in which the implantation
surgery took place. See Sanchez v. Boston Scientific
Corp., 2:12-cv-05762, 2014 WL 202787, at *4 (S.D. W.Va.
Jan. 17, 2014) (“For cases that originate elsewhere and
are directly filed into the MDL, I will follow the
better-reasoned authority that applies the choice-of-law
rules of the originating jurisdiction, which in our case is
the state in which the plaintiff was implanted with the
product.”). Ms. Justus filed this case in the Western
District of North Carolina and it was transferred to the
Southern District of West Virginia by order of the United
States Judicial Panel on Multidistrict Litigation.
Conditional Transfer Order [ECF No. 3]. Thus, the
choice-of-law principles of North Carolina guide this
court's choice-of-law analysis.
parties agree, as does this court, that these principles
compel application of North Carolina law. For tort claims,
North Carolina generally applies the lex loci
delicti approach, which provides that “the state
where the injury occurred is considered the situs of the
claim.” Harco Nat'l Ins. Co. v. Grant Thornton
LLP, 698 S.E.2d 719, 722-23 ( N.C. Ct. App. 2010). Here,
the alleged injury occurred in North Carolina, where Ms.
Justus was implanted with the allegedly defective device.
Thus, I apply North Carolina's substantive law to the
tort claims in this case. For warranty claims, North Carolina
applies the “most significant relationship”
approach, which “requires the forum to determine which
state has the most significant relationship to the
case.” Boudreau v. Baughman, 368 S.E.2d 849,
853-54 ( N.C. 1988). North Carolina courts have found that
“the place of sale, distribution, delivery, and use of
the product, as well as the place of injury . . . to be the
state with the most significant relationship to the warranty
claims.” Id. at 855-56. Thus, I also apply
North Carolina's substantive law to the warranty claims
in this case.
moves for summary judgment on all of the plaintiff's
substantive claims. Ms. Justus does not contest this motion
with regard to strict products liability,  negligent
manufacturing, negligent misrepresentation, negligent
infliction of emotional distress, breach of implied warranty
for a particular purpose, unjust enrichment, common law
fraud, fraudulent concealment, and constructive fraud.
Pl.'s Mem Supp. Resp. 4 n.2 [ECF No. 130]. Ethicon's
Motion for Summary Judgment is GRANTED as to
Justus opposes Ethicon's motion with regard to
negligence, negligent failure to warn, negligent design,
breach of express warranty, breach of implied warranty of
merchantability, violation of consumer protection laws, and
gross negligence. Below, I apply the summary judgment
standard to each remaining claim.
Negligent Failure to Warn
North Carolina law, “[n]o manufacturer . . . shall be
held liable in any product liability action for a claim based
upon inadequate warning or instruction unless the
claimant” can satisfy three requirements. N.C. Gen.
Stat. § 99B-5(a). First, the claimant must establish
“that the manufacturer . . . acted unreasonably in
failing to provide such warning or instruction.”
Id. Second, the claimant must establish “that
the failure to provide adequate warning or instruction was a
proximate cause of the harm for which damages are
sought.” Id. Finally, the claimant must
establish either of the following:
(1) At the time the product left the control of the
manufacturer . . ., the product, without an adequate warning
or instruction, created an unreasonably dangerous condition
that the manufacturer . . . knew, or in the exercise of
ordinary care should have known, posed a substantial risk of
harm to a reasonably foreseeable claimant[; or] (2) After the
product left the control of the manufacturer . . ., the
manufacturer or seller became aware of or in the exercise of
ordinary care should have known that the product posed a
substantial risk of harm to a reasonably foreseeable user or
consumer and failed to take reasonable steps to give adequate
warning or instruction or to take other reasonable action
under the circumstances.
argues that, under subsection (c) of the same statute, the
learned intermediary doctrine shields it from liability.
Defs.' Mem. Supp. Mot. Summ. J. 9 (citing N.C. Gen. Stat.
§ 99B-5(c)). Subsection (c) provides:
“[N]o manufacturer or seller of a prescription drug
shall be liable in a products liability action for failing to
provide a warning or instruction directly to a consumer if an
adequate warning or instruction has been provided to the
physician or other legally authorized person who prescribes
or dispenses that prescription drug for the claimant . . .
