Skinner v. Ethicon, Inc. et al
OPINION AND ORDER: granting in part and denying in part 9 Motion to Dismiss for Failure to State a Claim as follows: 1) the motion is GRANTED as to the strict-liability claim based on a design defect and as to the negligence claim based on the duty to exercise reasonable care in manufacturing. These claims are DISMISSED without prejudice; 2) the motion is GRANTED as to the negligence claim based on a breach of the duty to recall and the claims for negligence per se, breach of express a nd implied warranties, and violation of the KCPA. These claims are DISMISSED with prejudice; and 3) the motion is DENIED as to the strict liability claims based on a manufacturing defect and a failure to warn and as to the claim for negligent fail ure to warn. These three claims are the sole claims remaining in this action. The Court does not interpret the First Amended Complaint to assert any claims other than those addressed in this opinion. Signed by Judge Karen K. Caldwell on 2/18/21. (JLM)cc: COR
Case: 5:19-cv-00472-KKC Doc #: 12 Filed: 02/18/21 Page: 1 of 10 - Page ID#: 199
UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF KENTUCKY
CIVIL ACTION NO. 5:19-472-KKC
OPINION AND ORDER
ETHICON, INC. and
JOHNSON & JOHNSON,
*** *** ***
This matter is before the Court on the second motion to dismiss (DE 9) filed by
defendants Ethicon, Inc. and Johnson & Johnson (together, “Ethicon”). For the following
reasons, the motion will be granted in part and denied in part.
In its opinion on Ethicon’s prior motion to dismiss, the Court determined that
plaintiff Nelda Skinner had failed to set forth sufficient allegations in her complaint to
state any claim for relief. The Court permitted her to file an amended complaint
correcting the deficiencies. She has now filed the amended complaint. Ethicon argues that
the new complaint still fails to set forth sufficient allegations to state any claim.
With the amended complaint, Skinner alleges that Ethicon manufactures and sells
sutures that are sold under the brand name Vicryl. She alleges that she suffered personal
injuries as a direct result of “being implanted with” the sutures, which she alleges are
“defective and unreasonably dangerous.” (DE 8, Complaint, ¶4.) She alleges that, after
the sutures were implanted in her, she had to undergo another surgery to “repair the
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opened wounds and the dehiscence caused by the failure of the Vicryl sutures.” (DE 8,
Complaint, ¶10.) She alleges that the sutures were subject to a recall notice and that
Ethicon “knew or should have known there was a substantial likelihood of failed Ethicon
Vicryl sutures.” (DE 8, Complaint, ¶10.) She alleges that Ethicon nonetheless chose to
keep selling them. (DE 8, Complaint, ¶18.)
Ethicon moves pursuant to Federal Rule of Civil Procedure 12(b)(6) to dismiss
the complaint for failure to state any claim. In her cursory response, Skinner does not
point to the allegations in the complaint that support her specific claims. She asserts that
the specifics to support at least some of the claims will be determined during discovery.
This is insufficient.
A plaintiff cannot file suit and then claim that she will use discovery to obtain the
facts necessary to support it. New Albany Tractor, Inc. v. Louisville Tractor, Inc., 650
F.3d 1046, 1051 (6th Cir.2011). “Rule 8 marks a notable and generous departure from the
hyper-technical, code-pleading regime of a prior era, but it does not unlock the doors of
discovery for a plaintiff armed with nothing more than conclusions.” Ashcroft v. Iqbal,
556 U.S. 662, 678–79 (2009). The Sixth Circuit Court of Appeals “has rejected the
argument that a claim should survive a motion to dismiss on the basis that necessary
information is exclusively within the defendant's control, even in the context of the less
rigorous pleading requirements of the Federal Rule of Civil Procedure 8.” Chesbrough v.
VPA, P.C., 655 F.3d 461, 472 (6th Cir.2011) (citing New Albany Tractor, 650 F.3d at
1050–51). “[P]laintiff must allege specific facts . . . even if those facts are only within the
head or hands of the defendants. The plaintiff may not use the discovery process to obtain
these facts after filing suit.” New Albany Tractor, 650 F.3d at 1051.
