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Smith v. Howmedica Osteonics Corporation

United States District Court, E.D. Pennsylvania

April 27, 2017

GARY A. SMITH, TAMARA SMITH h/w, Plaintiffs,
v.
HOWMEDICA OSTEONICS CORP. AND STRYKER CORPORATION, Defendants.

          MEMORANDUM OPINION

          Wendy Beetlestone, J.

         In this products liability action, Gary Smith and his wife Tamara Smith (“Plaintiffs”) bring strict liability, negligence, breach of implied warranty and loss of consortium claims under Pennsylvania law following the surgical implantation of the Stryker Gamma 3 Nail System into Mr. Smith's left hip and leg. Howmedica Osteonics Corp. and Stryker Corporation (“Defendants”) move to dismiss the Complaint in its entirety for failure to state a claim pursuant to Rule 12(b)(6) of the Federal Rules of Civil Procedure. The motion will be granted in part and denied in part.

         I. Background

         On March 2, 2015, Mr. Smith underwent a surgical procedure performed by Dr. Ernest E. Cope, III, at Grand View Hospital in Bucks County to implant the Stryker Gamma 3 Nail System. Defendants “designed, manufactured, assembled, distributed and sold” the prosthetic implant system, including the product used in Mr. Smith's procedure.

         Mr. Smith's recovery did not go well. Although, on May 15, 2015, x-ray images “revealed a healed intertrochanteric fracture with good position of the Stryker gamma nail, ” on September 30, 2015, Plaintiff “reported pain in the region of the lag screw.” X-ray images taken that day showed “sclerosis . . . compatible with healing, ” but also “revealed a broken Stryker gamma nail.” Subsequent CT scans on October 6, 2015 and January 11, 2016 appeared to show that the fracture had healed, and that the implant was in the proper position. However, a later “addendum” to the January 11, 2016 scan indicated that there was “minimal healing at the fracture site with a now chronic ununited fracture.” On March 30, 2016, Dr. Paul L. Weidner informed Plaintiff that “the fracture had gone on to nonunion, ” and that the implanted device had “broken” or suffered a “mechanical complication.” As a result, on April 26, 2016, Mr. Smith was then required to undergo a “left total hip replacement . . . after which [he] developed an infection requiring further treatment and medical consequences.”

         Mr. Smith alleges various physical and economic injuries stemming from the failed implantation of the Stryker Gamma 3 Nail System and subsequent total hip replacement, and Ms. Smith alleges that due to these injuries, she was deprived of the consortium of her spouse.

         II. 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)). “In light of Twombly, ‘it is no longer sufficient to allege mere elements of a cause of action; instead a complaint must allege facts suggestive of [the proscribed] conduct.'” Great W. Mining & Mineral Co. v. Fox Rothschild LLP, 615 F.3d 159, 177 (3d Cir. 2010) (quoting Phillips v. County of Allegheny, 515 F.3d 224, 233 (3d Cir. 2008)).

         III. Discussion

         Defendants contend that Pennsylvania does not recognize strict liability or breach of implied warranty claims against manufacturers of prescription medical devices like the Stryker Gamma 3 Nail System. Additionally, they argue that Plaintiffs have failed to allege facts sufficient to support their strict liability, negligence, and breach of implied warranty claims. Noting that Ms. Smith's loss of consortium claim is purely derivative of her husband's tort claims, Defendants seek to dismiss it as well.

         A. Strict Liability - Count One

         1. Existence of strict liability claim against medical device manufacturers under Pennsylvania law

         To determine whether Pennsylvania law categorically exempts prescription medical devices, like the Stryker Gamma 3 Nail System, from all strict liability claims, it is necessary to begin with Pennsylvania's general approach to strict products liability.

         In products liability cases, Pennsylvania follows the formulation of strict liability set out in Section 402A of the Restatement (Second) of Torts. Webb v. Zern, 220 A.2d 853, 854 (Pa. 1966) (adopting the language of Section 402A as the law of the Commonwealth); see also Tincher v. Omega Flex, Inc., 104 A.3d 328, 394-99 (Pa. 2014) (overruling Azzarello v. Black Bros. Co., 391 A.2d 1020 (Pa. 1978), and declining to adopt the formulation of strict products liability set out in the Restatement (Third) of Torts). Strict liability under Section 402A allows a plaintiff to recover where their injury was caused by a product in “a defective condition unreasonably dangerous to the user or consumer.” Phillips v. A-Best Prod. Co., 665 A.2d 1167, 1170-71 (Pa. 1995). A defective condition may be established by proving either a manufacturing defect, a design defect, or a failure-to-warn defect.[1] Id. In this case, Count One is styled as a strict liability claim asserting both a design defect and a manufacturing defect, but not a failure-to-warn defect.

         At issue is Comment k to Section 402A, which creates an exception to the general rule of strict liability for “[u]navoidably unsafe products” to the extent that “[s]uch a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous.” Restatement (Second) of Torts, § 402A cmt. k. Where Comment k applies, its plain language bars strict liability claims that assert a design defect. Incollingo v. Ewing, 282 A.2d 206, 219 (Pa. 1971) (observing that Pennsylvania does not impose strict liability on prescription drugs “merely because of dangerous propensities of the product”); see also Baldino v. Castagna, 478 A.2d 807, 810 (Pa. 1984) (“In Incollingo we held that, assuming proper preparation and warning, a manufacturer of drugs is not strictly liable for unfortunate consequences attending the use of otherwise useful and desirable products which are attended with a known but apparently reasonable risk.”). As to the threshold question of whether the Stryker Gamma 3 Nail System is unavoidably unsafe, Plaintiffs do not dispute that it is, and so Comment k applies. See Opp'n at 4-6. Therefore, Defendants' motion to dismiss Plaintiffs' strict liability claim will be granted to the extent that it asserts a design defect.

         The issue that is actually disputed is whether Pennsylvania's interpretation of Comment k also forecloses Plaintiffs' strict liability claim insofar as it asserts a manufacturing defect. Comment k protection is explicitly conditioned on the product being “properly prepared, ” and “accompanied by proper directions and warning.” Restatement (Second) of Torts, § 402A cmt. k. On its face, this language might seem to preserve strict liability claims asserting a manufacturing defect and a failure-to-warn defect, even where Comment k applies. However, with respect to the “proper directions and warning” language, the Pennsylvania Supreme Court has interpreted it to limit recovery for failure-to-warn in Comment k cases to negligence. Hahn v. Richter, 673 A.2d 888, 889-91 (Pa. 1996) (“[W]here the adequacy of warnings associated with prescription drugs is at issue, the failure of the manufacturer to exercise reasonable care to warn of dangers, i.e., the manufacturer's negligence, ...


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