Diblasi v. Smith & Nephew, Inc. et al
ORDER: For the reasons in the attached ruling, Smith & Nephew's motion to dismiss 20 is granted in part and denied in part. Signed by Judge Michael P. Shea on 2/17/2021. (Constantine, A.)
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UNITED STATES DISTRICT COURT
DISTRICT OF CONNECTICUT
No. 3:20cv566 (MPS)
SMITH & NEPHEW, INC. and HEREAUS,
RULING ON MOTION TO DISMISS
Frank DiBlasi brings this product liability action under Conn. Gen. Statutes § 52-572m, et
seq. against Smith & Nephew, Inc. alleging that its artificial knee joint was defective, and against
Hereaus, Inc., a component supplier. Smith & Nephew moves to dismiss the complaint for failure
to state a claim under Fed. R. Civ. R. 12(b)(6).1 (ECF No. 20.) For the reasons that follow, the
motion is GRANTED IN PART and DENIED IN PART.
The following facts are drawn from DiBlasi's amended complaint, ECF No. 16, and are
accepted as true for the purpose of this motion.
Smith & Nephew is engaged in the manufacture, sale, and distribution of artificial knee
joints used in knee replacement procedures. ECF No. 16 at ¶ 3. Heraeus manufactures the cement
used with Smith & Nephew's knee joints. Id. at ¶ 5. In 2014, DiBlasi underwent total knee
replacement surgery in which a knee joint manufactured by Smith & Nephew was implanted. Id.
at ¶¶ 7 - 8. In 2018, DiBlasi noticed a prominent, firm object under the skin of his right knee
causing clicking and pain. Id. at ¶ 11. His surgeon determined that DiBlasi had a "loosening of
The Court also considered Smith & Nephew's prior brief, ECF No. 13, which the defendant
incorporates by reference, and its supplemental memorandum. ECF No. 21.
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his patella femoral component." Id. at ¶ 12. DiBlasi subsequently was diagnosed with "right knee
prosthetic MRSA infection of the right knee." Id. at ¶ 13. He underwent a total knee excision of
the infected implant, irrigation, and debridement, and revision with temporary prosthesis. Id. at
¶ 14. About a month later, he underwent a second total knee replacement, removing the temporary
prosthesis. Id. at ¶ 15.
Smith & Nephew advertises that its knee replacement implants last longer than other
similar devices. Id. at ¶ 19. Its knee replacement implants are made with oxidized zirconium
rather than cobalt or titanium, which are more commonly used in such replacement devices. 2 Id.
at ¶ 20. The FDA recalled thousands of Smith & Nephew defective knee joints.3 Id. at ¶ 25. After
the recall, Smith & Nephew continued to misrepresent the fitness of its knee joints and failed to
warn prospective end users. Id. at ¶ 26.
In deciding a motion to dismiss under Fed. R. Civ. P. 12(b)(6), the Court must determine
whether the plaintiff has alleged “enough facts to state a claim to relief that is plausible on its face.”
Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007). “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.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). The
Court accepts as true all of the complaint's factual allegations when evaluating a motion to dismiss,
id., and “must draw all reasonable inferences in favor of the non-moving party,” Vietnam Ass'n for
Smith & Nephew contests this allegation, asserting that "the only oxidized zirconium component
implanted in Plaintiff is the femoral component" and the complaint does not allege that that
particular component is defective. ECF No. 20 at 3. However, at this stage of proceedings, it is
not appropriate to contest the accuracy of the allegations.
The complaint provides no details about the recall and does not allege that the particular
prosthesis implanted in the plaintiff was recalled.
Case 3:20-cv-00566-MPS Document 31 Filed 02/17/21 Page 3 of 10
Victims of Agent Orange v. Dow Chem. Co., 517 F.3d 104, 115 (2d Cir. 2008). However,
“threadbare recitals of the elements of a cause of action, supported by mere conclusory statements,
do not suffice” to survive a motion to dismiss. Mastafa v. Chevron Corp., 770 F.3d 170, 177 (2d
The Connecticut Products Liability Act, Conn. Gen. Stat. § 52-572m, et seq., is the
"exclusive remedy for all product liability claims in Connecticut." Greco v. Broan-NuTone LLC,
No. 3:17cv953(SRU), 2020 WL 1044002, at *9 (D. Conn. Mar. 4, 2020). “The statute does not
abolish common law claims in product liability actions, but instead incorporates them into a single
count to simplify pleadings." Collazo v. Nutribullet, 473 F. Supp. 3d 49, 51 (D. Conn. 2020).