N.C. Gen. Stat. § 99B-5(c).
am not persuaded that the plain language of subsection (c)
provides the basis for application of the learned
intermediary doctrine to the instant case, “[t]here are
indications that North Carolina courts would adhere to the
learned intermediary doctrine” in matters of product
liability. Baraukas v. Danek Med., Inc., No.
6:97CV00613, 2000 WL 223508, at *4 (M.D. N.C. Jan. 13, 2000)
(citing Foyle ex rel. McMillan v. Lederle
Labs., 674 F.Supp. 530, 535-36 (E.D. N.C. 1987)). In
fact, in Baraukas, the United States District Court
for the Middle District of North Carolina determined that the
learned intermediary doctrine applied where the manufacturer
warned the plaintiff's physician about bone screws.
Id. Accordingly, consistent with the courts that
have addressed this issue before me, I assess Ms. Justus'
negligent failure to warn claim under the learned
FIND that genuine disputes of material fact exist with regard
to: (1) whether Ethicon's warning was adequate; and (2)
whether the alleged inadequate warning proximately caused the
alleged harm to Ms. Justus. Therefore, Ethicon's Motion
for Summary Judgment on the plaintiff's negligent failure
to warn claim is DENIED.
North Carolina law, a plaintiff alleging inadequate design
first must prove “that at the time of its manufacture
the manufacturer acted unreasonably in designing or
formulating the product, [and] that this conduct was a
proximate cause of the harm for which damages are sought . .
. .” N.C. Gen. Stat. § 99B-6(a). To determine
whether Ethicon acted unreasonably in designing the Prolift,
North Carolina requires that the following factors be
(1) The nature and magnitude of the risks of harm associated
with the design or formulation in light of the intended and
reasonably foreseeable uses, modifications, or alterations of
the product[;] (2) The likely awareness of product users,
whether based on warnings, general knowledge, or otherwise,
of those risks of harm[;] (3) The extent to which the design
or formulation conformed to any applicable government
standard that was in effect when the product left the control
of its manufacturer[;] (4) The extent to which the labeling
for a prescription or nonprescription drug approved by the
United States Food and Drug Administration conformed to any
applicable government or private standard that was in effect
when the product left the control of its manufacturer[;] (5)
The utility of the product, including the performance,
safety, and other advantages associated with that design or
formulation[;] (6) The technical, economic, and practical
feasibility of using an alternative design or formulation at
the time of manufacture[;] (7) The nature and magnitude of
any foreseeable risks associated with the alternative design
Id. § 99B-6(b). Additionally, a plaintiff must
prove one of the following:
(1) At the time the product left the control of the
manufacturer, the manufacturer unreasonably failed to adopt a
safer, practical, feasible, and otherwise reasonable
alternative design or formulation that could then have been
reasonably adopted and that would have prevented or
substantially reduced the risk of harm without substantially
impairing the usefulness, practicality, or desirability of
the product[; or] (2) At the time the product left the
control of the manufacturer, the design or formulation of the
product was so unreasonable that a reasonable person, aware
of the relevant facts, would not use or consume a product of
Id. § 99B-6(a).
FIND that genuine disputes of material fact
exist with regard to: (1) whether Ethicon acted unreasonably
in designing the Prolift; and (2) whether Ethicon
unreasonably failed to adopt a safer, practical, feasible,
and otherwise reasonable alternative design, or whether the
design or formulation of the product was so unreasonable that
a reasonable person, aware of the relevant facts, would not
use it. Therefore, Ethicon's Motion for Summary Judgment
on the plaintiff's negligent design claim is
Breach of Express Warranty
North Carolina law:
(1) Express warranties by the seller are created as follows:
(a) Any affirmation of fact or promise made by the seller to
the buyer which relates to the goods and becomes part of the
basis of the bargain creates an express warranty that the
goods shall conform to the affirmation or promise.
(b) Any description of the goods which is made part of the
basis of the bargain creates an express warranty that the
goods shall conform to the description.
(c) Any sample or model which is made part of the basis of
the bargain creates an express warranty that the whole of the
goods shall conform to the sample or model.
