The opinion
IN THE UNITED STATES DISTRICT COURT
FOR THE MIDDLE DISTRICT OF NORTH CAROLINA
CHRISTINA RENFROE, )
)
Plaintiff, )
)
v. ) 1:20CV362
)
ETHICON, INC. and )
JOHNSON & JOHNSON, )
)
Defendants. )
MEMORANDUM OPINION AND ORDER
LORETTA C. BIGGS, District Judge.
Plaintiff Christina Renfroe initiated this action in April 2020 alleging multiple violations
of North Carolina statutory and common law arising from injuries she suffered as a result of
the implantation of pelvic mesh products that were designed, manufactured, and marketed by
Defendants Ethicon, Inc. and Johnson & Johnson. (ECF No. 1.) Before the Court is
Defendants’ Partial Motion to Dismiss for failure to state a claim pursuant to Rule 12(b)(6) of
the Federal Rules of Civil Procedure. (ECF No. 8.) For the reasons stated below, the Court
grants Defendants’ motion in part and denies it in part.
I. BACKGROUND
According to Plaintiff, Defendants have marketed and sold pelvic mesh products that
are designed to treat “medical conditions in the female pelvis, primarily pelvic organ prolapse
and stress urinary incontinence,” since at least 2002. (ECF No. 1 ¶¶ 13–19.) In March 2017,
one of these products was implanted in Plaintiff, and she alleges that, as a result, she “has
experienced significant mental and physical pain and suffering, has sustained permanent injury
and permanent and substantial physical deformity[,] and has suffered financial or economic
loss.” (Id. ¶¶ 20, 23.) Plaintiff contends that her experience is not an outlier but rather that
these products have “high failure, injury, and complication rates.” (Id. ¶ 26.) Nevertheless,
according to Plaintiff, Defendants have suppressed information related to their products’
performance, have failed to perform adequate testing, have failed to design a safe and effective
procedure for product removal, and have declined to provide adequate training and
information to physicians implanting such products. (Id. ¶¶ 27, 28, 29, 30, 33.)
On these allegations, Plaintiff originally brought eleven counts before the Court. (Id.
¶¶ 37–148.) These include: a failure to warn; negligence; negligent misrepresentation; design
defect; manufacturing defect; breach of express and implied warranty; violation of the North
Carolina Consumer Protection and Deceptive Business Practices Act; fraud; fraud by
concealment; and punitive damages. (Id.) Defendants now move to dismiss eight of these
claims, (ECF Nos. 8 at 1–2; 9 at 1), and Plaintiff has declined to oppose the dismissal of four
counts,1 (ECF No. 10 at 1 n.1). Accordingly, there are only four counts to be considered by
the Court at this time: Count I (a failure to warn); Count II (negligence); Count V
(manufacturing defect); and Count VII (breach of implied warranty). The parties agree that
each of these claims are governed by North Carolina law. (See ECF Nos. 9 at 3–4; 10 at 2 n.2.)
1 The Counts that Plaintiffs concede are Count III (negligent misrepresentation), Count VI (breach of express
warranty), Count IX (fraud), and Count X (fraud by concealment). (ECF No. 10 at 1 n.1.)
II. STANDARD OF REVIEW
A motion to dismiss under Rule 12(b)(6) “challenges the legal sufficiency of a
complaint,” including whether it meets the pleading standard of Rule 8(a)(2). See Francis v.
Giacomelli, 588 F.3d 186, 192 (4th Cir. 2009). Rule 8(a)(2) requires a complaint to contain “a
short and plain statement of the claim showing that the pleader is entitled to relief,” Fed. R.
Civ. P. 8(a)(2), thereby “giv[ing] the defendant fair notice of what the . . . claim is and the
grounds upon which it rests,” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007) (quoting
Conley v. Gibson, 355 U.S. 41, 47 (1957)). To survive a Rule 12(b)(6) motion to dismiss, “a
complaint must contain sufficient factual matter, accepted as true, to ‘state a claim to relief
that is plausible on its face.’” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Twombly, 550
U.S. at 570). In assessing a claim’s plausibility, a court must draw all reasonable inferences in
the plaintiff’s favor. Vitol, S.A. v. Primerose Shipping Co., 708 F.3d 527, 539 (4th Cir. 2013).
A claim is plausible when the complaint alleges facts that allow the court “to draw the
reasonable inference that the defendant is liable for the misconduct alleged.” Iqbal, 556 U.S.
at 678. However, “mere conclusory and speculative allegations” are insufficient, Painter’s Mill
Grille, LLC v. Brown, 716 F.3d 342, 350 (4th Cir. 2013), and a court “need not accept as true
unwarranted inferences, unreasonable conclusions, or arguments,” Vitol, 708 F.3d at 548
(quoting Jordan v. Alt. Res. Corp., 458 F.3d 332, 338 (4th Cir. 2006)). A complaint may fail to
state a claim upon which relief can be granted in two ways: first, by failing to state a valid legal
cause of action, i.e., a cognizable claim, see Holloway v. Pagan River Dockside Seafood, Inc., 669 F.3d
448, 452 (4th Cir. 2012); or second, by failing to allege sufficient facts to support a legal cause
of action, see Painter’s Mill Grille, 716 F.3d at 350.
