McConologue v. Smith & Nephew, Inc.

• Decision Date: 24 March 2014
• Docket Number: Civil Action No. 3:13–CV–00880 VLB.
• Court: U.S. District Court — District of Connecticut
• Parties: JOHN McCONOLOGUE, Plaintiff, v. SMITH & NEPHEW, INC., Defendant.

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JOHN McCONOLOGUE, Plaintiff
v.
SMITH & NEPHEW, INC., Defendant.

Civil Action No. 3:13–CV–00880 VLB.

United States District Court, D. Connecticut.

Signed March 24, 2014.

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John–Henry McKim Steele, Dey Smith Steele, LLC, Milford, CT, for Plaintiff.

R. Cornelius Danaher, Jr., Thomas N. Lyons, Danaher Lagnese & Neal, P.C., Hartford, CT, for Defendant.

MEMORANDUM OF DECISION GRANTING IN PART AND DENYING IN PART DEFENDANT'S MOTION TO DISMISS [Dkt. 16]

VANESSA L. BRYANT, District Judge.

I. Introduction

The Plaintiff, John McConologue (“McConologue”), brings this action against Defendant Smith & Nephew, Inc. (“Smith & Nephew”) for injuries allegedly sustained as a result of the placement in Plaintiff's hip of the Defendant's allegedly defective medical device. The Plaintiff alleges one count sounding in products liability pursuant to Connecticut General Statute § 52–572m, encompassing the legal theories of strict liability in tort (itself encompassing design defect, manufacturing defect, failure to warn), negligence (also encompassing failure to warn), breach of express and implied warranty, and misrepresentation. The Defendant has moved to dismiss pursuant to Fed.R.Civ.P. 12(b)(6) for failure to state a claim upon which relief may be granted. For the reasons that follow, the Defendant's Motion to Dismiss is GRANTED in part and DENIED in part.

I. Factual Background

The following facts and allegations are taken from Plaintiff's complaint.

On or about March 22, 2010 John McConologue underwent a right total hip arthroplasty surgery, during which Dr. John M.

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Keggi implanted in McConologue's body an R3 Ceramic Ace Liner Biolox Forte, Ref. # 71338954, Lot # 09FT32751 (the “Liner” or “Ceramic Liner”), manufactured and marketed by Defendant Smith & Nephew. [Dkt. 1–1, Compl. ¶¶ 3, 4]. McConologue alleges that the Liner was expected to and did reach the Plaintiff without substantial change in condition from which it was manufactured and sold, and was not altered or modified in any way by McConologue or any third party from the condition in which it was manufactured, retailed, distributed, packaged and/or sold by Smith & Nephew. [Id. at ¶ 6].

Dr. Keggi notified McConologue by letter dated March 21, 2011 that Smith & Nephew was conducting a recall of the Liner that had been implanted in the Plaintiff. [Id. at ¶ 7]. A stated reason for the recall was that the Defendant failed to manufacture the Liner according to the U.S. Food and Drug Administration's (“FDA” ‘s) approved manufacturing process. [Id. at ¶ 8]. During the manufacturing process for several batches of R3 Ceramic Liners, including the Liner implanted in Mr. McConologue, titanium rings were pressed onto the ceramic component with a higher force than allowed by manufacturing specifications approved by the FDA, which had the potential to result in lower than expected strength for the liners. [Id. at ¶ 9]. Although the Liner implanted in the Plaintiff was subject to recall because it was manufactured outside of specifications, Dr. Keggi's letter indicated that “[t]he Smith & Nephew liners are expected to continue to function well and no change is recommended in your level of activity. No surgery is required to change the liner and Smith & Nephew has informed [Dr. Keggi] that the liner is expected to have the same durability as those not affected by the recall.” [Id. at ¶ 10].