(2) It is not necessary to the creation of an express
warranty that the seller use formal words such as
“warrant” or “guarantee” or that he
have a specific intention to make a warranty, but an
affirmation merely of the value of the goods or a statement
purporting to be merely the seller's opinion or
commendation of the goods does not create a warranty.
N.C. Gen. Stat. § 25-2-313. Accordingly, any actionable
express warranty under North Carolina law must turn on a
statement that is the “basis of the bargain.”
North Carolina law provides that a plaintiff need not prove
contractual privity for her express warranty claim to
survive. Alberti v. Manufactured Homes, Inc., 407
S.E.2d 819, 825 ( N.C. 1991) (“[O]ur case law has
recognized that a direct contractual relationship in the sale
of the product itself is not a prerequisite to recovery for
breach of express warranty against the manufacturer.”)
Ms. Justus relied only on Dr. Howden's medical judgment
in deciding to have the Prolift implanted, a reasonable juror
could find that Ms. Justus relied on the express warranties
of Ethicon as they were provided to Dr. Howden, which formed
the basis for Dr. Howden's medical judgment. Cf.
Michael v. Wyeth, LLC, No. CIV.A. 2:04-0435, 2011 WL
2150112, at *9 (S.D. W.Va. May 25, 2011) (denying summary
judgment on breach of express warranty because even though
“plaintiff testified that she did not rely on any
statements made by defendants . . . she did rely upon her
doctors' recommendations, ” and as a result,
“a presumption arises that [manufacturer's]
affirmations were at least part of the ‘basis of the
bargain' that led plaintiff to ingest [the]
drugs”); Forst v. SmithKline Beecham Corp.,
602 F.Supp.2d 960, 972 (E.D. Wis. 2009) (denying summary
judgment on express warranty claim where plaintiff did not
read drug manufacturer's labeling but relied upon
doctor's recommendations, and holding that “a
reasonable jury could find that [defendant's]
representations to [doctor], which were then communicated to
the [plaintiffs], constitute an affirmation forming a
‘basis of the bargain' for [plaintiff's] use of
Paxil.”); Knipe v. Smith Kline Beecham, 583
F.Supp.2d 602, 625 (E.D. Pa. 2008) (same).
FIND that genuine disputes of material fact exist with regard
to: (1) whether an express warranty was made; and (2) whether
Dr. Howden, the implanting physician, relied on the express
warranty as the “basis of the bargain.”
Therefore, Ethicon's Motion for Summary Judgment on the
plaintiff's breach of express warranty claim is DENIED.
Breach of Implied Warranty of Merchantability
North Carolina law, “a warranty that the goods shall be
merchantable is implied in a contract for their sale if the
seller is a merchant with respect to goods of that
kind.” N.C. Gen. Stat. § 25-2-314(1). For a good
to be “merchantable, ” it must
(a) pass without objection in the trade under the contract
description; and (b) . . . [be] of fair average quality
within the description; and (c) [be] fit for the ordinary
purposes for which such goods are used; and (d) run, within
the variations permitted by the agreement, of even kind,
quality and quantity within each unit and among all units
involved; and (e) [be] adequately contained, packaged, and
labeled as the agreement may require; and (f) conform to the
promises or affirmations of fact made on the container or
label if any.
Id. § 25-2-314(2). To establish a claim for
breach of implied warranty of merchantability, the plaintiff
must demonstrate: “(1) the goods bought and sold were
subject to an implied warranty of merchantability, (2) the
goods were defective at the time of the sale, (3) the
defective nature of the goods caused plaintiff's injury,
and (4) damages were suffered as a result.” Goodman
v. Wenco Foods, Inc., 423 S.E.2d 444, 454 ( N.C. 1992).
a reasonable juror could determine that Ethicon negligently
designed the Prolift, see supra Section III.B, a
reasonable juror could likewise find that Ethicon breached
the implied warranty of merchantability. See N.C.
Gen. Stat. § 25-2-314(2)(b). Therefore, Ethicon's
Motion for Summary Judgment on the plaintiff's breach of
implied warranty of merchantability claim is DENIED.