III. DISCUSSION
1. Failure to Warn (Count I)
Plaintiff first alleges that “Defendants failed to properly and adequately warn and
instruct the Plaintiff and her health care providers as to the proper candidates, and the safest
and most effective methods of implantation and use of the Defendants’ Pelvic Mesh Product.”
(ECF No. 1 ¶ 38.) Under North Carolina law, “[n]o manufacturer or seller of a product shall
be held liable . . . for a claim based upon inadequate warning or instruction” unless three
elements are satisfied. See N.C. Gen. Stat. § 99B-5(a). First, a plaintiff must show that the
defendant “acted unreasonably in failing to provide such warning or instruction.” Id. Second,
the lack of adequate warning must have been “a proximate cause of the harm for which
damages are sought.” Id. Third, the defendant must or should have known that, absent a
warning, its product “created an unreasonably dangerous condition . . . to a reasonably
foreseeable claimant.” Id. Alternatively, this final element may be satisfied if a defendant
became aware of the risk and nevertheless “failed to take reasonable steps to give adequate
warning or instruction or to take other reasonable action under the circumstances.” Id.
Here, Plaintiff alleges each of these elements. First, she claims that Defendants were
unreasonable in failing to provide such a warning given their “inadequate research and testing”
of the products and “the complete lack of a safe, effective procedure for [their] removal.”
(ECF No. 1 ¶ 40.) Second, she alleges that she has been injured” in multiple ways “[a]s a
proximate result of Defendants’ design, manufacture, marketing, sale, and distribution” of the
products. (Id. ¶ 43.) Third, and finally, Plaintiff alleges that Defendants “intentionally,
recklessly, and maliciously misrepresented the safety, risks, and benefits” of these products,
thereby creating an unreasonably dangerous situation for those who would be implanted with
such products. (Id. ¶ 42.)
Though Defendants object to Plaintiff’s use of the phrase “strictly liable,” (see ECF No.
9 at 4 (citing ECF No. 1 ¶ 44)), Plaintiff nevertheless states her claim with sufficiency to
survive a motion to dismiss that does not depend upon a theory of strict liability. Accordingly,
the Court denies Defendants’ motion with regards to Count I.
2. Negligence (Count II)
“To state a common law negligence claim [in North Carolina], [a] plaintiff must show
(1) a legal duty; (2) a breach thereof; and (3) injury proximately caused by the breach.” Bridges
v. Parrish, 742 S.E.2d 794, 796 (N.C. 2013) (citation and internal quotation marks omitted).
Here, Plaintiff claims that that “Defendants had a duty to exercise reasonable and ordinary
care in the manufacture, labeling, instructions, warning, sale, marketing, and distribution” of
the products at issue. (ECF No. 1 ¶ 46.) She further alleges that Defendants breached that
duty when they “under-reported, underestimated[,] and downplayed the serious dangers” of
those products. (Id. ¶ 48.) Finally, she contends that “[a]s a proximate result” of this breach,
she “has been injured” in several ways. (Id. ¶ 51.)
Defendants argue only that “Plaintiff vaguely alleges that ‘Defendants breached their
duty of care to the Plaintiff . . . in the manufacture . . . [of] the Pelvic Mesh Product.” (ECF
No. 9 at 5 (citing ECF No. 1 ¶ 47) (alterations in the original).) This contention ignores the
totality of Plaintiff’s allegations, and the Court finds that the assertions discussed above state
a plausible claim to relief sufficient to withstand a motion to dismiss. Accordingly, the Court
denies the motion to dismiss Plaintiff’s negligence claim.
3. Manufacturing Defect (Count V)
To establish a product liability claim in North Carolina, a plaintiff must demonstrate
that “(1) the product was defective at the time it left the control of the defendant, (2) the defect
was the result of defendant’s negligence, and (3) the defect proximately caused plaintiff’s
damage.” Red Hill Hosiery Mill, Inc. v. MagneTek, Inc., 540 S.E.2d 321, 326 (N.C. Ct. App. 2000).
Here, Plaintiff has alleged that the products “implanted in Plaintiff were not reasonably safe
at the time [they] left control of the Defendants.” (ECF No. 1 ¶ 78.) As discussed in more
detail above, Plaintiff has also sufficiently alleged that the defect was the result of negligence
on the part of Defendants. (See, e.g., ECF No. 1 ¶ 29 (“Defendants failed to perform or rely
on proper and adequate testing and research in order to determine and evaluate the risks and
benefits of the Defendants’ Pelvic Mesh Product.”) Further, Plaintiff alleges that she has been
injured “[a]s a proximate result of Defendants’ conduct.” (Id. ¶ 79.)
