Karazin v. Wright Medical Technology, Inc.

          RULING ON DEFENDANT'S MOTION TO DISMISS

          JANET BOND ARTERTON U.S.D.J

         Plaintiffs 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.

         I. Facts Alleged

         On 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).

         More 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.)

         Plaintiffs 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. ¶ 16.)

         Plaintiffs 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.)

         With 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.)

         More 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. ¶ 48(f).)

         Plaintiffs 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.)

         Finally, 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. ¶ 50.)

         II. Discussion

         A. Legal Standard

         "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.'" 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).

         For 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).

         B. Count One: Product Liability under CPLA

         All 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 ...