"[A]ny sub-claim brought under the CPLA, such as negligence, strict liability, or breach of
warranty, must sufficiently allege all elements that would be required at common law."
Philadelphia Indem. Ins. Co. v. Lennox Indus., Inc., No. 3:18cv217(CSH), 2020 WL 705263, at
*3 (D. Conn. Feb. 12, 2020).
Smith & Nephew argues that the complaint should be dismissed because DiBlasi fails to
allege sufficient factual allegations to support his claim that its product is defective. ECF No. 21
at 2 ("He does not plead any facts.")
"To state a claim based on strict liability, a plaintiff must plausibly allege that the product
designed, manufactured or sold by the defendant was defective and that the defect proximately
caused the plaintiff’s injuries." Philadelphia Indem. Ins. Co., 2020 WL 705263, at *3. “A product
may be defective due to a flaw in the manufacturing process, a design defect or because of
inadequate warnings or instructions." Id. Product liability claims, "whether alleging a design
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defect, manufacturing defect or failure to warn defect, are governed by the [following] elements .
. . : (1) the defendant was engaged in the business of selling the product; (2) the product was in a
defective condition unreasonably dangerous to the consumer or user; (3) the defect caused the
injury for which compensation was sought; (4) the defect existed at the time of the sale; and (5) the
product was expected to and did reach the consumer without substantial change in condition.”
Bifolck v. Philip Morris, Inc., 324 Conn. 402, 434 (2016). "Even under the liberal pleading
standards of Rule 8, a complaint generally must identify a specific problem with the design or
manufacturing of the subject products." Philadelphia Indem. Ins. Co. v. Lennox Indus., Inc., No.
3:18cv217(CSH), 2019 WL 1258918, at *4 (D. Conn. Mar. 18, 2019).
"[A] design defect claim is predicated on a product which is otherwise properly
manufactured, but is nonetheless unreasonably dangerous because its attributes can cause an
unexpected injury.” Leonard v. Gen. Motors LLC, No. 3:19cv1682(SRU), 2020 WL 7024906, at
*13 (D. Conn. Nov. 30, 2020) (citation and internal quotation marks omitted). "A product is
defectively designed if: (1) it failed to perform as safely as an ordinary consumer would expect
when used in a reasonably foreseeable manner (the “ordinary consumer expectations” test); or (2)
in the case of complex products, the risk of danger inherent in the design of the product outweighs
its utility (the “modified consumer expectations” test)." Moss v. Wyeth Inc., 872 F. Supp. 2d 162,
166 (D. Conn. 2012).
Smith & Nephew argues that DiBlasi fails to allege a design defect claim under either the
consumer expectations test or the risk utility test. ECF No. 21 at 2.
Admittedly, DiBlasi's pleading is sparse. But when the facts alleged are viewed in the light
most favorable to him, he alleges a specific defect - that the patellar component of the defendant's
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knee implant loosened, causing a visible bulge in his knee and pain, and necessitating the removal
of the prosthesis – from which the Court reasonably can infer that the prosthesis "failed to perform
as safely as an ordinary consumer would expect when used in a reasonably foreseeable manner."
Moss, 872 F. Supp. 2d at 166. This is sufficient to state a claim at this stage. See Leonard, 2020
WL 7024906, at *13 (plaintiff's allegations that the vehicle's airbags failed to deploy and the seat
belt failed to prevent him from hitting his head on the steering wheel upon impact "adequately
establish that the airbag and seat belt systems failed to perform as safely as a consumer ordinarily
would expect under the consumer expectation test," stating "a colorable design defect claim");
Mals v. Smith & Nephew, Inc., No. 3:19cv1770(VLB), 2020 WL 3270835, at *3 (D. Conn. June
17, 2020) (allegation that the “unicondylar poly insert failed causing an anterior translation of the
plastic prosthesis" sufficiently stated a plausible design defect claim). The motion to dismiss the
design defect claim is denied.
Failure to Warn
DiBlasi alleges that Smith & Nephew "failed to warn or instruct that the product in question
was dangerous . . . ." ECF No. 16 at 27(b).
