United States District Court, E.D. Pennsylvania
GARY A. SMITH, TAMARA SMITH h/w, Plaintiffs,
HOWMEDICA OSTEONICS CORP. AND STRYKER CORPORATION, Defendants.
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
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.
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.”
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.
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)).
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.
Strict Liability - Count One
Existence of strict liability claim against medical device
manufacturers under Pennsylvania law
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 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. 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
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.
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, ...