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As it must, the Court will review each claim to determine if the amended
complaint sets forth sufficient allegations to support it.
Under Federal Rule of Civil Procedure 8(a)(2), a complaint need only contain “a
short and plain statement of the claim showing that the pleader is entitled to relief,” but
the complaint must assert enough facts to provide the defendant with “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) (citation and ellipsis omitted).
“While a complaint attacked by a Rule 12(b)(6) motion to dismiss does not need
detailed factual allegations, a plaintiff's obligation to provide the ‘grounds’ of his
‘entitlement to relief’ requires more than labels and conclusions, and a formulaic
recitation of the elements of a cause of action will not do.” Id. at 555 (citations and
internal brackets omitted). To survive a motion to dismiss, the factual allegations in the
complaint “must be enough to raise a right to relief above the speculative level.” Id. The
plaintiff must plead “enough facts to state a claim to relief that is plausible on its face”
and to nudge his claim “across the line from conceivable to plausible.” Id. at 570.
“A claim has facial plausibility when the plaintiff pleads factual content that
allows the court to draw the reasonable inference that the defendant is liable for the
misconduct alleged.” Iqbal, 556 U.S. at 678. The plaintiff must plead facts that allow for
“more than a sheer possibility that a defendant has acted unlawfully.” Id. “Where a
complaint pleads facts that are ‘merely consistent with’ a defendant's liability, it ‘stops
short of the line between possibility and plausibility of ‘entitlement to relief.’” Id.
(quoting Twombly, 550 U.S. at 557).
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Skinner mentions 10 types of claims in this latest complaint: strict liability based
on manufacturing defect (Count I); strict liability based on design defect (Count II); strict
liability based on a failure to warn (Count II); negligence in manufacturing (Count III);
negligent failure to recall/retrofit (Count III); negligent failure to warn (Count III);
negligence per se (Count IV); breach of express warranty (Count V); breach of implied
warranty (Count VI); and a violation of the Kentucky Consumer Protection Act, KRS
§ 367.170 et seq (Count VII). Ethicon asserts that defendants have failed to set forth
sufficient allegations to state any of these claims.
As to the first claim – strict liability based on a manufacturing defect –Ethicon
argues that this claim must be dismissed because the Skinner does not identify a specific
manufacturing defect. Skinner asserts, however, that the sutures were subject to a medical
device recall, which states that the sutures “exhibited suture damage due to a
manufacturing equipment issue” which could result in a “superficial wound dehiscence or
contribute to impaired wound healing.” (DE 8, Complaint ¶25.)
Ethicon asserts that nothing in the documents attached to Skinner’s complaint
indicates that the sutures used to treat her were subject to the recall notice. At this point,
however, the issue is whether Skinner has made sufficient allegations, not whether she
has documents that can support the allegations. She explicitly alleges that the sutures she
was treated with were subject to the recall notice, which indicated that the sutures were
damaged during manufacturing and that the damage caused the kinds of wounds she
alleges. (DE 8, Complaint ¶24.) Nothing in the documents she attaches to the complaint,
including the recall notice, contradicts that assertion.
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For her second claim – product liability based on design defect– Ethicon asserts
that this claim must be dismissed because Skinner does not allege how the suture design
was defective or how any design defect caused her injury. As discussed, the complaint
adequately alleges that the sutures were defective due to a manufacturing defect. In other
words, it alleges that the sutures were not manufactured in accordance with their
specifications. See Greene v. B.F. Goodrich Avionics Systems, Inc., 409 F.3d 784, 788
(6th Cir. 2005) (“Under Kentucky law, a manufacturing defect exists in a product when it
leaves the hands of the manufacturer in a defective condition because it was not
manufactured or assembled in accordance with its specifications.”)