“Strict liability applies to failure to warn claims where adequate warnings or instructions
were not provided and where the harm suffered would not have occurred had adequate warnings
been given.” Karazin v. Wright Med. Tech., Inc., No. 3:17cv823(JBA), 2018 WL 4398250, at *5
(D. Conn. Sept. 14, 2018).
Smith & Nephew argues that this claim fails because it is conclusory. ECF No. 13-1 at 910. I agree. The complaint alleges only that the defendant: "knew" its knee joints are "inferior"
but did not warn consumers, ECF No. 16 at ¶ 21; misrepresented the fitness of its knee joints and
failed to warn consumers, ECF No. 16 at ¶ 26; failed to warn Plaintiff that "the products were
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dangerous and subject to instanteous shattering,"4 ECF No. 16 at 27(b); and failed to "disclose …
the dangerous propensities of the product." ECF No. 16 at ¶ 27(e). These are all conclusory
assertions. There are no facts alleged as to any warnings Smith & Nephew did provide and how
there were allegedly deficient. See Leonard, 2020 WL 7024906, at *15 (failure to warn claim
insufficient where plaintiff "failed to offer any specific factual allegations concerning the warnings
he did receive and how they were deficient); Philadelphia Indem. Ins. Co., 2019 WL 1258918, at
*3 (failure to warn claim insufficient where plaintiff made only conclusory assertion that defendant
had failed to provide adequate and sufficient warnings regarding blower motor without alleging
whether the motor was accompanied by any warnings or instructions, without alleging the content
of any warnings, and without alleging why the content was inadequate). The motion to dismiss is
granted as to the failure to warn claim.
DiBlasi alleges that Smith & Nephew was negligent because it failed to properly test the
product; designed the product in a defective manner; knew or should have known of the product's
dangerous characteristics yet continued to manufacture it; and used improper materials in the
manufacture of the device. ECF No. 16 at ¶ 27(f).
"Under Connecticut law, the elements of a cause of action for negligence are duty, breach
of that duty, causation, and actual injury." Philadelphia Indem. Ins. Co., 2020 WL 705263, at *6.
See Lamontagne v. E.I. Du Pont de Nemours & Co., 834 F. Supp. 576, 592 (D. Conn. 1993) (the
requirements applicable to ordinary negligence actions “are also applicable to negligence claims
against product manufacturers” under Connecticut's Product Liability Act).
Smith & Nephew pointed out in its initial motion to dismiss that there are no allegations that the
prosthesis shattered. ECF No. 13-1 at 9. The allegation, however, remains in the amended
complaint that DiBlasi subsequently filed.
Case 3:20-cv-00566-MPS Document 31 Filed 02/17/21 Page 7 of 10
As to the claim that Smith & Nephew failed to properly test the prosthesis prior to
marketing it, ECF No. 16 at ¶ 27(f), the only allegations concerning testing are that the defendant
was not required to conduct clinical studies but only had to demonstrate that its device was
substantially similar to those already in the market and that the "product goes into a patient's knee
and is not properly tested." ECF No. 16 at ¶¶ 23 - 24. This is insufficient to state a claim. See
Iqbal, 556 U.S. at 678 (A "naked assertion" devoid of “further factual enhancement" is insufficient
to state a claim.)
DiBlasi's claims that Smith & Nephew negligently failed to properly design and/or properly
manufacture the prosthesis also fall short. "Unlike strict liability, which focuses on the product
itself and finds the manufacturer liable if the product is defective, negligence centers on the
manufacturer’s conduct." Philadelphia Indem. Ins. Co. v. Lennox, 3:18cv217(CSH), 2020 WL
705263, at *6 (D. Conn. Feb. 12, 2020)(internal quotation marks omitted). Although DiBlasi
alleges that Smith & Nephew used oxidized zirconium rather than cobalt or titanium, he stops short
of alleging how this rendered the prosthesis defective. DiBlasi has not alleged sufficient factual
support for an inference that the alleged defective condition of the prosthesis was caused by Smith
& Nephew's negligent acts or omissions.
