United States District Court, D. Connecticut
EDWARD R. KARAZIN and IRENE M. KARAZIN, Plaintiffs,
WRIGHT MEDICAL TECHNOLOGY, INC., Defendant.
RULING ON DEFENDANT'S MOTION TO DISMISS
BOND ARTERTON U.S.D.J
Edward R. Karazin and his wife Irene M. Karazin bring this
action against Defendant Wright Medical Technology, Inc.
("Wright") to recover damages allegedly suffered in
connection with the malfunction of a Profemur Z device
implanted in Mr. Karazin. Plaintiffs assert one product
liability claim with multiple theories pursuant to the
Connecticut Product Liability Act ("CPLA") (Count
One) and one loss of consortium claim (Count Two). Defendant
now moves to dismiss both counts pursuant to Fed.R.Civ.P.
12(b)(6) for failure to state a claim upon which relief can
be granted. (Def.'s Mot. to Dismiss [Doc # 39] at 1.) For
the reasons that follow, Defendant's Motion is granted in
part and denied in part.
March 30, 2005, Mr. Karazin underwent total hip replacement
surgery. (Am. Compl. [Doc. # 35] ¶ 13.) As part of that
total hip replacement, Mr. Karazin's doctor implanted an
artificial hip stem and neck known as the "Profemur
Z," designed, manufactured, marketed, sold, and
distributed by Defendant. (Id.) The hip stem and
neck-together constituting the Profemur Z- are two of five
separate components which comprise a total hip replacement.
(Id. ¶¶ 10, 13).
than ten years later, on October 28, 2015, the Profemur Z
device implanted in Mr. Karazin suffered a "catastrophic
failure and fracture" requiring removal of the fractured
Profemur Z and replacement with another hip prosthesis.
(Id. ¶¶ 20-23.) As a result, Mr. Karazin
suffered "serious injuries, some [or] all of which maybe
permanent." (Id. ¶ 47.)
allege that the Profemur Z device is "more prone to
component fracture ... than hip devices manufactured by other
companies" and that Defendant "knew or had reason
to know" of that increased likelihood of fracture
"at a time before the implantation and/or failure of Mr.
Karazin's Profemur Z device. (Id. ¶J 14,
17.) Plaintiffs further allege that, before the implantation
of the Profemur Z device in Mr. Karazin, Defendant had
"regular and frequent communications from and/or to
surgeons who had implanted the Profemur Z, including
plaintiffs surgeon, regarding failures, fractures, and
complications" with the device. (Id. ¶
19.) Plaintiffs also allege that on October 12, 2015,
approximately two weeks before Plaintiffs surgery to remove
the fractured Profemur Z, Defendant recalled "a
version" of its Profemur Z due to an "unexpected
rate of fractures after surgery." (Id. ¶
also allege that Defendant failed to comply with Federal Drug
Administration regulations regarding timely reporting of
issues with medical devices, including failures to timely
"report adverse events; . . . conduct failure
investigations and analyses; . . . report any and all
information concerning product failures and corrections; . .
. fully inform FDA of unanticipated adverse effects,
increases in the incidence of adverse effects, or device
failures necessitating a labeling, manufacturing, or device
modification; ... [and] conduct necessary design
validation." (Id. ¶¶ 26-33.)
regard to the specific Profemur Z device implanted in Mr.
Karazin, Plaintiffs generally allege that the device was sold
by Defendant in a "defective condition unreasonably
dangerous to the user or consumer," that "said
defective condition existed at the time of sale," and
that the device reached Mr. Karazin and his implanting
physician "without substantial change in
condition." (Id. ¶¶ 41-42.)
Plaintiffs additionally allege that the Profemur Z device
implanted in Mr. Karazin "was not reasonably safe as
intended to be used;... was not reasonably safe for users or
consumers; . . . had an inadequate design for the purposes of
hip replacement; . . . had manufacturing errors or defects
that made it prone to premature failure or fracture;...
contained unreasonably dangerous design defects;... was
insufficiently tested" and included a warning about
dangers posed to consumers which was "inadequate."
(Id. ¶ 48.)
specifically, Plaintiffs allege manufacturing defects
resulting from "size tolerances out of specification and
not within industry acceptable standards, or manufacturing
processes that modified the components in a manner which
increased the likelihood of component failure or
fracture." (Id. ¶ 48(e).) Plaintiffs'
alleged design defect is "an inherently unstable and
defective design, which resulted in an unreasonably high
probability of early failure." (Id. ¶
also allege that Defendant provided insufficient warnings and
labeling for the Profemur Z. These alleged labeling problems
include warnings that were "insufficient to alert... as
to the risk of adverse events and/or reactions";
"misleading warnings emphasizing the efficacy of the
Profemur Z while downplaying the risks associated with
it"; "insufficient and/or incorrect warnings to
alert consumers . . . regarding the risk, scope, duration,
and severity of the adverse reactions associated with the
Profemur Z"; "fail[ure] to provide the requisite
information to a surgeon of standard competence and
experience for the safe and effective use of the Profemur
Z"; failure to "disclose that [the Profemur Z] was
inadequately tested"; "fail[ure] to convey adequate
post-marketing warnings regarding the risk, severity, scope,
and/or duration of the dangers posed by the Profemur Z";
and failure to give consumers the instructions and
"information necessary to avoid or mitigate" the
dangers posed by the Profemur Z. (Id. ¶ 48.)
Plaintiffs allege that Defendant "negligently
misrepresented material facts regarding the Profemur Z's
safety, efficacy, and fitness for human use by claiming"
that the device (1) "was fit for its intended purpose
when, in fact, it was not;" (2) "had been
adequately and reliably tested when, in fact, it was
not;" (3) had a risk of "serious events and/or
effects ... comparable to that of other hip replacement
systems, when in fact it was not;" and (4) "had not
caused or contributed to serious adverse events and/or
effects requiring the premature explants of the device when,
in fact, it had." (Id. ¶
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.'"
Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting
Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570
(2007)). Plaintiff must "plead  factual content that
allows the court to draw the reasonable inference that the
defendant is liable for the misconduct alleged."
Id. Mere "labels and conclusions" or a
"formulaic recitation of the elements of a cause of
action" are insufficient. Twombly, 550 U.S. at
555; see also Fed. R. Civ. P. 12(b)(6). However, to
plead a plausible claim "a complaint does not need to
contain detailed or elaborate factual allegations."
Keiler v. Harlequin Enterprises Ltd., 751 F.3d 64,
70 (2d Cir. 2014).
some claims, the facts necessary to prove the plaintiffs
allegations are likely to be primarily or entirely within the
control of the defendant until the discovery phase of
litigation. Where, as here, "'much of the critical
information ... is kept confidential as a matter of federal
law'" due to medical device regulations and
"will, therefore, be unavailable to a plaintiff without
discovery," courts may consider that lack of access in
assessing the sufficiency of a plaintiffs complaint.
Simoneau v. Stryker Corp., 2014 WL 1289426 at *6 (D.
Conn. 2014) (quoting Bausch v. Stryker Corp., 630
F.3d 546, 560 (7th Cir. 2010)) (finding plaintiffs complaint
for medical device malfunction under the CPLA sufficiently
stated a claim for relief).
Count One: Product Liability under CPLA
Connecticut state law product liability claims must be
asserted under the CPLA, which displaces related common law
causes of action and provides for several theories of
liability, including both strict liability and negligence
theories. Conn. Gen. Stat § 52-572(m)-(n). Strict
liability claims under the CPLA can include theories of
manufacturing defect, design defect, or state law
"malfunction theory." Plaintiffs' complaint