While a complaint can plead alternative theories of liability, the complaint does
not allege any facts from which the Court could infer that, in addition to the sutures being
manufactured contrary to their specifications, the design for the sutures was also
defective. In Count II, Skinner simply makes the conclusory allegation that the sutures
were “defective.” (DE 8, Complaint, ¶¶ 34, 35.) In her response, she argues that she will
determine the design defect in discovery. As discussed above, this is not sufficient. This
claim will be dismissed without prejudice.
Instead of alleging a design defect, the allegations contained in count II of the
complaint are centered on the alleged failure to warn. Skinner alleges that the Ethicon
knew the Vicryl sutures “posed a significant and higher risk of failure than other similar
sutures” (DE 8, Complaint, ¶33), but it failed to adequately warn customers about the
risks. (DE 8, Complaint, ¶36.) She specifically alleges that Ethicon knew that the sutures
“[h]ad previously caused serious bodily injury to its users with special medical conditions
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such as those of plaintiff.” (DE 8, Complaint, ¶41(c)) This is sufficient to state a product
liability claim based on a failure to warn.
As to the negligence claim in Count III of the complaint, Skinner mentions three
duties: a duty to exercise care in manufacturing the sutures (DE 8, Complaint, ¶ 44); a
duty to recall and/or retrofit the sutures (DE 8, Complaint, ¶ 51); and a duty to adequately
warn of the sutures’ alleged dangers (DE 8, Complaint, ¶ 56). Ethicon argues that Skinner
has failed to allege a negligence claim based on any of these duties.
As to the duty to exercise care in manufacturing, Skinner makes conclusory
allegations that Ethicon failed to use reasonable care in the manufacturing of the sutures.
(DE 8, Complaint ¶ 45(b), (c)). These allegations are insufficient to support the claim.
She also alleges that Ethicon did not adopt manufacturing processes that could have
reduced the risk of the product failure and that it failed to establish an adequate quality
assurance program in manufacturing the sutures. (DE 8, Complaint ¶¶ 45(a)(d)). She does
not allege any facts that would show how Ethicon’s manufacturing processes or quality
assurance program were inadequate. These allegations are insufficient to support a claim
that Ethicon was negligent in manufacturing the sutures. This claim will be dismissed
As to the duty to recall or retrofit the sutures, Skinner alleges that Ethicon knew
of the sutures’ defect before she was treated with them and, thus, had a duty to recall
them. (DE 8, Complaint, ¶ 50.) As discussed, however, Skinner also alleges that Ethicon
did recall the sutures at issue. (DE 8, Complaint, ¶24.) Further, she does not mention this
claim in her response to the motion to dismiss. Thus, it is not clear that Skinner even
intends to allege that Ethicon negligently failed to recall the product. Regardless,
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Kentucky does not recognize a negligence claim based on a duty to recall or retrofit a
product. Ostendorf v. Clark Equip. Co., 122 S.W.3d 530, 533, 534 (Ky. 2003) (“Product
recalls, however, are properly the province of administrative agencies, as the federal
statutes that expressly delegate recall authority to various agencies suggest.”) (quoting
Schwartz, The Post-Sale Duty to Warn: Two Unfortunate Forks in the Road to a
Reasonable Doctrine, 58 N.Y.U.L. Rev. 892, 201 (Oct. 1983)); May for Estate of May v.
Ford Motor Company, No. 09-165-GFVT 2011 WL 13234171, at *3 n.2 (E.D. Ky. Jan.
24, 2011) To the extent that Skinner attempts to assert such a claim, it will be dismissed
As to the alleged breach of the duty to warn, Skinner alleges that Ethicon knew of
the dangers presented by the sutures but failed to provide adequate warnings. As
discussed, Skinner has adequately alleged that the sutures were defective because of a
manufacturing defect, that the defect caused injuries, and that she suffered the kinds of
injuries caused by the defect. Skinner has also adequately alleged that Ethicon knew
about the injuries but failed to warn about the dangers.