Defendants take issue with what they call “bare legal conclusions” with “absolutely no
factual support,” (ECF No. 9 at 5), yet this argument ignores the comprehensive set of facts
alleged throughout the Complaint that this count incorporates. As discussed above, Plaintiff
has contended that the product defects caused harm in multiple ways, and these allegations
are sufficient to state a plausible claim under federal pleading standards. (See, e.g., ECF No. 1
¶¶ 34–35 (noting that the product “implanted into the Plaintiff was in the same or substantially
similar condition as it was when it left the possession of Defendants” and that Plaintiff
subsequently suffered “mesh erosion, mesh contraction, infection,” and several other serious
injuries following implantation).) Accordingly, the Court denies Defendants’ motion to
dismiss with regards to Plaintiff’s manufacturing defect claim.
4. Breach of Implied Warranty (Count VII)
The final count that Defendants move to dismiss is the breach of implied warranty.
They challenge this claim in two ways. First, they contend that it “should be dismissed for
lack of pre-suit notice.” (ECF No. 9 at 6.) In support of this claim, Defendants point to a
North Carolina statute which states that a plaintiff asserting a claim for breach of warranty
“must within a reasonable time after [s]he discovers or should have discovered the breach
notify the seller of the breach or be barred from any remedy.” (Id. (citing N.C. Gen. Stat. § 25-
2-607(3)(a)).) Further, Defendants contend that “Plaintiff does not allege that she provided
Defendants notice of the alleged breach of warranty prior to filing the instant action, and thus,
her [implied warranty claim] must be dismissed.” (Id.) However, as Plaintiff points out, “when
the plaintiff is a lay consumer and notification is given to the defendant by the filing of an
action within the period of the statute of limitations,” this requirement is satisfied. Horne v.
Novartis Pharms. Corp., 541 F. Supp. 2d 768, 786 (W.D.N.C. 2008) (quoting Maybank v. S.S.
Kresge Co., 273 S.E.2d 681, 685 (N.C. 1981)). Accordingly, the Court finds that Plaintiff has
satisfied the requirements of notice under North Carolina law.
Next, Defendants argue that the breach of implied warranty of fitness for a particular
purpose “fails because it is undisputed that [the product] was sold and implanted for its
ordinary purpose—to treat urinary incontinence.” (ECF No. 9 at 7 (citing ECF No. 1 ¶ 103).)
Under North Carolina law, when a “seller at the time of contracting has reason to know any
particular purpose for which the goods are required and the buyer is relying on the seller’s skill
or judgment to select of furnish goods,” there is “an implied warranty that the goods shall be
fit for such purpose.” N.C. Gen. Stat. § 25-2-315. That said, “ordinary, intended use prevents
recovery under the implied warranty of fitness for a particular purpose as a matter of law.”
McDonald Bros., Inc. v. Tinder Wholesale, LLC, 395 F. Supp. 2d 255, 266 (M.D.N.C. 2005) (citing
Halprin v. Ford Motor Co., 420 S.E.2d 686, 691 (N.C. Ct. App. 1992)).
Here, Plaintiff does not allege that the use of the products at issue were anything other
than what was originally intended by Defendants. Though she has certainly relied on their
expertise, such a claim more readily falls under a theory of an implied warranty of
merchantability, which Plaintiff has also claimed under the same count. (See ECF Nos. 1 ¶ 97
(“Defendants impliedly warranted the product to be of merchantable quality, safe[,] and fit for
such use.”); 10 at 7 n.3 (“Count VII of Plaintiff’s Complaint asserts claims for breach of
implied warranty of fitness for a particular purpose and breach of implied warranty of
merchantability.”).) Accordingly, Defendants’ Motion to Dismiss with regards to Count VII
is granted as to Plaintiff’s claim of implied warranty of fitness for a particular purpose only,
and it is denied as to any other claim in that count.
For these reasons, the Court enters the following:
ORDER
IT IS THEREFORE ORDERED that Defendants’ Rule 12(b)(6) Partial Motion to
Dismiss, (ECF No. 8), is GRANTED IN PART AND DENIED IN PART.
The motion is GRANTED with respect to Counts III, VI, IX, and X. Those claims
are hereby DISMISSED WITH PREJUDICE.
The motion is further GRANTED with respect to Count VII only as to the claim of
implied warranty of fitness for a particular purpose, however it is DENIED as to all other
claims in that Count.
The motion is additionally DENIED with respect to Counts I, II, and V.
This, the 30th day of March 2021.
/s/ Loretta C. Biggs
United States District Judge