About twenty-seven months after his hip surgery (and fifteen months after Dr. Keggi's letter), in June 2012, Mr. McConologue began to notice squeaking and pain in his right hip. [Id. at ¶ 11]. Dr. Keggi saw the Plaintiff approximately one month later in connection with this squeaking and pain. [Id. at ¶ 12]. A follow-up CT scan on the Plaintiff's right hip, which was ordered by Dr. Keggi and performed on August 17, 2012, indicated in an addendum to the report that the Ceramic Liner had fractured. [Id. at ¶ 13]. As a result of clinical findings from physical examinations of the Plaintiff, including findings that substantiated the pain, discomfort, and squeaking that McConologue reported, and the reported fracture to the Ceramic Liner reported in the addendum to the CT scan, McConologue underwent a total right hip arthroplasty revision surgery on September 11, 2012, performed by Dr. Keggi. [Id. at ¶ 14]. This revision surgery confirmed that the Liner was fractured. [Id. at ¶ 15].

The Plaintiff alleges that Smith & Nephew's conduct in manufacturing the Liner in violation of the FDA approved process makes the Defendant liable in products liability pursuant to Conn. Gen.Stat. § 52–572m in the following ways:

a. The Liner was in a defective and unreasonably dangerous condition, was inherently unsafe, was inherently unreliable, and could not be used without subjecting the plaintiff to an unreasonable risk of injury;

b. The defendant failed to properly or adequately warn, disclose or instruct the plaintiff that the product was defective prior to implantation;

c. The defendant misrepresented to the plaintiff and third parties that the Liner was safe for use;

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d. The defendant failed to disclose to the plaintiff and third parties that the Liner was defective and unreasonably dangerous;

e. The defendant was negligent:

(i) in failing to properly and adequately test the Liner prior to marketing it;

(ii) in designing, building and packaging the Liner in a defective manner;

(iii) in that the defendant knew or should have known that the liners, including the Liner implanted in the plaintiff, were being manufactured in violation of FDA approved manufacturing specifications, yet continued their manufacture and distribution;

(iv) in failing to perform a proper study to evaluate whether the press settings that were being used to press the titanium rings onto the Liner were appropriate;

f. The defendant breached an implied warranty of merchantability in that the Liner was not of merchantable quality and fit for its intended purpose;

g. The defendant breached its express warranty that the Liner was safe and effective for its intended use;

h. The defendant failed to employ adequate techniques in manufacturing, assembling, labeling, testing, inspecting and marketing the Liner.

Dkt. 1–1, Compl. ¶ 16].

III. Standard of Review

“ ‘To survive a 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.’ ” Sarmiento v. U.S., 678 F.3d 147 (2d Cir.2012) (quoting Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009) ). While Rule 8 does not require detailed factual allegations, “[a] pleading that offers ‘labels and conclusions' or ‘formulaic recitation of the elements of a cause of action will not do.’ Nor does a complaint suffice if it tenders ‘naked assertion[s]’ devoid of ‘further factual enhancement.’ ” Iqbal, 556 U.S. at 678, 129 S.Ct. 1937 (citations and internal quotations omitted). “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 Bell Atl. Corp. v. Twombly, 550 U.S. 544, 557, 127 S.Ct. 1955, 167 L.Ed.2d 929 (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.” Id. (internal citations omitted).

In considering a motion to dismiss for failure to state a claim, the Court should follow a “two-pronged approach” to evaluate the sufficiency of the complaint. Hayden v. Paterson, 594 F.3d 150, 161 (2d Cir.2010). “A court ‘can choose to begin by identifying pleadings that, because they are no more than conclusions, are not entitled to the assumption of truth.’ ” Id. (quoting Iqbal, 556 U.S. at 679, 129 S.Ct. 1937 ). “At the second step, a court should determine whether the ‘well-pleaded factual allegations,’ assumed to be true, ‘plausibly give rise to an entitlement to relief.’ ” Id. (quoting Iqbal, 556 U.S. at 679, 129 S.Ct. 1937 ). “The plausibility standard is not akin to a probability requirement, but it asks for more than a sheer possibility that a defendant has acted unlawfully.” Iqbal, 556 U.S. at 678, 129 S.Ct. 1937 (internal quotations omitted).

In general, the Court's review on a motion to dismiss pursuant to Rule 12(b)(6) “is limited to the facts as asserted within the four corners of the complaint, the documents attached to the complaint as exhibits, and any documents incorporated in the complaint by reference.” McCarthy v.

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Dun & Bradstreet Corp., 482 F.3d 184, 191 (2d Cir.2007). The Court may also consider “matters of which judicial notice may be...