In Count IV of the complaint, Skinner asserts a negligence per se claim, asserting
that Ethicon violated several state and federal regulations. The common law concept of
negligence per se is codified in Kentucky statute KRS § 446.070. Davidson v. American
Freightways, Inc., 25 S.W.3d 94, 99 (Ky.2000). The statute provides that “[a] person
injured by the violation of any statute may recover from the offender such damages as he
sustained by reason of the violation, although a penalty or forfeiture is imposed for such
violation.” KRS § 446.070. Kentucky courts have held that the “any statute” language in
KRS § 446.070 is limited to Kentucky statutes and does not extend to federal statutes and
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regulations. T & M Jewelry, Inc. v. Hicks ex rel. Hicks, 189 S.W.3d 526, 530 (Ky.2006).
The legislature did not intend the statute “to embrace the whole of federal laws and the
laws of other states and thereby confer a private civil remedy for such a vast array of
violations.” T & M Jewelry, Inc., 189 S.W.3d at 530. “Violations of federal laws and
regulations and the law of other states do not create a cause of action based on KRS
446.070.” St. Luke Hosp., Inc. v. Straub, 354 S.W.3d 529, 534 (Ky.2011). Skinner does
not address this claim in her response to the motion to dismiss. Because this claim is
premised entirely on the alleged violation of federal statutes and regulations, it must be
With Counts V, VI, and VII of the complaint, Skinner asserts claims for breach of
express and implied warranty and for violation of the Kentucky Consumer Protection
Act, KRS 367.170, et seq. Ethicon argues all these claims must be dismissed because all
require privity of contract. This is correct. See Waterfill v. Nat'l Molding Corp., 215 F.
App'x 402, 405 (6th Cir. 2007) (stating that, under Kentucky law, “claims for breach of
express or implied warranties may proceed only where there is privity between the
parties.”); Compex Int'l Co., Ltd. V. Taylor, 209 S.W.3d 462, 464 (Ky. 2006) (“[P]rivity
remains a prerequisite for products liability claims based on warranty....”); Yonts v.
Easton Tech. Prod., Inc., 676 F. App'x 413, 420 (6th Cir. 2017) (stating that, under the
KCPA, “a subsequent purchaser may not maintain an action against a seller with whom
he did not deal.”); Davis v. Norton Healthcare, Inc., No. 2020-CA-0151-MR, 2021 WL
223528, at *4 (Ky. Ct. App. Jan. 22, 2021) (“Claims may only be brought under the
KCPA by individuals who personally purchase goods or services from a merchant. . . .”).
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In her response to the motion to dismiss, Skinner argues that there was privity of
contract between her and Ethicon because she was billed for the sutures. In the amended
complaint, however, she asserts that she purchased the sutures from her “medical
providers.” (DE 8, First Amended Complaint ¶ 66.) Privity of contract exists only
between the seller and its immediate purchasers. Waterfill, 215 F. App'x at 405; Skilcraft
Sheetmetal, Inc. v. Ky. Machinery, Inc., 836 S.W.2d 907, 909 (Ky. 1992) (stating the
KCPA “plainly contemplates an action by a purchaser against his immediate seller”).
Because Skinner has not alleged or even argued that such privity exists between her and
Ethicon, both breach of warranty claims and the KCPA claim must be dismissed with
Accordingly, the Court hereby ORDERS the motion to dismiss is GRANTED in
part and DENIED in part as follows:
the motion is GRANTED as to the strict-liability claim based on a design
defect and as to the negligence claim based on the duty to exercise
reasonable care in manufacturing. These claims are DISMISSED without
the motion is GRANTED as to the negligence claim based on a breach of
the duty to recall and the claims for negligence per se, breach of express
and implied warranties, and violation of the KCPA. These claims are
DISMISSED with prejudice; and
the motion is DENIED as to the strict liability claims based on a
manufacturing defect and a failure to warn and as to the claim for
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negligent failure to warn. These three claims are the sole claims
remaining in this action.
The Court does not interpret the First Amended Complaint to assert any claims
other than those addressed in this opinion.
Dated February 18, 2021
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