Breach of Express Warranty
The complaint also asserts a breach of express warranty claim. ECF No. 16 at ¶ 27(h). "A
plaintiff asserting a claim for breach of express warranty must show: (1) existence of the warranty;
(2) breach of the warranty; and, (3) damages proximately caused by the breach.” Philadelphia
Indem. Ins. Co., 2020 WL 705263, at *7. “An express warranty is created when, among other
things, the seller makes [a]ny affirmation of fact or promise to the buyer which relates to the goods
and becomes part of the basis of the bargain.” Id. (quotation marks and citations omitted). Further,
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“[a]ny 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.” Id. (citations omitted).
DiBlasi alleges that Smith & Nephew breached "express warranties that the products were
safe and effective for [their] intended use." ECF No. 16 at ¶ 27(h). This is conclusory and
insufficient to state a plausible claim for breach of express warranty. See Leonard, 2020 WL
7024906, at *16 (plaintiff's allegation that defendants claimed that the car's airbag and seat belt
system “was safe and would operate and protect” him failed to a state a plausible claim for breach
of express warranty); Philadelphia Indem. Ins. Co., 2020 WL 705263, at *7 (allegation that
defendants “breach[ed] the express and/or implied warranties that the subject [furnace and blower
motor] would be free from defects, merchantable and safe to use for [their] general and intended
purposes” was not enough to state a breach of express warranty claim); Simoneau v. Stryker Corp.,
No. 3:13cv1200(JCH), 2014 WL 1289426, at *14 (D. Conn. Mar. 31, 2014) (dismissing breach of
express warranty claim where "[t]he underlying warranty of safety and effectiveness . . . is not
specifically pled, nor is the identity of the party to whom it was made as part of the basis of the
Implied Breach of Warranty of Merchantability
DiBlasi alleges that Smith & Nephew "breached an implied warranty of merchantability in
that said products were not of merchantable quality and for its intended purpose." ECF No. 16 at
To state a claim for breach of the implied warranty of merchantability, "a party must plead
that: 1) a merchant sold the goods; 2) the goods were defective and not merchantable at the time
of sale; 3) injury occurred to the buyer or his property; 4) the injury was caused by the merchant's
defective product; and 5) notice was given to the seller of the claimed breach." Ferry v. Mead
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Johnson & Co., LLC, No. 3:20cv99(SRU), 2021 WL 243119, at *17 (D. Conn. Jan. 25, 2021)
(citation omitted). DiBlasi's claim fails because he has not alleged that he ever notified Smith &
Nephew of the alleged defect. See Gallinari v. Kloth, 148 F. Supp. 3d 202, 215 (D. Conn. 2015)
(dismissing claim for breach of the implied warranty of merchantability when complaint did not
allege that the plaintiff “notified Defendants of any claimed defect in the [product at issue]”) (citing
DiBlasi asserts a claim of misrepresentation. ECF No. 16 at ¶ 27(d) ("The defendants
mispresented to Plaintiff and the general public that the products in questions were safe for use by
To state a claim for negligent misrepresentation, a plaintiff must establish "(1) that the
defendant made a misrepresentation of fact (2) that the defendant knew or should have known was
false, (3) that the plaintiff reasonably relied on the misrepresentation and thus (4) suffered
pecuniary harm." Ferry, 2021 WL 243119, at *18. Although "[c]ourts disagree about whether the
heightened pleading standard of Rule 9(b) applies to negligent misrepresentation claims[,]""courts
agree that when 'negligent misrepresentation is couched in fraud-like terms of known falsity,' the
heightened fraud pleading standard applies." Id. Here, the complaint alleges that Smith &
Nephew "knew" their knee joints were "inferior" and that some of its products had been subject to
a recall but continued to misrepresent the fitness of its knee joints. ECF No. 16 at ¶¶ 21, 25-26.
Because DiBlasi alleges that Smith & Nephew was aware that its representations were false, I
construe the claim to sound in fraud and subject to the heightened pleading standard of Rule 9(b).
It fails to meet this standard because the complaint does not allege any particular statements,
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identify a particular speaker, or state the particular time and place of the alleged
For these reasons, Smith & Nephew's motion to dismiss (ECF No. 20) is granted as to the
failure to warn, negligence, warranty, and misrepresentation claims and denied as to the strict
liability design defect claim.
IT IS SO ORDERED.
Michael P. Shea, U.S.D.J.
Dated: Hartford, Connecticut
February 17, 2021
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