Violation of Consumer Protection Laws
Justus alleges a violation of North Carolina's Unfair and
Deceptive Trade Practices Act (“UDTPA”), which
governs unfair and deceptive claims. “In order to
establish a prima facie claim for unfair trade
practices, a plaintiff must show: (1) [the] defendant
committed an unfair or deceptive act or practice, (2) the
action in question was in or affecting commerce, and (3) the
act proximately caused injury to the plaintiff.”
Bumpers v. Cmty. Bank of N. Va., 747 S.E.2d 220, 226
(2013) (alteration in original) (quoting Dalton v.
Camp, 548 S.E.2d 704, 711 (2001)); see also
N.C. Gen. Stat. § 75-1.1. To show proximate cause in a
claim stemming from misrepresentation, a plaintiff must
demonstrate reliance on the misrepresentation.
Bumpers 747 S.E.2d at 88. “Whether a trade
practice is unfair or deceptive usually depends upon the
facts of each case and the impact the practice has in the
marketplace.” Marshall v. Miller, 276 S.E.2d
397, 403 (1981) (citation omitted). “[T]here is no
explicit statutory requirement of a showing of bad faith . .
. [and] the intent or good faith belief of the actor is
moves for summary judgment on Ms. Justus' UDTPA claim,
arguing that she cannot show proximate cause because she
testified that she did not rely on information in any
brochures in deciding to use the Prolift. Ms. Justus puts
forth evidence that Ethicon actively withheld facts from her.
I FIND that there are material questions of fact as to (1)
whether Ethicon committed an unfair or deceptive act or
practice, and (2) proximate causation. Therefore,
Ethicon's Motion for Summary Judgment on the
plaintiff's consumer protection claim is DENIED.
North Carolina Supreme Court has said the following with
regard to ordinary negligence and gross negligence:
[T]he difference between the two is not in degree or
magnitude of inadvertence or carelessness, but rather is
intentional wrongdoing or deliberate misconduct affecting the
safety of others. An act or conduct rises to the level of
gross negligence when the act is done purposely and with
knowledge that such act is a breach of duty to others, i.e.,
a conscious disregard of the safety of others. An act or
conduct moves beyond the realm of negligence when the injury
or damage itself is intentional.
Yancey v. Lea, 550 S.E.2d 155, 158 ( N.C. 2001)
(emphasis omitted) (citing Brewer v. Harris, 182
S.E.2d 345, 350 ( N.C. 1971)).
asserts, without elaboration, that Ms. Justus has not
presented sufficient evidence to establish the elements of
gross negligence. Ms. Justus asserts that there is a dispute
of fact as to Ethicon's conduct. Ethicon's Reply
acknowledges that Ms. Justus asserts Ethicon purposefully
withheld knowledge about complications associated with the
Prolift, but Ethicon argues that Ms. Justus cannot prove
the facts in the light most favorable to Ms. Justus, I FIND
that there is a material dispute of fact regarding the issue
of gross negligence. Therefore, Ethicon's Motion for
Summary Judgment on the plaintiffs gross negligence claim is
reasons discussed above, it is ORDERED that Ethicon's
Motion for Summary Judgment [ECF No. 115] is GRANTED in part
and DENIED in part. The Court DIRECTS the Clerk to send a
copy of this Order to counsel of record and any unrepresented
 The plaintiff's Amended Short Form
Complaint does not allege any strict liability claims. Am.
Short Form Compl. ¶ 13. However, Ethicon moves for
summary judgment to the extent that the plaintiff's
claims for failure to warn, manufacturing defect, and design
defect might be deemed to assert strict liability claims.
Defs.' Mot. Summ. J. ¶ 1. The plaintiff agrees that
she will not pursue claims based on strict liability.
Pl.'s Resp. ¶ 1 [ECF No. 129].
 Ethicon does not address Count XVII
(punitive damages) or Count XVIII (discovery and rule
tolling). I do not make any rulings as to those claims.
Ethicon challenges several specific claims sounding in
negligence, but plaintiff points out that Ethicon does not
separately challenge Count I (negligence). I do not make any
rulings as to any negligence claims beyond those discussed